Gallagher 2001.

Methods	Pooled data from 1 randomised placebo‐controlled trials
Participants	770 healthy postmenopausal Caucasian or Asian women, mean duration of menopause 2.5 years, without osteoporosis (BMD of lumbar vertebrae within 2 standard deviations of age‐matched mean). Mean age: 52.4 years
Interventions	Tibolone 0.3 mg/d Tibolone 0.625 mg/d Tibolone 1.25 mg/d Tibolone 2.5 mg/d Placebo For 2 years. All groups also received 500 mg/d of calcium
Outcomes	Hot flashes, endometrial hyperplasia, endometrial cancer, thromboembolic events
Notes	Timing: not reported Location: USA Multi‐centre: more than 20 centres per study
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Defined by study authors as randomised but no details given on random sequence generation
Allocation concealment (selection bias)	Unclear risk	No details given
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Identical appearing tibolone and placebo tablets
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not specified, but given the nature of outcomes assessed, their evaluation is likely to be "objective"
Incomplete outcome data (attrition bias) All outcomes	High risk	85% of randomised participants analysed
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	High risk	Financed by drug manufacturer, no declaration of conflicts of interest