Chang 1996.
Study characteristics | ||
Methods | Trial design: "Randomised comparative study" | |
Participants | Participants: 45 women eligible; 45 were randomised and 33 were analysed. Mean age: 33 years (LA) Inclusion criteria:
Exclusion criteria: Setting: Taiwan Timing: not stated |
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Interventions | Leuprorelin acetate 3.75 mg SC depot every 28 days for 20 weeks (n = 30) versus Danazol 200 mg QID (800 mg/day) PO for 20 weeks (n = 15) |
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Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Need raw data for pain. Authors contacted, and additional methodological data provided, no raw data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomisation was in the ratio two LA to one danazol with this study having its randomisation list". No further details of method used to generate the randomisation sequence were provided. |
Allocation concealment (selection bias) | Low risk | "sequentially numbered, identical containers of identical drugs". No further details were provided of method used to conceal allocation to treatment groups. |
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 | Low risk | Outcome assessors were blinded to treatment group. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No details were provided on attrition. |
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 |