de Aloysio 1998.

Methods	Randomised controlled trial
Participants	50 women, 13 to 30 months since menopause (mean 20 months); 1 to 4 submucous or intramural asymptomatic uterine leiomyomas (with longest diameter ranging from 3 to 8 cm); body mass index (BMI) < 28; without blood coagulation disease; without endometrial pathology. Mean age: 51 years
Interventions	Tibolone 2.5 mg/d Conjugated equine oestrogens (CEE), 0.625 mg/d plus medroxyprogesterone acetate (MPA), 5 mg/d Administered for twelve 28‐day cycles
Outcomes	Irregular bleeding, endometrial hyperplasia
Notes	Bleeding measured as incidence of bleeding cycles/number of cycles Timing and trial location unclear Multi‐centre: no information provided
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	No information provided
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Not specified, but given the nature of the outcome assessed (endometrial hyperplasia), its evaluation is likely to be "objective"
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	3 participants excluded from analysis for non‐compliance (reasons not related to the study but not better specified)
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	Unclear risk	Not financed by drug manufacturer; other conflicts of interest not stated