Migraine was eliminated in 57% of patients in Dr. Guyuron’s study, but the cure rate in previous randomized, placebo-controlled drug trials is approximately 5%, said Dr. Diener. Comparing Dr. Guyuron’s study with open trials of patent foramen ovale closure for migraine might explain this discrepancy. “All the open trials have a cure rate of about 50%, but the only properly conducted randomized trial had a cure rate of 4%,” said Dr. Diener. Patients who had migraine elimination in Dr. Guyuron’s study “were responders to placebo, and this is the only way to show a success rate of 50%,” said Dr. Diener. “There was no cure of migraine.”
Another problematic aspect of Dr. Guyuron’s study is that patients were examined by neurologists before undergoing surgery, but not after surgery. In addition, the study’s premise that migraine results from trigger sites is implausible, said Dr. Diener. “Migraine is a complex disease of the brain. How could surgery affect the epigenetics of 22 different genes,” he asked.
“The study, unfortunately, has basically all the methodologic mistakes that can be made in a randomized trial,” added Dr. Diener. “If you actually want to use a placebo, use acupuncture. It will not hurt anyone.”
—Erik Greb
Senior Associate Editor