The aim of this pilot double-blind, randomized clinical trial, which initially targeted breast cancer survivors, was to obtain preliminary evidence of the effect of Hypericum perforatum extract (St. John's wort extract) compared with placebo on symptoms and quality of life of symptomatic perimenopausal women. We also assessed practical difficulties in recruiting women to such a trial.
Symptomatic perimenopausal women aged 40 to 65 years who experience hot flashes (three or more per day, Heart and Estrogen/Progestin Replacement Study scale) were randomly assigned to receive ethanolic St. John's wort extract (900 mg TID) or placebo. The women were asked to keep a daily diary during the week before randomization and during the week before the 3-month follow-up (primary outcome) to record hot flash frequency and intensity. A hot flash score (frequency × severity) was calculated. The Menopause-Specific Quality of Life questionnaire was used to assess menopause-specific quality of life.
Forty-seven women were randomized. After 12 weeks of treatment, a nonsignificant difference favoring the St. John's wort group was observed in the daily hot flash frequency (St. John's wort, −2.3 ± 3.6; placebo, −1.0 ± 2.2; P = 0.11) and the hot flash score (−3.8 ± 8.3 and −1.8 ± 6.5, respectively; P = 0.10). After 3 months of treatment, compared with the placebo group, women in the St. John's wort group reported significantly better menopause-specific quality of life (P = 0.01) and significantly fewer sleep problems (P = 0.05).
Hypericum perforatum may improve quality of life in ways that are important to symptomatic perimenopausal women, but these results need to be confirmed by a larger clinical trial.
This pilot, double-blind, randomized clinical trial suggests that Hypericum perforatum extract may improve symptoms and quality of life in ways that are important to symptomatic menopausal women compared to placebo.
From the 1Centre de Recherche, Centre Hospitalier Universitaire du Québec, Québec, QC, Canada; 2Unité de Recherche en Santé des Populations, Centre de Recherche du Centre Hospitalier Affilié Universitaire du Québec, Québec, QC, Canada; 3Unité de Recherche en Gériatrie, Université Laval, Québec, QC, Canada; and 4Centre des Maladies du sein Deschênes-Fabia, Hôpital St.-Sacrement du Centre Hospitalier Affilié Universitaire du Québec, Québec, QC, Canada.
Received April 29, 2008; revised and accepted June 13, 2008.
Fundings/support: Financial support for this study was provided by the Quebec Breast Cancer Foundation.
Financial disclosure: None reported.
Address correspondence to: Sylvie Dodin, MD, MSc, Département d'Obstétrique-Gynécologie, Centre de Recherche, Hôpital Saint-François d'Assise, Université Laval, Québec, QC, Canada G1L 3L5. E-mail: email@example.com.