A combination of alpha-lipoic acid and vitamins B, C and E for the management of restless legs syndrome

Background Restless legs syndrome (RLS) causes sleep disturbances and diminishes quality of life of affected patients. The aim of this study was to assess the effectiveness and safety of 6-month administration of T400, a supplement composed of alpha-lipoic acid (ALA), B-group vitamins, and vitamins C and E in patients with severe RLS. Methods Patients diagnosed with RLS received the supplement for 6 months. They answered the IRLS scale at baseline, after 1, 3 and 6 months of supplementation, and 1 month after discontinuation of the supplement. Results Twenty patients with severe RLS participated in the study. After 1 month of supplementation, IRLS total score had already improved with a 47% reduction, from 27.6 to 14.6 ( p < 0.0001). IRLS total scores at 3 and 6 months were also better, up to a 66% reduction ( p < 0.0001). Furthermore, RLS was classified as mild at the end of the study. Scores of all IRLS items also improved during the study, with all differences statistically significant compared to baseline. Sleep disturbance improved, from moderate-to-severe at baseline to mild at the end of the study, with a 60% reduction in the corresponding IRLS subscore ( p < 0.0001). Similarly, tiredness or sleepiness resulting from RLS symptoms improved from moderate to almost nonexistent ( p < 0.0001 for both). All these improvements partially reverted at the end of supplementation period. Conclusion This is the first study to assess T400, a combination of ALA and vitamins, in the treatment of RLS patients. This combination improved RLS, including sleep disturbances, with statistically significant effects as early as the first month of supplementation and with no severe adverse events, but supplementation may be administered continuously to maintain benefits. As this was a pilot study with a small population, a further study with a larger sample size, ideally a randomized controlled clinical trial, should be conducted to confirm these findings. However, our findings suggest that T400 could offer a new therapeutic approach to this troublesome neurological disorder.