| Ovarian failure is a group of diseases with diverse clinical manifestations,complex etiology,and progressive development(including the "three stages" of occult,biochemical,and clinical abnormalities).The concept has evolved over time.In 2008,the concept of“primary ovarian insufficiency" was proposed.In 2016,it was changed to " premature ovarian insufficiency,POI^and the diagnostic threshold of FSH(40 U/L)was reduced to 25 U/L.It is intended to find women suffered from ovarian insufficiency as early as possible,to achieve the goal of early diagnosis and early treatment.Before this time,premature ovarian failure has been a widely used terminology.POI is one of endocrine diseases that are difficult to cure with complex etiology in clinical gynecology.It seriously injures women's physical and mental health and family life quality.Estrogen and progesterone are often used as replacement therapy in modern medicine,but long-term use of that has obvious side effects.However,although there is literature on the treatment of POI with Chinese medicine,most of the studies are carried with small sample and the quality of the random method is poor.Currently there is a lack of comprehensive systematic and rigorous analysis on the clinical evidence of traditional Chinese medicine.Therefore,it is necessary to carry out more prudently study and synthesize the efficacy and safety of Chinese medicine in treatment of premature ovarian failure,in order to provide an efficacy and safety basis for Chinese medicine treatment of premature ovarian failure.ObjectiveTo analyze the efficacy of traditional Chinese medicine in treatment of premature ovarian failure by using meta?analysis,to summarize the outcomes and advantages of Chinese medicine in the treatment of premature ovarian failure and to provide a high?level evidence-based medical evidence for traditional 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 search of the Chinese Academic Literature Database(CNKI),Wanfang Data,VIP Journal Database,PubMed,and The Cochrane Library database was conducted to search for randomized controlled trials(RCT)of drugs for treatment of premature ovarian failure.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 independently collated and extracted the data.In case of disagreement,a third party was requested to help resolve the matter.According to the established inclusion and exclusion criteria,eligible documents were selected.The quality of this study was evaluated according to the risk assessment tool of bias produced by the Cochrane Collaboration.Review Manager 5.3 software was used for data processing of this article.ResultA total of 20 RCT articles were included,A total of 1432 patients with premature ovarian failure were included,including 712 in the experimental group and 720 in the control group.Analysis of the clinical efficacy of 18 RTC literature revealed that the studies were heterogeneous(x 2=41.16,P<0.05,12=59%).The literature of 18 RTC studies was divided into two subgroups(Z1,Z2)by using a random effects model and there is no heterogeneity within the two subgroups.The results suggested that the clinical comprehensive treatment of premature ovarian failure treated with traditional Chinese medicine was significantly better than that of the control group.The difference was statistically significant[Treatment group:504/603,Control group:413/601,OR=2.53,95%Cl(1.55,4.12),P<0.0001].The Meta-analysis funnel diagram shows incomplete symmetry,which means there may be certain publication biases and errors.The analysis of E2 levels reported in 20 RTC articles revealed that the studies were heterogeneous(X 2=525.60,P<0.05,12=96%),with random effects models being used.They were divided into 10 subgroups.There were no heterogeneities in the subgroups Z1,Z3,Z4,Z5,and Z6.Subgroups Z2,Z7,and Z8 were studied independently.The results indicated that Chinese medicine was superior to that of the control group in reducing the E2 level of patients with premature ovarian failure.The difference was statistically significant[OR=5.42,95%Cl(0.86,9.98),P<0.0001].The Meta-analysis funnel diagram shows incomplete symmetry,which means that there may be certain publication biases and errors.The analysis of 20 reported FSH levels in the RTC literature revealed that the studies were heterogeneous(X 2=441.75,P<O.05,12=96%),with random effects models being used.They were divided into 6 subgroups.There were no heterogeneities in the subgroups Z1,Z3,Z4,and Z5.Subgroup Z2 was an independent study.The results suggested that medication of the control group was superior to traditional Chinese medicine in reducing FSH levels 'in patients with premature ovarian failure.The difference was statistically significant[OR=-6.61,95%Cl(-9.84,-3.73),P<0.0001],The Meta-analysis funnel diagram shows incomplete syumetry,which means there may be certain publication biases and errors.Analysis of the 19 LTC reported in the LH level suggested that there was heterogeneity between studies(X 2=217.41,P<0.05,12=92%),by using a random effects model.They were divided into 5 subgroups.There was no heterogeneity in the subgroups Z1,Z2,Z3,and Z4.The Z5 subgroup was an independent study.The results indicated that the medication of the control group was superior to traditional Chinese medicine in reducing the LH level of patients with premature ovarian failure.The difference was statistically significant[OR=-2.72,95%Cl(-4.31,-1.13),P<0.0001].The Meta-analysis funnel diagram shows incomplete symmetry,which means that there may be certain publication biases and errors.ConclusionThe results of this study suggest that the comprehensive curative effect of traditional Chinese medicine in treatment of premature ovarian failure is significantly better than that of the control group and the effect of elevating E2 as well as decreasing FSH and LH in the experimental group is significantly better than that of the control group.However,the high-performing and persuasive meta-analysis conclusions are determined by whether or not there are high-quality RCT studies.The literature analyzed in this study is a randomized controlled clinical trial with low quality of clinical trial methods,which would have a great effect on the demonstration strength.Therefore,it requires proper caution using this conclusion. |
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