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

Eisensehr 2004.

Methods Randomised controlled crossover trial of slow‐release levodopa versus slow‐release valproic acid versus placebo
Dropouts/withdrawals: Total N of 20, no premature discontinuations
Participants Included/analysed: 20/20
Demographics: 8 male, age 58.9 years
Diagnosis: primary RLS according to IRLSSG, PLM/h > 10, symptoms daily for at least 6 months
Setting: 1 centre in Germany
Baseline: PLMSI (using PSG) 42.3 ± 40.7
Interventions Intervention 1: fixed single dose of 200 mg/50 mg slow‐release‐levodopa/benserazide (after 2 days of 100 mg/25 mg) for 3 weeks
Intervention 2: fixed single dose of slow‐release‐valproic acid (600 mg after 2 days of 300 mg) for 3 weeks
Control: fixed single dose of placebo capsules for 3 weeks
No washout between treatment periods
Outcomes Change of symptoms: Rating of severity of symptoms in the past 24 hours
Objective quality of sleep: TST, PLMSI (using PSG)
Safety: Number of dropouts due to adverse events, number of patients experiencing adverse events
funding source The study was supported by Sanofi pharmaceutical company.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Insufficient information.
Allocation concealment? Low risk Capsules were distributed when requested by blinded executor mentioning patient number and treatment session.
Blinding? 
 All outcomes Low risk Similar looking and tasting capsules, physicians did not know about sequences until end of study when analysis was completed.
Incomplete outcome data addressed? 
 All outcomes Low risk No incomplete outcome data.
Free of selective reporting? Low risk All results reported as prespecified with additional sleep data.
Free of other bias? Low risk Low indication of bias.