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. 2004 Jul 19;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2

Busacca 2001.

Methods Location: University of Milan, Italy
No. of centres: 1
Recruitment period: July 1997 to December 1999
Participants Inclusion criteria: < 40 yrs, laparoscopic diagnosis of endometriosis stage III‐IV 
 Exclusion criteria: previous medical or surgical therapy for endometriosis, other diseases that might affect fertility or cause pelvic pain; liver, endocrine or neoplastic disease 
 No. randomised: 89 
 No. analysed: 89
Interventions Post‐surgical medical therapy 
 Gr A (n=44): leuprolide acetate SC 3.5 mg 4 weekly x 3 doses 
 Gr B (n=45): no treatment
Outcomes Pain: pelvic pain recurrence at 18/12 
 AFS scores: objective disease recurrence 
 Cumulative pregnancy rates at 18/12
Notes Power calculation: yes 
 Funding: NS
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "randomization was performed according to a computer generated list unknown to the physicians"
Allocation concealment (selection bias) Unclear risk not described
Blinding (performance bias and detection bias) 
 All outcomes High risk not mentioned, no placebo
Incomplete outcome data (attrition bias) 
 All outcomes Low risk all randomised patients included in the analysis
Selective reporting (reporting bias) Low risk important outcomes of pregnancy and recurrence of endometriosis and pain reported
Other bias Low risk groups appear comparable at baseline