| ObjectiveBy comparing with the placebo, Single blind evaluate the effectiveness and safety of shujingfangtong Capsule in syndrome of stagnation of liver qi and blood stasis of primary dysmenorrhea.MethodologyAdopting controlled parallel group design of random, single blinding and placebo. From July 2010 to January 2011,74 patients,38 experimental groups,36 Treatment groups that conform to the diagnostic standard of primary dysmenorrheal (syndrome of stagnation of liver qi 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, shu jing fang tong Capsule use with 5 days before menstruation, 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. A total 32 patient during the 1 months of follow-up.Results1. Therapeutic effect on primary dysmenorrhea:The obvious curative rate in the experimental group was 73.69%; the total effective rate was 100%. The obvious curative rate in the Treatment group was 11.11% and the total effective rate was 30.55%. The efficacy of the treatment group than the control group dysmenorrheal.2. Therapeutic effect on pain severity:The obvious curative rate in the experimental group was76.31%, the total effective rate was92.10%. The obvious curative rate in the Treatment group was33.33% and the total effective rate was 52.77%. Group differences of the experimental group were statistically significant, the treatment group on pain of dysmenorrhea mitigation superiority in the control group.3. Therapeutic effect on syndrome of stagnation of liver qi and blood stasis:The obvious curative rate in the experimental group was65.79%; the total effective rate was97.3%. The obvious curative rate in the Treatment group was5.56% and the total effective rate was 33.34%. Between the two groups of the experimental group was statistically significant, the treatment group effect on the liver blood stasis syndrome than the control group.4. Therapeutic effect on various tcm symptoms:Studies show that the Treatment group can relieve the symptoms of dysmenorrhea, by the Menstrual flow,the Menstrual color,the Menstrual quality,Xiong Xie menstrual pain,premenstrual breast swelling,chest tightnessuncomfortable,good sigh and other symptoms effective than the control group, treatment group than the control group showed a better therapeutic effect between the two groups was statistically significant (P <0.05).5. 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.ConclusionShujingfangtong Capsule treatment of primary dysmenorrhea pain (syndrome of stagnation of liver qi and blood stasis) can pain (syndrome of stagnation of liver qi and blood stasis) can relieve the symptoms of dysmenorrhea, by the Menstrual flow, the Menstrual color,the Menstrual quality,Xiong Xie menstrual pain,premenstrual breast swelling,chest tightnessuncomfortable,good sigh and other symptoms. Sparse by anti-capsule on liver blood stasis due to the pain of primary dysmenorrhea effect is significant, but also has better security. |