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Investigators from multiple institutions conducted a prospective crossover randomized trial to assess the effectiveness of open label placebo (OLP), ie, honestly prescribed placebo, in reducing pain in youths with functional abdominal pain or irritable bowel syndrome (IBS). Study participants were children 8-18 years old, with either functional abdominal pain or IBS, defined by Rome III criteria, who were enrolled at 3 children’s hospitals in the US between 2015 and 2018. During a 7-day observation period, study patients assessed their pain daily using a 0 to 100 mm visual analogue scale. Following the observation period, those with a mean daily pain scale of 25 mm were randomized to either OLP for 3 weeks or the control period. After 3 weeks, each participant crossed over to the other treatment group. A standard script was used during clinical encounters, with an explanation of placebos provided when a study child began OLP treatment. OLP was an inert suspension containing 85% sucrose, citric acid, water, and methyl paraben as a preservative, and patients were instructed to take 1.5 mL twice daily. Participants were allowed to take hyoscyamine dissolvable tablets as needed as a rescue pain medication. During the 6-week treatment period, study children recorded their daily pain using the visual analogue scale, which was the primary outcome. Differences in mean daily pain scores when participants were taking OLP or in the control period were compared using repeated-measures analysis of covariance; the model included mean pain score during the observation period and accounted for order of treatment. The main secondary outcome was number of hyoscyamine tablets used, with use during the OLP or control periods compared with a t-test.
Data were analyzed on 30 patients, including 16 (53.3%) with functional abdominal pain and 14 (46.7%) with IBS. The mean age of study participants was 14.1 ±3.4 years, and 80% were female; the mean daily pain score in these youths during the 7-day observation period was 45.8 ±2.8 mm. Mean daily pain scores in study participants were 39.9 ±18.9 mm during the OLP period and 45.0 ±14.7 mm during the control period (difference, 5.2 mm; 95% CI, 0.2, 10.1; P = 0.03). Overall, 21 (70%) patients had higher daily pain scores during the control period than during the OLP period. Participants also took significantly more hysocyamine tablets during the control period than while receiving OLP (mean, 3.8 ±5.1 and 2.0 ±3.0 tablets, respectively; P = 0.001).
The authors conclude that youths with functional abdominal pain or IBS experienced less pain during the OLP period than during the control period.
Dr Rosenthal has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
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