Polisseni 2013.
Methods | Randomised double‐blind controlled trial | |
Participants | 174 postmenopausal women between 45 and 60 years of age with moderate or pronounced vasomotor symptoms and a Blatt–Kupperman menopausal index (BKMI) ≥ 20 points, with no treatment for menopausal symptoms in the past 6 months | |
Interventions | Tibolone 2.5 mg/d; 1 mg oestradiol + 0.5 mg norethindrone acetate; 50 mg calcium carbonate and 200 UI vitamin D3 (not considered in the meta‐analysis) | |
Outcomes | Vasomotor symptoms, insomnia (measured through the Women’s Health Questionnaire) | |
Notes | Trial location: Brazil (single centre) Follow‐up: 12 weeks Timing: June 2009 to June 2011 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated list of random numbers |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind trial; study authors declared that all capsules appeared identical |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
Incomplete outcome data (attrition bias) All outcomes | High risk | 47 participants lost to follow‐up (with differential attrition among groups); only treated women appear to have been assessed |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Conflict of interest | Low risk | Study authors declare that they have no conflicts of interest |