Al-Akoum Mahéra, Maunsell Elizabeth, Verreault René, Provencher Louise, Otis Hélène, Dodin Sylvie
Centre de Recherche, Centre Hospitalier Universitaire du Québec, Québec, QC, Canada.
Menopause. 2009 Mar-Apr;16(2):307-14. doi: 10.1097/gme.0b013e31818572a0.
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 x 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.
这项初步的双盲随机临床试验最初针对乳腺癌幸存者，旨在获取贯叶连翘提取物（圣约翰草提取物）与安慰剂相比，对有症状的围绝经期妇女症状及生活质量影响的初步证据。我们还评估了招募女性参与此类试验的实际困难。
年龄在40至65岁、有潮热症状（每日三次或更多，采用心脏和雌激素/孕激素替代研究量表）的围绝经期有症状妇女被随机分配接受贯叶连翘乙醇提取物（每日三次，每次900毫克）或安慰剂。这些妇女被要求在随机分组前一周以及3个月随访（主要结局）前一周记录每日潮热频率和强度，记录在日记中。计算潮热评分（频率×严重程度）。使用更年期特异性生活质量问卷评估更年期特异性生活质量。
47名妇女被随机分组。治疗12周后，贯叶连翘组在每日潮热频率方面观察到有利于该组的差异但不显著（贯叶连翘组，-2.3±3.6；安慰剂组，-1.0±2.2；P = 0.11），潮热评分也有类似情况（分别为-3.8±8.3和-1.8±6.5；P = 0.10）。治疗3个月后，与安慰剂组相比，贯叶连翘组妇女报告的更年期特异性生活质量显著更好（P = 0.01），睡眠问题显著更少（P = 0.05）。
贯叶连翘可能以对有症状的围绝经期妇女重要的方式改善生活质量，但这些结果需要通过更大规模的临床试验来证实。
