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. 2010 Dec 8;2010(12):CD008475. doi: 10.1002/14651858.CD008475.pub2

Palagiano 1994.

Study characteristics
Methods Trial design: Randomised, open study
Participants Participants: 50 women were randomised, 47 were analysed
Age: 20‐40
Inclusion criteria:
  • Laparoscopically diagnosed endometriosis

  • No treatment for endometriosis within previous 12 months


Exclusion criteria:
Setting: Italy
Timing:
Interventions Leuprolide acetate 3.75mg IM monthly for 6 months (n=30)
versus
Danazol 600mg OD PO for 6 months (n=20)
Outcomes Dysmenorrhoea, dyspareunia, pelvic pain
Adverse effects
Notes Intention‐to‐treat analysis:
Sample size calculation:
Funding:
Authors contacted regarding methods and replied
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "randomly allocated"
Allocation concealment (selection bias) Low risk Randomisation done by a pharmacy
Blinding (performance bias and detection bias)
All outcomes High risk Open study
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Withdrawals after randomisation <10%
"drop out patients without M.D. consultation"
Selective reporting (reporting bias) Low risk All primary outcomes stated were reported on