Summary.
In a double-blind, placebo-controlled randomized crossover trial, the acute efficacy of a combination treatment of 100 mg regular-release (rr) and 100 mg sustained-release (sr) L-dopa/benserazide in RLS was investigated by means of sleep laboratory methods, with a subsequent open clinical follow-up for 4 weeks. 21 RLS patients classified according to ICSD and IRLSSG criteria were included; 18 completed the study. Objective sleep quality was determined by polysomnography (PSG) in 3 subsequent nights (adaptation/screening, placebo and drug night), subjective sleep and awakening quality was evaluated by rating scales, objective awakening quality by psychometric tests. Clinical follow-up consisted of daily ratings of subjective sleep and awakening quality (SSA) and VAS for RLS symptomatology ratings, completion of the RLS (IRLSSG) Scale weekly and the Zung Depression (SDS) and Anxiety (SAS) Scale, Quality of Life Index, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale before and after therapy. Acute L-dopa/benserazide significantly (p < 0.001) and markedly (75%) decreased the target variable PLM/h of sleep as well as all other RLS/PLM variables, but failed to improve objective sleep efficiency and subjective sleep quality in comparison to placebo. After 4 weeks of therapy, however, subjective sleep and awakening quality also improved significantly. While RLS/PLM measures showed an immediate significant and marked response to the combination therapy subjective sleep quality only improved after chronic treatment.
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Received July 2, 2002; accepted January 20, 2003 Published online April 7, 2003
Acknowledgements The authors would like to express their thanks to Dr. G. Hofer and Dr. C. Scherübel from Roche Austria GmbH for their support of this project; further to the entire staff of the Section of Sleep Research and Pharmacopsychiatry, Department of Psychiatry, University of Vienna, the Sleep Laboratory Rudolfinerhaus, and the Department of Neurology, University of Innsbruck, as well as to Mag. E. Grätzhofer for her valuable editorial assistance.
Authors' address: Prof. B. Saletu, MD, Department of Psychiatry, School of Medicine, University of Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria, e-mail: bernd.saletu@akh-wien.ac.at
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Saletu, M., Anderer, P., Högl, B. et al. Acute double-blind, placebo-controlled sleep laboratory and clinical follow-up studies with a combination treatment of rr-L-dopa and sr-L-dopa in restless legs syndrome. J Neural Transm 110, 611–626 (2003). https://doi.org/10.1007/s00702-003-0814-z
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DOI: https://doi.org/10.1007/s00702-003-0814-z