Sesti 2007.
Methods | Location: Rome, Italy
No. of centres: one Recruitment period: January 1999 to May 2005 |
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Participants | Inclusion criteria: women of reproductive age <40, with endometriosis related symptoms (dysmenorrhoea, pelvic pain, deep dyspareunia), laparoscopic diagnosis of St III ‐IV endometriosis, desiring pregnancy, nulliparous Exclusion criteria: concurrent disease, such as cancer or pelvic inflammatory disease, previous surgery for endometriosis, contraindications to estrogens/progestins No. randomised: 234 No. analysed: 222 | |
Interventions | Gr A (n=115 ): placebo for 6 months
Gr B (n=119 ): post‐operative medical or dietary therapy patients in group B received either
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Outcomes | Pelvic pain | |
Notes | Power calculation: yes Funding: NS | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "randomized according to a computer generated randomization sequence" |
Allocation concealment (selection bias) | Low risk | allocated by serially numbered opaque sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "neither the surgeons not the patients were aware of the regimen prescribed during the study period". Hoever placebo not described and it seems unlikely that blinding of patients could be maintained when treatments are either SC, oral medication or diet plus supplements |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 5 and 3 lost to follow up from placebo and GNRHa groups and reasons given. 2 lost to follow up from each of OCP and diet groups but reasons not given. 222 evaluated |
Selective reporting (reporting bias) | Unclear risk | pain and health related quality of life reported. No pregnancy outcome in a group of women desiring pregnancy |
Other bias | Low risk | groups appear comparable at baseline |