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

Dmowski 1989a.

Study characteristics
Methods Trial design: "Open‐label, randomised, prospective study"
Participants Participants: 36 women eligible, 36 were randomised and 29 were analysed
Mean age: 30.8 ± 0.6 (SE) (range, 27 to 38 years)
Inclusion criteria: 
  • Laparoscopically diagnosed endometriosis within 3 months before enrolment in the study

  • No hormonal treatment 8 months prior to study entry


Exclusion criteria: not stated
Setting: United States of America
Timing: Not stated
Interventions Buserelin 400 μg three times a day (1200 μg/day) IN for 6 months (n = 10)
versus
Buserelin 200 mcg daily SC for 6 months (n = 9)
versus
Danazol 200 mg four times a day (800 mg/day) PO for 6 months (n = 10)
 
Outcomes
  • Relief of overall pain: dysmenorrhoea, dyspareunia, pelvic pain

  • Change in rAFS scores

  • Adverse effects 

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: supported in part by a grant from Hoechst‐Roussel Pharmaceuticals, Inc.
Note previous version: Authors contacted regarding allocation concealment
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk 2:1 buserelin: danazol. No further details of method used to generate the randomisation sequence were provided.
"Those who were randomised into Buserelin were given an option of SC injections or IN sprays of the drug".
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 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 Detail for attrition:
3 in SC buserelin, 2 in IN buserelin and 2 in danazol group. 2 withdrew for family reasons, 3 were non‐compliant, 1 had severe emotional side effects on IN buserelin and 1 was allergic to danazol.
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