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
|
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
| Conflict of interest | Unclear risk | No details given |