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. 2016 Oct 12;2016(10):CD008536. doi: 10.1002/14651858.CD008536.pub3

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
  • Tibolone 2.5 mg/d

  • Placebo


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
  • Placebo: 1 owing to dizziness, 2 owing to intense climacteric symptoms that did not improve

  • Tibolone: 1 moved to another city, 2 because of missing appointments

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