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

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Treatment of Vasomotor Symptoms of Menopause with Black Cohosh, Multibotanicals, Soy, Hormone Therapy, or Placebo

A Randomized Trial

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Figure 1. Participant recruitment and retention, Herbal Alternatives for Menopause Trial (HALT).

Reasons for discontinuing therapy are not mutually exclusive. All participants received allocated intervention. *In the original enrolled plan, all participants were enrolled in 1 of 5 groups. ${dagger}$ After publication of the Women's Health Initiative (WHI) estrogen–progestin (E + P) trial (2), women were given the option of 4-arm (without conjugated equine estrogen [CEE]) or 5-arm randomization. ${ddagger}$ After publication of the WHI Memory Study (8, 9), randomization to CEE was stopped and only 4-arm randomization (that is, random assignment to herb or placebo, excluding hormone therapy) was used. BMD = bone mineral density; FSH = follicle-stimulating hormone; HT = estrogen with or without progestin; MPA = medroxyprogesterone acetate, 2.5 mg (women without a uterus were randomly assigned to CEE only); soy = counseling to increase dietary soy; TSH = thyroid-stimulating hormone.

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Table 1. Baseline Clinical and Demographic Characteristics by Randomization Group

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Figure 2. Adjusted mean number of vasomotor symptoms per day, by study group.

Adjusted for age (continuous), body mass index (kg/m², continuous), hysterectomy (yes or no), previous use of hormone therapy (HT) (yes or no), menopausal status (menopausal transition vs. postmenopausal), and randomization arm (4-arm without hormone therapy vs. 5-arm with hormone therapy).

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Figure 3. Adjusted mean Wiklund Vasomotor Symptom Subscale scores, by study group.

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Table 2. Difference in Adjusted Mean Change in Vasomotor Symptom Frequency and Intensity and Wiklund Vasomotor Symptom Subscale Score between Intervention and Placebo Groups*

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Table 3. Difference in Adjusted Mean Change in Frequency of Hot Flashes and Night Sweats and Wiklund Menopause Symptom Scale Scores between Intervention and Placebo Groups*

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Table 4. Women with Adverse Events, Mean Adherence, and Reasons for Withdrawal or Discontinuation of Medication Use by Treatment Group over 12 Months of Follow-up