Background Numerous randomised controlled trials have proved the efficacy of dopaminergic and non-dopaminergic drugs in the treatment of restless legs syndrome (RLS). In contrast, epidemiological data demonstrate generally insufficient RLS treatment in clinical practice.
Objective To prospectively assess the success of RLS treatment in the clinical setting and to evaluate potential demographic factors and comorbidities that may influence the response to therapy.
Methods 100 patients with idiopathic RLS (40% had never received RLS specific treatment before) were examined at baseline and after 12 months. Recommendations for therapy according to RLS treatment guidelines of the German Neurological Society were given at baseline. Primary measures for the success of therapy were reduction of RLS symptoms (IRLS) and improvement of quality of life (RLS-QoL).
Results No statistically significant improvement of IRLS or RLS-QoL was detected after 12 months, in initially untreated or in pretreated patients. Poor treatment success, regarding improvement of RLS symptoms, quality of life and number of RLS related physician contacts was related to the presence of neuropsychiatric comorbidity—that is, somatoform disorders (prevalence 41%), chronic pain (32%), anxiety (20%) and major depression (16%).
Conclusion Success of guideline based treatment of RLS appears to be rather poor in clinical practice. Neuropsychiatric comorbidity may be a target for interventions to improve overall outcome.
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Competing interests CT has received honoraria for lectures or clinical advice from Boehringer Ingelheim, GSK, UCB, Novartis and Solvay. DB has received honoraria for lectures from UCB, GSK, TEVA and Lundbeck and for serving on scientific advisory boards for Novartis, UCB, GSK and TEVA. DB has received grants from the Michael J Fox Foundation, the BMBF, Janssen Pharmaceuticals, TEVA Pharma GmbH and the German Parkinson's Disease Association.
Ethics approval This study was conducted with the approval of the University of Tübingen ethics committee.
Provenance and peer review Not commissioned; externally peer reviewed.