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

Shaw 1990.

Study characteristics
Methods Trial design: Multi‐centre, placebo‐controlled, randomised trial
Participants 82 women were randomised; 74 were analysed.
Mean age: not stated
Inclusion criteria:
  • Endometriosis


Exclusion criteria: not stated
Setting: United Kingdom (2 sites)
Timing: not stated
Interventions Nafarelin 200 mcg BD IN + placebo PO for 6 months (n = 55)
versus
Danazol 200 mg three times a day PO + placebo IN for 6 months (n = 26)
Outcomes
  • Improvment of most troublesome symptom: dysmenorrhoea, dyspareunia, pelvic pain, pelvic tenderness and induration combined

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Note previous version: Authors contacted but unable to provide further details as trial was almost 20 years old
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomized". 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 Participants were blinded and received placebo nasal spray or tablets.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk Details for attrition given: 8 withdrew:
  • Nafarelin = 3 due to side effects, 1 left country, 1 poor compliance 

  • Danazol = 2 due to side effects, 1 poor compliance 

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