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

Benedek‐Jaszmann 1987.

Methods Parallel‐group RCT
Participants 60 healthy postmenopausal women 44 to 61 years old, with hot flushes, who had undergone natural or surgical menopause and were experiencing hot flushes and associated symptoms
Interventions
  • Tibolone 2.5 mg/d

  • Placebo 1 tablet/d


Administered for 1 year
Outcomes Hot flushes, insomnia
Following scoring system used for clinical parameters: absent = 0, mild = 1, moderate = 2, strong = 3
Notes Menopausal symptoms measured on a non‐validated scale
Timing: unclear
Trial location: Netherlands
Multi‐centre: no; single site
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 Low risk Study authors state that the trial is double‐blind and that identical‐looking placebo tablets have been used
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Outcomes evaluated through a questionnaire with insufficient information to judge whether outcome measurement could have been influenced
Incomplete outcome data (attrition bias) 
 All outcomes High risk 17/60 participants dropped out. Unclear how many were randomised to each group
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest Unclear risk No information provided