Gabapentin versus levodopa-c for the treatment of restless legs syndrome in hemodialysis patients: a randomized clinical trial.

To compare the efficacy of gabapentin and levodopa-c (Levodopa/Carbidopa) in reducing restless leg syndrome (RLS) symptoms and sleep problems in hemodialysis patients with RLS in a four-week randomized clinical trial. The diagnosis of RLS was made using the criteria of the International Restless Legs Study Group. Each subject completed three questionnaires: IRLS questionnaire, Pittsburgh Sleep Quality Index and Epworth sleepiness scale. After four weeks of washout period for previous treatments for RLS, subjects were randomly assigned to four weeks of gabapentin (200 mg) or levodopa-c (110 mg). After four weeks of therapy, the questionnaires administered at the outset of the study were re-administered. Both drugs were found effective for the management of RLS. But, the effect of gabapentin was more significant. Gabapentin significantly improved the IRLS total score (change from baseline to post-treatment ≈-17) compared with levodopa-c (change from baseline to post-treatment ≈-13) (P: 0.016). Regarding sleep parameters, levodopa improved sleep quality, sleep latency and sleep duration (P <0.0001). Gabapentin was also effective with respect to sleep parameters (P <0.0001). Our study shows that gabapentin is a safe effective therapy for RLS among hemodialysis patients. This medication may be considered as an alternative or additive treatment to current therapeutic remedies for hemodialysis patients with RLS.

RCT Entities:   Population Interventions Outcomes