EFFICACY AND SAFETY OF POLYHERBAL FORMULATIONS IN THE MANAGEMENT OF PRIMARY DYSMENORRHEA: A SYSTEMATIC REVIEW

Background: Primary dysmenorrhea is a common gynecological condition characterized by painful menstrual cramps in the absence of identifiable pelvic pathology. Although non-steroidal anti-inflammatory drugs (NSAIDs) and oral contraceptives are widely used, treatment failure and adverse effects have increased interest in herbal alternatives. Objective: To systematically evaluate the efficacy and safety of standardized botanical extracts and polyherbal formulations in the management of primary dysmenorrhea. Methods: A systematic review was conducted according to PRISMA 2020 guidelines. Electronic databases including PubMed/MEDLINE, Scopus, Web of Science, and CENTRAL were searched for randomized controlled trials (RCTs) published up to April 2026. Studies involving women with primary dysmenorrhea treated with herbal or polyherbal interventions were included. Methodological quality was assessed using the Cochrane RoB 2 tool. Due to clinical and methodological heterogeneity, a narrative synthesis was performed. Results: Sixteen RCTs involving 1,641 participants met the inclusion criteria. Frequently investigated interventions included Zingiber officinale (ginger), Cinnamomum zeylanicum (cinnamon), Foeniculum vulgare (fennel), and various polyherbal formulations. Most studies reported significant reductions in menstrual pain compared with placebo, while several demonstrated efficacy comparable to NSAIDs. Adverse events were infrequent, mild, and predominantly gastrointestinal in nature. Conclusion: Standardized botanical extracts and polyherbal formulations may provide effective and well-tolerated alternatives for the management of primary dysmenorrhea. However, further large-scale, prospectively registered RCTs using standardized formulations are required to confirm these findings and support clinical recommendations.