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Treatment of Refractory Mesial Temporal Lobe Epilepsy

Treatment of Refractory Mesial Temporal Lobe Epilepsy To the Editor: Dr Engel and colleagues1 presented important additional evidence on the superiority of surgical therapy over antiepileptic drugs (AEDs) in the treatment of refractory mesial temporal lobe epilepsy (MTLE). Their results corroborate and expand the findings of a previous randomized controlled trial,2 which led the American Academy of Neurology to issue a practice parameter in 2003 recommending surgery as the treatment of choice for pharmacoresistant MTLE.3 While the greater efficacy of surgical treatment for seizure control in MTLE is well established, the question of timing of surgery is still controversial. Clinicians generally perceive surgery as a last resort due to concern regarding the risks of adverse effects following surgical intervention and either fail to refer patients or refer them too late. Although not a universal finding, memory impairment has often been reported after an anterior temporal lobe resection and may compromise the patient's well-being and social functioning, even when seizure-free. However, MTLE is now regarded as a progressive disease and therefore it is critical to assess the comparative effect on health-related quality of life (HRQOL) and the psychosocial status of patients undergoing each treatment approach to make an informed decision concerning the use of surgery or pharmacotherapy. With the premature termination of the trial after only 38 patients were enrolled, the comparative effect of early surgery on cognition and HRQOL remains unanswered. The declared primary outcome of the Early Randomized Surgical Epilepsy Trial (ERSET) was seizure freedom, but the large planned sample size (200 patients) is not justifiable based on the expected difference in the primary outcome because there was previous evidence2 indicating that the surgical approach is superior in cases of refractory MTLE. In fact, supplementary material previously published describing the study design for ERSET4 confirms that “sample size was instead chosen largely to address the important secondary aim of examining treatment group differences in mean change in HRQOL.” Moreover, in 1999, when the original plan for ERSET was published, it stated that, at the end of 2 years, the primary outcome measure would be a quantitative assessment of HRQOL; seizure recurrence was defined as a secondary outcome.5 Early surgery can benefit patients with MTLE. Future trials with larger samples and longer follow-up should address the issue of whether surgery can also improve HRQOL compared with the natural history of the disease in appropriately selected patients with MTLE, in addition to providing better seizure control compared with medication. Back to top Article Information Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kieling reported receiving medication for a trial of attention-deficit/hyperactivity disorder from Novartis. Dr Palmini reported serving as a board member and receiving payment for lectures and travel from Novartis, Abbott, Janssen-Cilag, and Eli Lilly; receiving payment for manuscript preparation from Novartis, Abbott, and Janssen-Cilag; and receiving payment for organization of preceptorships and workshops paid to fund fellowships from Novartis and Biogen. Dr Paglioli reported no disclosures. References 1. Engel J Jr, McDermott MP, Wiebe S, et al; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Early surgical therapy for drug-resistant temporal lobe epilepsy: a randomized trial. JAMA. 2012;307(9):922-93022396514PubMedGoogle ScholarCrossref 2. Wiebe S, Blume WT, Girvin JP, Eliasziw M.Effectiveness and Efficiency of Surgery for Temporal Lobe Epilepsy Study Group. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001;345(5):311-31811484687PubMedGoogle ScholarCrossref 3. Engel J Jr, Wiebe S, French J, et al; Quality Standards Subcommittee of the American Academy of Neurology; American Epilepsy Society; American Association of Neurological Surgeons. Practice parameter: temporal lobe and localized neocortical resections for epilepsy: report of the Quality Standards Subcommittee of the American Academy of Neurology, in association with the American Epilepsy Society and the American Association of Neurological Surgeons. Neurology. 2003;60(4):538-54712601090PubMedGoogle ScholarCrossref 4. Engel J Jr, McDermott MP, Wiebe S, et al; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Design considerations for a multicenter randomized controlled trial of early surgery for mesial temporal lobe epilepsy. Epilepsia. 2010;51(10):1978-198620550556PubMedGoogle ScholarCrossref 5. Engel J Jr. The timing of surgical intervention for mesial temporal lobe epilepsy: a plan for a randomized clinical trial. Arch Neurol. 1999;56(11):1338-134110555652PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Treatment of Refractory Mesial Temporal Lobe Epilepsy

JAMA , Volume 307 (23) – Jun 20, 2012

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Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2012.4985
Publisher site
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Abstract

To the Editor: Dr Engel and colleagues1 presented important additional evidence on the superiority of surgical therapy over antiepileptic drugs (AEDs) in the treatment of refractory mesial temporal lobe epilepsy (MTLE). Their results corroborate and expand the findings of a previous randomized controlled trial,2 which led the American Academy of Neurology to issue a practice parameter in 2003 recommending surgery as the treatment of choice for pharmacoresistant MTLE.3 While the greater efficacy of surgical treatment for seizure control in MTLE is well established, the question of timing of surgery is still controversial. Clinicians generally perceive surgery as a last resort due to concern regarding the risks of adverse effects following surgical intervention and either fail to refer patients or refer them too late. Although not a universal finding, memory impairment has often been reported after an anterior temporal lobe resection and may compromise the patient's well-being and social functioning, even when seizure-free. However, MTLE is now regarded as a progressive disease and therefore it is critical to assess the comparative effect on health-related quality of life (HRQOL) and the psychosocial status of patients undergoing each treatment approach to make an informed decision concerning the use of surgery or pharmacotherapy. With the premature termination of the trial after only 38 patients were enrolled, the comparative effect of early surgery on cognition and HRQOL remains unanswered. The declared primary outcome of the Early Randomized Surgical Epilepsy Trial (ERSET) was seizure freedom, but the large planned sample size (200 patients) is not justifiable based on the expected difference in the primary outcome because there was previous evidence2 indicating that the surgical approach is superior in cases of refractory MTLE. In fact, supplementary material previously published describing the study design for ERSET4 confirms that “sample size was instead chosen largely to address the important secondary aim of examining treatment group differences in mean change in HRQOL.” Moreover, in 1999, when the original plan for ERSET was published, it stated that, at the end of 2 years, the primary outcome measure would be a quantitative assessment of HRQOL; seizure recurrence was defined as a secondary outcome.5 Early surgery can benefit patients with MTLE. Future trials with larger samples and longer follow-up should address the issue of whether surgery can also improve HRQOL compared with the natural history of the disease in appropriately selected patients with MTLE, in addition to providing better seizure control compared with medication. Back to top Article Information Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Kieling reported receiving medication for a trial of attention-deficit/hyperactivity disorder from Novartis. Dr Palmini reported serving as a board member and receiving payment for lectures and travel from Novartis, Abbott, Janssen-Cilag, and Eli Lilly; receiving payment for manuscript preparation from Novartis, Abbott, and Janssen-Cilag; and receiving payment for organization of preceptorships and workshops paid to fund fellowships from Novartis and Biogen. Dr Paglioli reported no disclosures. References 1. Engel J Jr, McDermott MP, Wiebe S, et al; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Early surgical therapy for drug-resistant temporal lobe epilepsy: a randomized trial. JAMA. 2012;307(9):922-93022396514PubMedGoogle ScholarCrossref 2. Wiebe S, Blume WT, Girvin JP, Eliasziw M.Effectiveness and Efficiency of Surgery for Temporal Lobe Epilepsy Study Group. A randomized, controlled trial of surgery for temporal-lobe epilepsy. N Engl J Med. 2001;345(5):311-31811484687PubMedGoogle ScholarCrossref 3. Engel J Jr, Wiebe S, French J, et al; Quality Standards Subcommittee of the American Academy of Neurology; American Epilepsy Society; American Association of Neurological Surgeons. Practice parameter: temporal lobe and localized neocortical resections for epilepsy: report of the Quality Standards Subcommittee of the American Academy of Neurology, in association with the American Epilepsy Society and the American Association of Neurological Surgeons. Neurology. 2003;60(4):538-54712601090PubMedGoogle ScholarCrossref 4. Engel J Jr, McDermott MP, Wiebe S, et al; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Design considerations for a multicenter randomized controlled trial of early surgery for mesial temporal lobe epilepsy. Epilepsia. 2010;51(10):1978-198620550556PubMedGoogle ScholarCrossref 5. Engel J Jr. The timing of surgical intervention for mesial temporal lobe epilepsy: a plan for a randomized clinical trial. Arch Neurol. 1999;56(11):1338-134110555652PubMedGoogle ScholarCrossref

Journal

JAMAAmerican Medical Association

Published: Jun 20, 2012

References