clinical trial of homoeopathic preparations of amyleum nitrosum, azathioprine cocainum muriaticum...

8/14/2019 Clinical Trial of Homoeopathic Preparations of Amyleum Nitrosum, Azathioprine Cocainum Muriaticum and Cyclosporine in HIV Disease

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Clinical Trial of Homoeopathic Preparations of

Amyleum Nitrosum, Azathioprine, Cocainum

Muriaticum and Cyclosporine in HIV Disease

Dr. V.P. Singh

Central Council for Research in Homoeopathy

New Delhi


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Since the presentation of the first cases of

immunodeficiency in homosexual men in 1981 inNew York and California, HIV infection has come

a long way and is currently a Global health

emergency (WHO). It is now the leading cause

of death in most parts of the World and the

fourth biggest killer globally.

Introduction


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By the End of 2006

39.5 million people were living with HIV Globally

5.7 million of these were in India

11000 new HIV infections reported every day

2.9 million people died of AIDS in 2005

HIV infections increasing among women at a fastpace


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CCRH and HIV

CCRH undertook a pilot research study in 1989

to ascertain whether homoeopathy can play arole in the treatment and management of HIV

infection

The study was undertaken at the RRI, Mumbai(May, 1989) and CRU, Chennai (October, 1991)


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CCRH and HIV

The results obtained during the pilot study

prompted a randomized placebo controlled studyat Mumbai (1995-97). The results of the study

were published in the British Homeopathic

Journal (1999)


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Early Years of Epidemic in India

In the late 1980s and early 1990s, no ARV drugs

were available in India People with HIV were referred to the Councils

Office at New Delhi for treatment

All these people were asymptomatic. As suchthey were treated on the basis of theircharacteristic mental/emotional, physicalattributes

The treatment also included extensive counselingand dietary advice


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ar y ears o p em c nIndia

Clinical presentation usually comprised of:

Anxiety about future

Fear of impending death

This caused:

Anorexia and Insomnia

Occasionally:

Diarrhea and weight loss


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HIV-PathogenesisHIV-Pathogenesis

HIV causes a slow decline in immune capacity

The infected person remains asymptomaticinitially

When his CMI is compromised, he becomessusceptible to a multitude of opportunistinfections

Still later develops a clinical state called AIDS


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Evolution of New Hypothetical Model

Based on the analogy that the damage starts at

cellular and molecular level and clinically activedisease develops only when organism stops

responding efficiently to invading microbes WILL

IT HELP ?

If treatment is aimed at restoring or maintaining

the capacity of T helper cells responsible for

instituting CMI?


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Whether drug substances that are known immune

suppressors in material doses would help if usedin homoeopathic potencies ?

If they work, how long would their action last ?

And whether they would work equally well in

asymptomatic and people with intermediary and

advanced stage ?


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These questions prompted a search for such

drug substances which can be tried

The first one was Amyleum Nitrosum, the

popper which was blamed for immune deficiency

in 1981-82

Later Cyclosporine and Azathioprine, both used

on people with organic transplants

Cocaine, another drug which is discredited withhaving killer effect on T helper cell and causing

rapid replication of HIV


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Objective

An objective was thus evolved which was-

To clinically evaluate the role of Amyleum

Nitrosum in Asymptomatic infection and to see

whether it could help:

delay the progression of HIV infection andoccurrence of OIs, and

whether clinical improvement corroborate with

corresponding rise in CD4/CD8 count


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Additions of New Medicines for Trial

Later Cyclosporine, Azathioprine,

and Cocainum Muriaticum were also added tothe list of medicines for trial

Azathioprine was potentised in 6, 9, 12

potencies initially and later in 30, 200 and 1M

potencies

Cyclosporine was procured from Ainsworth, UKin 30CH and raised to 200 CH potency


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Methodology

A study was conducted at New Delhi between

April 1998 and March 2003

237 HIV infected individuals including, 96

Females and 8 children less than 10 years ofage were enrolled in the study

Three of these individuals were suffering from

concurrent Hepatitis B infection and 2 were

reactive to VDRL


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Homoeopathic Medicines Used

Amyleum Nitrosum, Azathioprine,

Cocainum Muriaticum and Cyclosporine wereprimarily used as medicines under trial

Other Homoeopathic medicines were used onlyduring seasonal minor ailments based on

presenting signs and symptoms.


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Other Homoeopathic Medicines Used

Arsenicum album

Azadirachta indica Belladonna Borax Bryonia alba Calcarea carbonicum Carbo animalis China officinalis Colocynthis Dulcamara

Ficus religiosa Gelsemium sempervirens Hepar sulphuris calc.

Kali bichromicum

Kali carbonicum Kali Chloricum

Kali muriaticum

Lycopodium clavatum

Mercurius solubilis

Natrum muriaticum

Nitricum acidum

Nux vomica

Pulsatilla

Rhus toxicodendron

Sepia

Silicea


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Assessment of Outcome

The response to the treatment was assessed at

the end of the study and was based on thechange in clinical presentation

The response to treatment was also assessed

by the haematological and immunologicalinvestigations such as CD4/CD8 counts

Most of these investigations were conducted at

the Councils HIV Research Laboratory


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Assessment of Outcome

Parameters adopted for Assessment:

Clinical status

Immunological status

Quality of life

Response to


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Response toTherapy

Asymptomatic stage (At Entry) 149

Maintaining asymptomatic status 134

Progress to PGL Stage 02

Progress to ARC 00

Progress to Opportunistic infections 05

Under observation 08

PGL stage (At Entry) 01 Improvement (became Asymptomatic) 01


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Response to Therapy

ARC stage (At Entry) 25

Improvement 14

Not improved 04

Progressed to OIs 05


OIs/AIDS (At Entry) 14

Improvement 07

Progressed to ARC 01

No improvement 01



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Response to Therapy

Immunological status

Repeat CD4 + Count 103 cases*

Increase in CD4 Count 48 cases

No Change/Drop in CD4 Count 55 cases

* 80 of the cases had presented with CD4

cells


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Changes in CD4 Counts

CD4+ T-Lymphocyte

Count

Before

treatment

During treatment

Total no.of cases*

Improved Not improved

Range T M F T M F T M F

More than

1000/cumm1 - 1 - - - 1 - 1

Between 500 to

1000/cumm

22 6 16 17 4 3 5 2 3

Between 200 to500/cumm

62 40 22 25 20 5 37 20 17

Between 100 to

200/cumm

16 7 9 4 2 2 12 5 7

Less that 100

cells/cumm

2 1 1 2 1 1 - - -


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Response to Treatment: Symptoms

48 46

34 32

14

42 42

29 26

12

0

1020

30

40

50

60

loss

of

appetite

weakness

feve

r

cou

gh

diarrho

ea

presented

Improved


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Response to Treatment- Symptoms

1

11

5

16

12

16

1

10

5

1112

14

024

6

81012

141618

Lymp

hade

nopa

thy

candidia

sis

ulce

rs

weigh

tloss

h

erpe

szo

ster

derm

atiti

s

presented

Improved


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Observations and Discussion-1

The results showed that clinical improvement

does not necessarily corroborate withimprovement in CD4 Counts, universally

adopted parameter for the assessment of

effects of therapy


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People with HIV and CD4 Counts over 500/cu.mm

respond more favourably at cellular level thanthose having lower Counts between 200-500

However, surprising was that both of the 2subjects whose CD4 Counts were lower than

100/cu.mm at entry showed increase in CD4

Counts and clinical improvement

Observations and Discussion


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Observations and Discussion-

3

Significant observation was that many subjectsunder treatment experienced emotional andphysiological stability despite decline in CD4Counts

Another significant observation was that subjectsunder study did not develop any opportunistinfections even after 7-8 years of infection

Most subjects experienced improvement in qualityof life


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Only one subject manifested steady rise in CD4

Count over a period of 5 years without any drop

All other subjects who manifested changes in

CD4 Counts manifested fluctuations, sometime

drop and some time rise in CD4 Count which

can not be explained


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Another significant observation was that

candidiasis-oral ulcers, a hall mark ofprogressive HIV infection and known to recur

frequently, responded favourably to

homoeopathic therapy


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Clinical observation indicate a definite, intricaterelationship between Stress, malnutrition,sedentary habits and absence of psychologicalsupport from the family and friends and immunesystem

All these factors adversely affect immunesystem

On the other hand removal of one or more or allthese factors was seen to have a salutary effect

on immune system


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Conclusion

It is difficult to make a definitive conclusion as

CD4 estimation facility was not readily availablein the country in 1998 and only 103 subjects hadrepeat CD4 Counts

Another reason for not making a definitiveconclusion is that management of HIV infectionis a complex activity. Medicine alone does nothelp people with HIV. There are many other

issues which need to be addressed to


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Conclusion

However, based on the results it can safely be

assumed that: Specific Homoeopathic medicines which

affect immune system in material doses, can

be used for the treatment of Asymptomatic

HIV infection

These medicines can also be used in HIV+

people with CD4 Counts over 500/cu.mm with

varying results

New


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New

Studies

As a logical follow up, CCRH has undertaken two

multicentric studies

AMulticentric Clinical Trial of Homoeopathic Therapy

in HIV Infection at Mumbai, Chennai, Imphal,

Gudiwada and New Delhi A Multicentric Clinical Trial of Homoeopathic

Preparations of Amyleum Nitrosum,

Azathioprine,Cocainum Muriaticum and Cyclosporine

in HIV Infection at New Delhi, Mumbai and Gudiwada


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clinical trial of homoeopathic preparations of amyleum nitrosum, azathioprine cocainum muriaticum...

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