[Patent Traditional Chinese Medicine for idiopathic male infertility: A bibliometrical study].

Objective: To survey the current status of clinical studies on patent Traditional Chinese Medicine (TCM) for idiopathic male infertility in China.

Methods: Using the keywords "oligospermia", "azoospermia", "asthenozoospermia", "infertility" and "sperm", we searched China National Knowledge Internet (CNKI), Wanfang Database and SinoMed for randomized clinical trials (RCT), cohort studies, case-control studies and case series studies focusing on the treatment of male idiopathic infertility using TCM from January 2001 to May 2017. Two individual reviewers screened the literature, extracted the information separately, recorded the titles, authors, related institutions and regions, journals and years of publication, medication studied, and outcomes. The collected data was analyzed using Microsoft Excel and SPSS.

Results: Totally, 307 publications were included in this study, including 243 RCTs (79%), 57 case series studies (19%) and 7 retrospective cohort studies (2%). Fifty one patent TCM and in 146 journals were involved. The number of publications gradully increased from 2001 to 2017. The authors were from 243 institutions in 29 provinces, independent municipalities or autonomous regions, mostly in Guangdong, Guangxi, Henan, Beijing and Jiangsu. Majority of the studies focused on the evaluation of the efficacy and safety of the drugs, among which the most studied medication Wuziyanzong Pills (114/307, 37.13%), Fufangxuanju Capsules, Shengjing Capsules, Huangjingzanyu Capsules, and Liuweidihuang Pills. Chinese Journal of Andrology had the highest number of publications.

Conclusions: A rapid progress has been achieved in China in the studies of patent TCM for the treatment of male infertility. However, limitatiors stiu exist, ragarding inbalance among regions, low sample sizes, low quality of studies, poor involvement of phamacisis.