Tahara 2000.
| Study characteristics | ||
| Methods | Trial design: Prospective, randomised, longitudinal pilot study | |
| Participants | Participants: 15 women were randomised and analysed. Mean age: Control group: 35.2 ± 2.6 years Half‐dose group: 34.7 ± 5.7 years Inclusion criteria:
Exclusion criteria:
Setting: Japan Timing: not stated |
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| Interventions | Control group: full‐dose intranasal nafarelin treatment (200 μg twice daily) for 24 weeks (n = 7) versus Half‐dose group: full dose intranasal nafarelin treatment (200 μg twice daily) for 4 weeks followed by half‐dose intranasal nafarelin treatment (200 μg daily) for 20 weeks (n = 8) |
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| Outcomes |
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| Notes | Intention‐to‐treat analysis: not stated Sample size calculation: not stated Funding: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | The patients were assigned, using a random number table, to two groups. |
| 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 | Unclear risk | No details provided of blinding of participants or personnel |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided of blinding of outcome assessment |
| 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 |