Berning 2000.
Methods | Randomised placebo‐controlled trial | |
Participants | 94 healthy non‐smoking women, 1 to 3 years following spontaneous menopause (mean 22 months), with body mass index < 27 kg/m2, free of diseases or medication known to influence calcium metabolism or to contraindicate the trial medication. Mean age: 53 years | |
Interventions |
Administered for 2 years |
|
Outcomes | Vaginal bleeding | |
Notes | Timing: unclear Location: Netherlands Multi‐centre: number of sites not specified |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear what "random medication number" means |
Allocation concealment (selection bias) | Unclear risk | Method not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Although study authors do not state whether trial is double‐blind or single‐blind, they used identical looking interventions and a placebo control |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not specified, but given the nature of the outcome assessed, evaluation is likely to be "objective" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Bleeding: all randomised participants assessed |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Conflict of interest | High risk | Financed by the drug manufacturer. Study authors have conflicts of interest |