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 |
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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 |
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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 |
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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 |
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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. |