Surgery Viable for Epilepsy, Study Shows
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% of the patients who underwent the surgery were free of disabling seizures for the year after surgery, compared with only 8% of those receiving epilepsy drugs, a Canadian team reports in today’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 like this one.
“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 UCLA 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, of course. 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 College 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 get 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% 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 64% of the 36 patients who actually had surgery were free of seizures.
In comparison, only 8% 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 surgery patients 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.
“Patients do worry about possible negative effects of surgery, and that’s a legitimate concern,” said Patricia Osborne Shafer of the Beth Israel Deaconess Medical Center, who is a nurse and chairwoman of the Epilepsy Foundation’s professional advisory board.
“But there are also significant risks associated with seizures that don’t respond to treatment with anticonvulsant drugs, including an increased risk of sudden, unexplained death, sedation, memory loss, personality change and learning disabilities caused by over-medication,” she added.
Despite the success of this trial, “there are still a lot of barriers to overcome” before surgery is more widely used, Kim said. One is lack of access to specialized centers that evaluate epilepsy. “There are only a handful on the West Coast,” including UC Irvine and UCLA.
Cost can be a major obstacle to surgery. Many insurance companies will not pay for it because of what Kim terms “the misguided impression that it is cheaper to pay for medicines and emergency room visits than to pay for surgery.” Many potential candidates have no insurance at all because their condition prevents them from holding down a job.
For patients whose epilepsy cannot be controlled by drugs and who are not eligible for surgery, another possibility is a new device called a vagus nerve stimulator, which acts like a pacemaker for the brain. The new device has been shown to control seizures in many patients.
“The good news is that we have more options than ever before,” Barkley said. “This is a time of great hope for epilepsy patients.”
