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

Odukoya 1995.

Study characteristics
Methods Trial design: Randomised study
Participants Participants: 21 women were randomised and analysed.
Mean age: 33 ± 5 years
Inclusion criteria:
  • Laparoscopically diagnosed endometriosis

  • Pelvic pain


Exclusion criteria: not stated
Setting: United Kingdom
Timing: not stated
Interventions Leuprolide acetate 3.75 SC monthly for 3 months (n = 10)
versus
Danazol 400 mg daily PO for 3 months (n = 11)
 
Outcomes
  • Relief of overall pain (Biberoglu + Behrman scale)

  • Serum soluble CD23  

Notes Intention‐to‐treat analysis: Yes
Sample size calculation: not stated
Funding: not stated
Note previous version: Authors contacted regarding methods (blinding) and SD data; awaiting response
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was "computer generated". No further details of method used to generate the randomisation sequence were provided. 
Allocation concealment (selection bias) Low risk "concealed in an envelope only opened at commencement of treatment". No further 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 trial 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 No losses to follow‐up
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