Intervention: Mellow Menopause (γ-aminobutyric acid 50 mg with EstroG-100 514 mg) or placebo. Women (n = 80 randomized) completed a 5-week, double-blind study with PRN dosing in week 1 at vasomotor-symptom onset, followed by once-daily dosing in weeks 2–5; outcomes were collected via daily hot-flash diary/app and validated instruments.
Study Duration: 5 weeks
Eligibility Criteria:
- Healthy female participants aged 40 – 65 years.
- Self-reported menopausal symptoms (> 5 hot flashes per day) which have been present for a minimum of 60 days prior to baseline visit.
- Variable cycle length of > 7 days different from normal.
For more, plus the exclusion criteria, see:
Key Findings
1.
All participants were asked to record daily hot flash symptoms (intensity, duration and occurrence) daily for the duration of the study. Mellow Menopause significantly reduced the average number of hot flashes on day 2 (P = 0.002), day 3 (P = 0.001) and day 4 (P <0.001), and significantly reduced the severity of those flashes on day 1 (P = 0.001), day 2 (P < 0.001), day 3 (P = 0.001), day 4 (P = 0.001) and day 6 (P < 0.001), relative to placebo.
2.
When compared to historic recall values, Mellow Menopause significantly reduced the total average weekly hot flashes (P = 0.001), the intensity of hot flashes (P = 0.001) and average duration of hot flashes (P < 0.001), relative to placebo.
3.
All participants digitally tracked menopausal symptoms (overall wellbeing, anxiety / stress, headaches, mood swings) using a mobile application. Mellow Menopause significantly reduced anxiety and stress scores; findings that were observed after just one dose (day 0, P = 0.022) and further observed at day 1 (P = 0.042), day 3 (P = 0.010), day 4 (P = 0.032), day 5 (P = 0.008) and day 6 (P < 0.001), relative to placebo. Headache severity scores were also significantly reduced at day 3 (P = 0.005) and day 6 (P = 0.003), relative to placebo.
4.
After five weeks of supplementation with Mellow Menopause, a significant improvement in the Pittsburgh Sleep Quality Index was identified, relative to placebo (P = 0.03).
5.
The Greene Climacteric Scale was also implemented to assess menopausal symptoms. Significant improvements in the Mellow Menopause group were observed for vasomotor symptoms (P = 0.001) and for sexual function (P < 0.05) at day 7.
The Profile of Mood States was administered to measure different dimensions of mood. Mellow Menopause improved several domains: fatigue at week 3 (P < 0.05), feelings of depression at week 3 and week 5 (P < 0.05 and P < 0.01 respectively), tension at week 5 (P < 0.01) and anger at week 5 (P < 0.05).
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