Chinese herbal medicine for varicocele in subfertile men A protocol for systematic review and meta-analysis

BackgroundThe purpose of this protocol is to provide a updated systematic review and meta-analysis to prove the effectiveness and safety of Chinese herbal medicine in the treatment for the patients with varicocele. MethodThis protocol conforms to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) and the recommendations of the Cochrane Collaboration Handbook. We selected qualified studies published as of May 1, 2022, and systematically searched 6 English database (Embase, Pubmed, Scopus, Web of Science, Cochrane Central of Controlled Trials (CENTRAL), and Clinicaltrials.gov) and 5 Chinese database (China National Knowledge Infrastructure (CNKI), VIP Database for Chinese Technical Periodicals, Wanfandata, SinoMed, and Chinese Clinical Trial Registry). At the same time, relevant reviews and a list of references included in the study were retrieved, and Epistemonikos.org, ISI Web of Science and OpenGrey were manually searched to screen any other studies not included in the previous search. There will be no language restrictions. The inclusion criteria were clinical randomized controlled trial (RCT) involving the use of traditional Chinese medicine in the treatment of varicocele. The main results were fertility rate, adverse events, semen quality and scrotal pain score after 3 months, 6 months and 1 year follow-up. Bias analysis and evaluation will be performed based on risk of bias (ROB) assessment tool provided by the Cochrane Handbook. And use GRADEpro GDT to grade, evaluate and score the quality of the evidence. Heterogeneity will be judged by I2 value. At the same time, report bias assessment, subgroup analysis and sensitivity analysis were carried out. According to the Cochrane Manual of Systematic Evaluation of Interventions (Higgins 2011), if the data showed sufficiently high quality and some degree of similarity, we included the data for the meta-analysis. For dichotomy data, we selected an effect scale relative risk (RR) represented by a 95% confidence interval (CI). The continuous data is expressed as mean difference (MD) or standardized mean difference (SMD). ResultThis study will provide high-quality evidence for the efficacy and safety of Chinese herbal medicine in the treatment of varicocele in subfertile men. ConclusionThis study will provide an effective and safe choice for Chinese herbal medicine to improve the fertility of patients with varicocele. EthicsThe data of this study are based on published studies and do not require additional ethical approval. We will publish our findings through peer-reviewed journals. PROSPERO database registration number: CRD42022331218