Reid 2005.
| Methods | Randomisation by random permuted blocks by computer Parallel group design, single centre with no blinding 51 women randomised and analysed Number of withdrawals: MFA (4 discontinued: 1 for non‐compliance, 2 diarrhoea and 1 treatment ineffective); LNG IUS (4 discontinued: 2 partial expulsion and 2 full expulsion). ITT analysis Power calculation for sample size Source of funding: Schering |
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| Participants | Luton and Dunstable Hospital NHS Trust, UK Women aged 18–47 years, mean 39 years; in good general health; referred by general practitioners or self‐referred following advertisements; regular, ovulatory menstrual cycles (21–35 days); objective idiopathic menorrhagia (MBL > 80 mL/cycle confirmed in at least 1 cycle up to 4 months before study by the alkaline haematin method) Exclusion criteria: undiagnosed, abnormal bleeding, anovulatory; submucous fibroids or fibroids with total volume > 5 cm3; uterine size on ultrasound > 20 cm; abnormal cervical cytology; untreated hypertension; abnormal thyroid or liver function tests; asthma; IUCD in situ; treated for menorrhagia or used hormonal contraception in previous 4 months |
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| Interventions | Group 1: MFA 500 mg 3 times daily, days 1–4 of cycle) Group 2: LNG IUS duration 6 months |
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| Outcomes | MBL | |
| Notes | ITT analysis Data on MBL given |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random permuted blocks by computer |
| Allocation concealment (selection bias) | Low risk | Quote: "Randomisation and preparation of consecutively numbered, opaque, sealed envelopes was performed by Schering Oy (Finland). Women were allocated treatment by the author (PCR) opening the next numbered envelope, after screening, in the presence of the patient". |
| Blinding (performance bias and detection bias) All outcomes | High risk | No blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 8/51 women (4 from MFA group: 1 for non‐compliance, 2 for diarrhoea, 1 treatment ineffective; 4 from LNGIUS group: 2 for partial expulsion, 2 for full expulsion), ITT analysis |
| Other bias | Unclear risk | Nothing detected |