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 |
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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 |