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Background: Primary dysmenorrhea (PD), the most common gynecological diseases, seriously affects women's life and work; however, without more effective treatment. Chinese herbal medicine (CHM) has been widely used for relieving dysmenorrheic pain in patients with PD. To assess the effectiveness and safety of CHM in patients with PD, a systematic review and meta-analysis of current published evidence regarding CHM as treatment for PD would be conducted in this study.

Methods: Literatures related to CHM for PD from the establishment of the database to June 2019 will be retrieved from the following databases: MEDLINE, EMBACE, Wed of Science and Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, Chinese National Knowledge Infrastructure, and Wanfang Database. There are no language restrictions for retrieving literature. Eligible randomized clinical trials (RCTs) evaluating the effectiveness and safety of CHM in PD patients will be put in the study including outcomes of pain intensity, clinical effectiveness rate, quality of life, and adverse events. By scanning the titles, abstracts and full texts, 2 reviewers will independently select studies, extract data, and assess the quality of study. Meta-analysis of RCTs will be conducted using Review Manager 5.1 software. The results will be presented as risk ratio for dichotomous data, and standardized or weighted mean difference for continuous data.

Result: This study will provide high-quality available evidence for the treatment of PD with CHM based on pain, clinical efficacy, quality of life, and adverse events.

Conclusion: The systematic review willto evaluate the efficacy of CHM in treating PD and provide evidence for clinicians.

PROSPERO registration number: CRD42019121185.

Copyright (C) 2019 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.