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

Sesti 2007.

Methods Location: Rome, Italy 
 No. of centres: one
Recruitment period: January 1999 to May 2005
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
  • triptorelin or leuprorelin 3.75 mg depot monthly for 6 months (n=42)

  • continuous low dose monophasic oral contraceptives for 6 months, (ethinlyestradiol 0.03 mg + gestoden 0.75 mg) (n=40)

  • dietary therapy for 6 months (vitamins, mineral salts, lactic ferments and omega 3 and omega 6 fatty acids together with individually tailored diet) (n=37)

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