Jacobsen 2012.
| Methods | Randomised double‐blind double‐dummy placebo‐controlled trial | |
| Participants | 318 community‐living women > 70 years of age | |
| Interventions | Tibolone 1.25 mg/d, placebo, raloxifene 60 mg/d (not considered in the meta‐analysis) for 24 months | |
| Outcomes | Cardiovascular events (TIA; cerebrovascular events; myocardial infarction) | |
| Notes | Trial location: Netherlands (single centre) Timing: July 2003 to Jan 2008 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Block randomisation with computer‐generated list of random numbers |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind trial; study authors declared that use of double dummy blinded participants |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information provided |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Substantial losses to follow‐up (already > 20% at 3 months) |
| Selective reporting (reporting bias) | Low risk | Study reported data on outcomes as indicated in the protocol. Additional data on cardiovascular and cerebrovascular events available in the study publication and included in this review |
| Conflict of interest | Low risk | Sponsored by the Dutch Organization for Health Research and Development. Study authors declare that they have no conflicts of interest |