German RLS-Study with Implant-Acupuncture

Background: The Restless-Legs-Syndrome is one of the most common neurological disorders in Europe. The principle cause for RLS is not fully understood, but there is evidence for decreased dopamine levels in the central nervous system. Therefore, the intake of dopaminerge medications is the only rational therapy for these patients. However, in case of contraindication, intolerance and failure of these drugs, the patients are suffering enormously under the symptoms of RLS. Since 2005, Implant-Acupuncture is tested in Germany mainly for neurological disorders. This is the first study to evaluate efficacy and safety of this new method in Restless-Legs-Syndrome.

Method: Parameters for evaluation of efficacy were the international RLS-Score (IRLS), the change of dopaminerge drug intake after implantation and the psychological factor of "mood". The data were investigated in 4 weeks intervals. Endpoint were six month after Implant-Acupunctur.

Results: 97 patients were included for this prospective study. 59 patients (61%) significantly improved symptoms on IRLS-Score. 55 patients (57%) were able to reduce dopaminerge drug intake of at least 25% and 63 patients (65%) indicated a significant improvement of the factor "mood" during this investigation. There were no significant side effects detected in this study.

Conclusion: The data of this study for the evaluation of Implant-Acupuncture in Restless-Legs-Syndrome are very stimulating for further investigations. There is evidence to balance drug therapy and Implant-Acupuncture in the future.