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:
Exclusion criteria: not stated Setting: United States of America Timing: not stated |
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| 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) |
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| Outcomes |
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| 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. |
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| 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 |