A Randomized, Controlled Trial of Surgery for Temporal-Lobe Epilepsy
Samuel Wiebe, M.D., Warren T. Blume, M.D., John P. Girvin, M.D., Ph.D., Michael Eliasziw, Ph.D., for the Effectiveness and Efficiency of Surgery for Temporal Lobe Epilepsy Study Group
Background Randomized trials of surgery for epilepsy have notbeen conducted, because of the difficulties involved in designingand implementing feasible studies. The lack of data supportingthe therapeutic usefulness of surgery precludes making strongrecommendations for patients with epilepsy. We conducted a randomized,controlled trial to assess the efficacy and safety of surgeryfor temporal-lobe epilepsy.
Methods Eighty patients with temporal-lobe epilepsy were randomlyassigned to surgery (40 patients) or treatment with antiepilepticdrugs for one year (40 patients). Optimal medical therapy andprimary outcomes were assessed by epileptologists who were unawareof the patients' treatment assignments. The primary outcomewas freedom from seizures that impair awareness of self andsurroundings. Secondary outcomes were the frequency and severityof seizures, the quality of life, disability, and death.
Results At one year, the cumulative proportion of patients whowere free of seizures impairing awareness was 58 percent inthe surgical group and 8 percent in the medical group (P<0.001).The patients in the surgical group had fewer seizures impairingawareness and a significantly better quality of life (P<0.001for both comparisons) than the patients in the medical group.Four patients (10 percent) had adverse effects of surgery. Onepatient in the medical group died.
Conclusions In temporal-lobe epilepsy, surgery is superior toprolonged medical therapy. Randomized trials of surgery forepilepsy are feasible and appear to yield precise estimatesof treatment effects.
Source Information
From the Departments of Clinical Neurological Sciences (S.W., W.T.B., J.P.G., M.E.) and Epidemiology and Biostatistics (S.W., M.E.), University of Western Ontario; the London Health Sciences Centre (S.W., W.T.B., J.P.G.); and the Robarts Research Institute (M.E.) all in London, Ont., Canada.
Address reprint requests to Dr. Wiebe at the London Health Sciences Centre, University Campus, 339 Windermere Rd., London, ON N6A 5A5, Canada, or at swiebe{at}uwo.ca.
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