Acupuncture for Premenstrual Syndrome
Content
Acupuncture for premenstrual syndrome (Protocol)
Yu J, Liu B, Liu Z, Welch V, Wu T, Clarke J, Smith CA
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 premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
REFERENCES . . . . . . . .
APPENDICES . . . . . . . .
WHAT’S NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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[Intervention Protocol]
Acupuncture for premenstrual syndrome
Jinna Yu1 , Baoyan Liu2 , Zhishun Liu3 , Vivian Welch4 , Taixiang Wu5 , Jane Clarke6 , Caroline A Smith7
1 Acupuncture Department, Guang An Men Hospital of China Academy of Chinese Traditional Medicine, Beijing, China. 2 China
Academy of Traditional Chinese Medicine, Beijing, China. 3 Department of Acupuncture and Moxibustion, Chinese Academy of
Traditional Chinese Medicine, Beijing, China. 4 Centre for Global Health, Institute of Population Health, University of Ottawa, Ottawa,
Canada. 5 Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University, Chengdu, China. 6 Obstetrics
and Gynaecology, University of Auckland, Auckland, New Zealand. 7 Centre for Complementary Medicine Research, The University
of Western Sydney, Penrith South DC, Australia
Contact address: Jinna Yu, Acupuncture Department, Guang An Men Hospital of China Academy of Chinese Traditional Medicine,
No. 5 Bei Xian Ge, Xuan Wu Qu, Beijing, 100053, China. [email protected]. (Editorial group: Cochrane Menstrual Disorders and
Subfertility 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.CD005290
This version first published online: 20 April 2005 in Issue 2, 2005. (Help document - Dates and Statuses explained)
This record should be cited as: Yu J, Liu B, Liu Z, Welch V, Wu T, Clarke J, Smith CA. Acupuncture for premenstrual syndrome.
Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD005290. DOI: 10.1002/14651858.CD005290.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To evaluate the effectiveness and safety of acupuncture or electroacupuncture in the treatment of women with premenstrual syndrome.
Comparisons between groups intended for treatment with any type of acupuncture and groups allocated to ’sham’ acupuncture, no
treatment, Chinese medicine, Western medicine or other treatments. The following hypotheses will be tested:
(1) acupuncture is superior to ’sham’ acupuncture or no treatment in treating PMS;
(2) acupuncture is superior to other treatments or Western medicine or Chinese medicine in treating PMS;
(3) there are less adverse events in the acupuncture group than in the Chinese medicine or Western medicine groups.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
1
BACKGROUND
Premenstrual syndrome (PMS) is a group of symptoms that consistently occur in young and middle-aged women during the luteal
phase of the menstrual cycle. In order to diagnose PMS, the symptoms should abate when menstruation starts or stops and not recur until ovulation two weeks before the next period (Backstorm
1991; Dickerson 2004). More than 200 premenstrual symptoms
have been recorded and are usually divided into three broad categories:
(1) behavioral symptoms including fatigue, insomnia, dizziness,
changes in sexual interest, food cravings or overeating;
(2) psychological symptoms including irritability, anger, depressed
mood, crying and tearfulness, anxiety, tension, mood swings, lack
of concentration, confusion, forgetfulness, restlessness, loneliness,
decreased self-esteem, tension;
(3) physical symptoms including headaches, breast tenderness and
swelling, back pain, abdominal pain and bloating, weight gain,
swelling of extremities, water retention, nausea, muscle and joint
pain (Dickerson 2004; Reid 1986).
Premenstrual dysphoric disorder (PMDD) is a more severe form
of PMS. It is a condition characterized by intense emotional symptoms that occur between ovulation and menstruation. Symptoms
associated with PMDD are similar to those experienced with PMS;
however, they are much more severe. Symptoms include severe depression, irritability and/or mood swings which interfere with relationships, social functioning, and work or school (Bancroft 1993;
Medem 2004). PMDD should be diagnosed only when mood
symptoms seriously impact on relationships and impair functioning at work or school (Medem 2004).
It is reported that approximately 95% of women have one or
more premenstrual symptoms. Fifty percent of these women have
slight symptoms, 30% have moderate symptom, with about 5%
of women reporting severe PMS symptoms that disrupt their lives
in the two weeks before their periods (Hylan 1999). It is estimated
that only 3% to 8% of women are affected by PMDD (Medem
2004).
Description of the condition
The etiology of PMS is still not completely understood. Sex hormones produced by the corpus luteum are thought to be crucial
since the cyclical nature of the symptoms disappears in anovulatory cycles. The theory that PMS might simply result from a relative excess of either progesterone or oestrogen during the luteal
phase no longer seems tenable since progesterone, oestrogens and
progestogens can induce similar symptoms to those seen in PMS;
the severity of symptoms is dose sensitive (Backstrom 2003).
In recent years, it has been found that the sexual hormones are
neuroactive and modulate neural excitability and brain function.
Some progesterone metabolites, in particular allo pregnenolone,
are GABA-A agonists, with anxiolytic and anticonvulsant properties. By contrast, pregnenolone-sulphate and DHEAS-sulphate
are anxiogenic and pro-convulsant (Reddy 2003).
There is recent evidence that levels of oestrogens and progesterone
affect the transport of serotonin in the CNS, profoundly affecting the brain serotonergic system (Cameron 2004), and that, conversely, serotonin might affect ovarian levels of oestrogens and progesterone.
Some evidence suggests that an underlying serotonin deficiency
makes women more sensitive to progesterone (O’Brien 2000). Deficiencies in prostaglandins, which cause an inability to convert
linoleic acid to prostaglandin precursors, may be related to the onset of PMS (Daugherty 1998). Genetic factors also seem at work
as the concordance rate is two times higher in monozygotic twins
than in dizygotic twins (Kendler 1998). A more complex relationship between PMS and magnesium and calcium than either element alone was indicated by the highly significant high? Mg/Ca
ratio in blood cells in women with severe PMS. The significantly
lower calcium level in blood cells found in studies may provide
additional evidence that PMS may be involved in a calcium-deficiency state or a metabolic maladjustment involving calcium (
Shamberger 2003). One cross-sectional study reported that high
intake of fats and low intake of foods with high concentration
of carbohydrate may be associated with premenstrual symptoms (
Nagata 2004).
Description of the intervention
Many different treatments have been suggested as possible therapies for PMS due to the uncertainty of its pathogenesis and the
range of its manifestations. Because serotonin has been implicated
in the pathogenesis of PMS, luteal phase dosing of selective serotonin reuptake inhibitors (SSRIs) have been tested in these disorders (Freeman 2004; O’Brien 2000). The U.S. Food and Drug
Administration (FDA) has labelled fluoxetine (sarafem and sertraline (Zoloft, Pfizer Inc.)) for the treatment of PMS (Halbreich
2003).
Ovarian function appears to play a fundamental role in PMS, accordingly, treatment strategies designed to suppress ovulation have
generally been found to be effective for treatment of menstrually-related syndromes and symptoms. Gonadotrophin-releasing
hormone analogues (GnRHa) appear to be an effective treatment
of premenstrual syndrome (Backstrom 2003; Kouri 1998; Wyatt
2004).
In other studies, women with PMS who practiced aerobic exercise reported fewer symptoms than participants in the control
group (O’Brien 2000; Steege 1993). Dietary restrictions or supplements may also be useful in women with PMS (Kessel 2000;
Moline 2000). Sodium restriction has been proposed to minimize
bloating, fluid retention, and breast swelling and tenderness. Caffeine restriction is recommended because caffeine intake is related
to premenstrual irritability and insomnia. A systematic review of
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
2
placebo-controlled trials of evening primrose oil suggested lack of
benefit in PMS, although mild relief was demonstrated in women
with breast tenderness (Budeiri 1996).
A randomised placebo-controlled study reported there were significant improvements in the symptoms of negative feeling, pain,
water retention, and total PMS symptoms in women receiving
qigong therapy compared to placebo controls (Jang 2004). Qigong
consists primarily of meditation, relaxation, physical movement,
mind-body integration, and breathing exercises. Practitioners of
qigong develop an awareness of qi sensations (energy) in their body
and use their mind to guide the qi. When the practitioners achieve
a sufficient skill level (master), they can direct or emit external qi
for the purpose of healing others.
Some studies also indicate Chinese herbs (particularly preparations
containing the herbs Paeonia lactiflora and Dong Quai), homeopathy, aromatherapy, reflexology, Gingko biloba, kava kava, black
cohosh, and agnus castus can relieve the symptoms of PMS such
as anxiety, depression and irritability (Jones 2003; NAPS 2004;
Tesch 2003). Practitioners of Western herbal medicine routinely
use a group of herbs known for their hormonal modulation effect
as core treatment for pre-menstrual symptoms. Vitex agnus castus
(Chaste tree berries) is a particularly effective treatment for many
forms of PMS. This plant has also been the object of several randomised studies (Loch 2000).
Other treatments for PMS, for which there is inconclusive evidence, include cognitive behavioral therapy, relaxation therapy,
vitamin B6, L-tryptophan, stress reduction, spironolactone, or a
complex carbohydrate drink. Although evidence for relief of PMS
symptoms is inconclusive, it is reasonable to recommend these as
healthy lifestyle changes which may give people a more general
benefit (Douglas 2002; Girman 2003; Rapkin 2003).
could be taken as the indication of the change in nervous activity (
Zhang 1997). Recent data suggest that acupuncture has regionally
specific, quantifiable effects on relevant brain structures. Acupuncture may stimulate gene expression of neuropeptides (Kaptchuk
2002).
Based on this theory, acupuncture may have potential benefits for
the premenstrual syndrome. There were more than 20 studies reporting its effects in the treatment of premenstrual syndrome. One
study (You 1997) classified the patients into one group with yang
deficiency of the spleen and the kidney and another group with
stagnation of the liver qi (the spleen, kidney and liver in TCM
is different from in western medicine); it used Taichong, Taixi,
Qihai, Ganshu, Tanzhong, and Sanyingjiao as the main acupuncture points in the first group and Zusanli, Pishu, Shenshu, Taixi,
Sanyingjiao, Guanyuan (moxibustion) in another. Acupuncture
in treating edema during menstruation was also reported effective in two studies (Li 2002, Liu 2002). The first study only used
Fuliu as the point, and the second study used Zhongwan, Qihai,
Hegu, Zusanli, Sanyingjiao, Xuehai, Shenshu, and Yongquan as
the main points. Headache during menstruation could also be
treated by acupuncture, one study (Zhang 2001) selected Fengchi
and Zhengying as the points and another study (Sun 1999) used
Baihui, Qihai, Guanyuan, Zigong, Sanyingjiao, and Zusanli as
the acupuncture points, in conjunction with Chinese herbs. These
studies demonstrated that PMS symptoms may be alleviated by
acupuncture or acupuncture in conjunction with other means; a
systematic review is required.
OBJECTIVES
Why it is important to do this review
Acupuncture is a form of therapy based on traditional Chinese
medicine (TCM) and dates back thousands of years. To bring
about healing it involves inserting fine needles into specific points
on the skin in order to stimulate corresponding meridians points,
as defined by TCM theory. Other methods of stimulation of these
points are also traditionally used, such as the burning of moxa
(the plant Artemisia vulgaris or Mugwort) and applying pressure
(acupressure). Other methods developed more recently include
electronic stimulation, laser acupuncture and medicament. The
traditional concepts involve the regulating of imbalances of qi (vital energy) along with the theories of yin and yang, the five elements, meridians, vital substances, pathogenic factors, and the
eight principle patterns (Beal 1999). As the use of acupuncture
has become more prevalent in the West these theories have been
developed to fit in with a Western understanding of physiology,
for example, needling is thought to reduce local muscle tension
or release pain-killing endorphins (Green 2004). The temperature
in the cortex can be changed by electroacupuncture; the response
To evaluate the effectiveness and safety of acupuncture or electroacupuncture in the treatment of women with premenstrual syndrome.
Comparisons between groups intended for treatment with any
type of acupuncture and groups allocated to ’sham’ acupuncture,
no treatment, Chinese medicine, Western medicine or other treatments. The following hypotheses will be tested:
(1) acupuncture is superior to ’sham’ acupuncture or no treatment
in treating PMS;
(2) acupuncture is superior to other treatments or Western
medicine or Chinese medicine in treating PMS;
(3) there are less adverse events in the acupuncture group than in
the Chinese medicine or Western medicine groups.
METHODS
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
3
Criteria for considering studies for this review
Types of studies
Randomised controlled trials will be considered without restriction on language and publication types.
Types of participants
Women of reproductive age with one or more symptoms occurring
periodically during 0 to 14 days before menstruation, for three or
more menstrual periods, will be included. By thorough physical
examination and laboratory test, those who are confirmed to have
medical problems such as hypothyroidism, hypoglycaemia or a
tumour of the breast, brain or ovary will be excluded. Women
addicted to drink or with an alcoholic habit will be excluded;
women with allergic reactions to acupuncture will also be excluded.
Types of interventions
The type of acupuncture could be body acupuncture, electroacupuncture, scalp acupuncture, ear acupuncture, laser
acupuncture and other acupuncture interventions see Table 1.The
control intervention compared with acupuncture could be Chinese medicine, Western medicine, sham acupuncture (placebo),
no intervention, and any other interventions. Acupuncture therapy combined with other methods will also be included.
Table 1. Acupuncture Points
Acupuncture Points
Alternative name
Hegu
LI 4
Zusanli
ST 36
Sanyinjiao
SP 6
Xuehai
SP 10
Ganshu
BL 18
Pishu
BL 20
Shenshu
BL 23
Yongquan
KI 1
Taixi
KI 3
Zhengying
GB 17
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
4
Table 1. Acupuncture Points
Fengchi
GB20
Taichong
LR 3
Guanyuan
RN 4
Zhongwan
RN 12
Tanzhong
RN 17
Baihui
DU 20
Zigong
EX-CA 1
Qihai
RN 6
(Continued)
Types of outcome measures
(1) PMS scoring systems
Any validated objective scoring system used for premenstrual
symptoms, such as the Moos Menstrual Distress Questionnaire or
the Daily Symptom Report.
(2) Improvement of overall symptoms (as a dichotomous measure)
If the above two outcome measures were not used in a study, we
will also consider the outcome measures as following:
records made by participants or doctors by chart or using visual
analogue scales.
Severity of symptoms reported will be judged in accordance with
the definitions of numerical scales used in the charts.
(3) Quality of life
The Health Related Quality of Life (HRQOL) or other validated
scales will be considered in this review.
(4) Adverse events
Events such as needle sickness, pneumothorax and so on will be
recorded.
Search methods for identification of studies
A comprehensive and exhaustive search strategy will be formulated
in an attempt to identify all relevant studies regardless of language
or publication status (published, unpublished, in press, and in
progress).
(1) The Trials Registers of the Cochrane Menstrual Disorders and
Subfertility Group and the Cochrane Complementary Medicine
Field will be searched.
(2) The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library will be searched.
(3) We will also search MEDLINE (January 1966 to present), EMBASE (January 1980 to present), Chinese Biomedical Database
(CBM) (January 1975 to present), China National Knowledge
Infrastructure (CNKI) (January 1994 to present), and the VIP
Database (January 1989 to present).
Search strategy for the above electronic database Appendix 1.
This is a draft search strategy and will be adapted to include additional search terms where necessary.
(4) We also intend to search for ongoing trials in the Meta-register
of Controlled Trials, which includes the Medical Research Council
Clinical Trials Directory and the National Research Register, as
well as many other registers on ongoing trials.
(5) We will try to identify additional studies by searching the
reference lists of relevant trials and reviews identified.
(6) Unpublished and on-going trials will be identified by correspondence with authors.
(7) Major acupuncture and obstetrics and gynaecology conferences
proceedings and poster abstracts about this disease over the last
five years will be handsearched for further eligible studies.
(8) A search for side-effects studies will be carried out and contact
will be made with various adverse reaction reporting bodies.
(9) The Chinese Cochrane Centre is co-ordinating the handsearching of a variety of Chinese journals. We will contact the
Centre to obtain any handsearch results relevant to this review.
(10) Individual researchers working in the field, of unpublished
ongoing trials, involved in confidential reports and raw data of
published trials will be contacted.
Additional key words of relevance may be identified during any
of the electronic or other searches. If this is the case, electronic
search strategies will be modified to incorporate these terms. Studies published in any language will be included.
External referees will be requested to check the completeness of the
search strategy. This is a draft search strategy and will be adapted
to include additional search terms where necessary.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
5
Data collection and analysis
Study selection
YJ and LZ will select the trials to be included in the study. A quality
table will be used to record the quality of studies. According to
the empirical evidence (Jadad 1996; Juni 2001; Kjaergard 2001;
Moher 1998; Schulz 1995), we will assess the methodological
quality as described by the Cochrane Reviewers’ Handbook 4.2:
(1) generation of the allocation sequence: adequate (computergenerated random numbers, table of random numbers, or similar)
or inadequate (other methods or not described);
(2) allocation concealment: adequate (central independent unit,
sealed envelopes, or similar) or inadequate (not described or open
table of random numbers or similar);
(3) double blinding: adequate (identical sham acupuncture, or
similar) or inadequate (not performed or different); and
(4) follow up: adequate (number and reasons for dropouts and
withdrawals described) or inadequate (number or reasons for
dropouts and withdrawals not described).
Based on these criteria, studies will be broadly subdivided into the
following three categories.
A - all quality criteria met: low risk of bias.
B - one or more of the quality criteria only partly met: moderate
risk of bias.
C - one or more criteria not met: high risk of bias.
This classification will be used as the basis for subgroup analysis.
Additionally, we will explore the influence of individual quality
criteria in a sensitivity analysis. Each trial will be assessed independently by two reviewers (YJ and LZ). Inter-rater agreement will
be calculated using the Kappa statistic. In cases of disagreement,
the third reviewer (WT) will be consulted and a judgement will
be made based on consensus.
Data extraction
YJ and LZ will independently extract data using a piloted data
extraction form. We will extract data on study characteristics including methods, participants, interventions, and outcomes. We
will resolve any disagreements by referring to the trial report and
through discussion, or by consulting the Cochrane Menstrual Disorders and Subfertility Group. If data from the trial reports are
insufficient or missing, we will contact the authors for additional
information.
Where possible, we will extract data to allow an intention-to-treat
analysis (the analysis should include all the participants in the
groups to which they were originally randomly assigned). If the
number randomised and the numbers analysed are inconsistent,
we will calculate the percentage loss to follow up and report this
information in an additional table. For binary outcomes, we will
record the number of participants experiencing the event in each
group of the trial. For continuous outcomes, for each group we
will extract the arithmetic means and standard deviations. If the
data are reported using geometric means we will extract standard
deviations on the log scale. Medians and ranges will be extracted
and reported in tables.
Data analysis
We will analyse the data using Review Manager (Version 5.0). We
will compare outcome measures for binary data using relative risks.
For continuous data, we will use the weighted mean difference.
If continuous data has been reported using geometric means, we
will combine the findings on a log scale and report on the original
scale. We will report medians and ranges in tables only. We will
assess heterogeneity amongst trials by inspecting the forest plots
and using the Chi square test for heterogeneity with a 10% level
of statistical significance. Where it is appropriate to pool data and
heterogeneity is detected, we will use the random-effects model.
We do not intend to combine results of trials with different comparator drugs or interventions. Potential bias of publication will
be tested for using the funnel plot or other corrective analytical
methods, depending on the number of clinical trials included in
the systematic review (Egger 1997).
We intend to explore the following potential sources of heterogeneity using subgroup analyses or meta-regression because there
are clinical heterogeneity between them:
(a) different types of acupuncture intervention;
(b) different preparations of intervention combined with acupuncture;
(c) different control interventions;
(d) acupuncture points;
(e) period of treatment.
Reasons for heterogeneity in studies will be explored and, if necessary, sensitivity analyses will examine the effects of excluding study
subgroups, for example those studies with lower methodological
quality.
Non-controlled studies will be listed but not discussed further.
Studies relating to adverse effects will be described qualitatively.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
6
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Kaptchuk 2002
Kaptchuk TJ. Acupuncture: theory, efficacy, and practice. Annals of
Internal Medicine 2002;136(5):374–83.
Kendler 1998
Kendler KS, Karkowski LM, Corey LA, Neale MC. Longitudinal
population-based twin study of retrospectively reported premenstrual
symptoms and lifetime major depression. American Journal of Psychiatry 1998;155:1234–40.
Kessel 2000
Kessel B. Premenstrual syndrome. Advances in diagnosis and treatment. Obstetrics and Gynecology Clinics of North America 2000;27:
625–39.
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;135:982–9.
Kouri 1998
Kouri EM, Halbreich U. Hormonal treatments for premenstrual syndrome. Drugs Today (Barc) 1998;34(7):603–10.
Li 2002
Li Chen. Fuliu as the acupoint for edema during menstruation.
Chinese Acupuncture & Moxibustion 2002;22(9):612.
Liu 2002
Liu Haiying, Jiao Hongbo, Jiao Nianxue. Acupuncture for edema
during menstruation in 20 women. Journal of External Therapy of
TCM 2002;11(6):30.
Acupuncture for premenstrual syndrome (Protocol)
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Loch 2000
Loch EG, Selle H, Boblitz N. Treatment of premenstrual syndrome
with a phytopharmaceutical formulation containing Vitex agnus castus. Journal of Women’s Health & Gender-based Medicine 2000;9(3):
315–20.
Medem 2004
Medem Inc and American Psychiatric Association. Premenstrual
Dysphoric Disorder (PMDD). http://www.medem.com/medlb/article_
detaillb.cfm?article_ID=ZZZF9KNGTRC&sub_cat=2003 accessed
at 25 July, 2004.
Moher 1998
Moher D, Pham B, Jones A, Cook DJ, Jadad A, Moher M, et al.Does
quality of reports of randomised trials affect estimates of intervention
efficacy reported in meta-analysis. Lancet 1998;352:609–13.
Moline 2000
Moline ML, Zendell SM. Evaluating and managing premenstrual
syndrome. Medscape Womens Health 2000;5(2):1–16.
Nagata 2004
Nagata C, Hirokawa K, Shimizu N, Shimizu H. Soy, fat and other
dietary factors in relation to premenstrual symptoms in Japanese
women. BJOG: British Journal of Obstetrics and Gynaecology 2004;
111(6):594–9.
Reid 1986
Reid RL. Premenstrual syndrome: a time for introspection. American
Journal of Obstetrics and Gynecology 1986;155(5):921–6.
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of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA: Journal of the
American Medical Association 1995;273:408–12.
Shamberger 2003
Shamberger RJ. Calcium, magnesium, and other elements in the
red blood cells and hair of normals and patients with premenstrual
syndrome. Biological Trace Element Research 2003;94(2):123–9.
Steege 1993
Steege JF, Blumenthal JA. The effects of aerobic exercise on premenstrual symptoms in middle-aged women: a preliminary study. Journal of Psychosomatic Research 1993;37:127–33.
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Sun Yanming. Acupuncture and medicine for headache during menstruation in 27 women. Tian Jin Traditional Chinese Medicine 1999;
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(5):44–55.
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Syndrome
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(NAPS). Dr Claudine’s guide to complementary treatments. http:
The effectiveness of GnRHa with and without ’add-back’ therapy
//www.pms.org.uk/guidetocomplementarytreatments.php?sid=sid3e064576d7980d4bd452088c5644b336
in treating premenstrual syndrome: a meta analysis. BJOG: British
accessed at 24 July, 2004.
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O’Brien 2000
You 1997
O’Brien PM, Wyatt K, Dimmock PW. Premenstrual syndrome is
You Yafang. Acupuncture for premenstrual tensions in 56 women.
real and treatable. Practitioner 2000;224(1608):185-9, 191, 194-5.
Chinese Acupuncture & Moxibustion 1997;16(3):171.
Rapkin 2003
Rapkin A. A review of treatment of premenstrual syndrome and
premenstrual dysphoric disorder. Psychoneuroendocrinology 2003;28
(Suppl 3):39–53.
Reddy 2003
Reddy DS. Pharmacology of endogenous neuroactive steroids. Critical Reviews in Neurobiology 2003;15(3-4):197–234.
Zhang 1997
Zhang Xuexun. Electric needle therapy for peripheral facial paralysis.
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∗
Indicates the major publication for the study
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
8
APPENDICES
Appendix 1. MEDLINE
#1. Premenstrual syndrome
#2. Syndrome, premenstrual
#3. Syndrome*, premenstrual
#4. Premenstrual tensions
#5. Tensions, premenstrual
#6. Tension, prem*
#7. PMT
#8. PMS
#9.or/1-8
B. Search Strategy to locate acupuncture interventions:
#10. acupuncture
#11. electroacupuncture
#12. body acupuncture
#13. acupuncture points
#14. ear acupuncture
#15. scalp acupuncture
#16. laser acupuncture
#17.abdomen-acupuncture
#18. or/#10-#17
WHAT’S NEW
6 November 2008
Amended
Converted to new review format.
HISTORY
Protocol first published: Issue 2, 2005
CONTRIBUTIONS OF AUTHORS
Yu Jinna: was responsible for drafting the protocol and will be responsible for searching for studies, data extraction, data analysis, and
data presentation.
Vivian Robinson: contributed to protocol development and will contribute to data analysis.
Liu Zhishun: will contribute to data analysis.
Liu Baoyan: will contribute to data analysis
Wu Taixiang: contributed to protocol development and will contribute to data analysis.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
9
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
• Guang An Men Hospital of China Academy of Traditional Chinese Medicine, China.
External sources
• Chinese Cochrane Center, Chinese Centre of Evidence-based Medicine, West China Hospital of Sichuan University, China.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
10
Yu J, Liu B, Liu Z, Welch V, Wu T, Clarke J, Smith CA
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 premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
REFERENCES . . . . . . . .
APPENDICES . . . . . . . .
WHAT’S NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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i
[Intervention Protocol]
Acupuncture for premenstrual syndrome
Jinna Yu1 , Baoyan Liu2 , Zhishun Liu3 , Vivian Welch4 , Taixiang Wu5 , Jane Clarke6 , Caroline A Smith7
1 Acupuncture Department, Guang An Men Hospital of China Academy of Chinese Traditional Medicine, Beijing, China. 2 China
Academy of Traditional Chinese Medicine, Beijing, China. 3 Department of Acupuncture and Moxibustion, Chinese Academy of
Traditional Chinese Medicine, Beijing, China. 4 Centre for Global Health, Institute of Population Health, University of Ottawa, Ottawa,
Canada. 5 Chinese Cochrane Centre, Chinese EBM Centre, West China Hospital, Sichuan University, Chengdu, China. 6 Obstetrics
and Gynaecology, University of Auckland, Auckland, New Zealand. 7 Centre for Complementary Medicine Research, The University
of Western Sydney, Penrith South DC, Australia
Contact address: Jinna Yu, Acupuncture Department, Guang An Men Hospital of China Academy of Chinese Traditional Medicine,
No. 5 Bei Xian Ge, Xuan Wu Qu, Beijing, 100053, China. [email protected]. (Editorial group: Cochrane Menstrual Disorders and
Subfertility 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.CD005290
This version first published online: 20 April 2005 in Issue 2, 2005. (Help document - Dates and Statuses explained)
This record should be cited as: Yu J, Liu B, Liu Z, Welch V, Wu T, Clarke J, Smith CA. Acupuncture for premenstrual syndrome.
Cochrane Database of Systematic Reviews 2005, Issue 2. Art. No.: CD005290. DOI: 10.1002/14651858.CD005290.
ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To evaluate the effectiveness and safety of acupuncture or electroacupuncture in the treatment of women with premenstrual syndrome.
Comparisons between groups intended for treatment with any type of acupuncture and groups allocated to ’sham’ acupuncture, no
treatment, Chinese medicine, Western medicine or other treatments. The following hypotheses will be tested:
(1) acupuncture is superior to ’sham’ acupuncture or no treatment in treating PMS;
(2) acupuncture is superior to other treatments or Western medicine or Chinese medicine in treating PMS;
(3) there are less adverse events in the acupuncture group than in the Chinese medicine or Western medicine groups.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
1
BACKGROUND
Premenstrual syndrome (PMS) is a group of symptoms that consistently occur in young and middle-aged women during the luteal
phase of the menstrual cycle. In order to diagnose PMS, the symptoms should abate when menstruation starts or stops and not recur until ovulation two weeks before the next period (Backstorm
1991; Dickerson 2004). More than 200 premenstrual symptoms
have been recorded and are usually divided into three broad categories:
(1) behavioral symptoms including fatigue, insomnia, dizziness,
changes in sexual interest, food cravings or overeating;
(2) psychological symptoms including irritability, anger, depressed
mood, crying and tearfulness, anxiety, tension, mood swings, lack
of concentration, confusion, forgetfulness, restlessness, loneliness,
decreased self-esteem, tension;
(3) physical symptoms including headaches, breast tenderness and
swelling, back pain, abdominal pain and bloating, weight gain,
swelling of extremities, water retention, nausea, muscle and joint
pain (Dickerson 2004; Reid 1986).
Premenstrual dysphoric disorder (PMDD) is a more severe form
of PMS. It is a condition characterized by intense emotional symptoms that occur between ovulation and menstruation. Symptoms
associated with PMDD are similar to those experienced with PMS;
however, they are much more severe. Symptoms include severe depression, irritability and/or mood swings which interfere with relationships, social functioning, and work or school (Bancroft 1993;
Medem 2004). PMDD should be diagnosed only when mood
symptoms seriously impact on relationships and impair functioning at work or school (Medem 2004).
It is reported that approximately 95% of women have one or
more premenstrual symptoms. Fifty percent of these women have
slight symptoms, 30% have moderate symptom, with about 5%
of women reporting severe PMS symptoms that disrupt their lives
in the two weeks before their periods (Hylan 1999). It is estimated
that only 3% to 8% of women are affected by PMDD (Medem
2004).
Description of the condition
The etiology of PMS is still not completely understood. Sex hormones produced by the corpus luteum are thought to be crucial
since the cyclical nature of the symptoms disappears in anovulatory cycles. The theory that PMS might simply result from a relative excess of either progesterone or oestrogen during the luteal
phase no longer seems tenable since progesterone, oestrogens and
progestogens can induce similar symptoms to those seen in PMS;
the severity of symptoms is dose sensitive (Backstrom 2003).
In recent years, it has been found that the sexual hormones are
neuroactive and modulate neural excitability and brain function.
Some progesterone metabolites, in particular allo pregnenolone,
are GABA-A agonists, with anxiolytic and anticonvulsant properties. By contrast, pregnenolone-sulphate and DHEAS-sulphate
are anxiogenic and pro-convulsant (Reddy 2003).
There is recent evidence that levels of oestrogens and progesterone
affect the transport of serotonin in the CNS, profoundly affecting the brain serotonergic system (Cameron 2004), and that, conversely, serotonin might affect ovarian levels of oestrogens and progesterone.
Some evidence suggests that an underlying serotonin deficiency
makes women more sensitive to progesterone (O’Brien 2000). Deficiencies in prostaglandins, which cause an inability to convert
linoleic acid to prostaglandin precursors, may be related to the onset of PMS (Daugherty 1998). Genetic factors also seem at work
as the concordance rate is two times higher in monozygotic twins
than in dizygotic twins (Kendler 1998). A more complex relationship between PMS and magnesium and calcium than either element alone was indicated by the highly significant high? Mg/Ca
ratio in blood cells in women with severe PMS. The significantly
lower calcium level in blood cells found in studies may provide
additional evidence that PMS may be involved in a calcium-deficiency state or a metabolic maladjustment involving calcium (
Shamberger 2003). One cross-sectional study reported that high
intake of fats and low intake of foods with high concentration
of carbohydrate may be associated with premenstrual symptoms (
Nagata 2004).
Description of the intervention
Many different treatments have been suggested as possible therapies for PMS due to the uncertainty of its pathogenesis and the
range of its manifestations. Because serotonin has been implicated
in the pathogenesis of PMS, luteal phase dosing of selective serotonin reuptake inhibitors (SSRIs) have been tested in these disorders (Freeman 2004; O’Brien 2000). The U.S. Food and Drug
Administration (FDA) has labelled fluoxetine (sarafem and sertraline (Zoloft, Pfizer Inc.)) for the treatment of PMS (Halbreich
2003).
Ovarian function appears to play a fundamental role in PMS, accordingly, treatment strategies designed to suppress ovulation have
generally been found to be effective for treatment of menstrually-related syndromes and symptoms. Gonadotrophin-releasing
hormone analogues (GnRHa) appear to be an effective treatment
of premenstrual syndrome (Backstrom 2003; Kouri 1998; Wyatt
2004).
In other studies, women with PMS who practiced aerobic exercise reported fewer symptoms than participants in the control
group (O’Brien 2000; Steege 1993). Dietary restrictions or supplements may also be useful in women with PMS (Kessel 2000;
Moline 2000). Sodium restriction has been proposed to minimize
bloating, fluid retention, and breast swelling and tenderness. Caffeine restriction is recommended because caffeine intake is related
to premenstrual irritability and insomnia. A systematic review of
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
2
placebo-controlled trials of evening primrose oil suggested lack of
benefit in PMS, although mild relief was demonstrated in women
with breast tenderness (Budeiri 1996).
A randomised placebo-controlled study reported there were significant improvements in the symptoms of negative feeling, pain,
water retention, and total PMS symptoms in women receiving
qigong therapy compared to placebo controls (Jang 2004). Qigong
consists primarily of meditation, relaxation, physical movement,
mind-body integration, and breathing exercises. Practitioners of
qigong develop an awareness of qi sensations (energy) in their body
and use their mind to guide the qi. When the practitioners achieve
a sufficient skill level (master), they can direct or emit external qi
for the purpose of healing others.
Some studies also indicate Chinese herbs (particularly preparations
containing the herbs Paeonia lactiflora and Dong Quai), homeopathy, aromatherapy, reflexology, Gingko biloba, kava kava, black
cohosh, and agnus castus can relieve the symptoms of PMS such
as anxiety, depression and irritability (Jones 2003; NAPS 2004;
Tesch 2003). Practitioners of Western herbal medicine routinely
use a group of herbs known for their hormonal modulation effect
as core treatment for pre-menstrual symptoms. Vitex agnus castus
(Chaste tree berries) is a particularly effective treatment for many
forms of PMS. This plant has also been the object of several randomised studies (Loch 2000).
Other treatments for PMS, for which there is inconclusive evidence, include cognitive behavioral therapy, relaxation therapy,
vitamin B6, L-tryptophan, stress reduction, spironolactone, or a
complex carbohydrate drink. Although evidence for relief of PMS
symptoms is inconclusive, it is reasonable to recommend these as
healthy lifestyle changes which may give people a more general
benefit (Douglas 2002; Girman 2003; Rapkin 2003).
could be taken as the indication of the change in nervous activity (
Zhang 1997). Recent data suggest that acupuncture has regionally
specific, quantifiable effects on relevant brain structures. Acupuncture may stimulate gene expression of neuropeptides (Kaptchuk
2002).
Based on this theory, acupuncture may have potential benefits for
the premenstrual syndrome. There were more than 20 studies reporting its effects in the treatment of premenstrual syndrome. One
study (You 1997) classified the patients into one group with yang
deficiency of the spleen and the kidney and another group with
stagnation of the liver qi (the spleen, kidney and liver in TCM
is different from in western medicine); it used Taichong, Taixi,
Qihai, Ganshu, Tanzhong, and Sanyingjiao as the main acupuncture points in the first group and Zusanli, Pishu, Shenshu, Taixi,
Sanyingjiao, Guanyuan (moxibustion) in another. Acupuncture
in treating edema during menstruation was also reported effective in two studies (Li 2002, Liu 2002). The first study only used
Fuliu as the point, and the second study used Zhongwan, Qihai,
Hegu, Zusanli, Sanyingjiao, Xuehai, Shenshu, and Yongquan as
the main points. Headache during menstruation could also be
treated by acupuncture, one study (Zhang 2001) selected Fengchi
and Zhengying as the points and another study (Sun 1999) used
Baihui, Qihai, Guanyuan, Zigong, Sanyingjiao, and Zusanli as
the acupuncture points, in conjunction with Chinese herbs. These
studies demonstrated that PMS symptoms may be alleviated by
acupuncture or acupuncture in conjunction with other means; a
systematic review is required.
OBJECTIVES
Why it is important to do this review
Acupuncture is a form of therapy based on traditional Chinese
medicine (TCM) and dates back thousands of years. To bring
about healing it involves inserting fine needles into specific points
on the skin in order to stimulate corresponding meridians points,
as defined by TCM theory. Other methods of stimulation of these
points are also traditionally used, such as the burning of moxa
(the plant Artemisia vulgaris or Mugwort) and applying pressure
(acupressure). Other methods developed more recently include
electronic stimulation, laser acupuncture and medicament. The
traditional concepts involve the regulating of imbalances of qi (vital energy) along with the theories of yin and yang, the five elements, meridians, vital substances, pathogenic factors, and the
eight principle patterns (Beal 1999). As the use of acupuncture
has become more prevalent in the West these theories have been
developed to fit in with a Western understanding of physiology,
for example, needling is thought to reduce local muscle tension
or release pain-killing endorphins (Green 2004). The temperature
in the cortex can be changed by electroacupuncture; the response
To evaluate the effectiveness and safety of acupuncture or electroacupuncture in the treatment of women with premenstrual syndrome.
Comparisons between groups intended for treatment with any
type of acupuncture and groups allocated to ’sham’ acupuncture,
no treatment, Chinese medicine, Western medicine or other treatments. The following hypotheses will be tested:
(1) acupuncture is superior to ’sham’ acupuncture or no treatment
in treating PMS;
(2) acupuncture is superior to other treatments or Western
medicine or Chinese medicine in treating PMS;
(3) there are less adverse events in the acupuncture group than in
the Chinese medicine or Western medicine groups.
METHODS
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
3
Criteria for considering studies for this review
Types of studies
Randomised controlled trials will be considered without restriction on language and publication types.
Types of participants
Women of reproductive age with one or more symptoms occurring
periodically during 0 to 14 days before menstruation, for three or
more menstrual periods, will be included. By thorough physical
examination and laboratory test, those who are confirmed to have
medical problems such as hypothyroidism, hypoglycaemia or a
tumour of the breast, brain or ovary will be excluded. Women
addicted to drink or with an alcoholic habit will be excluded;
women with allergic reactions to acupuncture will also be excluded.
Types of interventions
The type of acupuncture could be body acupuncture, electroacupuncture, scalp acupuncture, ear acupuncture, laser
acupuncture and other acupuncture interventions see Table 1.The
control intervention compared with acupuncture could be Chinese medicine, Western medicine, sham acupuncture (placebo),
no intervention, and any other interventions. Acupuncture therapy combined with other methods will also be included.
Table 1. Acupuncture Points
Acupuncture Points
Alternative name
Hegu
LI 4
Zusanli
ST 36
Sanyinjiao
SP 6
Xuehai
SP 10
Ganshu
BL 18
Pishu
BL 20
Shenshu
BL 23
Yongquan
KI 1
Taixi
KI 3
Zhengying
GB 17
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
4
Table 1. Acupuncture Points
Fengchi
GB20
Taichong
LR 3
Guanyuan
RN 4
Zhongwan
RN 12
Tanzhong
RN 17
Baihui
DU 20
Zigong
EX-CA 1
Qihai
RN 6
(Continued)
Types of outcome measures
(1) PMS scoring systems
Any validated objective scoring system used for premenstrual
symptoms, such as the Moos Menstrual Distress Questionnaire or
the Daily Symptom Report.
(2) Improvement of overall symptoms (as a dichotomous measure)
If the above two outcome measures were not used in a study, we
will also consider the outcome measures as following:
records made by participants or doctors by chart or using visual
analogue scales.
Severity of symptoms reported will be judged in accordance with
the definitions of numerical scales used in the charts.
(3) Quality of life
The Health Related Quality of Life (HRQOL) or other validated
scales will be considered in this review.
(4) Adverse events
Events such as needle sickness, pneumothorax and so on will be
recorded.
Search methods for identification of studies
A comprehensive and exhaustive search strategy will be formulated
in an attempt to identify all relevant studies regardless of language
or publication status (published, unpublished, in press, and in
progress).
(1) The Trials Registers of the Cochrane Menstrual Disorders and
Subfertility Group and the Cochrane Complementary Medicine
Field will be searched.
(2) The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library will be searched.
(3) We will also search MEDLINE (January 1966 to present), EMBASE (January 1980 to present), Chinese Biomedical Database
(CBM) (January 1975 to present), China National Knowledge
Infrastructure (CNKI) (January 1994 to present), and the VIP
Database (January 1989 to present).
Search strategy for the above electronic database Appendix 1.
This is a draft search strategy and will be adapted to include additional search terms where necessary.
(4) We also intend to search for ongoing trials in the Meta-register
of Controlled Trials, which includes the Medical Research Council
Clinical Trials Directory and the National Research Register, as
well as many other registers on ongoing trials.
(5) We will try to identify additional studies by searching the
reference lists of relevant trials and reviews identified.
(6) Unpublished and on-going trials will be identified by correspondence with authors.
(7) Major acupuncture and obstetrics and gynaecology conferences
proceedings and poster abstracts about this disease over the last
five years will be handsearched for further eligible studies.
(8) A search for side-effects studies will be carried out and contact
will be made with various adverse reaction reporting bodies.
(9) The Chinese Cochrane Centre is co-ordinating the handsearching of a variety of Chinese journals. We will contact the
Centre to obtain any handsearch results relevant to this review.
(10) Individual researchers working in the field, of unpublished
ongoing trials, involved in confidential reports and raw data of
published trials will be contacted.
Additional key words of relevance may be identified during any
of the electronic or other searches. If this is the case, electronic
search strategies will be modified to incorporate these terms. Studies published in any language will be included.
External referees will be requested to check the completeness of the
search strategy. This is a draft search strategy and will be adapted
to include additional search terms where necessary.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
5
Data collection and analysis
Study selection
YJ and LZ will select the trials to be included in the study. A quality
table will be used to record the quality of studies. According to
the empirical evidence (Jadad 1996; Juni 2001; Kjaergard 2001;
Moher 1998; Schulz 1995), we will assess the methodological
quality as described by the Cochrane Reviewers’ Handbook 4.2:
(1) generation of the allocation sequence: adequate (computergenerated random numbers, table of random numbers, or similar)
or inadequate (other methods or not described);
(2) allocation concealment: adequate (central independent unit,
sealed envelopes, or similar) or inadequate (not described or open
table of random numbers or similar);
(3) double blinding: adequate (identical sham acupuncture, or
similar) or inadequate (not performed or different); and
(4) follow up: adequate (number and reasons for dropouts and
withdrawals described) or inadequate (number or reasons for
dropouts and withdrawals not described).
Based on these criteria, studies will be broadly subdivided into the
following three categories.
A - all quality criteria met: low risk of bias.
B - one or more of the quality criteria only partly met: moderate
risk of bias.
C - one or more criteria not met: high risk of bias.
This classification will be used as the basis for subgroup analysis.
Additionally, we will explore the influence of individual quality
criteria in a sensitivity analysis. Each trial will be assessed independently by two reviewers (YJ and LZ). Inter-rater agreement will
be calculated using the Kappa statistic. In cases of disagreement,
the third reviewer (WT) will be consulted and a judgement will
be made based on consensus.
Data extraction
YJ and LZ will independently extract data using a piloted data
extraction form. We will extract data on study characteristics including methods, participants, interventions, and outcomes. We
will resolve any disagreements by referring to the trial report and
through discussion, or by consulting the Cochrane Menstrual Disorders and Subfertility Group. If data from the trial reports are
insufficient or missing, we will contact the authors for additional
information.
Where possible, we will extract data to allow an intention-to-treat
analysis (the analysis should include all the participants in the
groups to which they were originally randomly assigned). If the
number randomised and the numbers analysed are inconsistent,
we will calculate the percentage loss to follow up and report this
information in an additional table. For binary outcomes, we will
record the number of participants experiencing the event in each
group of the trial. For continuous outcomes, for each group we
will extract the arithmetic means and standard deviations. If the
data are reported using geometric means we will extract standard
deviations on the log scale. Medians and ranges will be extracted
and reported in tables.
Data analysis
We will analyse the data using Review Manager (Version 5.0). We
will compare outcome measures for binary data using relative risks.
For continuous data, we will use the weighted mean difference.
If continuous data has been reported using geometric means, we
will combine the findings on a log scale and report on the original
scale. We will report medians and ranges in tables only. We will
assess heterogeneity amongst trials by inspecting the forest plots
and using the Chi square test for heterogeneity with a 10% level
of statistical significance. Where it is appropriate to pool data and
heterogeneity is detected, we will use the random-effects model.
We do not intend to combine results of trials with different comparator drugs or interventions. Potential bias of publication will
be tested for using the funnel plot or other corrective analytical
methods, depending on the number of clinical trials included in
the systematic review (Egger 1997).
We intend to explore the following potential sources of heterogeneity using subgroup analyses or meta-regression because there
are clinical heterogeneity between them:
(a) different types of acupuncture intervention;
(b) different preparations of intervention combined with acupuncture;
(c) different control interventions;
(d) acupuncture points;
(e) period of treatment.
Reasons for heterogeneity in studies will be explored and, if necessary, sensitivity analyses will examine the effects of excluding study
subgroups, for example those studies with lower methodological
quality.
Non-controlled studies will be listed but not discussed further.
Studies relating to adverse effects will be described qualitatively.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
6
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∗
Indicates the major publication for the study
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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APPENDICES
Appendix 1. MEDLINE
#1. Premenstrual syndrome
#2. Syndrome, premenstrual
#3. Syndrome*, premenstrual
#4. Premenstrual tensions
#5. Tensions, premenstrual
#6. Tension, prem*
#7. PMT
#8. PMS
#9.or/1-8
B. Search Strategy to locate acupuncture interventions:
#10. acupuncture
#11. electroacupuncture
#12. body acupuncture
#13. acupuncture points
#14. ear acupuncture
#15. scalp acupuncture
#16. laser acupuncture
#17.abdomen-acupuncture
#18. or/#10-#17
WHAT’S NEW
6 November 2008
Amended
Converted to new review format.
HISTORY
Protocol first published: Issue 2, 2005
CONTRIBUTIONS OF AUTHORS
Yu Jinna: was responsible for drafting the protocol and will be responsible for searching for studies, data extraction, data analysis, and
data presentation.
Vivian Robinson: contributed to protocol development and will contribute to data analysis.
Liu Zhishun: will contribute to data analysis.
Liu Baoyan: will contribute to data analysis
Wu Taixiang: contributed to protocol development and will contribute to data analysis.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
9
DECLARATIONS OF INTEREST
None known.
SOURCES OF SUPPORT
Internal sources
• Guang An Men Hospital of China Academy of Traditional Chinese Medicine, China.
External sources
• Chinese Cochrane Center, Chinese Centre of Evidence-based Medicine, West China Hospital of Sichuan University, China.
Acupuncture for premenstrual syndrome (Protocol)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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