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

Vercellini 1994.

Study characteristics
Methods Trial design: Open‐label, randomised study
Participants Participants: 42 women were randomised and analysed.
Mean age: 
Group 1: 29 ± 6 years
Group 2: 31 ± 6 years
Inclusion criteria:
  • Diagnostic laparoscopy with no attempts at endometriosis reduction other than biopsy up to 3 months before study entry


Exclusion criteria: 
  • Treatment for endometriosis other than NSAID in the previous 3 months

  • Usual contraindications for danazol 

  • Unwillingness to use barrier contraception


Setting: Italy
Timing: not stated
Interventions Group 1: Danazol only, oraly 50 mg/day for 9 months (n = 21)
versus
Group 2: Leuprolide 3.75 mg in a 28‐day IM depot for 3 months, followed by oral danazol 50 mg/day for 6 months + danazol (n = 21)
Outcomes
  • Relief of overall pain: dysmenorrhoea, non‐menstrual pelvic pain, deep dyspareunia

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "Computer‐generated randomisation list". No further details of method used to generate the randomisation sequence were provided.
Allocation concealment (selection bias) Unclear risk No 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 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 5/42 withdrew from this study, one in each group at the fifth month of treatment (for persistent pain) and one in each group during follow‐up (they requested additional therapy). One women in the Danazol group was lost to follow‐up.
 
Group 1: 18/21 completed follow‐up.
Group 2: 19/21 completed 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