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. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Strowitzki 2012.

Study characteristics
Methods Trial design: The study was a multi‐centre, randomised, open‐label, parallel‐group, non‐inferiority comparison.
Participants Participants: 252 women were randomised; 229 women were analysed.
Mean age: 18–45 years
Inclusion criteria:
  • Women aged 18‐45 years 

  • De novo or recurrent pain associated with a confirmed diagnosis of endometriosis


Exclusion criteria: 
  • Amenorrhea (≥ 3 months)

  • Need for surgical treatment

  • Previous use of hormonal treatments within specified times

  • Abnormal findings (other than endometriosis) at gynaecologic examination

  • Pregnancy or breastfeeding

  • Risk factors for decreased bone mineral density


Setting: Germany
Timing: not stated
Interventions Dienogest (DNG) 2 mg/day orally  (n = 124)
versus
Intramuscular leuprolide acetate 3.75 mg depot every 4 weeks (n = 128)
Outcomes
  • Relief of overall pain: pelvic pain, dysmenorrhoea, dyspareunia scores (VAS, Biberoglu and Behrman) 

  • Adverse events

  • Quality of life (SF‐36)

  • Improvement of most troublesome symptom

  • Markers of bone metabolism

Notes Intention‐to‐treat analysis: No. "Efficacy analyses were based on the per‐protocol set (PPS), which included all randomized patients without major protocol deviations (a 'conservative' strategy appropriate for non‐inferiority studies)".
Sample size calculation: yes
Funding: Funding for the study was provided by Bayer HealthCare.
J.M., C.G., T.F., and C.S. are full‐time employees of Bayer HealthCare. Editorial support funded by Bayer HealthCare was provided by PAREXEL. This editorial support consisted of the preparation of manuscript drafts based on detailed author guidance.
Authors contacted; awaiting response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Patients were randomized (1:1 ratio)". No further details of method used to generate the randomisation sequence were provided.
Allocation concealment (selection bias) Unclear risk weo details of method used to conceal allocation are provided.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No details provided of blinding of participants or personnel
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No details provided of blinding of outcome assessment
Incomplete outcome data (attrition bias)
All outcomes Low risk Overall, 109/124 (87.9%) women in the DNG group and 120/128 (93.8%) women in the LA group completed the study.
Selective reporting (reporting bias) Low risk The study protocol was not available but it was clear that the published reports included all expected outcomes, including those that were prespecified.
Other bias Low risk No other risk of bias detected