| BackgroundPremenstrual 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. It is reported that approximately 95% of women have one or more premenstrual symptoms. There is no "PMS" name in TCM, the ancients add "menstrual-" to different symptoms which occur in company with menses, whenever before or meanwhile or after it, they summarized all these symptoms as "menstrual-symptoms". So PMS belongs to the category of "menstrual-symptoms".The treatment methods that usually used in western medicine include: selective serotonin reuptake inhibitors (SSRI), Gonadotrophin-releasing hormone analogues (GnRH), danazol, antisterone spironolactone, diet regulation, aerobic exercise, and psychopathy. But the big side-effects of therapies with affirmative effect make women can not insist.The single clinical studies of acupuncture reported good curative effect for PMS, but there was no systematic review to provide high strength evidence to validate its effect. Objective1. Through developing the systematic review, we firstly definitude the curative effect and current status of studies on acupuncture for PMS, and secondly laid the groundwork on method for designing scientific and rational studies in the future.2. Based on the systematic review, to design and organize a small-sample RCT according to Clinical Epidemiology' request for high quality clinical studies, in expectation of providing technology data for such studies.Method1. Systematic review With the guidance of domestic and foreign experts, we registered on Cochrane Collaboration, and searched for prospective controlled studies on acupuncture for PMS according to the Cochrane Reviewers' Handbook, developedthe systematic review by Revman 4.2.8 software, discovered the shortage of clinical studies' design method, in expectation of providing method demonstration for such studies.2. Clinical study This study was a randomized controlled single-blinded (patients were blinded) trial, in which center-randomisation and data management by the third party were used to implify the research quality. On the ground of definitude participants' believe in placebo-acupuncture, they were randomized into acupuncture treatment group and placebo-acupuncture control group. Baihui, Shangyintang, Taiyang, Sanyinjiao, Xuehai, etc were used in treatment group as my tutors' experience, and skin-inclusive around acu-points needling was used in control group. Three treatments were carried during the seven days before menstruation;three month was a period with premenstrual diary as the international recognized outcome measure. Result1. Outcome of systematic review The title was registered in Cochrane Collaboration, protocol has been published and review will be published in Cochrane Library. Outcome: Eight studies involving 807 women (range, 61-225) met the inclusion criteria. All studies showed acupuncture was superior to other methods (i.e. Western medicine or Chinese herbs) except one in which no statistically significant difference was detected. None study reported adverse events. Because of the high possibility of muti-bias of studies in this systematic review, we can not make conclusion on acupuncture for PMS;more high-quality RCTs were needed to strengthen the intensity of evidence on validity and safety.2. Outcome of clinical study Sixty-five patients participate in this clinical study, 33 in treatment group and 32 in control group, 5 patients fell off during treatment. Finally, there were 30 patients finished evaluation in each group respectively. There were statistical differences between two groups in "total marks of discomfort" and "total days of discomfort" (P>0.05), mainly in alleviating the emotional symptoms, the alleviation in treatment group is more than in control group. Amount decreased and time shortened in two patients both in the second menstruation, and the phenomenondisappeared in the third menstruation, which showed that it has unsure relation to acupuncture. This trial primarily indicated that acupuncture is effective and safe for PMS. But because of limitation of study object, time, and fee, the study has a small sample and fixed treatment method without follow-up survey, we will design and organize large-sample pragmatic randomized controlled trials with follow-up survey in the future, to provide objective evidence for acupuncture in treating PMS. ConclusionUnder the guidance of domestic and overseas experts, we found that there were few high-quality clinical studies on acupuncture for PMS, and there were something wrong with the setting of control group, randomization concealing, outcome measures and data management, etc, which restricted the improvement of studies' quality. Based on these work, we organized a small-sample randmised controlled trial without the insufficiency of forepast studies. International recognized diagnostic cretiria, patient-reported outcome measures, center-randomisation, placebo-acupuncture, and rigorous data management were adopted here, and good outcomes were achieved, which indicated that acupuncture has some effect on PMS. This study provided some technology data for organizing large-sample, muti-center RCTs on acupuncture for PMS in the future, and accumulated experience and methodological base for perfecting the design project of acupuncture for PMS to produce academia recognized high-quality studies. |
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