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

Bouchard 2012.

Methods Randomised double‐blind placebo‐controlled trial
Participants 485 postmenopausal women 40 to 65 years of age, seeking treatment for hot flushes, who had completed their last natural menstrual period 12 months before screening (or had a follicle‐stimulating hormone (FSH) level 40 mIU/mL). Women had intact uterus, BMI ≤ 34 and minimum of 7 moderate and severe hot flushes per day, or 50 moderate and severe hot flushes per week, recorded for 7 consecutive days during screening. Mean age: 53.6 years
Interventions Tibolone 2.5 mg/d, placebo, desvenlafaxine 100 mg/d (not considered in meta‐analyses)
Outcomes Hot flushes (frequency), hot flushes (severity, through the Greene climacteric scale), uterine bleeding, endometrial cancer
Notes Multi‐centre trial (35 sites in Europe, 2 sites in South Africa, 1 site in Mexico)
Timing: unclear
Follow‐up: 12 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information provided
Allocation concealment (selection bias) Unclear risk No information provided
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Study authors declare that this is a double‐blind trial but do not provide information on blinding methods
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information provided
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 2 participants in each of tibolone and placebo groups not assessed for taking study medications for less than 5 days
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest High risk Study sponsored by Wyeth; 4 study authors are former Wyeth or current Pfizer employees