management of qillatul laban (inadequacy of lactation

Management of Qillatul Laban (Inadequacy of Lactation)

with a Unani Drug

by

Manjula S

Dissertation Submitted to the Rajiv Gandhi University of Health Sciences, Karnataka, Bangalore

in partial fulfillment of the requirements for the degree of

Mahire Jarahat (MS Unani)

in

Ilmul Qabalat wa Amraze Niswan (Obstetrics and Gynaecology)

Under the guidance of Dr. Arshiya Sultana

Dept. of Ilmul Qabalat wa Amraze Niswan National Institute of Unani Medicine

Bangalore

2012

ii

Rajiv Gandhi University of Health Sciences, Karnataka

DECLARATION BY THE CANDIDATE I hereby declare that this dissertation entitled “Management of Qillatul Laban

(Inadequacy of Lactation) with a Unani Drug” is a bonafide and genuine research

work carried out by me under the guidance of Dr. Arshiya Sultana, Lecturer,

Department of Ilmul Qabalat wa Amraze Niswan, National Institute of Unani

Medicine, Bangalore.

Date: Place: Bangalore Manjula S

iii

National Institute of Unani Medicine (Dept. of AYUSH, Ministry of Health & Family Welfare, Govt. of India)

Kottigepalya, Magadi Main Road, Bangalore-91

CERTIFICATE BY THE GUIDE

This is to certify that the dissertation entitled “Management of Qillatul Laban

(Inadequacy of Lactation) with a Unani Drug” is a bonafide research work done by

Manjula S in partial fulfillment of the requirement for the degree of Mahire Jarahat

(MS Unani) in Dept. of Ilmul Qabalat wa Amraze Niswan.

Date: Dr. Arshiya Sultana Place: Bangalore Lecturer

Dept. of Ilmul Qabalat wa Amraze Niswan, Bangalore

iv

National Institute of Unani Medicine (Dept. of AYUSH, Ministry of Health & Family Welfare, Govt. of India)

Kottigepalya, Magadi Main Road, Bangalore-91

ENDORSEMENT BY THE HOD/HEAD OF THE INSTITUTION

This is to certify that the dissertation entitled “Management of Qillatul Laban

(Inadequacy of Lactation) with a Unani Drug” is a bonafide research work done by

Manjula S under the guidance of Dr. Arshiya Sultana, Lecturer, Department of

Ilmul Qabalat wa Amraze Niswan, National Institute of Unani Medicine,

Bangalore.

Prof. Mansoor Ahmad Siddiqui Prof. M. A. Jafri I/C HOD Director Dept. of Ilmul Qabalat wa Amraze Niswan NIUM, Bangalore NIUM, Bangalore

Date: Date: Place: Bangalore Place: Bangalore

v

COPYRIGHT

Declaration by the Candidate I hereby declare that the Rajiv Gandhi University of Health Sciences, Karnataka shall

have the rights to preserve, use and disseminate this dissertation in print or electronic

format for academic/research purpose.

Date: Place: Bangalore Manjula S Signature of the Candidate © Rajiv Gandhi University of Health Sciences, Karnataka

DEDICATED

TO

MY HUSBAND

&

CHILDREN

vi

ACKNOWLEDGEMENT

First of all, I am thankful to God for giving me an opportunity to work in the

Field of research institute where poor people needs help from doctors. Hence, my

dream has come true to help patients in all aspects and I have tried my level best

in carrying out my research work honestly.

I express my deep sense of gratitude and sincere thanks to Prof. M. A. Jafri,

Director, National Institute of Unani Medicine, Bangalore, who provided

favorable environment for my research work and posted me in PHC’s for this

clinical study.

The writing of this dissertation was very challenging to me. I sincerely thank to

my in-charge HOD, Prof. Mansoor Ahmad Siddiqui for his valuable guidance

suggestions and in time proper decision regarding the selection of guide.

I Heart fully express my love, affection, respect and gratitude to my guide Dr.

Arshiya Sultana, Lecturer, when I really had tough time in my research work, she

was always very co-operative, encouraging and motivated me in bringing patients

from PHC. She had lot of confidence and faith in me. When I met with accident

she supported me lot. Without her help I wouldn’t have completed my dissertation

in time. Once again, I express my sincere thanks to my guide. I was very

comfortable in working with her throughout my dissertation.

I am highly thankful and pay my regards to my previous guide, Dr. Umraz

Mubeen, ex-HOD, Dept. of Ilmul Qabalat wa Amraze Niswan, for her time to

vii

time help, valuable suggestions, and co-operation showed throughout my research

work.

I am indebted to Dr. Wajeeha Begum, Reader for her academic support. I also

thank Dr. Ismath Shameem, Lecturer for having special concern, respect, caring

towards in-service candidates. I sincerely thank Dr. Ghulamuddin Sofi, Reader,

Dept. of Ilmul Advia, for his encouragement and support in research. I would like

to thank the teaching faculty of all the departments.

My humble regards to Dr. B. N. Renuka, Pathologist and Mrs Sanjeeda

Tabassum, Biochemist and all the lab staff. I sincerely extend my gratitude’s to

Dr. Nafis Khan, Chief pharmacist and Dr. Fazil, senior pharmacist and staff of

NIUM pharmacy for their sincere help.

I am deeply thankful to NIUM library staff Mr. Ehtesham, Danish Ghani and

Mudasir who never expressed signs of exhaustion in providing me literature.

I owe regards to my colleagues in GUMC Bangalore who had helped me lot during

my PG course.

I am also thankful to the Prof. Thimmappa District Health Officer old Madras

Road, Bangalore for having provided me an excellent base for me to undertake my

research work in PHCs of his jurisdiction.

I sincerely thankful to Dr. Chandrakala, Medical officers of PHC Heganahalli,

Dr. Shoba Medical Officer of PHC, Kamakshipalya and nursing staff for their

extensive help and cooperation.

viii

I would like to thank my friends Ruqaiya, Fazeena, Ghazia, Wajeeda and my

classmate Fathima Banu for helping me in MS course. I express my regards to

juniors Padmaja, Geetha, Farzana, Hina, Rumeza, Atiya, Tabassum, Lubna,

Fouzia and Masuma.

I sincerely express my regards to Abdur Rashid, Nadeem, Mohamad Ali, Abdal,

Basavraj Bagli for their curriculum support.

I am thankful to OPD attainders, Miss Firdous and Ms. Shivamma for full co

operation.

Above all I am really thankful to my Husband Mr. Prasad H. P. for his love,

caring attitude, and moral support for completing my Dissertation and my

children Ishita and Samyuk for cooperation and patience showed during my

research work.

Last but not least, I would to thank Department of AYUSH for deputing me to

pursue the MS Course in NIUM.

Date : MANJULA S

Place : Bangalore

ix

LIST OF ABBREVIATIONS

AAP - American Academy of Pediatrics

AHRQ - Alliance for Health Care Research and Quality

AIDS - Acquired Immuno Deficiency Syndrome

ARI - Acute Respiration Infection

B C - Before Christ

BFHI - Baby Friendly Hospital Initiative

Ch - Chapter

CMV - Cytomegalovirus

e.g. - Example

et al - et alia

FIL - Feedback Inhibition of Lactation

GH - Growth Hormone

GIT - Gastro Intestinal Tract

HIV - Human Immuno Deficiency Virus

IBFAN - International Baby Food Action Network

IDDM - Insulin Dependent Diabetes Mellitus

IGF - Insulin like Growth Factor

MMI - Mother Milk Insufficiency

NIUM - National Institute of Unani Medicine

P - Probability

x

PHC - Primary Health Centre

PIM - Perceived Insufficiency of Milk

PTH - Parathyroid Hormone

SD - Standard Deviation

SPSS - Statistical Package for the Social Sciences

TB - Tuberculosis

TRH - Thyrotropin Releasing Hormone

UNICEF - United Nations International Children's Emergency

Fund

W.H.O - World Health Organisation

xi

ABSTRACT

Background and Objective: The incidence of qillatul laban (inadequacy of

lactation) has been estimated to range from 23 to 63% during the first 4 months after

delivery. In Unani system of medicine, mudirre laban (galactagogue) drugs are in

use to increase the mother’s milk production in qillatul laban. Hence, an effort was

made to evaluate the efficacy of maghze tukhme pambadana (Gossypium herbaceum

L.) in qillatul laban.

Methods: A single-blind placebo-controlled randomized clinical trial was conducted

in the Institute’s Hospital from December 2010 to April 2012. In the test group

(n=30), maghze tukhme pambadana 10 g (powder filled in the capsules) was

administered orally in three divided doses for one month. In the placebo group

(n=15), wheat flour was administered same as that of test drug. The primary

outcomes measures (objective parameters) were reduction in volume of

supplementary feeds, and weight gain of the baby. The secondary outcomes

measures (subjective parameters) were improvement in subjective satisfaction of the

mothers regarding the well being and happiness of babies, feeling fullness in the

breast, contra lateral ejection of the milk, and mother’s observation in increase of

breast milk. These parameters were rated on a graded scale ranging from 1 to 5 (1

denoting unsatisfactory and 5 representing highly satisfactory). The results were

analysed and compared statistically by using Student’s t test, Chi-square or Fisher

exact test to find the significance (P<0.05) of the study parameters.

Results: The mean volume of supplementary feeds to the infant in the test group was

significantly reduced to 40±75.88 ml after treatment when compared with baseline of

the test group, 291.66±70.50 ml (P < 0.001) and placebo, 226.66±149.84 ml (P <

0.008) at completion of the trial. Comparison showed that the subjective parameters

of the test group were statistically more significant compared to the placebo group.

Interpretation and Conclusion:

The efficacy of test drug was comparable with that of placebo. It was found to be

effective, safe and cost effective in lactating mothers with qillatul laban.

Keywords: Inadequacy of lactation; galactagogues; Gossypium herbaceum L;

Randomised placebo-controlled trial

xii

TABLE OF CONTENTS

S. No.

Contents

Page No.

1 Introduction

1

2 Objectives 5

3 Review of Literature 6

4 Methodology 87

5 Results

95

6 Discussion 107

7 Conclusion 116

8 Summary

117

9 Bibliography

121

10 Annexure

142

xiii

LIST OF TABLES

S. No. Tables Page No.

1. Baseline Characteristics and Investigations of Mothers 99

2. Socioeconomic Characteristics 100

3. Baseline Characteristics of Infant 101

4. Distribution of Patients According to Mizaj 102

5. Obstetrics and Contraceptive History 103

6. Response of the Test Drug in Mothers with Qillatul Laban

104

7. Efficacy of Pambadana on Primary Outcomes 105

8. Efficacy of Pambadana on Secondary Outcomes 116

xiv

LIST OF FIGURES

S. No. Figures Page No.

1 Milk Ejection Reflex 12

2 Cause of Lactation Inadequacy 75

3 (a): Cotton seeds; (b): Cotton Plant 86

4 Flow Chart of Participants 98

5 Distribution of Patients According to Mizaj 102

6 Response of the Test Drug in Mothers with Qillatul Laban

104

7 Efficacy of Pambadana on Primary Outcomes 105

introduction

Introduction

1

Breast milk is very important for neonates. According to a WHO/UNICEF,

more than one million infants worldwide die every year because they are not breastfed

or given other foods too early.1 Millions more live in poor health, contract preventable

diseases, and battle malnutrition. Although the magnitude of this death and disease is

far greater in the developing world, thousands of infants in the United States suffer

the ill effects of an infant formula-feeding culture. Babies who are not breastfed, or

who are fed other foods too early may have an increased risk of obesity, diarrhoea, GI

problems, respiratory and ear infections,2 urinary tract infection, bacterial meningitis,

botulism, necrotizing enterocolitis 3 and allergic skin disorders.2 A non breastfed

infant are fourteen times more likely to die due to diarrhoea, three times more likely

to die of respiratory infection, and twice as likely to die of other infections than an

exclusively breast fed child.3 India is facing a grave challenge of having very high

rates of child under nutrition and a high infant and child mortality, which demands an

urgent need for comprehensive multi-pronged evidence based strategy to tackle the

situation.4 More than 2.4 million child deaths occur in India each year; two-thirds of

these are related to inappropriate infant feeding practices. Child-survival data (Lancet

2003) recommends promotion of exclusive breastfeeding in the first six month as the

single most effective intervention to reduce mortality by 13-15% below 5 years of

age. 3

Evidence based interventions, which include initiation of breastfeeding within

one hour of birth, exclusive breastfeeding for the first six months of life and

introduction of appropriate and adequate complementary food at 6-9 month of age,

prevent under nutrition in children and improve child survival.4 On 18th May 2001,

World Health Organisation endorsed exclusive breast-feeding till an infant is 6

Introduction

2

months of age.5 It is the recommended method of infant feeding worldwide6,7 and is

widely believed to be the most beneficial method of feeding for the health and well-

being of most infants.2, 5,8 Because of its nutritional superiority over animal milk

makes it more advantageous, especially in a developing country like India.8

A recent WHO/UNICEF publication expresses current thinking on this subject

as follows: Breast-feeding is an integral part of the reproductive process, the natural

and ideal way of feeding the infant, and a unique biological and emotional basis for

child development. This, together with its other important effects on the prevention of

infections, on the health and well-being of the mother, child spacing, family health,

family and national economics, and food production, makes it a key aspect of self-

reliance, primary health care and current development approaches. It is therefore a

responsibility of society to promote breast feeding and to protect pregnant and

lactating mothers from any influence that could disrupt it.9, 10

Breast feeding is instinctive and most mothers adapt to it naturally.10 The

value of breast milk in developing countries like India cannot be neglected.11

However, at the slightest problem encountered, mothers switch readily over to

top/supplementary feeding.10 Mother often feels that they have insufficient milk,11 and

faces numerous physical, emotional and logistical obstacles to breastfeeding and even

small anxieties about milk supply can lead to lactation failure.12 Failing to receive the

crucial breastfeeding support will also leads to lactation failure.11 Moreover, it is an

established fact that poor nutrition of the mother can lead to poor growth and

development of the foetus, and to an insufficient quantity of milk.9

Perceived insufficient milk (PIM) is one of the reasons mentioned most often

by women throughout the world for the early discontinuation of breast feeding and/or

Introduction

3

for the introduction of supplementary bottles.5, 13, 14 The incidence of PIM has been

estimated to range from 23 to 63% during the first 4 months after delivery.13 Its

pathogenesis still remains an enigma.

Unani Scholars discussed that qillatul laban (lactation inadequacy) is mainly

caused by awarizate nafsaniya, sue mizaj saada or maddi of badan or pistan,15- 18

excessive heamorrhage caused by fasd or puerperal or menstrual blood loss or

suffering from chronic diseases etc.17-19

It is not clear how many women genuinely have an inadequate supply of milk

however; it would be an advantage if some means exist to increase milk production

temporarily.20 Hence, galactagogues are used to increase milk production.

Galactagogues (or lactogogues) are medications or substances believed to assist

initiation, maintenance or augmentation of maternal milk production. Common

indications for galactagogues are adoptive nursing (induction of lactation in a woman

who was not pregnant with the current child), relactation (reestablishing milk supply

after weaning), and increasing a faltering milk supply because of maternal or infant’s

illness or separation.21, 22 Although certain medicines like metoclopramide and

domperidone are being used for augmenting lactation but are seldom recommended in

view of their limited efficacy prospects and major safety concern. Thus, there has

been no effective western medical treatment for the illness so far.23 However, from

earliest times of mankind a multitude of plant galactagogues has been used in the folk

medicine of all human cultures.24 In Unani system of medicine, mudirre laban

(galactagogue) drugs such as pambadana, satawar, zeera safaid, tudri, hulba, kalonji

etc are in use to increase lactation in qillatul laban.

The effect of mudirre laban drugs such as saunf (Foeniculum vulgare Mill), 25

zeera safaid (Cuminum cyminum Linn.) satawar (Asparagus racemosus Willd.),26, 27

Introduction

4

hulba (Trigonella foenum-graecum Linn.) etc28, 29 have been previously studied for

galactagogue activity. Yet, the test drug, maghze tukhme pambadana (Gossypium

herbaceum Linn) was not studied clinically for its galactagogue activity, though it has

been mentioned in classical Unani text and is in frequent use. Hence, an effort was

made to evaluate the efficacy of maghze tukhme pambadana in the management of

qillatul laban as it has moallide sheer,30, 31 muqawwie bah,32 musmmine badan,30

moallide mani etc properties. Moreover, the mizaj of the test drug is har wa ratab.17

This study was a prospective, single-blind simple randomised placebo

controlled, pre and post evaluation trial conducted on 45 lactating mothers with

qillatul laban. The research question was whether maghze tukhme pambadana is

effective in qillatul laban (inadequate lactation). The hypothesis of this study was that

the use of maghze tukhme pambadana in the test group compared with placebo group

would at one month, from the baseline to be effective in lactogenesis. Lactating

mothers were randomly allocated either to the test (n= 30) or control (n=15) group. In

the test group, 10 g powder (filled in capsules) of maghze tukhme pambadana with

125 ml milk was given orally in three divided doses for one month. The primary

outcomes (objective parameters) measured in the study were total elimination or

significant reduction in volume of supplementary feeds, and weight gain of the baby.

The secondary outcomes (subjective parameters) measured during the study were

improvement in subjective satisfaction of mothers regarding the well being and

happiness of babies, feeling fullness in the breast, contra lateral ejection of the milk,

and mother’s observation in increase of milk. These parameters were rated on a

graded scale ranging from 1 to 5 (1 denoting unsatisfactory and 5 representing highly

satisfactory). The data was analysed before and after the treatment. The findings were

statistically interpreted by Student’s ‘t’ test and Chi square/Fisher exact test. The level

of significance was 5% with 95% confidence interval to find the significant features.

Objectives

Objectives of the study

5

Objectives

To assess the efficacy of maghze tukhme pambadana in the management

of qillatul laban.

To observe weight gain of the baby.

Review of literature

Review of Literature

6

General Description

The mammary (mamma breast) glands are modified sudoriferous (sweat)

glands that produce milk.33 In female, breasts lie on the upper chest wall, the upper

edges at the level of the second or third rib and the lower edge at level of the sixth rib.

Medially, they extend to the edge of the sternum and laterally to the anterior axillary

line, although the tail may extend further in to the axilla. The breasts vary greatly in

size from individual to individual. It is not unusual for one breast to be slightly larger

than the other and the counter of the breasts to vary. 34

The breasts consists of three major components; the skin, the subcutaneous

adipose tissue and functional glandular tissue which comprises both parenchyma and

stroma. The nipple areolar complex, which is centrally placed, contains abundant

sensory nerves and sebaceous and apocrine glands, but no follicles except at the very

periphery. Morgagni’s tubercles located in the areola are elevations formed by the

opening of the ducts of Montgomery’s glands. These are of sebaceous type. At the tip

of the nipple are the openings of the collecting ducts through which the infant obtains

milk at suckling. Immediately, beneath the nipple the collecting ducts dilate to form

the lactiferous sinuses which are surrounded by intertwining fascicles of smooth

muscles continuous with the musculature of the nipple. Deep to this, the breast is

divided into 15–25 lobes, each based on a branching duct system leading from the

collecting duct via segmental and subsegmental ducts to the terminal duct-lobular

units, which are the functional site of milk production. Each duct drains a lobe made

up of 20-40 lobules. The main bulk of each lobe is made up of adipose tissue and

fibrous stroma, the so-called inter- or peri-lobular connective tissue. The superficial

pectoral fascia envelops the breast, which lies on the deep pectoral fascia; fibrous


7

bands connect these two layers (coopers suspensory ligments), providing a degree of

support to the breast. It is probable that increasing laxity of these ligaments with age

and parity is responsible for the pendulous shape of the breast in older women. 33, 34

In the nipple, the stratified squamous epithelium of the surface extends for a

variable but short distance in to the collecting ducts. There is then a relatively abrupt

change to the glandular epitheliums, which is present throughout the duct and lobular

system. In keeping with its phylogenetic origin this epithelium is composed of two

distinct types of cell, the secretory or luminal cell and the myoepithelial cell. In the

collecting ducts the luminal cells are generally columnar whilst in the lobular acini

they are more usually cuboidal. Detailed microanatomical studies have shown that

there are two types of luminal secretory cell. Basal cells have relatively clear

cytoplasm and form microvilli, where they are in contact with the lumen; the nucleus

is oval and lacks a nucleolus. Superficial cells are darker with basophilic cytoplasm,

rich in ribosomes. They undergo intercellular dehiscence, with swelling of

mitochondria forming buds within the lumen. The myoepithelial cells form a layer

between the luminal secretory cells and basement membrane. 34

Function of the Mammary Glands

The function of the mammary glands is milk synthesis, secretion and ejection

which are associated with pregnancy and child birth and together are called lactation.

Milk production is stimulated largely by the hormone prolactin, with contribution

from progesterone and oestrogens. The ejection of milk occurs in the presence of

oxytocin, which is released from the posterior pituitary gland in response to the

sucking action of an infant on mother’s nipple. 33


8

Physiology of Lactogenesis

At puberty the milk ducts which lead from the nipple to the secretory alveoli

are stimulated by oestrogen to sprout, branch and form glandular tissue buds from

which milk secreting glands will develop.35 Lactation is the process of milk secretion,

and it occurs as long as milk is removed from the breast on a frequent basis. There are

five distinct stages of human mammary gland development: embryogenesis, puberty,

pregnancy, lactation, and involution. The first two stages lay the groundwork for

glandular growth; full development and maturation of the mammary epithelium await

the hormones of pregnancy. By mid-pregnancy, the mammary glands have developed

extensively and small amounts of secretion product are formed; however, the glands

continue to develop until parturition, with the secretory process being held in check

by the high circulating plasma concentrations of progesterone. The change that occurs

between pregnancy and lactation is called lactogenesis. 36

Lactogenesis is a two-stage event. Lactogenesis I occur during pregnancy and

is the initiation of the synthetic capacity of the mammary glands. Lactogenesis II

commences after delivery and is the initiation of plentiful milk secretion. Concurrent

with the increase in milk secretion associated with lactogenesis II are significant

changes in several milk constituents, termed “biomarkers of lactation,” as the

transition from colostrums (high concentration of total protein, immunoglobulins,

sodium, and chloride; low concentration of lactose, potassium, glucose, and citrate) to

mature milk (a reversal in concentration of these factors) takes place. These changes

in milk composition—coupled with a sudden feeling of breast fullness—identify the

onset of lactogenesis II, which usually occurs between 30 and 40 hours following the

birth of full-term infants.36


9

Lactation is influenced by a complex hormonal milieu including reproductive

hormones (estrogen, progesterone, placental lactogen, prolactin, and oxytocin) and

metabolic hormones (glucocorticoids, insulin, growth, and thyroid). The reproductive

hormones act directly on the mammary gland, whereas the metabolic hormones act

indirectly by altering endocrine response and nutrient flux to the mammary gland.

Ductal growth is primarily regulated by estrogen and growth hormone, and alveolar

development requires progesterone, prolactin, and possibly placental lactogen.

During pregnancy, the high levels of circulating progesterone inhibit the secretory

process of the mammary gland. Once the placenta is expelled after birth, progesterone

levels decline rapidly, and increasing prolactin levels trigger the beginning of

lactogenesis II, which is the onset of copious milk secretion.36

After that, lactogenesis phase 3, known as galactopoiesis, begins. This phase,

which lasts up to the end of lactation, is controlled by autocrine mechanisms and

basically depends on the emptying of the breast. Therefore, the quality and quantity of

suction by the infant now regulate the synthesis of maternal milk. With the suction

and transfer of the milk to the infant, the hypothalamus inhibits dopamine secretion

(prolactin inhibitory factor); this decrease in dopamine levels stimulates prolactin

secretion, which promotes milk secretion. The integrity of the hypothalamic-pituitary

axis, which regulates prolactin and oxytocin levels, is essential to trigger and maintain

breastmilk synthesis. 37

During lactogenesis, the synthesis of individual milk constituents increases

rapidly and shortly thereafter, the tight junctions between neighbouring secretory cells

become truly tight, preventing paracellular ionic flux. This explains why colostrums

has a considerably higher Na+:K+ ratio than mature milk.38


10

Milk Production

Two similar but independent mechanisms are involved in the establishment of

successful lactation (lactogenesis); the first mechanism causes the release of prolactin

and the second induces the release of oxytocin, to induce milk ejection reflex.

Although these two mechanisms are similar in that they can both be activated by

suckling, they are mediated through two entirely different neuroendocrinological

pathways. The key event in lactogenesis is suckling and the sensitivity of the breast

accommodates itself to this important activity.

During pregnancy the skin of the areola is relatively insensitive to tactile

stimuli but becomes much more sensitive immediately after delivery. This is an

ingenious physiological adaptation which ensures that there is an adequate stream of

different neurological stimuli from the nipple to the hypothalamus to initiate and

maintain the release of prolactin and oxytocin both of which are required for

successful lactation. 35

Milk Ejection Reflex

The milk ejection reflex is mediated by the release of oxytocin causes

contraction of the sensitive myoepithelial cells, which are situated around the milk

secreting glands and also dilates the ducts by acting up on the muscles cells, which lie

longitudinally in the duct walls. Contraction of these cells therefore has dual effect of

expelling milk from the glands and of encouraging free flow of milk along dilated

ducts. This is recognized by the mother as the milk let down and she may be aware of

milk being ejected from the opposite breast from which the baby is suckling. 35, 39


11

The main role of insulin appears to be in regulating nutrient fluctuation to the

mammary gland by shunting nutrients away from traditional storage depositories,

thereby making them more readily available for milk synthesis. Thyroid hormones are

essential for efficient milk production and, in animals, appear to be necessary for

mammary responsiveness to growth hormone and prolactin during lactation. 36

Local Control

The early influence of these reproductive and metabolic hormones sets the

stage for a transition to the autocrine function of the mammary gland. Autocrine

control, also known as local control, refers to a mechanism whereby the gland

regulates its own function through the local production of hormones and growth

factors. Evidence that the rate of milk secretion within individuals (and between

breasts in the same mother) is directly correlated with the frequency of milk removal

strengthens the theory of local control. The mechanisms that regulate local control are

not fully understood, but may include factors such as intra-mammary pressure, milk

removal, bioactive factors in the milk that interact with milk cell membranes, or a

combination of these factors.36

In addition to these anatomical and physiologic processes, breast feeding is a

process that also involves psychological and emotional responses in the mother. Many

areas within the maternal brain, such as the amygdala, the striatum, the vagal motor

and sensory nuclei, and pre ganglionic sympathetic neurons of the intermediolateral

column of the spinal cord undergo profound morphologic and secretory changes

during lactation. Although prolactin and oxytocin are primarily secreted by the

pituitary gland, both hormones are also secreted in these higher brain regions and

have been implicated in promoting maternal behaviour. Furthermore, these lactogenic

hormones can be released in the brain not only by suckling, but also by close physical

contact such as that experienced during breast feeding, thereby maximizing the

neurohormonal response.36


12

Fig. 1: Milk Ejection Reflex


13

Involution

When lactation comes to an end there is a gradual return to the ‘resting’ state;

it has been estimated that this takes, on average, 3 months. It is not known whether

the factors which control these changes are vascular, mechanical or hormonal,

although it is assumed that the reduction in prolactin levels is a major influence.

Involution of the epithelial tissue occurs, with regression towards the resting ratio of

connective tissue to lobules. 34

Hormonal Regulation of Lactation

Development of the breast involves the coordinated action of reproductive and

metabolic hormones which have been discussed above. Despite an enormous amount

of work, however, the precise roles of each hormone are difficult to delineate because

a given hormone, besides acting directly on the breast, may also influence the

secretion and activity of other hormones.40

Prolactin

Prolactin is essential for mammary gland development during puberty and

pregnancy, and for the initiation and maintenance of lactation.41 It controls many

steps in lactogenesis, including the synthesis of the milk proteins, casein and α-

lactalbumin. Prolactin receptors in mammary tissues appear to increase in number

during gestation and after parturition. The human prolactin receptor is a protein of 598

amino acids. Suckling is a powerful stimulus in women post partum for the release of

prolactin.40 The frequency and duration of pulses of prolactin do not change during

the postpartum period.42 In first few weeks after delivery, maternal serum prolactin

levels are continuously high and undergo further elevation (5-10 folds) with each


14

nursing episode. Between 3 and 7 week after parturition, concentrations of prolactin

fall to the normal range between nursing episodes (<20 to 25 µg/L) most of the time.

However, in most women, some rise in prolactin levels continues during each

suckling episode for many months. This rise in prolactin levels in response to suckling

is probably important in maintaining the breast in the lactating state, but is not

demonstrable in all women who continue to lactate for long periods. Therefore, high

levels of prolactin appear to be necessary for the initiation of lactation, but once breast

enzyme systems are activated lactation can continue with mean prolactin

concentrations that are normal or only modestly elevated. Even at these low levels,

however, prolactin is essential for maintenance of lactation, and lactation ceases if

prolactin levels are further lowered by dopamine agonists. 40

Oxytocin

In contrast to prolactin, which is secreted only in response to suckling,

oxytocin can be released in response to sensory inputs such as the mother seeing the

baby or hearing its cry. Oxytocin has a very short life in the circulation and is released

from the posterior pituitary in a pulsatile manner. The highest levels of oxytocin may

be released prior to suckling in response to the baby’s cry, while prolactin is released

only after suckling commences.35, 40 Suckling the breast increases intra-mammary

pressure bilaterally. This leads to contraction of the myoepithelial cells in response to

oxytocin in just 35 to 65 seconds.42 The milk ejection reflex is readily inhibited by

emotional stress and this may explain why maternal anxiety frequently leads to a

failure of lactation. Successful breast feeding depends upon engendering confidence

in the mother and ensuring correct fixing and suckling at breast. 35, 40


15

Other Hormones

Collier et al implicated that hormone action is often mediated indirectly,

perhaps by stimulation of the local production of growth factors. For example, GH

may increase insulin-like growth factor I (IGF-I) production by stromal cells within

the mammary gland. In as much as this effect would not happen without the IGF-I, it

could be termed local control.38 The administration of supplemental hGH to normal

nursing mothers enhances milk yields. Parathyroid hormone-related protein (PTH-rP)

can be detected in the blood of nursing women and it is suggested that the hormone

plays a physiological role in lactation, possibly in the mobilization of calcium for

milk. The thyrotrophin-releasing hormone stimulates oxytocin release in vivo and

may participate in the release of prolactin, oxytocin, and GH of these pituitary

hormones by nursing. 40

Breast Feeding

Human milk is decidedly superior to other milks.1 It is the ideal and complete

food for the first 6 months of life. After delivery the breasts begin to secrete

colostrums within 72 hours, which is thick, sticky, yellowish coloured liquid.3 It

usually can be expressed from the nipples by the second day.

Colostrum

Colostrum is a pre milk substance produced immediately after birth. This lasts

for 2-4 days after the lactation has started. This is the source of fats, proteins, sugars

and micronutrients in the form of vitamins and minerals. This is very rich source of

secretory IgA to give protection to gastrointestinal tract (GIT) from various infections

in the new born. Certain maternal conditions like eclampsia, diabetes and anaemia can


16

affect the composition of colostrum. Colostrum has been reported to be very safe and

effective for its use in repair of tissue as well as for enhancing the immunity. It has

been found to be effective in infantile hemorrhagic diarrhoeas, other diarrhoeas and

reduces the likelihood of disease progressing to haemolytic uraemic syndrome. It has

also been tested in H. pylori infection and diarrhoea in immunodeficiency.43 Other

host resistance factors that are found in colostrums and milk include complement

macrophages, lymphocytes, lactoferrin, lactoperoxidese and lysozmes.

Milk

Human milk is not a uniform body fluid but a secretion of the mammary gland

of changing composition. Foremilk differs from hind milk. Colostrum differs from

transitional and mature milks. Milk changes over time of day and as time goes by. As

concentrations of protein, fat, carbohydrates, minerals, and cells differ, physical

properties such as osmolarity and pH change. The impact of changing composition on

the physiology of the infant gut is beginning to be appreciated. Many constituents

have dual roles; not only nutrition but infection protection, immunity, or a host of

other effects.44 Human milk is a suspension of fat and protein in a carbohydrate

mineral solution. Gestational weight gain has little impact on milk quantity.

Composition of Human Milk

The breask milk contains 1.2 g protein, 3.8g fat, carbohydrate 7 g and water 87

ml per 100 ml. 45 Human milk is a complex biological fluid composed of thousands of

constituents in several compartments; an aqueous phase with true solutions (87%)

colloidal dispersions of casein molecules (0.3%), emulsions of fat globules (4%), fat

globule membranes, and live cells. Human milk constituents can be broadly

categorised according to their physical or physiological properties. The protein


17

constituents of human milk serve diverse function. Besides providing essential amino

acids for growth, they provide protective factor (e.g. immunoglobulins, lysozymes

and lactoferrin) carriers for vitamins and for hormones (e.g. thyroxin and

corticosteroid binding proteins), enzymatic activity (e.g. amylase) and other biological

activities e.g. insulin and prolactin. The assimilation of fatty acids by young infants is

crucial not only for energy to support growth but also for the synthesis and

development of retinal and neural tissues. Some of the oligosaccharides may have

biologic activity in infants, such as inhibiting the binding of pathogens to their

receptors and promoting growth of several species of bifidobacteria in the intestine.

Vitamin B12 supplementation leads to rapid resolution of heamatologic abnormalities

and cerebral atrophy in infants, evidence suggests that vitamin B12 deficiency early in

infancy may cause lasting neurodisability. The investigator speculated that elevated

values for serum calcium and magnesium and depressed values for phosphorus are

important for bone remodeling in infancy. Iodine is required for synthesis of thyroid.46

Volume of Breast Milk

During the first 24 hrs of the puerperium, the human breast usually secretes

small volumes of milk but with regular suckling, milk volumes steadily increase and

by the sixth day of the puerperium, an average volume of 500 ml will be taken by the

baby. Once lactation is fully established an average daily milk volume is about 800

ml.35 However, this amount can range from 440 to 1220 ml/day in infants who are

growing within the normal range.14 Baby needs 100 calories/kg and 150 ml milk/kg

of body weight daily.45 In well established lactation, it is possible to sustain a baby on

breast milk alone for 4–6 months.35


18

Berens mentioned that the milk secretion increases from less than 100 ml/day

at the beginning to approximately 600 ml on the fourth day, on an average.47 The

volume of milk produced in the established lactation varies according to the infant’s

demand. On average, it amounts to 850 ml a day in exclusive breast feeding. The rate

of breast milk synthesis after each breast feeding varies, but it is higher when the

breast is emptied on a regular basis.48 In general, the mother’s capacity to produce

milk is larger than the infant’s appetite. The storage capacity of the breast varies

among women and may vary between the two breasts in the same woman. This

capacity tends to increase with breast size, but it is not related to milk production in

24 hours. It may be important to determine the frequency of feedings. Thus, infants of

mothers with a lower storage capacity satisfy their demand by breast feeding more

frequently.49 Maternal age, parity, exercise, and nutrition (except in the extreme)

have little, if any, influence on milk volume.

Time of Initiation of Breast feeding: Early initiation of breast feeding, within

one hour of birth, is recommended by the World health organisation (WHO) and the

United Nations Children's Fund (UNICEF) to stimulate breast milk production, to

increase uterine activity (thereby reducing the risk of heavy bleeding and infection),

to foster mother-child bonding and increase the duration of breast feeding. 50

It has been observed that breast feeding duration varies from one country or

geographic region of another. Study in Eldoret District Hospital, Kenya by Esmai et

al. found only 32% who breast fed their children up to 2 years, 33% up to 12 months

and 13% stopping at 6 month. In Bangkok and Bogota, the median duration for

lactation was less than 7 months. Nairobi exhibited a longer duration of 16 months

and in Semarang, median duration was 20 months. In Latin America and the


19

Caribbean, only 35% to 60% of their children continue being break fed up to an age

of 6 month and within Latin America, in Mexico, frequency of breast feeding has

declined notably. A study by Maria et al showed only 34.8% of the study infant breast

fed for not more than 1 month.51

Duration of Breast Feeding

Because of the compelling evidence that prolonged and exclusive breast

feeding have multiple health benefits for infants and their mothers, both the American

Academy of Pediatrics (AAP) and the World health organisation recommend

exclusive breast feeding for the first 6 months of life. 52 Before 2001, the World

health organisation (WHO) recommended that infants be exclusively breastfed for 4–

6 month with the introduction of complementary foods (any fluid or food other than

breast milk) thereafter. In 2001, after a systematic review and expert consultation, this

advice was changed, and exclusive breast feeding is now recommended for the first 6

month of life. The systematic review commissioned by the WHO compared infant and

maternal outcomes for exclusive breast feeding for 3–4 month versus 6 month. That

review concluded that infants exclusively breastfed for 6 month experienced less

morbidity from gastrointestinal infection and showed no deficits in growth.53

In Brazil, mean duration of exclusive breast feeding is only 28.9 days. It has

been found in a study that only 14% of mothers exclusively breast fed for 120 days of

age and only 4% for 180 days. In Malaysia, however, the results are no better as only

25% of babies are breast fed exclusively at 2 months. In westernised cities of Bogota

and Bankok, only 12% and 21% of babies respectively are breast fed exclusively at 1

month. In Nairobi, the decline is no better. Only 20% of babies are breast fed


20

exclusively up to 2 months. In Jemarang, however, about 42.0% of babies were

exclusively breast fed for 2 months. 51

The United Nations Children's Fund (UNICEF) has estimated that exclusive

breast feeding in the first six months of life can reduce under-five mortality rates in

developing countries by 13%. 54

Breast feeding is to be continued for a year or more. WHO and UNICEF also

recommend continuation of breast feeding for two years or more.55

Statistics indicate, however, that initiation and maintenance of exclusive breast

feeding are low in the United States. Between 1991 and 1994, 47% of mothers were

exclusively breast feeding at 7 days after birth, but exclusive breast feeding rates were

only 10% at 6 months.56 In 2001, exclusive breast feeding rates at 6 months were

found to be just 7.9% in a national study of 896 households.57

Advantages of Breast Feeding

Breast feeding is advised as human milk is species specific nourishment for

the baby, produces optimum growth and development, and provides substantial

protection from illness. Lactation is beneficial to mother's health and biologically

supports a special mother/baby relationship.58 It is nature’s gift to baby and meant for

human infant. 45

It is economical for poor community. 45, 59 It is easily digestible by infant. 45

It is always available at right temperature.45

It is sterile, free of bacterial contamination with less chance of gastroenteritis

in infant. 45


21

Emotional factors: Breast feeding promotes close physical and emotional

bonds between the mother and the baby. 59

Breast feeding is considered eco-friendly. 59

Nutritional aspects of breast milk 35

Protection against infection 35, 58,59

Prevents breast cancer in mother

Contraceptive effect in mother

1. Infants Health Benefits

Nutritional Aspects of Breast Milk

Human milk is not a constant substance because colostrum differs from

mature milk and the milk of the early puerperium differs from milk of late lactation.

Indeed the contents of milk vary at differing stages of the same feed. Nevertheless, the

appropriate concentration of human milk and cow’s milk show substantial differences

with human milk having less protein but more fat and lactose. A number of specific

components also differ between human milk and formulae, such as the long chain

polyunsaturated fatty acids, which have important neuro developmental consequences

for the baby. There is no doubt that breast milk is the ideal nutrition for the human

baby.35

Protection against Infection

One of the most important secondary functions of breast feeding is to protect

the infant against infection. This is particularly important in developing countries

where it has been estimated that in each year there are 500 million cases of diarrhoea

in infants and children and about 20 million of these are fatal. The extent to which

breast feeding protects against infection in infants in developed countries, however,


22

has been a matter of dispute. 35 Research in developed and developing countries of the

world, including middle-class populations in developed countries, provides strong

evidence that human milk feeding decreases the incidence and/or severity of a wide

range of infectious diseases 60 including bacterial meningitis, bacteraemia, diarrhoea,

respiratory tract infection, necrotizing enterocolitis, otitis media, urinary tract

infection, and late-onset sepsis in preterm infants. A number of studies also showed a

possible protective effect of human milk feeding against sudden infant death

syndrome, IDDM, Crohn’s disease, ulcerative colitis, lymphoma, allergic diseases,

and other chronic diseases. 3, 61

In addition, post neonatal infant mortality rates in the United States are

reduced by 21% in breastfed infants.62

Human milk feeding is clearly protective against enteric infections caused by

multiple bacterial, protozoal, and viral pathogens, against upper aerodigestive tract

infections caused by bacteria and viruses, and even against bacterial urinary tract

infections. Protection is provided directly and indirectly via multiple milk components

and activities that include immunoglobulins, various glycoproteins such as mucins

and lactadherin, oligosaccharides, binding proteins and enzymatic activities,

antioxidants, soluble cytokine receptors/cytokine antagonists, free fatty acids, acidic

fecal pH, and a characteristic fecal flora. Direct binding effects, which aggregate

potential pathogens/toxins and prevent disease by preventing their attachment to host

target tissue, are mediated by secretory immunoglobulin A (IgA), oligosaccharides,

and even milk fat globule membranes. Notably, by minimizing attachment/infection

potential via organism binding rather than overt organism killing (as occurs in

classical human immunity), a pertinent point can be made: recovery of live pathogens


23

from asymptomatic breastfed infants would be expected to occur, and symptom

severity for a given type of infection may be minimized. The latter effect may also be

affected by the anti-inflammatory components contained in human milk. Indirect

effects of nonnutritive components mediating protection from infection relate to

unexpected, nonhuman consumers of the lactose and oligosaccharides in human

milk—the colonic microbial flora that occurs in the breastfed infant. This acid-

producing, fermentative flora likely controls the numbers of potentially pathogenic

adult enteric flora in the breastfed infant. Recent sequencing of the genome of Bifido

bacterium longum subsp. infantis, clearly illustrates that this organism is

metabolically optimized to use human milk carbohydrates as an energy source,

reinforcing appreciation of the interactions and impacts of this infant support system.

It would be incorrect to presume that breast feeding and human milk benefit the

infants only via effects that counter/prevent infection. The meta-analysis summary

from the Alliance for Healthcare Research and Quality (AHRQ) makes the point

clearly that breast feeding decreases adult obesity as well as adult-onset type 2

diabetes mellitus. Although these effects are less well understood mechanistically, the

infant support system standpoint might suggest that human milk. Feeding has long-

range effects on metabolic efficiency and energy balance. 63

A number of mechanisms contribute to the anti infective properties of breast

milk. Breast milk contains lactoferrin, which binds iron, and because E coli require

iron for growth, the multiplication of this organism is inhibited. Breast feeding also

encourages colonization of the gut by non pathogenic flora which will competitively

inhibit pathogenic strains. In addition, there are bacteriocidal enzymes such as

lysozyme, present in breast milk, which will contribute to its protective effect. 35


24

The most specific anti infective mechanism, however, is an immunological

one. If a mother ingests, a pathogen which she has previously encountered, the gut

associated lymphoid tissue situated in peyers patches of the small intestine will

respond by producing specific immunoglobulin A, which is transferred to the breast

milk, via the thoracic duct. This immunoglobulin which is present in large in breast

milk, is not absorbed from the infants gastrointestinal tract but remains in the gut to

attach to the specific offending pathogen against which it is directed. In this way the

breast fed infant is given protection from the endemic infections in the environment

against which the mother will already have immunity. Breast milk contains living

cells, such as polymorphs, lymphocytes and plasma cells and although their functions

are not yet fully understood they may also be active against invading pathogens. 35

The important role of appropriate breast feeding practices in the survival of

infants is clear from this analysis. The reduction of ARI deaths underscores the broad-

based beneficial effect of exclusive breast feeding in prevention of infectious diseases

beyond its role in reducing exposure to contaminated food, which may have

contributed to the strong protection against diarrhea deaths.64

Yoon et al65 reported a higher risk of diarrhoea mortality associated with not

breast feeding, whereas the risk for death attributable to ARI, although higher, was

not statistically significant. A similar pattern also has been reported from other

studies. 66, 67 In a recent meta-analysis of data from 6 developing countries, breast

feeding provided a greater degree of protection against diarrhoea deaths than against

deaths attributable to ARI in the first 6 months of life, whereas the level of protection

was similar for infants who were 6 to 11 months of age. 68 Similar to findings from

previous studies, the risk ratio estimates associated with partial or not breast feeding


25

were higher for diarrhoea deaths than for ARI deaths, although the CI overlapped.

The highest risk group for diarrhoea deaths included infants who were either not

breastfed or who received, in addition to breast milk, other energy-containing foods at

an age when they were not necessary. Contaminated complementary foods are

primary sources of gastrointestinal pathogens and are the most likely explanation for

the observed association. There was approximately a 2.5-fold increase in the risk of

ARI deaths when infants received energy containing food in addition to breast milk or

were not breastfed in early infancy. Although there is considerable evidence of an

increased risk of respiratory infections associated with not breast feeding from both

developed and developing countries,69, 70, 71 there have been few reports of increased

risk of ARI deaths among non breastfed infants.

Other Health Outcomes

Some studies suggest decreased rates of sudden infant death syndrome in the

first year of life and reduction in incidence of insulin-dependent (type 1) and non

insulin dependent (type 2) diabetes mellitus lymphoma, leukaemia, and Hodgkin

disease, hypercholesterolaemia, and asthma in older children and adults who were

breastfed, compared with individuals who were not breastfed. Additional research in

this area is warranted. 62

Breast Feeding and Neurological Development

A number of studies have shown positive associations between breast feeding

and improved child hood cognitive functions, such as increased intelligence

quotient,35, 62 which persists even after allowing for potential confounding variables.


26

The mechanism for the improved neurological development is not fully

understood but the presence of long chain 3 fatty acids in breast milk, particularly

docosohexanoic acid, may be important, the composition of the infant brain is

sensitive to dietary intake but the relationship between the biochemical composition

of brain lipid and cognitive function is not yet known. Nevertheless, the possible

beneficial effect of breast feeding on cognitive function is a topic of great potential

importance.35

Pérez-Escamilla provides examples of studies in which breast feeding is

associated with more advanced motor development in infants, as indicated by the

early attainment of certain milestones, such as crawling. Pollitt suggested that delayed

development in malnourished infants may give the appearance of the child being

“young,” and therefore elicit less stimulation from the mother and the household

environment. 72

Breast Feeding and Obesity

Artificially fed children have twice the risk of child hood obesity in

comparison to breastfed children. Breastfed children have a significantly reduced

blood pressure. These children have a significantly reduced chance of being obese as

adults and dying prematurely from cardiovascular disease.35

Breast Feeding and Atopic Illness

There are a number of reports that show lower incidences of atopic illness

such as eczema and asthma in breastfed babies. This effect is particularly important

when there is a family history of atopic illness is present, it is commonly associated

with raised levels of immunoglobulin E, especially cow’s milk protein. Oddy et al


27

suggests that apart from a positive family history , the most important presiding factor

for atopic illness is the early introduction of weaning foods. The protective effect of

breast feeding against atopic illness, therefore, may be secondary, rather than primary,

because breast feeding mothers tend to introduce supplements at a later stage.

Nevertheless, mothers with a family history of atopic illness should be informed of

the advantages of breast feeding and of the dangers of introducing supplements too

quickly. 35

2. Maternal Health Benefits

Important health benefits for mothers include decreased postpartum bleeding and

more rapid uterine involution attributable to increased concentrations of oxytocin,

decreased menstrual blood loss, earlier return to prepregnancy weight, decreased

risk of breast cancer, decreased risk of ovarian cancer, and possibly decreased risk

of hip fractures and osteoporosis in the postmenopausal period. 62

Breast Feeding and Breast Cancer

There is an epidemic of breast cancer among women of developed countries in

the Western world. A Number of recent studies have shown a reduced risk of breast

cancer among women who have breastfed their babies. Because breast feeding

appears to have no effect on the incidence of postmenopausal breast cancer, its overall

protective effect will be relatively small but the protection offered by lactation still

represents an important advantage against a much feared and common disease. 35

Breast feeding and Fertility

Women who breastfeed their children have a longer period of amenorrhea and

infertility following delivery than women who do not breastfeed. The length of


28

postpartum amenorrhea varies greatly and depends on several factors, including

maternal age and parity and the duration and frequency of breast feeding. In lactating

women, prolactin levels stay elevated, with spikes of increased secretion during and

following suckling. The evidence points strongly to the fact that persistent

hyperprolactinemia caused by breast feeding postpartum results in an anovulatory or

oligo-ovulatory state, and this results in relative infertility. 73

The natural contraceptive effect of breast feeding has received scant attention

in the Western world because it is not a reliable method of family planning in all

cases. Nevertheless, on a population basis, the anti-fertility effect of breast feeding is

large and of major importance in the developing world. It has to be remembered that

the majority of women in the developing world do not use artificial contraception and

relay on natural checks to their fertility. By far the most important of these natural

checks is the inhibition of fertility by breast feeding. In many developing countries

mothers breastfeed for 2 years or more with the effect that their babies are spaced at

about 3 yearly intervals. In the developing world, more pregnancies are still prevented

by breast feeding than by all other methods of family planning combined. The current

decline in breast feeding in the developing world is a cause for great concern because

without a sharp rise in contraceptive usage, the loss of its anti-fertility effect will

aggravate the population increase in thses countries.35

Mechanism of Lactational Amenorrhoea

The mechanism of lactational amenorrhoea is complex and incompletely

understood. The key is a suckling induced change in the hypothalamic sensitivity to

the feedback effects on ovarian steroids. During lactation, the hypothalamus becomes

more sensitive to the negative feedback effects and less sensitive to the positive


29

feedback effects of oestrogen. This means that if the pituitary secretes enough

follicles stimulating and luteinizing hormones to initiate the development of an

ovarian follicle the consequent oestrogen secretion will inhibit gonadotrophin

production and the follicle will fail to mature. During lactation there is inhibition of

the normal pulsatile release of luteinizing hormone from the anterior pituitary gland

which is consistent with this explanation. From a clinical stand point the major factor

is the frequency and duration of the sucking stimulus although other factors such as

maternal weight and diet may be important confounding factors. If supplementary

food is introduced rapidly at an early stage, the suckling stimulus will fail and early

ovulation and a return to fertility will be the consequence. 35

3. Community Benefits

In addition to specific health advantages for infants and mothers, economic,

family, and environmental benefits have been described. These benefits include the

potential for decreased annual health care costs of $3.6 billion in the United States;

decreased costs for public health programs such as the Special Supplemental Nutrition

Program for Women, Infants, and Children (WIC); 62, 63, 74 decreased parental

employee absenteeism and associated loss of family income; more time for attention

to siblings and other family matters as a result of decreased infant illness; decreased

environmental burden for disposal of formula cans and bottles; and decreased energy

demands for production and transport of artificial feeding products. These savings for

the country and for families would be offset to some unknown extent by increased

costs for physician and lactation consultations, increased office-visit time, and cost of


30

breast pumps and other equipment, all of which should be covered by insurance

payments to providers and families. 62

Contraindication:

Although breast feeding is optimal for infants, there are a few conditions

under which breast feeding may not be in the best interest of the infant. 62 There is

virtually no absolute contraindication. Situations where breast feeding may be

avoided are

In Mother

Chronic diseases such as active tuberculosis, 1, 39 leprosy, malignancy, beriberi,1

AIDS, 1, 39 etc. Many authorities advocate continuing breast feeding in the first

two provided chemotherapeutic coverage is being given. 1 In the United States,

mothers who are infected with human immunodeficiency virus (HIV) have been

advised not to breastfeed their infants. In developing areas of the world with

populations at increased risk of other infectious diseases and nutritional

deficiencies resulting in increased infant death rates, the mortality risks associated

with artificial feeding may outweigh the possible risks of acquiring HIV infection.

One study in Africa detailed in 2 reports found that exclusive breast feeding for

the first 3 to 6 months after birth by HIV-infected mothers did not increase the

risk of HIV transmission to the infant, whereas infants who received mixed

feedings (breast feeding with other foods or milks) had a higher rate of HIV

infection compared with infants who were exclusively formula-fed. Women in the

United States who are HIV-positive should not breastfeed their offspring.

Additional studies are needed before considering a change from current policy

recommendations.62


31

Mothers stubbornly addicted to alcohol or heavy doses of some drugs such as

phenobarbital, hydantoin, steroids etc should also not be allowed to breast feed

their babies. 1, 62

Psychosis 1

Local conditions, e.g. breast abscess, cracked nipples, etc. Breast feeding must be

resumed as soon as possible. 1

Mothers who are receiving diagnostic or therapeutic radioactive isotopes or have

had exposure to radioactive materials (for as long as there is radioactivity in the

milk) 1, 62

Mothers who have herpes simplex lesions on a breast (infant may feed from other

breast if clear of lesions) 62

Mothers who are receiving anti-metabolites or chemotherapeutic agents or a small

number of other medications until they clear the milk.62

In Infant

Gross prematurity of the baby or other condition in which the newborn cannot

suckle.

Inborn errors such as phenylketonuria, galactosemia (galactose 1-phosphate

uridyltransferase deficiency)1, 62 or lactose intolerance.1

Breast milk jaundice, provided that serum bilirubin approaches critical level. 1

Biological mother may avoid breast feeding an infant who is to be passed on to

another couple. 1


32

Conditions that are not contraindications to breast feeding

Certain conditions have been shown to be compatible with breast feeding.

Breast feeding is not contraindicated for infants born to mothers who are hepatitis

B surface antigen–positive, mothers who are infected with hepatitis C virus

(persons with hepatitis C virus antibody or hepatitis C virus-RNA–positive blood)

Mothers who are febrile (unless cause is a contraindication outlined in the

previous section), mothers who have been exposed to low level environmental

chemical agents, and

Mothers who are seropositive carriers of cytomegalovirus (CMV) (not recent

converters if the infant is term). Decisions about breast feeding of very low birth

weight infants (birth weight _1500 g) by mothers known to be CMV-seropositive

should be made with consideration of the potential benefits of human milk versus

the risk of CMV transmission. Freezing and pasteurization can significantly

decrease the CMV viral load in milk.

Tobacco smoking by mothers is not a contraindication to breast feeding, but

health care professionals should advise all tobacco-using mothers to avoid

smoking within the home and to make every effort to wean themselves from

tobacco as rapidly as possible.

Breast feeding mothers should avoid the use of alcoholic beverages, because

alcohol is concentrated in breast milk and its use can inhibit milk production. An

occasional celebratory single, small alcoholic drink is acceptable, but breast

feeding should be avoided for 2 hours after the drink.

For the great majority of newborns with jaundice and hyperbilirubinemia, breast

feeding can and should be continued without interruption. In rare instances of


33

severe hyperbilirubinemia, breast feeding may need to be interrupted temporarily

for a brief period. 62

Use of Medications during Breast Feeding

Drugs which are absolutely contraindicated during breast feeding are

bromocriptine, ergotamine, lithium, methotrexate, cyclophosphamide, cyclosporine,

doxorubicin and phenindione. Drugs of abuse which are contraindicated include

cocaine and phencyclidine. 39

Baby Friendly Hospital Initiative

Two international organizations with responsibilities for global breast feeding

promotion programmes UNICEF and the WHO took note of this policy situation and

developed guideline titled protecting, promoting and supporting breast feeding: The

special role of maternity care practices.

Since its launch in 1991-1992 the UNICEF/WHO Baby Friendly Hospital

Initiative (BFHI) has been implemented by over 19,000 hospitals and maternity

services in more than 150 countries. A hospital or birth centre can receive baby

friendly status if they show compliance with the ten steps to successful breast

feeding.75

UNICEF and WHO recommends that health personnel should help mothers to

initiate breast feeding within half-an-hour of birth 76, 77

The Ten Steps to Successful Breast feeding for Hospitals and Birth Centres are:

1. Maintain a written breast feeding policy that is routinely communicated to

all health care staff.


34

2. Train all health care staff in skills necessary to implement this policy.

3. Inform all pregnant women about the benefits and management of breast

feeding.

4. Help mothers initiate breast feeding within half an hour of birth.

5. Show mothers how to breastfeed and how to maintain lactation, even if

they are separated from their infants.

6. Give infants no food or drink other than breast milk, unless medically

indicated.

7. Practice “rooming in”- allow mothers and infants to remain together 24

hours a day.

8. Encourage unrestricted breast feeding.

9. Give no pacifiers or artificial nipples to breast feeding infants.

10. Foster the establishment of breast feeding support groups and refer

mothers to them on discharge from the hospital or clinic.61


35

Historical Aspect

The Ebers Papyrus is an Egyptian medical papyrus dating to circa 1550 BC

and the oldest preserved medical documents. 78 In Ebers Papyrus, it is also mentioned

that if the mother could not breast-feed then a ‘wet nurse’ whose breasts would

continue to lactate after she had finished suckling her own child providing that a new

baby was placed on them was enlarged. 79

In the earliest Indian literature, the Vedas mention that milk and breast are

symbolic of longevity and nectarine sweetness. The Charak Samhita (400–200 BC)

(verses 8/52:957, 8/46:950) depicts the importance of breast feeding, and the Kashyap

Samhita describes the qualities of breast milk. Breast milk has been thought to have

great powers. Its life giving powers are highlighted in select quotations from the

religious texts Shiva, the god of destruction, as well as the lord of cattle, yogis, and

asceticism, grants his wife, the goddess Parvati, her wish for a son by creating a baby

boy from part of her dress. Despite Parvati’s skepticism, the baby Ganesh comes to

life when Parvati puts him to her breast. Sushruta Samhita (400 BC) describes the

power of breast milk. Historically, colostrum has been used for various illnesses in

India for thousands of years. Colostrum has been used for treatment of rheumatoid

arthritis. 43

Beliefs about colostrum vary in communities; many mothers discard

colostrum, believing that it is deleterious to the child. The infant may be fed cow’s

milk, water, or honey during this initial, very important period for establishment of

lactation. Delaying breast feeding until the fifth day has been reported in the

Brahminical literature (second century BC). 80


36

In the Egyptian, Greek and Roman empires, women usually fed only their own

children. However, breast feeding began to be seen as something too common to be

done by royalty, and wet nurses were employed to breastfeed the children of the royal

families. This was extended over the ages, particularly in western Europe, where

noble women often made use of wet nurses. The Moche artisans of Peru (1–800 A.D.)

represented women breast feeding their children in ceramic vessels.81

Feeding vessels dating from about 2000 BC have been found in Egypt. A

mother holding a very modern-looking nursing bottle in one hand and a stick,

presumably to mix the food, in the other is depicted in a relief found in the ruins of

the palace of King Ashurbanipal of Nineveh—who died in 888 BC. Clay feeding

vessels were found in graves with infants from the first to fifth centuries AD in

Rome.81

The modest knowledge of anatomy is evidenced by the Hippocratic (460- 370

BC) notion that the clear or white liquid in the intestinal lymphatic vessels was

mother’s milk en route to the breasts. The growing uterus was said to squeeze this

milk from the abdomen to the lactating mamme. 79 Greek writings from Aristotle later

suggested that women should breastfed while no menstruation was occurring,

typically between child ages of 1 and 2 years. 82

Patterns of duration of breast feeding were longer in ancient times. Eastern

and Western civilization thrived with longer breast feeding patterns. Among ancient

Hebrews, total weaning took place at approximately age 3 years. A breast feeding

duration for at least 2 years is specified in such sources as the Talmud, the Quran,

medical texts from India, and wet nursing contracts found in Babylonia.82


37

Maternal breast feeding was advocated, but Soranus (98-138) believed that

there should be a lapse of 3 weeks to allow the mother to recover from her labour. In

the mean time a wet nurse (nutrix) was employed.79 He also suggested that infants

should breastfeed until their complete set of teeth have erupted, whereas Galen (131-

201) recommended breast feeding, as evidenced in their respect and representation of

their breast feeding goddesses and myths; however, the remains of Roman children

and adults with rickets suggests that Roman women cut short their breast feeding

experience. 82 Mentions of galactagogues are found in the antique works by the Greek

physician Dioscorides (c. 50 after Ch.) and the Roman officer and scholar Pliny. (27-

79 after Ch.) 24

The Prophet Mohammed (570 –632) said ‘a wife’s breast will nourish the

infant and rejoice the father’. There have been different phases in history when the

popularity of breast feeding waxed and waned. 79

Zakariya Razi (852) described that qillatul laban is caused by alteration in

quality of blood, which can be because of qillatut dam, ghalbae safra or balgham. 15

Ali bin Abbas Majoosi (930-994) described that in the production of milk

secondary faculties simply serve the nutritive one of the breast. 83

Ismail Jurjani (1042–1136) was of opinion that mainly qillatul laban is caused

by sue mizaj saada or maddi of badan or pistan. 16

Ibn Sina (980-1037) mentioned about prenatal and postnatal care, delivery,

newborn baby care, milk feeding and how to choose the suitable wet nurse. In the

first book, he devoted a special part for talking about children bringing up and their

diseases. This part consists of four chapters: the first chapter is for the management of


38

the newborn until the walking age. In the second chapter he wrote about milk

feedings, the characters of the good wet nurse and weakling. In this regard Ibn Sina

stresses on the necessity to keep the newborn on his mother milk. 84 He also discussed

about the enlargement of the breasts and change of colour in the areolae during

pregnant state.

Ibn Rushd (1188) stated that in females, specific azae tanasuliyah

(reproductive system) are rehm (uterus) and pistan.85 Encouraging lactating women to

drink alcohol as a means to increase milk production is a widespread folklore that is

still perpetuated by early evidence, albeit in men and nonlactating women, that

alcohol consumption can increase circulating prolactin. 86

Valerie Fildes writes in her book Breasts, bottles and babies. A history of

Infant Feeding about examples from the 9th to 15th centuries of children getting

animal's milk. 81 In 1582, the Italian physician Geronimo Mercuriali wrote in De

morbis mulieribus (On the diseases of women) that women generally finished breast

feeding an infant exclusively after the third month and entirely around 13 months of

age. In the 17th and 18th century Icelandic babies got cow's milk with cream and

butter.81

Cadogan (1711-1797), from Bristol Founding Hospital, who advocated against

early introduction of solid foods and censuring feeding customs that interfere with

successful breast feeding practices. He criticized the practice of separating mothers

from their infants to be sent to wet nurses because he contended that these children

would suffer from lack of bonding and the benefits of their mothers’ milk. Smith

(1736-1789), was the first to recommend breast feeding solely for the first 6 months.82


39

In the 18th century, wet nursing was considered one of the main problems.

Campaigns were launched against the custom among the higher class to use a wet

nurse. Women were advised or even forced by law to nurse their own children. In

1752 Linnaeus, wrote a pamphlet against the use of a wet nurse. He considered this

against the law of nature. A baby not nursed by the mother was deprived of the

laxative colostrum. Linnaeus thought that the lower class wet nurse ate too much fat,

drank alcohol and had contagious (venereal) diseases, therefore producing lethal

milk.81

William Fetherston Montgomery (1797-1859), wrote his An Exposition of the

Signs and Symptoms of pregnancy which contained a detailed description of the breast

changes in pregnancy. He noted that a condition of fullness of the breasts may be

natural to the individual or it may take place at the turn of life, when the menses

become naturally suppressed, the person grows at the same time fatter, and the breasts

under such circumstances become full and are not frequently painful..’ He thus

alluded to the lack of specificity of increased breast size in the diagnosis of

pregnancy. He speaks about ‘mammary sympathies’ and he pointed out that there

were differences of opinion between the Denman who did not believe that the

changes in the areola occurred only in pregnancy. 79

Though first developed by Henri Nestlé in the 1860s, infant formula received

a huge boost during the post World War II Baby Boom. When business and births

decreased, and government strategies in industrialised countries attempted to highlight

the benefits of breast feeding, Nestlé and other such companies focused their

aggressive marketing campaigns on developing countries. 81


40

Until 1950, human milk was the food of choice for sick and was administrated

with medicine droppers on 1-2 hourly bases. In 1950, indwelling nasogastric

polyethylene tubes were introduced and feeding via that route was a major advance in

sustaining preterm infants. 79

In 1979, the International Baby Food Action Network (IBFAN) was formed to

help raise awareness of such practices as supplementary feeding of new babies with

formula and the inappropriate promotion of baby formula, and to help change

attitudes that discourage or inhibit mothers from breast feeding their babies. 81

Improper feeding technique was the primary cause of infant mortality in the

nineteenth century and was one of the main reasons for the origins of pediatrics as a

specialty in medicine. Nutritional deficiencies with increased morbidity (e.g., scurvy

and rickets) appeared as breast feeding diminished. Data from the US census of 1900-

1910 revealed that children who were breastfed had a 40% lower mortality rate that

did their formula-fed peers.82 As Recently as the nineteenth century upper class ladies

thought it was beneath their dignity to breast feed and employed wet nurses who

nourished their babies for them. Later formulas which added and subtracted various

substances from cow’s milk to make it more digestible for new born infants. During

the nineteenth century the gentle art of breast feeding came under attack. Infants were

fed animal milk and various formulated milks. In Europe and the new world sanitary

visitors were recruited to instruct mothers in cleanliness and in the newer methods of

feeding. 79 The feeding of flour or cereal mixed with broth or water became the next

alternative in the 19th century, but once again quickly faded. Around this time there

became an obvious disparity in the feeding habits of those living in rural areas and

those in urban areas. Most likely due to the availability of alternative foods, babies in


41

urban areas were breastfed for a much shorter length of time, supplementing the feeds

earlier than those in rural areas. 81

In the 19th century, the mother's milk was considered best for babies, but the

quality of the breastmilk was found to be varied. The quality of breastmilk was

considered good only if the mother had a good diet, had physical exercise and was

mentally in balance. In Europe (especially in France) and less in the USA it was a

practice among the higher and middle class to hire a wet nurse. If it was too difficult

to find a wet nurse, people used formula to feed their babies, but this was considered

very dangerous for the health and life of the baby.81

Traditionally, Japanese women gave birth at home and breastfed with the help

of breast massage. Weaning was often late, with breast feeding in rare cases

continuing until early adolescence. After World War II, Western medicine was taken

to Japan and the women began giving birth in hospitals, where the baby was usually

taken to the nursery and fed formula. In 1974, a new breast feeding promotional

campaign by the government helped to boost the awareness of its benefits and its

prevalence has sharply increased. Japan became the first developed country to have a

baby-friendly hospital, and as of 2006 has another 24 such facilities. 81

A 1994 Canadian government health survey found that 73% of Canadian

mothers initiated breast feeding, up from 38% in 1963. It has been speculated that the

gap between breast feeding generations in Canada contributes to the lack of success of

those who do attempt it: new parents cannot look to older family members for help

with breast feeding since they are also ignorant on the topic. Western Canadians are

more likely to breastfeed; just 53% of Atlantic province mothers breastfeed, compared

to 87% in British Columbia. More than 90% of women surveyed said they breastfeed


42

because it provides more benefits for the baby than does formula. Of women who did

not breastfeed, 40% said formula feeding was easier (the most prevalent answer).

Women, who were older, more educated, had higher income, and were married were

the most likely to breastfeed. Immigrant women were also more likely to breastfeed.

About 40% of mothers who breastfeed do so for less than three months. 81

A 2003 La Leche League International study found that 72% of Canadian

mothers initiate breast feeding and that 31% continue to do so past four to five

months. 81

Unani Perspective of Qillatul Laban

Introduction:

Ibn Sina mentioned that pistan (breast) is an organ, developed to produce milk

and provide nutrition to the infant till the organs of infant are efficient to perform their

function properly. He also writes that mother’s milk helps in growth and development

of newborn. 18, 87 Ibn Rushd stated that rehm (uterus) and pistan are specific azae

tanasuliyah (reproductive system) in females. 85 Breast is made of glandular tissue

with the purpose that weight of the organ can be reduced. In females, it is enlarged so

that they can feed the baby. 87 Unani scholars mentioned that breast feeding mothers

have scanty menstrual flow or amenorrhoea 83, 85 and usually do not conceive till they

are breast feeding the infant. 85

Pistan is the azae murrakabah (compound organs), 87 soft in consistency, 85

white 85 and made of fibroglandular tissue. 18, 83, 85, 87 It consists of numerous veins,

arteries and nerves intertwined on each other and resembles the vessels of uterus.85, 87

In between the glandular tissue of breast small spaces are present in which rutubat


43

and blood enter and gets converted into milk. The veins are connected with these

spaces so that blood which reaches in breast gets converted into milk. The arteries

help in transferring the hararat (heat) that helps in formation of milk from blood. The

breasts are situated on the chest wall, so that it is nearer to the heart and hararat

produced in the heart helps in the formation of milk. Moreover, breasts also protect

the chest wall from injury. 87 Ali bin Abbas Majoosi opined that the recoiling fashion

and the arrangement of these structures in pistan is especially designed for the

synthesis of breast milk. 83

At puberty, nodular formation take place in breasts in both genders, but due to

ghalbae hararat in males it dissolves, whereas in females because of zofe hararat and

haiz, nodular enlargement becomes prominent and helps in breast feeding. 17 Ismail

Jurjani and Akbar Arzani discussed that production of mani (semen), blood and milk

occurs in different organs, and look dissimilar but asbab paydaish (origin) is

similar.16, 17

Ibn Sina mentioned that during pregnancy, the breasts get hypertrophied

engorged and the superficial vessels appear yellowish or greenish. When the fetus

initiates moving, the initiation of production of milk takes place. 88

Advantages of Milk

Ibn Sina mentioned that mother’s milk is the best milk.89 It is decidedly

superior to other milk. It is remarkably adapted to the requirements of the infant and

provides the best start in life. The advantages of milk other than providing

nourishment for the infant to grow and develop are

It is useful in cleaning the morbid matter from the organs.


44

Good and sweet milk is useful in coryza.

It prevents entry of tez khilt in the organ. Above mentioned benefits

are seen when the milk is directly drunk from the breast since, the

hararat in air changes it quality.

It is the best substitute, in dissipation of rutubat asliya of the organ. In

this context especially mother’s milk is best substitute followed by

donkey’s and goat’s milk.

It is very beneficial in diq (tuberculosis).

It is very advantageous, since its constituents are similar to madda

oola from which rutubat asliya are formed. Hence, milk is tabayi

ghiza for infants.

Milk contains constituent like earthy matter, fat, proteins, water etc.

It has laxative property. It is also useful in septic wounds, diarrhoea,

conjunctivitis, nazla har, cancerous wounds, uterine and anal ulcers,

mouth ulcers etc.85

Production of Milk: The mizaj of human milk is har and ratab. 17, 89 Ali bin

Abbas Majoosi described that in the production of milk, secondary faculties simply

serve the nutrition to the breast and are four i.e. Quwate jaziba (attractive), maseka

(retentive), hazma (digestive) and dafea (expulsive facutly). The quwate jazba

(attractive faculty) of breast is responsible to attract what is beneficial (i.e. nutriment)

from the blood. The quwate maseka was created to retain these nutriments as long as

quwate mughaiyara (alterative faculty) acts upon it and derives nutrition from it. The

quwate hazema (digestive faculty) absorbs the matter drawn by the quwate jazba and

transforms it into a consistency ready for the action by quwate mughaiyara and also


45

change its temperament to become an actual nutriment viz., breast milk. The secretion

and discharge of the breast milk takes place with the help of the quwate dafea.83

Ajmal Khan mentioned that for the formation of milk quwate jaziba and

hazima of breast should be normal. 90

Regimen during Lactation

Ibn Sina described that following is the mode in which feeding of infant is to

be arranged. Whenever possible, the mother’s milk should be given by suckling. 91 As

the mother’s milk is nearest to the blood from which the baby has grown up as the

feotus. Such milk is better adapted for its further growth and development. The

blood in mother’s breast is converted into milk. This is beneficial for the infant and

more attractive and acceptable to its constitution.92 Experience shows that merely to

place the mother’s nipple into the infant’s mouth is a great help towards removing

whatever is hurtful to the infant. 91

The breast-feeding in the beginning should be given only two or three times a

day and large feeds avoided especially during first few days. 92

The infant should not be allowed to take much milk at one time. It is better to

feed little and often, at small intervals.91 The feeds should be small because large

feeds produce distension of the abdomen, cause excessive flatulence and urine

becomes white. 92

Inability to Breastfeed the Child: If mother is unable to feed her baby for

instance owing to her weakness or to the defective quality of her milk, or because it

runs too quickly, a wet nurse should be selected according to the following rules: age,

form or physique, personal character or habits, the shape of nipples, the quality of the


46

milk, the interval of time which has elapsed since her parturition, characters of her

own child.91

Testing the Milk: The consistency of milk may be tested by allowing it to run

over the finger nail. If flows easily, it is thin; if it does not flow over the inclined nail,

it is thick. Again place some in a glass vessel, and drop a little myrrh into it, and stir.

The aquosity and the degree of caseity are then evident. 91 It is to be regarded as a

good quality, if the mil separates into equal quantities of cheese and water. 92

Regimen for the Wet (suckling) Nurse:

Ibn Sina mentioned that the nurse should take moderate exercise daily and eat

wholesome food. During the period of nursing, she should abstain from sexual

intercourse as it would activate the menstrual flow and make the milk foul and

deficient. It also leads to a fresh pregnancy, which is harmful to both lives; the baby at

breast and the feotus in the womb. The suckling baby suffers because the lighter

portion of blood goes towards the feotus while the fetus suffers from nutritional

deficiency because it has to share the food with baby at the breast. It is necessary that

a small quantity of milk should be squeezed from the breasts and discarded before

each feed, especially before the morning feed. It is also necessary to keep the breast

(gently) pressed during feed, to assist the flow of milk and thus save the baby from

unnecessary strain and the exertion of suckling and thus prevent hurting the throat and

oesophagus. The feeds should be small because large feeds produce distension of the

abdomen, cause excessive flatulence and make the urine white. Sleep should be

encouraged to assist digestion. If the wet nurse becomes ill from some temperamental

disease or disturbance or from excessive diarrhoea or severe constipation then feeding

from her should be suspended and an arrangement made for the another wet nurse.


47

When, after the feed baby goes to sleep the cradle should be rocked gently and not

vigorously so that there is no splashing of milk in the stomach. A little crying before

the feeds is generally beneficial for babies. 92

Duration of Breast Feeding: The normal period of breast feeding is two

years. 18, 91, 92

Qillatul laban

Introduction:

Unani scholars mentioned that in qillatul laban, maternal milk production is

scanty. Ajmal Khan mentioned that qillatul laban causes psychological and emotional

trauma to the mother as the baby is not satisfied by the feeds, cries frequently,

malnourished, and fall sick recurrently. 90

Aetiopathogenesis: Ibn Sina mentioned that in qillatul laban, the milk

production is scanty, thus, the causes should be evaluated. The causes are altered

quality of blood where the madda khoon is decreased, or sue mizaj (abnormal

temperament) or ghair tabayi khilt.18 Ismail Jurjani was of opinion that mainly

qillatul laban is caused by sue mizaj saada or maddi of badan or pistan.16 Zakariya

Razi described that qillatul laban is caused by alteration in quality of blood occurs

due to qillatut dam, ghalbae safra or balgham.15 Akbar Arzani described that the

three causes for qillatul laban are (1) qillatut dam because of excessive heamorrhage

caused by fasd or puerperal or menstrual blood loss or suffering from chronic disease,

(2) in kasrate dam breasts are supplied by excessive blood and quwate hazima of

breast is not able to digest the nutriment sufficiently, thereby leading to decrease in


48

milk production and (3) sue mizaj saada or maddi will lead to fasad dam. Sue mizaj

can be diagnosed by sign and symptoms of sue mizaj. 19

Ajmal Khan described that the causes of qillatul laban are decrease

production of blood, anxiety, depression, or excessive hemorrhage, which leads to

zofe quwate jaziba (weakness of attractive faculty) of breast. He also mentioned that

excessive intercourse, excessive heat, or less affection for the child also leads to

qillatul laban. 90

Akbar Arzani17 described that the main causes of qillatul laban are qillatut

dam, kasrate khoon, and fasad khoon. He mentioned that qillatut dam can be caused

by fasd (venesection) nafaas (puerperal blood loss), haiz (menstrual blood loss),

qillate ghiza, the diet which is cold and dry, arazae badani or nafsani or sue mizaj.

In view of Kabiruddin and Azam Khan, the milk production depends upon on

the quality of blood, correct mizaj of breast, hence, the cause of qillatul laban might

be fasad khoon, or kasrate khoon. 93, 94

Symptoms

Ajmal Khan mentioned that patients will have symptoms depending on the

cause. The other features of qillatul laban are related to the baby that baby is not

satisfied by the feeds, cries frequently, and malnourished. 90

Ibn Sina mentioned that if the cause is abnormally hot temperament, it would

be known from the signs and symptoms. When milk is scanty due to excessive heat in

the breast, it would be known from their feel. 92, 95 In abnormal cold temperament,

sudda or obstruction will be present or zofe quwate jaziba of the body will be

present.18


49

The colour of the milk is yellowish, the consistency decreases and burning is

present when safra is dominant. The milk is more white and sour in taste because of

predominance of balgham. The milk becomes scanty, more viscid and turbid white in

dominance of khilte sauda. 16, 18, 19 Ismail Jurjani mentioned that sign and symptoms

of dominance of khilte balgham, safra, and sauda in the blood is noticed. 16

Diagnosis:

The dominance of khilt in qillatul laban is diagnosed by examing the pulse

and urine. If there is no dominance of khilt, history of not taking the proper diet or

taking barid or yabis diet or excessive blood loss or psychological and emotional

stress are present. 93, 94

Ilaj (Treatment):

Usoole Ilaj

The treatment is advised according to the cause.16

In sue mizaj saada, the mizaj is rectified by diet and drugs. 16, 18,94 In sue

mizaj of pistan like in ghalbae hararat, mubarrid zamad are applied

locally, in ghalbae burdat, musakhkhin tadabir is used.94

In dominance of khilt, istrefagh khilt is done.16, 93, 94

Ali bin Abbas Majoosi said that in ghalbae safra, tanqiya of safra is done.

He also mentioned that to enhance the milk secretion, diet or drugs that

increase the hararat of khilte balgham are used. It increases the flow of milk

toward the breast.83

In excessive hemorrhage, bleeding should be stopped.


50

The production of milk is increased by using drugs which increases the

production of mani (moallide mani). 16, 18, 19, 93 such as tudri safaid, tukhm

kashkhash safaid, and the nutritious diet which is hot and moist.16, 83

Zakariya Razi mentioned that all types of muqawwie bah advia are useful in

qillatul laban. If the milk had dried in the breast, tila with ushq is used.15

Diet:

Azam Khan mentioned that balance and nutritious diet is enough to treat

qillatul laban and drugs are not needed.94 He also mentioned that the diet which is hot

and moist such as milk, rice, chicken or honey with milk, faluda, halwa of egg yolk

or carrot are useful.93, 94 If the milk production is less because of malnutrition and

dryness, animal milk is useful. 16, 19

Akbar Arzani mentioned that qillatul laban caused by qillatut dam, diet such

as milk, egg yolk, and chicken meat are used to increase blood production. In kasrate

dam, fasd and hijamat are done and fasad khoon is to be rectified (Blood purification)

19

Ibn Sina writes that if qillatul laban, is caused by qillate ghiza, diet such as

harira of jaw, mixed with tukhme badiyan, bekh badiyan, tukhme shibat, kalonji is

useful.95

Advices:

Bed rest, avoid strenuous exercise and work.

Avoid psychological stress. 16, 18, 94


51

Treatment:

Ibn Sina mentioned that abnormal hot temperament should be treated with a

cooling diet consisting of barley water and spinach.92, 95

If there are signs of cold temperament, obstruction or inadequate absorption, diet

should consist have lateef (light) and slight hot things. Gentle cupping is also

given under the breasts. 92 In zofe quwate jaziba, or obstruction, tukhm gazar is

useful.95

In ghalbae safra, sheera maghze tukhme kaddu, sheera tukhme kurfa, ab anar,

sikanjabeen sada and tursh drugs as well as diet are given or sharbat niloufer

with maush shaeer is administered orally.

In ghalbae balgham, drugs with hot mizaj such as badiyan sabaz, shibat, and

fresh karaf is used. Harira of ard gandum with hulba, badiyan and honey is

advised and then hab mushil is given.93, 94 Ibn Sina mentioned that drug with first

degree mizaj is useful in qillatul laban.18

In ghalbae sauda, musakhkhin and muratib drugs such as harira of anjeer, jaw,

gandum with roghane badam is used. 93, 94

Mudir laban drugs are useful in qillatul laban such as methi, tukhme shaljam,

ghee, chana, etc.15


52

Inadequacy of Lactation

Synonyms:

Lactational inadequacy; 26 Breast milk insufficiency; 96 Lactation failure;97, 98

Mothers milk insufficiency (MMI);96 Perceived insufficient milk (PIM);13, 14

Insufficient breast milk; Partial lactation failure; 97, 99, 100 Neonatal insufficient milk

syndrome (Nims); Hypogalactia or lactation inadequacy; Breast feeding failure; 54

Suboptimal infant breast feeding (SIB) 74

Introduction: Scientific evidence overwhelmingly indicates that breast

feeding confers significant health benefits to mother and child and is the ideal method

for feeding and nurturing infants. The US public health goals are for at least 75% of

the nation’s new mothers to breastfeed at hospital discharge and at least 50% to

breastfeed throughout the first 6 months of their child’s life. 86 In populations with

sufficient economic resources, this may have minor consequences on the growth and

health of the infant, because adequate substitute nourishment is available. However, in

populations of low socioeconomic status, inadequate lactation can lead to severe

health problems in the newborn, whereas a full lactation can assure the normal growth

and development of the newborn even in situations of deficient availability of

nutrients for the general population.101 Moreover, inadequate breast feeding

contributes significantly to the high prevalence of malnutrition. 12 Malnutrition has

been responsible, directly or indirectly for 60% of 109 million deaths among children,

two-thirds being associated with inappropriate feeding practices. 3 Lactation

insufficiency or failure is relatively common among women.101 The commonest cause

of lactation failure was insufficient milk or no milk (80%). The age, parity, education,

socio-economic status, religion, family structure and urban vs rural status of motherall


53

had a bearing on the occurrence of lactation failure.11Mother’s perception of not

having enough milk is the commonest cause of discontinuation of breast feeding. This

perception often leads to infrequent suckling, leading to a true reduction in production

of breast milk. 12 Segura Millan et al. called oligogalactia as perceived insufficient

milk (PIM) and stated that it is one of the reasons mentioned most often by women

throughout the world for the early discontinuation of breast feeding and/or for the

introduction of supplementary bottles. 13 This is of public health concern because the

use of breast milk substitutes increases the risk of morbidity and mortality among

infants in developing countries and shortens birth intervals. It is interesting to note

that studies on infant feeding have shown that when women supplement with top

feeds the most common reason given is inadequacy of breast milk. 102

The complaint of “insufficient milk” is more often than not a wrong

perception of the mother, fostered by the mother’s uncertainty about her capacity to

feed her baby properly, no knowledge about the normal behavior of a baby (who

usually nurses frequently) and negative opinions of significant persons. The wrong

perception by the mother often leads to the introduction of complementary feeding,

which negatively affects milk production, as the infant tends to suckle less. 103

The reasons why a mother feels that she has insufficient milk are because the

baby cries often, wakes up frequently, demands frequent feeds or is irritable. The

mother should be told that an exclusively breast fed baby showing a weight gain of

500-1000 gm/month and passing urine at least 6-8 times/day is definitely getting

enough milk.3

The process of lactation and the act of breast feeding is quite complex,

because a range of factors in the mother’s external and internal environment


54

determines her breast feeding efficacy. Her internal environment includes her

physical and mental health, past experiences and intentions related to breast feeding,

and body image, all of which impact her breast feeding experience. Her external

environment, such as socioeconomic factors, her general physical environment, and

spousal, family, and hospital staff support also influence breast feeding success. And

most importantly, the quality and quantity of maternal–infant interaction during the

early postpartum period, sometimes described as the fourth trimester, sets the stage

for a successful breast feeding experience. 36

Definition: Lactation failure was defined as the need to start top feeds for the

baby within 3 months of delivery because of inadequate breast milk supply. 98

Total lactation failure was defined as either a total absence of milk flow or

secretion of just a few drops of breast milk following suckling for at least 7 days. 97,100

Partial lactation failure was defined as either inadequate milk output or the

need for supplemental feedings to sustain growth.97, 100

Incidence and Prevalence: Perceived insufficient milk supply is common

among postpartum women and is a major reason for early weaning. Studies indicate a

significantly higher incidence of insufficient milk supply in women who undergo

caesarean section as compared with women who undergo vaginal delivery. 104

Segura Millan et al stated that the incidence of oligogalactia has been

estimated to range from 23 to 63% during the first four months after delivery.13

Between 12.8% and 44% of infants reportedly experience suboptimal infant breast

feeding (SIB). 74


55

Forman and his colleagues in their prospective cohort study of 1005 Bedouin

Arab women who delivered healthy newborns in 1981 and 1982 described the factors

associated with milk insufficiency versus another reason for introducing the bottle and

its potential health effects by two months postpartum, 72% introduced the infant to

the bottle with 72% reporting milk insufficiency as the reason for introducing the

bottle. The percentage of milk insufficiency declined with increasing age of the infant.

105 In a study of breast feeding problems in rural Karnataka it was observed that not

enough milk was the reason for starting top feeds in 53.6% of cases. 106

Lindquist conducted a prospective study on perceived breast milk

insufficiency in a group of 51 healthy, well educated Swedish women during the

period three days to 18 months after delivery. The aims were to investigate the

incidence, causes and consequences of perceived breast milk insufficiency (transient

lactation crises), by relating this phenomenon to the infant's breast milk consumption

and growth, and to the course of breast-feeding. It was found that every second

mother experienced transient lactation crises on at least one occasion (the crisis

group). The crises were mostly caused by emotional disturbances in the mothers (e.g.

anxiety, stress and discomfort), or by the infant's refusal to suckle, by unmotivated

crying, or by illness. Within the crisis group no significant difference was found

between the infants’ intake of breast milk during the crises compared with control

measurements one week later. Nor had the crises any immediate impact on the growth

of the infants. A comparison between the mothers with crises and those who did not

experience any crises, revealed that the breast milk consumption among the infants in

the crisis group was lower throughout with significant differences at three and five

months. The infants in the crisis group also had a significantly lower weight at two,

three, four and nine months, although both groups were above the NCHS mean. The


56

reasons for initiating breast feeding differed between the two groups. The crisis group

tended to give infant related reasons to a higher degree than the mothers in the non

crisis group who more frequently mentioned mother related motives. The mothers

with crises also showed a greater ambivalence during the lactation period and

terminated the breast feeding somewhat earlier. Consequently they also introduced

taste portions and started the weaning significantly earlier. Some general findings

revealed a wide variation in breast milk consumption, not only between infants but

also in the same infant from one occasion to another. The total energy intake was

almost the same for the partially breast fed infants, receiving breast milk plus

supplementary food, and those who were exclusively breast fed. Although most

mothers in both groups initiated the weaning in accordance with general

recommendations, a wide variation was also found in the length of the weaning

period. In some cases it lasted for more than five months. 107

In Kabul, many mothers complain of a lack of breast milk and believe that this

is due to stress and not eating enough good food. Mothers presenting with breast milk

insufficiency raise a number of challenges for treatment of infants in feeding centres.

The admission criteria and treatment of these young infants in the TFUs in Kabul has

evolved over time. In 2003, the criterion of mother’s milk insufficiency (MMI), was

added to the existing admission criteria. In June 2005, the criteria were amended

further to admit infants with a weight for length less than or equal to 80% if the

mother reported she was suffering from a 'lack' of breast milk and the infant was not

gaining or was losing weight at home. 96

A lot of women discontinue breast feeding during the first few weeks of the

post partum period because of perceived insufficient milk and approximately 35% of


57

all women who wean early report PIM as the primary reason. Many women utilize

infant satisfaction cues as their main indication of milk supply and many researchers,

clinicians, and breast-feeding women do not evaluate actual milk supply. 108

Insufficient Milk Production

Primary Lactation Insufficiency

Five percent of mothers may have a primary inability to lactate due to

inadequate glandular tissue resulting from hypoplastic breasts, breast surgery such as

mastectomy, breast reduction, or cyst removal. 109, 110, 111

Breast surgery, including nipple piercing can disrupt the ductal and

neurological pathways. Additional causes of primary inability to lactate are severe

illness such as postpartum hemorrhage with Sheehan’s syndrome, infection, or

hypertension. 109

Clinicians also need to consider the possibility of retained placental fragments

that can be responsible for maintaining maternal progesterone levels sufficient to

delay or inhibit secretory activation (lactogenesis II). 14

Secondary Lactation Insufficiency: To establish a diagnosis of secondary

lactation insufficiency, the first step should be an objective measurement of the

mother’s milk production.14

Aetiopathogenesis:

Pre disposing Factors

Some factors pre disposing to or associated with inadequate suckling and lactational

failure includes


58

Factors in the Baby

Prematurity/low birth weight

Birth asphyxia

Illness

Defects e.g. cleft palate. 102 congenital heart disease, urinary tract infection 112

Maternal Factors

Maternal health: Anaemia, postpartum haemorrhage, 112 smoking

(moderate/heavy) 102, 112

Mammogenesis: Insufficient breast tissue, breast surgery (reduction)

Lactogenesis: Retained placenta, delayed breast feeding

Galactopoiesis: Inadequate breast drainage, infant tongue-tie

Milk intake: Restriction of frequency or duration of feeds 102, 112

Poor motivation or ignorance leading to discontinuation of feeds for minor

ailments, administration of infrequent strict time scheduled feeds, etc.

Inappropriate management of local problems in the breast e.g. flat and sore

nipples, engorgement, 102 retracted, short or too large nipples etc. 1

Sedation (also influences the baby) 102

Over anxiety 102

Excessive fatigue102

Drugs e.g. oral contraceptives 102

Wrong technique of breast feeding 1

Previous or chronic psychiatric disorders including depression may recur in

the postpartum period and interfere with maternal parenting abilities.111


59

Environmental Factors and Hospital Practices

Separation of the baby from the mother

Painful infections e.g. episiotomy, caesarian section etc. 102

Early introduction of bottle feeds102

Use of pacifiers102

Inadequate facilities for working women102

Inadequate support and guidance from health professionals102

High pressure advertisement of baby foods. 102

The causes of breast feeding failure are:

A. Perceived or Actual Milk Insufficiency, caused by:

1. Inappropriate feeding practices, rooted in:

2. Lack of understanding of the process of lactation.

3. Lack of knowledge of infant behavior.

B. Pain during Breast Feeding, caused by:

1. Nipple trauma from inappropriate technique or practices.

2. Breast pain from inappropriate technique.

3. Nipple or breast pain from pathological organisms

C. Lack of Support or Undermining the Decision, from:

1. Family and friends.

2. Health professionals.

3. Employers and school administrators. 58


60

Pathophysiology: Any maternal or infant factor that restricts the emptying of

the breasts may reduce breast milk synthesis, by mechanical and chemical inhibition.

The continuous removal of feedback inhibitor of lactation (FIL) from the milk

guarantees the total restoration of the removed milk. 37 Inappropriate latch on is the

major cause of inefficient milk removal. Infrequent and/or short breast feedings,

scheduled feedings, absence of breast feedings at night, breast engorgement, use of

complementary foods and use of pacifiers and nipple shields can also result in

inappropriate emptying of the breasts. Other less frequent situations associated with a

poor suck (cleft lip and/or palate, short frenulum, micrognathia, macroglossia, choanal

atresia, maternal or infant medication that causes drowsiness, neonatal asphyxia,

preterm birth, Down’s syndrome, hypothyroidism, neuromuscular dysfunction, central

nervous system diseases, abnormal suck), anatomical breast disorders (oversized,

inverted or flat nipples), maternal diseases (infection, hypothyroidism, untreated

diabetes, pituitary tumour, mental disease), retention of placental membranes,

maternal fatigue, emotional disorders, medications that reduce breastmilk synthesis,

important dietary restriction, breast reduction surgery, smoking and pregnancy are

possible determinants of low milk production. Therefore, it is important to have a

detailed history and a careful observation of breast feedings in order to rule out such

problems. 37 Women suffering a PPH may experience a transient hypotensive insult

and pituitary ischaemia and/or infarction resulting in inhibition of the hormonal

triggering of lactogenesis Stage II by prolactin. In rare cases, women who bleed

severely during childbirth may develop Sheehan's syndrome, or ischaemic necrosis of

the pituitary gland, in particular of the anterior lobe, secondary to hypoperfusion.

Failure to lactate or difficulties with lactation, due to absent or deficient prolactin

secretion, are common initial symptoms of Sheehan's syndrome. In addition, elevated


61

cortisol levels following such a stressful labour and delivery may also adversely affect

lactogenesis Stage II. Delayed early contact between mother and baby following a

complicated birth with PPH may also impact on a mother's ability to successfully

establish and maintain breast feeding. 50

Assessment of Adequacy of Milk

When milk is not sufficient, the infant does not feel satisfied after feedings,

cries a lot, wants to nurse frequently, takes very long feedings and does not gain

weight properly (< 20 g a day). The number of wet diapers a day (less than Problems

during lactation six to eight) and infrequent bowel movements, with a small amount

of stools, which are dry and hard, indirectly indicate low intake of milk. The

following signs indicate that an infant is not receiving enough milk in the first weeks

of life: weight loss greater than 10% of the birth weight, not regaining birth weight up

to two weeks of life, no urinary output for 24 hours, absence of yellow stools in the

first week and clinical signs of dehydration.103, 113 An infant’s milk ingestion is

accurately measured by test weighing, which entails weighing the infant before and

after a breastfeed without changing clothes or accessories between the two weighings.

14 This age old practice of test-weighing, recording the baby's weight before and after

feeding, is not only tedious but also fallacious and often just a waste of time in day-to-

day practice, although careful use of electronic balances and other more sophisticated

methods constitute good research tools. In clinical practice, however, the best way is

to determine how contented the infant is and to note whether he is sucking and

sleeping well and gaining weight at suitable intervals commonly employed in well-

baby and under five clinics 102 Is the baby wetting 4-6 diapers each day? After each


62

feeding the baby appear to be satisfied, or does the baby appear hungry by crying

vigorously and sucking frantically on his or her fist? 113

Diagnosis

There are a number of questions to ask about the mother’s general health:

Any medical conditions or breast surgery?

Does she smoke? (Smoking over 15 cigarettes daily may reduce milk

supply)

Any endocrinological issues such as hypothyroidism or polycystic ovarian

syndrome (PCOS)? Although some women with PCOS have no problems

breast feeding, there appears to be a group of women with PCOS with

insufficient glandular tissue to produce an adequate milk supply. 111, 112

Most women will experience breast growth during pregnancy (or rarely

this occurs in the postpartum period only. The general practitioner can ask

the mother if she noticed breast changes in the pregnancy or after the birth

– no changes may be an indication of insufficient glandular tissue.

If remnants of placenta are retained, lactogenesis II may be delayed.

Therefore, questions need to be asked about the birth and the completeness of the

placenta. Did she lose a lot of blood after the birth? Anaemic women are less likely to

continue breast feeding than other women.

Next, information is collected about the baby’s birth weight, condition and

loss of weight in the first few days.


63

Finally, more detail about the breast feeding pattern is ascertained:

How many feeds in 24 hours

How long is each feed

Does the mother offer one breast or two?

During the consultation, the GP will have noticed the mother’s general

appearance and mood. New mothers may be reluctant to disclose feelings of anxiety

or depression.

Studies have shown that obese women are less likely to be successful at breast

feeding, but at this stage it is not clear if this is physiological or behavioural.

The examination then focuses on the mother’s breasts. Indicators of possible

insufficient glandular tissue are: ‘tubular’ breast shape, noticeable breast asymmetry,

stretch marks, and wide intramammary distance (>4 cm). Evidence suggests that this

problem occurs in about one in 1000 women. Parents appreciate a careful examination

of the baby.

Ideally, the infant is examined before a feed, on an examination table with a

good light. Assessment includes the infant’s general health; hydration and looking for

possible muscle wasting (examine the gluteal region). Check the infant’s mouth for

congenital conditions that may not have been noticed in hospital: tongue-tie, cleft of

the soft palate, or sub-mucous cleft palate. Exclude congenital heart disease by

listening to the baby’s heart and checking pulses. If time permits, observation of a

breastfeed will provide more information. Improving attachment to the breast may

allow the infant to feed more effectively. Alternatively the infant may be sucking

poorly at the breast and may need supplemental feeding (with expressed breast milk if


64

available, or with infant formula) to ensure adequate intake until the mother’s supply

can be improved. 112

Investigation of Low Supply

When indicated, the woman’s haemoglobin level or thyroid function should be

checked. Uterine ultrasound can assess retained products of conception if this is

suspected. Maternal testosterone is raised in the presence of gestational ovarian theca

lutein cysts, a rare cause of delayed lactogenesis. Urinary tract infection may be

asymptomatic in infants, apart from failure to thrive, so a urine test may be

worthwhile for the infant. If the baby appears unwell, further investigations may be

required.112

Treatment

If milk production seems to be insufficient for the infant, due to low weight

gain, in the absence of diseases, the first thing to do is to check whether the infant is

properly positioned during breast feeding and whether the latch-on is appropriate. To

increase milk production, the following measures are useful:

Improve latch on, if necessary

Increase the frequency of feeding

Offer both breasts in each breast feeding

Allow the infant to empty the breasts completely

Alternate between breasts during the same feeding if the infant feels drowsy or

if he/she is not sucking vigorously

Avoid the use of bottles, pacifiers and nipple shields

Eat a balanced diet


65

Drink enough fluids (recall that excessive intake of fluids does not increase

milk production, and can even reduce it

Take a rest37

Relactation

When a mother chooses to stimulate lactation after a period of weaning or

decides to breast feed after having never breastfed, the term relactation is used. 114

In Partial Lactation Failure

Satisfactory relactation in these mothers is attained by motivation and

encouragement. They need to be educated on the supremacy of breast milk and

actively involved in achieving success with ‘commitment for the cause’. As the days

pass by, the amount of top feed needs to be reduced in increments until the infant is

entirely of mother’s milk. 1

In complete Lactation Failure

This is rather more difficult situation. In addition to motivation,

encouragement and moral support, the following actions are warranted:

Nipple stimulation exercises by nipple stroking, massaging the breast and

rolling the nipple between thumb and the index finger.

Frequent suckling, at least 8 to 10 times a day, each session lasting 10 to 15

minutes for each breast.

Drop and drip method may be employed if the infant fails to suckle for 8 to 10

minutes. The method consists in expressing some breast milk or top milk in a

cup and gradually pouring it over as drops over the breast. As the drops slide


66

over the nipple down into infant’s mouth, he is stimulated to suckle at the

breast. 1, 115 Nursing supplement may be used to induce suckling in the infant.

This gadget consists of a fine infant feeding tube. The tube is employed as a

drawing straw. It is made to pass from milk in a cup to the infant’s mouth. Its

end is placed along with mother’s nipple so that the baby suckles at both the

nipple and the tube simultaneously. As he suckles when milk passes into his

mouth, the nipple gets stimulated, thereby enhancing the prolactin reflex

which increases the milk production.1

Evidence of Successful Relactation

Appearance of first milk secretion in 2 to 10 days.

Partial restoration of breast feeding with reduction of top feed to half of the

initial.

Complete restoration of breast feeding with total withdrawal of top feed.

Satisfactory weight gain by the infant. 1

Galactagogues

Galactagogues (or lactogogues) are medications or other substances believed

to assist initiation, maintenance or augmentation of maternal milk production.

Because low milk supply is one of the most common reasons given for discontinuing

breast feeding, both mothers and physicians have sought medicine to address this

concern. Common indications for galactagogues are adoptive nursing (induction of

lactation in a woman who was not pregnant with the current child), relactation

(reestablishing milk supply after weaning), and increasing a faltering milk supply

because of maternal or infant illness or separation. 21, 22 Mothers who are not directly


67

breast feeding but are expressing milk by hand or with a pump often experience a

decline in milk production after several weeks. One of the most common indications

for galactagogues is to augment a declining milk supply in mothers.21

Metaclopramide

The vast majority of published clinical data evaluating the use of drug therapy

for breast milk production focuses on metoclopramide, which promotes lactation by

antagonizing the release of dopamine in the central nervous system. 22, 116 This drug

can cause extrapyramidal side effects, which may include tremor, bradykinesia, (slow

movements) and other dystonic reactions. Kauppila et al reported a dose response

relationship between improved lactation and metoclopramide 5, 10, or 15 mg 3 times

daily in 37 mothers who had deemed their breast milk production insufficient during

the initial 2 months after delivery. Daily doses of 30 and 45 mg of metoclopramide

resulted in significant increases in serum prolactin levels and milk yield, with the 45

mg daily dose producing a faster onset of effect. 22

Metoclopramide have been linked to accelerated declines in the protein

concentration of breast milk and also to changes in the electrolyte composition of

breast milk. 117

Domperidone

Domperidone is also a dopamine antagonist 22, 117 that is available outside the

United States for the treatment of chronic postprandial dyspepsia, reflux oesphagitis,

and emesis. The usual oral dosing range varies from 10 mg 3 times daily to 40 mg 4

times daily dependent upon indication. 22 Administration of domperidone results in

increases of mean serum prolactin levels in normal women from 8 to 111 ng/mL


68

following a single 20 mg dose.22, 117 Doses used for induction and maintenance of

lactation range from 10 to 30 mg 3 times daily. In a recent, randomized, double-

blind, placebo controlled study, 20 women were assigned to receive either

domperidone (11 women) 10 mg orally 3 times daily or placebo (9 women) for 7

days.17 In the final analysis, 4 women were excluded, 3 had incomplete milk records,

and 1 infant died of neonatal complications. As compared to baseline, the mean

increase in milk yield from days 2 to 7was significantly higher (P < .05) in the

domperidone group (50 ± 29 mL) as compared to the placebo group (8 ± 40 mL),

even though the domperidone group had a significantly higher milk volume at

baseline. In addition, serum prolactin levels were significantly increased by

domperidone therapy (P = .008). 22

Sulpiride

Sulpiride is a typical antipsychotic that serves as a galactagogue by increasing

hypothalamic prolactin releasing hormone. The typical dosage for initiation of

lactation is 50 mg 2 to 3 times daily. Maternal side effects include extrapyramidal

effects such as tremors, bradykinesia, or acute dystonic reactions, and possible

endocrinological concerns such as weight gain. The use of sulpiride to increase milk

production has been evaluated in 2 studies. Ylikorkala et al administered sulpiride 50

mg orally 3 times daily or placebo to 24 women who believed their milk yields to be

insufficient during the initial 4 months after delivery. Therapy was continued for a 2

week period. In addition, supplemental buccal oxytocin was administered to some

patients. One woman in the sulpiride group and 3 in the placebo group discontinued

therapy owing to lack of effect. Daily milk yield was significantly greater with

sulpiride therapy versus placebo both at 1 week (628 ± 51 mL vs. 440 ± 68 mL) and 2


69

weeks (684 ± 67mLvs. 423 ± 60 mL) of treatment (P < .05). Higher serum prolactin

concentrations were also noted in women receiving sulpiride therapy. 22

Thyrotrophin-Releasing Hormone

Thyrotrophin-releasing hormone (TRH) is available in the United States as a

diagnostic agent in the assessment of thyroid function. It is structurally similar to

naturally occurring TRH, which increases the release of both TSH and prolactin.

Peters et al evaluated the use of TRH as a galactagogue in 19 women with inadequate

lactation, defined as less than 50% of normal milk yield, on the fifth day postpartum.

In a random fashion, 10 of the women received a nasal spray formulation of TRH and

9 received a 0.9% sodium chloride spray for 10 days starting on day 6 postpartum.

One spray, equivalent to 1 mg of TRH, was administered 4 times daily at pre

specified times. At the end of the initial 10-day period, milk production was

significantly increased in the TRH group from a mean of 142 gm/day to 253 gm/ day

(P = 0.014). Seven women in the TRH group requested further treatment for an

additional 10-day period. Continued therapy resulted in a further increase in milk

yield, up to 424.3 gm/day. Administration of long-term high-dose (40 mg) oral TRH

administration has been associated with the development of hyperthyroidism in

women administered the medication, but this effect was not observed in patients in

this trial. 22

Oxytocin

Although used commonly in the past in the United States, oxytocin is no

longer on the market. Oxytocin is typically used to promote milk letdown; however, it

has been evaluated to enhance the onset of lactation among 8 mothers of premature

infants. Subjects were given a spray bottle containing either oxytocin 40 U/mL or a


70

blank solution and were instructed to administer 1 spray in each nostril (total dose of

3 U oxytocin) prior to pumping milk. The effect of the spray on milk production was

highly significant, resulting in a 3- to 5-fold increase in milk production in primiparas

and a 2-fold increase in multiparas. No significant change in composition of breast

milk was noted. 22

Chlorpromazine

Chlorpromazine, another typical antipsychotic, has also been used as a

galactagogue. It is conformationally similar to the dopamine molecule and has the

ability to bind and block the dopamine receptor, resulting in increased prolactin

levels. 22

Growth Hormone

The exact mechanism of action by which human growth hormone may

stimulate lactation remains unknown. The development of a controlled trial to

evaluate the effects of human growth hormone on lactation was based on animal data

observed in cows. In this randomized, double-blind, placebo-controlled trial, 16

healthy, lactating women received either recombinant human growth hormone in a

dose of 0.1 IU/kg/day subcutaneously, or placebo injection, on days 3 to 9 of a 10-day

study period. At baseline, milk production volumes were similar in both groups. After

7 days of therapy, there was a significant increase (P< .02) in milk volume in the

human growth hormone–treated group (18.5 ± 1.5%) as compared with the placebo-

treated group (11.6 ±2.0%). mothers. The use of this drug as a galactagogue is

limited. Studies evaluating the use of human growth hormone in women with actual

lactational insufficiency are lacking, as is safety data in breast feeding infants.


71

Therefore, metoclopramide 10 mg orally 3 times daily for approximately 1 to

2 weeks should be considered the therapy of choice for the initiation and maintenance

of lactation; improvement in milk production generally occurs in 2 to 5 days. Both

mothers and infants should be observed for extrapyramidal side effects. Domperidone,

another dopamine receptor antagonist, crosses into the breast milk and blood-brain

barrier to a lesser degree than metoclopramide and may be an alternative option if

available. Sulpiride and chlorpromazine are typical antipsychotics that have been

documented to be effective as galactagogues. However, the possibility of adverse

effects such as extra pyramidal reactions and weight gain limit their use. Human

growth hormone and thyrotrophin-releasing hormone are other agents that have been

utilized, but these agents have very limited clinical experience behind them. Oxytocin,

although widely used in the past, has limited scientific data as a galactagogue and is

no longer available in the US market. 22

In some selected cases, when the measures mentioned above do not work, the

use of medications may be useful. The most widely used medications are

domperidone and metoclopramide, dopamine antagonists, which increase prolactin

levels. Domperidone, widely used in Canada and Mexico, does not cross the blood-

brain barrier, which makes it safer than metoclopramide, with fewer side effects, and

may be used for an undetermined time period. However, these drugs seemingly do not

stimulate milk secretion when prolactin levels are already sufficiently high or when

there is not enough glandular tissue. 118

Metoclopramide and chloropromazine may help certain mother with lactation

failure to revert to normal milk production through their galactagogue effect. 1


72

Metoclopramide (Maxolon, Beecham) is a more effective releasing agent for

prolactin than TRH. There is some indication that it increases milk production in

women with lactation failure (Sousa, 1975). One placebo controlled trial showed that

metoclopramide was more effective than placebo at maintaining failing lactation. 20

Herbs and Natural Substances

The use of natural products believed to be able of increasing milk production

has a long history. The most frequently used products include fenugreek, galega, and

Mary's thistle. Anise, basil, fennel, mauve, verbena, cumin, grape, and coffee have

also been traditionally used.

Fenugreek (Trigonella foenum graecum)

Fenugreek is a natural product that is a member of the pea family. It has been

used for a variety of indications, including treatment of cough, bronchitis, sore

throats, and menstrual pain. Anecdotal reports of the successful use of fenugreek as a

galactagogue have been documented as far back as 1945. However, formal published

clinical data are lacking. A specific mechanism of action is unknown; however, it has

been theorized that fenugreek may affect breast milk production by stimulating sweat

production, and the breast is a modified sweat gland. In a clinical practice setting,

Huggins describes the anecdotal use of the herb in at least 1200 women. Generally, all

the women who consumed fenugreek reported an increase in milk production within

24 to 72 hours after initiation of therapy. Discontinuation of the herb can occur after

milk production is stimulated to an appropriate level and maintained as long as breast

stimulation and emptying continue. The recommended dose of fenugreek for use as a

galactagogue is 2 to 3 capsules 3 times daily. 22


73

Fenugreek is used in India and in some middle Eastern countries as a spice and

a medicine. It is believed to have a number of therapeutic uses, including anti-

inflammatory, reconstituent and galactagogic effect. One study on the effect of

fenugreek on lactation has been reported. Swafford asked 10 mothers to maintain a

diary of the quantity of milk produced with a pump for a period of two weeks. In the

first week, baseline milk production was evaluated; in the second week, mothers took

fenugreek, 3 cups, three times daily. In the first week average quantities were 207

ml/day, whereas, milk production in the second week averaged 464 ml/day (p =

0.004). Unfortunately, the report excluded any information regarding the

characteristics of the mothers enrolled in the study or the postpartum period during

which the study was done. Nevertheless, the daily milk quantities reported during

treatment do not seem to be particularly high. 116

Silymarin (Milk thistle, Silybum marianum)

While its major application has been to act as a liver protector, in recent years

silymarin has been reported to have a galactogogic effect. The active compound in

milk thistle, derived from dried seeds, is silymarin. Silymarin comprises four

flavolignans: silybin (60-70%), silychristin (20%), silydianin (10%) and isosilybin

(5%). Silybin in the most active component of the mixture and is available in poison

centers as an injectable medication for the treatment of food poisoning by Amanita

phalloides The flavolignans are bioflavonoid phytoestrogens. They posses a steroid-

like structure which might explain their ability to protect the liver by stimulating

protein synthesis. It is also possible that they could act on estrogen receptors (ER2) by

limiting the endogenous receptors antagonism of milk production. In addition to the

data on the galactagogic activity of milk thistle in cows, a single human is also


74

available. The authors who stated that the product was not transferred to maternal

milk administered, to 25 women, 420 mg orally of micronized silymarin and to

another 25 placebo for 63 days. They evaluated the quantity of milk produced on days

0, 30, and 63, and they collected milk samples for a qualitative profile. The authors

reported an increase in daily milk production equal to 86% in the treated group,

versus 32% in the placebo group. A significant limitation of this study was the lack of

detailed information regarding the characteristics of mothers and infants under test.

The average age of infants at enlistment time was 4.5–5.2 months. The study was

neither randomized nor double blinded. 116


75

Fig 2: Cause of Lactation Inadequacy

Maternal psychological risk factors

Maternal biological risk factors

Preparation of lactation inadequate

Maternal social risk factors

Breast stimulation inadequate

Maintenance of lactation inadequate

Breast drainage incomplete

Maternal breast feeding incorrect

technique

Infant breast feeding: ineffective technique

Milk transfer inefficient Milk ejection reflex impaired

Frequency: infrequent

Duration: inadequate

Milk intake inadequate Pattern of breast use inappropriate

Infant growth impaired


76

Pambadana

Introduction: Maghze tukhme pambadana is kernel of Gossypium herbaceum

Linn. It is one of the most important and earliest domesticated plants in the world.

The word "cotton" originated from the Arabic term ‘al qutn’, which became in

Spanish ‘algodón’ and cotton in English. Cotton was first domesticated in the Old

World about 7,000 years ago.119 It was native to India, having numerous varieties in

this region.120 A legend was perpetuated from a factual description of this plant by

Greek historian Herodotus in the 5th century BC.121 It was first cultivated in China by

about 600 AD.121 The plant is mainly grown for its fibres, which were used to make

clothing and similar products. However, it has been widely used in the production of

food and medicine as well. Cotton is not only a valuable source of vitamins but an

excellent pain reliever.

Botanical Name : Gossypium herbaceum Linn.122 or Gossypium

indicum Lam.123

Family : Malvaceae123

Vernacular Name:

Unani name : Pambadana 124

Arabic : Habbul qutn; 125, 126 Qutn 122

English : Bona; 125 Kapasia; 125 Common cotton; 125 Indian

cotton; 122, 123, 125 Levant cotton127

Urdu : Pambadana; Habbul qutn; Rui 122


77

Hindi : Kapasa; 125 Binaula; 125 Kapas; 32, 122, 124, 125

Kupas; 125 Rui; 32, 122, 125, 126, 127

Persian : Pambadana 125, 126, 127

Sanskrit : Tundakesi; 125 Karpas; 125 Anagnika ; 122, 123

Chavya ; 122, 125 Karpasasarini; 122, 125

Kannada : Hati; Arale; Ambara; Arali; Karpasa 125

Mahiyat (Description in Unani literature): Pambadana is a famous drug,

which is also called tukhme kapas. The maghz (kernel) of the seed is used. It is grown

in India, Pakistan and America.30 The seeds are very small. It has two varieties of

plants. The outer covering of the seed is gray with white kernel. The taste is slightly

bitter.126 The pambadana oil is used for edible purposes. The oil is sweet and has

special smell. The flour of pambadana is five times more muqawwie than wheat flour

and two and half times more muqawwie than meat. 31

Mizaj (Temperament):

Seed: Har and ratab in 2nd degree 30, 31, 124, 126, 128

Leaf: Har and yabis in 2nd degree 126

Nafae Khas: Seed

Muqawwie bah 30, 126

Mulaiyan seena 30, 126


78

Af’al (Actions): Seed

Moallide sheer 31, 30

Muqawwie bah 30, 31, 32, 124, 125

Musmmine badan 30, 88, 124, 125

Moallide mani 30, 31, 124, 125

Munaffise balgham 30, 31, 124, 125

Jali 30, 124, 125

Mulaiyan 30, 32, 88

Iste’mal (Uses):

Seed:

It is used for qillatul laban, sual, 30, 32, 126 zeequan nafas, 31, 124 zofe

bah,30, 31, 124, 126 zofe aam,125 ziabetes 31 ikhtenaqurrehm, 31, 126 amraz riya,

31 amraz jild 31, 32, 126

Leaves:

Water of leaves is used in ishal atfal.

Zimad of leaves with roghan gul is used in niqras

Zaroor is used to stop bleeding from the wound 126

Miqdar khurak (Dosage): 3-7 g;30, 124, 125, 126 6 – 20 g; 126 25.5 g 128

Muzir (Adverse effects): Harmful to kidney 124, 126 and hot temperament patients 30

Musleh (Corrective): Banafsha; 128 khamira banafsha; sharbat banafsha 30, 126


79

Badal (Substitutes): Phali babool (Acacia nilotica);124 tukhm kikar 129 tukhm

qurtum126

Important formulations: Majoon arad khurma,124, 125 majoon mumsik124 and majoon

pambadana124, 125

Ethno botanical Description: It is a shrub 0.6 – 2.4 m height extensively

cultivated in India, having numerous varieties in this region. This plant was

mentioned in indigenous systems of medicine. An erect, shrubby, hairy plant, 2-8 feet

high with thick woody stem and twigs and leaves sparsely hairy, rarely glabrous.

Leaves are 5-7 lobed, lobes ovate, and rotundus only slightly constricted at base.124, 127

Bracteoles with 6-8 serrated teeth on the margin, broadly triangular, usually broader

than long. Flowers are large, yellow with purple center. Calyx base with black

glandular dots. Capsules ovate, and pointed.124

Cotton seed is a by-product of the cotton ginning industry. Commercial cotton

seed as obtained from the Gin, contains besides the seed proper, remnants of unginned

lint and a thick coating of short fibers constituting the fuzz. The fuzz is present in

almost all types of cotton. The seeds after the removal of fuzz are dark brown or

nearly black in colour, pointed ovoid in shape and vary in size from 5.0 to 20 mm in

Length.

Habitat: It is native to the semi-arid regions of sub Saharan Africa and Arabia

where it still grows in the wild as a perennial shrub. It was probably first cultivated in

Ethiopia or southern Arabia and from there, cultivation spread to Persia, Afghanistan,

Turkey, North Africa, Spain, Ukraine, Turkestan and finally, to China.121

Part used: Seeds,124, 127 leaves,127 root,124, 127 and root bark. 127


80

Taste: Slightly bitter

Phyto-chemical Constituents:

Organic: The cotton seed contains glycosides, steroids, resins, saponins,

carbohydrates, proteins and phenolic compounds tannins.124, 130 It contains an

adequate amount of other essential amino acids. The biological value and digestibility

of the total proteins of cotton seed are 91 and 78 respectively. The mineral

constituents of the cotton seed are: phosphorus 1.03–1.33; calcium 0.24-0.04; iron

0.02-0.03; 124, 131 potassium 0.94-1.07; sodium 0.05-0.14; magnesium 0.44-0.56;

manganese 0.03-0.04; aluminium 0.01- 0.06; silica 0.12-0.39; sulphur 0.17-0.28 and

chlorine 0.92–0.04. Traces of copper, boron, zinc, nickel, strontium and barium are

also reported to be present. The oil free cotton seed meal contains iodine and fluorine.

Cottonseed is rich in vitamins of the B-Complex (thiamine, 3.2; riboflavin, 2.3;

nicotinic acid, 16; pantothenic acid, 11; pyridoxine,0.91; biotin,0.29; inositol 3,400

and folic acid, 3.8g on dry wt basis). Vitamins A, D, and E are also present. 131

The principle pigment of cotton seed is gossypol, a phenolic compound,

present to the extent of 0.4-2.0% in the kernels. Other pigments present in the seed are

gossypupurin, gossyfulvin, gossycaerulin, carotenoids and flavones, yellow pigment.

The unsaponifiable fraction of Indian cottonseed oil contains sitosterol and

ergostoerol.

Other substances present in cotton seeds are saponins, lactic acid, choline,

betaine and sulphydryl compounds. Cottonseed is rich in total phosphorus, phytins

and phosphatides. Phytins accounts for 72% of the total phosphours present. 131


81

Actions:

Cottonseed is demulcent, laxative, expectorant,123, 131 galactagogue,31, 131 and

aphrodisiac. 123

Uses:

Seeds

It is used as a nervine tonic in headaches and brain affections, and decoction

of the seeds are given in dysentery and intermittent fever. 31, 123, 131

The seeds in the form of emulsion are given in dysentery.

Pounded and mixed with ginger and water they are applied to orchitis.

The seeds in the form of poultice make a good application to burns and scalds.

The cotton seed oil is useful in clearing the skin of spots and freckles. 123

Leaves

The juice of the leaves is useful in dysentery.

The leaves externally in the form of poultice hasten the maturation of boils

and with oil they are applied as a plaster to gouty joints. 123

Leaves of Bambusa arundinacea (Retz.) Willd., (bans) and root bark of

Gossypium herbaceum Linn. (kapas) are mixed together and given with water

to induce abortion. 132

Leaves of Gossypium herbaceum Linn. (kapas) and Bambusa arundinacea

(Retz.) Willd. (Bans) are given orally to augument labour. 132

Leaves of Gossypium herbaceum Linn. (kapas) are given orally in retention of

placenta. 132


82

Root

The root has emmenagogue property, useful in dysmenorrhoea and

suppression of the menses produced by cold.

It is used to enhance the first stage of labour. 123 It is used for sual (cough),

zeequn nafas (asthma) and zofe bah (sexual weakness).

Decoction of root of Gossypium herbaceum Linn are given orally in retention

of placenta. 132

Pharmacological Studies:

Anti-bacterial Activity: Agarwal et al mentioned that the extracts

of Gossypium herbaceum have antimicrobial, anti- mutagenic and

hepatoprotective properties. 133

Anti-cancer Activity: Mi et al investigated the in vitro and in vivo activities

and related mechanism of apogossypolone (ApoG2) alone or in combination

with adriamycin (ADM) against human hepato-cellular carcinoma (HCC).

They concluded that ApoG2 is a potential non-toxic target agent that induces

apoptosis by up regulating Noxa, while inhibiting anti-apoptotic proteins and

promoting the effect of chemotherapy agent ADM in HCC.134

Anti-depressant Activity: One of the study showed that aqueous extract of

Gossypium herbaceum showed significant antidepressant-like effect due to

activation of adenyl cyclase-cAMP pathway in signal transduction system and

hence protecting the neurons from the lesion. 135

Anti-fertility Activity:


83

1. Gossypol, a yellow phenolic compound isolated from cotton seed oil was

proposed as a male contraceptive. Hadley et al found that gossypol

treatment reduced the level of serum testosterone and luteinizing hormone

levels in dose and duration dependent manner. Gossypol acts directly on

testes and induces azoospermia or oligospermia. Zavos and Zavos

demonstrated that gossypol blocked cAMP formation in sperm, which

resulted into inhibition of sperm motility. Nair and Bhiwgade have studied

the effect of gossypol on pituitary gonadal axis and found the decreased

secretary activity of accessory sex glands. Bai and Shi also investigated

inhibition of T type Ca currents in mouse spermatogenic cells by gossypol.

Antifertility activities were also found in hamsters and in rats. 136

2. Bender et al examined the tissues of female rats treated with gossypol

acetic acid for morphologic evidence of an underlying mechanism of

infertility. The number of oestrous cycles, and body and adrenal weights

were also compared. The number of oestrous cycles decreased in rats

treated with 60 mg/kg gossypol acetic acid for 30 days. Body weights were

also reduced in rats treated with 40 mg or 60 mg/kg per day for 30 days

when compared to controls. However, no significant differences were

found in any group when comparing adrenal weights, adrenal weight/body

weight ratios or adrenal histology. The body weight loss was related, at

least in part, to diarrhoea and dehydration in eight of the treated animals. It

is interesting that though the gossypol treated rats had reduced numbers of

estrous cycles, no histopathologic changes were found in their ovaries,

uterus or vagina.137


84

3. A study was carried to examine the role of Sertoli cells in the anti-

spermatogenic action of two non steroidal male contraceptive compounds

(CDRI-84/35 and gossypol) by evaluating their effect on some key

parameters of Sertoli cell function in vitro. The authors concluded that that

the anti-spermatogenic action of CDRI-84/35 and gossypol is routed

through Sertoli cells by disruption of important cell functions that support

spermatogenesis in-vivo. However, the two compounds appear to have

different course of action in Sertoli cells, ultimately leading to

spermatogenic failure.138

Anti-microbial Activity: Free flavonoid fraction of seeds of G. herbaceum and

G. hirsutum showed activity against B. cerus, S. epidermidis, T. viride and

Salmonella typhimurium, E. coli, T. viride respectively but effective on C.

albican. 139

Anti-oxidant Activity: Gossypium herbaceum L. seeds are reported to have

antioxidant activity, anti-diarrhoeic, wound healing, anti-migraine, diuretic and

dysmenorrhoea. 140

Galactagogue Activity: The studies conducted in buffaloes, showed that cotton

seed feeding enhances the milk production significantly (P<0.0l) in comparison

to concentrate mixture fed control group animals. 141, 142, 143

Hepatoprotective Effect: A hepatoprotective effect of G. hirsutum and G.

herbaceum extracts is reported by Batur et al. (2008). A “tintura do algodoeiro” is

used as a component in a phyto-therapeutic agent (Robuterina®), which is used to

treat menstrual cycle disorders. This medicine further includes Berberis vulgaris

L., and Gossypium herbaceum L. It also acts as an emmenagogue, hemostatic and

oxytocic and has anti-inflammatory activity.


85

Preclinical Toxicity: A phyto-therapeutic preparation containing Gossypium

herbaceum (cotton plant) was tested by Mello et al. (2008) for preclinical

toxicity, and the results revealed the absence of systemic toxicity at a therapeutic

dose.

Gossypium herbaceum L. and other species of the Malvaceae family were tested

using AchE inhibition in vivo for acetycholinesterase inhibition. 144


86

(a)

(b)

Fig 3: (a): Cotton seeds; (b): Cotton Plant

methodology

Methodology

87

A single-blind randomized placebo controlled study was carried out to

evaluate the efficacy of maghze tukhme pambadana in the management of qillatul

laban (inadequacy of lactation). The hypothesis of this study was that the use of

maghze tukhme pambadana pambadana in the test group compared with placebo

group would at one month from the baseline to be effective in enhancing maternal

milk production.

Study Design: A prospective, pre and post evaluation, single-blind, placebo-

controlled simple randomised trial was conducted between December 2010 and April

2012. The participants with qillatul laban who fulfilled the inclusion criteria were

recruited from the Department of Ilmul Qabalat wa Amraze Niswan, NIUM, Primary

health care (PHC) centre of Heganahalli and Kamikshipalya. A total of 45 lactating

mothers were randomized by lottery method to either receive test drug (n=30) or

placebo (n=15). The study was approved by the institutional ethical committee and

written consent was obtained. The data was analysed and compared after completion

of the trial.

Participant Selection: The lactating mothers with qillatul laban were

selected on the basis of inclusion and exclusion criteria.

Inclusion Criteria

Lactating mothers who delivered at term without complication

Baby weight not less than 2000 g at birth

Baby between 10-180 days of age

Failure to regain infant’s birth weight at 15 days of life

Mothers supplementing top feed ≥250 ml/day after 4 weeks of birth

Methodology

88

Exclusion Criteria

Mothers

Chronic diseases such as Tuberculosis, malignancy and AIDS

Breast abscess, cracked nipples, epilepsy, psychosis, alcohol addiction, and

mastitis

Had previous breast surgery

Infants

Weight less than 2000 g

Prematurity and inborn errors

Data Collection

Procedure

The mothers who came for routine immunization of the baby in the PHCs and

NIUM were screened. A total of 45 lactating mothers were selected and randomized

on the basis of clinical diagnosis and serum prolactin level. They were regarded to

have inadequacy of lactation, if they stated that her breast milk supply was not enough

to meet the breast milk demand of her infant. Firstly, the inadequacy of lactation was

considered when lactating mothers had introduced supplementary feeds or

discontinued breast feeding. Secondly, if the lactating mother was fully breast feeding

or did not report inadequate lactation in response to previous question, she was asked

directly, if she had experienced inadequate lactation. Qillatul laban or inadequate

lactation was defined as the maternal report of delayed “milk arrival” “low milk

supply” “infant not full after feeding” and/or “milk dried up”. Few mothers did not

mention the name and parameters for the inadequacy of breast milk production.

Methodology

89

During the selection procedure lactating mother’s and infant’s complete

history, general physical, and systemic examination were done to assess health,

nutritional status and to identify the cause for introducing top feeds and subsequent

lactation failure. All the information was recorded on a prescribed case record form

(Annexure I). The participants were enquired about their name, age, sex, marital

status, menstrual history, parity, and address. In socioeconomic history, subjects were

inquired about their monthly income, education and occupation, which were assessed

by Kuppuswamy’s Socioeconomic Scale. 145

History of inadequacy of lactation was elaborated to include the duration of

complaints and quantity of breast milk, number of feedings, duration of feeding and

the time of introduction of top feeds. History was taken regarding baby’s excessive

cry, not gaining weight, sucks fingers, and appears dissatisfied in spite of frequent

breast feeding, at night disturbing the sleep, and associated complaints were noted.

Information regarding suckling of infant in term of good/average or poor was noted.

Volumes of supplemental feed, frequency of urine, motion and sleep in hours were

enquired.

Detailed obstetrical history was obtained. More emphasis was given for

present delivery whether, it was normal or assisted and if cesarean, whether

emergency or elective was noted. The history after delivery relevant to breast

feeding was also recorded e.g. pre-lacteal feeds was given, time of first feed after

delivery, if initial delay was found then they were asked either due to medical reason

or traditional.

Emphasis was also given on family history of inadequacy of lactation, past

history of taking medications, other gynaecological and systemic disorders. Dietary

Methodology

90

and other habits were inquired in personal history. The mizaj was assessed by using

temperamental scale (on the basis of alamate ajnase ashra) as described by ancient

Unani scholars (Annexure III). General physical and systemic examination was

conducted to exclude general and systemic diseases respectively. Examination of the

mother included height, weight, general physical examination, nutritional status,

anaemia and vital were noted. Examination of breasts and nipples regarding colour,

condition of nipples like cracked, fissured, discharge or any other abnormality in

nipples were noted. In examination of baby, sex, height (cm), head circumference

(cm) and weight (g) were recorded. Weight was recorded by the same observer using

electronic digital baby scale, which was periodically standardized. Pattern of breast

feeding was noted, if history of bottle f/supplementary feed was found positive, the

mothers were provided similar bottles of 125 ml capacity. Mothers were advised to

note the volumes of top feed per day given to the infant.

Informed Consent

Lactating mothers who fulfilled the inclusion criteria were shown information sheet

having details regarding the nature of study, and the drugs to be used. They were

given enough time to go through the study details mentioned in the information sheet.

They were given the opportunity to ask any question and if they agree to participate in

the study, they were asked to sign the informed consent form.

Investigations

Routine investigations like complete blood picture, ESR, RBS SGOT, SGPT,

alkaline phosphatase, serum creatinine, blood urea and routine urine examination

were done to exclude general diseases.

Methodology

91

Specific Investigation

Serum prolactin

Intervention

Criteria for Selection of Drug: Test drug, maghze tukhme pambadana is in

use for long time to enhance maternal milk production. It has moallide sheer,30, 31

muqawwie bah,32 and musmmine badan 30 properties.

Test Drug: Orally

Maghze tukhme pambadana was provided by the pharmacy of the institute.

The Maghz (kernel) was removed from the seeds and cleansed.

Method of Preparation, Route of Administration and Dosage

The test drug was finely powdered. Ten gram of powder filled in the capsules

was administered orally with 125 ml of milk, in three divided doses for one month.

Placebo

Preparation: The roasted wheat flour was provided by the pharmacy of the institute.

Dosage: 10 g powder was given for the same period of time as that of the test drug.

Assessment of Efficacy

The efficacy was assessed by considering successful lactation in qillatul

laban, if the following subjective and objective criteria were fulfilled.

Methodology

92

Subjective Parameters

Tingling sensation or feeling of fullness in the breast before and while breast

feeding

Contra lateral ejection of milk flow during feeding

Satisfaction of baby after breast feeding

Satisfaction of mother and observation regarding increase in breast milk

Objective Parameters

Total elimination or significant decrease in quantity of artificial milk or

supplementary feed to the child per day

Baby weight gain

Outcome Measures

Primary Outcomes (Objective Parameters): The primary outcomes (objective

parameters) measured in the study were total elimination or significant reduction

in volume of supplementary feed, and weight gain of the baby.

The secondary outcomes (subjective parameters) measured during the study

were improvement in subjective satisfaction of mothers regarding the well being

and happiness of babies, feeling fullness in the breast during breast feeding, contra

lateral ejection of the milk, and mother’s observation regarding increase in milk.

These parameters were rated on a graded scale ranging from 1 to 5 (1 denoting

unsatisfactory and 5 representing highly satisfactory). 116

Moreover, the results were also analyzed based on complete relactation, partial

relactation, lactation failure and no response.

Methodology

93

Relactation was defined as resumption of breast feeding following cessation or

significant decrease in maternal milk production.

Complete relactation: Relactation was termed complete when no top feed was

supplemented.

Partial relactation: It was termed partial, when top feeding requirement was reduced

by more than half.

Lactation failure: If all attempts at relactation failed, in spite of completion of a trial

of four weeks it was termed as lactation failure or failed relactation. In this condition

babies were totally on top feeding. 11

No response: When top feeding requirement did not reduced by more than half or

increased.

Assessment and Follow up during Study Period

The efficacy of test drug was assessed by observing the increase in milk

production. At baseline and after treatment the mothers were asked about the clinical

features of lactogenesis, elimination or significant reduction in supplementary feeds

and baby weight gain was recorded in the case record form.

Adverse Effects Documentations: Adverse drug reactions were noted

during or after treatment.

Documentation: The records were submitted to the department after

completion of study.

Withdrawal Criteria: Failure to follow the protocol and the cases in which

drug adverse reactions were noticed.

Methodology

94

Statistical Analysis: Statistical analysis was performed by Graph Pad Instat

version 3.00 for window (Graph Pad Software, San Diego, Calif, USA). The

descriptive statistical analysis has been carried out in the present study. Results on

continuous measurements are presented on Mean±SD and results on categorical

measurements are presented in Number (%). P values lower than 0.05 were regarded

as significant. The Student’s ‘t’ test (two tailed, independent) has been used to find

the significance of study parameters on continuous scale between two groups-inter

group analysis and Student’s ‘t’ test (two tailed, dependent) has been used to find the

significance of study parameters on continuous scale within each group. Student’s‘t’

test has been used to find the homogeneity of parameters on continuous scale and Chi-

square/Fisher exact test has been used to find the homogeneity of samples on

categorical scale.

results

Results

95

A total number of 138 lactating mothers were screened for qillatul laban

(inadequacy of lactation) during the study period. Ninety mothers were excluded from

the study because of different reasons. Forty eight mothers were subjected to

preliminary investigations and randomly allocated to the test (n=32) and control

(n=16) group allowing 10% drop out (Fig 4). Statistical analysis for efficacy of

maghze tukhme pambadana was performed to observe any difference in both groups.

The parameters were evaluated before and after treatment.

Therapeutic Outcomes:

Primary Outcomes (Objective Parameters): The primary outcomes

(objective parameters) measured in the study were total elimination or significant

reduction in volume of supplementary feed, and weight gain of the baby. They were

assessed before and after the treatment.

Volume of Supplementary Feed: The mean volume of

supplementary feed to the babies before treatment was 291.66±70.50 ml and

291.66±56.43 ml in the test and control group respectively (P=0.99). The mean

volume supplemented to the babies after treatment was 40 ±75.88 ml and

226.66±149.84 ml in the test and control group respectively (P<0.008) (Table 7).

Weight Gain in the Infant: The mean weight of the infant before

treatment was 4876.66 ± 1118.4 g and 5026.66±890.80 g in the test and control

group respectively (P=0.62). The mean weight of the infant after treatment was

5790.66 ±1121.4 g and 5940±885.44 g in the test and control group respectively

(P=0.65) (Table 7).

Results

96

Further, the response of the test drug was also assessed upon the bases of

complete relactation, partial lactation, lactation failure and no response. It was found

that out of 30 mothers in the test group, 21 (70%), 7(23.33%) and 2(6.67%) mothers

had complete relactation, partial relactation and no response respectively, whereas in

the control group 4(26.67%) mothers had complete relactation, and 11(73.33%)

mothers had no response (Table 6).

Secondary Outcomes (Subjective Parameters):


were improvement in subjective satisfaction of mothers regarding the well being and

happiness of babies, feeling fullness in the breast during breast feeding, contra lateral

ejection of the milk, and mother’s observation in increase of milk. These parameters

were rated on a graded scale ranging from 1 to 5 (1 denoting unsatisfactory and 5

representing highly satisfactory).116 The parameters were comparable after treatment

from baseline and placebo. Though the subjective parameters were statistically

significant in both groups after treatment from baseline but comparison between the

groups showed that the test group was statistically more significant compared to the

placebo group (Table 8).

Baseline Characteristics and Investigation of Lactating Mothers: The

mothers randomly allocated to the test and control group were assessed for various

baseline variables. The baseline variables (age, religion, diet, residence, height,

weight, body mass index, married life, parity) and blood investigations of lactating

mothers were almost comparable and statistically not significant in two groups.

Alkaline phosphatase was statistically significant but clinically not significant (Table

1). All the babies were given demand feeding.

Results

97

Age: The age of 45 mothers with qillatul laban ranged from 18 to 30 years.

The mean age was 23.8±3.21 and 23.33±3.016 in the test and control group

respectively. Out of 45, maximum number of mothers, 25(55.55%), were in the age

group of 21-25 years followed by 12(26.67%) and 8(17.78%) in the age groups of 26-

30 years and <20 years respectively (Table1).

Religion and Residence: Out of 45 mothers, 27(60%) and 18(40%) were

Hindus and Muslims respectively. All the mothers were from urban area (Table 1).

Diet: Of the 45 mothers, 39(86.67%) and 6 (13.33%) were non-vegetarians

and vegetarians respectively (Table 1).

Socioeconomic Status: Kuppuswamy’s scale was used to assess the

socioeconomic status. It was comparable in two groups and was found statistically not

significant (Table 2).

Baseline Characteristics of Infants: The baseline variables (birth weight,

sex, length, head circumference, type of pre-lacteal feed, time of top feeding started,

time of starting breast feeding, age and weight at entry) of infant were almost

comparable in two groups and statistically not significant (Table 3).

Mizaj: Balghami mizaj was found in 13 (43.33%) and 9(60%) mothers in the

test and control group respectively, whereas damvi mizaj was found in 2(6.67%)

mothers in the test group. Distribution of mizaj was statistically similar between the

two groups with P=0.48 (Table 4 and Fig 5).

Obstetrics and Contraceptive History: At baseline both groups were almost

comparable and statistically not significant in parity, mode of delivery, place of

delivery and use of contraception. Eighteen (40%) mothers had only one child, 22 (48.

89%) of them had two children and 5 (11.11%) had three or more than three children

(Table 5).

Results

98

Mother not fulfilling the criteria (n=35) Lactating mothers not willing to participate (n=25) Not reviewed (n=27) Excluded (n=3) 1. Cracked Nipple (n=2) 2. Mastitis (n=1)

Analysis Analyzed (n=15) Analyzed (n=30)

2nd follow up

1st follow up

Intervention

2nd follow up Intervention received

(n=15) Drop out (n=0)

2nd follow up Intervention received


1st follow up Intervention received


1st follow up Intervention received


Control group Intervention received

(n=16)

Test drug formulation Intervention received

(n=32)

Randomization (n=48)

Allocation

Mother’s Interrogated (n=138)

Fig 4: Flow Chart of Participants

Results

99

Table 1: Baseline Characteristics and Investigations of Mothers

Characteristics (Mother)

Test group (n=30)

Control group (n=15)

Total (n=45)

P value

Age (y) ≤20 21-25 26-30

23.8±3.21 5(16.67) 16(53.33)

9(30)

23.33±3.016 3(20) 9(60) 3(20)

8(17.78) 25(55.55) 12(26.67)

0.6186

0.83

Religion Hindu Muslim

17(56.67 ) 13(43.33)

10(66.67) 5(33.33)

27(60) 18(40)

0.748

Residence Urban Rural

30(100)

0

15(100)

0

45(100)

0

1.00

Diet Non-vegetarian Vegetarian

27(90) 3(10)

12(80)

3(20)

39(86.67) 6(13.33)

0.38

Height (cm) 152.46±6.23 150.67±5.52 0.33

Weight (kg) 52.21±8.062 50.92±5.52 0.61

Body mass index (kg/m2)

22.17±3.25 21.99±2.30 0.85

Married life 4.17±3.12 5.2±2.45 0.24

Parity 1.67±0.84 1.93±0.70 0.294

Investigations Hb (%) RBS (mg/dl) ESR (mm)

Blood urea(mg/dl) S. creatinine(mg/dl) Uric Acid(mg/dl SGOT (IU/ml) SGPT(IU/ml) Alk. phosphatase(IU/ml) Serum prolactin

11.77±1.24

86.83±17.301 28.16±19.86

23.6±5.29 0.79±0.12 4.42±1.42

19.93±4.48 20.56±7.75 136±19.78

40.78±42.15

11.51±0.74 84.2±4.67

33.47±23.17 23.46±5.06 0.76±0.105 5.39±1.79 20±2.97

17.93±3.39 156.8±22.091 41.46±47.85

0.38 0.57 0.46 0.93 0.32 0.29 0.95 0.22 0.005 0.96

Data presented: Mean±SD or No (%); P>0.05, considered not significant Test used: Unpaired Student’s‘t’ test for continuous measurement and Fisher exact/Chi-square test for categorical measurements

Results

100

Table 2: Socio-economic Characteristics

Data presented: Mean±SD or No (%); P>0.05, considered not significant Test used: Unpaired Student’s‘t’ test for continuous measurement and Fisher exact/Chi- square test for categorical measurements

Socioeconomic characteristics

Test group (n=30)


Total (n=45)

P value

Mother’s education Illiterate Primary Middle Higher Secondary Graduate Post Graduate Professional

1(3.33) 7(23.33)

0 9(30)

5(16.67) 7(23.33) 1(3.33)

0

0

1(6.67) 0

7(46.67) 5(33.33) 2(13.33)

0 0

1(2.22) 8(17.77)

0 16(35.55) 10(22.22)

9(20) 1(2.22)

0

0.43

Income =19575 9788-19574 7323-9787 4894-7322 2936-4893 980-2935 =979

9950±1031.1

1(3.33) 10(33.33) 4(13.33)

10(33.33) 5(16.67)

0 0

8930±2915 0

6(40) 4(16.67) 4(26.67)

0 1(6.67)

0

1(2.22) 16(35.55) 8(17.77)

14(31.11) 5(11.11) 1(2.22)

0

0.7113

0.714

Maternal employment Employed Unemployed

4(13.33)

26(86.67)

0

15(100)

4(8.88)

41(91.11)

0.285

Socioeconomic status Upper (I) Upper middle (II) Lower middle (III) Upper lower (IV) Lower (V)

1(3.33) 9(26.67)

10(33.33) 8(26.67) 2(6.67)

0

6(40) 8(53.33) 1(6.67)

0

1(2.22)

15(33.33) 18(40) 9(20)

2(4.44)

0.338

Results

101

Table 3: Baseline Characteristics of Infant

Characteristics (Infant)

Test group (n=30)


Total (n=45)

P value

Birth weight (g)

2847.66±363.31

2830±345.79

0.876

Sex of Child Male Female

12(40) 18(60)

7(46.66) 8(53.33)

19(42.22) 26(57.78)

0.7

Infant’s age at entry (days) 31-60 61-90 91-120 121-150 151-180

96.1±36.47 9(30)

7(23.33) 3(10)

11(36.67) 1(3.33)

93.2±30.92 3(20) 6(40) 2(10) 3(20)

0

12(26.67) 13(28.89) 5(11.11)

14(31.11) 1(2.22)

0.79

0.637

Infant’s weight at entry (g)

4876.66±1118.4 5026.66±890.80 0.62

Length (cm) 66.66±6.5 61.6±7.27 0.975

Head circumference (cm)

40.143±2.33 39.4±2.05 0.2

Type of pre-lacteal feed

No Honey Glucose water

23(76.66) 5(16.67) 2(6.67)

11(73.33)

1(6.67) 3(20)

34(75.55) 6(13.33) 5(11.11)

0.364

Top feeding started (age in days)

10-30 31-60 61-90 91-120

62.1±36.12

9(30) 10(33.33) 5(16.67)

6(20)

55.8±29.91

4(26.67) 7(46.67)

3(20) 1(6.67)

13(28.88) 17(37.78) 8(17.78) 7(15.55)

0.53

0.63

Time of starting breast feeding

Day 1 Day 2

1.3±0.46

21(70) 9(30)

1.13±0.35

13(86.67) 2(13.33)

34(75.55) 11(24.44)

0.22

0.28

Data presented: Mean±SD or No (%); P>0.05, considered not significant Test used: Unpaired Student’s‘t’ test for continuous measurement and Fisher exact /Chi-square test for categorical measurements

Results

102

Table 4: Distribution of Patients According to Mizaj

Data presented: No (%); P>0.05, considered not significant

Test used: Fisher exact test

Fig 5: Distribution of Patients According to Mizaj

2

0

15

6

13

9

0 00

2

4

6

8

10

12

14

16

Test group Control group

No.

of

lact

atin

g m

othe

rs

Mizaj

Damavi Safravi Balghami Saudavi

Mizaj

No of patients (Percentage) Total

(Percentage)

(n=45)

P value Test group (n=30)


Damvi

Safravi

Balghami

Saudavi

2(6.67)

15(50)

13(43.33)

0

0

6(40)

9(60)

0

2(4.44)

21(46.67)

22(48.89)

0

0.48

Total 30(100) 15(100) 45(100)

Results

103

Table 5: Obstetrics and Contraceptive History

Obstetric History Test

group (n=30)

Control group (n=15) Total (%) P value

Parity

P1 14(46.67) 4(26.67) 18(40)

0.26 P2 14(46.67) 8(53.33) 22(48.89)

≥P3 2(6.67) 3(20) 5(11.11)

Mode of delivery

Normal vaginal delivery

20(66.67) 10(66.67) 30(66.67)

1.00 Caesarean section

10(33.33) 5(33.33) 15(33.33)

Place of delivery

Home delivery 0 0 0

1.00 Hospital delivery

30(100) 15(100) 45(100)

Lactating amenorrhoea

Yes 22(73.33) 12(80) 34(75.55) 0.726

No 8(26.67) 3(20) 11(24.44)

Contraceptive history

Not using any contraceptive method

13(43.33) 6(40) 19(42.22)

0.83 Barrier method 13(43.33) 6(40) 19(42.22)

Tubectomy 4(13.33) 3(20) 7(15.55)

Data presented: No (%); P>0.05, considered not significant Test used: Fisher exact/ Chi-square test for categorical measurements

Results

104

Table 6: Response of the Test Drug in Lactating Mothers with Qillatul Laban

Response

Complete relactation Partial relactation No response

Test group (n=30)


Test group (n=30)


Test group (n=30)


After

treatment 21(70) 4(26.67) 7(23.33) 0 2(6.67) 11(73.33)

Data presented: No (%)

Fig 6. Response in

Fig 6: Response of the Test Drug in Lactating Mothers with Qillatul Laban

0

5

10

15

20

25

CRL TG CRL CG PRL TG PRL CG No R TG No R CG

No.

of

lact

atin

g m

othe

rs

CRL: Complete Relactation; TG: Test Group; CG: Control Group; PRL: Partial Relactation; NoR: No Response

Results

105

Table7: Efficacy of Pambadana on Primary Outcomes

Data presented: Mean±SD; P>0.05, considered not significant; P<0.001, considered extremely significant; Test used: Unpaired and paired Student’s ‘t’ test; BT: Before treatment; AT: After treatment

SF: Supplemented feed; TG: Test group; CG: Control group

Fig 7: Efficacy of Pambadana on Primary Outcomes

291.66 291.66

40

226.66

0

50

100

150

200

250

300

350

Vol. of SF TG Vol. SF CG

Before treatment After treatment

4876.66

5790

5026.66

5940

0500

10001500200025003000350040004500500055006000

Wt gain BT Wt gain AT

Test Group Control Group

Outcome Test group (n=30)

Control group (n=15) P value

Supplemented feed (ml/day)

BT 291.66±70.50 291.66±56.43 0.99

AT 40±75.88 226.66±149.84 0.008

P value 0.001 0.199

Weight of baby (g)

BT 4876.66±1118.4 5026.66±890.80 0.62

AT 5790.66±1121.4 5940±885.44 0.65

P value 0.001 0.001

Results

106

Table 8: Efficacy of Pambadana on Secondary Outcomes

Data presented: Mean±SD; P>0.05,considered not significant; P<0.001, considered Significant; Test used: Unpaired and paired Student’s‘t’ test; BT: Before treatment; AT: After treatment; NA: Not applicable

Secondary Outcome

Test group

(n=30)

Control group

(n=15) P value

Feeling fullness in breast

BT 1.06±0.253 1 NA

AT 3.46±.94 1.93±0.79 0.001

P value 0.0001 0.0005

Contralateral ejection of milk

BT 1 1 NA

AT 3.193±1.138 1.93±0.79 0.004

P value 0.0001 0.0005

Mother’s observation in increase milk

BT 1 1 NA

AT 3.42±0.922 1.93±0.79 0.001

P value 0.0001 0.0005

Satisfaction of the mother

BT 1 1 NA

AT 3.562±1.073 1.93±0.79 0.001

P value 0.0001 0.0005

discussion

Discussion

107

The present single-blind placebo-controlled simple randomised study was

conducted to assess the efficacy of maghze tukhme pambadana in 45 lactating

mothers with qillatul laban. But to date, clinical studies, evaluating the efficacy of

the test drug are scarce. Results were analyzed and comparison was made between

test group with placebo control by using Student’s t’ test and Chi-square/ Fisher exact

test.

Primary and Secondary Outcomes

Primary Outcomes (Objective Parameters): The primary outcomes

(objective parameters) measured in the study were total elimination or significant

reduction in volume of supplementary feed, and weight gain of the baby.

In the present study, exclusively lactating mothers with qillatul laban

(inadequacy of lactation) who were supplementing top feeding to their babies were

selected. It was found that the main reason for starting supplementary feeds in all the

babies was mothers were perceiving insufficiency of breast milk. De et al. in their

study reported that about 90% mothers stated ‘inadequate breast milk’ to be the cause

of starting supplementary feeds, the other causes being problems of nipple/breast and

chronic ill health of mother/infant. Most mothers perceived ‘cry’ of the infant as

hunger and thus erroneously started top feeding.97 Osman et al. in their study found

the quantity of breast milk that a mother produces to be a common concern and a

major source of anxiety. Batal et al in their study noted inadequate milk to be the

primary reason for early introduction of formula in Lebanese women. Researchers

cited similar concerns about insufficiency of breast milk as a common reason for early

discontinuation of breast feeding in many different countries including Iran, Turkey,

Discussion

108

Brazil, and the United States, among others. The perception of insufficient breast milk

has been attributed to the mother's interpretation of the baby's crying as a sign of

hunger. In their population, this concern was related to both the crying of the infant,

as well as the resolution of breast engorgement, which was interpreted by the mother

as a sign for concern.54 Recent researches have demonstrated that giving young

infants supplementary fluids such as water and teas addition to breast milk is

associated with significant increase in the risk of diarrhoeal disease, decreased milk

intake and premature termination of breast feeding.146 Hence, this study was

conducted to assess the efficacy of the test drug in increasing breast milk production

in mothers with inadequacy of lactation so that exclusive breast feeding and complete

relactation can be achieved.

In our study, the mean volume of supplementary feeds to the infant in the test

group was significantly reduced to 40±75.88 ml after treatment when compared with

baseline of the test group (291.66±70.50 ml) (P< 0.001) and placebo (226.66±149.84

ml) (P < 0.008) at completion of the trial.

Moreover, the response of the test drug was also assessed upon the bases of

complete relactation, partial lactation, lactation failure and no response. It was found

that out of 30 mothers in the test group, 21(70%), 7(23.33%) and 2(6.67%) mothers

had complete relactation, partial relactation and no response respectively, whereas in

the control group 4(26.67%) mothers had complete relactation, and 11(73.33%)

mothers had no response. This result was similar to the finding of Mathur et al. who

tried relactation intervention in 75 mothers. Forty-nine (69%) mothers in the partial

failure group had complete success in relactation. 11

Discussion

109

The weight gain in both groups was within normal range before and after

treatment and followed their channel in growth curve. This finding is in accordance

with previous study where the weight gain of all the infants in complete as well as

partially successful relactation group was within normal range and followed their

channel in growth curve. 97 In the present study, after treatment, the comparison

between groups showed no statistical significant difference (P=0.65). It is

hypothesized that in complete relactation weight gain in the babies was due to

increase in breast milk production, whereas in partial relactation and lactation failure

the weight gain in the babies were because of supplementary feeds as they were not

deprived from top feeding. There was significant weight gain in the placebo group

because of supplementary feeds given to the babies. However, the aim of complete

relactation in the baby is not only for weight gain but it is well known that the babies

who are not breastfed, or who are fed other foods too early may have an increased risk

of obesity, diarrhoea and other GI problems, respiratory and ear infections,2 urinary

tract infection, bacterial meningitis, botulism, necrotizing enterocolitis 3 and allergic

skin disorders.2 Thus, WHO has recommended exclusive breast feeding till an infant

is 6 months of age as breast milk is always superior to top feeding . 5

Secondary Outcomes (Subjective Parameters): The secondary outcomes

(subjective parameters) measured during the study were improvement in subjective

satisfaction of mothers regarding the well being and happiness of babies, feeling

fullness in the breast, contra lateral ejection of the milk, and mother’s observation in

increase of milk. Comparison of the groups showed that the subjective parameters of

the test group were statistically more significant compared to the placebo group. The

subjective parameters were statistically significant in the both groups after treatment

from baseline. During interrogation both groups were motivated and insisted to

Discussion

110

employ proper technique of breast feeding as helping mothers with proper

attachment at the breast appears to be crucial for successful lactation.100 Increase in

milk production in the placebo group is assumed to be due to proper adoption of

breast feeding technique, but as milk production in the test group was comparatively

higher than placebo, which proves that maghze tukhme pambadana is having

galactagogue effect.

Gossypium herbaceum Linn has been described in ancient Unani classical

textbooks regarding its moallide sheer, 30, 31 muqawwie bah, 32 musmmine badan,30

and moallide mani properties.31, 123 It has been used for a variety of indications,

such as qillatul laban (inadequate lactation), zofe aam (general debility), 125 zofe bah

(loss of libido), 30, 31, 124, 126 zeequan nafas (bronchial asthma), 31, 124 ziabetes

(diabetes), 31 ikhtenaqur rehm (hysteria), 31, 126 and amraz jild (skin diseases). 31, 32, 126

The galatagogue activity of this drug has been studied in live stocks however, formal

published clinical data are lacking. A specific mechanism of action is unknown;

nevertheless, it has been theorized that cottonseeds may affect in enhancement of

breast milk production because of it’s the nutritive value.131 It contains all the

necessary vitamins, essential amino acids and minerals which protect and nurture the

baby. 131

Unani scholars such as Ibn Sina,95 Azam Khan, 94 and Akbar Arzani17

mentioned that one of the important cause of qillatul laban is qillate ghiza. Azam

Khan also said that balance and nutritious diet is enough to treat qillatul laban and

drugs are not needed.94 He also mentioned that the diet or drugs, which are hot and

moist such as milk, rice, chicken or honey with milk, faluda, halwa of egg yolk or

carrot are useful.93, 94 Zakariya Razi mentioned that all types of muqawwie bah advia

Discussion

111

are useful in qillatul laban. Ali bin Abbas Majoosi mentioned that to augment the

milk secretion, diet or drugs that increase the hararat of khilte balgham are to be

used. It increases the flow of milk towards the breast.83 It is hypothesized by these

readings that maghze tukhme pambadana was responsible for enhancing the

milk production because of its har wa ratab mizaj, 17 mughzi, muqawwie bah 32 and

moallide sheer 30, 31 properties.

According to the Unani medicine, mother’s milk is the best nutritive substance

for the child since it is sweet, emollient, laxative, wholesome, appetizing and easy to

digest.89 Ibn Sina described that whenever possible, the mother’s milk should be

given by suckling.91 As the mother’s milk is nearest to the blood from which the baby

has grown up as the foetus. Such milk is better adapted for its further growth and

development. The blood in mother’s breast is converted into milk. This is beneficial

for the infant and more attractive and acceptable to its constitution.92 Experience

shows that merely to place the mother’s nipple into the infant’s mouth is a great help

towards removing whatever is hurtful to the infant. 91

Baseline Characteristics of Lactating Mothers and Infant: The baseline

variables (age, religion, diet, residence, height, weight, body mass index, married life,

parity) and investigations of lactating mothers were statistically not significant and

homogenous in both groups. Alkaline phosphatase was statistically significant but

clinically not significant as the values were within normal limit. All the babies were

given demand feeding.

The baseline variables (birth weight, sex, length, head circumference, type of

prelacteal feed, time of top feeding started, age and weight at entry) of infants were

statistically not significant and homogenous in both groups .

Discussion

112

Age: In this study, the mean age of mothers with inadequacy of lactation was

23.8±3.21 and 23.33±3.016 in the test and control group respectively. This finding is

in accordance with previous studies reported by Mathur et al , 11 Grossman et al, 147

and Shrivastava et al. 148 In this study, 82.22% lactating mothers interrogated were

between ages 21-30, whereas Singh in his study reported 76.07% mothers were of this

age. He also mentioned that there was not much significant relation between mother’s

age and duration of breast feeding. 51

Residence: In the study, all the mothers were from urban area. Studies in

India have also shown a decline in breast feeding trends, especially in urban areas. 8

This study was not in agreement with previous studies. 149 , 150 as this study was

carried in the urban area i.e. the metropolitan city, Bangalore. Moreover, mothers

were recruited from the nearby selected PHCs.

Religion: In the study, 27(60%) and 18 (40%) mothers were Hindus and

Muslim respectively. Majority of mothers were Hindus because they were recruited

from the PHC, which was located in area dominated by Hindus. Mathur et al in their

study reported that 81.3% Hindus mothers had lactation failure. 11

Socioeconomic Status: Majority (73.33%) of the mothers with inadequate

lactation were from the middle class, whereas only one (2.22%) mother was from the

upper class. Since, mothers of low and middle socioeconomic status visit more

frequently to the government established sub centres as compared to the upper class

mothers. Furthermore, this hospital and PHCs are located in the area were middle

class people resides. However, studies have clearly demonstrated that the breast

feeding is negatively or inversely related to socioeconomic development. 150

Discussion

113

Parity: In the present study, the parity of the mothers was also recorded. Out

of 45 mothers, 18 (40%) mothers had only one child. This is finding is in agreement

with previous studies in which 45% mother had one child.51, 77 The mean parity of

mothers in this study was is in agreement with a previous study, 2.0 (1.11). 7 This

finding shows that most of the families are opting for small family. In this study,

multiparous mothers with inadequacy of lactation were 60%, whereas primiparous

were 40%, which is in accordance with previous reports. 13, 105, 151 Forman et al. in

their study reported that parity was directly related to the milk insufficiency (but just

missed significance) during one to two months and was statistically significantly

associated with the milk insufficiency during 3-18 months. Yet, multiparous women

with a 3-18 month index child were more likely to state milk insufficiency as a reason

to begin bottle feeding than primiparous mothers (OR=1.12). Multiparous mothers

needed a rest between breast feeds and introducing the bottle allowed them this rest.

Thus, they gave milk insufficiency as justification for this behavior regardless of its

occurrence or not.105 Rasheed et al in their study reported that the odds of being in the

continuous mixed feeding trajectory increased with increasing maternal age. In a

study by Huffman et al. conducted in Matlab, Bangladesh high work load was

associated with reduced suckling frequency. Another qualitative study revealed that

multiparous (and thus older) mothers received little help with household chores. It is

possible that older mothers, constrained by work load, reduced feeding frequency. As

a result, breast milk volume decreased to amounts that were inadequate to meet their

infants’ needs, requiring early complementary feeding.151 The positive association

between multiparity and perceived breast milk inadequacy has been was reported by

other researcher. 13

Discussion

114

Mizaj: In the study, balghami, safravi and damavi mizaj was found in

22(48.89), 21(46.67%) and 2(4.44%) lactating mothers respectively. This finding

conforms the writings of ancient Unani scholars that qillatul laban is common in

balghami and safravi mizaj mothers. 15, 83

Pre-Lacteal Feeds: In this study only 11(24. 45%) babies were given pre-

lacteal feeds, whereas in 34 (75.55%) babies it was not given. This finding is not in

agreement with the study conducted by Mathur et al. about 20 years previously, where

all babies were given pre-lacteal feeds. It was also observed that pre-lacteal feeds

were common practice in India.150 This observation in our study shows that in present

era there is changing trend towards pre-lacteal feeds in the general population because

of motivation and awareness about early and exclusive breast feeding.

Time of Breast Feeding Started: In the study, breast feeding was started in

34 (75.55%) babies within 24 hours. This finding confirms the previous reports

where breast feeding was initiated within 24 hours in 76.7% lactating mothers106

which is a positive sign. In the present study, the breast feeding pattern was observed

to be healthy, though not optimal, as only two third of mothers initiated breast feeding

within 24 hours. Mothers who delay breast feeding even beyond 24 hours should be

targeted before time for health education in subsequent pregnancy. A formal lactation

counseling and management should be introduced in the curriculum of paramedics.

Early breast feeding time, contact through breast feeding is also important for the

development of psychological bonding with the mother and child. Breast-feeding

initiated early for the first child was also shown to be associated with higher

prevalence of subsequent breast-feeding practice.8

Discussion

115

Adverse Effects: No adverse effects of the test drug were reported during the

trial.

Strength of this Study: This is the first of its kind of study in our knowledge

where maghze tukhme pambadana was used in clinical interventional study to

evaluate its efficacy in qillatul laban. Furthermore, allocation was done by

randomization, placebo was used as a control and all the lactating mothers were

motivated for exclusive breast feeding till 6 months of age, which is need of the hour.

The limitations were lack of power in the study, single-blind, smaller and

unequal sample size.

The test drug was effective in boosting the breast milk production. Further,

double-blind, phase III trials with longer duration study is recommended.

Furthermore, the efficacy of the test drug can also be appraised in complete lactation

failure and to find the specific role of the test drug on serum prolactin levels in qillatul

laban.

conclusion

Conclusion

116

A prospective, single-blind placebo-controlled, simple randomized, pre and

post evaluation trial was conducted on 45 lactating mothers with qillatul laban to

prove the efficacy of maghze tukhme pambadana. The test drug was found to be more

effective in enhancing the maternal milk production than placebo. Overall

improvement was also observed in subjective parameters. This study validates the

claim of the Unani scholars.

Laboratory investigations were within normal limit at the baseline in both

groups. The test drug was safe without any adverse drug reactions. As qillatul laban

can be caused by dominance of khilte balgham and safra, it was observed that most of

the lactating mothers with qillatul laban had balghami and safravi mizaj. The test

drug is safe, well tolerated, cost effective and easily available.

Further Recommendation:

In this study, test drug was effective in augmenting the maternal milk

production. This is the first of its kind of clinical study to evaluate the efficacy of this

drug.

Further, double-blind, randomized, standard controlled trials in large number

of lactating mothers with inadequacy of lactation for longer duration is recommended.

It is also required to confirm the effect of test drug on etiological factors of qillatul

laban.

summary

Summary

117

Qillatul laban (inadequate lactation) or perceived insufficient milk (PIM) is

commonest cause of lactation failure in 80 to 95%. It is one of the reasons mentioned

most often by women throughout the world for the early discontinuation of

breastfeeding and/or for the introduction of supplementary bottles. This is of public

health concern because the use of breast milk substitutes increases the risk of

morbidity and mortality among infants in developing countries and shortens birth

intervals. Mudirre laban (Galactagogues or lactogogues) are medications or

substances believed to assist initiation, maintenance or augmentation of maternal milk

production. Because low milk supply is one of the most common reasons given for

discontinuing breastfeeding, both mothers and physicians have sought medicine to

address this concern. Thus, one of the most common indications for mudirre laban is

to augment a declining milk supply in lactating mothers. Although certain medicines

like metoclopramide and domperidone are being used for augmenting lactation but are

seldom recommended in view of their limited efficacy prospects and major safety

concern.

Maghze tukhme pambadana is a Unani medicine with mudirre laban property,

which is in use since antiquity, to enhance the maternal milk production in qillatul

laban. But, validation and published clinical data is deficient. Hence, present study

was conducted to assess its efficacy in qillatul laban.

Clinically diagnosed (n=45) lactating mothers with qillatul laban were

enrolled in a prospective, single-blind, placebo-controlled, simple randomised; trial

was conducted in the Institute’s Hospital. In the test group (n=30), maghze tukhme

pambadana, 10 g (powder filled in capsules) was administered orally in three divided

doses for 30 days. In the control group (n=15), placebo was given in same as that of

Summary

118

the test group. To assess the efficacy of the test drug, primary (objective) and

secondary (subjective parameters) outcome measures were compared with the

baseline and placebo after treatment. Routine investigations were carried out to

exclude systemic and other diseases. The baseline characteristics, primary and

secondary outcome measures were analysed and compared between both groups with

unpaired and paired Student’s ‘t’ test and Fisher exact test.

The summary of the study was as follows.

Baseline Characteristics and Investigation of Lactating Mothers

The baseline characteristics (age, religion, diet, residence, height, weight,

body mass index, married life, parity) and investigations of lactating mothers were

homogenous in both groups. Alkaline phosphatase was statistically significant but

clinically not significant as the values were within normal limit.

Baseline Characteristics of Infant

The baseline characteristics (birth weight, sex, length, head circumference,

type of pre-lacteal feed, time of top feeding started, age and weight at the time of

entry) of infant were homogenous in both groups.

Mizaj

Majority of the mothers were having safravi or balghami mizaj.

Age

The age of 45 mothers with inadequate lactation ranged from 18 to 30 years.

The mean age was 23.8±3.21 and 23.33±3.016 in the test and control group

Summary

119

respectively. Out of 45, maximum number of mothers, 25(55.55%), were in the age

group of 21-25 years.

Religion and Residence

Out of 45 mothers, 27(60%) and 18(40%) were Hindus and Muslims

respectively. All the mothers were from urban area.

Diet

Of 45 mothers, 39(86.67%) and 6(13.33%) were non-vegetarian and

vegetarian respectively.

Socioeconomic Status

As per the Kuppuswamy’s scale, majority (73.33%) of the mothers with

inadequacy of lactation were from the middle class, whereas only one (2.22%) mother

was from the upper class.

Obstetrics and Contraceptive History

At the baseline both groups were homogenous and statistically not significant

in parity, mode of delivery, place of delivery and use of contraception. Out of 45

mothers, 18 (40%) mothers had only one child, 22 (48. 89%) had two children and 5

(11.11%) had three or more children.

Primary Outcomes (Objective Parameters)

The primary outcomes (objective parameters) measured in the study were total

elimination or significant reduction in volume of supplementary feed, and weight gain

of the baby.

Summary

120

Volume of Supplementary Feeds: In this study, the mean volume of

supplementary feeds given to the infant in the test group was significantly reduced

to 40±75.88 ml after treatment when compared with the baseline of the test group

(291.66±70.50 ml) and placebo (226.66±149.84 ml) at completion of the trial.

Weight Gain in the Infant: The mean weight of the infant before treatment was

4876.66 ± 1118.4 g and 5026.66±890.80 g in the test and control group

respectively (P=0.62). The mean weight of the infant after treatment was 5790.66

±1121.4 g and 5940±885.44 g in the test and control group respectively (P=0.65).

Secondary Outcomes


were improvement in subjective satisfaction of mothers regarding the well being and

happiness of babies, feeling fullness in the breast, contra lateral ejection of the milk,

and mother’s observation regarding increase of milk. Though subjective parameters

were statistically significant in both groups after the treatment from baseline, but

comparison between the groups showed that the test group was statistically more

significant compared to the placebo group.

Adverse Effects

No adverse effects of the test drug were reported during the trial.

Further, it is recommended that double-blind standard-controlled randomized

trial in large number of patients for longer duration is needed.

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annexure

Annexure

142

Annexure 1

NATIONAL INSTITUTE OF UNANI MEDICINE, BANGALORE

Dept of Ilmul Qabalat wa Amraze Niswan

Management of Quillatul laban (Inadequacy of Lactation) with a Unani Drug

Case record form

CR NO :

Randomization No :

PHC No :

Date of commencement of trail :

Completion of trail : � Yes � No,

If no, then

Identification

Patient’s Name :

Father’s / Husband’s Name :

Age :

Address with contact No. :

Religion : �Hindu �Islam �Christian

�Other

Annexure

143

Socio- economic History

Socio- economic status : � Upper �Upper Middle

� Lower Middle

(Kuppuswamy’s scale) � Upper Lower � Lower

Education : �Illiterate � Primary

�Middle School

�Higher �Secondary �Graduate

�Post Graduate �Professional

Monthly Family Income :

Occupation :

Habitation : � Rural � Urban

Proposed treatment given : Group � A � B

Annexure

144

History of present illness with Duration

Inadequate breast � Yes � No

Excessive cry of baby in spite of frequent feeding � Yes �No

Infant appears dissatisfied with the feeds and at night disturbing the sleep

� Yes � No

Baby wakes up frequently � Yes � No

Baby doesn’t increase in weight � Yes � No

Increase sucking of fingers � Yes � No

Others: � Baby demands Frequent Feeds � Baby

Irritable

Top / supplement feeds to the baby � Yes � No

History of prelacteal feeds: � Yes � No

Breast milk: � Delayed Milk arrival � Inadequate � Scanty � Milk

dried up

� Low Milk Supply � Milk not enough

When the feeding was started after delivery:

Reason for initial delay: � Traditional � Medical

Annexure

145

Suckling of baby: � Good � Average �

Poor

Maternal stress � Yes, then � Irritability

� Worry

� Lack of confidence �No

History of Past Illness

H/o of Anemia � Present � Absent

H/o Hypertension/DM/Asthma/Tuberculosis � Present � Absent

H/o Breast surgery � Present � Absent

Previous breast feeding experience � Good � Poor �

Very poor

Duration of breast feeding in months:

Age at which top feed was introduced to the previous child

Drug History

H/o use of any milk suppressant: � Yes � No

Family History

H/o Quillat ul laban in sister / Mother � Present � Absent

H/o of Anemia � Present � Absent

Annexure

146

H/o Hypertension/DM/Asthma/Tuberculosis � Present � Absent

Personal History

Diet � Veg � Non-Veg � Mixed

Appetite � Poor � Good

Sleep � Disturbed � Sound

Bowel � Constipation � Diarrh0ea � Regular

Bladder � Burning � Dysuria � Free

Life Style � Sedentary � Average � Labourer

Habits

Menstrual History:

Age of Menarche

Menstrual Cycle � Regular � Irregular

Duration of Cycle � <30 days � 30-35 days � >35

days

Amount of Flow � Spotting � Scanty � Moderate � Heavy

Duration of Flow � 1-2days � 2-3 days � 3-4days � >4 days

Lactational amenorrhoea � Yes � No

If No, Date of LMP

Annexure

147

Obstetrical History:

M L :

P L A D

L C B:

S

No.

Year

and

Date

Pregna

ncy

with or

without

ANC

Events

during

pregnancy

Events

during

labour

Mode of

Delivery

Events

during

puerperi

um

Baby

weight

and

immuni

zation

Baby

weight

Contraceptive history: � Yes � No

OC Pills/ Barrier method/ Natural method

Duration of use: Months

Sterilization: � Yes

General Physical Examination

Annexure

148

Built :

Height (cm) :

Weight (Kg) :

BMI (Kg/m2) :

Nutritional status : � Poor � Average � Good

Pallor :

Lymphadenopathy :

Temperament of the Mother:

� Damavi � Balgami � Safravi � Saudavi

Vitals

Temperature : �F; Pulse : /mt

Respiratory Rate : /mt; Blood Pressure : mm/Hg

Systemic Examination

Central Nervous system

Cardiovascular system

Respiratory system

Gastrointestinal system

Musculoskeletal system

Gynaecological Examination

Breast and Nipples

Annexure

149

On inspection:

Nipple: Right/left/both; � Cracked � Retracted � Fissure � Redness

� Any discharge � Dry � NAD

On palpation: Lump Right/left/both � Absent � Present � Site:

Tenderness � Absent � Present � Site:

Engorged � Absent � Present

Others:

Abdominal Examination

Inspection:

Skin condition:

Scar: � Present � Absent

� Healthy � Infected

Palpation: Uterus: � Involuted � Subinvoluted

Examination of the baby:

Age of baby: ______________days

Sex: � Male � Female

Present weight: _____________g, Head Circumference: Initial visit--------- 1st ---

---- 2nd

Present height (cm): ----------------

Annexure

150

INVESTIGATIONS

INVESTIGATIONS BEFORE

TREATMENT AFTER TREATMENT

Hb ( gm%)

TLC (cells/cu mm)

DLC P: % L:

%

E: % M:

%

B: %

ESR /1hr

RBS (gm/dl)

CUE

SAFETY PROFILE

Bl .Urea ( mg/dl)

S. creatinine ( mg/dl)

S. Uric acid ( mg/dl)

SGOT (AST)( IU/L)

SGPT (ALT)( IU/L)

AlK phosphate ( IU/dL)

SPECIFIC

Serum prolactin (ng/dL)

Annexure

151

Assessment Parameters

Observation:

Signature of PG Scholar Signature of Guide

S.

No

Clinical Features

Before

Treatment (BT)

After Treatment

(AT)

Subjective

Parameters

1 Feeling of fullness in breast before feeding

2 Contra lateral ejection of milk flow during feeding

3 Mothers observation in increase in flow

4 Satisfaction of baby with breast feeding

5 Frequency of breast feeding/24hrs

6 Frequency of urine (infant)/24hrs & quantity

7. Frequency of stool (infant) / 24hrs

Objective parameters

1 Weight of baby in Grams

2 Serum Prolactin 3 Volume of

supplemental milk (ml/day)

Annexure

152

CONSENT FORM

I --------------------------------------------- exercising my free power of choice,

hereby give my consent to be included as a subject in the clinical trial of the drug(s)

for the treatment of---------------------------------------, the disease I am suffering from.

I have been informed to my satisfaction, by the attending physician regarding

the purpose of the clinical trial and the nature of the drug treatment and follow up

including the laboratory investigations to monitor and safeguard my body function.

I am also aware of my right to opt out of the trial at any time during the course

of the trial without having to give the reasons for doing so

___________________ _______________________

Signature of the P G Scholar Signature of the Lactating mother

Dr. Manjula S

Dept. of Qabalat wa Amraze Niswan,

Contact No:9731628373

Guide: Dr. Arshiya Sultana

Lecturer,

Dept. of Qabalat wa Amraze Niswan, NIUM Bangalore-91

Contact No: 09740915911

Date:

Place: Bangalore

Annexure

153

Annexure -II

Mizaj Assesment Chart

Sl. No

Name Sex: Age

Address:

Blood Pressure Systolic: mm of Hg Diastolic: mm of Hg 1 Built Muscular &

Broad Fatty & Broad Muscular &

Thin Lean

2. Tact us Hot & Soft Cold & Soft Hot & Rough Cold & Rough

3. Complexion Ruddy Chalky Pale Purple

4. Hairs

a) Structure Thick Thin Thin Thick

b) Shape Straight Curly Curly Curly

c) Number Dense Scarce Dense Scarce

d) Colour Black Brown Black Black and White

e) Growth Rapid Slow Rapid Slow

5. Veins Visible Inconspicuous Prominent Visible & firm

6. Pulse rate Normal low High Low

7. Pulse stroke Strong Weak Strong Weak

8. Appetite Normal Subnormal Normal Distaste (Hyper)

9. Sleep Normal Excess Less Least

10. Movement Active Slow Hyperactive Less active

11. Diet (most liked)

Cold & dry Hot & dry Cold & moist Hot & moist

12. Weather (most suitable)

Cold & dry Hot & dry Cold & humid Hot & humid

13. Emotions Moderate Calm & quiet Easily provoked Anxious

14. Discharge P/V Viscous Liquid Viscous Scanty, Viscid

15. Urine Reddish concentrated

Colour less Fiery & yellow Dark concentrated

16 Stool Soft Jelly like Dry, dark colour Hard

Conclusion Mizaj: Damvi Balghami Safravi Saudavi

Annexure

154

Key to Master Chart

AT After Treatment

BT Before Treatment

B Balghami

BF Breast Feeding

B M Barrier Method

C Cerelac

Cm Centimeter

CR NO Case Record Number

CUE Complete Urine Examination

D Damvi

DOB Date of birth

E Employed

ESR Erythrocyte sedimentation rate

F Female

g gram

Gr Graduate

H Hindu

Hb Haemoglobin

HC Head Circumference

Hi Higher school

HO Honey

H/o History of

HOS Hospital

Annexure

155

IL Illiterate

IU/L International Unit per Litre

L Lower

LM Lower middle

LMP Last menstrual period

LSCS Lower Segment caesarean section

M Male

Mg/dl Miligram per desilitre

mm/hr Millimetre per hour

MU Muslim

N No

NA Non applicable

NG Non Veg

NVD Normal Vaginal Delivery

PG Post graduate

Pr Primary

Pro Professional

R Rural

Ra Ragi

RBS Random blood sugar

R NO Roll number

S Safravi

SES Socio Economic Status

SS Sugar Syrup

SGOT Serum glutamic oxaloacetic transaminase

Annexure

156

SGPT Serum glutamic pyruvic transaminase

S NO Serial Number

SC Secondary

T Tubectomy

U Upper

UE Unemployed

UM Upper Middle

UL Upper Lower

UR Urban

V Veg

Vol Volume

Wt Weight

Y Yes

Yr Year

SN

OT

est

gro

up

CR

NO

R.

No.

Nam

e

Ag

e(Y

)

Rel

igio

n

Hab

itat

Ed

uca

tion

Inco

me

(Thousa

nd)

Occ

upa

tion

SE

S

Die

t

Miz

aj

ML

(Yea

r)

Hei

ght

(cm

)

Weig

ht

(Kg)

BM

I(k

g\m

)

Pa

rity

Liv

ing

Ab

orit

on

Lac

tati

onal

amen

no

rrh

oea

LM

P

Co

nra

cep

tive

Pla

ceof

del

iver

y

Mod

eof

del

iver

y

1 1191 1 Sumaiya 21 MU UR PR 7 UE UL NV B 3 146 45 22 1 1 1 Y NA BM HOS NVD

2 1756 2 Salma Banu 20 MU UR PR 8 UE LM NV B 1 147 53 24 1 1 0 Y NA N HOS LSCS

3 7192 3 Shabana Taj 25 MU UR PR 7 UE UL NV B 9 155 55 22 3 3 0 Y NA T HOS NVD

4 112252 4 Sameena 23 MU UR SC 14 UE LM NV S 3 152 42 18 2 2 0 Y NA BM HOS LSCS

5 11720 5 Khushboo 25 MU UR GR 14 UE UM NV B 8 152 63 27.26 2 2 0 N 23/6/11 N HOS LSCS

6 124499 10 Manasa 25 H UR PR 4 UE L NV S 1.6 154 60 25 1 1 0 N 24/11/11 N HOS NVD

7 118609 11 Shabeena banu 26 MU UR GR 6 E UL NV D 3 160 48 18.75 2 2 0 Y NA BM HOS NVD

8 118974 12 Bhagya Lakshmi 28 H UR GR 12 UE UM NV S 3 151 50 21 2 2 0 N 16/12/11 T HOS NVD

9 119737 13 Padmini 30 H UR GR 6 E LM NV B 4 158 51 20 2 2 0 N 09-07-2011 N HOS NVD

10 12151 14 Sumaiya 22 MU UR PR 12 UE UM NV B 2 150 41.5 18.44 1 1 0 N 14/10/11 N HOS NVD

11 121830 15 Saira Banu 23 MU UR PR 7 UE UL NV S 7 159 62 24 2 2 2 Y NA T HOS LSCS

12 119528 16 Yasmeen 22 MU UR HI 15 UE UM NV B 8 149 53 23 5 5 0 Y NA BM HOS NVD

13 123206 18 Shilpa 21 H UR HI 5 UE LM NV S 5.6 149 47.9 21 2 2 0 Y NA N HOS NVD

14 124092 19 Shazia 20 MU UR HI 7 UE UL NV B 1.5 154 55.5 23.2 1 1 0 Y NA N HOS NVD

15 124797 20 Manjula 25 H UR SC 4 UE LM V D 7 150 48 21 2 2 0 Y NA N HOS NVD

16 124796 21 Neelama 25 H UR IL 1.5 UE L V S 15 135 40 21 2 2 0 Y NA BM HOS NVD

17 124785 22 Manjula Gowda 21 H UR GR 10 UE UM NV B 4 162 66 25 2 2 0 Y NA N HOS LSCS

18 125945 23 Praveena 28 H UR HI 4 UE LM NV S 6 157 45 18.25 2 2 0 N 30/1/11 T HOS NVD

19 126110 24 Nagarathna 21 H UR HI 6 UE UL NV B 1 154 55.2 23.2 1 1 0 Y NA BM HOS NVD20 127846 27 Nazneen 28 MU UR SC 10 E UM NV S 1.6 155 45 18 1 1 0 Y NA BM HOS NVD21 128424 28 Nandini 19 H UR HI 3 UE UL NV S 2 164 51 18 1 1 0 Y NA N HOS NVD

22 129107 34 Girija 23 H UR PR 5 UE UL NV S 3 152 45 19 1 1 0 Y NA BM HOS NVD

23 129288 35 Suhasini 27 H UR GR 18 E UM V B 4 150 70.2 31 1 1 0 Y NA N HOS LSCS

24 129287 36 Vasanthi 27 H UR GR 15 UE UM NV S 3 150 66.7 29 1 1 0 Y NA BM HOS LSCS

25 129494 37 Leelavathi 23 H UR SC 8 UE LM NV S 4 154 50 21 2 2 0 Y NA N HOS LSCS

26 129558 38 Veda 20 H UR HI 12 UE UM NV B 1 148 55 25 1 1 0 Y NA N HOS NVD

27 129556 39 Sridevi 30 H UR PG 60 UE U NV S 2 164 60 22 1 1 0 Y NA BM HOS LSCS

28 129953 41 Anapoornima 19 H UR HI 5 UE LM NV S 1 144 42 20 1 1 0 Y NA BM HOS NVD

29 130627 44 Mahboobunnisa 26 MU UR HI 8 UE LM NV B 7 144 46 22 2 2 2 N 22/2/12 BM HOS LSCS

30 131274 45 Qamarunnisa 22 MU UR SC 5 UE LM NV S 4 155 54.5 24.22 2 2 0 N 15/3/12 BM HOS NVD

MASTER CHART (TEST GROUP)

Mother

t

r

S.N

o.Testgroup

Date

of

Bir

th

Age

of

the

ba

by

at

entr

y

(days)

Sex

Bir

thw

eig

ht

(g)

H/o

pre

-lacta

lfe

ed

s

Tim

eof

Sta

rti

ng

BF

Top

feed

ing

start

ed

(A

ge

in

days)

Hb

%(g

ms)

ES

R(m

m/h

r)

RB

S(m

g/d

l)

Blo

od

Ure

a(m

g/d

l)

S.C

rea

tin

ine

(mg/d

l)

S.U

ric

acid

(mg

/dl)

SG

OT

(IU

/L)

SG

PT

(IU

/L)

Alk

ali

ne

phosp

hata

se(I

U/L

)

BT AT BT AT BT AT BT AT BT AT BT BT BT BT BT BT BT BT BT

1 24/11/10 57 F 2900 55 57.5 37.5 38.75 N 1 4 6 5 6 2 2 45 12.3 20 60 30 0.8 2.7 16 17 168

2 29/10/10 83 F 2500 60 62.5 40 41.25 N 1 4 5 5 6 2 2 60 13.8 30 78 31 0.9 2.6 22 30 120

3 30/11/10 57 F 2500 60 62.5 40 41 N 1 3 5 5 6 1 1 60 13.3 9 96 29 0.8 5 11 18 125

4 23/3/11 89 M 3300 65 67.5 45 46.25 N 2 4 6 5 6 1 1 60 10.4 24 104 19 0.6 2.6 21 18 137

5 17/2/11 132 F 2500 68 70.5 46 47.25 N 1 6 6 5 6 1 1 120 12.3 31 84 24 0.9 4.6 20 16 125

6 16/6/11 90 M 3400 65 67.5 41.25 42.5 Y (HO)

5 6 5 6 1 1 30 13.2 20 120 17 0.6 4.6 21 13 125

7 7/5/11 135 F 3300 67.5 67.5 41 42.5 Y (SS) 1 7 8 7 8 1 1 90 10.8 21 110 22 0.9 3.1 18 21 138

8 14/4/11 160 F 2750 72.5 75 43 44.25 Y (HO) 1 7 6 7 8 1 1 30 12.6 18 94 29 0.8 4.5 34 38 113

9 23/5/11 140 F 3200 70 72.5 41 42.5 N 1 4 7 5 6 1 1 45 13 11 86 20 0.8 3.6 17 12 139

10 20/8/11 68 M 2500 61.25 63.75 37.5 38.75 N 1 4 7 5 8 1 1 60 8.6 17 98 15 0.6 4.3 27 26 169

11 27/7/11 120 M 3500 57.5 60 39 40.25 N 2 5 7 6 8 2 1 90 13 63 71 29 0.9 3.9 21 28 125

12 24/8/11 46 F 3600 57 59.5 37.5 38.75 N 1 4 6 4 6 2 2 10 10 8 75 25 0.8 3.6 25 43 91

13 30/9/11 56 F 3000 60 62.5 40 41.25 N 2 4 6 5 6 1 1 15 10.5 15 86 25 0.9 5.3 24 23 128

14 27-10-11 39 M 2500 46.25 48.8 37.5 38.75 N 1 4 4 5 5 1 1 30 10 31 78 22 0.9 3.4 18 19 147

15 12/7/11 135 F 2500 70 72.5 42.5 43.75 N 1 5 7 7 10 1 1 107 12.6 30 77 19 0.8 3.7 21 15 121

16 1/8/11 124 M 2500 65 67.5 40 41.5 Y (HO) 1 3 5 4 6 2 1 90 12.6 8 82 15 0.7 2 19 15 140

17 19/8/11 136 M 3500 70 72.5 42.5 43.75 N 2 7 8 8 9 1 1 120 13 16 74 20 1 4.4 26 14 141

18 25/8/11 128 F 3000 60 62.5 40 41.25 N 1 3 6 5 8 1 2 90 11.6 14 83 19 0.9 3.4 22 20 143

19 18/10/11 84 M 3000 50 52.5 39 41.3 Y(HO) 1 4 6 5 6 2 2 50 11.5 37 70 22 0.9 4.4 17 16 190

20 16/9/11 148 F 2500 70 72.5 41.25 42.25 N 1 4 6 4 5 2 2 120 12.6 17 70 25 0.8 3.8 16 14 148

21 13/12/11 58 M 2600 56 58.5 40 41.25 N 1 5 7 5 6 1 1 45 12.1 60 88 32 0.9 5.9 15 22 123

22 11/12/11 75 M 2500 61 63.5 39 41.25 Y (SS) 1 5 7 4 5 1 1 60 11 27 79 18 0.6 5.7 18 17 125

23 29/12/11 58 F 2830 56 58.5 37 38.25 N 2 4 6 4 5 1 1 15 10.8 80 109 31 1 6.2 19 32 139

24 6/1/12 60 M 2900 57 59.5 38 39.25 N 2 2 5 4 6 2 2 20 10.8 62 74 32 0.8 7.9 20 28 129

25 3/11/11 115 M 2800 65 67.5 40 41.25 N 2 5 5 6 6 1 1 100 11.4 41 88 21 0.7 4.6 25 26 147

26 7/1/12 49 F 2750 55 57.5 38 39.25 N 1 4 5 4 6 1 1 20 10.6 70 84 21 0.7 4.9 18 20 139

27 3/11/11 93 F 3000 65 67.5 39 40.25 N 2 3 5 4 6 1 1 15 12 16 145 26 0.7 6.9 16 13 165

28 9/12/11 84 F 2500 55 57.5 35 36.25 N 1 4 6 4 5 2 2 56 12.3 8 83 16 0.6 6.6 15 13 104

29 23/10/11 133 F 2500 70 72.5 41 42.25 Y (HO) 2 6 8 8 9 1 1 120 11.2 12 72 25 0.7 2.5 19 15 135

30 9/11/11 131 F 2600 60 62.5 42 43.25 N 1 8 9 9 9 1 1 90 13.4 29 87 29 0.9 5.9 17 15 141

Baby Investigations

Len

gth

(in

ch)

HC

(cm

)

Freq

uen

cyof

BF

in24h

rs

Fre

qu

ency

of

Urin

ein

24

hr

s

Fre

qu

ency

of

Sto

ols

in

24h

rs

S.No.Testgroup

S.P

rola

ctin

CU

E

Com

ple

terel

acta

tion

Parti

al

rel

acta

tion

Lacta

tion

fail

ure

No

resp

onse

BT BT BT AT BT AT BT AT BT AT BT AT BT AT1 165 WNL 2 3 1 1 1 2 1 2 300 100 3100 4200 x ? x x

2 59.57 WNL 2 3 1 1 1 2 1 1 450 150 4100 5000 x ? x x

3 50 WNL 1 4 1 4 1 4 1 4 450 100 4000 5000 x ? x x

4 4.12 WNL 1 2 1 3 1 3 1 4 300 0 4500 5500 ? x x x

5 7.39 WNL 1 4 1 4 1 4 1 4 300 0 6700 7700 ? x x x

6 129.6 WNL 1 4 1 4 1 4 1 4 300 0 4300 5300 ? x x x

7 54.3 WNL 1 3 1 3 1 3 1 4 Ra 250 0 5000 6000 ? x x x

8 10.8 WNL 1 2 1 2 1 2 1 2 Ra 150 150 4300 5800 x ? x x

9 6.8 WNL 1 5 1 5 1 5 1 5 Ra 450 0 5900 6900 ? x x x

10 29.8 WNL 1 4 1 4 1 4 1 5 C 150 0 4000 5000 ? x x x

11 14.1 WNL 1 3 1 3 1 3 1 3 Ra 250 Ra 100 6500 7500 x ? x x

12 29.2 WNL 1 5 1 5 1 4 1 5 300 0 4500 5500 ? x x x

13 6.1 WNL 1 3 1 3 1 3 1 3 Ra 250 0 4500 5500 ? x x x

14 79.8 WNL 1 4 1 4 1 4 1 4 350 0 4100 5000 x ? x x

15 132.2 WNL 1 3 1 3 1 3 1 3 Ra 250 0 6500 7500 ? x x x

16 21.1 WNL 1 2 1 2 1 2 1 2 300 100 4000 4500 x ? x x

17 41.7 WNL 1 3 1 3 1 3 1 3 350 0 7500 8500 ? x x x

18 10.9 WNL 1 4 1 4 1 4 1 4 Ra 300 0 6000 7000 ? x x x

19 20.5 WNL 1 5 1 5 1 5 1 5 C 250 0 4100 5500 ? x x x

20 66.6 WNL 1 3 1 3 1 3 1 3 300 0 4500 5500 ? x x x

21 41.6 WNL 1 4 1 4 1 4 1 4 C 250 0 4800 5800 ? x x x

22 15 WNL 1 4 1 4 1 4 1 4 250 0 4000 5000 ? x x x

23 30.4 WNL 1 3 1 3 1 3 1 4 300 0 3700 4700 ? x x x

24 101.7 WNL 1 3 1 3 1 3 1 4 275 0 3600 4600 ? x x x

25 7.1 WNL 1 4 1 4 1 4 1 4 250 200 6200 6200 x x x ?

26 30.5 WNL 1 1 1 1 1 1 1 1 300 250 3800 3800 x x x ?

27 8.6 WNL 1 4 1 4 1 4 1 4 275 0 5800 6500 ? x x x

28 24.5 WNL 1 4 1 4 1 4 1 4 350 0 4500 5400 ? x x x

29 9.7 WNL 1 4 1 2 1 4 1 4 250 0 5600 6500 ? x x x

30 14.8 WNL 1 4 1 2 1 4 1 4 Ra 250 0 6200 6800 ? x x x

Subjective Parameters Objective Parameters Response

Fee

ling

full

nes

sin

bre

ast

befo

re

feed

ing

Con

trala

teral

eject

ion

of

mil

k

flow

du

rin

gfe

edin

g

Moth

er

ob

serv

ati

on

in

incre

ase

of

mil

k

flo

w

Sati

sfact

ion

of

moth

erw

ith

BF

Vol

of

Supple

men

tati

on

of

Mil

k/o

ther

sup

ple

men

ts

Weig

htofth

ebaby

(g)

Mother

S.

No.con

trol

gro

up

CR

.N

o.

R.

No.

Na

me

Age

(Y)

Rel

igio

n

Hab

itat

Ed

ucat

ion

Inco

me

(Th

ou

san

d)

Occ

up

ati

on

SE

S

Die

t

Miz

aj

ML

(yea

rs)

Hei

ght

(cm

)

Wei

gh

t(K

g)

BM

I(k

g\m

)

Par

ity

Liv

ing

Ab

orit

on

Lac

tati

ona

l

am

enn

orrh

oea

LM

P

Co

nra

cep

tive

Pla

ce

ofdeli

ver

y

1 111639 6 Ashwini 21 H UR HI 6 UE LM V B 3 149 56 25 1 1 0 Y NA N HOS

2 126086 7 Kalavathi 24 H UR SC 8 UE LM NV B 7 150 43.3 19 2 2 0 Y NA BM HOS

3 124209 8 Latha 25 H UR SC 12 UE UM NV B 7 156 62 25 2 2 0 Y NA T HOS

4 118351 9 Lekha 22 H UR SC 10 UE UM NV S 5 150 47 22 2 2 0 Y NA N HOS

5 123060 17 Waheeda 27 MU UR HI 8 UE LM NV B 5 146 48 22 2 2 2 N 30/10/11 BM HOS

6 125889 25 Sultana 28 MU UR SC 15 UE LM NV S 11 149 42 18.9 3 3 0 Y NA T HOS

7 127875 26 Vidya 20 H UR HI 7 UE LM NV B 1 146 40 18 1 1 0 Y NA N HOS

8 128571 29 Kavya 22 H UR GR 12 UE UM NV B 7 148 55 25 2 2 0 Y NA N HOS

9 128615 30 Susheela 28 H UR SC 6 UE LM V S 6 156 52.2 21 2 2 0 Y NA BM HOS

10 128655 31 Sangeetha 23 H UR HI 12 UE UM NV S 4 144 45.4 21 3 3 0 Y NA N HOS

11 128192 32 Neha 18 H UR HI 8 UE UM V B 4 162 65 24 1 1 0 Y NA BM HOS

12 128854 33 Salma 25 MU UR PR 4 UE UL NV B 4 144 45 21 2 2 0 Y NA BM HOS

13 129886 40 Nandini R 25 H UR GR 7 UE UM NV S 5 152 50 21 2 2 0 Y NA N HOS

14 130094 42 Umme Salma 20 MU UR HI 9 UE LM NV B 2 148 54 24 1 1 0 N 20/2/12 BM HOS

15 130359 43 Arshiya Jaan 22 MU UR HI 10 UE LM NV S 7 160 59 23 3 3 0 N 24/2/12 T HOS

MASTER CHART (Control group)

t

r

S.

No.

Co

ntro

lgro

up

Mod

eof

del

iver

y

Dat

eof

Bir

th

Age

of

the

ba

by

ate

ntr

y(d

ays

)

Sex

Bir

thw

eigh

t(g

)

H/o

pre

-la

ctal

feed

s

Tim

eo

fst

arti

ng

BF

To

pfe

edin

gst

arte

d(

Age

in

day

s)

Hb

%(g

ms)

ES

R(m

m/h

r)

RB

S(m

g/d

l)

Blo

odU

rea

(mg

/dl)

BT AT BT AT BT AT BT AT BT AT BT BT BT BT

1 LSCS 24-2-11 124 F 3750 70 72.5 41 42.25 N 1 4 6 4 5 1 1 60 12.1 24 84 25

2 NVD 20-4-11 150 M 2800 74 76.5 43.5 44.75 Y (SS) 1 4 5 6 6 1 1 90 11.5 22 80 18

3 NVD 29-4-11 126 M 3000 70 72.5 41.5 42.75 N 1 3 4 4 5 1 1 110 12 15 78 15

4 NVD 24-7-11 47 F 2750 52.5 55 36.5 37.75 N 1 5 6 6 7 1 1 10 10.6 20 86 17

5 NVD 23-8-11 90 F 3300 68 70.5 37.5 38.75 N 1 5 7 4 5 1 1 60 11.2 15 87 33

6 NVD 15-9-11 127 M 2700 65 67.5 42 43.25 Y (HO) 1 4 4 6 7 1 1 30 11.5 35 94 25

7 LSCS 14-11-11 76 F 2500 54 56.5 37 38.25 Y (SS) 2 3 3 5 6 1 1 30 11.8 90 91 18

8 NVD 30-11-11 76 F 3000 55 57.5 37 38.25 N 1 3 3 4 5 1 1 60 12 55 86 23

9 LSCS 15/12/11 60 F 3000 57 59.5 38 39.25 N 1 4 6 3 5 1 1 40 12.4 15 80 24

10 NVD 20-11-11 86 M 2750 55 57.5 39 4025 N 1 3 3 5 6 1 1 70 11.4 34 86 23

11 NVD 18/12/11 60 M 2500 58 60.5 38 39.25 N 1 3 6 5 6 2 2 2 12.3 9 80 27

12 LSCS 23-10-11 120 F 2500 65 67.5 40 41.25 N 2 4 4 5 6 1 1 95 12.4 35 84 31

13 NVD 9/11/11 111 M 2500 64 66.5 41 42.25 N 1 4 4 4 4 1 1 60 11.1 19 86 27

14 NVD 15-12-11 65 M 2600 65 67.5 40 41.25 Y (SS) 1 4 4 4 4 1 1 60 10.1 73 84 21

15 LSCS 21-12-11 80 F 2800 51.5 52.5 39 40.25 N 1 4 4 4 4 1 1 60 10.3 41 77 25

InvestigationsBaby

Len

gth

(in

ch)

HC

(cm

)

Fr

equ

ency

ofB

Fin

24h

rs

Fre

qu

enc

yof

Uri

ne

in24

hrs

Fr

equ

ency

ofS

tool

sin

24h

rs

S.

No

.c

on

tro

lg

rou

p

S.

Cre

ati

nin

e(m

g/d

l)

S.

Uri

ca

cid

(mg

/dl)

SG

OT

(IU

/)

SG

PT

(IU

/)

Alk

ali

ne

ph

osp

hata

se(I

U/L

)

S.

Pro

lac

tin

CU

E

Co

mp

lete

rel

act

aio

n

Pa

rti

al

rel

ac

tati

on

La

cta

tio

nfa

ilu

re

No

res

po

nse

BT BT BT BT BT BT BT BT AT BT AT BT AT BT AT BT AT BT AT

1 0.9 5.72 23 19 164 5.7 WNL 1 2 1 2 1 2 1 2 C 250 250 6500 7500 x x x ?

2 0.8 3.6 22 20 135 33 WNL 1 3 1 3 1 3 1 3 450 0 7000 8000 ? x x x

3 0.8 3.7 24 20 149 50 WNL 1 3 1 3 1 3 1 3 350 0 5000 6000 ? x x x

4 0.9 4.3 18 16 138 10 WNL 1 1 1 1 1 1 1 1 250 350 4600 5600 x x x ?

5 0.8 3.5 20 25 159 40 WNL 1 3 1 3 1 3 1 3 350 0 5300 6000 ? x x x

6 0.6 6.3 18 16 165 7.1 WNL 1 1 1 1 1 1 1 1 300 400 5000 6000 x x x ?

7 0.6 3 16 14 149 11 WNL 1 2 1 2 1 2 1 2 Ra 250 250 3600 4600 x x x ?

8 0.7 7.9 23 19 157 195 WNL 1 2 1 2 1 2 1 2 300 400 5000 6000 x x x ?

9 0.6 7 14 13 137 53 WNL 1 1 1 1 1 1 1 1 275 250 4500 5500 x x x ?

10 0.7 7.6 24 20 201 15 WNL 1 2 1 2 1 2 1 2 Ra 250 Ra 350 5400 6400 x x x ?

11 0.8 7.6 20 14 141 72 WNL1 1 1 1 1 1 1 1 300 300 4000 5000 ? x x x

12 0.9 5.9 17 18 156 9.7 WNL 1 2 1 2 1 2 1 2 C 250 300 (C 5000 5500 x x x ?

13 0.7 7.2 20 22 207 64 WNL 1 1 1 1 1 1 1 1 C 250 250 5500 6000 x x x ?

14 0.8 4.3 21 19 132 16 WNL 1 3 1 3 1 3 1 3 C 250 0 4000 5000 x x x ?

15 0.8 3.3 20 14 162 39 WNL 1 2 1 2 1 2 1 2 300 300 5000 6000 x x x ?

Investigation Subjective Parameters Objective Parameters Response

Fe

elin

gfu

lln

ess

inb

rea

st

bef

ore

feed

ing

Co

ntr

ala

ter

al

ejec

tio

no

f

mil

kfl

ow

du

rin

gfe

edin

g

Mo

the

ro

bse

rva

tio

nin

incr

ea

seo

fm

ilk

flo

w

Sa

tisf

act

ion

of

mo

ther

wit

hB

F

Vo

lo

fS

up

ple

me

nta

tio

no

f

Mil

k/o

ther

sup

ple

me

nts

Wei

gh

to

fth

eb

ab

y(g

)

L L

management of qillatul laban (inadequacy of lactation

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