Egarter 1996.
Methods | Randomised controlled trial | |
Participants | 129 women with physiological menopause (for ≥ 12 months), mean age 53 years | |
Interventions |
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 |