Skip to main content
. 2023 Jun 21;2023(6):CD014788. doi: 10.1002/14651858.CD014788.pub2

Mäkäräinen 1996.

Study characteristics
Methods Trial design: Randomised, double blind, placebo‐controlled trial
Participants Participants: 38 women were randomised; 29 women were analysed after second‐look laparoscopy.
Mean age: 30.6 years (range 22 to 38 years)
Inclusion criteria:
  • Symptomatic pelvic endometriosis 

  • Revised American Fertility Society [AFS] score ≥ 2


Exclusion criteria: not stated
Setting: Finland
Timing: not stated
Interventions Once‐a‐month SC injections of goserelin acetate 3.6 mg (Zoladex depot; Zeneca Pharmaceutics, Cheshire, United Kingdom) randomly combined with either 
Medroxyprogesterone acetate 100 mg daily (n = 19) 
versus
Placebo, one tablet daily (n = 19) 
Outcomes
  • Relief of overall pain: dysmenorrhea, dyspareunia, pelvic pain

  • Adverse effects

  • Endometriotic implants

  • Biochemical changes

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: Zeneca Pharma, Helsinki, Finland, for supplying the active drugs and placebo
Author could not be contacted due to lack of information.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "Randomly assigned". No further details of method used to generate the randomisation sequence were provided.
Allocation concealment (selection bias) Unclear risk No details of method used to conceal allocation were provided.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind, placebo‐controlled study
Incomplete outcome data (attrition bias)
All outcomes Low risk Four patients interrupted the treatment because of side effects (three in the medroxyprogesterone acetate group and one in the placebo group). Increasing pelvic symptoms in one patient receiving medroxyprogesterone acetate required laparoscopy already 4 months after the end of treatment. Four women (two in the medroxyprogesterone acetate group and two in the placebo group) became pregnant within 6 months after the treatment. Thus, 29 women (13/19 in the medroxyprogesterone acetate and 16/19 in the placebo group) were included in the second‐look laparoscopy, which was performed 6 months after the end of medical treatment.
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