Enough Is Enough
2009; American Medical Association; Volume: 66; Issue: 6 Linguagem: Inglês
10.1001/archneurol.2009.82
ISSN1538-3687
AutoresMichael S. Okun, Kelly D. Foote,
Tópico(s)Genetic Neurodegenerative Diseases
ResumoJAMA Bilateral Deep Brain Stimulation vs Best Medical Therapy for Patients With Advanced Parkinson Disease: A Randomized Controlled Trial Frances M. Weaver, PhD; Kenneth Follett, MD, PhD; Matthew Stern, MD; Kwan Hur, PhD; Crystal Harris, PharmD; William J. Marks Jr, MD; Johannes Rothlind, PhD; Oren Sagher, MD; Domenic Reda, PhD; Claudia S. Moy, PhD; Rajesh Pahwa, MD; Kim Burchiel, MD; Penelope Hogarth, MD; Eugene C. Lai, MD, PhD; John E. Duda, MD; Kathryn Holloway, MD; Ali Samii, MD; Stacy Horn, DO; Jeff Bronstein, MD, PhD; Gatana Stoner, RN, CCRC; Jill Heemskerk, PhD; Grant D. Huang, PhD; for the CSP 468 Study Group Context: Deep brain stimulation is an accepted treatment for advanced Parkinson disease (PD), although there are few randomized trials comparing treatments, and most studies exclude older patients. Objective: To compare 6-month outcomes for patients with PD who received deep brain stimulation or best medical therapy. Design, Setting, and Patients: Randomized controlled trial of patients who received either deep brain stimulation or best medical therapy, stratified by study site and patient age ( Intervention: Bilateral deep brain stimulation of the subthalamic nucleus (n = 60) or globus pallidus (n = 61). Patients receiving best medical therapy (n = 134) were actively managed by movement disorder neurologists. Main Outcome Measures: The primary outcome was time spent in the “on” state (good motor control with unimpeded motor function) without troubling dyskinesia, using motor diaries. Other outcomes included motor function, quality of life, neurocognitive function, and adverse events. Results: Patients who received deep brain stimulation gained a mean of 4.6 h/d of on time without troubling dyskinesia compared with 0 h/d for patients who received best medical therapy (between group mean difference, 4.5 h/d [95% CI, 3.7-5.4 h/d]; P P P P Conclusion: In this randomized controlled trial of patients with advanced PD, deep brain stimulation was more effective than best medical therapy in improving on time without troubling dyskinesias, motor function, and quality of life at 6 months, but was associated with an increased risk of serious adverse events. Trial Registration: clinicaltrials.gov Identifier:NCT00056563 JAMA. 2009;301(1):63-73..
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