The Phase ⅡClinical Research On The Treatment Of Primary Dysmenorrhea(Qi Stagnation And Blood Stasis Syndrome)with BaiTongShu Capsule

Objective:To evaluate the efficacy and security of BaiTongShu capsule on primary dysmenorrhea of qi stagnation and blood stasis syndrome, explore the clinical effective dose and provide bases for its promotion and application.Methods:Stratified randomization, double-blind, multicenter and placebo-controlled design were performed. Selected60patients with primary dysmenorrhea (qi stagnation and blood stasis syndrome) presented to gynecological clinic. Affiliated hospital of Chengdu University of Traditional Chinese Medicine from Feb.2011to Jan.2012. All subjects whose age ranged from18to30were randomly divided into the testl group, the test2group and the control group. The course of treatment was set as starting medication at7days before menstruation, taking for10days (3days for menstruation medication) and taking for3menstrual cycles consecutively. Cured cases were followed up for3menstrual cycles to observe the symptom scores before and after treatment in three groups as well as the changes of relevant efficacy indexes and security index.Results:(1) The efficacy of TCM syndrome:The cured and markedly effective rate was65%and the total effective rate was85%in test1group. In test2group, the cured and markedly effective rate and the total effective rate was47.62%and76.19%respectively. In the control group, the cured and markedly effective rate and the total effective rate was10.53%and42.11%respectively. There was a significant difference among the three groups (P<0.05). No significant difference was found between test1group and test2group (P>0.05).The test1group achieves the same curative effect as that of test2group. The curative effects of test1group and test2group on improving TCM syndrome are superior to that of control group.(2) The efficiency of the degree of pain:the cured and markedly effective rate and the total effective rate were75%and95%respectively in test1group,66.67%and90.48%respectively in test2group and15.79%and42.11%in the control group. The test1group achieves the same curative effect as that of test2group. The curative effects of test1group and test2group on improving the degree of pain are superior to that of contrast group. (3) The changes of duration time of pain:there was a significant difference within groups before and after treatment (all P<0.05), and there was a significant difference among the three groups after treatment (P<0.05). In respect of shortening the duration time, Test1group is superior to control group.(4) Comparisons of the efficiency of TCM minor symptom:test1group and test2group achieve better curative effects than contrast group does in terms of hypomenorrhea accompanied with obstructed menstruation, dark-red menstrual blood with blood clots and breast distending pain.There were significant differences in the comparisons of minor symptoms after treatment among the three groups (P<0.05) except that no statistical difference was found in chest discomfort after treatment (P>0.05).(5) Security results:found no adverse reactions and physical-chemical examination indexes with clinical significance about investigational medication in this trial, so the clinical application is comparatively safe.Conclusion:BaiTongShu capsule can obviously alleviate menstrual pain, shorten the duration time of dysmenorrheal as well as improve hypomenorrhea, impeded discharge of menses, dark-red menstrual blood with blood clots, chest discomfort, breast distending pain and other symptoms. The product is safe and convenient in clinical application so it is worthy of further promotion.