acupuncture for chronic fatigue syndrome
DESCRIPTION
chinese medicine researchTRANSCRIPT
![Page 1: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/1.jpg)
Acupuncture for chronic fatigue syndrome (Protocol)
Zhang W Liu Z Wu T Peng W
This is a reprint of a Cochrane protocol prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2009 Issue 2
httpwwwthecochranelibrarycom
Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
T A B L E O F C O N T E N T S
1HEADER
1ABSTRACT
2BACKGROUND
3OBJECTIVES
3METHODS
5REFERENCES
6WHATrsquoS NEW
6HISTORY
6CONTRIBUTIONS OF AUTHORS
6DECLARATIONS OF INTEREST
6SOURCES OF SUPPORT
iAcupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
[Intervention Protocol]
Acupuncture for chronic fatigue syndrome
Wei Zhang1 Zhishun Liu1 Taixiang Wu2 Weina Peng1
1Department of Acupuncture and Moxibustion Chinese Academy of Traditional Chinese Medicine Beijing China 2 Chinese Cochrane
Centre Chinese EBM Centre West China Hospital Sichuan University Chengdu China
Contact address Wei Zhang Department of Acupuncture and Moxibustion Chinese Academy of Traditional Chinese Medicine
Guang An Men Hopital No5 Bei Xian Ge Street Beijing Xuanwu District 100053 China zhangwei_7108hotmailcom (Editorial
group Cochrane Depression Anxiety and Neurosis Group)
Cochrane Database of Systematic Reviews Issue 2 2009 (Status in this issue Unchanged)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
DOI 10100214651858CD006010
This version first published online 19 April 2006 in Issue 2 2006 (Help document - Dates and Statuses explained)
This record should be cited as Zhang W Liu Z Wu T Peng W Acupuncture for chronic fatigue syndrome Cochrane Database of
Systematic Reviews 2006 Issue 2 Art No CD006010 DOI 10100214651858CD006010
A B S T R A C T
This is the protocol for a review and there is no abstract The objectives are as follows
Our objective is to conduct a systematic review and if possible a quantitative meta-analysis with any evidence collected from randomised
controlled trials and quasi-randomised trials of acupuncture for adults and children with chronic fatigue syndrome (CFS) In this way
we can assess the efficacy and safety of acupuncture therapy for CFS and test the hypothesis that acupuncture is more effective than
other interventions
1Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
B A C K G R O U N D
Chronic fatigue syndrome (CFS) is a clinically defined condi-
tion characterised by severe disabling fatigue and other symp-
toms including self-reported musculoskeletal pain sleep distur-
bance headaches and impairments in concentration and short-
term memory These symptoms as opposed to a debilitating but
nonspecific condition shared by many diseases are usually medi-
cally unexplained A diagnosis of chronic fatigue syndrome can be
made only after all the physical and psychiatric causes of chronic
fatigue have been excluded Because of the absence of objective
clinical signs CFS patients are often annoyed by the lack of un-
derstanding from others including medical professionals
Historically CFS has also been called Royal Free disease Iceland
disease neurasthenia myalgic encephalomyelitis (rsquoMErsquo) and post-
viral fatigue syndrome Nowadays the term CFS is widely adopted
for research in the field however sometimes rsquoMErsquo is also seen in
articles and textbooks
Epidemiological research in western countries has demonstrated
that the prevalence of CFS is 02-26 depending on the criteria
used (Wessely 1997 Steele 1998) In China it was reported in
2004 that among 2000 citizens interviewed in the cities of Beijing
and Baotou 198 of them had symptoms that were consistent
with CDC criteria of CFS (Zhang 2004)
In 1987 the US Centers for Disease Control and Prevention
(CDC) developed a diagnostic criteria of CFS These criteria were
updated in 1994 which widened their use (Fukuda 1994) The
Oxford criteria also called the British criteria is another opera-
tional criteria for research (Sharpe 1991) There are two important
differences between these definitions The British criteria insist
on the presence of mental fatigue the American criteria include
a requirement for several physical symptoms reflecting the belief
that chronic fatigue syndrome has an underlying immunological
or infective pathology
Etiologically the cause of chronic fatigue syndrome is poorly un-
derstood There has been some new work in virology immunol-
ogy and imaging which also holds promise but still does not pro-
vide any diagnostic test or a mechanism for the production of
symptoms of CFS (Sabin 2003)
The treatment of CFS is attracting more and more attention How-
ever so far no single pharmacological treatment has been shown
to be effective for people with CFS Two Cochrane systematic
reviews were published concerning cognitive behaviour therapy
for chronic fatigue syndrome in adults (Price 2003) and exercise
therapy for chronic fatigue syndrome (Edmonds 2004) They sug-
gested that cognitive behaviour therapy appears to be an effective
and acceptable treatment for adult out-patients with chronic fa-
tigue syndrome and encouraging evidence has demonstrated that
some patients may benefit from exercise therapy In 2002 clinical
practice guidelines for chronic fatigue syndrome were conducted
by a working group convened under the auspices of the Royal Aus-
tralasian College of Physicians (CFS workshop 2002) There the
management of CFS was described in detail Cognitive-behaviour
therapy and graded exercise were strongly supported (Level I and
Level II respectively) to be effective for some people with CFS
Acupuncture is a very important constituent of Traditional Chi-
nese Medicine (TCM) with a history of literature spanning over
2000 years Acupuncture is a therapy implemented by inserting
needles into certain points on the human body which are called
ldquoXue Weirdquo in Chinese Generally acupoints can be classified into
meridian points which are located on the pathway of a meridian
or so called ldquoJing Luordquo in Chinese and extra points which are dis-
covered through practical experience There are types of needling
methods other than the frequently used filiform needle such as fire
needle seven star needle three-edged needle (mainly for bleeding)
and so on With the development of technology electricity was
introduced into the stimulation method of acupuncture and now
electro-acupuncture is a very important type of acupuncture apart
from the traditional hand manipulation According to the location
where needling is carried out acupuncture can also be classified
into body acupuncture scalp acupuncture auricular acupuncture
and ankle-wrist acupuncture etc Acupuncture is not just a therapy
alone many centuries ago acupuncture developed into a discipline
which has its own theory and practice system It is believed in
TCM theory that acupuncture can strengthen the vital essence of
the human body which is called ldquoQirdquo in Chinese and remove the
blockage of channels There are a wide range of diseases that are
thought to benefit from treatment with acupuncture
According to our search of main medical and biological bibliogra-
phy databases both inside and outside China so far no study has
been done on acupuncture for CFS in any foreign institution In
China from a preliminary search we found 15 clinical trials on
the topic of acupuncture for CFS From a rough review of these
trials we can see that the quality of these were uneven however
some could provide evidence for further analysis All the Chinese
trials that had control groups got results of benefit in the acupunc-
ture group with success rates ranging from 8890 (Ni 2002) to
9429 (Liu 2004)
No research was done concerning the mechanism of acupuncture
for CFS with modern medical measures Traditionally it can be
explained as adjusting the balance of Yin-Yang and nourishing the
Qi and blood if a deficiency exists This explanation is based on the
theory of traditional Chinese medicine which stems from ancient
Chinese philosophy
So far the clinical application of acupuncture for CFS is mainly
based on experience and its effects have not been evaluated In
past decades acupuncture has gained more popularity both inside
and outside China because of its advantages of convenience econ-
omy and reports of effectiveness A precise evaluation of acupunc-
ture is required This review will assess the efficacy and safety of
acupuncture therapy for CFS
2Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
O B J E C T I V E S
Our objective is to conduct a systematic review and if possible a
quantitative meta-analysis with any evidence collected from ran-
domised controlled trials and quasi-randomised trials of acupunc-
ture for adults and children with chronic fatigue syndrome (CFS)
In this way we can assess the efficacy and safety of acupuncture
therapy for CFS and test the hypothesis that acupuncture is more
effective than other interventions
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials and quasi-randomised trials
Types of participants
Patients with CFS according to the criteria of Centre for Disease
Control (CDC) (Fukuda 1994) Oxford (Sharpe 1991) ICD-
10 (WHO 1992) or any other validated criteria will be included
irrespective of gender race age and setting
Types of interventions
Any type of acupuncture therapy including body acupuncture
auricular acupuncture scalp acupuncture or electroacupuncture
will be considered The stimulation method can be hand manip-
ulation or electricity pulse Acupuncture methods without needle
insertion such as seed stimulation or seven-star needle will also be
included
The control interventions will be
(1) No intervention placebo acupuncture (using points very near
to normal acupuncture points but not the exact acupuncture
point) or sham acupuncture (using different acupuncture instru-
ments which can cause a similar sensation to acupuncture but are
not inserted into the skin) (Streitberger 1998)
(2) Pharmacological treatments (herbal medicine or western
medicine such as antidepressant or combination of them)
(3) Cognitive behaviour therapy (CBT)
(4) Exercise therapy
(5) Any other interventions
Types of outcome measures
Primary outcome measure
Fatigue is the key characteristic of CFS so we will take fatigue
symptoms as the main outcome of this review (eg Chalder Fatigue
Scale (Chalder 1993) or any type of instrument considered to scale
fatigue)
Secondary outcome measures
(1) Mood such as depression (eg Hamilton Depression Rating
Scale (Hamilton 1960)) and sleep disturbance using any instru-
ment (eg sleep onset latency (SOL) and wakefulness after sleep
onset (WASO) (Buscemi 2005))
(2) Quality of life score (eg SF-36 (Garratt 2002))
(3) Other symptoms such as pain headache using any instrument
(eg Visual analog scale (VAS) (WSDLI 2002) or quality of life)
(4) Adverse effects (eg pain (VAS) bleeding broken needles)
Search methods for identification of studies
1 Electronic searches
We will search the following electronic databases irrespective of
language and publication status
a) The Cochrane Collaboration Depression Anxiety amp Neurosis
Controlled Trials Register (CCDANCTR-Studies)
b) The Cochrane Central Register of Controlled Trials (CEN-
TRAL) on The Cochrane Library (Issue 4 2004)
c) MEDLINE (1966-2004)
d) EMBASE (1998-2004)
e) Chinese Biomedical Database (1979-2004)
CCDANCTR-Studies will be searched using the following strat-
egy
Diagnosis = Chronic Fatigue
and
Intervention = Acupuncture
In the Cochrane Reviewersrsquo Handbook 422 [updated December
2003] a highly sensitive search strategy for identifying reports of
randomized controlled trials in MEDLINE is provided for review-
ers We will put its 5b2 Format for MEDLINE on Ovid web ver-
sion (1-29) into usage in order to locate randomized controlled
trials
Below is the further search strategy for MEDLINE
30 chronic fatigue syndrome or CFS
31 myalgic encephalomyelitis or ME
32 or30-31
33 acupuncture
34 acupuncture points
35 (electroacupuncture or electro- acupuncture)tw
36 electroacupuncturetw
37 acupuncture$tw
38 acupointstw
39 meridians
40 or 33-39
41 29 and 32 and 40
2 Reference Lists
The reference lists of all identified papers will be searched for
further information
3 Personal Communication
We will contact authors for unpublished studies
Data collection and analysis
Eligibility
3Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Two reviewers Zhang and Peng will independently decide on
eligibility
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers (Zhang and
Peng) The following data will be extracted from each included
study
a) patientsrsquo demographic characteristics including maximum min-
imum and mean age
b) inclusion and exclusion criteria
c) type frequency treatment course of acupuncture therapy and
outcomes
d) type severity and number of adverse effects
e) number and reasons for dropouts withdrawals and lost to fol-
low-ups will also be recorded
Information not available in the reports of trials will be sought
from authors by email or telephone Extracted data will be reviewed
by the principal reviewer and discrepancies will be judged by an
arbitrator (Liu)
Quality assesment
Quality assessment will be carried out by two independent review-
ers (Zhang and Peng) and a third party (Liu) will be involved to
resolve any disagreement in case of occurrence
In line with the empirical evidence (Schulz 1995 Jadad 1996
Juni 2001 Kjaergard 2001) we intend to assess the methodolog-
ical quality as described by Kjaergard et al (Kjaergard 2001) and
Cochrane Reviewerrsquos Handbook 422
1) Method of randomisation
Treatments administered in a clinical trial should be selected by a
random process which allows each study participant to have the
same probability of receiving them and the investigators should
not be able to predict which treatment is next We will assess the
quality of the method of randomisation as follows
a) Adequate random number table computer randomization
tossing of a coin will be considered rsquoadequatersquo
b) Inadequate methods of allocation using odd-even numbers
patient social security numbers days of the week or medical record
numbers will be regarded as only pseudo- or quasi-random pro-
cesses instead of real randomization and will be considered inad-
equate
c) Unclear those who only used ldquorandomizationrdquo as a decoration
of article and no explanation available in articles will be regarded
as ldquounclearrdquo on randomization procedure
2) Allocation concealment
a) Adequate allocation concealment such as a central randomisa-
tion scheme by telephone or controlled by pharmacy numbered
or coded identical containers administered sequentially sequen-
tially numbered opaque sealed envelopes on site computer system
which can only be accessed after entering the characteristics of an
enrolled participant
b) Unclear authors did not report conditions of allocation con-
cealment or approach did not fall into one of the adequate mea-
sures Also sealed envelopes were not sequentially numbered or
opaque open list enrollment
c) Inadequate Alternation odd-even date of birth or week or case
record numbers
3) Blinding
Since blinding is not possible for treatment providers trials using
blinding for outcome assessors alone or together with blinding for
patients will be regarded as adequate
4) Follow-ups
Number and reason for dropouts withdrawals and fail to fulfill
follow ups should be described in articles
a) Good A rate of dropouts withdrawals and lost to follow ups
le 10
b) Acceptable A rate of dropouts withdrawals and lost to follow
ups le 20
c) Unacceptable A rate of dropouts withdrawals and lost to follow
ups gt20
Trials which meet the criteria of good or acceptable rate of
dropouts withdrawals and lost to follow ups will be included for
analysis
Data synthesis
First we will test for heterogeneity between trial results using a
standard chi-squared test and I-squared test to make sure that they
are appropriate to be combined
A meta-analysis will be implemented with the Cochrane Col-
laboration Review Manager (RevMan 43) software All the pri-
mary and secondary outcome measures under consideration will
be combined and analysed if there is evidence of homogeneity
(Pgt01) using a random effects model Results will be expressed as
relative risks (RR ratio of risk of treatment group vs that of con-
trol group) with their 95 confidence intervals for dichotomous
data For continuous variables measured with the same scale the
weighted mean differences ((WMD) the difference between treat-
ment and control pooled means at endpoint) along with their 95
confidence intervals will be calculated and standardised mean dif-
ference (SMD) will be calculated in case different scales are used
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size
(i) Repeating the analysis taking into account quality only trials
with adequate randomisation allocation concealment and blind-
ing will be included
(ii) Repeating the analysis excluding any trials with long duration
or large studies to establish how much they dominate the results
(iii) Repeat the analysis excluding trials using the following filters
diagnostic criteria (criterias except CDC ICD-10 and Oxford will
be excluded considering the prevalence) language of publication
(languages except English will be excluded because of the potential
inaccuracy in translation) Ethnic group (ethnic groups except
Asian will be excluded because most trials on acupuncture are
carried out in Asia especially China)
4Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Subgroup Analyses
Here we will compare the effects between subgroups below
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR)
R E F E R E N C E S
Additional references
Buscemi 2005
Buscemi N Vandermeer B Friesen C Bialy L Tubman M Ospina
M et alManifestations and management of chronic insomnia in adults
Evidence ReportTechnology Assessment no 125 Vol AHRQ Publica-
tion No 05-E021-2 Rockville MD Prepared by University of Al-
berta Evidence-based Practice Centre under contract C400000021
June 2005
CFS workshop 2002
CFS workshop Clinical Practice Guidelines-Chronic fatigue syn-
drome Clinical practice guidelines - 2002 MJA 20029 SupplS17ndash
S55
Chalder 1993
Chalder T Berelowitz G Pawlikowska T Development of a fatigue
scale Journal of Psychosomatic Research 199337(6)147ndash53
Edmonds 2004
Edmonds M McGuire H Price J Exercise therapy for chronic fa-
tigue syndrome The Cochrane Library 2004 Issue 3[Art No
CD003200 DOI 10100214651858CD003200pub2]
Fukuda 1994
Fukuda K Straus SE Hickie I The chronic fatigue syndrome a
comprehensive approach to its definition and study Annals of Inter-
nal Medicine 1994121953ndash9
Garratt 2002
Garratt A Schmidt L Mackintosh A et alQuality of life measure-
ment bibliographic study of patient assessed health outcome mea-
sures British Medical Journal 2002June 15324(7351)1417
Hamilton 1960
Hamilton M A rating scale for depression Journal of Neurology and
Neurosurgery 19602356ndash62
Jadad 1996
Jadad AR Moore RA Carroll D Jenkinson C Reynolds DJ Gav-
aghan DJ et alAssessing the quality of reports of randomized clini-
cal trials is blinding necessary Controlled Clinical Trials 199617
1ndash12
Juni 2001
Juni Peter Altman DG Egger M Assessing the quality of controlled
clinical trials BMJ 2001323(7303)42ndash6
Kjaergard 2001
Kjaergard LL Villumsen J Gluud C Reported methodologic quality
and discrepancies between large and small randomized trials in meta-
analyses Annals of Internal Medicine 2001135(11)982ndash9
Liu 2004
Liu J Acupuncture with herbs for CFS Journal of Chinese Clinical
medicine 20045(3)113ndash4
Ni 2002
Ni K Acupuncture with herbs for 35 cases of CFS Journal of Fujian
College of TCM 200212(4)22ndash3
Price 2003
Price JR Couper J Cognitive behaviour therapy for chronic fatigue
syndrome in adults The Cochrane Library 2003 Issue 4[Art No
CD001027 DOI 10100214651858CD001027pub2]
Reid 2000
Reid S Chalder T Extracts from ldquoClinical Evidencerdquo BMJ 2000
320292ndash6
Sabin 2003
Sabin TD An approach to chronic fatigue syndrome in adults Neu-
rologist 20039(1)28ndash34
Schulz 1995
Schulz KF Chalmers I Hayes RJ Altman DG Empirical evidence of
bias dimensions of methodological quality associated with estimates
of treatment effects in controlled trials JAMA 1995273408ndash12
Sharpe 1991
Sharpe M Archard L Banatvala J Borysiewicz LK Clare AW David
A Chronic fatigue syndrome guidelines for research Journal of the
Royal Society of Medicine 199184(2)118ndash21
Steele 1998
Steele L Dobbins JG Fukuda K Reyes M Randall B Koppelman
M The epidemiology of chronic fatigue in San Francisco American
Journal of Medecine 1998105(suppl 3A)83ndash90S
Streitberger 1998
Streitberger K Kleinhenz J Introducing a placebo needle into
acupuncture research The Lancet 1998352364ndash365
Wessely 1997
Wessely S Chalder T Hirsch S Wallace P Wright D The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome a
prospective primary care study American Journal of Public Health
199787(Not known)1449ndash55
5Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 2: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/2.jpg)
T A B L E O F C O N T E N T S
1HEADER
1ABSTRACT
2BACKGROUND
3OBJECTIVES
3METHODS
5REFERENCES
6WHATrsquoS NEW
6HISTORY
6CONTRIBUTIONS OF AUTHORS
6DECLARATIONS OF INTEREST
6SOURCES OF SUPPORT
iAcupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
[Intervention Protocol]
Acupuncture for chronic fatigue syndrome
Wei Zhang1 Zhishun Liu1 Taixiang Wu2 Weina Peng1
1Department of Acupuncture and Moxibustion Chinese Academy of Traditional Chinese Medicine Beijing China 2 Chinese Cochrane
Centre Chinese EBM Centre West China Hospital Sichuan University Chengdu China
Contact address Wei Zhang Department of Acupuncture and Moxibustion Chinese Academy of Traditional Chinese Medicine
Guang An Men Hopital No5 Bei Xian Ge Street Beijing Xuanwu District 100053 China zhangwei_7108hotmailcom (Editorial
group Cochrane Depression Anxiety and Neurosis Group)
Cochrane Database of Systematic Reviews Issue 2 2009 (Status in this issue Unchanged)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
DOI 10100214651858CD006010
This version first published online 19 April 2006 in Issue 2 2006 (Help document - Dates and Statuses explained)
This record should be cited as Zhang W Liu Z Wu T Peng W Acupuncture for chronic fatigue syndrome Cochrane Database of
Systematic Reviews 2006 Issue 2 Art No CD006010 DOI 10100214651858CD006010
A B S T R A C T
This is the protocol for a review and there is no abstract The objectives are as follows
Our objective is to conduct a systematic review and if possible a quantitative meta-analysis with any evidence collected from randomised
controlled trials and quasi-randomised trials of acupuncture for adults and children with chronic fatigue syndrome (CFS) In this way
we can assess the efficacy and safety of acupuncture therapy for CFS and test the hypothesis that acupuncture is more effective than
other interventions
1Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
B A C K G R O U N D
Chronic fatigue syndrome (CFS) is a clinically defined condi-
tion characterised by severe disabling fatigue and other symp-
toms including self-reported musculoskeletal pain sleep distur-
bance headaches and impairments in concentration and short-
term memory These symptoms as opposed to a debilitating but
nonspecific condition shared by many diseases are usually medi-
cally unexplained A diagnosis of chronic fatigue syndrome can be
made only after all the physical and psychiatric causes of chronic
fatigue have been excluded Because of the absence of objective
clinical signs CFS patients are often annoyed by the lack of un-
derstanding from others including medical professionals
Historically CFS has also been called Royal Free disease Iceland
disease neurasthenia myalgic encephalomyelitis (rsquoMErsquo) and post-
viral fatigue syndrome Nowadays the term CFS is widely adopted
for research in the field however sometimes rsquoMErsquo is also seen in
articles and textbooks
Epidemiological research in western countries has demonstrated
that the prevalence of CFS is 02-26 depending on the criteria
used (Wessely 1997 Steele 1998) In China it was reported in
2004 that among 2000 citizens interviewed in the cities of Beijing
and Baotou 198 of them had symptoms that were consistent
with CDC criteria of CFS (Zhang 2004)
In 1987 the US Centers for Disease Control and Prevention
(CDC) developed a diagnostic criteria of CFS These criteria were
updated in 1994 which widened their use (Fukuda 1994) The
Oxford criteria also called the British criteria is another opera-
tional criteria for research (Sharpe 1991) There are two important
differences between these definitions The British criteria insist
on the presence of mental fatigue the American criteria include
a requirement for several physical symptoms reflecting the belief
that chronic fatigue syndrome has an underlying immunological
or infective pathology
Etiologically the cause of chronic fatigue syndrome is poorly un-
derstood There has been some new work in virology immunol-
ogy and imaging which also holds promise but still does not pro-
vide any diagnostic test or a mechanism for the production of
symptoms of CFS (Sabin 2003)
The treatment of CFS is attracting more and more attention How-
ever so far no single pharmacological treatment has been shown
to be effective for people with CFS Two Cochrane systematic
reviews were published concerning cognitive behaviour therapy
for chronic fatigue syndrome in adults (Price 2003) and exercise
therapy for chronic fatigue syndrome (Edmonds 2004) They sug-
gested that cognitive behaviour therapy appears to be an effective
and acceptable treatment for adult out-patients with chronic fa-
tigue syndrome and encouraging evidence has demonstrated that
some patients may benefit from exercise therapy In 2002 clinical
practice guidelines for chronic fatigue syndrome were conducted
by a working group convened under the auspices of the Royal Aus-
tralasian College of Physicians (CFS workshop 2002) There the
management of CFS was described in detail Cognitive-behaviour
therapy and graded exercise were strongly supported (Level I and
Level II respectively) to be effective for some people with CFS
Acupuncture is a very important constituent of Traditional Chi-
nese Medicine (TCM) with a history of literature spanning over
2000 years Acupuncture is a therapy implemented by inserting
needles into certain points on the human body which are called
ldquoXue Weirdquo in Chinese Generally acupoints can be classified into
meridian points which are located on the pathway of a meridian
or so called ldquoJing Luordquo in Chinese and extra points which are dis-
covered through practical experience There are types of needling
methods other than the frequently used filiform needle such as fire
needle seven star needle three-edged needle (mainly for bleeding)
and so on With the development of technology electricity was
introduced into the stimulation method of acupuncture and now
electro-acupuncture is a very important type of acupuncture apart
from the traditional hand manipulation According to the location
where needling is carried out acupuncture can also be classified
into body acupuncture scalp acupuncture auricular acupuncture
and ankle-wrist acupuncture etc Acupuncture is not just a therapy
alone many centuries ago acupuncture developed into a discipline
which has its own theory and practice system It is believed in
TCM theory that acupuncture can strengthen the vital essence of
the human body which is called ldquoQirdquo in Chinese and remove the
blockage of channels There are a wide range of diseases that are
thought to benefit from treatment with acupuncture
According to our search of main medical and biological bibliogra-
phy databases both inside and outside China so far no study has
been done on acupuncture for CFS in any foreign institution In
China from a preliminary search we found 15 clinical trials on
the topic of acupuncture for CFS From a rough review of these
trials we can see that the quality of these were uneven however
some could provide evidence for further analysis All the Chinese
trials that had control groups got results of benefit in the acupunc-
ture group with success rates ranging from 8890 (Ni 2002) to
9429 (Liu 2004)
No research was done concerning the mechanism of acupuncture
for CFS with modern medical measures Traditionally it can be
explained as adjusting the balance of Yin-Yang and nourishing the
Qi and blood if a deficiency exists This explanation is based on the
theory of traditional Chinese medicine which stems from ancient
Chinese philosophy
So far the clinical application of acupuncture for CFS is mainly
based on experience and its effects have not been evaluated In
past decades acupuncture has gained more popularity both inside
and outside China because of its advantages of convenience econ-
omy and reports of effectiveness A precise evaluation of acupunc-
ture is required This review will assess the efficacy and safety of
acupuncture therapy for CFS
2Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
O B J E C T I V E S
Our objective is to conduct a systematic review and if possible a
quantitative meta-analysis with any evidence collected from ran-
domised controlled trials and quasi-randomised trials of acupunc-
ture for adults and children with chronic fatigue syndrome (CFS)
In this way we can assess the efficacy and safety of acupuncture
therapy for CFS and test the hypothesis that acupuncture is more
effective than other interventions
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials and quasi-randomised trials
Types of participants
Patients with CFS according to the criteria of Centre for Disease
Control (CDC) (Fukuda 1994) Oxford (Sharpe 1991) ICD-
10 (WHO 1992) or any other validated criteria will be included
irrespective of gender race age and setting
Types of interventions
Any type of acupuncture therapy including body acupuncture
auricular acupuncture scalp acupuncture or electroacupuncture
will be considered The stimulation method can be hand manip-
ulation or electricity pulse Acupuncture methods without needle
insertion such as seed stimulation or seven-star needle will also be
included
The control interventions will be
(1) No intervention placebo acupuncture (using points very near
to normal acupuncture points but not the exact acupuncture
point) or sham acupuncture (using different acupuncture instru-
ments which can cause a similar sensation to acupuncture but are
not inserted into the skin) (Streitberger 1998)
(2) Pharmacological treatments (herbal medicine or western
medicine such as antidepressant or combination of them)
(3) Cognitive behaviour therapy (CBT)
(4) Exercise therapy
(5) Any other interventions
Types of outcome measures
Primary outcome measure
Fatigue is the key characteristic of CFS so we will take fatigue
symptoms as the main outcome of this review (eg Chalder Fatigue
Scale (Chalder 1993) or any type of instrument considered to scale
fatigue)
Secondary outcome measures
(1) Mood such as depression (eg Hamilton Depression Rating
Scale (Hamilton 1960)) and sleep disturbance using any instru-
ment (eg sleep onset latency (SOL) and wakefulness after sleep
onset (WASO) (Buscemi 2005))
(2) Quality of life score (eg SF-36 (Garratt 2002))
(3) Other symptoms such as pain headache using any instrument
(eg Visual analog scale (VAS) (WSDLI 2002) or quality of life)
(4) Adverse effects (eg pain (VAS) bleeding broken needles)
Search methods for identification of studies
1 Electronic searches
We will search the following electronic databases irrespective of
language and publication status
a) The Cochrane Collaboration Depression Anxiety amp Neurosis
Controlled Trials Register (CCDANCTR-Studies)
b) The Cochrane Central Register of Controlled Trials (CEN-
TRAL) on The Cochrane Library (Issue 4 2004)
c) MEDLINE (1966-2004)
d) EMBASE (1998-2004)
e) Chinese Biomedical Database (1979-2004)
CCDANCTR-Studies will be searched using the following strat-
egy
Diagnosis = Chronic Fatigue
and
Intervention = Acupuncture
In the Cochrane Reviewersrsquo Handbook 422 [updated December
2003] a highly sensitive search strategy for identifying reports of
randomized controlled trials in MEDLINE is provided for review-
ers We will put its 5b2 Format for MEDLINE on Ovid web ver-
sion (1-29) into usage in order to locate randomized controlled
trials
Below is the further search strategy for MEDLINE
30 chronic fatigue syndrome or CFS
31 myalgic encephalomyelitis or ME
32 or30-31
33 acupuncture
34 acupuncture points
35 (electroacupuncture or electro- acupuncture)tw
36 electroacupuncturetw
37 acupuncture$tw
38 acupointstw
39 meridians
40 or 33-39
41 29 and 32 and 40
2 Reference Lists
The reference lists of all identified papers will be searched for
further information
3 Personal Communication
We will contact authors for unpublished studies
Data collection and analysis
Eligibility
3Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Two reviewers Zhang and Peng will independently decide on
eligibility
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers (Zhang and
Peng) The following data will be extracted from each included
study
a) patientsrsquo demographic characteristics including maximum min-
imum and mean age
b) inclusion and exclusion criteria
c) type frequency treatment course of acupuncture therapy and
outcomes
d) type severity and number of adverse effects
e) number and reasons for dropouts withdrawals and lost to fol-
low-ups will also be recorded
Information not available in the reports of trials will be sought
from authors by email or telephone Extracted data will be reviewed
by the principal reviewer and discrepancies will be judged by an
arbitrator (Liu)
Quality assesment
Quality assessment will be carried out by two independent review-
ers (Zhang and Peng) and a third party (Liu) will be involved to
resolve any disagreement in case of occurrence
In line with the empirical evidence (Schulz 1995 Jadad 1996
Juni 2001 Kjaergard 2001) we intend to assess the methodolog-
ical quality as described by Kjaergard et al (Kjaergard 2001) and
Cochrane Reviewerrsquos Handbook 422
1) Method of randomisation
Treatments administered in a clinical trial should be selected by a
random process which allows each study participant to have the
same probability of receiving them and the investigators should
not be able to predict which treatment is next We will assess the
quality of the method of randomisation as follows
a) Adequate random number table computer randomization
tossing of a coin will be considered rsquoadequatersquo
b) Inadequate methods of allocation using odd-even numbers
patient social security numbers days of the week or medical record
numbers will be regarded as only pseudo- or quasi-random pro-
cesses instead of real randomization and will be considered inad-
equate
c) Unclear those who only used ldquorandomizationrdquo as a decoration
of article and no explanation available in articles will be regarded
as ldquounclearrdquo on randomization procedure
2) Allocation concealment
a) Adequate allocation concealment such as a central randomisa-
tion scheme by telephone or controlled by pharmacy numbered
or coded identical containers administered sequentially sequen-
tially numbered opaque sealed envelopes on site computer system
which can only be accessed after entering the characteristics of an
enrolled participant
b) Unclear authors did not report conditions of allocation con-
cealment or approach did not fall into one of the adequate mea-
sures Also sealed envelopes were not sequentially numbered or
opaque open list enrollment
c) Inadequate Alternation odd-even date of birth or week or case
record numbers
3) Blinding
Since blinding is not possible for treatment providers trials using
blinding for outcome assessors alone or together with blinding for
patients will be regarded as adequate
4) Follow-ups
Number and reason for dropouts withdrawals and fail to fulfill
follow ups should be described in articles
a) Good A rate of dropouts withdrawals and lost to follow ups
le 10
b) Acceptable A rate of dropouts withdrawals and lost to follow
ups le 20
c) Unacceptable A rate of dropouts withdrawals and lost to follow
ups gt20
Trials which meet the criteria of good or acceptable rate of
dropouts withdrawals and lost to follow ups will be included for
analysis
Data synthesis
First we will test for heterogeneity between trial results using a
standard chi-squared test and I-squared test to make sure that they
are appropriate to be combined
A meta-analysis will be implemented with the Cochrane Col-
laboration Review Manager (RevMan 43) software All the pri-
mary and secondary outcome measures under consideration will
be combined and analysed if there is evidence of homogeneity
(Pgt01) using a random effects model Results will be expressed as
relative risks (RR ratio of risk of treatment group vs that of con-
trol group) with their 95 confidence intervals for dichotomous
data For continuous variables measured with the same scale the
weighted mean differences ((WMD) the difference between treat-
ment and control pooled means at endpoint) along with their 95
confidence intervals will be calculated and standardised mean dif-
ference (SMD) will be calculated in case different scales are used
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size
(i) Repeating the analysis taking into account quality only trials
with adequate randomisation allocation concealment and blind-
ing will be included
(ii) Repeating the analysis excluding any trials with long duration
or large studies to establish how much they dominate the results
(iii) Repeat the analysis excluding trials using the following filters
diagnostic criteria (criterias except CDC ICD-10 and Oxford will
be excluded considering the prevalence) language of publication
(languages except English will be excluded because of the potential
inaccuracy in translation) Ethnic group (ethnic groups except
Asian will be excluded because most trials on acupuncture are
carried out in Asia especially China)
4Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Subgroup Analyses
Here we will compare the effects between subgroups below
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR)
R E F E R E N C E S
Additional references
Buscemi 2005
Buscemi N Vandermeer B Friesen C Bialy L Tubman M Ospina
M et alManifestations and management of chronic insomnia in adults
Evidence ReportTechnology Assessment no 125 Vol AHRQ Publica-
tion No 05-E021-2 Rockville MD Prepared by University of Al-
berta Evidence-based Practice Centre under contract C400000021
June 2005
CFS workshop 2002
CFS workshop Clinical Practice Guidelines-Chronic fatigue syn-
drome Clinical practice guidelines - 2002 MJA 20029 SupplS17ndash
S55
Chalder 1993
Chalder T Berelowitz G Pawlikowska T Development of a fatigue
scale Journal of Psychosomatic Research 199337(6)147ndash53
Edmonds 2004
Edmonds M McGuire H Price J Exercise therapy for chronic fa-
tigue syndrome The Cochrane Library 2004 Issue 3[Art No
CD003200 DOI 10100214651858CD003200pub2]
Fukuda 1994
Fukuda K Straus SE Hickie I The chronic fatigue syndrome a
comprehensive approach to its definition and study Annals of Inter-
nal Medicine 1994121953ndash9
Garratt 2002
Garratt A Schmidt L Mackintosh A et alQuality of life measure-
ment bibliographic study of patient assessed health outcome mea-
sures British Medical Journal 2002June 15324(7351)1417
Hamilton 1960
Hamilton M A rating scale for depression Journal of Neurology and
Neurosurgery 19602356ndash62
Jadad 1996
Jadad AR Moore RA Carroll D Jenkinson C Reynolds DJ Gav-
aghan DJ et alAssessing the quality of reports of randomized clini-
cal trials is blinding necessary Controlled Clinical Trials 199617
1ndash12
Juni 2001
Juni Peter Altman DG Egger M Assessing the quality of controlled
clinical trials BMJ 2001323(7303)42ndash6
Kjaergard 2001
Kjaergard LL Villumsen J Gluud C Reported methodologic quality
and discrepancies between large and small randomized trials in meta-
analyses Annals of Internal Medicine 2001135(11)982ndash9
Liu 2004
Liu J Acupuncture with herbs for CFS Journal of Chinese Clinical
medicine 20045(3)113ndash4
Ni 2002
Ni K Acupuncture with herbs for 35 cases of CFS Journal of Fujian
College of TCM 200212(4)22ndash3
Price 2003
Price JR Couper J Cognitive behaviour therapy for chronic fatigue
syndrome in adults The Cochrane Library 2003 Issue 4[Art No
CD001027 DOI 10100214651858CD001027pub2]
Reid 2000
Reid S Chalder T Extracts from ldquoClinical Evidencerdquo BMJ 2000
320292ndash6
Sabin 2003
Sabin TD An approach to chronic fatigue syndrome in adults Neu-
rologist 20039(1)28ndash34
Schulz 1995
Schulz KF Chalmers I Hayes RJ Altman DG Empirical evidence of
bias dimensions of methodological quality associated with estimates
of treatment effects in controlled trials JAMA 1995273408ndash12
Sharpe 1991
Sharpe M Archard L Banatvala J Borysiewicz LK Clare AW David
A Chronic fatigue syndrome guidelines for research Journal of the
Royal Society of Medicine 199184(2)118ndash21
Steele 1998
Steele L Dobbins JG Fukuda K Reyes M Randall B Koppelman
M The epidemiology of chronic fatigue in San Francisco American
Journal of Medecine 1998105(suppl 3A)83ndash90S
Streitberger 1998
Streitberger K Kleinhenz J Introducing a placebo needle into
acupuncture research The Lancet 1998352364ndash365
Wessely 1997
Wessely S Chalder T Hirsch S Wallace P Wright D The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome a
prospective primary care study American Journal of Public Health
199787(Not known)1449ndash55
5Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 3: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/3.jpg)
[Intervention Protocol]
Acupuncture for chronic fatigue syndrome
Wei Zhang1 Zhishun Liu1 Taixiang Wu2 Weina Peng1
1Department of Acupuncture and Moxibustion Chinese Academy of Traditional Chinese Medicine Beijing China 2 Chinese Cochrane
Centre Chinese EBM Centre West China Hospital Sichuan University Chengdu China
Contact address Wei Zhang Department of Acupuncture and Moxibustion Chinese Academy of Traditional Chinese Medicine
Guang An Men Hopital No5 Bei Xian Ge Street Beijing Xuanwu District 100053 China zhangwei_7108hotmailcom (Editorial
group Cochrane Depression Anxiety and Neurosis Group)
Cochrane Database of Systematic Reviews Issue 2 2009 (Status in this issue Unchanged)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
DOI 10100214651858CD006010
This version first published online 19 April 2006 in Issue 2 2006 (Help document - Dates and Statuses explained)
This record should be cited as Zhang W Liu Z Wu T Peng W Acupuncture for chronic fatigue syndrome Cochrane Database of
Systematic Reviews 2006 Issue 2 Art No CD006010 DOI 10100214651858CD006010
A B S T R A C T
This is the protocol for a review and there is no abstract The objectives are as follows
Our objective is to conduct a systematic review and if possible a quantitative meta-analysis with any evidence collected from randomised
controlled trials and quasi-randomised trials of acupuncture for adults and children with chronic fatigue syndrome (CFS) In this way
we can assess the efficacy and safety of acupuncture therapy for CFS and test the hypothesis that acupuncture is more effective than
other interventions
1Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
B A C K G R O U N D
Chronic fatigue syndrome (CFS) is a clinically defined condi-
tion characterised by severe disabling fatigue and other symp-
toms including self-reported musculoskeletal pain sleep distur-
bance headaches and impairments in concentration and short-
term memory These symptoms as opposed to a debilitating but
nonspecific condition shared by many diseases are usually medi-
cally unexplained A diagnosis of chronic fatigue syndrome can be
made only after all the physical and psychiatric causes of chronic
fatigue have been excluded Because of the absence of objective
clinical signs CFS patients are often annoyed by the lack of un-
derstanding from others including medical professionals
Historically CFS has also been called Royal Free disease Iceland
disease neurasthenia myalgic encephalomyelitis (rsquoMErsquo) and post-
viral fatigue syndrome Nowadays the term CFS is widely adopted
for research in the field however sometimes rsquoMErsquo is also seen in
articles and textbooks
Epidemiological research in western countries has demonstrated
that the prevalence of CFS is 02-26 depending on the criteria
used (Wessely 1997 Steele 1998) In China it was reported in
2004 that among 2000 citizens interviewed in the cities of Beijing
and Baotou 198 of them had symptoms that were consistent
with CDC criteria of CFS (Zhang 2004)
In 1987 the US Centers for Disease Control and Prevention
(CDC) developed a diagnostic criteria of CFS These criteria were
updated in 1994 which widened their use (Fukuda 1994) The
Oxford criteria also called the British criteria is another opera-
tional criteria for research (Sharpe 1991) There are two important
differences between these definitions The British criteria insist
on the presence of mental fatigue the American criteria include
a requirement for several physical symptoms reflecting the belief
that chronic fatigue syndrome has an underlying immunological
or infective pathology
Etiologically the cause of chronic fatigue syndrome is poorly un-
derstood There has been some new work in virology immunol-
ogy and imaging which also holds promise but still does not pro-
vide any diagnostic test or a mechanism for the production of
symptoms of CFS (Sabin 2003)
The treatment of CFS is attracting more and more attention How-
ever so far no single pharmacological treatment has been shown
to be effective for people with CFS Two Cochrane systematic
reviews were published concerning cognitive behaviour therapy
for chronic fatigue syndrome in adults (Price 2003) and exercise
therapy for chronic fatigue syndrome (Edmonds 2004) They sug-
gested that cognitive behaviour therapy appears to be an effective
and acceptable treatment for adult out-patients with chronic fa-
tigue syndrome and encouraging evidence has demonstrated that
some patients may benefit from exercise therapy In 2002 clinical
practice guidelines for chronic fatigue syndrome were conducted
by a working group convened under the auspices of the Royal Aus-
tralasian College of Physicians (CFS workshop 2002) There the
management of CFS was described in detail Cognitive-behaviour
therapy and graded exercise were strongly supported (Level I and
Level II respectively) to be effective for some people with CFS
Acupuncture is a very important constituent of Traditional Chi-
nese Medicine (TCM) with a history of literature spanning over
2000 years Acupuncture is a therapy implemented by inserting
needles into certain points on the human body which are called
ldquoXue Weirdquo in Chinese Generally acupoints can be classified into
meridian points which are located on the pathway of a meridian
or so called ldquoJing Luordquo in Chinese and extra points which are dis-
covered through practical experience There are types of needling
methods other than the frequently used filiform needle such as fire
needle seven star needle three-edged needle (mainly for bleeding)
and so on With the development of technology electricity was
introduced into the stimulation method of acupuncture and now
electro-acupuncture is a very important type of acupuncture apart
from the traditional hand manipulation According to the location
where needling is carried out acupuncture can also be classified
into body acupuncture scalp acupuncture auricular acupuncture
and ankle-wrist acupuncture etc Acupuncture is not just a therapy
alone many centuries ago acupuncture developed into a discipline
which has its own theory and practice system It is believed in
TCM theory that acupuncture can strengthen the vital essence of
the human body which is called ldquoQirdquo in Chinese and remove the
blockage of channels There are a wide range of diseases that are
thought to benefit from treatment with acupuncture
According to our search of main medical and biological bibliogra-
phy databases both inside and outside China so far no study has
been done on acupuncture for CFS in any foreign institution In
China from a preliminary search we found 15 clinical trials on
the topic of acupuncture for CFS From a rough review of these
trials we can see that the quality of these were uneven however
some could provide evidence for further analysis All the Chinese
trials that had control groups got results of benefit in the acupunc-
ture group with success rates ranging from 8890 (Ni 2002) to
9429 (Liu 2004)
No research was done concerning the mechanism of acupuncture
for CFS with modern medical measures Traditionally it can be
explained as adjusting the balance of Yin-Yang and nourishing the
Qi and blood if a deficiency exists This explanation is based on the
theory of traditional Chinese medicine which stems from ancient
Chinese philosophy
So far the clinical application of acupuncture for CFS is mainly
based on experience and its effects have not been evaluated In
past decades acupuncture has gained more popularity both inside
and outside China because of its advantages of convenience econ-
omy and reports of effectiveness A precise evaluation of acupunc-
ture is required This review will assess the efficacy and safety of
acupuncture therapy for CFS
2Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
O B J E C T I V E S
Our objective is to conduct a systematic review and if possible a
quantitative meta-analysis with any evidence collected from ran-
domised controlled trials and quasi-randomised trials of acupunc-
ture for adults and children with chronic fatigue syndrome (CFS)
In this way we can assess the efficacy and safety of acupuncture
therapy for CFS and test the hypothesis that acupuncture is more
effective than other interventions
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials and quasi-randomised trials
Types of participants
Patients with CFS according to the criteria of Centre for Disease
Control (CDC) (Fukuda 1994) Oxford (Sharpe 1991) ICD-
10 (WHO 1992) or any other validated criteria will be included
irrespective of gender race age and setting
Types of interventions
Any type of acupuncture therapy including body acupuncture
auricular acupuncture scalp acupuncture or electroacupuncture
will be considered The stimulation method can be hand manip-
ulation or electricity pulse Acupuncture methods without needle
insertion such as seed stimulation or seven-star needle will also be
included
The control interventions will be
(1) No intervention placebo acupuncture (using points very near
to normal acupuncture points but not the exact acupuncture
point) or sham acupuncture (using different acupuncture instru-
ments which can cause a similar sensation to acupuncture but are
not inserted into the skin) (Streitberger 1998)
(2) Pharmacological treatments (herbal medicine or western
medicine such as antidepressant or combination of them)
(3) Cognitive behaviour therapy (CBT)
(4) Exercise therapy
(5) Any other interventions
Types of outcome measures
Primary outcome measure
Fatigue is the key characteristic of CFS so we will take fatigue
symptoms as the main outcome of this review (eg Chalder Fatigue
Scale (Chalder 1993) or any type of instrument considered to scale
fatigue)
Secondary outcome measures
(1) Mood such as depression (eg Hamilton Depression Rating
Scale (Hamilton 1960)) and sleep disturbance using any instru-
ment (eg sleep onset latency (SOL) and wakefulness after sleep
onset (WASO) (Buscemi 2005))
(2) Quality of life score (eg SF-36 (Garratt 2002))
(3) Other symptoms such as pain headache using any instrument
(eg Visual analog scale (VAS) (WSDLI 2002) or quality of life)
(4) Adverse effects (eg pain (VAS) bleeding broken needles)
Search methods for identification of studies
1 Electronic searches
We will search the following electronic databases irrespective of
language and publication status
a) The Cochrane Collaboration Depression Anxiety amp Neurosis
Controlled Trials Register (CCDANCTR-Studies)
b) The Cochrane Central Register of Controlled Trials (CEN-
TRAL) on The Cochrane Library (Issue 4 2004)
c) MEDLINE (1966-2004)
d) EMBASE (1998-2004)
e) Chinese Biomedical Database (1979-2004)
CCDANCTR-Studies will be searched using the following strat-
egy
Diagnosis = Chronic Fatigue
and
Intervention = Acupuncture
In the Cochrane Reviewersrsquo Handbook 422 [updated December
2003] a highly sensitive search strategy for identifying reports of
randomized controlled trials in MEDLINE is provided for review-
ers We will put its 5b2 Format for MEDLINE on Ovid web ver-
sion (1-29) into usage in order to locate randomized controlled
trials
Below is the further search strategy for MEDLINE
30 chronic fatigue syndrome or CFS
31 myalgic encephalomyelitis or ME
32 or30-31
33 acupuncture
34 acupuncture points
35 (electroacupuncture or electro- acupuncture)tw
36 electroacupuncturetw
37 acupuncture$tw
38 acupointstw
39 meridians
40 or 33-39
41 29 and 32 and 40
2 Reference Lists
The reference lists of all identified papers will be searched for
further information
3 Personal Communication
We will contact authors for unpublished studies
Data collection and analysis
Eligibility
3Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Two reviewers Zhang and Peng will independently decide on
eligibility
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers (Zhang and
Peng) The following data will be extracted from each included
study
a) patientsrsquo demographic characteristics including maximum min-
imum and mean age
b) inclusion and exclusion criteria
c) type frequency treatment course of acupuncture therapy and
outcomes
d) type severity and number of adverse effects
e) number and reasons for dropouts withdrawals and lost to fol-
low-ups will also be recorded
Information not available in the reports of trials will be sought
from authors by email or telephone Extracted data will be reviewed
by the principal reviewer and discrepancies will be judged by an
arbitrator (Liu)
Quality assesment
Quality assessment will be carried out by two independent review-
ers (Zhang and Peng) and a third party (Liu) will be involved to
resolve any disagreement in case of occurrence
In line with the empirical evidence (Schulz 1995 Jadad 1996
Juni 2001 Kjaergard 2001) we intend to assess the methodolog-
ical quality as described by Kjaergard et al (Kjaergard 2001) and
Cochrane Reviewerrsquos Handbook 422
1) Method of randomisation
Treatments administered in a clinical trial should be selected by a
random process which allows each study participant to have the
same probability of receiving them and the investigators should
not be able to predict which treatment is next We will assess the
quality of the method of randomisation as follows
a) Adequate random number table computer randomization
tossing of a coin will be considered rsquoadequatersquo
b) Inadequate methods of allocation using odd-even numbers
patient social security numbers days of the week or medical record
numbers will be regarded as only pseudo- or quasi-random pro-
cesses instead of real randomization and will be considered inad-
equate
c) Unclear those who only used ldquorandomizationrdquo as a decoration
of article and no explanation available in articles will be regarded
as ldquounclearrdquo on randomization procedure
2) Allocation concealment
a) Adequate allocation concealment such as a central randomisa-
tion scheme by telephone or controlled by pharmacy numbered
or coded identical containers administered sequentially sequen-
tially numbered opaque sealed envelopes on site computer system
which can only be accessed after entering the characteristics of an
enrolled participant
b) Unclear authors did not report conditions of allocation con-
cealment or approach did not fall into one of the adequate mea-
sures Also sealed envelopes were not sequentially numbered or
opaque open list enrollment
c) Inadequate Alternation odd-even date of birth or week or case
record numbers
3) Blinding
Since blinding is not possible for treatment providers trials using
blinding for outcome assessors alone or together with blinding for
patients will be regarded as adequate
4) Follow-ups
Number and reason for dropouts withdrawals and fail to fulfill
follow ups should be described in articles
a) Good A rate of dropouts withdrawals and lost to follow ups
le 10
b) Acceptable A rate of dropouts withdrawals and lost to follow
ups le 20
c) Unacceptable A rate of dropouts withdrawals and lost to follow
ups gt20
Trials which meet the criteria of good or acceptable rate of
dropouts withdrawals and lost to follow ups will be included for
analysis
Data synthesis
First we will test for heterogeneity between trial results using a
standard chi-squared test and I-squared test to make sure that they
are appropriate to be combined
A meta-analysis will be implemented with the Cochrane Col-
laboration Review Manager (RevMan 43) software All the pri-
mary and secondary outcome measures under consideration will
be combined and analysed if there is evidence of homogeneity
(Pgt01) using a random effects model Results will be expressed as
relative risks (RR ratio of risk of treatment group vs that of con-
trol group) with their 95 confidence intervals for dichotomous
data For continuous variables measured with the same scale the
weighted mean differences ((WMD) the difference between treat-
ment and control pooled means at endpoint) along with their 95
confidence intervals will be calculated and standardised mean dif-
ference (SMD) will be calculated in case different scales are used
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size
(i) Repeating the analysis taking into account quality only trials
with adequate randomisation allocation concealment and blind-
ing will be included
(ii) Repeating the analysis excluding any trials with long duration
or large studies to establish how much they dominate the results
(iii) Repeat the analysis excluding trials using the following filters
diagnostic criteria (criterias except CDC ICD-10 and Oxford will
be excluded considering the prevalence) language of publication
(languages except English will be excluded because of the potential
inaccuracy in translation) Ethnic group (ethnic groups except
Asian will be excluded because most trials on acupuncture are
carried out in Asia especially China)
4Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Subgroup Analyses
Here we will compare the effects between subgroups below
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR)
R E F E R E N C E S
Additional references
Buscemi 2005
Buscemi N Vandermeer B Friesen C Bialy L Tubman M Ospina
M et alManifestations and management of chronic insomnia in adults
Evidence ReportTechnology Assessment no 125 Vol AHRQ Publica-
tion No 05-E021-2 Rockville MD Prepared by University of Al-
berta Evidence-based Practice Centre under contract C400000021
June 2005
CFS workshop 2002
CFS workshop Clinical Practice Guidelines-Chronic fatigue syn-
drome Clinical practice guidelines - 2002 MJA 20029 SupplS17ndash
S55
Chalder 1993
Chalder T Berelowitz G Pawlikowska T Development of a fatigue
scale Journal of Psychosomatic Research 199337(6)147ndash53
Edmonds 2004
Edmonds M McGuire H Price J Exercise therapy for chronic fa-
tigue syndrome The Cochrane Library 2004 Issue 3[Art No
CD003200 DOI 10100214651858CD003200pub2]
Fukuda 1994
Fukuda K Straus SE Hickie I The chronic fatigue syndrome a
comprehensive approach to its definition and study Annals of Inter-
nal Medicine 1994121953ndash9
Garratt 2002
Garratt A Schmidt L Mackintosh A et alQuality of life measure-
ment bibliographic study of patient assessed health outcome mea-
sures British Medical Journal 2002June 15324(7351)1417
Hamilton 1960
Hamilton M A rating scale for depression Journal of Neurology and
Neurosurgery 19602356ndash62
Jadad 1996
Jadad AR Moore RA Carroll D Jenkinson C Reynolds DJ Gav-
aghan DJ et alAssessing the quality of reports of randomized clini-
cal trials is blinding necessary Controlled Clinical Trials 199617
1ndash12
Juni 2001
Juni Peter Altman DG Egger M Assessing the quality of controlled
clinical trials BMJ 2001323(7303)42ndash6
Kjaergard 2001
Kjaergard LL Villumsen J Gluud C Reported methodologic quality
and discrepancies between large and small randomized trials in meta-
analyses Annals of Internal Medicine 2001135(11)982ndash9
Liu 2004
Liu J Acupuncture with herbs for CFS Journal of Chinese Clinical
medicine 20045(3)113ndash4
Ni 2002
Ni K Acupuncture with herbs for 35 cases of CFS Journal of Fujian
College of TCM 200212(4)22ndash3
Price 2003
Price JR Couper J Cognitive behaviour therapy for chronic fatigue
syndrome in adults The Cochrane Library 2003 Issue 4[Art No
CD001027 DOI 10100214651858CD001027pub2]
Reid 2000
Reid S Chalder T Extracts from ldquoClinical Evidencerdquo BMJ 2000
320292ndash6
Sabin 2003
Sabin TD An approach to chronic fatigue syndrome in adults Neu-
rologist 20039(1)28ndash34
Schulz 1995
Schulz KF Chalmers I Hayes RJ Altman DG Empirical evidence of
bias dimensions of methodological quality associated with estimates
of treatment effects in controlled trials JAMA 1995273408ndash12
Sharpe 1991
Sharpe M Archard L Banatvala J Borysiewicz LK Clare AW David
A Chronic fatigue syndrome guidelines for research Journal of the
Royal Society of Medicine 199184(2)118ndash21
Steele 1998
Steele L Dobbins JG Fukuda K Reyes M Randall B Koppelman
M The epidemiology of chronic fatigue in San Francisco American
Journal of Medecine 1998105(suppl 3A)83ndash90S
Streitberger 1998
Streitberger K Kleinhenz J Introducing a placebo needle into
acupuncture research The Lancet 1998352364ndash365
Wessely 1997
Wessely S Chalder T Hirsch S Wallace P Wright D The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome a
prospective primary care study American Journal of Public Health
199787(Not known)1449ndash55
5Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 4: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/4.jpg)
B A C K G R O U N D
Chronic fatigue syndrome (CFS) is a clinically defined condi-
tion characterised by severe disabling fatigue and other symp-
toms including self-reported musculoskeletal pain sleep distur-
bance headaches and impairments in concentration and short-
term memory These symptoms as opposed to a debilitating but
nonspecific condition shared by many diseases are usually medi-
cally unexplained A diagnosis of chronic fatigue syndrome can be
made only after all the physical and psychiatric causes of chronic
fatigue have been excluded Because of the absence of objective
clinical signs CFS patients are often annoyed by the lack of un-
derstanding from others including medical professionals
Historically CFS has also been called Royal Free disease Iceland
disease neurasthenia myalgic encephalomyelitis (rsquoMErsquo) and post-
viral fatigue syndrome Nowadays the term CFS is widely adopted
for research in the field however sometimes rsquoMErsquo is also seen in
articles and textbooks
Epidemiological research in western countries has demonstrated
that the prevalence of CFS is 02-26 depending on the criteria
used (Wessely 1997 Steele 1998) In China it was reported in
2004 that among 2000 citizens interviewed in the cities of Beijing
and Baotou 198 of them had symptoms that were consistent
with CDC criteria of CFS (Zhang 2004)
In 1987 the US Centers for Disease Control and Prevention
(CDC) developed a diagnostic criteria of CFS These criteria were
updated in 1994 which widened their use (Fukuda 1994) The
Oxford criteria also called the British criteria is another opera-
tional criteria for research (Sharpe 1991) There are two important
differences between these definitions The British criteria insist
on the presence of mental fatigue the American criteria include
a requirement for several physical symptoms reflecting the belief
that chronic fatigue syndrome has an underlying immunological
or infective pathology
Etiologically the cause of chronic fatigue syndrome is poorly un-
derstood There has been some new work in virology immunol-
ogy and imaging which also holds promise but still does not pro-
vide any diagnostic test or a mechanism for the production of
symptoms of CFS (Sabin 2003)
The treatment of CFS is attracting more and more attention How-
ever so far no single pharmacological treatment has been shown
to be effective for people with CFS Two Cochrane systematic
reviews were published concerning cognitive behaviour therapy
for chronic fatigue syndrome in adults (Price 2003) and exercise
therapy for chronic fatigue syndrome (Edmonds 2004) They sug-
gested that cognitive behaviour therapy appears to be an effective
and acceptable treatment for adult out-patients with chronic fa-
tigue syndrome and encouraging evidence has demonstrated that
some patients may benefit from exercise therapy In 2002 clinical
practice guidelines for chronic fatigue syndrome were conducted
by a working group convened under the auspices of the Royal Aus-
tralasian College of Physicians (CFS workshop 2002) There the
management of CFS was described in detail Cognitive-behaviour
therapy and graded exercise were strongly supported (Level I and
Level II respectively) to be effective for some people with CFS
Acupuncture is a very important constituent of Traditional Chi-
nese Medicine (TCM) with a history of literature spanning over
2000 years Acupuncture is a therapy implemented by inserting
needles into certain points on the human body which are called
ldquoXue Weirdquo in Chinese Generally acupoints can be classified into
meridian points which are located on the pathway of a meridian
or so called ldquoJing Luordquo in Chinese and extra points which are dis-
covered through practical experience There are types of needling
methods other than the frequently used filiform needle such as fire
needle seven star needle three-edged needle (mainly for bleeding)
and so on With the development of technology electricity was
introduced into the stimulation method of acupuncture and now
electro-acupuncture is a very important type of acupuncture apart
from the traditional hand manipulation According to the location
where needling is carried out acupuncture can also be classified
into body acupuncture scalp acupuncture auricular acupuncture
and ankle-wrist acupuncture etc Acupuncture is not just a therapy
alone many centuries ago acupuncture developed into a discipline
which has its own theory and practice system It is believed in
TCM theory that acupuncture can strengthen the vital essence of
the human body which is called ldquoQirdquo in Chinese and remove the
blockage of channels There are a wide range of diseases that are
thought to benefit from treatment with acupuncture
According to our search of main medical and biological bibliogra-
phy databases both inside and outside China so far no study has
been done on acupuncture for CFS in any foreign institution In
China from a preliminary search we found 15 clinical trials on
the topic of acupuncture for CFS From a rough review of these
trials we can see that the quality of these were uneven however
some could provide evidence for further analysis All the Chinese
trials that had control groups got results of benefit in the acupunc-
ture group with success rates ranging from 8890 (Ni 2002) to
9429 (Liu 2004)
No research was done concerning the mechanism of acupuncture
for CFS with modern medical measures Traditionally it can be
explained as adjusting the balance of Yin-Yang and nourishing the
Qi and blood if a deficiency exists This explanation is based on the
theory of traditional Chinese medicine which stems from ancient
Chinese philosophy
So far the clinical application of acupuncture for CFS is mainly
based on experience and its effects have not been evaluated In
past decades acupuncture has gained more popularity both inside
and outside China because of its advantages of convenience econ-
omy and reports of effectiveness A precise evaluation of acupunc-
ture is required This review will assess the efficacy and safety of
acupuncture therapy for CFS
2Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
O B J E C T I V E S
Our objective is to conduct a systematic review and if possible a
quantitative meta-analysis with any evidence collected from ran-
domised controlled trials and quasi-randomised trials of acupunc-
ture for adults and children with chronic fatigue syndrome (CFS)
In this way we can assess the efficacy and safety of acupuncture
therapy for CFS and test the hypothesis that acupuncture is more
effective than other interventions
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials and quasi-randomised trials
Types of participants
Patients with CFS according to the criteria of Centre for Disease
Control (CDC) (Fukuda 1994) Oxford (Sharpe 1991) ICD-
10 (WHO 1992) or any other validated criteria will be included
irrespective of gender race age and setting
Types of interventions
Any type of acupuncture therapy including body acupuncture
auricular acupuncture scalp acupuncture or electroacupuncture
will be considered The stimulation method can be hand manip-
ulation or electricity pulse Acupuncture methods without needle
insertion such as seed stimulation or seven-star needle will also be
included
The control interventions will be
(1) No intervention placebo acupuncture (using points very near
to normal acupuncture points but not the exact acupuncture
point) or sham acupuncture (using different acupuncture instru-
ments which can cause a similar sensation to acupuncture but are
not inserted into the skin) (Streitberger 1998)
(2) Pharmacological treatments (herbal medicine or western
medicine such as antidepressant or combination of them)
(3) Cognitive behaviour therapy (CBT)
(4) Exercise therapy
(5) Any other interventions
Types of outcome measures
Primary outcome measure
Fatigue is the key characteristic of CFS so we will take fatigue
symptoms as the main outcome of this review (eg Chalder Fatigue
Scale (Chalder 1993) or any type of instrument considered to scale
fatigue)
Secondary outcome measures
(1) Mood such as depression (eg Hamilton Depression Rating
Scale (Hamilton 1960)) and sleep disturbance using any instru-
ment (eg sleep onset latency (SOL) and wakefulness after sleep
onset (WASO) (Buscemi 2005))
(2) Quality of life score (eg SF-36 (Garratt 2002))
(3) Other symptoms such as pain headache using any instrument
(eg Visual analog scale (VAS) (WSDLI 2002) or quality of life)
(4) Adverse effects (eg pain (VAS) bleeding broken needles)
Search methods for identification of studies
1 Electronic searches
We will search the following electronic databases irrespective of
language and publication status
a) The Cochrane Collaboration Depression Anxiety amp Neurosis
Controlled Trials Register (CCDANCTR-Studies)
b) The Cochrane Central Register of Controlled Trials (CEN-
TRAL) on The Cochrane Library (Issue 4 2004)
c) MEDLINE (1966-2004)
d) EMBASE (1998-2004)
e) Chinese Biomedical Database (1979-2004)
CCDANCTR-Studies will be searched using the following strat-
egy
Diagnosis = Chronic Fatigue
and
Intervention = Acupuncture
In the Cochrane Reviewersrsquo Handbook 422 [updated December
2003] a highly sensitive search strategy for identifying reports of
randomized controlled trials in MEDLINE is provided for review-
ers We will put its 5b2 Format for MEDLINE on Ovid web ver-
sion (1-29) into usage in order to locate randomized controlled
trials
Below is the further search strategy for MEDLINE
30 chronic fatigue syndrome or CFS
31 myalgic encephalomyelitis or ME
32 or30-31
33 acupuncture
34 acupuncture points
35 (electroacupuncture or electro- acupuncture)tw
36 electroacupuncturetw
37 acupuncture$tw
38 acupointstw
39 meridians
40 or 33-39
41 29 and 32 and 40
2 Reference Lists
The reference lists of all identified papers will be searched for
further information
3 Personal Communication
We will contact authors for unpublished studies
Data collection and analysis
Eligibility
3Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Two reviewers Zhang and Peng will independently decide on
eligibility
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers (Zhang and
Peng) The following data will be extracted from each included
study
a) patientsrsquo demographic characteristics including maximum min-
imum and mean age
b) inclusion and exclusion criteria
c) type frequency treatment course of acupuncture therapy and
outcomes
d) type severity and number of adverse effects
e) number and reasons for dropouts withdrawals and lost to fol-
low-ups will also be recorded
Information not available in the reports of trials will be sought
from authors by email or telephone Extracted data will be reviewed
by the principal reviewer and discrepancies will be judged by an
arbitrator (Liu)
Quality assesment
Quality assessment will be carried out by two independent review-
ers (Zhang and Peng) and a third party (Liu) will be involved to
resolve any disagreement in case of occurrence
In line with the empirical evidence (Schulz 1995 Jadad 1996
Juni 2001 Kjaergard 2001) we intend to assess the methodolog-
ical quality as described by Kjaergard et al (Kjaergard 2001) and
Cochrane Reviewerrsquos Handbook 422
1) Method of randomisation
Treatments administered in a clinical trial should be selected by a
random process which allows each study participant to have the
same probability of receiving them and the investigators should
not be able to predict which treatment is next We will assess the
quality of the method of randomisation as follows
a) Adequate random number table computer randomization
tossing of a coin will be considered rsquoadequatersquo
b) Inadequate methods of allocation using odd-even numbers
patient social security numbers days of the week or medical record
numbers will be regarded as only pseudo- or quasi-random pro-
cesses instead of real randomization and will be considered inad-
equate
c) Unclear those who only used ldquorandomizationrdquo as a decoration
of article and no explanation available in articles will be regarded
as ldquounclearrdquo on randomization procedure
2) Allocation concealment
a) Adequate allocation concealment such as a central randomisa-
tion scheme by telephone or controlled by pharmacy numbered
or coded identical containers administered sequentially sequen-
tially numbered opaque sealed envelopes on site computer system
which can only be accessed after entering the characteristics of an
enrolled participant
b) Unclear authors did not report conditions of allocation con-
cealment or approach did not fall into one of the adequate mea-
sures Also sealed envelopes were not sequentially numbered or
opaque open list enrollment
c) Inadequate Alternation odd-even date of birth or week or case
record numbers
3) Blinding
Since blinding is not possible for treatment providers trials using
blinding for outcome assessors alone or together with blinding for
patients will be regarded as adequate
4) Follow-ups
Number and reason for dropouts withdrawals and fail to fulfill
follow ups should be described in articles
a) Good A rate of dropouts withdrawals and lost to follow ups
le 10
b) Acceptable A rate of dropouts withdrawals and lost to follow
ups le 20
c) Unacceptable A rate of dropouts withdrawals and lost to follow
ups gt20
Trials which meet the criteria of good or acceptable rate of
dropouts withdrawals and lost to follow ups will be included for
analysis
Data synthesis
First we will test for heterogeneity between trial results using a
standard chi-squared test and I-squared test to make sure that they
are appropriate to be combined
A meta-analysis will be implemented with the Cochrane Col-
laboration Review Manager (RevMan 43) software All the pri-
mary and secondary outcome measures under consideration will
be combined and analysed if there is evidence of homogeneity
(Pgt01) using a random effects model Results will be expressed as
relative risks (RR ratio of risk of treatment group vs that of con-
trol group) with their 95 confidence intervals for dichotomous
data For continuous variables measured with the same scale the
weighted mean differences ((WMD) the difference between treat-
ment and control pooled means at endpoint) along with their 95
confidence intervals will be calculated and standardised mean dif-
ference (SMD) will be calculated in case different scales are used
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size
(i) Repeating the analysis taking into account quality only trials
with adequate randomisation allocation concealment and blind-
ing will be included
(ii) Repeating the analysis excluding any trials with long duration
or large studies to establish how much they dominate the results
(iii) Repeat the analysis excluding trials using the following filters
diagnostic criteria (criterias except CDC ICD-10 and Oxford will
be excluded considering the prevalence) language of publication
(languages except English will be excluded because of the potential
inaccuracy in translation) Ethnic group (ethnic groups except
Asian will be excluded because most trials on acupuncture are
carried out in Asia especially China)
4Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Subgroup Analyses
Here we will compare the effects between subgroups below
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR)
R E F E R E N C E S
Additional references
Buscemi 2005
Buscemi N Vandermeer B Friesen C Bialy L Tubman M Ospina
M et alManifestations and management of chronic insomnia in adults
Evidence ReportTechnology Assessment no 125 Vol AHRQ Publica-
tion No 05-E021-2 Rockville MD Prepared by University of Al-
berta Evidence-based Practice Centre under contract C400000021
June 2005
CFS workshop 2002
CFS workshop Clinical Practice Guidelines-Chronic fatigue syn-
drome Clinical practice guidelines - 2002 MJA 20029 SupplS17ndash
S55
Chalder 1993
Chalder T Berelowitz G Pawlikowska T Development of a fatigue
scale Journal of Psychosomatic Research 199337(6)147ndash53
Edmonds 2004
Edmonds M McGuire H Price J Exercise therapy for chronic fa-
tigue syndrome The Cochrane Library 2004 Issue 3[Art No
CD003200 DOI 10100214651858CD003200pub2]
Fukuda 1994
Fukuda K Straus SE Hickie I The chronic fatigue syndrome a
comprehensive approach to its definition and study Annals of Inter-
nal Medicine 1994121953ndash9
Garratt 2002
Garratt A Schmidt L Mackintosh A et alQuality of life measure-
ment bibliographic study of patient assessed health outcome mea-
sures British Medical Journal 2002June 15324(7351)1417
Hamilton 1960
Hamilton M A rating scale for depression Journal of Neurology and
Neurosurgery 19602356ndash62
Jadad 1996
Jadad AR Moore RA Carroll D Jenkinson C Reynolds DJ Gav-
aghan DJ et alAssessing the quality of reports of randomized clini-
cal trials is blinding necessary Controlled Clinical Trials 199617
1ndash12
Juni 2001
Juni Peter Altman DG Egger M Assessing the quality of controlled
clinical trials BMJ 2001323(7303)42ndash6
Kjaergard 2001
Kjaergard LL Villumsen J Gluud C Reported methodologic quality
and discrepancies between large and small randomized trials in meta-
analyses Annals of Internal Medicine 2001135(11)982ndash9
Liu 2004
Liu J Acupuncture with herbs for CFS Journal of Chinese Clinical
medicine 20045(3)113ndash4
Ni 2002
Ni K Acupuncture with herbs for 35 cases of CFS Journal of Fujian
College of TCM 200212(4)22ndash3
Price 2003
Price JR Couper J Cognitive behaviour therapy for chronic fatigue
syndrome in adults The Cochrane Library 2003 Issue 4[Art No
CD001027 DOI 10100214651858CD001027pub2]
Reid 2000
Reid S Chalder T Extracts from ldquoClinical Evidencerdquo BMJ 2000
320292ndash6
Sabin 2003
Sabin TD An approach to chronic fatigue syndrome in adults Neu-
rologist 20039(1)28ndash34
Schulz 1995
Schulz KF Chalmers I Hayes RJ Altman DG Empirical evidence of
bias dimensions of methodological quality associated with estimates
of treatment effects in controlled trials JAMA 1995273408ndash12
Sharpe 1991
Sharpe M Archard L Banatvala J Borysiewicz LK Clare AW David
A Chronic fatigue syndrome guidelines for research Journal of the
Royal Society of Medicine 199184(2)118ndash21
Steele 1998
Steele L Dobbins JG Fukuda K Reyes M Randall B Koppelman
M The epidemiology of chronic fatigue in San Francisco American
Journal of Medecine 1998105(suppl 3A)83ndash90S
Streitberger 1998
Streitberger K Kleinhenz J Introducing a placebo needle into
acupuncture research The Lancet 1998352364ndash365
Wessely 1997
Wessely S Chalder T Hirsch S Wallace P Wright D The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome a
prospective primary care study American Journal of Public Health
199787(Not known)1449ndash55
5Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 5: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/5.jpg)
O B J E C T I V E S
Our objective is to conduct a systematic review and if possible a
quantitative meta-analysis with any evidence collected from ran-
domised controlled trials and quasi-randomised trials of acupunc-
ture for adults and children with chronic fatigue syndrome (CFS)
In this way we can assess the efficacy and safety of acupuncture
therapy for CFS and test the hypothesis that acupuncture is more
effective than other interventions
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled clinical trials and quasi-randomised trials
Types of participants
Patients with CFS according to the criteria of Centre for Disease
Control (CDC) (Fukuda 1994) Oxford (Sharpe 1991) ICD-
10 (WHO 1992) or any other validated criteria will be included
irrespective of gender race age and setting
Types of interventions
Any type of acupuncture therapy including body acupuncture
auricular acupuncture scalp acupuncture or electroacupuncture
will be considered The stimulation method can be hand manip-
ulation or electricity pulse Acupuncture methods without needle
insertion such as seed stimulation or seven-star needle will also be
included
The control interventions will be
(1) No intervention placebo acupuncture (using points very near
to normal acupuncture points but not the exact acupuncture
point) or sham acupuncture (using different acupuncture instru-
ments which can cause a similar sensation to acupuncture but are
not inserted into the skin) (Streitberger 1998)
(2) Pharmacological treatments (herbal medicine or western
medicine such as antidepressant or combination of them)
(3) Cognitive behaviour therapy (CBT)
(4) Exercise therapy
(5) Any other interventions
Types of outcome measures
Primary outcome measure
Fatigue is the key characteristic of CFS so we will take fatigue
symptoms as the main outcome of this review (eg Chalder Fatigue
Scale (Chalder 1993) or any type of instrument considered to scale
fatigue)
Secondary outcome measures
(1) Mood such as depression (eg Hamilton Depression Rating
Scale (Hamilton 1960)) and sleep disturbance using any instru-
ment (eg sleep onset latency (SOL) and wakefulness after sleep
onset (WASO) (Buscemi 2005))
(2) Quality of life score (eg SF-36 (Garratt 2002))
(3) Other symptoms such as pain headache using any instrument
(eg Visual analog scale (VAS) (WSDLI 2002) or quality of life)
(4) Adverse effects (eg pain (VAS) bleeding broken needles)
Search methods for identification of studies
1 Electronic searches
We will search the following electronic databases irrespective of
language and publication status
a) The Cochrane Collaboration Depression Anxiety amp Neurosis
Controlled Trials Register (CCDANCTR-Studies)
b) The Cochrane Central Register of Controlled Trials (CEN-
TRAL) on The Cochrane Library (Issue 4 2004)
c) MEDLINE (1966-2004)
d) EMBASE (1998-2004)
e) Chinese Biomedical Database (1979-2004)
CCDANCTR-Studies will be searched using the following strat-
egy
Diagnosis = Chronic Fatigue
and
Intervention = Acupuncture
In the Cochrane Reviewersrsquo Handbook 422 [updated December
2003] a highly sensitive search strategy for identifying reports of
randomized controlled trials in MEDLINE is provided for review-
ers We will put its 5b2 Format for MEDLINE on Ovid web ver-
sion (1-29) into usage in order to locate randomized controlled
trials
Below is the further search strategy for MEDLINE
30 chronic fatigue syndrome or CFS
31 myalgic encephalomyelitis or ME
32 or30-31
33 acupuncture
34 acupuncture points
35 (electroacupuncture or electro- acupuncture)tw
36 electroacupuncturetw
37 acupuncture$tw
38 acupointstw
39 meridians
40 or 33-39
41 29 and 32 and 40
2 Reference Lists
The reference lists of all identified papers will be searched for
further information
3 Personal Communication
We will contact authors for unpublished studies
Data collection and analysis
Eligibility
3Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Two reviewers Zhang and Peng will independently decide on
eligibility
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers (Zhang and
Peng) The following data will be extracted from each included
study
a) patientsrsquo demographic characteristics including maximum min-
imum and mean age
b) inclusion and exclusion criteria
c) type frequency treatment course of acupuncture therapy and
outcomes
d) type severity and number of adverse effects
e) number and reasons for dropouts withdrawals and lost to fol-
low-ups will also be recorded
Information not available in the reports of trials will be sought
from authors by email or telephone Extracted data will be reviewed
by the principal reviewer and discrepancies will be judged by an
arbitrator (Liu)
Quality assesment
Quality assessment will be carried out by two independent review-
ers (Zhang and Peng) and a third party (Liu) will be involved to
resolve any disagreement in case of occurrence
In line with the empirical evidence (Schulz 1995 Jadad 1996
Juni 2001 Kjaergard 2001) we intend to assess the methodolog-
ical quality as described by Kjaergard et al (Kjaergard 2001) and
Cochrane Reviewerrsquos Handbook 422
1) Method of randomisation
Treatments administered in a clinical trial should be selected by a
random process which allows each study participant to have the
same probability of receiving them and the investigators should
not be able to predict which treatment is next We will assess the
quality of the method of randomisation as follows
a) Adequate random number table computer randomization
tossing of a coin will be considered rsquoadequatersquo
b) Inadequate methods of allocation using odd-even numbers
patient social security numbers days of the week or medical record
numbers will be regarded as only pseudo- or quasi-random pro-
cesses instead of real randomization and will be considered inad-
equate
c) Unclear those who only used ldquorandomizationrdquo as a decoration
of article and no explanation available in articles will be regarded
as ldquounclearrdquo on randomization procedure
2) Allocation concealment
a) Adequate allocation concealment such as a central randomisa-
tion scheme by telephone or controlled by pharmacy numbered
or coded identical containers administered sequentially sequen-
tially numbered opaque sealed envelopes on site computer system
which can only be accessed after entering the characteristics of an
enrolled participant
b) Unclear authors did not report conditions of allocation con-
cealment or approach did not fall into one of the adequate mea-
sures Also sealed envelopes were not sequentially numbered or
opaque open list enrollment
c) Inadequate Alternation odd-even date of birth or week or case
record numbers
3) Blinding
Since blinding is not possible for treatment providers trials using
blinding for outcome assessors alone or together with blinding for
patients will be regarded as adequate
4) Follow-ups
Number and reason for dropouts withdrawals and fail to fulfill
follow ups should be described in articles
a) Good A rate of dropouts withdrawals and lost to follow ups
le 10
b) Acceptable A rate of dropouts withdrawals and lost to follow
ups le 20
c) Unacceptable A rate of dropouts withdrawals and lost to follow
ups gt20
Trials which meet the criteria of good or acceptable rate of
dropouts withdrawals and lost to follow ups will be included for
analysis
Data synthesis
First we will test for heterogeneity between trial results using a
standard chi-squared test and I-squared test to make sure that they
are appropriate to be combined
A meta-analysis will be implemented with the Cochrane Col-
laboration Review Manager (RevMan 43) software All the pri-
mary and secondary outcome measures under consideration will
be combined and analysed if there is evidence of homogeneity
(Pgt01) using a random effects model Results will be expressed as
relative risks (RR ratio of risk of treatment group vs that of con-
trol group) with their 95 confidence intervals for dichotomous
data For continuous variables measured with the same scale the
weighted mean differences ((WMD) the difference between treat-
ment and control pooled means at endpoint) along with their 95
confidence intervals will be calculated and standardised mean dif-
ference (SMD) will be calculated in case different scales are used
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size
(i) Repeating the analysis taking into account quality only trials
with adequate randomisation allocation concealment and blind-
ing will be included
(ii) Repeating the analysis excluding any trials with long duration
or large studies to establish how much they dominate the results
(iii) Repeat the analysis excluding trials using the following filters
diagnostic criteria (criterias except CDC ICD-10 and Oxford will
be excluded considering the prevalence) language of publication
(languages except English will be excluded because of the potential
inaccuracy in translation) Ethnic group (ethnic groups except
Asian will be excluded because most trials on acupuncture are
carried out in Asia especially China)
4Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Subgroup Analyses
Here we will compare the effects between subgroups below
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR)
R E F E R E N C E S
Additional references
Buscemi 2005
Buscemi N Vandermeer B Friesen C Bialy L Tubman M Ospina
M et alManifestations and management of chronic insomnia in adults
Evidence ReportTechnology Assessment no 125 Vol AHRQ Publica-
tion No 05-E021-2 Rockville MD Prepared by University of Al-
berta Evidence-based Practice Centre under contract C400000021
June 2005
CFS workshop 2002
CFS workshop Clinical Practice Guidelines-Chronic fatigue syn-
drome Clinical practice guidelines - 2002 MJA 20029 SupplS17ndash
S55
Chalder 1993
Chalder T Berelowitz G Pawlikowska T Development of a fatigue
scale Journal of Psychosomatic Research 199337(6)147ndash53
Edmonds 2004
Edmonds M McGuire H Price J Exercise therapy for chronic fa-
tigue syndrome The Cochrane Library 2004 Issue 3[Art No
CD003200 DOI 10100214651858CD003200pub2]
Fukuda 1994
Fukuda K Straus SE Hickie I The chronic fatigue syndrome a
comprehensive approach to its definition and study Annals of Inter-
nal Medicine 1994121953ndash9
Garratt 2002
Garratt A Schmidt L Mackintosh A et alQuality of life measure-
ment bibliographic study of patient assessed health outcome mea-
sures British Medical Journal 2002June 15324(7351)1417
Hamilton 1960
Hamilton M A rating scale for depression Journal of Neurology and
Neurosurgery 19602356ndash62
Jadad 1996
Jadad AR Moore RA Carroll D Jenkinson C Reynolds DJ Gav-
aghan DJ et alAssessing the quality of reports of randomized clini-
cal trials is blinding necessary Controlled Clinical Trials 199617
1ndash12
Juni 2001
Juni Peter Altman DG Egger M Assessing the quality of controlled
clinical trials BMJ 2001323(7303)42ndash6
Kjaergard 2001
Kjaergard LL Villumsen J Gluud C Reported methodologic quality
and discrepancies between large and small randomized trials in meta-
analyses Annals of Internal Medicine 2001135(11)982ndash9
Liu 2004
Liu J Acupuncture with herbs for CFS Journal of Chinese Clinical
medicine 20045(3)113ndash4
Ni 2002
Ni K Acupuncture with herbs for 35 cases of CFS Journal of Fujian
College of TCM 200212(4)22ndash3
Price 2003
Price JR Couper J Cognitive behaviour therapy for chronic fatigue
syndrome in adults The Cochrane Library 2003 Issue 4[Art No
CD001027 DOI 10100214651858CD001027pub2]
Reid 2000
Reid S Chalder T Extracts from ldquoClinical Evidencerdquo BMJ 2000
320292ndash6
Sabin 2003
Sabin TD An approach to chronic fatigue syndrome in adults Neu-
rologist 20039(1)28ndash34
Schulz 1995
Schulz KF Chalmers I Hayes RJ Altman DG Empirical evidence of
bias dimensions of methodological quality associated with estimates
of treatment effects in controlled trials JAMA 1995273408ndash12
Sharpe 1991
Sharpe M Archard L Banatvala J Borysiewicz LK Clare AW David
A Chronic fatigue syndrome guidelines for research Journal of the
Royal Society of Medicine 199184(2)118ndash21
Steele 1998
Steele L Dobbins JG Fukuda K Reyes M Randall B Koppelman
M The epidemiology of chronic fatigue in San Francisco American
Journal of Medecine 1998105(suppl 3A)83ndash90S
Streitberger 1998
Streitberger K Kleinhenz J Introducing a placebo needle into
acupuncture research The Lancet 1998352364ndash365
Wessely 1997
Wessely S Chalder T Hirsch S Wallace P Wright D The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome a
prospective primary care study American Journal of Public Health
199787(Not known)1449ndash55
5Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 6: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/6.jpg)
Two reviewers Zhang and Peng will independently decide on
eligibility
Data extraction
A data extraction form will be developed and study data will be
assessed and extracted independently by two reviewers (Zhang and
Peng) The following data will be extracted from each included
study
a) patientsrsquo demographic characteristics including maximum min-
imum and mean age
b) inclusion and exclusion criteria
c) type frequency treatment course of acupuncture therapy and
outcomes
d) type severity and number of adverse effects
e) number and reasons for dropouts withdrawals and lost to fol-
low-ups will also be recorded
Information not available in the reports of trials will be sought
from authors by email or telephone Extracted data will be reviewed
by the principal reviewer and discrepancies will be judged by an
arbitrator (Liu)
Quality assesment
Quality assessment will be carried out by two independent review-
ers (Zhang and Peng) and a third party (Liu) will be involved to
resolve any disagreement in case of occurrence
In line with the empirical evidence (Schulz 1995 Jadad 1996
Juni 2001 Kjaergard 2001) we intend to assess the methodolog-
ical quality as described by Kjaergard et al (Kjaergard 2001) and
Cochrane Reviewerrsquos Handbook 422
1) Method of randomisation
Treatments administered in a clinical trial should be selected by a
random process which allows each study participant to have the
same probability of receiving them and the investigators should
not be able to predict which treatment is next We will assess the
quality of the method of randomisation as follows
a) Adequate random number table computer randomization
tossing of a coin will be considered rsquoadequatersquo
b) Inadequate methods of allocation using odd-even numbers
patient social security numbers days of the week or medical record
numbers will be regarded as only pseudo- or quasi-random pro-
cesses instead of real randomization and will be considered inad-
equate
c) Unclear those who only used ldquorandomizationrdquo as a decoration
of article and no explanation available in articles will be regarded
as ldquounclearrdquo on randomization procedure
2) Allocation concealment
a) Adequate allocation concealment such as a central randomisa-
tion scheme by telephone or controlled by pharmacy numbered
or coded identical containers administered sequentially sequen-
tially numbered opaque sealed envelopes on site computer system
which can only be accessed after entering the characteristics of an
enrolled participant
b) Unclear authors did not report conditions of allocation con-
cealment or approach did not fall into one of the adequate mea-
sures Also sealed envelopes were not sequentially numbered or
opaque open list enrollment
c) Inadequate Alternation odd-even date of birth or week or case
record numbers
3) Blinding
Since blinding is not possible for treatment providers trials using
blinding for outcome assessors alone or together with blinding for
patients will be regarded as adequate
4) Follow-ups
Number and reason for dropouts withdrawals and fail to fulfill
follow ups should be described in articles
a) Good A rate of dropouts withdrawals and lost to follow ups
le 10
b) Acceptable A rate of dropouts withdrawals and lost to follow
ups le 20
c) Unacceptable A rate of dropouts withdrawals and lost to follow
ups gt20
Trials which meet the criteria of good or acceptable rate of
dropouts withdrawals and lost to follow ups will be included for
analysis
Data synthesis
First we will test for heterogeneity between trial results using a
standard chi-squared test and I-squared test to make sure that they
are appropriate to be combined
A meta-analysis will be implemented with the Cochrane Col-
laboration Review Manager (RevMan 43) software All the pri-
mary and secondary outcome measures under consideration will
be combined and analysed if there is evidence of homogeneity
(Pgt01) using a random effects model Results will be expressed as
relative risks (RR ratio of risk of treatment group vs that of con-
trol group) with their 95 confidence intervals for dichotomous
data For continuous variables measured with the same scale the
weighted mean differences ((WMD) the difference between treat-
ment and control pooled means at endpoint) along with their 95
confidence intervals will be calculated and standardised mean dif-
ference (SMD) will be calculated in case different scales are used
Sensitivity Analyses
We will implement a sensitivity analyses in order to explore the
influence of the following factors on effect size
(i) Repeating the analysis taking into account quality only trials
with adequate randomisation allocation concealment and blind-
ing will be included
(ii) Repeating the analysis excluding any trials with long duration
or large studies to establish how much they dominate the results
(iii) Repeat the analysis excluding trials using the following filters
diagnostic criteria (criterias except CDC ICD-10 and Oxford will
be excluded considering the prevalence) language of publication
(languages except English will be excluded because of the potential
inaccuracy in translation) Ethnic group (ethnic groups except
Asian will be excluded because most trials on acupuncture are
carried out in Asia especially China)
4Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
Subgroup Analyses
Here we will compare the effects between subgroups below
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR)
R E F E R E N C E S
Additional references
Buscemi 2005
Buscemi N Vandermeer B Friesen C Bialy L Tubman M Ospina
M et alManifestations and management of chronic insomnia in adults
Evidence ReportTechnology Assessment no 125 Vol AHRQ Publica-
tion No 05-E021-2 Rockville MD Prepared by University of Al-
berta Evidence-based Practice Centre under contract C400000021
June 2005
CFS workshop 2002
CFS workshop Clinical Practice Guidelines-Chronic fatigue syn-
drome Clinical practice guidelines - 2002 MJA 20029 SupplS17ndash
S55
Chalder 1993
Chalder T Berelowitz G Pawlikowska T Development of a fatigue
scale Journal of Psychosomatic Research 199337(6)147ndash53
Edmonds 2004
Edmonds M McGuire H Price J Exercise therapy for chronic fa-
tigue syndrome The Cochrane Library 2004 Issue 3[Art No
CD003200 DOI 10100214651858CD003200pub2]
Fukuda 1994
Fukuda K Straus SE Hickie I The chronic fatigue syndrome a
comprehensive approach to its definition and study Annals of Inter-
nal Medicine 1994121953ndash9
Garratt 2002
Garratt A Schmidt L Mackintosh A et alQuality of life measure-
ment bibliographic study of patient assessed health outcome mea-
sures British Medical Journal 2002June 15324(7351)1417
Hamilton 1960
Hamilton M A rating scale for depression Journal of Neurology and
Neurosurgery 19602356ndash62
Jadad 1996
Jadad AR Moore RA Carroll D Jenkinson C Reynolds DJ Gav-
aghan DJ et alAssessing the quality of reports of randomized clini-
cal trials is blinding necessary Controlled Clinical Trials 199617
1ndash12
Juni 2001
Juni Peter Altman DG Egger M Assessing the quality of controlled
clinical trials BMJ 2001323(7303)42ndash6
Kjaergard 2001
Kjaergard LL Villumsen J Gluud C Reported methodologic quality
and discrepancies between large and small randomized trials in meta-
analyses Annals of Internal Medicine 2001135(11)982ndash9
Liu 2004
Liu J Acupuncture with herbs for CFS Journal of Chinese Clinical
medicine 20045(3)113ndash4
Ni 2002
Ni K Acupuncture with herbs for 35 cases of CFS Journal of Fujian
College of TCM 200212(4)22ndash3
Price 2003
Price JR Couper J Cognitive behaviour therapy for chronic fatigue
syndrome in adults The Cochrane Library 2003 Issue 4[Art No
CD001027 DOI 10100214651858CD001027pub2]
Reid 2000
Reid S Chalder T Extracts from ldquoClinical Evidencerdquo BMJ 2000
320292ndash6
Sabin 2003
Sabin TD An approach to chronic fatigue syndrome in adults Neu-
rologist 20039(1)28ndash34
Schulz 1995
Schulz KF Chalmers I Hayes RJ Altman DG Empirical evidence of
bias dimensions of methodological quality associated with estimates
of treatment effects in controlled trials JAMA 1995273408ndash12
Sharpe 1991
Sharpe M Archard L Banatvala J Borysiewicz LK Clare AW David
A Chronic fatigue syndrome guidelines for research Journal of the
Royal Society of Medicine 199184(2)118ndash21
Steele 1998
Steele L Dobbins JG Fukuda K Reyes M Randall B Koppelman
M The epidemiology of chronic fatigue in San Francisco American
Journal of Medecine 1998105(suppl 3A)83ndash90S
Streitberger 1998
Streitberger K Kleinhenz J Introducing a placebo needle into
acupuncture research The Lancet 1998352364ndash365
Wessely 1997
Wessely S Chalder T Hirsch S Wallace P Wright D The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome a
prospective primary care study American Journal of Public Health
199787(Not known)1449ndash55
5Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 7: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/7.jpg)
Subgroup Analyses
Here we will compare the effects between subgroups below
(i) different acupuncture types
(ii) different comparisons
Publication Bias
Potential biases will be investigated using the funnel plot We will
use a linear regression approach to measure funnel plot asymmetry
on the logarithm scale of the relative risk (RR)
R E F E R E N C E S
Additional references
Buscemi 2005
Buscemi N Vandermeer B Friesen C Bialy L Tubman M Ospina
M et alManifestations and management of chronic insomnia in adults
Evidence ReportTechnology Assessment no 125 Vol AHRQ Publica-
tion No 05-E021-2 Rockville MD Prepared by University of Al-
berta Evidence-based Practice Centre under contract C400000021
June 2005
CFS workshop 2002
CFS workshop Clinical Practice Guidelines-Chronic fatigue syn-
drome Clinical practice guidelines - 2002 MJA 20029 SupplS17ndash
S55
Chalder 1993
Chalder T Berelowitz G Pawlikowska T Development of a fatigue
scale Journal of Psychosomatic Research 199337(6)147ndash53
Edmonds 2004
Edmonds M McGuire H Price J Exercise therapy for chronic fa-
tigue syndrome The Cochrane Library 2004 Issue 3[Art No
CD003200 DOI 10100214651858CD003200pub2]
Fukuda 1994
Fukuda K Straus SE Hickie I The chronic fatigue syndrome a
comprehensive approach to its definition and study Annals of Inter-
nal Medicine 1994121953ndash9
Garratt 2002
Garratt A Schmidt L Mackintosh A et alQuality of life measure-
ment bibliographic study of patient assessed health outcome mea-
sures British Medical Journal 2002June 15324(7351)1417
Hamilton 1960
Hamilton M A rating scale for depression Journal of Neurology and
Neurosurgery 19602356ndash62
Jadad 1996
Jadad AR Moore RA Carroll D Jenkinson C Reynolds DJ Gav-
aghan DJ et alAssessing the quality of reports of randomized clini-
cal trials is blinding necessary Controlled Clinical Trials 199617
1ndash12
Juni 2001
Juni Peter Altman DG Egger M Assessing the quality of controlled
clinical trials BMJ 2001323(7303)42ndash6
Kjaergard 2001
Kjaergard LL Villumsen J Gluud C Reported methodologic quality
and discrepancies between large and small randomized trials in meta-
analyses Annals of Internal Medicine 2001135(11)982ndash9
Liu 2004
Liu J Acupuncture with herbs for CFS Journal of Chinese Clinical
medicine 20045(3)113ndash4
Ni 2002
Ni K Acupuncture with herbs for 35 cases of CFS Journal of Fujian
College of TCM 200212(4)22ndash3
Price 2003
Price JR Couper J Cognitive behaviour therapy for chronic fatigue
syndrome in adults The Cochrane Library 2003 Issue 4[Art No
CD001027 DOI 10100214651858CD001027pub2]
Reid 2000
Reid S Chalder T Extracts from ldquoClinical Evidencerdquo BMJ 2000
320292ndash6
Sabin 2003
Sabin TD An approach to chronic fatigue syndrome in adults Neu-
rologist 20039(1)28ndash34
Schulz 1995
Schulz KF Chalmers I Hayes RJ Altman DG Empirical evidence of
bias dimensions of methodological quality associated with estimates
of treatment effects in controlled trials JAMA 1995273408ndash12
Sharpe 1991
Sharpe M Archard L Banatvala J Borysiewicz LK Clare AW David
A Chronic fatigue syndrome guidelines for research Journal of the
Royal Society of Medicine 199184(2)118ndash21
Steele 1998
Steele L Dobbins JG Fukuda K Reyes M Randall B Koppelman
M The epidemiology of chronic fatigue in San Francisco American
Journal of Medecine 1998105(suppl 3A)83ndash90S
Streitberger 1998
Streitberger K Kleinhenz J Introducing a placebo needle into
acupuncture research The Lancet 1998352364ndash365
Wessely 1997
Wessely S Chalder T Hirsch S Wallace P Wright D The prevalence
and morbidity of chronic fatigue and chronic fatigue syndrome a
prospective primary care study American Journal of Public Health
199787(Not known)1449ndash55
5Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 8: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/8.jpg)
WHO 1992
World Health Organisation The ICD-10 Classification of Mental and
Behavioural Disorders Geneva World Health Organisation 1992
WSDLI 2002
Washington State Department of Labor and Industries Guidelines for
outpatient prescription of oral opioids for injured workers with chronic
non-cancer pain Olympia Washington Washington State Depart-
ment of Labor and Industries 2002
Zhang 2004
Zhang R Epidemiological study on CFS Chinese journal of rehabil-
itation medicine 200419(4)296ndash7lowast Indicates the major publication for the study
W H A T rsquo S N E W
31 October 2008 Amended Converted to new review format
H I S T O R Y
Protocol first published Issue 2 2006
C O N T R I B U T I O N S O F A U T H O R S
Wei Zhang designed and wrote the protocol Zhang will participate in the whole review procedure including data extraction contacting
editors statistical analysis quality assessment and completion of the review Zhishun Liu checked the protocol and gave comments
Weina Peng and Wei Zhang will extract data and assess quality In case of disagreement between the two data extractors Wu will advise
on methodology and Liu will work as arbitrator
D E C L A R A T I O N S O F I N T E R E S T
Not known
S O U R C E S O F S U P P O R T
Internal sources
bull Department of Acupuncture and Moxibustion Guang An Men Hospital Chinese Academy of TCM China
6Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd
![Page 9: Acupuncture for Chronic Fatigue Syndrome](https://reader038.vdocuments.site/reader038/viewer/2022100421/563db9df550346aa9aa0b807/html5/thumbnails/9.jpg)
External sources
bull No sources of support supplied
7Acupuncture for chronic fatigue syndrome (Protocol)
Copyright copy 2009 The Cochrane Collaboration Published by John Wiley amp Sons Ltd