Pharmacologic and hormonal treatments for menopausal sleep disturbances: A network meta-analysis of 43 randomized controlled trials and 32,271 menopausal women.
Study Goal
The researchers aimed to investigate the efficacy and tolerability of pharmacologic and hormonal interventions, including melatonin-fluoxetine, for menopausal sleep disturbances.
Results Summary
The study found that melatonin-fluoxetine showed a therapeutic effect against sleep disturbances compared to placebo, with a significant standardized mean difference (SMD = -2.47). However, dropout rates were comparable between interventions and placebo/control, and no specific adverse events for melatonin were highlighted.
Population
Women during or after the menopausal transition (mean age: 61.24 ± 4.23 years).
Effective Dosage
Not specified
Duration
Mean duration: 90.83 ± 66.29 weeks
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
melatonin-fluoxetine | decrease | sleep disturbances | women during/after menopausal transition | SMD = -2.47 (95% CI:-4.19-0.74) | showed therapeutic effect | #1 |
gabapentin | decrease | vasomotor symptoms | women during/after menopausal transition | SMD = -1.04 (95% CI:-1.90-0.18) | demonstrated superior benefits | #2 |
oral combined hormone therapy | decrease | vasomotor symptoms | women during/after menopausal transition | SMD = -0.62 (95% CI:-1.06-0.18) | demonstrated superior benefits | #3 |
bazedoxifene-conjugated estrogens | decrease | vasomotor symptoms | women during/after menopausal transition | SMD = -0.50 (95% CI:-0.96-0.04) | demonstrated superior benefits | #4 |
raloxifene-only | decrease | sleep disturbances | women during/after menopausal transition | SMD = -1.86 (95% CI:-3.09-0.63) | benefits | #5 |
raloxifene-oral estrogen | decrease | sleep disturbances | women during/after menopausal transition | SMD = -2.64 (95% CI:-4.64-0.63) | benefits | #6 |
interventions | no change | overall dropout rates | women during/after menopausal transition | - | dropout rates were comparable | #7 |
eszopiclone | increase | adverse event-related discontinuation | women during/after menopausal transition | RR = 3.84 (95% CI: 1.14-12.87) | associated with higher rates | #8 |
oral combined hormone therapy | increase | adverse event-related discontinuation | women during/after menopausal transition | RR = 2.51 (95% CI: 1.04-6.07) | associated with higher rates | #9 |
combined estrogen-progesterone therapy | decrease | menopausal sleep disturbances associated with vasomotor symptoms | women during/after menopausal transition | - | support | #10 |
hypnotics | no change | menopausal sleep disturbances | women during/after menopausal transition | - | showed no significant effects | #11 |
This network meta-analysis aimed at investigating efficacy/tolerability of pharmacologic/hormonal interventions for menopausal sleep disturbances. Major databases were searched for randomized controlled trials (RCTs) examining pharmacologic or hormonal interventions with either placebo or active controlled designs. Primary outcomes were improvements in sleep disturbance severity/tolerability (i.e., overall dropout rates), whereas secondary outcome was adverse event-related discontinuation rates. Analysis of 43 RCTs with 25 treatment arms involving 32,271 women during/after menopausal transition (age: 61.24 ± 4.23, duration: 90.83 ± 66.29 wks) showed therapeutic effect of melatonin-fluoxetine [SMD = -2.47 (95% CI:-4.19-0.74)] against sleep disturbances compared to placebo. Subgroup analysis of 15 RCTs on vasomotor symptoms demonstrated superior benefits of gabapentin [SMD = -1.04 (95% CI:-1.90-0.18)], oral combined hormone therapy [SMD = -0.62 (95% CI:-1.06-0.18)], and bazedoxifene-conjugated estrogens [SMD = -0.50 (95% CI:-0.96-0.04)] to placebo/control. Despite benefits of raloxifene-only [SMD = -1.86 (95% CI:-3.09-0.63)] and raloxifene-oral estrogen [SMD = -2.64 (95% CI:-4.64-0.63)], patient selection may be a confounder. Dropout rates were comparable between interventions and placebo/control. Eszopiclone [RR = 3.84 (95% CI: 1.14-12.87)] and oral combined hormone therapy [RR = 2.51 (95% CI: 1.04-6.07)] were associated with higher rates of adverse event-related discontinuation. The results support combined estrogen-progesterone therapy for menopausal sleep disturbances associated with vasomotor symptoms but showed no significant effects of hypnotics in this clinical setting.