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

Burry 1992.

Study characteristics
Methods Trial design: "Multi‐centre, double‐blind study"
Participants Participants: 169 women eligible; 169 were randomised and 147 analysed for efficacy.
Mean age: not stated
Inclusion criteria:
  • Laparoscopically diagnosed endometriosis


Exclusion criteria: not stated
Setting: United States of America
Timing: not stated
Interventions Nafarelin 400 μg daily IN for 6 months (n = 111)
versus
Danazol 600 mg daily PO for 6 months (n = 58)
Outcomes
  • Adverse effects

  • Quality of life score 

  • Improvement of most troublesome symptom

  • Change in laparoscopic scores

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Note previous version: Need more info on randomisation and participants and raw data for quality of life. Authors contacted, awaiting response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The randomisation procedure assigned two of
every three patients to receive nafarelin, 400 μg daily (n = 111), and one of three patients to danazol, 600 mg daily (n = 58). No further details were provided of method used to generate the randomisation sequence. 
Allocation concealment (selection bias) Unclear risk No details were provided of method used to conceal treatment group allocation.  
Blinding of participants and personnel (performance bias)
All outcomes Low risk The study was "double‐blind". No further details were provided on the method of blinding.
Blinding of outcome assessment (detection bias)
All outcomes Low risk The study was "double‐blind". No further details were provided on the method of blinding.
Incomplete outcome data (attrition bias)
All outcomes Low risk Sufficient details for attrition:
  • Side effects n = 6 (N) n = 3 (D)

  • Elevated liver enzyme n = 1 (D)

  • Administrative reasons n = 12

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