By Mary Brophy Marcus
Researchers from Harvard Medical School and Beth Israel Deaconess Medical Center in Boston compared the effects of a common migraine drug and an inactive placebo in 66 people who suffer from migraines. The condition includes throbbing headache, nausea, vomiting and sensitivity to light and sound.
The results consistently showed that taking the pills accompanied by positive information increased the effectiveness of the treatment, whether the patient had taken the real deal -- the drug Maxalt -- or a pill labeled "placebo."
Headache specialist Dr. Andrew Charles said the study demonstrates that expectation about response plays an important role in the ultimate response to a treatment.
"When migraine patients were told by their doctor that a pill would help ease their headaches, this advice seemed to produce results whether or not the pill was a real migraine medication or a dummy placebo," said Charles, professor and director of the headache research and treatment program in the department of neurology at University of California School of Medicine, Los Angeles.
"Relief was still higher with the actual medicine, so drugs do work beyond the placebo effect, but the researchers say that the placebo effect may still account for half of the therapeutic value of a drug," said Charles, who was not involved in the research.
For the study, published online Jan. 8 in the journal Science Translational Medicine, the scientists studied more than 450 migraine attacks in the study participants, following them over seven separate episodes.
To establish a baseline, each person was asked to report their pain and symptoms 30 minutes after the onset of an unmedicated migraine episode, and again 2.5 hours after its onset.
Each participant then received six treatment envelopes. The envelopes were labeled in one of three ways: "Maxalt" (rizatriptan); "placebo"; or "Maxalt or placebo." The labels were true for four attacks and false for two attacks.
The three situations were labeled by the researchers as positive (meaning a drug that could help with migraine symptoms was provided), negative (meaning no drug, only a placebo pill was provided), or neutral (meaning it was unknown if the drug or placebo pill was within the envelope). But for two situations, one of the "Maxalt" envelopes actually held a placebo and one of the "placebo" envelopes contained Maxalt.
The participants were asked to self-report their responses to treatment over the course of their next six migraine episodes.
Dr. Ted Kaptchuk, a senior author of the study, said that even though Maxalt was superior to the placebo in terms of alleviating pain, "we found that under each of the three messages, the placebo effect accounted for at least 50 percent of the subjects' overall pain relief."
When Maxalt was labeled "Maxalt," the patients' reports of pain relief more than doubled compared to when Maxalt was labeled "placebo," said Kaptchuk, a professor of medicine at Harvard. "This tells us that the effectiveness of a good pharmaceutical may be doubled by enhancing the placebo effect," he said.
When patients received Maxalt labeled as placebo, they were being treated by the medication but without any positive expectation, the other senior author, Rami Burstein, a professor of medicine at Harvard, said in a Beth Israel news release. "This was an attempt to isolate the pharmaceutical effect of Maxalt from any placebo effect," Burstein said.
The authors were surprised to find that even when patients were given a placebo labeled as "placebo," they reported pain relief, compared with no treatment.
"We don't know what that's about. It's a novel finding," added Kaptchuk.
Charles said the study was interesting and confirms what many experts believe about the placebo effect. "It's more rigorous than perhaps a number of the other studies that have been done previously," he noted.
Could these results play out across the spectrum of medical care?
"Obviously we don't know, we only looked at migraine," said Kaptchuk, "but I think that in many categories of illness and drugs, this would be proof of concept.
"This is likely to be operating in many other conditions, especially in conditions like nausea or irritable bowel syndrome, where a person's illness is defined by self-report," he added. "Self-reporting is a big part of what people feel."
More research will be needed to explore how these findings could be applied to clinical care and to learn more about how placebos might help boost drug treatment care, Kaptchuk said.
Some research has suggested that simply hearing the words of medicine can have a healing effect, he noted.
The study was partly funded by Merck and Co., the maker of Maxalt.