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TABLE OF CONTENTS
HEADER . . . . . . . . . .
ABSTRACT . . . . . . . . .
BACKGROUND . . . . . . .
OBJECTIVES . . . . . . . .
METHODS . . . . . . . . .
REFERENCES . . . . . . . .
ADDITIONAL TABLES . . . . .
APPENDICES . . . . . . . .
WHATS NEW . . . . . . . .
HISTORY . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS
DECLARATIONS OF INTEREST .
SOURCES OF SUPPORT . . . .
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[Intervention Protocol]
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. ayujinnaa@sina.com.
Editorial group: Cochrane Gynaecology and Fertility Group.
Publication status and date: Edited (no change to conclusions), published in Issue 11, 2010.
Citation: 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.
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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.
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 cate-
gories:
(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;
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).
tive 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
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
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
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.
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.
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.
REFERENCES
Additional references
Backstorm 1991
Backstrom T, Hammarback S. Premenstrual syndrome-psychiatric or gynaecological disorder. Annals of Medicine
1991;23(6):62533.
Backstrom 2003
Backstrom T, Andreen L, Birzniece V, Bjorn I, Johansson
IM, Nordenstam-Haghjo M, et al. The role of hormones
and hormonal treatments in premenstrual syndrome. CNS
Drugs 2003;17(5):32542.
Bancroft 1993
Bancroft J. The premenstrual syndrome - a reappraisal of
the concept and the evidence. Psychological Medicine 1993;
Suppl 24:147.
Beal 1999
Beal MW. Acupuncture and acupressure. Applications
to womens reproductive health care. Journal of Nurse
Midwifery 1999;44(3):21730.
Budeiri 1996
Budeiri D, Li Wan Po A, Dornan JC. Is evening primrose
oil of value in the treatment of premenstrual syndrome?.
Controlled Clinical Trials 1996;17:608.
Cameron 2004
Cameron JL. Interrelationships between hormones,
behavior, and affect during adolescence: complex
relationships exist between reproductive hormones, stressrelated hormones, and the activity of neural systems that
regulate behavioral affect. Annals of the New York Academy
of Science 2004;1021:13442.
Daugherty 1998
Daugherty JE. Treatment strategies for premenstrual
syndrome. American Family Physician 1998;58:18392,
197-8.
Dickerson 2004
Dickerson LM, Mazyck PJ, Hunter MH. Premenstrual
Syndrome. American Family Physician 2004; Vol. 57, issue
8:174352.
Douglas 2002
Douglas S. Premenstrual syndrome. Evidence-based
treatment in family practice. Canadian Family Physician
2002;48:178997.
Egger 1997
Egger M, Smith GD, Schneider M, Minder C. Bias in
meta-analysis detected by a simple, graphical test. BMJ
1997;315:62934.
Freeman 2004
Freeman EW. Luteal phase administration of agents for the
treatment of premenstrual dysphoric disorder. CNS Drugs
2004;18(7):45368.
Girman 2003
Girman A, Lee R, Kligler B. An integrative medicine
approach to premenstrual syndrome. American Journal of
Obstetrics and Gynecology 2003;188 Suppl(5):5665.
Green 2004
Green S, Buchbinder R, Barnsley L, Hall S, White M, Smidt
N, et al. Acupuncture for lateral elbow pain. Cochrane
Database of Systematic Reviews 2004, Issue 3.
Halbreich 2003
Halbreich U, Kahn LS. Treatment of premenstrual
dysphoric disorder with luteal phase dosing of sertraline.
Expert Opinion on Pharmacotherapy 2003;4(11):206578.
Hylan 1999
Hylan TR, Sundell K, Judge R. The impact of premenstrual
symptomatology on functioning and treatment-seeking
behavior: experience from the United States, United
Kingdom, and France. Journal of Womens Health & Genderbased Medicine 1999;8(8):104352.
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.
Jang 2004
Jang HS, Li MS. Effects of qi therapy (external qigong) on
premenstrual syndrome: a randomized placebo-controlled
study. Journal of Alternative and Complementary Medicine
2004;10(3):45662.
Jones 2003
Jones A. Homeopathic treatment for premenstrual
symptoms. Journal of Family Planning & Reproductive
Health Care 2003;29(1):258.
Juni 2001
Juni P, Altman DG, Egger M. Systematic reviews in health
care: Assessing the quality of controlled clinical trials. BMJ
2001;323:426.
Kaptchuk 2002
Kaptchuk TJ. Acupuncture: theory, efficacy, and practice.
Annals of Internal Medicine 2002;136(5):37483.
Kendler 1998
Kendler KS, Karkowski LM, Corey LA, Neale MC.
Longitudinal population-based twin study of retrospectively
OBrien 2000
OBrien PM, Wyatt K, Dimmock PW. Premenstrual
syndrome is real and treatable. Practitioner 2000;224
(1608):185-9, 191, 194-5.
Rapkin 2003
Rapkin A. A review of treatment of premenstrual
syndrome and premenstrual dysphoric disorder.
Psychoneuroendocrinology 2003;28(Suppl 3):3953.
Reddy 2003
Reddy DS. Pharmacology of endogenous neuroactive
steroids. Critical Reviews in Neurobiology 2003;15(3-4):
197234.
Reid 1986
Reid RL. Premenstrual syndrome: a time for introspection.
American Journal of Obstetrics and Gynecology 1986;155(5):
9216.
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: Journal of the American Medical Association
1995;273:40812.
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):1239.
Steege 1993
Steege JF, Blumenthal JA. The effects of aerobic exercise
on premenstrual symptoms in middle-aged women: a
ADDITIONAL TABLES
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
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)
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
Acupuncture for premenstrual syndrome (Protocol)
Copyright 2010 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
WHATS NEW
Date
Event
Description
20 September 2010
Amended
HISTORY
Protocol first published: Issue 2, 2005
Date
Event
Description
6 November 2008
Amended
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.
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.
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