Treatment of Vasomotor Symptoms of Menopause With Black Cohosh, Multibotanicals, Soy, Hormone Therapy, or Placebo: A Randomized Trial

Abstract

Possible risks from even short-term hormone therapy have led many women to try herbs, multibotanical supplements, and dietary soy as alternative treatments for vasomotor symptoms occurring at or after menopause. The Herbal Alternatives for Menopausal Trial (HALT) was a 12-month double-blind, randomized, controlled study assessing the effectiveness and safety of three naturopathic measures as compared to hormone therapy and placebo in 351 women 45 to 55 years of age who were either in late menopausal transmission (52%) or postmenopausal (48%). The participants had at least two vasomotor symptoms each day. Five interventions were compared: 160 mg of black cohosh daily; a multibotanical containing 200 mg of black cohosh daily and nine other ingredients; the multibotanical plus dietary soy counseling; 0.625 mg daily of conjugated equine estrogen, with or without 2.5 mg daily of medroxyprogesterone acetate; and placebo. The rate and intensity of vasomotor symptoms were scored from 1 (mild) to 3 (severe), and the Wiklund Vasomotor Symptom Subscale was used to assess symptoms after 3, 6, and 12 months. At baseline, the women in this study averaged 6.5 vasomotor symptoms daily and symptom intensity averaged 1.8 on the 1-to-3 scale. The number of symptoms per day as well as Wiklund scores decreased in the first 3 months in all groups. No significant differences in either the number of daily symptoms or their intensity was found between the herbal interventions and placebo at 3, 6, or 12 months, with the exception of more intense symptoms at 12 months with the multibotanical plus soy intervention than in the placebo group. Negative findings also were obtained when hot flashes and night sweats were analyzed separately. At no time did Wiklund scores differ significantly between the herbal intervention and placebo groups. In contrast, differences favoring hormone therapy over placebo were significant at all follow-up intervals. Women taking hormone therapy experienced more breast pain and menstrual disorders than did placebo recipients, but there were no significant differences in gastrointestinal symptoms, nausea and vomiting, fatigue, malaise, or headache. Adherence to assigned treatment averaged 86% during the 12-month follow-up period. In view of the urgent need for safe ways of relieving vasomotor symptoms in perimenopausal and menopausal women, it is unfortunate that these results fail to support the use of black cohosh-alone or as part of a multibotanical product-to control these symptoms.