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:
Exclusion criteria:
Setting: United States of America (9 academic medical centres) Timing: not stated |
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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) |
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Outcomes |
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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. |
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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 |