[HTML][HTML] A randomized, controlled trial of surgery for temporal-lobe epilepsy
S Wiebe, WT Blume, JP Girvin… - New England Journal of …, 2001 - Mass Medical Soc
S Wiebe, WT Blume, JP Girvin, M Eliasziw
New England Journal of Medicine, 2001•Mass Medical SocBackground Randomized trials of surgery for epilepsy have not been conducted, because of
the difficulties involved in designing and implementing feasible studies. The lack of data
supporting the therapeutic usefulness of surgery 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 …
the difficulties involved in designing and implementing feasible studies. The lack of data
supporting the therapeutic usefulness of surgery 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 …
Background
Randomized trials of surgery for epilepsy have not been conducted, because of the difficulties involved in designing and implementing feasible studies. The lack of data supporting the therapeutic usefulness of surgery 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 year (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 self 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 of seizures impairing awareness was 58 percent in the surgical group and 8 percent in the medical group (P<0.001). The patients in the surgical group had 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 medical therapy. Randomized trials of surgery for epilepsy are feasible and appear to yield precise estimates of treatment effects.
The New England Journal Of Medicine