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

Tahara 2000.

Study characteristics
Methods Trial design: Prospective, randomised, longitudinal pilot study
Participants Participants: 15 women were randomised and analysed.
Mean age: 
Control group: 35.2 ± 2.6 years
Half‐dose group: 34.7 ± 5.7 years
Inclusion criteria:
  • Symptomatic endometriosis who were candidates for 6 months of GnRH agonist therapy

  • Diagnosis of endometriosis was confirmed by laparoscopy or laparotomy

  • Menstruated regularly

  • Normal hepatic and renal function


Exclusion criteria: 
  • No recent medical treatment for endometriosis

  • Not taking medications known to affect bone metabolism


Setting: Japan
Timing: not stated
Interventions Control group: full‐dose intranasal nafarelin treatment (200 μg twice daily) for 24 weeks (n = 7)
versus
Half‐dose group: full dose intranasal nafarelin treatment (200 μg twice daily) for 4 weeks followed by half‐dose intranasal nafarelin treatment (200 μg daily) for 20 weeks (n = 8)
Outcomes
  • Symptoms of endometriosis (dysmenorrhoea, dyspareunia, and pelvic pain)

  • Vasomotor symptoms (hot flashes or dizziness)

  • Bone mineral density

  • Fasting serum and urine samples

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: not stated
Funding: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The patients were assigned, using a random number table, to two groups. 
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