The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women - A randomised controlled trial
The effects of Chinese medicinal herbs on postmenopausal vasomotor symptoms of Australian women - A randomised controlled trial
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DOI：
10.5694/j.1326-5377.2001.tb143156.x
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发表时间：
2001-01-15
影响因子：
11.4
通讯作者：
Burger, HG
中科院分区：
文献类型：
--
作者：
Davis, SR;Briganti, EM;Burger, HG
设计：一项双盲、随机、安慰剂对照试验。方法：从1998年8月至1999年4月，从城市人群中招募的55名绝经后澳大利亚妇女完成了12周的干预，其中28人服用确定的中药配方，27人服用安慰剂，每天两次作为饮料。主要观察指标：主要终点是血管舒缩事件(潮热和盗汗)频率的变化。次要终点是更年期特定生活质量(MENQOL)问卷测量领域的得分变化。结果：CMH组和安慰剂组血管运动事件的平均每周频率降低(-15%，95%可信区间，-31%至+1%)和安慰剂组(-31%，95%可信区间，-42%至-21%)。两组之间的差异倾向于使用安慰剂；然而，这并不显著(P=0.09)。虽然观察到CMH和安慰剂在MENQOL问卷的各个领域的得分都有显著下降，但两个治疗组在任何领域都没有显著差异。有证据表明，以前使用自然疗法对MENQOL问卷中的血管运动、生理和性领域的效果进行了修改：先前没有使用自然疗法治疗更年期症状的女性对治疗有反应，而先前的使用者没有。结论：CMH的定义配方在减少澳大利亚绝经后妇女的血管运动发作方面并不比安慰剂有效，也不能改善MENQOL问卷中的四个症状领域中的任何一个。MENQOL问卷中的三个领域通过先前使用的自然疗法进行了修改。这一发现对未来的研究具有重要意义。
Objective: To evaluate the effects of a defined formula of Chinese medicinal herbs (CMH) on menopausal symptoms.Design: A double-blind randomised placebo-controlled trial.Methods: Between August 1998 and April 1999, 55 postmenopausal Australian women recruited from an urban population completed 12 weeks of intervention with either a defined formula of CMH (n=28) or placebo (n=27) taken twice daily as a beverage.Main outcome measures: The primary end-point was change in frequency of vasomotor events (hot flushes and night sweats). The secondary end-points were changes in score for the domains measured in the Menopause Specific Quality of Life (MENQOL) Questionnaire.Results: There was a reduction in average weekly frequency of vasomotor events with CMH (-15%, 95% CI, -31% to +1%) and with placebo (-31%, 95% CI, -42% to -21%). The difference between groups favoured the use of placebo; however, this was not significant (P=0.09). Although significant reductions in scores for the various domains of the MENQOL Questionnaire were observed for both CMH and placebo, there were no significant differences between the two treatment groups for any domain. There was evidence for effect modification by previous use of natural therapies for the vasomotor, physical and sexual domains of the MENQOL Questionnaire: women with no prior use of natural therapies for their menopausal symptoms responded to therapy, whereas prior users did not.Conclusions: The defined formula of CMH was no more effective than placebo in reducing vasomotor episodes in Australian postmenopausal women, or in improving any of the four symptom domains in the MENQOL Questionnaire. Three of the MENQOL Questionnaire domains were modified by prior use of natural therapies. This finding has implications for future studies.