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Open-Label Placebo Improves Symptoms in Pediatric IBS and Functional Abdominal Pain

0 2 years ago

A spoonful of sugar helps the medicine go down — but what if the sugar is the medicine?

Nearly 3 in 4 children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.

The findings, published online in JAMA Pediatrics January 31, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the US Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of children in the United States.

Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.

“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, West Virginia, told Medscape Medical News.

Study leader Samuel Nurko, MD, MPH, the director of the Functional Abdominal Pain Program at Harvard Medical School, Boston, Massachusetts, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”

Between 2015 and 2018, Nurko and colleagues randomly assigned 30 children and adolescents, ages 8 to 18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo — consisting of 85% sucrose, citric acid, purified water, and the preservative methylparaben — twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.

Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.


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