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

Siseles 1995.

Methods Randomised open‐label controlled trial
Participants 30 postmenopausal women ≥ 1 year postmenopausal and reporting hot flushes and other menopausal symptoms (but otherwise healthy). Age range 48 to 62 years
Interventions
  • Tibolone 2.5 mg/d

  • Conjugated oestrogens 0.625 mg/d continuously, medroxyprogesterone 5 mg/d sequentially for 12 days of each 28‐day cycle


Administered for six 28‐day cycles
Outcomes Hot flushes, sweating, sleeplessness, irregular bleeding, endometrial hyperplasia
Notes Menopausal symptoms measured through Kupperman Index but results available only as a graph
Bleeding not evaluable because insufficient information provided
Timing: June to Dec 1990
Trial location: Argentina
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 High risk Open trial
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not specified, but given the nature of the outcome of interest (endometrial hyperplasia), its evaluation is likely to be "objective"
Incomplete outcome data (attrition bias) 
 All outcomes High risk 6/30 patients excluded from final analyses
Selective reporting (reporting bias) Unclear risk Study protocol not available
Conflict of interest High risk Financed by drug manufacturer. Study authors' conflicts of interest not stated