A randomized study of 97 patients with chronic lower back pain (cLBP) found that patients who knowingly took placebo pills in conjunction with their usual treatment had significantly improved pain symptoms compared to those taking only treatment as usual.

“These findings turn our understanding of the placebo effect on its head,” said joint senior author Ted Kaptchuk, of Beth Israel Deaconess Medical Center and 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.” 

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After the 97 patients were screened and examined by a nurse and board certified pain specialist, they were given a 15-minute explanation of the placebo effect. The patients were subsequently divided into two groups, a treatment-as-usual group (TAU) or the open-label placebo (OLP) group. Most patients were taking NSAIDs for their pain; patients taking opioids were excluded from the trial.

The placebo group was given a bottle labeled ‘placebo pills’, containing microcrystalline cellulose and no active medication, and directed to take two capsules twice daily.

At the end of their three-week course of pills, the OLP group overall reported 30% reductions in both usual pain and maximum pain, while the TAU group reported just 9 and 16% reductions, respectively. Additionally, the placebo group reported a 29% drop in pain-related disability, while the TAU group reported almost no improvement in this area.

Musing on the reason for their findings, Dr. Kaptchuk said, “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, the body responds to that.”

The authors speculated that other symptoms based on self-observation could also be modulated by such open-label treatment. Co-author of the study Claudia Carvalho, PhD, of Instituto Superior de Psicologia Aplicada (ISPA) in Lisbon said that, “taking placebo pills to relieve symptoms without a warm and empathic relationship with a healthcare provider relationship probably would not work.”

For more information visit jpain.org.