Winkler 2000.

Methods	Randomised controlled trial
Participants	62 healthy postmenopausal women, between 45 and 70 years of age (mean age 54 years), spontaneous menopause with last menstrual period ≥ 36 months before enrolment or artificial menopause (hysterectomy and/or oophorectomy) with FSH level > 30 IU/L (mean time since menopause 8.5 years)
Interventions	Tibolone 2.5 mg/d Oestradiol 2 mg/d + oestriol 1 mg/d + norethindrone acetate 1 mg/d Administered for 24 weeks
Outcomes	Vaginal bleeding/spotting (defined as requiring > 1/just 1 tampon/d), hot flushes, sweating
Notes	Menopausal symptoms measured as frequency but number of participants evaluated is unclear Timing: Feb 1995 to 1996 Location: Germany Multi‐centre: no; participants were selected from private practices of 2 specialists in Germany
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information provided. Concern because participants were selected from private practices of 2 specialists
Allocation concealment (selection bias)	Unclear risk	No information provided. Concern because participants were selected from private practices of 2 specialists
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐dummy
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not specified, but given self‐assessment of the outcome of interest (vaginal bleeding/spotting), its evaluation is likely to be "objective"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All women with a uterus were evaluated for vaginal bleeding/spotting
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	High risk	Financed by the drug producer. One study author was an employee of the drug producer