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. 2010 Dec 8;2010(12):CD008475. doi: 10.1002/14651858.CD008475.pub2

Ferreira 2010.

Study characteristics
Methods Trial design: Randomised, prospective open labelled study
Participants Participants: 44 women with endometriosis (confirmed laparoscopically/histologically), consecutively selected at the pain and endoscopy out‐patient clinic.
Mean age: 28.8 ±4.9 years for LNG‐IUS and 41.4±5.8 years for GnRHa
Inclusion criteria: 18‐40 years of age
chronic pelvic pain.
No use of oral hormone contraceptives for at least 3 months or with depot progestogens or GnRHa for at least 6 months prior to randomisation.
Exclusion: obese patients (BMI >30kg/m2), smokers, diabetics, alcohol or drug users, patients wishing to conceive, those with chronic disease, acute and/or chronic inflammatory and/or infectious processes, family history of thromboembolic events, taking medications known to interfere with inflammation markers for a period of less than 15 days before the study.
Setting: Brazil
Timing: not stated.
Interventions LNG‐IUS (n=22)
versus
GnRHa (n=22) 3.75mg leuprolide i.m. monthly treatment for 6 months
Outcomes BMI, SAP, DAP, HR, pain score (VAS), inflammatory markers
Notes No ITT analysis
Intention‐to‐treat analysis:
Sample size calculation:
Funding:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk 'Randomised by computer programme'
Allocation concealment (selection bias) Unclear risk No details provided of method used to conceal allocation to treatment group.
Blinding (performance bias and detection bias)
All outcomes High risk Open labelled. Blinding not possible due to nature of invtervention and comparison.
Incomplete outcome data (attrition bias)
All outcomes Low risk GnRHa (1 pregnancy before drug administered and 3 moved and lost to follow‐up)
Selective reporting (reporting bias) Low risk All a priori outcomes discussed