Cai's gynecology cyclical therapy with stasis-clearing and meridian-warming method for primary dysmenorrhea: a randomized controlled trial.

Background: First-line treatment with non-steroidal anti-inflammatory drugs like ibuprofen for primary dysmenorrhea is effective for short-term pain relief but is often associated with a high recurrence of pain upon discontinuation. Traditional Chinese Medicine (TCM) offers a holistic approach aimed at regulating the body's fundamental balance, yet high-quality evidence from randomized controlled trials (RCTs) comparing comprehensive TCM protocols to standard care is needed. Objective: To evaluate the clinical efficacy of an integrated TCM protocol-Cai's Gynecology Cyclical Therapy combined with the Stasis-Clearing and Meridian-Warming Method-for primary dysmenorrhea, and to compare its with ibuprofen. Methods: In this RCT, 80 patients with primary dysmenorrhea of the Qi stagnation and blood stasis type were recruited at Shanghai East Hospital from February to July 2025. Participants were randomly assigned to either the TCM group (n=40) or the ibuprofen group (n=40). The TCM group received herbal treatment tailored to the menstrual cycle: Chaihushugan San combined with Siwu Decoction during the post- and inter-menstrual phases for root-cause regulation, and the Stasis-Clearing and Meridian-Warming Formula during the pre-menstrual and menstrual phases for symptom relief. The ibuprofen group received oral ibuprofen sustained-release capsules (300 mg twice daily for 2 days during menstruation, total daily dose 600 mg). The treatment spanned three menstrual cycles. Primary outcomes included TCM syndrome scores, visual analog scale (VAS) scores for pain, and recurrence rates during follow-up. Results: The total effective rate was 97.5% in both groups after three cycles. Both groups showed significant reductions in TCM syndrome and VAS scores (P<0.01). However, the TCM group showed progressive improvement from cycle 1 to cycle 3 (P<0.01), while the ibuprofen group did not (P = 0.844 for syndrome scores; P = 0.795 for VAS). While ibuprofen provided superior pain relief after the first cycle (P<0.01), the two groups were comparable by cycle 3 (P = 0.083 for syndrome scores; P = 0.059 for VAS). Crucially, the recurrence rate in the TCM group (12.8%) was significantly lower than that in the ibuprofen group (89.7%). Conclusion: While ibuprofen offers faster short-term relief, the integrated Cai's Gynecology Cyclical Therapy achieves comparable efficacy after three cycles and is significantly more effective at preventing recurrence. Clinical trial registration: https://itmctr.ccebtcm.org.cn/mgt/project/view/7448163107044166727, identifier ITMCTR2025000425.