| ObjectiveThe objective of this systematic review is to evaluate the literature quality of Chinese medicine for uterine leiomyoma by evidence-based medical analysis,with the aid of META analysis and data mining technology based frequency analysis,and to find out the existing problems of clinical research literature on the treatments of uterine fibroids in scientific research design,research implementation process,efficacy evaluation and safety issue,in order to further improve the research level of evidence-based analysis,the literature quality and provide recommendations for future clinical use.Research Methodology1.Data source and inclusion criteriaWe analysed clinical research literature on traditional Chinese medicine for treating uterine fibroids published in medical journals.Inclusion criteria:(1)The experiment uses a randomized controlled design,such as using a coin toss or computer-generated random number,or the experiment refers to the words "randomized grouping";(2)the efficacy outcomes included total effective rate,size measurement of the uterus and uterine fibroid volume,changes in sex hormones,etc.as indicative measurements,with unified standard of curative efficacy;(3)experimental selection of patients with uterine fibroids;(4)research interventions:Chinese medicine preparations(single drug,Chinese patent medicine,Chinese medicine decoction,etc.)compared with western medicine group,other Chinese medicine or Chinese patent medicine,placebo or blank group,and the comparison of traditional Chinese medicine with specific treatment and its treatment alone,the administration route is not limited.2.Search strategiesThrough searching database including Wanfang database,China Academic Journal from China National Knowledge Infrastructure(CNKI),China Biomedical Journal Literature Database(CBM),Chinese Science and Technology Periodical Database(VIP),and MEDLINE,EMBASE and other foreign language databases,according to the inclusion criteria.The search period is set between 2004-2018.To identify studies involving relevant participants,we performed searches using the following keywords:"fibromyoma uteri","uterine leiomyoma","uterus myoma".To identify studies involving intervention,we performed searches using the following keywords:"Chinese medicine","Traditional Chinese medicine","Chinese patent medicine","medical complementary".To identify studies involving research design,we performed searches using the following keywords:"randomize","placebo","blank","control".3.Evaluation of methodologyFollowing the principles of the Design,Measurement and Evaluation in Clinical Research(DME)method,a standardized "Systematic Evaluation Form for Clinical Research of Treatment of Uterine Fibroids with Traditional Chinese Medicine" was developed.Two evaluators cross check the effectiveness of the quality evaluation of all research experiments.If there is disagreement between the two parties and no judgement is made,further study is needed or a third-party assessment is introduced.The methodological quality assessment included in the study uses the Jadad rating scale to score randomization generation,randomization concealment,blinding,withdrawal for the literature.The score for each part is 0-2 points according to the standard,and the total score is 0-7 points.1-3 points are considered low quality studies and 4-7 points are considered high quality studies.At the same time,a descriptive analysis of the literature's general situation,randomization methods,use of blinding method,allocation concealment,inter-group balance,adverse reactions,loss of follow-up,statistical methods,and conclusion derivation were made.4.Statistical analysisThis study used Microsoft Office Excel to create a database,input and manage related data.Meta Analysis was performed using the Review Manager 5.3 provided by the Cochrane platform to assist in the analysis and calculation process for system evaluation.If the analytical indicator was a dichotomous variable,the relative risk(RR)was used as the combined statistic;if it was necessary to analyze the numerical variables,the mean difference(MD)was used as the combined statistic.A heterogeneity test was performed on each experimental result,and if there was heterogeneity,it was expressed using a random effects model.Otherwise,it was expressed using a fixed effects model.ResultsBy searching through various databases,the original 856 articles were initially obtained,212 duplicate articles were removed,leaving 644 articles.After reading the topics and abstracts,21 articles involving other diseases were removed,leaving 623 articles.After reading the full text,according to the inclusion and exclusion criteria,126 articles were finally included,all were Chinese literatures.In recent years,the literature on the treatment of uterine fibroids with Chinese medicine has shown an increasing trend,and 56 articles(44.4%)were published between 2016 and 2018 out of 126 articles.There are 2 fund support(1.6%)and no multi-center researcher.38 articles(30.2%)of the literature used the "random number table method" and did not make a detailed description;84 articles(66.7%)referred to the words "randomized" and did not describe the method in detail.Only one article(0.8%)used the double-blind method.The 118 articles(93.7%)in this study had good balance between groups.A total of 37(29.4%)reported the number and symptoms of each group of adverse reactions and performed statistical tests.Only 3 articles(2.4%)mentioned loss of follow-up.35 articles(27.8%)provided the actual statistics and range of P values;90 articles(71.4%)only gave range of P values.40 articles were selected for meta-analysis.The results show that although there were many literatures on traditional Chinese medicine treatment of uterine fibroids in recent years,the quality of the literature was generally fair due to poor skill on research methods and reporting.Meta analysis showed that Xuefuzhuyu Decoction was superior to mifepristone in overall effectiveness and lowering blood hormone level.Guizhi Fuling Capsule combined with mifepristone was superior to mifepristone alone in overall effectiveness,reducing fibroid volume and lowering blood hormone levels.There was no significant difference in the incidence of adverse reactions between the two groups.Gongliuqing Capsule combined with mifepristone in the treatment of uterine fibroids was superior to mifepristone alone in overall effectiveness,reducing fibroid volume and lowering blood estrogen and progesterone levels.In existence of the adverse reaction,Gongliuqing capsule combined with mifepristone was lower than mifepristone alone.Lengjiaxiaozheng Decoction was superior to Guizhi Fuling Capsule in overall effectiveness and reducing fibroid volume.This study also analyzed the rule of Chinese medicine for the treatment of uterine fibroids.Through the analysis of drug types,four properties,five tastes and class of meridians,the clinical drug tendency of treating uterine fibroids was obtained.The drug types were mainly activating blood circulation type,supplementing deficiency type and heat-clearing type;and the drug tastes were mainly bitter,spicy and sweet.Cold-cooling drugs was used more often than neutral drugs and warming drugs;and the class of meridians involved were mainly liver,heart and spleen.Commonly used traditional Chinese medicines included Tao Ren,Chi Shao,Fu Ling,San Leng,Dang Gui,E zhu,Gui zhi,Chai Hu,Mu Dan Pi and Mu Li.Conclusion1.Traditional Chinese medicine or the combination of traditional Chinese medicine and western medicine in the treatment of uterine fibroids was superior to western medicine in overall effectiveness,reducing fibroids volume and lowering the blood hormones level,and had less adverse effects.2.The drug types of treating uterine fibroids were mainly activating blood circulation type,supplementing deficiency type and heat-clearing type;and the drug tastes were mainly bitter,spicy and sweet.Cold-cooling drugs was used more often than neutral drugs and warming drugs;and the class of meridians involved were mainly liver,heart and spleen.3.The literature quality of Chinese medicine in treating uterine fibroids was generally not high.The quality of scientific research methods should be improved in future researches related to the treatment of uterine fibroids with traditional Chinese medicine.Due to low methodological quality of the literature included in this study,it failed to provide strong evidence for clinical applications.This systematic review has not yet established a definitive conclusion on the effectiveness and safety of Chinese medicine in treating this disease.Future researchers should pursue higher quality research to improve the clinical therapeutic effect of traditional Chinese medicine and promote the development of TCM in the current medical field. |
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