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Evidence summaries

Bioidentical Hormones for Women with Postmenopausal Vasomotor Symptoms

Bioidentical hormone 17 beta-estradiol in various forms may be effective for moderate to severe menopausal hot flushes compared to placebo. Level of evidence: "C"

Comment: The quality of evidence is downgraded by severe study limitations (most studies at high or unclear risk of bias in most domains).

Summary

A Cochrane review [Abstract] 1 included 23 studies with a total of 5 779 subjects mostly with moderate to severe hot flushes. All studies compared unopposed 17 beta-estradiol (beta-estradiol, a bioidentical hormone) versus placebo or conjugated equine estrogens (CEE). There was low (to moderate) quality evidence that beta-estradiol in various forms and doses is more effective than placebo for treating moderate to severe menopausal hot flushes (table T1).There was low to moderate quality evidence of higher rates of adverse effects such as headache, vaginal bleeding, breast tenderness and skin reactions in the beta-estradiol group. Higher doses of beta-estradiol tended to be associated with greater effectiveness but also with higher risk of adverse effects. There was no good evidence of a difference in effectiveness between beta-estradiol and 0.625 mg conjugated equine estrogens, but the data were unsuitable for analysis (2 trials of patch versus CEE and 1 trial of oral beta-estradiol versus CEE).

Beta-estradiol versus placebo for women with hot flushes

OutcomeAnticipated absolute effects (95% CI)№of participants(studies)
Frequency of hot flushes:Beta-estradiol patch 0.0375-0.10 mg/dayFewer hot flushes in the beta-estradiol group. Effect size moderate: SMD -0.68, 95% CI -0.83 to -0.53793(4)
Frequency of hot flushes:Beta-estradiol gel 0.27-1.5 mg/dayData unsuitable for analysis reported a benefit in the beta-estradiol gel group (P value < 0.05)930(3)
Frequency of hot flushes:Oral beta-estradiol 0.5-1.0 mg/dayFewer hot flushes in the beta-estradiol group. Effect size moderate: SMD -0.80, 95% CI -1.03 to -0.57356(2)
Frequency of hot flushes:Intranasal beta-estradiol 0.021 mg/day, 0.029 mg/day or 0.040 mg/dayThe mean rate of hot flushes per day was lower in the beta-estradiol group: MD - 3.04, 95% CI -4.05 to -2.03458(1)

Clinical comments

Note

Date of latest search: 29 July 2015

    References

    • Gaudard AM, Silva de Souza S, Puga ME et al. Bioidentical hormones for women with vasomotor symptoms. Cochrane Database Syst Rev 2016;(8):CD010407. [PubMed]

Primary/Secondary Keywords