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

Irahara 2001.

Study characteristics
Methods Trial design: Randomised controlled trial
Participants Participants: 21 women were randomised and analysed.
Mean age:   Group 1: 36.0 ±10.0 years, group 2: 35.5 ± 8.6 years
Inclusion criteria:
  • Negative smear and negative mammogram in 6 months prior to the start of the study

  • No previous hormonal treatment received for endometriosis


Exclusion criteria: not stated
Setting: Japan
Timing: not stated
Interventions Group 1: monthly injection of 3.75 mg leuprolide acetate depot (n = 10)
versus 
Group 2: monthly injection of 3.75 mg leuprolide acetate + 0.625 mg conjugated equine oestrogen + 2.5 mg medroxyprogesterone acetate every other day from 2nd month of GnRHa treatment (n = 11)
Outcomes
  • Bone mineral density

  • Laboratory results

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Author contacted for further information; awaiting response
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk  Randomised controlled trial. 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 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 No losses to follow‐up
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