Surgery is much more effective than drugs for treating epilepsy and should no longer be considered the treatment of last resort, according to the first clinical trial to compare the two approaches.
A full 64 percent of the patients who underwent the surgery were free of disabling seizures for the year after surgery, compared with only 8 percent of those receiving epilepsy drugs, a Canadian team will report in Thursday's New England Journal of Medicine.
At least 100,000 of the 2 million Americans with epilepsy could benefit from surgery, but only about 1,500 undergo it each year -- at least in part because its benefits have never been proved directly in a study.
"In all of modern medicine, few generally accepted therapeutic interventions are as underutilized as surgical treatment for epileptic seizures," said Dr. Jerome Engel Jr., of the University of California, Los Angeles School of Medicine, in an accompanying editorial.
"What makes this study significant is that, for the first time, we have a strong prospective study that clearly shows the value of epilepsy surgery," said Dr. Gregory L. Barkley of the Henry Ford Comprehensive Epilepsy Program in Detroit. "The bottom line is that, if you've tried several drug combinations for a year to a year and a half, then you should think about surgery so that the patients can get on with their lives."
The surgery is not for everyone. About three-quarters of the epilepsy population is able to control seizures with one or more of the two dozen medications now available. For many others, the brain abnormalities that trigger seizures are spread around the brain or are located in areas that have important functions. For them, the surgery, which removes part of the brain, could run the risk of impairing a vital function such as speech.
But that still leaves a large pool of patients for whom surgery could be lifesaving. Patients who have regular seizures are five times as likely to die as those who are able to control their seizures. "Epilepsy (with uncontrolled seizures) can have a devastating effect on people's lives," said Dr. Richard B. Kim of the UC Irvine School of medicine. "They can't work, they can't go to school, they can't drive."
After the surgery, many regain their lives, he added. "They are very satisfied with the results."
Epilepsy surgery has been around since the 1930s, long before clinical trials became the most important method of validating new drugs and medical procedures. Many researchers have felt the need to conduct a direct trial comparing surgery and drugs, but felt ethically constrained. Because they believed in the superior efficacy of surgery, they were unwilling to randomly assign some eligible patients to receive only medications.
Dr. Samuel Wiebe and his colleagues at the University of Western Ontario in London, however, were able to circumvent this ethical problem by taking advantage of the medical rationing that is the norm in Canada. Epilepsy patients who are eligible for the surgery there must wait an average of at least a year before they are able to receive it.
Wiebe obtained a special grant that allowed him to jump some patients to the head of the queue so that they could receive immediate surgery.
He and his colleagues identified 80 patients with a temporal lobe abnormality that made them good candidates for the procedure, then randomly assigned them to receive either surgery or medications. The patients were then followed for an average of about a year, at which time the patients receiving drugs became eligible for surgery through the normal course of events.
Among the 40 patients randomly selected for surgery, after one year, 58 percent had not experienced the kind of disabling seizures that limited their awareness of their surroundings. Four of the 40 originally chosen did not undergo the surgery, so that 64 percent of the 36 patients who actually had surgery were free of seizures.
In comparison, only 8 percent of those on medications were free of seizures after a year. Patients who underwent the surgery were better able to participate in social activities, hold jobs and lead satisfying lives.
Four of the patients undergoing surgery had adverse effects. One developed a sensory abnormality in the thigh, one had an infection at the surgical site, and two had slight impairments of memory. One patient in the group receiving drugs died of unexplained causes.
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