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

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
  • Tibolone 2.5 mg/d

  • Tibolone 1.25 mg/d

  • Placebo


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