Effects of a continuous-combined regimen of low-dose hormone therapy (oestradiol and norethindrone acetate) and tibolone on the quality of life in symptomatic postmenopausal women: A double-blind, randomised study

Polisseni, Álvaro Fernando; Andrade, Arnaldo F.B.; Ribeiro, Luíz Cláudio; Castro, Isabela Queirós; Brandão, Marcos Antônio Fernandes; Polisseni, Fernanda; Guerra, Martha de Oliveira

doi:10.1016/j.maturitas.2012.11.001

Cited by 17 publications

(15 citation statements)

References 34 publications

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“…Seven of the nine trials included a placebo treatment arm [15, 24–29], while 2 had parallel comparisons of MHT formulations [30, 31]. Therefore, the seven RCTs with placebo arm as comparator had similar interventions and reported sufficient quantitative data to allow for statistical pooling (Table 1).…”

Section: Resultsmentioning

confidence: 99%

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

et al. 2016

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Sleep complaints are reported by 40–60 % of menopausal women. Poor sleep is a risk factor for cardiovascular disease, diabetes, and obesity. The effect of menopausal hormone therapy on sleep quality is unclear. A systematic review and meta-analysis were conducted to summarize the efficacy of menopausal hormone therapy on self-reported sleep quality. Electronic databases (PubMed, Scopus, Ovid MEDLINE, EMBASE, EBM Reviews CENTRAL, and Psyclnfo) were searched from 2002 to October 2015. Randomized trials assessing the effect of menopausal hormone therapy with a minimum follow up of 8 weeks were included. Titles, abstracts, and full texts were screened independently and in duplicate. Primary outcome included sleep items within a questionnaire, scale or diary. Standardized mean differences across trials were pooled using random-effects models. The search identified 424 articles, from which 42 trials were included. Seven trials at a moderate to high risk of bias enrolling 15,468 women were pooled in meta-analysis. Menopausal hormone therapy improved sleep quality in women who had vasomotor symptoms at baseline [standardized mean difference −0. 54 (−0. 91 to −0. 18), moderate quality evidence]. No difference was noted when women without such symptoms were analyzed separately or combined. Across 31 sleep quality questionnaires, daytime dysfunction was the most evaluated sleep domain. Menopausal hormone therapy improves sleep in women with concomitant vasomotor symptoms. Heterogeneity of trials regarding study population, formulations, and sleep scales; limit overall certainty in the evidence. Future menopausal hormone therapy trials should include assessment of self-reported sleep quality using standardized scales and adhere to reporting guidelines.

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Section: Resultsmentioning

confidence: 99%

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

et al. 2016

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“…Of these, 330 were excluded; 59 included fewer than 20 women per study arm and 54 were not an RCT; 126 did not clearly state a sample size calculation; 52 did not measure vasomotor symptoms as the primary outcome; 39 were secondary analysis. Following these exclusions, 214 RCT were included…”

Section: Resultsmentioning

confidence: 99%

“…The second largest group was composite outcomes, all of which included vasomotor symptoms as one of the parameters. Nine trials assessed quality of life and five trials assessed interference as primary outcomes (Table ).…”

Section: Resultsmentioning

confidence: 99%

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Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Iliodromiti

Wang

Lumsden

et al. 2019

BJOG

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Background There is substantial variation in how menopausal vasomotor symptoms are reported and measured among intervention studies. This has prevented meaningful comparisons between treatments and limited data synthesis. Objectives To review systematically the outcome reporting and measures used to assess menopausal vasomotor symptoms from randomised controlled trials of treatments. Search strategy We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials from inception to May 2018. Selection criteria Randomised controlled trials with a primary outcome of menopausal vasomotor symptoms in women and a sample size of at least 20 women per study arm. Data collection and analysis Data about study characteristics, primary vasomotor‐related outcomes and methods of measuring them. Main results The search identified 5591 studies, 214 of which were included. Forty‐nine different primary reported outcomes were identified for vasomotor symptoms and 16 different tools had been used to measure these outcomes. The most commonly reported outcomes were frequency (97/214), severity (116/214), and intensity (28/114) of vasomotor symptoms or a composite of these outcomes (68/214). There was little consistency in how the frequency and severity/intensity of vasomotor symptoms were defined. Conclusions There is substantial variation in how menopausal vasomotor symptoms have been reported and measured in treatment trials. Future studies should include standardised outcome measures which reflect the priorities of patients, clinicians, and researchers. This is most effectively achieved through the development of a Core Outcome Set. This systematic review is the first step towards development of a Core Outcome Set for menopausal vasomotor symptoms. Tweetable summary Menopausal hot flushes and night sweats have been reported in 49 different ways in clinical research. A core outcome set is urgently required.

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“…In a large trial of postmenopausal women with coronary artery disease, EPT was associated with improved quality of life and reduction of depressive symptoms in women with climacteric symptoms (hot flushes) relative to the placebo group, whereas no significant difference was found in women without menopausal symptoms. 19 Polisseni et al 68 found improvement in quality of life (including the depressed mood domain), relative to baseline, in postmenopausal women aged 45 to 60 years even 8 weeks after the end of a 4-week cycle of oral EPT (1 mg estradiol + 0.5 mg norethindrone). However, no significant difference was found in comparison with the control group (calcium carbonate plus vitamin D 3 ) or with the group receiving tibolone 2.5 mg.…”

Section: Ept and Moodmentioning

confidence: 99%

Hormone therapy and mood in perimenopausal and postmenopausal women

2015

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Effects of a continuous-combined regimen of low-dose hormone therapy (oestradiol and norethindrone acetate) and tibolone on the quality of life in symptomatic postmenopausal women: A double-blind, randomised study

Cited by 17 publications

References 34 publications

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

Efficacy of menopausal hormone therapy on sleep quality: systematic review and meta-analysis

Variation in menopausal vasomotor symptoms outcomes in clinical trials: a systematic review

Hormone therapy and mood in perimenopausal and postmenopausal women

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