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

Abstract

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.

• Authors: S Wiebe, W T Blume, J P Girvin, M Eliasziw, Effectiveness and Efficiency of Surgery for Temporal Lobe Epilepsy Study Group
• Journal: The New England journal of medicine (N Engl J Med) Vol. 345 Issue 5 Pg. 311-8 (Aug 02 2001) ISSN: 0028-4793 [Print] United States
• PMID: 11484687 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticonvulsants

Topics

• Adult
• Anticonvulsants (therapeutic use)
• Disease-Free Survival
• Employment (statistics & numerical data)
• Epilepsy, Temporal Lobe (drug therapy, surgery)
• Female
• Humans
• Male
• Neurosurgery (methods)
• Postoperative Complications
• Quality of Life
• Temporal Lobe (surgery)
• Treatment Outcome