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

Orwoll 1994.

Study characteristics
Methods Trial design: randomised, double‐blinded, placebo‐controlled trial
Participants Participants: 183 women were randomised and 137 analysed.
Mean age:  31 years (range 17 to 46 years)
Inclusion criteria:
  • Symptomatic endometriosis, proved by laparoscopy

  • Bone density measures during treatment

  • Regular menstrual cycles for at least 3 months before enrolment

  • Using a barrier method of contraception


Exclusion criteria: 
  • Therapy with danazol, androgenix hormones, oestrogens, progestins, glucocorticoids, GnRH agonists, or any other medication known to influence bone or mineral metabolism for at least 3 months before study

  • > 2 ounces of alcohol per day

  • Pregnant or breastfeeding

  • Had a significant laboratory abnormality


Setting: United States of America (9 academic medical centres)
Timing: not stated
Interventions 200 μg of nafarelin intranasally twice per day for 6 months (n = 92) 
versus
200 μg of nafarelin intranasally twice per day for 3 months followed by 3 months of placebo (n = 91)
Outcomes
  • Bone mineral density

Notes Intention‐to‐treat analysis: yes
Sample size calculation: not stated
Funding: Supported by Syntex Laboratories, Inc
Note: Drs. Orwoll and Hornstein have been salaried consultants for Syntex Laboratories, Inc.
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 "Subjects were randomised". 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 Randomised, double‐blinded, placebo‐controlled trial
Blinding of outcome assessment (detection bias)
All outcomes Low risk Randomised, double‐blinded, placebo‐controlled trial
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not stated; appeared that all women included also were analysed
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