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

Bergqvist 1997.

Study characteristics
Methods Trial design: "Double‐blind randomised study"
Participants Participants: 49 eligible women; 49 were randomised and 47 were analysed 
Mean age: mean age not stated, median age 30 years (range 21‐46years) 
Inclusion criteria: 
  • Laparoscopically diagnosed endometriosis 

  • Not to use any hormonal preparations during study 

  • No hormone treatment in previous 3 months 

  • No GnRHas for previous 12 months 

  • No steroid therapy for previous 12 months 


Exclusion criteria: not stated
Setting: Europe 
Timing: not stated
Interventions Nafarelin 200 mcg daily IN + placebo PO for 6 months (n = 12) 
versus 
Nafarelin 400 mcg daily IN + placebo PO for 6 months (n = 12) 
versus 
Nafarelin 200 mcg daily IN + norethisterone 1.2 mg daily PO for 6 months (n = 25)
Outcomes
  • Relief of overall pain: dysmenorrhoea, dyspareunia, pelvic pain, pelvic tenderness and induration 

  • Adverse effects 

  • AFS score

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Note previous version: Need raw data for symptom scores. Authors contacted regarding methods and data. No response to date
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomisation was carried out on a block basis". 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‐blinded, placebo‐controlled study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blinded, placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk Two participants (2/25) from the nafareline + norethisterone group withdrew from the trial due to mood swings (1 participant) and pregnancy (1 participant).
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