The Clinical Study Of Effect Of The Capsule Of Yang Yin Shu Gan On The Primary Ovarian Insufficiency With Kidney Deficiency And Liver Stagnancy

ObjectiveIn this study, we carry a prospective, randomized, controlled clinical trial to evaluate and compare the efficacy and safety on primary ovarian insufficiency. And provide evidence for clinical treatment.MethodsIn this randomized, double-blind trial, we screened 63 patients with POI from October 2013 to January 2015 in Guangdong honpital of TCM. The pathogenesis is Kidney deficiency and liver Stagnancy. All the eligible subjects were recruited and randomly assigned to receive either TCM therapy (Yangyin Shugan Capsule group) or Placebo therapy (Placebo therapy). All the patients are treated for 12 weeks and followed up for 4 weeks. The Clinical symptom scores, Sex hormone levels (FSH、LH、E2)、 AMH、INHB、Endometrial thickness and ovarian blood were used to evaluate the treatment effect. And the safety parameters were heart rate, blood pressure, blood routine, urin-routine, liver function test (ALT), renal function test(BUN, Cr), and EKG.The time points of the research were baseline,12th week and 16th week (time point of follow-up). At each time point, The Clinical symptom scale were completed. Before and after the treatment, the sex hormones and safety parameters were measured. At the same time, adverse events and adverse effect were observed and recorded. The data were analyzed by SPSS 17.0. Result1. Efficacy of the treatment period(1) TCM Syndrome Scale score① Within group:Yangyin Shugan Capsule can effective mitigate the patients’menstrual situation, irritability, dry lips and throat, headache, dizziness, dry eyes, chest tightness, backache, and there was significant difference between before and after treatment (P<0.05). theplacebo group can itigate the patients’irritability and hot flush (P<0.05).② between groups:Yangyin Shugan Capsule can effective mitigate the patients’menstrual situation and all the symptoms with Kidney deficiency and liver Stagnancycompare to the placebo group (P<0.05).(2) The basis of FSH, LH, E2 level① Within group:Yangyin Shugan group can reduce the FSH level and upgrade the E2 level;While the placebo-group has no effect, the difference was significant (P<0.05).② between groups:Yangyin Shugan group can reduce the FSH and LH levels, compare to the placebo group, the difference was significant (P<0.05).(3) the AMH, INHB level① Within group:Each groupscan not change the AMH and INHB level, there was no statistically significant difference between each group (P>0.05).② between groups:Both groupscan not change the AMH and INHB level, there was no statistically significant difference between the two groups (P>0.05).(4) AFC and PSV, RI① Within group:Yangyin Shugan group can upgrade the AFC, While the placebo-group has no effect, the difference was significant (P<0.05).② between groups:Yangyin Shugan group can change the number of ovarian PSV level, compare to the placebo group, the difference was significant (P<0.05).1. Efficacy of the follow-up period(1) TCM Syndrome Scale score① Within group:Yangyin Shugan Capsule can continue decrease the patients’menstrual situation, and totalsymptom score, the difference was significant (P<0.05). Theplacebo group can itigate most of the patients’ symptoms (P<0.05).② between groups:Yangyin Shugan Capsule can effective stimulate the patients’symptoms, compare to the placebo group (P<0.05).(2) The basis of FSH, LH, E2 level① Within group:Each groups can not change the FSH, LH, E2 level, there was no statistically significant difference between each group (P>0.05).② between groups:Both groups can not change the FSH, LH, E2 level, there was no statistically significant difference between the two groups (P>0.05).(3) AFC and PSV, RI① Within group:Each groups can not change the AFC and PSV, RI situation, there was no statistically significant difference between each group (P>0.05).② between groups:Both groups can not change the AFC, PSV, RI, there was no statistically significant difference between the two groups (P>0.05).3. Security AnalysisBefore and after treatment, bothgroups showed no obvious abnormalities and no adverse reactions, suggesting Yangyin Shugan capsules are safe. Conclusion1. Yangyin Shugan capsules can effectively promote the clinical symptoms and menstrual symptoms of Kidney deficiency and liver Stagnancy.2. Yangyin Shugan capsule can effectively regulate basic FSH, E2 levels in patients, but its continuing effect worthy of further discussion.3.Yangyin Shugan Capsule has no effect in changing serum AMH and INHB levels, may be due to the shorter treatment period, need further study.4. Yangyin Shugan capsule can effectively improve the ovarian blood flow condition of the patient, theclinical effect was significant.5. The Yangyin Shugan capsule is an effective and relatively safe drug and more Stable strategy for the POI with Kidney deficiency and liver Stagnancy.6. Yangyin Shugan capsule can improve the POI patient’s menstrual disorders situation, ovarian function and kidney liver depression symptoms, should be widely applied.