Neurokinin pathway botanical antagonist for menopausal vasomotor symptoms: A randomized, double-blind, placebo-controlled study

Objective Vasomotor symptoms (VMS) are a prevalent and disruptive manifestation of menopause, and many women prefer nonhormonal, nonpharmacologic treatment options. This study evaluated the efficacy of a patented multi-ingredient botanical neurokinin inhibitor (BNI) on VMS and other patient-reported outcome measures. Study design A randomized, double-blind, placebo-controlled trial was performed in menopausal women with 5 or more moderate to severe hot flashes daily. Participants were enrolled from community medical practices in the United States and randomized to BNI or placebo for 12 weeks. BNI is a novel formulation of plant extracts that attenuates neurokinin receptor signaling in vivo. Main outcome measures Primary endpoints were changes in daily VMS frequency and score on the Hot Flash Related Daily Interference Scale (HFRDIS). Secondary endpoints included changes in Menopause-Specific Quality of Life (MENQOL) and Pittsburgh Sleep Quality Index (PSQI). Serum estrogen and liver function were assessed in a subgroup of patients. Results Of 74 randomized participants, 68 completed the trial (BNI, n = 32; placebo, n = 36). BNI supplementation reduced VMS frequency by 2.2 hot flashes per day more than placebo ( p = 0.003), corresponding to a 47.7% relative decrease. HFRDIS was improved in the BNI group ( p = 0.037), with significant reduction on all subscales. No significant differences were observed in global menopause symptoms (MENQOL) or sleep quality (PSQI). No changes in serum estradiol or liver function abnormalities were detected. BNI was well tolerated, with no difference in adverse events between groups. Conclusion A combination of botanically derived neurokinin inhibitors produces significant and sustained relief of vasomotor symptoms in menopausal women. ClinicalTrials.gov registration: NCT05813067