Efficacy of Micronized Progesterone for Sleep: A Systematic Review and Meta-analysis of Randomized Controlled Trial Data

Nolan, Brendan J; Liang, Bonnie; Cheung, Ada S

doi:10.1210/clinem/dgaa873

Cited by 16 publications

(14 citation statements)

References 29 publications

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“…A previous meta-analysis favored oral micronized progesterone for sleep onset latency but not total sleep time or sleep efficiency. 39 We also analyzed the effects of HT on different sleep parameters of polysomnography. Because previous studies showed significant improvements in other menopausal symptoms in women who received estrogen therapy for four weeks, 40 , 41 we excluded the studies with HT less than four weeks.…”

Section: Discussionmentioning

confidence: 99%

Different regimens of menopausal hormone therapy for improving sleep quality: a systematic review and meta-analysis

et al. 2022

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Importance: Long-term sleep disturbances in menopausal women are closely related to cardiovascular disorders, metabolic disorders, and cognitive impairment. At present, hormone therapy (HT) is a standard treatment for menopausal symptoms. However, it remains unclear whether HT can improve sleep quality. Objective: We did a systematic review and meta-analysis to assess the effects of different HT regimens on menopausal sleep quality. Evidence Review: We systematically searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, PsycINFO, CINAHL, and Web of Science for randomized controlled trials of menopausal HT on sleep disturbances up to June 14,2021. Information about ongoing and unpublished trials was collected by searching WHOICTRP and ClinicalTrials.gov. Our primary outcome was sleep quality with objective measurements. We estimated the standardized mean difference (SMD) using random-effects models. Findings: We identified a total of 3,059 studies and finally included 15 studies in the meta-analysis. Compared with placebo, HT improved self-reported sleep outcomes (SMD = –0.13; 95% CI, –0.18 to -0.08, P < 0.00001 and I 2 = 41%), but not sleep parameters measured by polysomnography. Subgroup analyses according to the regimen of HT showed that 17β-estradiol (17β-E 2 ) (SMD = –0.34; 95% CI, –0.51 to -0.17, P < 0.0001, and I 2 = 0%) and conjugated equine estrogens (SMD = –0.10; 95% CI, −0.12 to −0.07, P < 0.00001, and I 2 = 0%) improved sleep quality. Moreover, transdermal administration (SMD = −0.35; 95% CI, −0.64 to −0.06, and P = 0.02) was more beneficial than oral (SMD = −0.10; 95% CI, −0.14 to −0.07, and P < 0.00001). In addition, the combination of estrogen and progesterone had a positive effect on sleep disturbance (SMD = −0.10; 95% CI, −0.13 to −0.07, P < 0.00001, and I 2 = 0%), while estrogen monotherapy did not. The results showed that estrogen/micronized progesterone (SMD = −0.22; 95% CI, −0.37 to −0.06, P = 0.007, and I 2 = 0%) and estrogen/medroxyprogesterone acetate (SMD = −0.10; 95% CI, −0.13 to −0.07, P < 0.00001, and I 2 = 0%) could alleviate sleep disturbance. Conclusions and Relevance: HT has a beneficial effect on sleep disturbance to some extent, and the formulations and routes of administration of hormonal agents influence the effect s...

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Section: Discussionmentioning

confidence: 99%

Different regimens of menopausal hormone therapy for improving sleep quality: a systematic review and meta-analysis

et al. 2022

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“…Progesterone metabolites are positive allosteric modulators of the GABA-A receptor ( 24 , 25 ) and have been shown to produce similar changes to sleep architecture as benzodiazepines ( 26 ). Micronised progesterone treatment has been shown to improve various polysomnography parameters, including sleep onset latency, in a meta-analysis of randomised-controlled trials predominantly enrolling post-menopausal cisgender women ( 9 ). Micronised progesterone was prescribed at doses of 200–300 mg but other studies have demonstrated improvement in self-reported sleep outcomes utilising 100 mg micronised progesterone, though concomitant prescription of oestradiol limit conclusions ( 9 ).…”

Section: Discussionmentioning

confidence: 99%

“…Micronised progesterone treatment has been shown to improve various polysomnography parameters, including sleep onset latency, in a meta-analysis of randomised-controlled trials predominantly enrolling post-menopausal cisgender women ( 9 ). Micronised progesterone was prescribed at doses of 200–300 mg but other studies have demonstrated improvement in self-reported sleep outcomes utilising 100 mg micronised progesterone, though concomitant prescription of oestradiol limit conclusions ( 9 ). We did not find a between-group difference using 100 mg micronised progesterone and further studies will need to evaluate higher doses.…”

Section: Discussionmentioning

confidence: 99%

“…Micronised progesterone is often prescribed for endometrial protection with oestradiol as menopausal hormone therapy for cisgender women with an intact uterus ( 8 ). Pre-clinical data demonstrates modulation of the γ-aminobutyric acid type A (GABA-A) receptor, and micronised progesterone treatment has been found to reduce sleep onset latency and to improve self-reported sleep outcomes in randomised-controlled trials enrolling predominantly cisgender post-menopausal women ( 9 , 10 , 11 ). A reduction in anxiety has been reported in a randomised trial of women with pre-menstrual dysphoric disorder ( 12 ).…”

Section: Introductionmentioning

confidence: 99%

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Effects of low-dose oral micronised progesterone on sleep, psychological distress, and breast development in transgender individuals undergoing feminising hormone therapy: a prospective controlled study

Nolan

Frydman

Leemaqz

et al. 2022

Endocrine Connections

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Objective: The role of micronised progesterone in hormone regimens for transgender individuals undergoing feminising hormone therapy remains uncertain. We aimed to determine the effect of oral micronised progesterone (progesterone) on sleep quality, psychological distress and breast development in transgender individuals undergoing feminising hormone therapy. Design: Prospective case-control study. Twenty-three transgender individuals on stable estradiol treatment newly commencing 100mg oral progesterone (n=23) and controls continuing standard care (n=19) were assessed over 3 months. Methods: Pittsburgh Sleep Quality Index (PSQI), Kessler psychological distress scale (K10), and Tanner stage to assess breast development were assessed at 0 and 3 months. Non-parametric ANCOVA were used to compare differences between groups. Results: Compared with controls over 3 months, there was no difference in PSQI (P=0.35), K10 (P=0.64) or Tanner stage (P=0.42). There was no significant difference in the proportion of individuals with clinically significant improvement in PSQI (25% vs. 22%, P=0.84). One individual had a significant deterioration in psychological distress that improved following cessation of progesterone. Conclusions: Low-dose progesterone was not associated with changes in sleep quality, psychological distress, or breast development over three months follow-up, though there was significant inter-individual variability. Larger, placebo-controlled trials are required to further evaluate different doses of progesterone in feminising hormone therapy regimens.

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“… 76 Consistently, progesterone showed sleep-promoting effects in postmenopausal women. 26 , 77 , 78 Furthermore, besides progesterone also estradiol contributes to the regulation of sleep stages. 27 In men, low testosterone levels were associated with impaired sleep.…”

Section: Discussionmentioning

confidence: 99%

Non-Right Handedness is Associated with More Time Awake After Sleep Onset and Higher Daytime Sleepiness Than Right Handedness: Objective (Actigraphic) and Subjective Data from a Large Community Sample

Taubert¹,

Schroeter²,

Sander³

et al. 2022

NSS

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Purpose Handedness has been linked to various physiological and pathological phenomena including memory function and psychiatric disorders. Also for sleep, several studies have reported associations. However, large-scale studies including a broad age span of participants and studies analyzing women and men separately are lacking. Methods Therefore, objective sleep data were determined using at-home actigraphy from 1764 healthy participants (18 to 80 years, 908 women), averaging five consecutive nights. In addition, subjective sleep-related data were captured by self-report diaries, the Pittsburgh Sleep Quality Index (PSQI), the Epworth Sleepiness Scale (ESS) and the Morningness-Eveningness-Questionnaire (MEQ). Handedness was determined with the Edinburgh Handedness Inventory (EHI) providing information on the direction (left vs right) and the degree of handedness (strong vs weak). To address the potential endocrine effects, premenopausal women (≤45 years) and postmenopausal women (≥55 years) were analyzed separately. This was also done for men. Results The degree and direction of handedness were correlated with “wake after sleep onset” (WASO) in the total sample and all women (the more right-handed/lateralized the shorter WASO). In postmenopausal women, additionally, time in bed (TIB) and total sleep time (TST) were correlated. There were no other significant associations between an objective sleep variable and handedness. In both premenopausal women and >55-year-old men subjective quality of sleep (PSQI) was correlated with direction and degree of handedness (the more right-handed/lateralized the better). In the total sample and postmenopausal women, the degree and direction of handedness were negatively correlated with daytime sleepiness. The chronotype was not associated with handedness in any group. Conclusion While associations were not consistent in all groups, overall, right-handedness tended to be associated with better sleep and less daytime sleepiness. Handedness and sleep seemed to be differentially associated in women and men, being in line with endocrine interactions.

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Efficacy of Micronized Progesterone for Sleep: A Systematic Review and Meta-analysis of Randomized Controlled Trial Data

Cited by 16 publications

References 29 publications

Different regimens of menopausal hormone therapy for improving sleep quality: a systematic review and meta-analysis

Different regimens of menopausal hormone therapy for improving sleep quality: a systematic review and meta-analysis

Effects of low-dose oral micronised progesterone on sleep, psychological distress, and breast development in transgender individuals undergoing feminising hormone therapy: a prospective controlled study

Non-Right Handedness is Associated with More Time Awake After Sleep Onset and Higher Daytime Sleepiness Than Right Handedness: Objective (Actigraphic) and Subjective Data from a Large Community Sample

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