LAUSR

Abstract Background: Premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) are common disorders that manifest themselves in the late luteal phase, and significantly interfere with an individual's daily activities. Clinical evidence suggests that traditional Chinese medicine (TCM) may ease PMS/PMDD symptoms. Here, we review a protocol for exploring the effectiveness and safety of TCM in PMS/PMDD management. Methods: We will conduct a literature search for randomized controlled trials (RCT) for TCM use in PMS/PMDD on PubMed, web of science, EMBASE, the Cochrane central register of controlled trials (Cochrane Library), Chinese national knowledge infrastructure, Chinese VIP Information, Wanfang, as well as Chinese biomedical literature database. The search included all relevant reports for up to June 1, 2020. The search results were independently analyzed by 2 reviewers who extracted the data. RCT quality will be assessed using the risk-of-bias tool. The evidence will be inspected using the grading of recommendations assessment development and evaluation (GRADE). We will utilize Stata and Revman for systematic review and meta-analysis and analysis of direct and indirect evidence. Results: Based on current evidence, this study will elucidate the rationale for the utilization of TCM in PMS/PMDD treatment. Conclusion: Conclusions from this study will inform about the effectiveness and safety of TCM in PMS/PMDD management. Trial registration number: CRD42020192822. Ethics and dissemination: Since all data utilized in this systematic review and meta-analysis are published, ethical approval is not needed. Additionally, in the trial of the review process, all data will be evaluated anonymously.