A Systematic Evaluation Of The Clinical Efficacy Of Chinese Patent Medicines In The Treatment Of Primary Dysmenorrhea

Objective:Summarize and analyze the clinical efficacy of using Chinese patent medicine in the treatment of primary dysmenorrhea through systematic evaluation and Meta-analysis,therefore to provide evidence-based evidence to clinicians in using Chinese patent medicine rationally.Methods:1.Determine clinical issues:Investigate the most pressing clinical issues in the treatment of primary dysmenorrhea by surveying experts;design a searching plan around the clinical problems.2.Determine the commonly used Chinese patent medicine:Specify listed Chinese patent drugs that are used for the treatment of dysmenorrhea,abdominal pain and menstrual pain,by querying their instructions and China Food and Drug Administration(CFDA).Sift out most commonly used and recommended Chinese patent medicines that are designated for the treatment of primary dysmenorrhea,by means of surveying gynecologists.3.Medical literature retrieval along with Meta-analysis:Examine both Chinese and English databases once the researching strategy was determined;strictly screen literature according to inclusion criteria.Conduct methodological quality evaluation to the referenced studies.Apply Meta-analysis to randomized controlled trials(RCTs)that are with the same type of study,outcome indicators and data types by using Review Managers.3.5.Results:Experts regard the following as the most pressing clinical issues:1.Whether Chinese patent medicines can alleviate the pain caused by primary dysmenorrhea;2.Whether Chinese patent medicines can shorten the duration of pain in patients with primary dysmenorrhea;3.Whether Chinese patent medicines can improve accompanying symptoms of primary dysmenorrhea such as nausea and vomiting;4.Whether Chinese patent medicines can reduce the recurrence rate of primary dysmenorrhea;5.Safety concerns of Chinese patent medicines in the treatment of primary dysmenorrhea.The following 25 Chinese patent medicines are selected by experts through investigation:Shaofu Zhuyu Capsule(Pill),Aifu Nuangong Pill,Tianqi Tongjing Capsule(Powder),Funv tongjing Pill(granule),Dan'e Fukang Decoction,Tongjingbao Granules,Tongj ingling Granules,Yuanhu Zhitong Tablets(Dropping pills,dispersible tablets,capsules,granules,oral liquid,soft capsules),Shixiao Powder,Sanjie Zhentong Capsule,Dysmenorrhea Oral Liquid,Tongjingning Granules(syrup),Guizhi Fuling Capsule,Yuetai Tieqi Stick,Shure Jing Granules(capsule),Bawei Tongjing tablets,Qizhi Xiangfu pills,Cuzhi Xiangfu pills,Dysmenorrhea Cream,Dingkundan,Fuke Tiaojing capsules(tablets,pills,granules),Tiaojing Huoxue capsules(tablets),Zhitong Huazheng capsule,Wenjing pill,Danggui Shaoyao granules.Dan'e Fukang Decoction,Guizhi Fuling Fapsule,Sanjie Zhentong Capsule,Zhitong Huazheng Capsule and Tongjingbao Granules all have multicentral clinical trials.Comparing to the control group-western medicine or placebo,these Chinese patent medicines basically implied better therapeutic effect.In addition,there was sufficient research literature on Guizhi Fuling Capsule,and Guizhi Fuling Capsule indicated better performance on the level and duration of pain.There was enough sample size,correct random method,sufficient allocation and hiding,reasonable double-blind,and credible evaluation on the efficacy.Thus,these medicines can be further promoted in clinical application.Dingkundan,Funv tongjing Pill,Tianqi Tongjing Capsule,Tiaojing Huoxue Capsule and Tongjingning granule all had only one RCT report respectively,and the sample size was small.The RCT method was not ideal.Although they had better clinical effects compared with western medicine or placebo,the reliability and evidence-based evidence were insufficient.There were no referenced RCT reports on Shaofu Zhuyu Capsule(pill),Aifu Nuangong Pill,Tongjingling Granules,Yuanhu Zhitong Tablets(dropping pill,dispersible tablets,capsules,granules,oral liquid,soft capsule),Shixiao Powder,Dysmenorrhea Oral Liquid,Yuetai Tieqi Stick,ShuErJing Granules(capsule),Bawei Tongjing tablets,Qizhi Xiangfu pills,Cuzhi Xiangfu pills,Dysmenorrhea Cream,Fuke Tiaojing capsules(tablets,pills,granules),Wenjing pill,Danggui Shaoyao granules's treatment of primary dysmenorrhea.Though they are reputable and are widely used in clinic,there aren't sufficient evidence-based evidence.Conclusion1.Reduces pain symptoms and duration:Guizhi Fuling Capsule has corresponding outcome indicators of the level and the duration of pain and can effectively a lleviate and shorten the duration of pain.Danshen Fu Kang cream,Sanjie Zhentong capsules,Zhitong Huazheng capsules,Tongjingbao granules outcome indicators showed that the symptoms of dysmenorrhea disappeared completely after the treatment,hence,this can also be considered as an improvement in the level and duration of pain in the patients.Dingkundan,Funv tongjing pills,Tiaojing Huoxue Capsules and Tongjingning granules's sample size were small,the reliability and evidence-based evidence were insufficient.2.Reduce recurrence rate:Tianqi Tongjing capsule was significantly lower than Ibuprofen Sustained Release Capsules groups,and the sample size was small,the reliability and evidence-based evidence were insufficient.3.There is a lack of relevant evidence-based evidence for improving the accompanying symptoms and safety of patients with primary dysmenorrhea.