Shaw 1990.
Study characteristics | ||
Methods | Trial design: Multi‐centre, placebo‐controlled, randomised trial | |
Participants | 82 women were randomised; 74 were analysed. Mean age: not stated Inclusion criteria:
Exclusion criteria: not stated Setting: United Kingdom (2 sites) Timing: not stated |
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Interventions | Nafarelin 200 mcg BD IN + placebo PO for 6 months (n = 55) versus Danazol 200 mg three times a day PO + placebo IN for 6 months (n = 26) | |
Outcomes |
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Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated Note previous version: Authors contacted but unable to provide further details as trial was almost 20 years old |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomized". 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 | Participants were blinded and received placebo nasal spray or tablets. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo‐controlled study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Details for attrition given: 8 withdrew:
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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 |