(P09-007-23) Cooling Menopause Symptoms With Fan Club: A Randomized, Double-Blind, Placebo-Controlled Study of a Dietary Supplement on Vasomotor and Common Menopausal Symptoms

Objectives: Peri- and menopausal hormonal changes lead to unpleasant vasomotor and psychosomatic symptoms that negatively affect quality of life. This study examined the effect of a dietary supplement containing a novel combination of botanical extracts and a probiotic compared to a placebo to improve menopause symptoms in a double-blind, randomized, placebo-controlled study.

Methods: Healthy females ages 38-60 (n=101) experiencing at least mild hot flash symptoms and a break in cycle regularity during the past 12 months or last menstruation at least 3 months ago were enrolled. After obtaining informed consent, subjects were randomized to placebo or intervention and instructed to consume 1 capsule per day. Subjects completed surveys at baseline, 4 weeks and 8 weeks, reporting number of hot flashes in the past 24 hours, hours of sleep the previous night, the Perceived Stress Scale, and the 11-item Menopause Rating Scale to assess hot flash severity, heart discomforts, sleep problems, depressive mood, irritability, anxiety, physical and mental exhaustion, sexual problems, bladder problems, vaginal dryness, and joint and muscular discomfort.

Results: Repeated measures analysis of the treatment group showed statistically significant decreases in hot flash frequency and increased hours of sleep from baseline to week 8, with improvements noted at week 4. Statistically significant differences were noted between placebo and treatment from weeks 0 to 8 with fewer report of severity of sleep problems, depressive mood, anxiety, sexual problems, vaginal dryness, joint and muscle discomfort. Statistically significant improvements in Perceived Stress scores compared to the placebo were found for some items: controlling important things in your life, feeling nervous and stressed, coping with things to do, and being on top of things.

Conclusions: A dietary supplement containing clinically studied botanical extracts and a probiotic provided beneficial improvements for common symptoms of menopause, including vasomotor, sleep, and mood problems, indicating an effective alternative treatment for peri- and menopausal discomforts.

Funding Sources: HUM Nutrition, Inc.