Curcuminoid supplementation for vasomotor symptoms in postmenopausal women: a pilot, randomized, double-blind, placebo-controlled proof-of-concept trial

Abstract Background Vasomotor symptoms are common during menopause and can impair quality of life. Although hormone therapy is effective, concerns about risks and adverse effects contribute to limited utilization, highlighting the need for non-hormonal options. Curcuminoids have antioxidant and anti-inflammatory properties and may improve vasomotor symptoms. Methods This 12-week, randomized, double-blind, placebo-controlled pilot proof-of-concept trial evaluated the preliminary efficacy of curcuminoids (1000 mg/day) versus placebo in healthy postmenopausal women (41–65 years; n = 40). The prespecified primary endpoint was the between-group difference in change in weekly hot flash frequency from baseline to Week 12. Secondary outcomes included changes in Menopause Rating Scale II (MRS II) and Menopause-Specific Quality of Life (MENQOL) scores. Safety and tolerability were assessed throughout. Results All participants completed the intervention with high adherence and no serious adverse events. At Week 12 (primary endpoint), the between-group difference in change in weekly hot flash frequency from baseline was − 7.35 episodes/week (95% CI − 10.29 to − 4.41; p < 0.001), favoring curcuminoids; results were concordant using the Hodges–Lehmann estimate (− 6.00; 95% CI − 10.00 to − 4.00; p < 0.001). A significant between-group difference was also observed at Week 6. No statistically significant between-group differences were observed at Week 12 for total MENQOL or total MRS II, although the MENQOL vasomotor domain improved at Week 6 and showed supportive evidence in baseline-adjusted sensitivity analysis at Week 12. Conclusion In this pilot proof-of-concept randomized trial, curcuminoid supplementation significantly reduced weekly hot flash frequency compared with placebo and showed a preliminary signal toward improved vasomotor-related quality of life, particularly at Week 6, with good tolerability. These preliminary, hypothesis-generating findings require confirmation in larger, adequately powered randomized trials, ideally incorporating biomarker endpoints. Trial registration Thai Clinical Trials Registry (TCTR) TCTR20241210002 (retrospectively registered).