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Herbal Treatments Lack Consistent Rigorous Evidence of Efficacy for Treatment of Vasomotor Symptoms

The use of herbs like black cohash, multibotanical supplements, and dietary soy to treat symptoms in women with menopause has grown despite lack of scientific evidence to support efficacy and safety.1

The Herbal Alternatives for Menopause Trial (HALT) study was designed to provide rigorous evidence for the efficacy and short-term safety of herbal interventions including black cohosh, multibotanical supplements, and dietary soy for the management of vasomotor symptoms in menopausal women.1

This large, 1-year double-blind, randomized, placebo-controlled trial of 351 women who were 45 to 55 years of age studied the effects of herbal treatment, hormone therapy and placebo over 3, 6, and 12 months.

None of the 3 herbal treatments had clinically meaningful effects on any of the primary outcomes:1

  • Black cohosh was not effective treatment for menopausal women with moderate-to-severe vasomotor symptoms
  • Multibotanical supplements had no clinically meaningful effects on symptoms
  • Intake of dietary soy was not achieved for definitive results

Limited Vasomotor Symptom Control with Herbal Treatments

Patients receiving the herbal interventions had the same change in vasomotor symptoms as placebo. In fact, patients taking multibotanicals plus dietary soy had more severe symptoms at 12 months.1

It is important to keep in mind that herbal treatments for menopause have not been determined to be safe and effective by the US Food and Drug Administration. Because they are not FDA-approved, they do not have to go through the same rigorous clinical tests as prescription products. Currently, there is no substantial scientific evidence that has found these herbal treatments to be effective for treating hot flashes.1

Elestrin Provides Symptom Control for Patients

Elestrin contains 17 ß-estradiol, which is identical to what is found in the body.2 Elestrin has proven efficacy based on a randomized, placebo-controlled trial conducted in difficult-to-treat patients with moderate-to-severe vasomotor symptoms associated with menopause.2

Help Your Patients Save with Elestrin

For women with vasomotor symptoms associated with menopause, Elestrin delivers effective relief. And with each Elestrin prescription, your patients will pay no more than $25.

Download and Print the Elestrin Coupon for Your Patients

Indication

Elestrin is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Important Safety Information

Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia. The use of estrogens and progestins has shown an increased risk of breast cancer, myocardial infarction, and pulmonary embolism. The use of estrogen, with or without progestins, has shown an increased risk of stroke, dementia, and DVT while estrogen alone therapy increases the risk of endometrial cancer. The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.

Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses.

CARDIOVASCULAR AND OTHER RISKS Estrogens, with or without progestins, should not be used for the prevention of cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with oral conjugated estrogens (CE 0.625 mg) per day relative to placebo.

The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) per day relative to placebo.

The Women's Health Initiative Memory Study (WHIMS), a substudy of the WHI study, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with CE 0.625 mg alone and during 4 years of treatment with CE 0.625 mg combined with MPA 2.5 mg relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Other doses of conjugated equine estrogens with medroxyprogesterone acetate and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

Please see full Prescribing Information, including Boxed Warning and Patient Information Sheet.

You are encouraged to report negative side effects of prescription drugs to the FDA (Food and Drug Administration).
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, call 1-800-890-3098.

References

  1. Newton KM, Reed SD, LaCroix AZ, et al. Treatment of vasomotor symptoms of menopause with black cohosh, multibotanicals, soy, hormone therapy, or placebo. Ann Intern Med. 2006;145:869-879.
  2. Elestrin (estradiol gel) full Prescribing Information. Azur Pharma, Philadelphia, PA, July 2010