Vasomotor symptoms: Hormonal interventions

Menopause hormone therapy

One RCT (with a low risk of bias) in women after breast cancer found that tibolone (2.5 mg/d) for up to 2.75 years significantly reduced the frequency and severity of hot flushes compared to placebo; however, tibolone was also shown to increase the risk of breast cancer recurrence.34, 35. One RCT (with a high risk of bias) of menopause hormone therapy (sequential or continuous combined oestrogen/progestogen) versus electro-acupuncture reported improvements with both interventions but did not report between-group differences.36, 37 [ES7]

Four RCTs (with a high risk of bias) identified in a Systematic Review (with a low risk of bias) in postmenopausal women (including women surgically treated for breast cancer) found that tibolone (2.5 mg/d) significantly reduced hot flush frequency compared with placebo; however, tibolone was found to be less effective than hormone therapy.38 [ES33]

Nine RCTs (with a low risk of bias) identified in a Systematic Review (with a low risk of bias) in peri- and postmenopausal women (not including women with breast cancer) found that oral hormone therapy (oestrogen and combined oestrogen/progestogen therapy) significantly reduced the frequency and severity of hot flushes compared with placebo.39 [ES34]

Seven RCTs (with a low risk of bias) and two RCTs (with a high risk of bias) identified in a Systematic Review (with a low risk of bias) in postmenopausal women (at least seven hot flushes per day and/or at least 50 hot flushes per week) found that transdermal low-dose oestradiol (< 0.05 mg/d) significantly reduced hot flush frequency compared with placebo; greater reductions were seen with the higher dose range (0.029 mg/d to 0.045 mg/d) than the lower doses.40 [ES37]

Five RCTs (with an unknown risk of bias) identified in a Systematic Review (with a moderate risk of bias) in postmenopausal women (natural or surgically induced) found that transdermal oestradiol gel preparations (0.25-1.5 mg/day) significantly reduced hot flush frequency and severity compared with placebo. The greatest effect was seen for dosing around 1mg/day but this also caused the greatest number of adverse events.41 [ES38]

Compounded hormones

Compounded hormones are often referred to as ‘bioidentical’ hormones. In a population of postmenopausal women, three RCTs identified in a Systematic Review (with a moderate risk of bias) found inconsistent evidence of effect of compounded progesterone cream on vasomotor symptoms. One of the RCTs found a significant improvement in vasomotor symptoms severity for a compounded progesterone cream compared to placebo. Two of the RCTs found no significant difference in vasomotor symptoms severity between commercially available progesterone creams and placebo.42 [ES40]

Other hormone therapies

Five RCTs (with a low risk of bias) identified in a Systematic Review (with a low risk of bias) in postmenopausal women with vulvovaginal dyspareunia and atrophy found that at 12 weeks, ospemifene (60 mg/d) significantly increased hot flushes compared with placebo.43 [ES36]

In a population of peri- and postmenopausal women, two RCTs in a systematic review found that the addition of testosterone to menopause hormone therapy had no effect on vasomotor symptoms.44 [ES39]