Cheng 2005.
Study characteristics | ||
Methods | Trial design: "Randomised, parallel, comparative study" | |
Participants | Participants: 59 women eligible; 59 were randomised and 41 were analysed for efficacy. Mean age: 34.8 ± 6.6 (nafarelin) and 32.4 ± 7.2 (danazol) Inclusion criteria:
Exclusion criteria:
Setting: Taiwan Timing: started in January 1998 and ended in October 2000 |
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Interventions | Nafarelin acetate 200 μg twice daily (400 μg/day) IN for 180 days (n = 29) versus Danazol 200 mg (600 mg/day) PO for 180 days (n = 30) | |
Outcomes |
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Notes | Intention‐to‐treat analysis: yes Sample size calculation: not stated Funding: This study was partly supported by a grant (VGH94‐ 195) from Taipei Veterans General Hospital, Taipei, Taiwan, R.O.C. Note previous version: Authors provided additional data on methods. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation done by a pharmacy. Authors provided additional data to previous authors, and therefore this study was assigned as having low risk of bias. |
Allocation concealment (selection bias) | Low risk | Sealed, opaque, sequentially numbered, identical envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Investigators, outcome assessors and clinicians were blinded according to author. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators, outcome assessors and clinicians were blinded according to author. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "All 59 patients were considered as the intent‐to‐treat population". Forty‐one of 59 patients (22/29 nafarelin and 19/30 danazol recipients) who completed 90 days’ treatment, and who underwent laparoscopic examinations before and after treatment, qualified for the efficacy evaluation. |
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 |