AIMS: The current study estimates the prevalence of vasomotor symptoms (VMS) and quality of life (QOL) among peri- and post-menopausal women.
METHODS: Participants were recruited from a Knowledge Networks panel, the only online panel based on a random digit dial sample of the full US population. Over 4,000 pre-, peri- and post-menopausal women (n= 4,402) completed portions of the web-based survey. Analyses are limited to the 3,135 peri- and post-menopausal participants meeting study criteria. In addition to reporting VMS frequency, severity, and related healthcare, respondents completed the Menopause-Specific Quality of Life Questionnaire (MENQOL), a 29-item self-report measure assessing the presence and bothersomeness of menopausal symptoms. Subjects were classified into 3 groups based on VMS in the past month: 1) met FDA draft guidance (7 or more moderate-to-severe daily hot flashes/night sweats); 2) hot flashes/night sweats but less than FDA draft guidance; or 3) no hot flashes/night sweats. METHODS [2] Survey • Eligible participants completed the web-based survey: • Menopause-Specific Quality of Life Questionnaire (MENQOL)3 29-item self-report measure Assesses the presence (Yes/No) and bothersomeness (rating 0-6) of menopausal symptoms Higher scores on any symptom indicate greater levels of bothersomeness. • Additional survey items addressed VMS frequency, severity, and related healthcare.
RESULTS: Mean age of the sample was 55.1 years. Over two-thirds of the sample (67%) reported any VMS within the past month (59% reported daytime hot flashes, 55% reported night sweats). Only 7% of the sample met FDA draft guidance. MENQOL scores between the peri- and post-menopausal groups did not dramatically differ. However, significant differences in MENQOL total and subscale (Vasomotor, Psychosocial, Physical, Sexual) scores were observed among the 3 VMS groups, with both VMS groups reporting significantly diminished QOL (p<0.05).
CONCLUSIONS: The current study provides much-needed prevalence estimates of VMS and their impact on QOL among menopausal women. US regulatory draft guidance focuses on women with 7 or more moderate-to-severe menopausal symptoms per day. However, VMS significantly impact QOL for a much larger portion of the peri- and post-menopausal population.
