Baoming Ge, MD, MClSc
Potential Financial Conflicts of Interest: Dr. Ge is the medical director of a clinical research organization, China Clinical Trial Coordination Center, Beijing, China.
Ge B.; Alternative Treatments of Vasomotor Symptoms of Menopause. Ann Intern Med. 2007;147:346. doi: 10.7326/0003-4819-147-5-200709040-00013
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Published: Ann Intern Med. 2007;147(5):346.
TO THE EDITOR:
I read the paper on Newton and colleagues' excellent work (1) with great interest. My study group has just finished a pilot study of a black cohosh ethanol extract in Beijing, China, and we are on track to conduct a nationwide, multicenter, randomized, controlled trial. The double-blind pilot study enrolled 120 Chinese women with climacteric symptoms who were stratified into perimenopausal and postmenopausal groups, according to the standard of STRAW (Stages of Reproductive Aging Workshop). We divided each group into 3 intervention groups—low-dose black cohosh (1 pill twice daily), high-dose black cohosh (1 pill thrice daily), and placebo—with 20 persons in each group. The primary outcome was the Kupperman index score, evaluated before the study and at 2 and 4 weeks after treatment. We also used the menopause rating scale as the secondary outcome after the scale was introduced in China and was validated. Although some results of the pilot study were negative (there was an absolute difference among the groups, but the change in the Kupperman index score in the high-dose group was not statistically significant compared with that in the placebo group), similar to Newton and colleagues' study, we were very careful to accept the null hypothesis. We believe that the sample size we calculated before the study was not powerful enough to detect the difference.
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