Open-Label Placebo Offers New Treatment for Disorders of Gut-Brain Interaction in Children

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02/03/2022

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ChildrenHospital.org

Pain-predominant disorders of gut-brain interaction (DGBIs) in children — such as functional abdominal pain (FAP) and irritable bowel syndrome (IBS) — can lead to disabling symptoms, poor quality of life, and high use of health care resources. While optimal treatment for these conditions remains elusive, we know that this patient population tends to have high placebo response rates. Although this can make it difficult to identify effective therapies, it can also present new opportunities for care.

Studies suggest that an open-label placebo (OLP) approach — in which patients are aware that they are receiving a placebo — can benefit adults with DGBIs. However, no similar research had been conducted on the effects of OLP in pediatric DGBI patients, or other pediatric conditions. To learn more, a group of investigators led by Samuel Nurko, MD, MPH, director of the Motility and Functional Gastrointestinal Disorders Center at Boston Children’s Hospital, conducted the first OLP study in pediatrics in a multicenter randomized crossover trial of 30 children between ages 8 and 18 with diagnosed IBS or FAP.

Patients Responded to Placebo With no Deception

The patients tracked their pain for seven days leading up to the study. They were then randomized to either a control or OLP group, with a crossover after three weeks. The researchers explained to the parents and the patients the basic concept of a placebo, as well as the idea that placebos have produced benefits in some studies. Families understood they were getting placebo and not an active medication. The OLP involved taking 1.5 ml of an inert liquid placebo twice a day; this syrup mimicked the appearance of other medications used in pediatric care. All of the patients were given access to hyoscyamine for use as a rescue medication and kept symptom diaries throughout the study.

Nurko and his colleagues found that patients’ mean pain scores were significantly lower during the OLP treatment than during the control period. Patients also took nearly twice as many tablets of hyoscyamine during the control period than during the OLP period. There were no side effects. The findings were published in the January 31 issue of JAMA Pediatrics.

The results of this first-of-its-kind study in pediatric patients with DGBIs show promise as a future non-pharmacologic therapy of these difficult-to-treat conditions.

A significant placebo effect has been observed in double-blind clinical studies in children with DGBIs. It’s widely believed that concealment or deception is required to elicit a placebo response, but our study shows that the open administration of a placebo treatment — i.e. non-concealed and without deception — is effective,” says Nurko. “The exact nature of the response is still not known, but my hope is to be able to understand the process so we’ll be able to harness it and use in routine clinical care.”

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