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

Elfituri 2005.

Methods Randomised controlled trial
Participants 100 healthy Lybian women with a uterus, with natural or surgical menopause, with menopausal symptoms. All had received no previous oestrogen and/or progestogen in preceding 12 months. 1 to 9 years since menopause (mean 2 years). Mean age 44.3 years
Interventions
  • Tibolone 2.5 mg/d

  • 17beta‐oestradiol 2 mg sequentially combined with dydrogesterone 10 mg


For 1 year
Outcomes Unscheduled bleeding, endometrial cancer, vasomotor symptoms quantified as none (0), mild (1), moderate (2) and severe (3)
Notes Timing: not reported 
 Location: Lybia
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 Unclear risk No information provided
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not specified, but given the nature of outcomes assessed, their evaluation is likely to be "objective"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Reasons given for withdrawals/dropouts (2 women)
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest Unclear risk Not reported