Muzii 2000.
| Methods | Location: University departments, Rome, Italy
No. of centres: 2 Recruitment period: January 1994 to June 1997 |
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| Participants | Inclusion criteria: 20‐35 yrs, moderate to severe dysmenorrhoea and/or chronic pelvic pain, not desiring fertility Exclusion criteria: treatment for endometriosis in previous 6 months No. randomised: 70 No. analysed: 68 | |
| Interventions | Post‐surgical medical therapy Gr A (n=35): cyclic monophasic oral contraceptive pill (ethinyl estradiol 0.03 mg, gestodene 0.075 mg) for 21 days with 7 pill free days x 6/12 Gr B (n=35): no treatment | |
| Outcomes | Recurrence of pain and time to recurrence Recurrence of cysts | |
| Notes | Power calculation: yes Funding: NS. Drugs supplied by Population Council | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "randomly allocated to one of two management arms on the basis of a computer generated sequence" |
| 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 | two post‐randomisation withdrawals. Unlikely to have introduced a bias |
| Selective reporting (reporting bias) | Low risk | important outcomes reported ‐ recurrence of endometriosis, pain, AFS scores. Patients not desiring pregnancy |
| Other bias | Unclear risk | no information of the baseline characteristics of the groups reported |