Recommended measurement instruments for menopausal vasomotor symptoms: the COMMA (Core Outcomes in Menopause) consortium.

Objective: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects.

Methods: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome.

Use of a multibotanical (Nutrafem) for the relief of menopausal vasomotor symptoms: a double-blind, placebo-controlled study.

Objective: This study aimed to compare the efficacy and safety of a multibotanical (Nutrafem) with those of placebo for the treatment of menopausal vasomotor symptoms.

Methods: In this phase III, double-blind, randomized, placebo-controlled study, 159 postmenopausal women experiencing at least 21 vasomotor symptoms per week were treated with Nutrafem (Bionutra Pte Ltd, Singapore) or a matched placebo for 12 weeks. Treatment outcome was evaluated by the change from baseline in the average weekly number of vasomotor symptoms.