Open-Label Placebo Study on Children with DGBI

Children with pain-predominant disorders of gut-brain interaction (DGBI) can have severely disabling symptoms, resulting in poor quality of life, high use of health care resources, and social isolation. A recent study suggests that an open-label placebo may be used to reduce pain and decrease the use of rescue medications for children and adolescents with functional abdominal pain or irritable bowel syndrome (IBS). The study findings were published in the JAMA Pediatrics on January 31, 2022.

Until recently, it has been widely believed that patient blinding (via deception or concealment) is required to elicit placebo effects, but recent studies with adults suggest that the open-label placebo (OLP) honestly prescribed treatment can yield positive effects, including in patients with DGBI. However, no studies of OLP have been performed with children. Therefore, Dr. Samuel Nurko and his team conducted a study to evaluate the efficacy of OLP for the treatment of children and adolescents with functional abdominal pain or irritable bowel syndrome.

In a multicenter crossover randomized study, the researchers included 30 children ages 8 to 18 to receive 3 weeks of twice-daily placebo treatment with 1.5 mL of liquid (containing mostly sucrose) for 3 weeks, followed by a 3-week control period, or to have the control first followed by the placebo. They used hyoscyamine as rescue medication. The major outcome assessed was the mean daily pain score during each of the interventions, measured on a 0- to 100-mm visual analogue scale, where higher scores indicated greater pain. They further assessed the number of rescue medications taken during each intervention.

Key findings of the study:

• Upon analysis, the researchers found that the mean (SD) pain scores were significantly lower during OLP treatment compared with the control period (39.9 [18.9] vs 45.0 [14.7]; difference, 5.2).
• They further noted that patients took nearly twice as many hyoscyamine pills during the control period compared with during the OLP period (mean [SD] number, 3.8 [5.1] pills vs 2.0 [3.0] pills; difference, 1.8 pills).

The authors concluded, "During OLP, patients with functional abdominal pain or irritable bowel syndrome reported significantly less pain and took significantly fewer pain medications. Open-label placebo may be an effective treatment for children and adolescents with functional abdominal pain or irritable bowel syndrome."

For further information:

DOI: 10.1001/jamapediatrics.2021.5750