Boston—The pills might be fake, but that doesn’t mean they can’t relieve pain.

Or so says a new study in the journal Pain. It is the first to demonstrate a beneficial placebo effect for lower-back pain sufferers who knew they were taking ‘fake pills.’

In fact, according to the study involving Beth Israel Deaconess Medical Center, Harvard Medical School and Portuguese colleagues from the Instituto Superior de Psicologia Aplicada (ISPA), even though patients knowingly took placebos, they reported 30% less pain and 29% reduction in disability compared to a control group.

Another benefit to the study, according to the authors, is that “open-labeling,” as used in this circumstance, solves a common ethical dilemma by allowing patients to choose placebo treatments with informed consent.

“These findings turn our understanding of the placebo effect on its head,” explained joint senior author Ted Kaptchuk, director of the Program for Placebo Studies and the Therapeutic Encounter at Beth Israel Deaconess Medical Center and an associate professor of medicine at Harvard Medical School. “This new research demonstrates that the placebo effect is not necessarily elicited by patients‘ conscious expectation that they are getting an active medicine, as long thought. Taking a pill in the context of a patient-clinician relationship—even if you know it’s a placebo—is a ritual that changes symptoms and probably activates regions of the brain that modulate symptoms.”

For the study, researchers focused on 97 patients with chronic lower-back pain (cLBP), none of them using opioids. After being screened and examined by a registered nurse practitioner and board-certified pain specialist, participants were provided a 15-minute explanation of the placebo effect. Following that, the patients were randomized into one of two groups; the treatment-as-usual (TAU) group or the open-label placebo (OLP) group.

Participants in the OLP group were given a medicine bottle labeled “placebo pills” with directions to take, twice daily, two capsules containing only microcrystalline cellulose and no active medication. Yet, at the end of their 3-week course of pills, the OLP group overall reported 30% reductions in both usual pain and maximum pain, compared to 9% and 16% reductions, respectively, for the TAU group.

In addition, the placebo pill group also had a 29% decrease in pain-related disability, while the treatment-as-usual group reported little or no improvement.

“It‘s the benefit of being immersed in treatment: interacting with a physician or nurse, taking pills, all the rituals and symbols of our healthcare system,” Kaptchuk suggested. “The body responds to that.”

“Our findings demonstrate the placebo effect can be elicited without deception,” added lead author, Claudia Carvalho, PhD, of ISPA. “Patients were interested in what would happen and enjoyed this novel approach to their pain. They felt empowered.

“Taking placebo pills to relieve symptoms without a warm and empathic relationship with a health-care provider relationship probably would not work,” Carvalho pointed out.

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