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

Rolland 1990.

Study characteristics
Methods Trial design: parallel, randomised, double‐blind, double‐placebo study
Participants Participants: 194 women were randomised; 170 were analysed.
Mean age: between 18 and 45 years
Inclusion criteria:
  • Laparoscopically confirmed endometriosis

  • 18‐45 years old

  • Body weight of 45‐110kg

  • Menstrual cycle of 24‐36 days

  • Symptomatic

  • Not pregnant

  • Negative pap smear test


Exclusion criteria:
  • Prescence of amenorrhoea

  • Interfering concurrent disease

  • Surgical treatment at baseline laparoscopy or within 6 months prior to study

  • Gonadal hormone or danazol use within 3 months prior to study

  • Simultaneous participation in other studies


Setting: 13 medical centres in seven European countries
Timing: not stated
Interventions Nafarelin 200 μg twice daily IN + placebo PO twice daily for 6 months (n = 127)
versus
Danazol 200 mg twice daily PO + placebo IN twice daily for 6 months (n = 67) 
Outcomes
  • Pain defined by symptoms severity score

  • Adverse effects 

  • AFS score

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Authors contacted regarding methods and data. Letter returned with author unknown at Department
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomised 2:1 nafarelin: danazol. 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 Low risk Double‐placebo, double‐blind study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐placebo, double‐blind study
Incomplete outcome data (attrition bias)
All outcomes Low risk Details for attrition:
  • 20 in nafarelin and 4 in danazol group withdrew due to:

    • adverse effects 7 (Naf) vs 2 (Dan)

    • intercurrent illness 1 (Naf) vs 2 (Dan)

    • personal reasons 3 (Naf)

    • lost to follow‐up 3 (Naf)

    • lack of drug efficacy 1 (Naf)

    • other 5 (Naf)


Nafarelin: 20/127 discontinued treatment.
Danazol: 4/67 discontinued treatment.
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