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

Cirkel 1995.

Study characteristics
Methods Trial design: "randomised controlled comparative clinical study"
Participants Participants: 60 women eligible; 60 were randomised and 55 were analysed.
Mean age: 30 ± 0.5 (triptorelin depot) and 30 ± 0.8 (danazol)
Inclusion criteria:
  • Laparoscopically diagnosed endometriosis

  • Premenopausal

  • No medication affecting pituitary or ovarian function in preceding 6 months


Exclusion criteria:
  • Stage I endometriosis


Setting: Germany
Timing: February 1989 and December 1990
Interventions Triptorelin 3.75 mg IM depot every 28 days for 24 weeks (n = 30)
versus
Danazol 200 mg three times a day (600 mg/day) PO for 24 weeks (n = 25)
 
Outcomes
  • Relief of overall pain: dysmenorrhoea, dyspareunia, pelvic pain, pelvic tenderness and induration

  • Adverse effects

  • Change in AFS score

  • Endocrine effects 

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Note previous version: Authors contacted and awaiting response regarding methods
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Patients were allocated to a computer‐generated randomisation list.
Allocation concealment (selection bias) Unclear risk No further details of method used to conceal allocation were provided.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Open‐label trial as blinding of study personnel and participants would not have been possible due to nature of the intervention.
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 High risk Five women assigned to danazol could not be included further: three patients refused to fulfill the protocol after randomisation and two others conceived spontaneously before starting medication.
Twenty‐four weeks after the end of endocrine therapy, 20 women (12/30 in the triptorelin and 8/25 in the danazol group) had an additional follow‐up for evaluation of clinical symptomatology as well as laboratory parameters.
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