A randomized, controlled trial of surgery for temporal-lobe epilepsy

Background: Randomized trials of surgery for epilepsy have not been conduct ed, because of the difficulties involved in designing and implementing feas ible studies. The lack of data supporting the therapeutic usefulness of sur gery precludes making strong recommendations for patients with epilepsy. We conducted a randomized, controlled trial to assess the efficacy and safety of surgery for temporal-lobe epilepsy. Methods: Eighty patients with temporal-lobe epilepsy were randomly assigned to surgery (40 patients) or treatment with antiepileptic drugs for one yea r (40 patients). Optimal medical therapy and primary outcomes were assessed by epileptologists who were unaware of the patients' treatment assignments . The primary outcome was freedom from seizures that impair awareness of se lf and surroundings. Secondary outcomes were the frequency and severity of seizures, the quality of life, disability, and death. Results: At one year, the cumulative proportion of patients who were free o f seizures impairing awareness was 58 percent in the surgical group and 8 p ercent in the medical group (P<0.001). The patients in the surgical group h ad fewer seizures impairing awareness and a significantly better quality of life (P<0.001 for both comparisons) than the patients in the medical group . Four patients (10 percent) had adverse effects of surgery. One patient in the medical group died. Conclusions: In temporal-lobe epilepsy, surgery is superior to prolonged me dical therapy. Randomized trials of surgery for epilepsy are feasible and a ppear to yield precise estimates of treatment effects.