Objective: Through randomized double-blind controlled trial of Shugan granule in the treatment of PMDD after severe premenstrual syndrome(Gan Yuxing)the efficacy and improvement of symptoms, and the results of statistical analysis,provide the basis for its clinical application.Method: According to the basic principles of clinical epidemiology randomized,double-blind and controlled, through the questionnaire survey method during 2013-2015, at the Shanxi University of Traditional Chinese medicine female students and Affiliated Hospital of Shanxi University of Traditional Chinese medicine medical personnel, screened with severe premenstrual syndrome(PMDD) in 90 cases of liver qi stagnation syndrome diagnostic criteria and diagnostic criteria for patients as the research object, randomly divided into the treatment group of Pizhenqing granule,respectively with fluoxetine and placebo groups, each group had 30 cases, requiring continuous medication for 3 menstrual cycles(10 days before the next menstruation began to use 10 days), through the "serious daily record(DRSP)" and "Ganqi depression symptoms the severity evaluation form" to observe three groups of patients before and after treatment of symptoms, syndrome score, and statistical analysis. Study on Shugan granule in the treatment of severe premenstrual syndrome(liver type) clinical efficacy and improvement of symptoms.Results:1 Of Pizhenqing granule therapeutic effect in the treatment of PMDD disease:Shugan particles on the treatment of PMDD diseases in the total efficiency was90%, control group total effective rate was 86.67%, the total effective rate was 30%in the placebo group. The statistical analysis of Pizhenqing granule group and placebo group, fluoxetine group and placebo group compared the effect of P is less than 0.05, there were significant differences, that of Pizhenqing granule and fluoxetine are effective in treatment of PMDD; Shugan granules group and fluoxetine group compared with total curative effect of P is more than 0.05, there was no significant difference between the two effects.2 PMDD Shugan granule in the treatment of liver qi stagnation syndrome effect:Shugan granule group PMDD liver qi stagnation syndrome total effective rate was 93.33%, Fu Xiting control group total effective rate was 83.33%, total effective20% of the placebo group, the statistical analysis of Pizhenqing granule group and placebo group, Fu Xiting group and the placebo group the total effect compared to P< 0.05, there were significant differences, that of Pizhenqing granule and Fu Xiting the effective of PMDD liver qi stagnation syndrome of traditional Chinese medicine therapy; Shugan granule group and Fu Xiting group compared the effect of P is more than 0.05, there was no significant difference between the two effects.3 Main curative effect index:3.1 PMDD disease symptoms: statistical analysis of three groups of patients before and after treatment of disease symptoms: the symptom scores before and after the Shugan granule group(P < 0.01), the symptom scores before and after treatment with fluoxetine group(P < 0.01), integral comparison before and after placebo treatment of symptoms(P > 0.01). Show of Pizhenqing granule and fluoxetine can both improve PMDD symptoms, disease symptom score had no significant difference before and after treatment with placebo. Shugan granule group and fluoxetine group compared to the control group: the difference between the two diseases symptom score P < 0.05, that of Pizhenqing granule to improve the symptoms of PMDD is better than that of fluoxetine.3.2 PMDD of liver qi stagnation syndrome symptoms: statistical analysis of three groups of patients before and after treatment of TCM syndrome integral:comparison of symptom scores before and after the Shugan granule group(P < 0.01),symptom scores before and after treatment with fluoxetine group(P < 0.01),symptom scores before and after placebo treatment of symptoms(P > 0.01). Show of Pizhenqing granule and fluoxetine can improve PMDD liver qi stagnation syndrome symptoms, syndrome symptoms had no significant difference before and after placebo treatment. Shugan granule group and fluoxetine group compared to the control group: TCM syndrome integral comparison between two P < 0.05, that of Pizhenqing granule in improving the disease than the TCM symptoms effect of fluoxetine.4 Safety comparison: three groups of patients before and after treatment, liver and kidney function tests and ECG were not significantly changed. Show that the toxic side effects of Shugan granule, can be safely used in this experiment;fluoxetine in 30 patients after 3 menstrual cycles were found in liver and kidney toxicity.Conclusion: Shugan granule can effectively treat liver qi stagnation type PMDD can significantly alleviate the symptoms, and being safe and reliable, no obvious adverse reactions, it is worthy of clinical application. |