The Clinical Study Of Blood Circulation, Qi Analgesia (Shenbai Dysmenorrhea Particles) For The Treatment Of Primary Dysmenorrhea (Qi Stagnation And Blood Stasis)

Objective:By comparing with the placebo, evaluate the effectiveness and safety of Shenbai dysmenorrhea particles in curing qi stagnation and blood stasis of primary dysmenorrhea.Methodology:Adopting controlled parallel group design of random, double blinding and placebo. From December 2008 to June 2009,48 patients,32 experimental groups,16 control groups that conform to the diagnostic standard of primary dysmenorrhea(qi stagnation and blood stasis) in gynecology clinic of attached hospital of Chengdu University of Traditional Chinese Medicine were treated by adopting and control drug therapy with placebo, the course of treatment lasts 2 months. Observe the symptoms scores before and after treatment as well as the changes of the relevant endpoint and safety index.Results:A. Therapeutic effect on primary dysmenorrhea:The obvious curative rate in the experimental group was 67.74%; the total effective rate was 83.87%. The obvious curative rate in the control group was26.67% and the total effective rate was 40.00%. Experimental group than the control group the efficacy of dysmenorrhea.B. Therapeutic effect on QI STAGNATION AND BLOOD STASIS:The obvious curative rate in the experimental group was74.19%; the total effective rate was83.87%. The obvious curative rate in the control group was20.00% and the total effective rate was 46.67%. Between the two groups of the experimental group was statistically significant, the experimental group on the efficacy of qi stagnation card than the control group.C. Therapeutic effect on pain severity:The obvious curative rate in the experimental group was80.69%, the total effective rate was90.32%. The obvious curative rate in the control group was26.67% and the total effective rate was 40.00%. Group differences of the experimental group were statistically significant. Experimental group dysmenorrhea pain relief superior efficiency of the control group.D. Therapeutic effect on various tem symptoms:The experimental group provide obvious improvements for QI STAGNATION AND BLOOD STASIS symptoms such as the black menstrual blood, unclear menstruation, breast distention before menstruation, chesttightness as well as dysmenorrhea. Group differences of the experimental group were statistically significant. there is have statistical significance of the differences between the two.E.Safety Result:In the process of the experiment, neither observed adverse effect nor any unusual physiochemical index of any clinical significance was yet seen and it is much safer in clinical applications.Conclusion:Shenbai dysmenorrhea particles can improvePain intensity of dysmenorrhea and obvious improve the symptoms like the black menstrual blood, unclear menstruation, breast distention before menstruation, chesttightnes. Shenbai dysmenorrhea particles have significant effect on primary dysmenorrhea due to qi stagnation and blood stasis and meanwhile with better safety.