Can a phytoestrogen+melatonin supplement improve quality of life and hot flashes in postmenopausal women? Original paper

In this clinical study, postmenopausal women who consumed a supplement containing phytoestrogens and melatonin had improved health-related quality of life and experienced fewer hot flashes. However, important shortcomings reduce the strength of these findings.

This Study Summary was published on February 8, 2024.

Quick Summary

In this clinical study, postmenopausal women who consumed a supplement containing phytoestrogens and melatonin had improved health-related quality of life and experienced fewer hot flashes. However, important shortcomings reduce the strength of these findings.

What was studied?

Whether the combination of soy isoflavones, 8-prenylnaringenin (a phytoestrogen, and melatonin can improve hot flashes and quality of life in postmenopausal women.

The primary outcomes was health-related quality of life (QoL). The secondary outcomes included hot flashes and the adherence, acceptability, and safety/tolerability of the supplement.

Who was studied?

40 women (average age of 53) who were postmenopausal and reported experiencing more than 5 hot flashes per day or more than 35 hot flashes per week.

How was it studied?

In this 12-week nonrandomized noncontrolled study, the participants were given a multi-ingredient food supplement once daily before bedtime. The supplement contained 54.4 mg of soy isoflavones (24.5 mg of genistein and 16.3 mg of daidzein), 100 micrograms of 8-prenylnaringenin, and 1 mg of melatonin.

QoL was measured using the Menopause-Specific Quality of Life Questionnaire (MENQoL) and the Cervantes Scale. Hot flashes were recorded by each participant using a daily hot flash diary.

What were the results?

MENQoL scores decreased (improved) after 12 weeks of supplementation; the vasomotor, psychosocial, physical, and sexual domains of the MENQoL were all improved compared to baseline.

Furthermore, scores on the Cervantes Scale also decreased at 12 weeks, indicating improved quality of life. The menopause & health domain, the psychic domain, and the couple relationship domain (but not the sexuality domain) were all improved compared to baseline.

Hot flash frequency was reduced from 65 per week to 26 per week. This included a reduction in total and moderate-to-severe hot flashes (but not mild hot flashes). Nearly 40% of the participants reported experiencing no hot flashes at the end of the study.

Treatment adherence was 95%, treatment satisfaction was 76%, and tolerability (i.e., safety) was 87%. There were no adverse events related to the study supplement.

Anything else I need to know?

The lack of randomization and the absence of a control group limits the conclusions that can be drawn about the effectiveness of the supplement for postmenopausal women — we can’t rule out that expectancy or placebo effects contributed to some of the benefits.

Furthermore, due to multiple ingredients being studied in one group, we can not say which ingredient(s) might be responsible for a given effect.

At the time of publication, three of the authors were employees of or received honoraria from Italfarmaco Research Pharma SLU, the manufacturer of the food supplement and the company that funded the study.

This Study Summary was published on February 8, 2024.