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

Hornstein 1998.

Study characteristics
Methods   Trial design: Multi‐centre randomised, double‐blind, placebo‐controlled trial
Participants Participants: 201 women were randomised and analysed.
Mean age: Group A: 28.4 ± 6.1, group B: 28.7 ± 6.2, group C: 29.0 ± 5.6, group D: 27.9 ± 5.7
Inclusion criteria:
  • Women

  • Aged 18‐43

  • Regular menstrual cycles

  • History of symptomatic endometriosis diagnosed surgically within 12 months of study entry

  • Persistent or recurrent pain


Exclusion criteria: not stated
Setting: United States of America
Timing: not stated
Interventions All patients received GnRH agonist (Lupron depot 3.75 mg every 4 weeks for 52 weeks) and calcium supplementation as elemental calcium 1000 mg daily. 
Group A: received daily oral placebos for progestin and oestrogen (n = 51)
Group B: received daily oral norethindrone acetate 5 mg with placebo for oestrogen (n = 55)
Group C: received norethindrone 5 mg and conjugated equine oestrogens 0.625 mg (n = 47)
Group D: received norethindrone 5 mg and conjugated equine oestrogens 1.25 mg (n = 48)
Outcomes
  • Relief of overall pain

  • Bone mineral density

  • Serum lipid analyses

  • Adverse effects

Notes Intention‐to‐treat analysis: not stated
Sample size calculation: yes
Funding: Grant received from TAP Pharmaceuticals Inc.
Ms Castro is a paid employee of TAP Pharmaceuticals Inc; Dr Weissberg was a paid employee of TAP Pharmaceuticals Inc. at the time the study was undertaken. Drs Hornstein and Surrey have received honoraria for participating in a limited number of lectureships and symposias sponsored by TAP Pharmaceuticals Inc.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Patients were assigned randomly to a treatment group by permuted blocks of four at each of 26 study sites.
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 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