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. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

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: 
  • Laparoscopic diagnosis of endometriosis 

  • Pain symptoms 


Exclusion criteria: 
Setting: Taiwan 
Timing: not stated
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)
Outcomes
  • Dysmenorrhoea, dyspareunia, pelvic pain

  • Adverse effects

  • Change in AFS score

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
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