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Do herbs help for hot flashes?

The Problem

A 54-year-old woman presents with hot flashes, difficulty sleeping, and night sweats for several months. She has had a hysterectomy for fibroid disease and is concerned about taking estrogen because of the recent information in the lay press about results from the Women's Health Initiative (WHI) trial. She wonders if there are any options other than estrogen for her symptoms. She has friends who have been on a variety of herbal therapies with mixed results.

The Question

Are herbal medications more effective than placebo for treatment of women with menopausal symptoms?

The Search

You go to PubMed (www.pubmed.gov) and, after clicking on "special queries," search for "complementary and alternative medicine." You further limit the search to randomized, controlled trials.

Our Critique

This well-conducted study provides the best available evidence regarding the efficacy of herbal products. The investigators took great pains to ensure the purity and consistency of the herbal products. Some concern exists regarding the blinding of the soy group because of the additional counseling.

Although some evidence suggests that botanicals may be helpful for other postmenopausal symptoms (insomnia, depression), this evidence adds to the body of literature suggesting that no botanicals are effective for vasomotor symptoms. We know that patients will continue to experiment and some may find various preparations helpful, but no basis exists to recommend them. Other nonpharmacologic interventions on the horizon, such as paced breathing, may be helpful and need to be tested.

Clinical Decision

After a long discussion about the risks of estrogen therapy and assessment of her potential contraindications, the patient decides to try an estrogen patch.

K.M. Newton et al.

Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo. Ann. Intern. Med. 2006;145:869-79.

* Design and Setting: Randomized clinical trial, Group Health, Washington State.

* Subjects: Eligible subjects were aged 45-55 years; in late menopausal transition (had one or more skipped menses within the preceding 12 months) or postmenopausal (no bleeding within 12 months); and had two or more vasomotor symptoms per day over 2 weeks (six or more moderate to severe symptoms). Women were excluded for contraindications to hormone therapy, use of hormone therapy or oral contraceptives within previous 3 months, soy allergy, bilateral oophorectomy, history of breast cancer, and nonadherence during the run-in period (took less than 80% of capsules).

* Intervention: The original design of the study randomly assigned patients to black cohosh 160 mg daily; a multibotanical; a multibotanical plus soy diet counseling; oral conjugated equine estrogen (CEE) 0.625 mg four times daily with (for women with a uterus) or without (for women without a uterus) medroxyprogesterone acetate (MPA) 2.5 mg; or placebo. The multibotanical contained black cohosh, alfalfa, boron, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, and Siberian ginseng. The soy intervention included five telephone calls from a clinical dietician and literature recommending soy. Following the publication of the WHI results, the hormone arm was discontinued.

* Outcomes: The primary outcomes were the change in the mean frequency and intensity of vasomotor symptoms (daytime hot flashes plus night sweats) and the mean Wiklund Vasomotor Symptom Subscale score at baseline and at 3, 6, and 12 months. The change from baseline to follow-up for daytime hot flash rate, night sweat rate, and total Wiklund Menopause Symptom Scale score were also evaluated. Participants used a vasomotor symptom diary to record daytime hot flashes and night sweats (rating intensity as mild, moderate, or severe) and completed the Wiklund Menopause Symptom Scale rating the severity of 13 menopausal symptoms.

* Results: Of the 3,433 women screened, 351 were randomized (80 to black cohosh, 76 to multibotanical, 79 to multibotanical plus dietary soy, 29 to CEE plus MPA, 3 to CEE alone, and 84 to placebo). The only significant difference between any treatment group and the placebo group was that at 12 months the multibotanical plus soy group had worse symptom relief than did the placebo group (P = .016). The average difference in number of vasomotor symptoms per day between the placebo and herbal treatments was fewer than one symptom per day at all follow-ups. The average adjusted difference for hormone therapy compared with placebo was -4.55 vasomotor symptoms per day at 3 months and -4.06 vasomotor symptoms per day on average for all follow-up time points. On the Wiklund Vasomotor Symptom Subscale, no significant differences were observed between the herbals and placebo at any time point, but the score was statistically significantly lower with hormone therapy, compared with placebo, at all follow-ups (P < .001). Women on hormone therapy had more breast pain and menstrual disorders. Adherence was greater than 80% for all groups.

BY JON O. EBBERT, M.D., AND ERIC G. TANGALOS, M.D.

DR. EBBERT and DR. TANGALOS are with the Mayo Clinic in Rochester, Minn. They have no conflicts of interest to report. To respond to this column or suggest topics for consideration, write to Dr. Ebbert and Dr. Tangalos at our editorial offices or e-mail them at imnews@elsevier.com.
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Article Details
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Title Annotation:MINDFUL PRACTICE
Author:Ebbert, Jon O.; Tangalos, Eric G.
Publication:Internal Medicine News
Article Type:Clinical report
Geographic Code:1USA
Date:Mar 15, 2007
Words:837
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