Bonduelle 1991.
| Methods | Single centre, parallel‐group design with no blinding Number of women randomized: n = 30 (15 in each treatment group) Withdrawals post‐randomization: n = 6 (2, selection criteria not met; 4, did not return), 5 from danazol group and 1 from NET group Loss to follow‐up: n = 8 (during treatment), 4 from each group, all because of adverse events | |
| Participants | Patients (with mean ages 39 and 32) recruited from the Menstrual Disorders Clinic at the Royal Infirmary, Glasgow, UK Inclusion criteria: complaint of MBL requiring > 5 pads/tampons/day for > 6 days in cycle; presence of flooding or clots on any day of the cycle; presence of secondary anaemia; excessive MBL proving socially and domestically disruptive. Exclusion criteria: underlying pathology (from history, examination and D&C within the last year) | |
| Interventions |
Duration: 3 cycles (1 pre‐treatment) |
|
| Outcomes | Duration of menstruation (days) Prevalence of side effects | |
| Notes | Considered by authors to be a "pilot study". Poor‐quality trial because of high proportion of participants excluded or lost to follow‐up No source of funding given |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomization technique not stated |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) PBAC, satisfaction, Adverse effect, response to treatment, bleeding | High risk | Open trial, with different dosage schedule. All outcomes likely to be influenced by lack of blinding |
| Blinding of participants and personnel (performance bias) Haematin alkaline | Unclear risk | Alkaline haematin was not measured. |
| Blinding of outcome assessment (detection bias) PBAC, satisfaction, Adverse effect, response to treatment | High risk | Open trial, all outcomes likely to be influenced by lack of blinding |
| Blinding of outcome assessment (detection bias) Haematin Alkaline | Unclear risk | Alkaline haematin was not measured. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 30 women randomized, 6 lost post randomization and 8 during treatment |
| Selective reporting (reporting bias) | Unclear risk | No protocol available |
| Other bias | Low risk |
Similar at baseline: yes Disclaimer: not stated CoI: not stated Source of funding: not given |