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

Bergqvist 2000.

Study characteristics
Methods Trial design: Randomised controlled trial
Participants Participants: 252 women were randomised; 224 were analysed.
Mean age: 18‐45 years (median 31 years)
Inclusion criteria:
  • Regular menstruating

  • Not been on sex hormones (including oral contraceptives) within 2 months of treatment

  • Not received GnRH agonist therapy within the previous 6 months and not for more than 3 months altogether

  • Not pregnant or breastfeeding


Exclusion criteria:
  • Women with serious renal, hepatic, hematopoietic or endocrine disease, or with allergic rhinitis


Setting: Scandinavia (28 centres = 7 centres in Sweden, 8 centres in Norway, 6 centres in Denmark and 7 centres in Finland)
Timing: not stated
Interventions Goserelin depot, 3.6 mg, administered subcutaneously into the anterior abdominal wall every 28 ±3 days (Zoladex; AstraZeneca) (n = 130) 
versus 
Nafarelin 200 μg nasally twice daily, giving a total daily dose of 400 μg (Synarel; Syntex) (n = 122)
Outcomes
  • Overall relief of pain (pelvic symptoms)

  • Adverse effects

  • Menstrual details

  • Extent of endometriosis (rAFS, ADI scores)

  • Haematological parameters: follicle‐stimulation hormone (FSH), luteinising hormone (LH), oestradiol, creatinine, urea, sodium and potassium in plasma

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: The study was supported by AstraZeneca Pharmaceuticals, Alderley Park, Macclesfield, Cheshire SK10 4TF, UK.
 
Authors contacted regarding methods and data. Awaiting response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomisation was being performed within each centre. No further details were provided of method used to generate the randomisation sequence. 
Allocation concealment (selection bias) Unclear risk No details were provided of method used to conceal treatment group allocation.  
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 Altogether, 39 women withdrew from the study, four of whom commenced any therapy, two because they changed their minds and two because they became pregnant between the date of randomisation and the planned date of starting the trial medication. Twenty‐four patients withdrew during the active treatment period, adverse events being the most common reason. Sixteen women, nine in the goserelin group and seven in the nafarelin group, withdrew owing to adverse events, two women in the nafarelin group, withdrew because of local side effects of the treatment such as nasal irritation, one woman because of a worsening of symptoms and five for other reasons. 
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