Baracat 2002.

Methods	Randomised controlled trial; open label, multi‐centre
Participants	85 generally healthy postmenopausal women, with an intact uterus, in menopause for ≥ 4 years, absence of endometrial hyperplasia, mean age 52 years
Interventions	Tibolone 2.5 mg/d CEE/MPA 0.625 mg/5.0 mg/d For 13 treatment cycles, each of 28 days
Outcomes	Hot flushes, unscheduled bleeding, vaginal dryness, painful intercourse, endometrial hyperplasia
Notes	Timing: not available Location: Brasil Multi‐centre: number of sites not specified Hot flushes not measured with a validated score (frequency and intensity of hot flushes for each participant in each cycle were calculated as the sum of the mean # of hot flushes per day multiplied by the respective score (1 = mild, 2 = moderate, 3 = severe)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Describe: “the randomization was performed in balanced blocks of ten subjects using the table of aleatory numbers; each study center received 20 envelopes with the number of the subject and respective code (treatment group)” (p 62)
Allocation concealment (selection bias)	Low risk	Describe: “the randomization was performed in balanced blocks of ten subjects using the table of aleatory numbers; each study center received 20 envelopes with the number of the subject and respective code (treatment group)” (p 62)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Describe: open‐label design
Blinding of outcome assessment (detection bias) All outcomes	High risk	Describe: participants unblinded to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Low risk	Describe: similar rates of discontinuation, reasons given
Selective reporting (reporting bias)	Unclear risk	Study protocol not available
Conflict of interest	High risk	Describe: sponsored by manufacturer of CEE/MPA