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 |
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 |
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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 |