Abstract
BackgroundDopamine Replacement Therapy (DRT) represents the most effective treatment for Parkinson’s disease (PD). Nevertheless, several symptoms are unresponsive to treatment and its long-term use leads to serious side effects. To optimize the pharmacological management of PD, dopamine-agonists are often prescribed to “de-novo” patients. Moreover, several studies have shown the effectiveness and the synergic effect of rehabilitation in treating PD.ObjectiveTo evaluate the synergism between DRT and rehabilitation in treating PD, by investigating the short and the long-term effectiveness of a multidisciplinary, intensive and goal-based rehabilitation treatment (MIRT) in a group of patients treated with Rotigotine.Materials and methodsIn this multicenter, single blinded, parallel-group, 1:1 allocation ratio, randomized, non-inferiority trial, 36 “de-novo” PD patients were evaluated along 18 months: 17 were treated with Rotigotine plus MIRT; 19 were treated with Rotigotine alone (R). The primary outcome measure was the total score of Unified Parkinson’s Disease Rating Scale (UPDRS). The secondary outcomes included the UPDRS sub-sections II and III (UPDRS II-III), the 6-Minute Walk Test (6MWT), the Timed Up and Go Test (TUG) and the amount of Rotigotine. Patients were evaluated at baseline (T0), 6 months (T1), 1 year (T2), and at 18 months (T3).ResultsNo differences in UPDRS scores in the two groups (total score, III part and II part, p = 0.48, p = 0.90 and p = 0.40, respectively) were found in the time course. Conversely, a greater improvement in Rotigotine + MIRT group was observed for 6MWT (p < 0.0001) and TUG (p = 0.03). Along time, the dosage of Rotigotine was higher in patients who did not undergo MIRT, at all observation times following T0.ConclusionsOver the course of 18 months, the effectiveness of the combined treatment (Rotigotine + MIRT) on the patients’ global clinical status, evaluated with total UPDRS, was not inferior to that of the pharmacological treatment with Rotigotine alone. Importantly, rehabilitation allowed patients to gain better motor performances with lower DRT dosage.
Highlights
Parkinson’s disease (PD) is one of the most common progressive neurodegenerative diseases
The cornerstone of symptomatic treatment for PD is the dopamine replacement therapy (DRT), which works by restoring the physiological synaptic plasticity in the dopamine-denervated striatum [1]. l-dopa still remains the most effective drug for PD [2], but other dopaminergic agents, such as dopamine agonists (DAs), monoamine oxidase (MAO)-B inhibitors and catechol-O-methyl transferase (COMT) inhibitors are used in the clinical practice
In order to investigate and better define the potential advantages coming from the synergism between Dopamine Replacement Therapy (DRT) and rehabilitation in treating PD, in this study we have investigated the short- and the long-term (18 months) effectiveness of MIRT in a group of “de-novo” patients treated with rotigotine as monotherapy, in comparison with a control group of patients treated with the same DA, but who did not undergo rehabilitation
Summary
Parkinson’s disease (PD) is one of the most common progressive neurodegenerative diseases. A relevant issue regarding DRT concerns its long-term use, as it might cause aberrant structural changes in the striatum leading to the development of motor and behavioural side effects (such as motor fluctuations, wearing-off, dyskinesias, dopamine dysregulation syndrome) [3], which worsen the patients’ clinical conditions and the quality of their lives [4]. Dopamine Replacement Therapy (DRT) represents the most effective treatment for Parkinson’s disease (PD). Objective To evaluate the synergism between DRT and rehabilitation in treating PD, by investigating the short and the longterm effectiveness of a multidisciplinary, intensive and goal-based rehabilitation treatment (MIRT) in a group of patients treated with Rotigotine. Conclusions Over the course of 18 months, the effectiveness of the combined treatment (Rotigotine + MIRT) on the patients’ global clinical status, evaluated with total UPDRS, was not inferior to that of the pharmacological treatment with Rotigotine alone. Rehabilitation allowed patients to gain better motor performances with lower DRT dosage
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