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

Jelley 1986.

Study characteristics
Methods Trial design: "Open, prospective, randomised, parallel study", multi‐centre
Participants Participants: 80 women were randomised; 68 were analysed.
Median age: Buserelin = 28 and danazol = 30 
Inclusion criteria: 
  • Laparoscopically diagnosed endometriosis 18‐40 years old 

  • Symptomatic disease 

  • Active menstrual cycle 


Exclusion criteria: 
  • Previous use of danazol or hormone treatment without success 

  • Use of danazol within 6 months prior to study 

  • Serious endocrine disease or use of other drugs which may interfere with therapy 


Setting: UK 
Timing: not stated
Interventions Buserelin 300 mcg three times a day intranasally for 7 months (n = 34) 
versus 
Danazol 600 mg once daily per OS for 7 months (n = 34)
Outcomes
  • Relief of overall pain: Dysmenorrhoea, dyspareunia, pelvic pain, pelvic tenderness, induration 

  • Adverse effects

  • rAFS score

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Note previous version: Preliminary findings for the first 68 women treated only. Attempted to contact author regarding data. Author not contactable
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "The code was derived from random number tables". No further details were provided of method used to generate the randomisation sequence.
Allocation concealment (selection bias) Low risk "A sealed envelope was provided for each patient, and opened only after the patient's name had been entered on it".
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Open study, no blinding
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Open study, no blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Detail for attrition: 
  • 1 randomised patient failed to start treatment as her symptoms improved 

  • So far 4 have withdrawn from study due to adverse effects: 3 (Dan) and 1 (Bus)

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