PLACEBO breakthrough in the management of irritable bowel syndrome (IBS) and functional abdominal pain in paediatric patients.
The placebo effect and the idea that IBS and functional abdominal pain are disorders of gut–brain interactions have been well documented for many years. Samuel Nurko, Director of the Motility and Functional Gastrointestinal Disorders Center, Boston Children’s Hospital, Massachusetts, USA, and Professor of Paediatrics, Harvard Medical School, Boston, Massachusetts, USA, took this knowledge of the placebo effect and applied it to disorders of the gut–brain interaction. They questioned whether the placebo effect could be enhanced and applied to patients struggling with the symptoms of such disorders.
Nurko stated: “Previous studies in adults have shown that the use of [open-label placebo (OLP)] or a placebo with no deception have shown benefit in patients with these disorders of gut–brain interaction.”
A multicentre, randomised, crossover clinical trial, which took place over 3 years and included 30 patients, investigated whether OLP can be beneficial in children and young adults with IBS or functional abdominal pain. Patients were recruited for a 6-week period and split into two groups. In one group, the OLP was given twice per day for the first 3 weeks, followed by a three-week period without the OLP. The second group had their control phase for the first 3 weeks, followed by the twice daily OLP for the second 3 weeks. Hyoscyamine was allowed as a rescue medication for symptomatic relief that could be used at any time during the study.
Findings showed that using an OLP resulted in significant reduction in mean pain scores as well as a reduction in the use of rescue medication. This is promising given that both patients and their parents were aware that the OLP liquid they would receive contained no active medication, indicating that the knowledge of a placebo did not negate the placebo effect in this trial. However, this study had a small sample, a short follow-up period, and did not assess the long-term response to or impact of OLP treatments.
The findings from this study pose the question of the placebo effect mechanism of action and how a better understanding of the effect may help patient–doctor interactions, explanations, and expectation management in order to effectively manage functional disorders to improve quality of life. Further work may be needed to create a culture of understanding and acceptance surrounding the use of placebos in place of active medication for appropriate conditions.