(P03-069-23) Therapeutic Effects of a Novel Botanical Blend on Neurokinin B and Kisspeptin in Ovariectomized Rats

Objectives: Menopausal women often experience vasomotor symptoms (VMS), including hot flashes and night sweats, due to diminished thermoregulatory control. Thermoregulation is controlled in the hypothalamus by the kisspeptin (KP)/neurokinin B (NKB)/dynorphin (KNDy) neurons. Low levels of estrogen increase NKB signaling and contribute to hot flashes. Recent research has shown that inhibiting this pathway can be an effective treatment for VMS. VMS-BH02 is a proprietary natural botanical blend formulated to reduce VMS through the novel NKB pathway. The current study investigated the impact of VMS-BH02 on thermoregulatory efficacy endpoints in ovariectomized rats.

Methods: Eight-week-old female Sprague-Dawley rats (n = 18) were divided into the following groups: sham-operated control, ovariectomized (OVX) untreated, OVX + VMS-BH02 treated. Vehicle or VMS-BH02 was administered for 8 days. On day 8 of repeated administration, tail, core, and skin temperatures were measured every 30 minutes for 24 hours. Approximately 2 hours after the final administration, blood samples were collected.

Results: All markers (NKB, KP, c-FOS, GnRH, and TRPV1) of the KNDy neuron pathway related to VMS significantly increased in the OVX group compared to sham-operated controls (p < 0.0001). After treatment, VMS-BH02 reduced NKB and KP compared to the OVX untreated group (p < 0.0001). In addition, VMS-BH02 treatment resulted in a significant improvement in c-FOS, GnRH, and TRPV1 (p < 0.0001). While body temperature was not significantly different between groups, the tail temperature of the OVX untreated group was elevated post-treatment (p < 0.0001). VMS-BH02 treatment lowered tail temperature compared to the OVX group and decreased the difference between body and tail temperature (p < 0.0001).

Conclusions: This study confirmed the ability of VMS-BH02 to significantly decrease c-FOS, GnRH, KP, NKB, and TRPV1, which all exert effects on the etiology of hot flashes. VMS-BH02 lowered KP and NKB to the levels of healthy control. These findings provide substantial support for the effectiveness of the novel botanical blend as a treatment for VMS. Future clinical studies in women will be conducted to confirm these results.

Funding Sources: This study was funded by Bonafide Health, LLC. USA.