Myths and facts about the EARLYSTIM study.
Identifieur interne : 000505 ( Main/Exploration ); précédent : 000504; suivant : 000506Myths and facts about the EARLYSTIM study.
Auteurs : W M Michael Schüpbach [Suisse] ; Jörn Rau ; Jean-Luc Houeto ; Paul Krack ; Alfons Schnitzler ; Carmen Schade-Brittinger ; Lars Timmermann ; Günther DeuschlSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2014.
English descriptors
- KwdEn :
- MESH :
- physiology : Movement.
- physiopathology : Subthalamic Nucleus.
- therapy : Parkinson Disease.
- Deep Brain Stimulation, Humans, Placebo Effect, Quality of Life.
Abstract
DBS of the STN improves quality of life (QoL) and motor function not only in advanced Parkinson's disease (PD), but also in PD with early motor complications, as shown in the recent EARLYSTIM study. In spite of the evidence in favor of STN-DBS, the findings of the EARLYSTIM study have recently been controversially debated. Here, we argue that a placebo or lessebo effect is unlikely to have relevantly contributed to the favorable outcome of STN-DBS in the EARLYSTIM study. The method of quantification of the placebo effect of DBS in a previous publication reveals flaws leading to implausible results, and therefore the placebo effect of DBS remains currently elusive, especially because blinding of PD patients with STN-DBS as a crucial preassumption for assessing a placebo effect is practically impossible. Moreover, we claim that the extent of such a placebo effect is most likely very small. Specific challenges of STN-DBS at an earlier stage of PD and inclusion criteria are the risk of inclusion of patients who later evolve to atypical parkinsonism, the risk of a floor effect for the benefit from DBS, the need for experienced multidisciplinary care including prevention of suicidal behavior, and the need for highly qualified long-term follow-up. The EARLYSTIM study has shown that STN-DBS may be proposed earlier on in the course of PD, as soon as motor complications start to cause relevant disability despite proper medical management. This can lead to a gain of several years of improved QoL.
DOI: 10.1002/mds.26080
PubMed: 25399678
Affiliations:
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Centre d'Investigation Clinique 9503, Institut du Cerveau et de la Moelle épinière; Département de Neurologie, Université Pierre et Marie Curie-Paris 6 et INSERM, CHU Pitié-Salpêtrière, Paris, France, and Movement Disorders Center, Department of Neurology, Bern University Hospital and University of Bern, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>Assistance-Publique Hôpitaux de Paris; Centre d'Investigation Clinique 9503, Institut du Cerveau et de la Moelle épinière; Département de Neurologie, Université Pierre et Marie Curie-Paris 6 et INSERM, CHU Pitié-Salpêtrière, Paris, France, and Movement Disorders Center, Department of Neurology, Bern University Hospital and University of Bern</wicri:regionArea><wicri:noRegion>Bern University Hospital and University of Bern</wicri:noRegion></affiliation></author><author><name sortKey="Rau, Jorn" sort="Rau, Jorn" uniqKey="Rau J" first="Jörn" last="Rau">Jörn Rau</name></author><author><name sortKey="Houeto, Jean Luc" sort="Houeto, Jean Luc" uniqKey="Houeto J" first="Jean-Luc" last="Houeto">Jean-Luc Houeto</name></author><author><name sortKey="Krack, Paul" sort="Krack, Paul" uniqKey="Krack P" first="Paul" last="Krack">Paul Krack</name></author><author><name sortKey="Schnitzler, Alfons" sort="Schnitzler, Alfons" uniqKey="Schnitzler A" first="Alfons" last="Schnitzler">Alfons Schnitzler</name></author><author><name sortKey="Schade Brittinger, Carmen" sort="Schade Brittinger, Carmen" uniqKey="Schade Brittinger C" first="Carmen" last="Schade-Brittinger">Carmen Schade-Brittinger</name></author><author><name sortKey="Timmermann, Lars" sort="Timmermann, Lars" uniqKey="Timmermann L" first="Lars" last="Timmermann">Lars Timmermann</name></author><author><name sortKey="Deuschl, Gunther" sort="Deuschl, Gunther" uniqKey="Deuschl G" first="Günther" last="Deuschl">Günther Deuschl</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Deep Brain Stimulation</term><term>Humans</term><term>Movement (physiology)</term><term>Parkinson Disease (therapy)</term><term>Placebo Effect</term><term>Quality of Life</term><term>Subthalamic Nucleus (physiopathology)</term></keywords><keywords scheme="MESH" qualifier="physiology" xml:lang="en"><term>Movement</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Subthalamic Nucleus</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Deep Brain Stimulation</term><term>Humans</term><term>Placebo Effect</term><term>Quality of Life</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">DBS of the STN improves quality of life (QoL) and motor function not only in advanced Parkinson's disease (PD), but also in PD with early motor complications, as shown in the recent EARLYSTIM study. In spite of the evidence in favor of STN-DBS, the findings of the EARLYSTIM study have recently been controversially debated. Here, we argue that a placebo or lessebo effect is unlikely to have relevantly contributed to the favorable outcome of STN-DBS in the EARLYSTIM study. The method of quantification of the placebo effect of DBS in a previous publication reveals flaws leading to implausible results, and therefore the placebo effect of DBS remains currently elusive, especially because blinding of PD patients with STN-DBS as a crucial preassumption for assessing a placebo effect is practically impossible. Moreover, we claim that the extent of such a placebo effect is most likely very small. Specific challenges of STN-DBS at an earlier stage of PD and inclusion criteria are the risk of inclusion of patients who later evolve to atypical parkinsonism, the risk of a floor effect for the benefit from DBS, the need for experienced multidisciplinary care including prevention of suicidal behavior, and the need for highly qualified long-term follow-up. The EARLYSTIM study has shown that STN-DBS may be proposed earlier on in the course of PD, as soon as motor complications start to cause relevant disability despite proper medical management. 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