Brodeur 1988.
Methods | Randomised controlled crossover trial of levodopa versus placebo Dropouts/withdrawals: Total N of 6, no premature discontinuations |
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Participants | Included/analysed: 6/6 Demographics: 3 male, age 51.3 years Diagnosis: primary RLS according to clinical evaluation, nocturnal awakenings and daytime sleepiness Setting: 1 centre in Canada Baseline: PLMSI (using PSG) 38.2 ± 12.7 |
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Interventions | Intervention: fixed dose of 100 mg/25 mg levodopa/benserazide twice daily (1hour before, 3 hours after going to bed) for 14 days Control: fixed dose of placebo capsules twice daily (1hour before, 3 hours after going to bed) for 14 days Washout for 1 week between treatment periods |
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Outcomes | Objective quality of sleep: change in sleep parameters (TST), PLMSI (using PSG) Safety: Number of dropouts due to adverse events |
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funding source | The study was supported by the Medical Research Council of Canada, the Fonds de la recherche en santé du Québec and the Fond pour la formation de chercheurs et l'aide à la recherche du Québec. | |
Notes | TST: total sleep time; PSG: polysomnography | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Insufficient information. |
Allocation concealment? | Unclear risk | Insufficient information. |
Blinding? All outcomes | Unclear risk | No information concerning blinding of staff, examiners, polysomnography analysis. |
Incomplete outcome data addressed? All outcomes | Low risk | All patients were included in analyses. |
Free of selective reporting? | Unclear risk | No outcomes prespecified. |
Free of other bias? | Low risk | Low indication of bias. |