Objectives: This study,by means of clinical trial,is to evaluate the efficacy and safety of the treatment on primary dysmenorrhea(cold blood stasis syndrome)by combination of Shaofu Zhuyu decoction with Moxibustion and Ironing,in order to provide the new treatment methods by TCM treatment on this disease.Methods:The study used the experimental methods of random,control,single-blind and single-center.Patients with cold blood stasis syndrome were selected.We collected a total of 80 cases in accordance with the inclusion and exclusion criteria from the Gynecology clinic of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from 2017 May to 2018 Febrary,then randomly divided into 2groups: the trial group-combination of Shaofu Zhuyu decoction with Moxibustion and Ironing,and the control group-Shaofu Zhuyu decoction,which were all 40 cases.The two groups began from 3 days before menstruation to take boil-free granule of Shaofu Zhuyu decoction,lasting for 6 days.The trial group should start moxibustion on Guanyuan and Shuidao in the 7 days before each menstrual cramps,lasting for 7days,and began iron from the first day of menstruation to the third day every time.According to the above treatment method,3 menstrual cycles were continuously intervened and 3 menstrual cycles were followed up after withdrawal.Observe the changes of symptoms and related indicators and safety indexes of the two groups before and after the experiment.Results:(1)In terms of the degree of dysmenorrhea score,duration of abdominal pain,TCM syndrome integration and CMSS scale:Compared within group before and after the treatment of the two groups,the differences of the two groups had statistical significance(p < 0.05).The comparison of the difference(pre-treatment score minus after-treatment score)before and after treatment between groups of the two groups had statistical significance(p<0.05).(2)Comparison of the curative effect of two groups after the treatment:(1)The comparison of the curative effect about TCM Syndrome: The effective rate of the trailgroup was 87.5%,while the control group was 65.0%.The difference about TCM syndromes of the two groups had statistical significance(p < 0.05).(2)Comparison of the comprehensive curative effect:The effective rate of the trail group was90.0%,while the control group was 60.0%.The difference about comprehensive curative effect of the two groups had statistical significance(p < 0.05).(3)Safety comparison: Before and after the treatment,the two group ′ s various safety indicators were all in the normal range.No patients complained of any adverse reactions.Conclusions:(1)It is effective to treat primary dysmenorrhea,cold stasis and blood stasis syndrome,by taking Shao Fu Zhuyu Decoction in advance,combining with moxibustion before menstruation and menstrual ironing,which can improve the degree of dysmenorrhea,TCM syndrome and the average severity of dysmenorrhea,shorten the duration of abdominal pain and the total duration of symptoms of dysmenorrhea.(2)Premenstrual moxibustion and menstrual ironing are effective in the treatment of primary dysmenorrhea,cold stasis and blood stasis syndrome.And the clinical application of external treatment is simple,quick,safe and effective.No adverse reactions have been found and can be used in clinical application. |