Ross 1999.
Methods | Parallel‐group RCT | |
Participants | 36 perimenopausal women (amenorrhoea ≥ 3 months), > 45 years old, with no past psychotic history nor current use of antidepressants or psychotherapeutic agents. All participants "suffering from menopausal symptoms and requesting HRT" | |
Interventions | • Tibolone 2.5 mg/d • 0.625 mg conjugated oestrogens daily for 28 days, plus 150 μg norgestrel daily on days 17 to 28 Administered for 12 weeks |
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Outcomes | Women’s Health Questionnaire (subscales on vasomotor symptoms, sleep ) Greene’s Climacteric Scale (subscale on vasomotor symptoms) |
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Notes | Timing: unclear Trial location: Scotland Multi‐centre: no; single site |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by pre‐generated, sequential randomisation lists |
Allocation concealment (selection bias) | Low risk | Used a block size of 10, and each packet was given a code number. Copies of the code were kept in opaque sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Study authors state that some of the women knew which drug they were on. Therefore, it is likely that clinicians/researchers had been unblinded too |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Incomplete blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | 22% of participants withdrew (2 in tibolone group and 6 in HT group) |
Selective reporting (reporting bias) | Unclear risk | Study protocol not available |
Conflict of interest | High risk | Study funded by Organon |