Placebos, inactive substances that don’t contain any medication, shouldn’t make a clinical impact. Yet their effects can still be powerful, even if patients know they’re taking a placebo. It’s counterintuitive, but new research supports the suggestion that placebos have a place in modern medical care. Here’s a rundown of recent studies that legitimize the benefits of open-label placebo (OLP).
A PLoS One randomized controlled trial of 83 adults reporting chronic low back pain (cLBP) for more than three months and diagnosed by a board-certified pain specialist investigated whether adding OLP to treatment as usual (TAU) for additional three weeks could benefit patients with chronic low back pain.
The study was the first to demonstrate potentially significant benefits of OLP treatment in cLBP. “We found that adding OLP to TAU resulted in significantly greater reductions in cLBP and pain-related disability than TAU alone,” the authors wrote. Overall, OLP produced an additional pain reduction of approximately 30 percent of baseline pain and disability ratings.
In a randomized controlled trial in PLoS One, 46 German patients with allergic rhinitis were either given OLP or no pills and advised to also take their regular allergy medicine. In half of all subjects in both groups, researchers induced positive expectations about the placebo effect, telling subjects that although placebos contain no medication, placebo effects may still be powerful.
After two weeks, researchers conducted a statistical analysis, which included ANOVAs of allergic symptoms before and after the treatment for both groups to assess whether symptoms and quality of life had changed. The study found that OLP may reduce symptoms in allergic rhinitis better than a control group with comparable patient-advisor contact. The effect wasn’t related to positive expectancies or to specific symptoms.
“The results of this randomized controlled study underline that placebo without deception may successfully reduce symptoms in allergic rhinitis.
In a PLoS One randomized controlled trial involving 80 patients with irritable bowel syndrome, patients either received OLP 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, with the same quality of provider interaction. The primary outcome was measured using the IBS Global Improvement Scale (IBS-GIS). The study found that OLP produced significantly higher mean IBS-GIS scores at the 11 day midpoint and 21 day endpoint. “Placebos administered without deception may be an effective treatment for IBS,” the authors wrote.
A trial in Scientific Reports involving 74 cancer patients with chronic fatigue randomized to receive TAU or OLP, the OLP group reported statistically significant improvements in fatigue compared to the TAU group, suggesting that OLP may be an effective treatment for cancer-related fatigue (CRF). “Although our results suggest that OLP may be a beneficial treatment for CRF, replication studies are needed as well as studies exploring how OLP works, why and under what circumstances,” the authors wrote.
A BMJ study investigated the outcome of four small clinical trials of OLPs with patients with IBS, chronic low back pain, cancer fatigue and acute episodic migraine and allergic rhinitis), each trial with over 60 patients, patients were randomized to receive open label placebo (pills described as “inert placebos containing no medication”) plus usual treatment or usual treatment, and in one case, no treatment. The study found that OLP is significantly different than treatment as usual, producing clinically meaningful results.
More research is needed to determine how open-label placebos work and their effect on the brain. Bottom line? In a BMJ Talk Medicine audio report discussing the results of the BMJ study, the study’s lead researcher Ted J. Kaptchuk, MD, professor of medicine at Harvard Medical School, said that early theories about the benign nature of placebo, as in “no better than placebo,” may no longer be accurate or relevant.
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Carvalho C, Caetano JM, Cunha L, Rebouta P, Kaptchuk TJ, Kirsch I. Open-label placebo treatment in chronic low back pain: a randomized controlled trial. Pain. 2016; 157:2766-2772.
Schaefer M, Sahin T, Berstecher B. Who do open-label placebos work? A randomized controlled trial of an open-label placebo induction with and without extended information about the placebo effect in allergic rhinitis. PLoS One. 2018; 13:e0192759.
Kaptchuk TJ, Friedlander E, Kelley JM, et al. Placebos without deception: a randomized trial in irritable bowel syndrome. PLoS One. 2010; 5:e15591.
Hoenemeyer TW, Kaptchuk TJ, Mehta TS, Fontaine KR. Open-label placebo treatment for cancer-related fatigue: a randomized-controlled clinical trial. Sci Rep. 2018; 8:2784.
Kaptchuk TJ, Miller FG. Open label placebo: can honestly prescribed placebos evoke meaningful therapeutic benefits? BMJ. 2018; 363:k8889. https://www.bmj.com/content/363/bmj.k3889.long
Last updated on 9/26/19.