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

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
Outcomes Women’s Health Questionnaire (subscales on vasomotor symptoms, sleep )
Greene’s Climacteric Scale (subscale on vasomotor symptoms)
Notes Timing: unclear
Trial location: Scotland
Multi‐centre: no; single site
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