Randomized Controlled Trail Of Treating Primary Dysmenorrhea With Shaofu-zhuyu Decoction Acupoint Application

Objective:This study aimed to evaluate the clinical efficacy and safety of Shaofu-Zhuyu decoction acupoint application in the treatment of primary dysmenorrhea,and to compare the effects of Shaofu-Zhuyu decoction acupoint application with placebo.To provide research basis for the selection and spread of the advantage scheme of acupoint application for PD.Methods:104 PD patients were randomly divided into two groups,therapy group and placebo group,52 patients in each group.Both groups used the same treatment.Observed changes in the Visual Analogue Scale?VAS?,COX Dysmenorrhea Symptom Scale,Self-rating Anxiety Scale?SAS?,Self-rating Depression Scale?SDS?,patient global impression of change?PGIC?,venous serum prostaglandin PGF_2a,PGE₂,sex hormones?estradiol,progesterone?,compared the clinical efficacy of the two groups.Results:1.96 PD patients have finished the reserach including 48 cases in each group.2.There are no statistically significant differences between the two groups in the basic vital signs,demographic charateristics,baseline conditions of dysmenorrhea,anxiety and depression,serum prostaglandins(PGF_2a,PGE₂),and sex hormones?estradiol,progesterone?levels,?P>0.05?.Baseline equilibrium.3.Comparison of clinical symptoms after treatment in the two groups:?1?Within group analysis shows that,therapy group shows significant changes in VAS score,COX time score and severity score,total pain time score and severity score of small abdominal after treatment and in the follow-up?P<0.05?.Placebo group just have changes in VAS score,COX severity score after treatment and in the follow-up?P<0.05?.There is no statistically significant in COX time score,total pain time score and severity score of small abdominal after treatment?P>0.05?.?2?Between group analysis shows that,compared with placebo group,therapy group shows significant changes on VAS score,COX time score and severity score,total pain time score and severity score of small abdominal,SAS score,PGIC score after treatment and in the follow-up?P<0.05?.4.Therapy group shows significant changes in serum prostaglandin PGF_2a levels after treatment?P<0.05?.5.The total effective rate after treatment are:therapy group:87.5%,placebo group:22.9%.6.There are no significant differences in adverse events and the use of drugs?P>0.05?.Conclusion:1.Acupoint application of Shaofu-Zhuyu decoction has a definite effect on the treatment of primary dysmenorrhea,which can reduce the pain of the lower abdomen and the severity of the accompanying symptoms,shorten the pain of the lower abdomen and the duration of the accompanying symptoms,the curative effect is significantly better than the placebo application group.2.The Shaofu-Zhuyu decoction acupoint application group has significantly decreased in serum prostaglandins PGF_2a,and there is significant difference compared with the placebo application group,and its efficacy is related to drugs and acupoints,but no significant difference in PGE_2,sex hormones?estradiol,progesterone?levels.3.Treating primary dysmenorrhea with acupoint application of Shaofu-Zhuyu decoction has good compliance,security and reliability.