Busacca 2001.
Methods | Location: University of Milan, Italy No. of centres: 1 Recruitment period: July 1997 to December 1999 |
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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 |