Hudita 2003.

Methods	Randomised placebo‐controlled trial
Participants	162 healthy, non‐obese, postmenopausal women (with evidence of ≥ 12 months of amenorrhoea with levels of FSH > 30 mlU/mL and of 17β‐oestradiol < 50 pg/mL), between 40 and 65 years of age (mean age 55), with an intact uterus
Interventions	Tibolone 2.5 mg/d Tibolone 1.25 mg/d Placebo Administered for 24 weeks
Outcomes	Vaginal bleeding and spotting, hot flushes, sweating, vaginal dryness
Notes	Used a non‐validated scale to assess menopausal symptoms; they were reported also as frequency reduction from baseline Timing: unclear Location: Romania Multi‐centre: no; single site
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	Defined as "double‐blind" but no other specific information provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No information provided about assessment of vaginal bleeding; unclear if trial is truly "double‐blind"
Incomplete outcome data (attrition bias) All outcomes	High risk	42/162 participants not analysed because of adverse events, loss to follow‐up, lack of efficacy, etc
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	Unclear risk	Not reported