Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome

Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome

3 April 2008 | Ted J Kaptchuk, John M Kelley, Lisa A Conboy, Roger B Davis, Catherine E Kerr, Eric E Jacobson, Irving Kirsch, Rosa N Schyner, Bong Hyun Nam, Long T Nguyen, Min Park, Andrea L Rivers, Claire McManus, Efi Kokkotou, Douglas A Drossman, Peter Goldman, Anthony J Lembo
A randomized controlled trial investigated whether the placebo effect in patients with irritable bowel syndrome (IBS) could be separated into three components: assessment and observation, therapeutic ritual (placebo treatment), and patient-practitioner relationship. The study involved 262 adults with IBS, diagnosed according to Rome II criteria and scoring ≥150 on the symptom severity scale. Participants were randomly assigned to three groups: waiting list (no treatment), limited interaction (placebo acupuncture with minimal practitioner interaction), or augmented interaction (placebo acupuncture with a warm, empathetic, and confident patient-practitioner relationship). At three weeks, half of the participants were randomly assigned to continue in their original group for an additional three weeks. The main outcomes included global improvement scale, adequate relief of symptoms, symptom severity score, and quality of life. At three weeks, the augmented group showed the greatest improvement in all outcomes compared to the limited and waiting list groups. The augmented group had significantly higher scores on the global improvement scale, adequate relief of symptoms, symptom severity score, and quality of life. These results were consistent at the six-week follow-up. The study found that the patient-practitioner relationship was the most robust component of the placebo effect, contributing significantly to clinical improvement. The results suggest that non-specific effects can produce statistically and clinically significant outcomes, and that a positive patient-practitioner relationship enhances the effects of placebo treatment. The study highlights the importance of patient-practitioner interactions in clinical care and suggests that reducing these interactions could decrease the effectiveness of treatment. The findings have important implications for routine clinical care, indicating that a positive patient-practitioner relationship can make a difference in treatment outcomes.A randomized controlled trial investigated whether the placebo effect in patients with irritable bowel syndrome (IBS) could be separated into three components: assessment and observation, therapeutic ritual (placebo treatment), and patient-practitioner relationship. The study involved 262 adults with IBS, diagnosed according to Rome II criteria and scoring ≥150 on the symptom severity scale. Participants were randomly assigned to three groups: waiting list (no treatment), limited interaction (placebo acupuncture with minimal practitioner interaction), or augmented interaction (placebo acupuncture with a warm, empathetic, and confident patient-practitioner relationship). At three weeks, half of the participants were randomly assigned to continue in their original group for an additional three weeks. The main outcomes included global improvement scale, adequate relief of symptoms, symptom severity score, and quality of life. At three weeks, the augmented group showed the greatest improvement in all outcomes compared to the limited and waiting list groups. The augmented group had significantly higher scores on the global improvement scale, adequate relief of symptoms, symptom severity score, and quality of life. These results were consistent at the six-week follow-up. The study found that the patient-practitioner relationship was the most robust component of the placebo effect, contributing significantly to clinical improvement. The results suggest that non-specific effects can produce statistically and clinically significant outcomes, and that a positive patient-practitioner relationship enhances the effects of placebo treatment. The study highlights the importance of patient-practitioner interactions in clinical care and suggests that reducing these interactions could decrease the effectiveness of treatment. The findings have important implications for routine clinical care, indicating that a positive patient-practitioner relationship can make a difference in treatment outcomes.
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[slides and audio] Components of placebo effect%3A randomised controlled trial in patients with irritable bowel syndrome