Dmowski 1989a.
Study characteristics | ||
Methods | Trial design: "Open‐label, randomised, prospective study" | |
Participants | Participants: 36 women eligible, 36 were randomised and 29 were analysed Mean age: 30.8 ± 0.6 (SE) (range, 27 to 38 years) Inclusion criteria:
Exclusion criteria: not stated Setting: United States of America Timing: Not stated |
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Interventions | Buserelin 400 μg three times a day (1200 μg/day) IN for 6 months (n = 10) versus Buserelin 200 mcg daily SC for 6 months (n = 9) versus Danazol 200 mg four times a day (800 mg/day) PO for 6 months (n = 10) | |
Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: supported in part by a grant from Hoechst‐Roussel Pharmaceuticals, Inc. Note previous version: Authors contacted regarding allocation concealment |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 2:1 buserelin: danazol. No further details of method used to generate the randomisation sequence were provided. "Those who were randomised into Buserelin were given an option of SC injections or IN sprays of the drug". |
Allocation concealment (selection bias) | Unclear risk | No details of method used to conceal allocation were provided. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided of blinding of participants or personnel |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided of blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Detail for attrition: 3 in SC buserelin, 2 in IN buserelin and 2 in danazol group. 2 withdrew for family reasons, 3 were non‐compliant, 1 had severe emotional side effects on IN buserelin and 1 was allergic to danazol. |
Selective reporting (reporting bias) | Low risk | The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | No other risk of bias detected |