one menstrual cycle in the preceding 12 months, or were postmenopausal, having had no menstrual cycle in at least 12 months. Researchers included women who were perimenopausal (or in the menopause transition) because most previous studies looked only at postmenopausal women, who tend to have fewer symptoms than women going through menopause.
Initially, the women were randomly assigned to receive one of five therapies:
· Black cohosh
· A multibotanical supplement, including black cohosh, alfalfa, boron, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate and Siberian ginseng
· A multibotanical supplement plus diet counseling to increase consumption of foods containing soy
· Menopausal hormone therapy, consisting of estrogen with or without a progestin
· A placebo, containing no drug or supplement
Participants met with clinic staff at three, six, and 12 months after the beginning of the study and also received monthly telephone calls from study nurses. The women were recruited into the study from May 2001 through August 2003. When the first reports from the Women's Health Initiative (WHI) in July 2002 raised possible concerns about the safety of menopausal hormone therapy*, researchers informed all women in the study about those findings and offered them the opportunity to take part in a study without a menopausal hormone therapy group. Most women consented to continue participation in the trial. All participants were informed about subsequent WHI publications, and later recruits were enrolled in the trial without the option of a menopausal hormone therapy group.
Newton and colleagues found no significant difference between the number of daily hot flashes and/or night sweats in any of the herbal supplement groups when compared to the placebo group. At the end of one year, the average difference was less than 0.6 symptom per day. However, the average difference at one year in symptoms betwee
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