Magos 1986.
Methods | Randomized double blind placebo‐controlled parallel trial | |
Participants | Women aged 25 to 45 years, with regular periods and confirmed PMS on at least 1 of the 6 clusters in the MDQ during prospective daily symptom ratings. | |
Interventions | Subcutaneous oestradiol implants versus placebo, 33 women given 100 mg subcutaneous oestradiol implant with 5 mg oral norethisterone for 7 days per cycle. 35 women given placebo implant with 5 mg placebo for 7 days per cycle. Duration: 2 consecutive cycles. |
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Outcomes |
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Notes | Trial was conducted in the UK and sponsored by a King's College Voluntary Research Trust. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number table |
Allocation concealment (selection bias) | Low risk | Independent physician concealed the allocation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Identical looking implants used, dispensed by independent physician |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Patient‐reported scores |
Incomplete outcome data (attrition bias) All outcomes | High risk | 20% of patients lost to follow‐up due to incomplete data |
Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
Other bias | Low risk | All data reported, no specific reasons to suspect other bias |