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

Egarter 1996.

Methods Randomised controlled trial
Participants 129 women with physiological menopause (for ≥ 12 months), mean age 53 years
Interventions
  • Tibolone 2.5 mg/d

  • Oestradiol 2 mg + medrogestone 2 × 5 mg/d for 12 days/mo


For 6 months
Outcomes Unscheduled bleeding, severity of menopausal symptoms (hot flashes, insomnia, vaginal dryness)
Notes Data on unscheduled bleeding reported in a graph but number of events unclear
Timing: not reported
Location: Austria
Multi‐centre: 5 sites
To register severity of climacteric symptoms, a modified Kupperman Index was used
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 High risk Open label
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Open label
Incomplete outcome data (attrition bias) 
 All outcomes High risk Participants lost to follow‐up: 19.4% in tibolone group, 34.6% in combined HT group
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest Unclear risk Not reported