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

Bergqvist 1998.

Study characteristics
Methods Trial design: "Prospective, randomised, placebo‐controlled, double‐blind, parallel study"
 
Participants Participants: 49 women eligible; 49 were randomised and 46 were analysed
Age: mean of 31 years (19‐44years)
Stage: most mild‐to‐moderate (IV n = 1)
Inclusion criteria:
  • Menstruating regularly 3 months before study

  • Clinical symptoms of endometriosis

  • Not taken oral contraceptive or oral steroid therapy for 3 months

  • Not taken long‐acting depot gestagens or GnRHas within past 6 months

  • Not pregnant in prior 3 months

  • Not breastfeeding

  • No history of osteoporosis or coagulation disorders


Exclusion criteria:
  • Intraperitoneal adhesions making visual inspection and careful evaluation of the extension of endometriotic lesions difficult or impossible


Setting: Sweden
Timing: Not stated
Interventions Triptorelin 3.75 mg IM depot every 4 weeks for 24 weeks (n = 24)
versus
Placebo IM every 4 weeks for 24 weeks (n = 25)
 
Outcomes
  • Relief of overall pain

  • Adverse effects

  • Visible endometriosis extension

  • rAFS

  • Frequency and amount of bleeding

  • Serum concentrations of estradiol

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Note previous version: Needs raw score for pain. Authors contacted and awaiting response
 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details were provided of method used to generate the randomisation sequence. 
Allocation concealment (selection bias) Unclear risk No details were provided of method used to conceal treatment group allocation. 
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants and researchers were blinded through the use of identical kits for injections.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Participants and researchers were blinded through the use of identical kits for injections.
Incomplete outcome data (attrition bias)
All outcomes Low risk Three participants withdrew from the study. Two from the placebo group (1 prior to the first injection due to pregnancy, and one after 4 months due to lack of effect), and one from the triptorelin group due to hypoestrogenic side effects and depression.
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