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. 2016 Oct 12;2016(10):CD008536. doi: 10.1002/14651858.CD008536.pub3

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
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