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Minimal decrease in hot flashes desired by postmenopausal women in family practice

Butt, Debra A. MD, MSc, CCFP1; Deng, Linda Y.R. MA1; Lewis, Jacqueline E. MD, MSc, FCFP2; Lock, Michael MD, CCFP, FRCPC3

doi: 10.1097/01.gme.0000235370.32103.4c
Articles

Objective: To determine the minimal important difference in the frequency and severity of hot flashes that postmenopausal women desire from a nonhormonal agent.

Design: Women recorded their number of hot flashes daily, along with their degree of severity, using a diary for 1 week and completed the Menopause-Specific Quality of Life Questionnaire. Women were asked to report the percentage reduction in hot flashes that they would find clinically important. Distribution-based estimates were used to estimate the minimal important difference.

Results: Approximately 69% of the postmenopausal women who reported their hot flashes as moderate to severe responded that they wanted a nonhormonal agent that provided at least a 50% mean reduction in the frequency of hot flashes (95% CI, 32% to 66%). Median hot flash reduction for all respondents was 50%.

Conclusions: The minimal clinically important difference in hot flashes is approximately 50%. This estimate can provide the basis to calculate sample size in clinical trials of anti-hot flash agents and in selecting possible candidates for investigation.

The minimal important difference in hot flashes that postmenopausal women want from a nonhormonal agent is approximately 50%. This estimate can provide the basis to calculate sample size in clinical trials of anti-hot flash agents.

©2007The North American Menopause Society