Placebos help, even when patients know about them
WASHINGTON | Wed Dec 22, 2010 5:50pm EST
WASHINGTON (Reuters) - Placebos can help patients feel better, even if they are fully aware they are taking a sugar pill, researchers reported on Wednesday on an unusual experiment aimed to better understand the "placebo effect."
Nearly 60 percent of patients with irritable bowel syndrome reported they felt better after knowingly taking placebos twice a day, compared to 35 percent of patients who did not get any new treatment, they report in the Public Library of Science journal PLoS ONE.
"Not only did we make it absolutely clear that these pills had no active ingredient and were made from inert substances, but we actually had 'placebo' printed on the bottle," Ted Kaptchuk of Harvard Medical School and Beth Israel Deaconess Medical Center in Boston, who led the study, said in a statement.
The placebo effect has been documented almost since the beginning of medicine.
Placebos are also vital to research on new drugs or treatments, and in general scientists have documented that 30 percent to 40 percent of patients will report feeling better or will show documented improvement of symptoms even when unknowingly taking a placebo.
But it is considered unethical to give a patient a placebo as part of standard medical treatment and not tell them that it is just a sugar pill. Most people have assumed that a placebo will not work if the patient knows it is a placebo.
To test this common wisdom, Kaptchuk and colleagues enrolled 80 patients with irritable bowel syndrome or IBS, a chronic condition characterized by abdominal pain.
The volunteers were recruited for a "mind-body" study, given placebo or nothing for three weeks and carefully monitored. Those given placebos were reminded they were taking inert pills.
"I felt awkward asking patients to literally take a placebo. But to my surprise, it seemed to work for many of them," Anthony Lembo, an IBS expert who worked on the study, said.
The study was funded by the National Center for Complementary and Alternative Medicine.
(Reporting by Maggie Fox; Editing by Jackie Frank)
PLoS ONE: Research Article, published 22 Dec 2010 10.1371/journal.pone.0015591
Placebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome
Ted J. Kaptchuk1,2*, Elizabeth Friedlander1, John M. Kelley3,4, M. Norma Sanchez1, Efi Kokkotou1, Joyce P. Singer2, Magda Kowalczykowski1, Franklin G. Miller5, Irving Kirsch6, Anthony J. Lembo1
1 Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America, 2 Osher Research Center, Harvard Medical School, Boston, Massachusetts, United States of America, 3 Psychology Department, Endicott College, Beverly, Massachusetts, United States of America, 4 Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America, 5 Department of Bioethics, National Institutes of Health, Bethesda, Maryland, United States of America, 6 Department of Psychology, University of Hull, Hull, United Kingdom
Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS).
Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47±18 with IBS diagnosed by Rome III criteria and with a score ?150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as “placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes” or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL).
Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2±1.0 vs. 4.0±1.1, p<.001) and at 21-day endpoint (5.0±1.5 vs. 3.9±1.3, p = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p = .008 and p = .03) and adequate relief (IBS-AR, p = .02 and p = .03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (p = .08).
Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent.
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