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 |