Written by Vivian Lei
Children with functional abdominal pain and irritable bowel syndrome (IBS) taking an open-label placebo (OLP) reported significantly less pain and took fewer rescue pain medications.
Why does this matter?
Placebo therapy has a high response rate in children with disorders of gut-brain interaction such as irritable bowel syndrome (IBS) and functional abdominal pain. This small trial explores whether deception can be avoided when prescribing a placebo to children.
Just a spoonful of sugar
This was a multicenter, crossover, randomized controlled trial enrolling 30 patients aged 8 to 18 years with functional abdominal pain or IBS. The mean age was 14, and 80% were female. Patients had a baseline 7-day observational period and were then randomized to receive an open-label placebo (i.e. “sugar pill”) twice a day for 3 weeks followed by no placebo for 3 weeks, or the reverse. Mean daily pain scores were recorded using a 100 mm visual analog scale and were significantly lower during the OLP period compared to the control period (39.9 vs. 45.0). Patients took an average of 3.8 tablets of rescue hyoscyamine tablets during the control period compared with 2.0 tablets during the OLP period.
Since the trial design with administration of OLP made blinding impossible, I wonder how much of the treatment effect was due to children wanting to please the researchers. The small size of the trial also limits its generalizability. However, harnessing the placebo effect in a transparent way is an interesting concept for future research and therapy.
Effect of Open-label Placebo on Children and Adolescents With Functional Abdominal Pain or Irritable Bowel Syndrome: A Randomized Clinical Trial. JAMA Pediatr. 2022 Apr 1;176(4):349-356. doi: 10.1001/jamapediatrics.2021.5750. Erratum in: doi: 10.1001/jamapediatrics.2022.0359.