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 |