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Acupuncture for chronic constipation (Protocol)

Zhao H, Liu JP, Liu Z, 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
http://www.thecochranelibrary.com

Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
ACKNOWLEDGEMENTS
. . .
REFERENCES . . . . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .

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Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Protocol]

Acupuncture for chronic constipation


Hong Zhao1 , Jian Ping Liu2 , Zhishun Liu3 , Weina Peng4
1 Department of Acupuncture and Moxibustion, Guang An Men Hospital, Chinese Academy of Traditional Chinese Medicine, Beijing,
China. 2 Centre for Evidence-Based Chinese Medicine , Beijing University of Chinese Medicine, Beijing, China. 3 Department of
Acupuncture & Moxibustion, Guang An Men Hospital, China Academy of Traditional Chinese Medicine, Beijing, China. 4 Department
of Acupuncture and Moxibustion, Chinese Academy of Traditional Chinese Medicine, Beijing, China

Contact address: Hong Zhao, Department of Acupuncture and Moxibustion, Guang An Men Hospital, Chinese Academy of Traditional
Chinese Medicine, No.5,Beixiange Street, Beijing, Xuanwu district, 100053, China. hongzhao253@hotmail.com. (Editorial group:
Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders 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.CD004117
This version first published online: 22 April 2003 in Issue 2, 2003. (Help document - Dates and Statuses explained)
This record should be cited as: Zhao H, Liu JP, Liu Z, Peng W. Acupuncture for chronic constipation. Cochrane Database of Systematic
Reviews 2003, Issue 2. Art. No.: CD004117. DOI: 10.1002/14651858.CD004117.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the beneficial and harmful effects of acupuncture therapy for chronic constipation.

Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

BACKGROUND
Chronic constipation is a prevalent disorder. It comprises a group
of disorders which present as persistent, difficult, infrequent or
seemingly incomplete defecation. The overall prevalence of constipation in the United States was 14.7% ( Stewart 1999). Prevalence of chronic constipation in the United States compared to
Guangzhou City was 4.6% and 3.0% respectively (Stewart 1999;
Wei 2001). The prevalence of constipation increased with higher
education levels (Stewart 1999) and increased age (Talley 1996).
Tally (Talley 1996) reported that the prevalence of chronic constipation among persons aged 65 years and over was 24.4%. Women
have also been found to have a higher prevalence of chronic constipation than men (Schaefer 1998; Chen 2000).
Chronic constipation results from a disturbed colonic passage
and/or an impaired evacuation of the rectum. Secondary forms
of constipation due to systemic disorders or medications are frequent (Denis 1997). Diagnosing chronic constipation depends on
clinical symptom evaluation using standard scales such as Rome II
gastrointestinal questionnaire, Bristol Stool Form Scale, Cleveland
Clinic Score, or KESS (Knowles 2000; Pare 2001). Transit time
measurement (radiopaque markers), functional rectoanal evaluation (proctoscopy, anorectal manometry, defecography, cinedefecography), and electromyography (EMG) can help make the
diagnosis of chronic constipation and identify other underlying
disease (Kamm 1990; Stivland 1991; Heymen 1993; Jorge 1994;
Maleki 1998; Penning 2001).
The classification of chronic constipation is not very clear. Some
investigators separate constipated patients into three pathophysiological groups: slow colonic transit, pelvic floor dysfunction,
and irritable bowel syndrome (IBS) (Schiller 1996). Other investigators separate chronic constipation into four subgroups: disordered defecation, slow gastrointestinal transit, disordered defecation combined with slow-transit stool, and non-specific disorder
with no pathologic finding (Koch 1997; Nam 2001).
Therapy of chronic constipation is comprehensive and should be
managed according to the type of constipation. The general therapy includes fluid intake, dietary fibers and medications such as
laxatives and enemas, when necessary (Voderholzer 1997; Dey
1998; Wong 1999; Gorazziari 1999; Ni 2001). Functional obstructions in the rectum may require surgical therapy or specialized
forms of treatment such as biofeedback (Piccirillo 1995; Lubowski
1996; Pluta 1996).
In Traditional Chinese Medicine (TCM), chronic constipation is
called bianmi, dabiannan. It is divided into five types in TCM
according to the diagnosis through the tongue, pulse, and symptoms. The types included dry-heat of Intestine and Stomach, block
of Qi of Intestine, deficiency of Stomach and Spleen, deficiency
of Yang of Spleen and Kidney, deficiency of Yin of Intestine.
Acupuncture is a very important form of TCM, which is a
3000-year-old holistic system. Acupuncture therapy includes body

acupuncture, auricular acupuncture, scalp acupuncture, electroacupuncture, laser acupuncture, acupressure, or a combination of the above approaches. Body acupuncture and auricular
acupuncture are the most commonly used therapies for chronic
constipation (Yang 1996; Wu 1996). The record of acupuncture
in treatment of constipation can be traced back to the Jin Dynasty
according to the book A-B Classic of Acupuncture and Moxibustion. In China, many clinical studies have been done during
the last decades. Preliminary searches identified about 90 trials
on treatment of constipation with acupuncture in the Chinese
Biomedical Database (December 2002). The role and efficacy of
acupuncture for chronic constipation are unclear.
These inconclusive results may be due to the methodological weakness of the trials, such as inadequate blinding of patients, investigators or both, inadequate allocation concealment and insufficient duration of treatment. There is no known systematic review
of acupuncture in the treatment of chronic constipation. This review aims to review systematically all randomised controlled trials
(RCTs) and controlled clinical trials (CCTs), which examine the
effectiveness of acupuncture for chronic constipation.

OBJECTIVES
To assess the beneficial and harmful effects of acupuncture therapy
for chronic constipation.

METHODS

Criteria for considering studies for this review


Types of studies
Randomised controlled trials and quasi-randomised trials comparing acupuncture therapy for chronic constipation with routine
therapies such as laxative agents, biofeedback, hypnosis, or yogic
breathing. All eligible trials will be included regardless of language
and publication types. In randomised cross-over trials only data
from the first period will be included. Controlled clinical trials
are excluded from the primary analysis, but will be evaluated in a
sensitivity analysis.
Types of participants
Patients, male or female, of any age or gender, with chronic constipation will be included.
Chronic constipation is diagnosed according to the following diagnostic criteria (Thompson 1999):
At least 12 weeks, which need not be consecutive, in the preceding
12 months of two or more of:
1. straining in >1/4 defecations;
2. lumpy or hard stools in >1/4 defecations;

Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

3. sensation of incomplete evacuation in >1/4 defecation;


4. sensation of anorectal obstruction/blocked in 1/4 defecation;
5. manual maneuvers to facilitate >1/4 defecation (e.g., digital
evacuation, support of the pelvic floor); and/or
6. <3 defecation/week.
Constipation caused by other disease such as diabetes mellitus,
hypothyroidism, tumour, anal fissure, as well as acute constipation
will be excluded.
Types of interventions
Any types of acupuncture therapy comparing with the following
control interventions: placebo, no intervention, herbal medicine,
conventional therapies, or any other interventions. Acupuncture
therapy can be body acupuncture, auricular acupuncture, scalp
acupuncture, electroacupuncture, laser acupuncture, or acupressure. Acupuncture therapy combined with other treatments such
as Chinese herb will also be included. If sham (placebo) acupuncture is used, it will be defined as the needling of non-acupuncture points without needle manipulation, done either proximally
and/or distally to the true acupuncture.
Types of outcome measures
The primary outcome measure will be:
1. Clinical symptoms including but not limited to frequency
of defecation, straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction/blockage,
manual maneuvers to facilitate defecation (e.g., digital evacuation,
support of the pelvic floor).
The secondary outcome measures will include:
2. Quality of life;
3. Transit time measurement (radiopaque markers), functional rectoanal evaluation (proctoscopy, anorectal manometry, defecography, cinedefecography), or electromyography (EMG);
4. Cost effectiveness;
5. Number and types of adverse effects.

Search methods for identification of studies


Electronic searches
The following electronic databases will be searched irrespective of
language and publication status:
- The Trials Registers of the Inflammatory Bowel Disease Group,
the Cochrane Complementary Medicine Field, and the Cochrane
Central Register of Controlled Trials (CENTRAL) on The
Cochrane Library (Issue 1, 2003).
- MEDLINE (1966-2002), EMBASE (1998-2002), Chinese
Biomedical Database (1979-2002).
The search strategy for MEDLINE is as follows:
1 exp constipation/
2 exp acupuncture/
3 exp electroacupuncture/
4 exp meridians/
5 exp acupuncture points

6 exp body acupuncture/


7 acupuncture$.tw.
8 (electroacupuncture or electro- acupuncture).tw.
9 acupoints.tw.
10 electroacupuncture.tw.
11 acupressure.tw.
12 or/2-11
13 1 and 12
Handsearches
The following journals published in Chinese will be searched: Chinese Acupuncture and Moxibustion (1981-2002), Journal of Clinical Acupuncture and Moxibustion (1985-2002), Journal of Traditional Chinese Medicine (1960-2002), New Journal of Traditional
Chinese Medicine (1969-2002), Shanghai Journal of Acupuncture and Moxibustion (1982-2002), Research of Acupuncture and
Moxibustion (1976-2002) from their first publication date onwards to 2002. Conference proceedings relevant to this topic will
also be handsearched.
Additional searches
The reference lists of identified randomised clinical trials and review articles will be checked in order to find randomised trials not
identified by the electronic or hand searches. Ongoing trials will be
searched through the National Research Register and the website
www.controlled-trials.com, and grey literature through the SIGLE
database.

Data collection and analysis


Studies identification:
Potentially relevant articles will be reviewed independently by two
reviewers (Peng and Zhao) to determine if they meet the prespecified criteria and the grade of their methodological quality. Any
disagreement between reviewers will be resolved by consensus with
a third party.
Assessment of methodological quality
The methodological quality will be assessed by (Peng and Zhao)
using separated quality components, i.e., adequacy of generation
of the allocation sequence, allocation concealment, double blinding, and follow-up.
The components are:
- generation of the allocation sequence: adequate (computer generated random numbers or similar) or inadequate (other methods
or not described),
- allocation concealment: adequate (central independent unit, serially numbered, opaque, sealed envelopes, or similar) or inadequate (not described or open table of random numbers or similar),
- follow-up: adequate (number and reasons for dropouts and withdrawals described) or inadequate (number or reasons for dropouts
and withdrawals not described).
Data extraction:

Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

The following characteristics and data will be extracted by two


reviewers (Peng and Zhao) and validated by a third party (Liu)
using a self-developed data extraction form: mean age, proportion
of men, patient inclusion and exclusion criteria, the way diagnosis was made, type, administration, and duration of acupuncture
therapy, regimen of the control intervention, follow-up, outcome
measures, and number and type of adverse events. The data for
the primary outcome are the number of patients randomised into
each treatment group and the number of patients in each group
who entered remission. The numbers lost to follow-up will be also
recorded as well as the duration of follow-up. Treatment and control modalities will be summarised, as the demographics of the
study population. When required data are not available from the
trials, the principle investigators will be contacted and requested
for further information.
Data analyses:
The statistical validity of combining the results of the various trials
will be assessed by examining the homogeneity of the outcomes
from the various trials. This will be carried out in two ways: 1) using
a Mantel-Haenszel chi-square test of homogeneity of the relative
risk, and 2) using a graphic display. The outcome measure to be
examined is relative risk (RR) comparing the risks of remission in
the treatment group to that of the control group. This is based on
the total number of patients randomised to each of the two groups
and the number of patients in remission at the end of follow-up
in each group. The log RR and its 95% confidence interval (CI)
will be calculated and plotted for each trial. These plots will be
examined to identify any possible outliers as well as to explore
any trends in outcome due to differences in methodology, patient
population or treatment regimes.
Data from individual trials will be combined for meta-analysis
when the interventions are sufficiently similar (i.e., individual trials compare the same acupuncture therapy versus the same control
intervention). Dichotomous data are presented as RR and continuous outcomes as weighted mean difference (WMD), both with
95% CI. The analyses will be carried out using MetaView 4.1 in
Review Manager 4.1 (Cochrane software).

Sensitivity Analyses:
A sensitivity analysis will be carried out to determine if the findings from the primary analysis is changed by incorporating different trials in the analysis. This will be done by varying the inclusion criteria and repeating the analysis with the new data set.
In addition, the effect of including randomised controlled trials
reported only in abstracts and in languages other than English will
be examined. Furthermore, if a sufficient number of randomised
trials is identified, we plan to perform sensitivity analysis to explore the influence of trial quality on effect estimates. The quality components of methodology include adequacy of generation
of allocation sequence, concealment of allocation, and the use of
intention-to-treat (yes or no).
Subgroup Analyses:
If a sufficient number of randomised trials is identified, we will
perform the following subgroups analyses:
1. different types of acupuncture therapies (body acupuncture, auricular acupuncture, scalp acupuncture, electroacupuncture, laser
acupuncture, acupressure);
2. treatment duration (less than two weeks or more than two
weeks); and
3. duration of disease (less than 5 years, 5 to 10 years, more than
10 years).
Publication Bias:
Potential biases will be investigated using the funnel plot or other
corrective analytical methods (Egger 1997). We will use a linear
regression approach to measure funnel plot asymmetry on the
natural logarithm scale of the odds ratio.

ACKNOWLEDGEMENTS
Interim funding for the IBD Review Group has been provided by
the Canadian Institutes of Health Research (Institutes of Infection
and Immunity & Nutrition, Metabolism and Diabetes). Miss Ila
Stewart has provided support for the IBD Review Group through
the Olive Stewart Fund.

REFERENCES

Additional references
Chen 2000
Chen LY, Ho KY, Phua KH. Normal bowel habits and prevalence
of functional bowel disorders in Singaporean adults--findings from
a community based study in Bishan. Singapore Med J 2000;41(6):
2558.
Denis 1997
Denis P. Constipation. Contracept Fertil Sex 1997;25(9):7302.
Dey 1998
Dey AB. Constipation. Natl Med J India 1998;11(6):2802.

Egger 1997
Egger M, Davey Smith G, Schneider M, Minder C. Bias in metaanalysis detected by a simple, graphical test. BMJ 1997; Vol. 315,
issue 7109:629634.
Gorazziari 1999
Gorazziari E. Need of the ideal drug for the treatment of chronic
constipation. Ital J Gastroenterol Hepatol 1999;31(Suppl 3):S2323.
Heymen 1993
Heymen S, Wexner SD, Gulledge AD. MMPI assessment of patients
with functional bowel disorders. Dis Colon Rectum 1993;36(6):593
6.

Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Jorge 1994
Jorge JM, Wexner SD, Ehrenpreis ED. The lactulose hydrogen breath
test as a measure of orocaecal transit time. Eur J Surg 1994;160(8):
40916.
Kamm 1990
Kamm MA, Lennard-Jones JE. Rectal mucosal electrosensory testing-evidence for a rectal sensory neuropathy in idiopathic constipation.
Dis Colon Rectum 1990;33(5):41923.
Knowles 2000
Knowles CH, Eccersley AJ, Scott SM, Walker SM, Reeves B, Lunniss
PJ. Linear discriminant analysis of symptoms in patients with chronic
constipation: validation of a new scoring system (KESS). Dis Colon
Rectum 2000;43(10):141926.
Koch 1997
Koch A, Voderholzer WA, Klauser AG, Muller-Lissner S. Symptoms
in chronic constipation. Dis Colon Rectum 1997;40(8):9026.
Lubowski 1996
Lubowski DZ, Chen FC, Kennedy ML, King DW. Results of colectomy for severe slow transit constipation. Dis Colon Rectum 1996;
39(1):239.
Maleki 1998
Maleki D, Camilleri M, Burton DD, Rath-Harvey DM, Oenning L,
Pemberton JH, Low PA. Pilot study of pathophysiology of constipation among community diabetics. Dig Dis Sci 1998;43(11):23738.
Nam 2001
Nam YS, Pikarsky AJ, Wexner SD, Singh JJ, Weiss EG, Nogueras
JJ, Choi JS, Hwang YH. Reproducibility of colonic transit study in
patients with chronic constipation. Dis Colon Rectum 2001;44(1):
8692.
Ni 2001
Ni YH, Lin CC, Chang SH, Yeung CY. Use of cisapride with magnesium oxide in chronic pediatric constipation. Acta Paediatrica Taiwanica 2001;42(6):3459.
Pare 2001
Pare P, Ferrazzi S, Thompson WG, Irvine EJ, Rance L. An epidemiological survey of constipation in Canada: definitions, rates, demographics, and predictors of health care seeking. Am J Gastroenterol
2001;96(11):31307.

Schaefer 1998
Schaefer DC, Cheskin LJ. Constipation in the elderly. Am Fam
Physician 1998;58(4):90714.
Schiller 1996
Schiller L. Chronic constipation: pathogenesis, diagnosis, treatment.
In: Champion MC, Orr WC editor(s). Evolving concepts of gastrointestinal motility. Oxford: Blackwell Science Ltd, 1996:22150. [:
0865429448]
Stewart 1999
Stewart WF, Liberman JN, Sandler RS, Woods MS, Stemhagen
A, Chee E, Lipton RB, Farup CE. Epidemiology of constipation
(EPOC) study in the United States: relation of clinical subtypes to
sociodemographic features. Am J Gastroenterol 1999;94(12):3530
40.
Stivland 1991
Stivland T, Camilleri M, Vassallo M, Proano M, Rath D, Brown M,
Thomforde G, Pembertom J, Phillips S. Scintigraphic measurement
of regional gut transit in idiopathic constipation. Gastroenterology
1991;101(1):10715.
Talley 1996
Talley NJ, Fleming KC, Evans JM, OKeefe EA, Weaver AL, Zinsmeister AR, Melton LJ 3rd. Constipation in an elderly community:
a study of prevalence and potential risk factors. Am J Gastroenterol
1996;91(1):1925.
Thompson 1999
Thompson WG, Longstreth GF, Drossman DA, Heaton KW, Irvine
EJ, Muller-Lissner SA. Functional bowel disorders and functional
abdominal pain. Gut 1999;45(Suppl 2):II4347.
Voderholzer 1997
Voderholzer WA, Schatke W, Muhldorfer BE, Klauser AG, Birkner
B, Muller-Lissner SA. Clinical response to dietary fiber treatment of
chronic constipation. Am J Gastroenterol 1997;92(1):958.
Wei 2001
Wei X, Chen M, Wang J. The epidemiology of irritable bowel
syndrome and functional constipation of Guangzhou residents.
Zhonghua Nei Ke Za Zhi 2001;40(8):517520.

Penning 2001
Penning C, Steens J, van der Schaar PJ, Kuyvenhoven J, Delemarre
JB, Lamers CB, Masclee AA. Motor and sensory function of the
rectum in different subtypes of constipation. Scand J Gastroenterol
2001;36(1):328.

Wong 1999
Wong PW, Kadakia S. How to deal with chronic constipation. A
stepwise method of establishing and treating the source of the problem. Postgrad Med 1999;106(6):199210.

Piccirillo 1995
Piccirillo MF, Reissman P, Wexner SD. Colectomy as treatment for
constipation in selected patients. Br J Surg 1995;82(7):898901.

Wu 1996
Wu S. Treatment of 38 cases of constipation by aural acupuncture.
Chinese Acupuncture and Moxibustion 1996;16(6):57.

Pluta 1996
Pluta H, Bowes KL, Jewell LD. Long-term results of total abdominal
colectomy for chronic idiopathic constipation: value of preoperative
assessment. Dis Colon Rectum 1996;39(2):1606.

Yang 1996
Yang J. Treatment of habitual constipation by acupuncture on Sanyinjiao. Chinese Acupuncture and Moxibustion 1996;16(8):59.

Indicates the major publication for the study

Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

WHATS NEW

15 October 2008

Amended

Converted to new review format.

HISTORY
Protocol first published: Issue 2, 2003

CONTRIBUTIONS OF AUTHORS
Hong Zhao initiated, designed the study and drafted the protocol. She will extract the data, conduct quality assessment and the statistical
analyses.
Jianping Liu provided methodological perspectives and techniques for writing the protocol, acted as an ombudsman for data extraction
and statistical analysis, and revised the protocol.
Zhishun Liu commented on and revised the protocol, and checked the data extraction.
Weina Peng will extract data, assess quality, and analyse data.

DECLARATIONS OF INTEREST
None 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

Acupuncture for chronic constipation (Protocol)


Copyright 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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