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Recommendations about traditional hormone therapy, nonhormonal strategies, and recently approved treatments

Sponsoring Organization: American College of Obstetricians and Gynecologists (ACOG)

Target Population: Women's healthcare providers

Background and Objective

Despite much new data, management of menopausal symptoms remains controversial. Now, ACOG reviews conventional systemic and vaginal hormone therapy (HT), details recently approved treatments, and provides information about nonhormonal strategies.

Key Recommendations

Management of Vasomotor Symptoms (VMS)

• Systemic HT (including oral and transdermal routes), alone or combined with progestin, is the most effective therapy for menopausal VMS.
• Although less effective than standard-dose systemic HT, lower-dose HT regimens are associated with more-favorable adverse effect profiles.
• Systemic estrogen-progestin HT raises risk for venous thromboembolism (VTE) and breast cancer.
• Compared with oral estrogen, transdermal estrogen may be associated with lower risk for VTE.
• Because some women aged ≥65 might still need systemic HT for VMS, HT should not be routinely discontinued at age 65, but, as in younger women, should be individualized.
• In women with a uterus, an alternative to estrogen-progestin HT for VMS is conjugated equine estrogen (0.45-mg oral tablets) combined with the selective estrogen receptor modulator (SERM) bazedoxifene (20-mg oral tablets).

Compounded Bioidentical Hormones

• Because such preparations have not been rigorously tested, only FDA-approved HT formulations are recommended.

Nonhormonal Treatments for VMS

• Paroxetine (7.5 mg) is the only FDA-approved formulation for management of VMS. Venlafaxine, desvenlafaxine, clonidine, and gabapentin are all more effective than placebo for VMS.
• Complementary botanicals and natural products, including over-the-counter isoflavones, Chinese herbs, black cohosh, ginseng, St. John's wort, and gingko biloba have not been shown to be effective for VMS.

Treatment of Vulvovaginal Atrophy (VVA)

• For women with VVA and no indications for systemic HT, vaginal estrogen is effective for relieving symptoms.
• Neither routine progestational endometrial protection nor endometrial surveillance is recommended in conjunction with vaginal estrogen therapy, given its low dose (e.g., 10-µg estradiol vaginal tablets).
• The oral selective estrogen receptor modulator ospemifene is effective for relief of dyspareunia associated with VVA.

What's Changed

This new guidance refers to three formulations that received FDA approval in 2013: oral ospemifene (60 mg) for dyspareunia associated with VVA; oral paroxetine (7.5 mg) for bothersome VMS; and oral conjugated equine estrogen (0.45 mg) combined with bazedoxifene (20 mg) to manage VMS and prevent osteoporosis in women with a uterus.