Open-label placebo reduces pain in pediatric, adolescent functional GI disorders
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Open-label placebo reduced pain and rescue medication use among pediatric and adolescent patients with functional abdominal pain and irritable bowel syndrome, according to research published in JAMA Pediatrics.
“Although placebo responses probably play a role in virtually every clinical intervention, the use of deceptive placebos as stand-alone treatments has largely been discouraged because of ethical concerns about patient deception,” Samuel Nurko, MD, MPH, of the Center for Motility and Functional Gastrointestinal Disorders at Boston’s Children’s Hospital, and colleagues wrote. “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 honestly prescribed treatment can yield positive effects.”
In a multicenter, crossover randomized trial, researchers investigated the effectiveness of open-label placebo among 30 pediatric and adolescent patients (mean age 14.1 years, 80% girls) with functional abdominal pain (53.3%) or IBS (46.7%). Patients received either placebo twice daily (1.5 mL inert liquid) for 3 weeks followed by a 3-week control period or vice versa; researchers allowed 0.125 mg dissolvable hyoscyamine tablets on an as-needed basis for pain. Studied outcomes included mean daily pain score during intervention and use of rescue medication.
Researchers observed lower pain scores during the placebo period compared with the control period (39.9 [18.9] vs. 45 [14.7]; 95% CI, 0.2-10.1), as well as reduced usage of rescue medication (mean 2 [3] tablets vs. 3.8 [5.1] tablets; 95% CI, 0.5-3.1). Further, 46.7% of patients reported global improvement during the placebo period compared with 30% during the control period, and half of the patients reported that the placebo improved their pain score by more than 50%. Researchers noted no adverse effects associated with placebo.
“Open-label placebo can significantly reduce pain in children and adolescents with disorders of gut-brain interaction as well as decrease their use of rescue medications. Our findings suggest that open-label placebo may provide an ethical way to harness the placebo effect as a therapeutic tool in the clinic,” Nurko and colleagues concluded. “More research is required to confirm and extend these findings.”
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