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      The efficacy and tolerability of rotigotine on patients with periodic limb movement in sleep: A systematic review and meta-analysis

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          Abstract

          Objective

          There is still no consensus on the treatment for periodic limb movement in sleep (PLMS). This study aimed to determine the efficacy and tolerability of rotigotine in patients suffering from PLMS.

          Methods

          Publications listed in PubMed, ScienceDirect, The Cochrane Library, and ClinicalTrials.gov were reviewed to assess the efficacy of rotigotine on PLMS. Analyses of PLMS frequency before and after rotigotine treatments (pre- and post-intervention studies) and PLMS frequency between placebo and rotigotine treatments (placebo-controlled trial studies) were included in our study. A systematic review and meta-analysis was conducted.

          Results

          Five publications involving 197 participants were included in this study. Among these articles, pre- and post-intervention data involving 55 participants were available from three articles, while placebo-controlled trial data from 107 participants receiving rotigotine and 70 participants receiving a placebo were available from an additional three articles. In the pre- and post-intervention studies, the periodic limb movement index was significantly decreased after therapy with rotigotine with a difference in means of −5.866/h (95% CI, −10.570 to −1.162, p = 0.015). In comparison with the placebo, the use of rotigotine significantly lowered the periodic limb movement index, with a difference in means of −32.105/h (95% CI, −42.539 to −21.671, p < 0.001), reduced the PLMS with arousal index, with a difference in means of −7.160/h (95% CI, −9.310 to −5.010, p < 0.001), and increased the withdrawal rate, with an odds ratio of 3.421 (95% CI, 1.230 to 9.512, p = 0.018).

          Conclusions

          This meta-analysis revealed the considerable efficacy of rotigotine in alleviating the frequency of PLMS. However, the high withdrawal rate should be taken into account.

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          Most cited references67

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          Clinical, polysomnographic, and genetic characteristics of restless legs syndrome: a study of 133 patients diagnosed with new standard criteria.

          One hundred thirty-three cases of restless legs syndrome (RLS), diagnosed with criteria recently formulated by an international study group, were studied by questionnaire and with all-night polysomnographic recordings. Results show that RLS starts at a mean age of 27.2 years and before age 20 in 38.3% of patients. Symptoms often appear in one leg only and also involve upper limbs in about half of all cases. Most patients (94%) report sleep-onset insomnia or numerous nocturnal awakenings due to RLS symptoms. A strong relationship was found between these complaints and polysomnographic findings; increasing sleep latency and number of awakenings and decreasing sleep efficiency were associated with worsening symptoms. Periodic leg movements in sleep (index > 5 movements/h sleep) were found in 80.2% of patients. This study shows that this percentage is increased when 2 recording nights are considered (most severe score). Eighty patients of 127 (63%) reported the presence of RLS in at least one of their first-degree relatives. In these families, 221 of 568 first-degree relatives (39%) were reported by the patients to be affected with RLS.
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            Assessing the influence of a single study in meta-analysis

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              Restless legs syndrome: revisiting the dopamine hypothesis from the spinal cord perspective.

              Restless legs syndrome (RLS) involves abnormal limb sensations that diminish with motor activity, worsen at rest, have a circadian peak in expression in the evening and at night, and can severely disrupt sleep. Primary treatment is directed at CNS dopaminergic systems, particularly activation of D(2)-like (D(2), D(3), and D(4)) receptors. Although RLS affects 2% to 15% of the general population, the neural circuitry contributing to RLS remains speculative, and there is currently no accepted animal model to enable detailed mechanistic analyses. Traditional views suggest that RLS arises from supraspinal sources which favor facilitation of the flexor reflex and emergence of the RLS phenotype. The authors forward the hypothesis that RLS reflects a dysfunction of the little-studied dorsoposterior hypothalamic dopaminergic A11 cell group. They assert that, as the sole source of spinal dopamine, reduced drive in this system can lead to spinal network changes wholly consistent with RLS. The authors summarize their recent investigations on spinal cord dopamine dysfunction that rely on lesions centered on A11, and on studies in D(3) receptor knockout (D(3)KO) mice. Excessive locomotor behavior is evident in both sets of animals, and D(3)KO mice exhibit facilitation rather than the expected depression of spinal reflexes in the presence of dopamine as well as a reversal in their circadian expression of the rate-limiting enzyme for dopamine synthesis, tyrosine hydroxylase. Taken together, these findings are consistent with an involvement of spinal dopamine dysfunction in the etiology of RLS, and they argue that the D(3)KO mouse might serve as a relevant animal model to study the underlying mechanisms of RLS.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Writing – original draft
                Role: ConceptualizationRole: Data curationRole: Formal analysis
                Role: ConceptualizationRole: Visualization
                Role: Conceptualization
                Role: Visualization
                Role: Visualization
                Role: ConceptualizationRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                18 April 2018
                2018
                : 13
                : 4
                : e0195473
                Affiliations
                [1 ] Department of Neurology, Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
                [2 ] Department of Master’s Program in Neurology, Faculty of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
                [3 ] Department of Psychiatry, Tsyr-Huey Mental Hospital, Kaohsiung, Taiwan
                [4 ] WinShine Clinics in Specialty of Psychiatry, Kaohsiung City, Taiwan
                [5 ] Department of Psychiatry, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan
                [6 ] Prospect Clinic for Otorhinolaryngology & Neurology, Kaohsiung, Taiwan
                [7 ] Department of Psychiatry, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan
                [8 ] Center for Translational Research in Biomedical Sciences, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan
                University of Rome Tor Vergata, ITALY
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0002-9880-5944
                Article
                PONE-D-17-27789
                10.1371/journal.pone.0195473
                5905969
                29668694
                2c6bf4cb-2576-4214-8dc6-4f1cc964181b
                © 2018 Wu et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 28 August 2017
                : 25 March 2018
                Page count
                Figures: 5, Tables: 1, Pages: 15
                Funding
                The authors received no specific funding for this work.
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