| Ovarian failure is a group of diseases with complex etiology,diverse clinical manifestations,and progressive development(including the"three stages"of occult,biochemical,and clinical abnormalities).The concept has changed over the years.In 2008,the concept of"primary ovarian insufficiency"was proposed by ASRM And to 2016,it was changed to"premature ovarian insufficiency,POI"and the diagnostic threshold of FSH(40 U/L)was reduced to 25 U/L by ESHRE.The purpose of this change is to achieve the goal of early diagnosis and treatment for those women who suffered from premature ovarian insufficiency.But previously,”Premature Ovarian Failure”was the terminology that has been more widely used.It is one of the gynecological diseases that lack of clearly curable treatment with complex etiology.Currently,the HRT treatment which use estrogen and progesterone as replacement therapy is the main treatment to treat POI in modern medicine,but there are both indications and contraindications.Traditional Chinese medicine has a clear clinical effect and has certain advantage in treating POI.Although there are quite many literatures about the treatment of POI with Chinese medicine,most of the studies are conducted with small sample and the quality of the random grouping method is poor.At present,there is a lack of comprehensive,systematic and rigorous analysis for the clinical evidence of Chinese medicine.Therefore,it is necessary to carry out more rigorous research and synthesize the efficacy and safety of using Chinese medicine to treat premature ovarian insufficiency.ObjectiveThe objective is to analyze the efficacy of Chinese medicine in treatment of premature ovarian failure by using Meta-analysis,and to summarize the outcomes and advantages of Chinese medicine in the treatment of premature ovarian failure.It also provides a high-level evidence-based medical evidence for Chinese medicine in treatment of premature ovarian failure as well as the scientific basis for the use of clinical medicine by summarizing the outcome indicators.MethodsA computer-based retrieval of the Chinese Academic LiteratureDatabase(CNKI),Wanfang Data,VIP Journal Database,Pub Med,and The Cochrane Library database was conducted to collect relative randomized controlled trials(RCT).The search terms were“Chinese medicine”,“Chinese and Western medicine”,“Chinese herbs”,“Ovarian dysfunction”,“Premature ovarian failure”,and“Random”keywords and their corresponding free words.The search period was from January 2015 to April 2018.Two people collated and extracted the data independently,and if there is a disagreement,asked a third party for assistance.According to the established criteria of inclusion and exclusion,qualified literatures were selected and quality of this study was evaluated according to the bias risk assessment tool produced by the Cochrane Collaboration.Review Manager 5.3 software was used for data processing of this article.ResultA total of 20 RCTs were included.A total of 1368 cases with POI were included,including 680 cases in the experimental group and 688 cases in the control group.The analysis of the overall clinical efficacy of 16 RCTs articles revealed that hat the heterogeneity between the studies is minor(I~2=32%).So the random effects model is adopted in this analysis,and the results suggested that the clinical overall effect of premature ovarian failure treated with Chinese medicine was more effective than the control group.The difference was statistically significant(OR=1.98,95%CI:1.32,2.97,P=0.001).Due to the analysis of FSH levels reported in 20 RCT articles revealed that the heterogeneity between the studies was quite major(I~2=95%),the random effects models were adopted in this analysis.They were divided into 4subgroups according to the received score from Jadad scale,and subgroup 1and Subgroup 3 had quite major heterogeneity.The results indicated that Chinese medicine was more effective to that of the control group in decrease the FSH level of in patients with premature ovarian failure.The difference was statistically significant(MD=-4.95,95%CI:-7.50,-2.40,P=0.0001)。Due to the analysis of reported E2 levels in the 19 RCTs literature revealed that the heterogeneity between the studies was quite major,the random effects models were adopted in this analysis.They were also divided into 4 subgroups according to the received score from Jadad scale,and subgroup 1 and Subgroup 3 had quite major heterogeneity too.The results suggested that Chinese medicine was more effective compare with medication of the control group in increase E2 levels of patients with premature ovarian failure.The difference was statistically significant(MD=5.15,95%CI:0.53,9.77,P=0.03).To the analysis of the reported in the LH levels in 17 RCTs,suggested that there was quite major heterogeneity between studies(I~2=91%)too.By using a random effects model,they were divided into 4 subgroups according to the received score from Jadad scale.Subgroup 1 and Subgroup 3 had quite major heterogeneity.The results indicated that Chinese medicine was more effective to the medication of the control group in reducing the LH level of patients with premature ovarian failure.The difference was statistically significant(MD=-2.88,95%CI:-4.53,-1.23:,P=0.0006.The outcome of four indicator Meta-analysis funnel plot shows incomplete symmetry,which means that there may be certain publication biases and errors.ConclusionThe results of this study suggest that the overall clinical effect of Chinese medicine in treatment of POI is more effective than that of the control group,and the effect of increasing E2 level and decreasing FSH and LH level in the Chinese medicine experimental group(experimental group)is better than that of the control group too.However,the high-performing and persuasive meta-analysis conclusions are depending on whether there are high-quality RCT studies.The literature analyzed in this study is a randomized controlled clinical trial with low methodological quality,which would have a strong effect on the demonstration strength.Therefore,it requires a proper caution to apply this conclusion. |
