Study Shows Many Patients Feel Better Even When Their Medicine Is Just a 'Dummy Pill'
By Salynn Boyles
WebMD Health News
Reviewed by Laura J. Martin, MD
May 23, 2011 -- There is a substantial "placebo effect" in the treatment of migraines and tension headaches, a new research analysis shows.
Placebo treatments or no treatment appeared to work just as well as drugs in a large percentage of headache patients participating in more than 100 studies.
Researchers from Erasmus University in The Netherlands analyzed the studies in an effort to determine the magnitude of the placebo effect on headache recovery.
A placebo effect occurs when a treatment with no known effectiveness, such as a dummy pill, is given to a patient and the patient nevertheless has subsequent improvement in symptoms.
Just over one in three patients in the placebo or no treatment portions of the studies (36%) reported improvement in headache symptoms.
The placebo effect was much greater in studies where a dummy pill was compared to drugs than in studies examining lifestyle interventions and other non-drug treatments.
Role of Patients' Expectations
Almost 40% of placebo-treated patients participating in the drug trials got better after receiving dummy pills, compared to 15% of patients in the sham-therapy portions of the non-pharmaceutical trials.
Since drugs used to treat migraines and other recurring headaches can have side effects, study co-author Bart W. Koes, PhD, says the findings suggest that many patients might benefit from non-pharmaceutical interventions.
Koes is a professor of general practice medicine at Erasmus Medical Center in Rotterdam.
"Patient expectations appear to have a lot to do with outcomes," Koes tells WebMD. "If we understood more about why this placebo effect occurs it could impact both clinical practice and future research."
Placebo Effect in Migraine Patients
More than nine out of 10 people experience occasional or frequent headaches, and various drug treatments, lifestyle interventions, and alternative approaches are used to treat and prevent head pain.
Tension headaches, which account for about 90% of all headaches, typically originate in the neck, upper back, or other muscle groups, while migraines most often involve pulsating pain on one side of the head and may also include nausea, vomiting, and sensitivity to light or sound.
The newly reported analysis included data on more than 7,000 patients with migraines or tension headaches participating in 119 clinical trials of pharmaceutical and non-pharmaceutical headache treatments.
The placebo effect was highest for trials involving drug treatments given to children. Almost half (45%) of children in the placebo arms of these trials got better after taking the dummy pills, compared to 36% of adults.
The placebo effect was also greater in trials involving migraine patients, with almost 41% of these patients who got the sham treatments or no treatment recovering, compared to 34% of tension headache patients.
While the research suggests that patients who unknowingly take placebo pills have better outcomes than those who get no treatment at all, the researchers acknowledge that "a placebo cannot easily be prescribed in daily practice."
The research analysis appears in the June issue of the Journal of Manipulative and Physiological Therapeutics.
Chicago-based neurologist Merle Diamond, MD, who is managing director of the Diamond Headache Clinic, says she is not surprised by the findings.
"We don't really understand why, but placebo treatments do work," she says, adding that under certain circumstances dummy pills might have a place in clinical practice.
"Some people say they should never be prescribed, but I believe that if it works for someone there is little harm," she says. "There is still a lot we don't understand about headaches.
Diamond says non-drug approaches that were once considered alternative are now widely used because they work for many patients. These therapies include biofeedback, acupuncture, physical therapy, meditation, and even Tai Chi.
Likewise, simple lifestyle changes, such as eating regular meals, having a regular sleep schedule, avoiding trigger foods and limiting caffeine can help modify response to pain.
"I still see patients who drink coffee or other drinks with caffeine all day long and wonder why they can't sleep and are having headaches," she says. "Lifestyle is very important. It is important to fix what is fixable."
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SOURCES: de Groot, F.M. Journal of Manipulative and Physiological Therapeutics, June, 2011; vol 34: online edition.Bart W. Koes, PhD, professor of general practice medicine, Erasmus Medical Center, Rotterdam, The Netherlands.Merle Diamond, MD, managing director, Diamond Headache Clinic, Chicago.News release, Journal of Manipulative and Physiological Therapeutics. ©2011 WebMD, LLC. All Rights Reserved.