This systematic review aims to systematically evaluate the efficacy and safety of Chinese patent medicines with resolving hard lump function for the treatment of cyclomastopathy. We searched CNKI, WanFang, SinoMed, PubMed, EMbase, and The Cochrane Library from the inception to January 3 2018, to collect the randomized controlled trials（RCTs）on Chinese patent medicines with resolving hard lump function in treating cyclomastopathy. Two reviewers independently screened literature, extracted data and assessed the methodological quality of included studies. Then, statistical analysis was performed by using Stata 12.0 and WinBUGS 1.4.3 software. A total of 52 RCTs involving 9 605 patients were finally included. The inventions included 11 commercial Chinese patent medicines with functions of resolving hard lump, such as Rupi Sanjie Capsules, Xiaoru Sanjie Capsules, Ruhe Sanjie Pills, and Hongjin Xiaojie Capsules. The result of direct Meta-analysis showed that: as compared with the simple western medicine group, the Chinese patent medicines such as Hongjin Xiaojie Capsules, Ruhe Sanjie Pills, Rupi Sanjie Capsules, Xiaoru Sanjie Capsules and Xiakucao Oral Liquid could significantly improve the clinical efficacy. In addition, the incidence of adverse reactions of Chinese patent medicines with resolving hard lump function was lower than that in Western medicine group in gastrointestinal reactions, menstrual disorders, leucorrhea abnormalities, liver dysfunction and estrogen-like effect. The network Meta-analysis showed that: Xiaoru Sanjie Capsules, Ruhe Sanjie Pills, Yanlu Rukang Capsules, Quyu Sanjie Capsules, and Hongjin Xiaojie Capsules were the top five in terms of treatment effect. Chinese patent medicines with resolving hard lump function had better clinical efficacy. Due to the low quality of included studies， more high quality RCTs are needed to verify the above conclusion.
Keywords: Chinese patent medicine; Ruanjian Sanjie; cyclomastopathy; network Meta-analysis.
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