Professional Documents
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This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2009, Issue 2
http://www.thecochranelibrary.com
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
REFERENCES . . . . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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[Intervention Protocol]
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, No.5 Bei Xian Ge Street, Beijing, Xuanwu District, 100053, China. zhangwei_7108@hotmail.com. (Editorial
group: Cochrane Depression, Anxiety and Neurosis Group.)
Cochrane Database of Systematic Reviews, Issue 2, 2009 (Status in this issue: Unchanged)
Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
DOI: 10.1002/14651858.CD006010
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: 10.1002/14651858.CD006010.
ABSTRACT
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.
BACKGROUND
Chronic fatigue syndrome (CFS) is a clinically defined condition characterised by severe, disabling fatigue and other symptoms, including self-reported musculoskeletal pain, sleep disturbance, headaches and impairments in concentration and shortterm memory. These symptoms, as opposed to a debilitating but
nonspecific condition shared by many diseases, are usually medically 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 understanding from others, including medical professionals.
Historically, CFS has also been called Royal Free disease, Iceland
disease, neurasthenia, myalgic encephalomyelitis (ME), and postviral fatigue syndrome. Nowadays the term CFS is widely adopted
for research in the field, however sometimes ME is also seen in
articles and textbooks.
Epidemiological research in western countries has demonstrated
that the prevalence of CFS is 0.2-2.6%, 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, 1.98% 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 operational 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 understood. There has been some new work in virology, immunology, and imaging which also holds promise but still does not provide 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. However, 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 suggested that cognitive behaviour therapy appears to be an effective
and acceptable treatment for adult out-patients with chronic fatigue 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-
OBJECTIVES
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.
METHODS
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), ICD10 (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 manipulation 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 instruments 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 instrument (eg sleep onset latency (SOL) and wakefulness after sleep
onset (WASO), (Buscemi 2005)).
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).
REFERENCES
Additional references
Buscemi 2005
Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina
M, et al.Manifestations and management of chronic insomnia in adults.
Evidence Report/Technology. Assessment no 125. Vol. AHRQ Publication No. 05-E021-2, Rockville, MD: Prepared by University of Alberta Evidence-based Practice Centre, under contract C400000021,
June 2005.
CFS workshop 2002
CFS workshop. Clinical Practice Guidelines-Chronic fatigue syndrome Clinical practice guidelines - 2002. MJA 2002;9 Suppl:S17
S55.
Chalder 1993
Chalder T, Berelowitz G, Pawlikowska T. Development of a fatigue
scale. Journal of Psychosomatic Research 1993;37(6):14753.
Edmonds 2004
Edmonds M, McGuire H, Price J. Exercise therapy for chronic fatigue syndrome. The Cochrane Library 2004, Issue 3.[Art. No.:
CD003200. DOI: 10.1002/14651858.CD003200.pub2]
Fukuda 1994
Fukuda K, Straus SE, Hickie I. The chronic fatigue syndrome: a
comprehensive approach to its definition and study. Annals of Internal Medicine 1994;121:9539.
Garratt 2002
Garratt A, Schmidt L, Mackintosh A, et al.Quality of life measurement: bibliographic study of patient assessed health outcome measures. British Medical Journal 2002;June 15;324(7351):1417.
Hamilton 1960
Hamilton M. A rating scale for depression. Journal of Neurology and
Neurosurgery 1960;23:5662.
Jadad 1996
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al.Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Controlled Clinical Trials 1996;17:
112.
Juni 2001
Juni Peter, Altman DG, Egger M. Assessing the quality of controlled
clinical trials. BMJ 2001;323(7303):426.
Kjaergard 2001
Kjaergard LL, Villumsen J, Gluud C. Reported methodologic quality
and discrepancies between large and small randomized trials in metaanalyses. Annals of Internal Medicine 2001;135(11):9829.
Liu 2004
Liu J. Acupuncture with herbs for CFS. Journal of Chinese Clinical
medicine 2004;5(3):1134.
Ni 2002
Ni K. Acupuncture with herbs for 35 cases of CFS. Journal of Fujian
College of TCM 2002;12(4):223.
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: 10.1002/14651858.CD001027.pub2]
Reid 2000
Reid S, Chalder T. Extracts from Clinical Evidence. BMJ 2000;
320:2926.
Sabin 2003
Sabin TD. An approach to chronic fatigue syndrome in adults. Neurologist 2003;9(1):2834.
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 1995;273:40812.
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 1991;84(2):11821.
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 1998;105(suppl 3A):8390S.
Streitberger 1998
Streitberger K, Kleinhenz J. Introducing a placebo needle into
acupuncture research. The Lancet 1998;352:364365.
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
1997;87(Not known):144955.
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 Department of Labor and Industries, 2002.
Zhang 2004
Zhang R. Epidemiological study on CFS. Chinese journal of rehabilitation medicine 2004;19(4):2967.
WHATS NEW
31 October 2008
Amended
HISTORY
Protocol first published: Issue 2, 2006
CONTRIBUTIONS OF AUTHORS
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.
DECLARATIONS OF INTEREST
Not known
SOURCES OF SUPPORT
Internal sources
Department of Acupuncture and Moxibustion, Guang An Men Hospital, Chinese Academy of TCM, China.
External sources
No sources of support supplied