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. 2011 Feb 15;2011(2):CD005504. doi: 10.1002/14651858.CD005504.pub2

Brodeur 1988.

Methods Randomised controlled crossover trial of levodopa versus placebo
Dropouts/withdrawals: Total N of 6, no premature discontinuations
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
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
Outcomes Objective quality of sleep: change in sleep parameters (TST), PLMSI (using PSG)
Safety: Number of dropouts due to adverse events
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.