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Efficacy of vitamins C, E, and their combination for treatment of restless legs syndrome in hemodialysis patients: A randomized, double-blind, placebo-controlled trial
Sleep Medicine, 04/27/2012
Clinical Article
Sagheb MM et al. – Vitamins C and E and their combination are safe and effective treatments for reducing the severity of Restless legs syndrome (RLS) in hemodialysis patients over the short–term.
Methods- Sixty stable hemodialysis patients who had all four diagnostic criteria for RLS developed by the International Restless Legs Syndrome Group with no acute illness or history of renal stone were randomly allocated to four fifteen-patient parallel groups to receive vitamin C (200mg) and vitamin E (400mg), vitamin C (200mg) and placebo, vitamin E (400mg) and placebo, and double placebo daily for eight weeks.
- International Restless Legs Scale (IRLS) scores were measured for all patients at baseline and at the end of treatment phase.
- The primary outcome was absolute change in IRLS sum score from baseline to the end of treatment phase.
- Means of IRLS sum score decreased significantly in the vitamins C and E (10.3±5.3, 95%CI: 7.4-13.3), vitamin C and placebo (10±3.5, 95%CI: 8.1-11.9), and vitamin E and placebo groups (10.1±6, 95%CI: 6.8–13.5) compared with the double placebo group (3.1±3, 95%CI: 1.5-4.8), (P<0.001); however, no differences were observed between these treatment groups.
