Efficacy and safety of external therapy of TCM for primary dysmenorrhea A protocol for systematic review and meta-analysis

Background: Primary dysmenorrhea (PD) is a painful disease that severely affects the daily lives of young women. External therapy using traditional Chinese medicine (TCM) is widely used in the clinical treatment of this disease and has achieved a good effect. There are many kinds of TCM external therapies, but the effectiveness, safety, and advantages of various methods have not been confirmed by high-quality meta-analyses. The purpose of this study was to evaluate the efficacy and safety of representative TCM external therapies in patients with PD. Methods: Published randomized controlled trials that assessed the efficacy of these interventions in patients with PD were included. We searched the following electronic databases: PubMed, Cochrane Library, Embase, Web of Science, China Science and Technology Journal, China National Knowledge Infrastructure, Wanfang, and Chinese Biomedical Literature Database and other sources. The main outcomes included menstrual pain intensity and the clinical effectiveness rate. The secondary outcomes were the quality of life and safety. The meta-analysis will be performed using the Review Manager version 5.3 software. Results: We will provide more practical results investigating the efficacy of external TCM therapy with high clinical frequency for PD patients in several respects, including the improvement of menstrual pain intensity, quality of life, and safety. Conclusion: This review systematically reviews the effectiveness and safety of common TCM external therapies for PD and provides clinicians with the best treatment options. Ethics and dissemination: This systematic review aimed to evaluate the efficacy and safety of external TCM therapy for PD. Since all data included were published, the systematic review did not require ethical approval. Registration number: CRD42021297078.