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#2973 Randomized Controlled Trial of Venlafaxine Versus Black Cohosh as a Treatment for Menopausal Symptoms in Women with Breast Cancer.
RM Look, KT Morris, L Homer, K Arnold, C Purdy, D Walts, T Hudson, N Johnson, RE Weinstein; Legacy Cancer Center, Portland, OR; OHSU, Portland, OR
Hot flashes are an important clinical problem in treating patients with breast cancer. Venlafaxine has been reported to decrease hot flashes (Loprinzi et al. JCO 1998; 16:2377).
This prospective, double-blinded study was undertaken to compare the efficacy of velafaxine versus black cohosh, a widely used herbal medicine containing phytoestrogen, in controlling menopausal symptoms.
Twenty-one breast cancer patients, age 34 to 79, experiencing significant menopausal symptoms were enrolled. They were randomized to receive and encapsulated medication, either black cohosh 40 mg po BID or venlafaxine, 12.5 mg po BID, for the first 60 days.
After a one week "wash-out" period, patients were then crossed over to the other agent for the next 60 days. Each patient kept a daily hot flash log, monthly menopausal symptom log, and completed FACT-B quality of life questionnaires at the start, midpoint, and end of study.
Early crossover was allowed for adverse symptoms or lack of symptom control. One patient dropped out from the study after one dose. Four patients crossed over early during the first phase; one for dyspnea and three from lack of improvement of symptoms. Five patients ended the study early during the second phase; one for dyspnea and four for lack of improvement of symptoms.
Eighteen out of 20 evaluable patients experienced symptom reduction at day 60 with either medication, as documented by improvements in their menopausal symptom log.
Venlafaxine reduced hot flashes 13% more effectively than black cohosh (p=0.05). At the end of the study, patients were unblinded and offered a choice of medication. Eleven (55%) chose velafaxine, six (30%() chose black cohosh and three (15%) chose no treatment.
Although venlafaxine showed greater reduction of symptoms, black cohosh offers and herbal alternative for reducing menopausal symptoms.
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