PMU-Autor/inn/en
Kunz AlexanderAbstract
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.
Useful keywords (using NLM MeSH Indexing)
Adult
Aged
Aged, 80 and over
Benserazide/pharmacology*
Benserazide/therapeutic use
Cross-Over Studies
Delayed-Action Preparations/pharmacology
Delayed-Action Preparations/therapeutic use
Double-Blind Method
Drug Administration Schedule
Drug Combinations
Female
Follow-Up Studies
Humans
Levodopa/pharmacology*
Levodopa/therapeutic use
Male
Middle Aged
Restless Legs Syndrome/drug therapy*
Sleep/drug effects*
Sleep/physiology
Treatment Outcome
Find related publications in this database (Keywords)
restless legs syndrome