Wender 2004.
Methods | Randomised double‐blind placebo‐controlled trial | |
Participants | 40 healthy postmenopausal women, mean age 55 years, mean time since natural menopause 5 to 7.7 years, mean BMI 26 kg/m2 | |
Interventions |
For 1 year |
|
Outcomes | Endometrial thickness, endometrial cancer, uterine bleeding | |
Notes | Timing: not specified Location: Brasil Single centre |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | page 424: “the tibolone and the placebo tablets and bottles looked identical; the bottles were identified with numbers from 1 to 40. The correspondence between the numbers and the group to which the participant belonged was not disclosed until the end of the study” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | page 424: “all ultrasonographic exams were performed at the Hospital’s Gynecology and Obstetrics Service by the same operator, who was blinded to information concerning participant groups. […] “ The material was analysed twice by 2 pathologists who were also blinded to participant information” |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for withdrawal given: 3 participants/group withdrew from the study
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Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Conflict of interest | Unclear risk | No details given |