Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024;3(2):221-229.
doi: 10.1016/j.gastha.2023.10.003. Epub 2023 Oct 14.

Factors That Predict Magnitude, Timing, and Persistence of Placebo-Like Response in Patients With Irritable Bowel Syndrome

Jeffrey M Lackner  1 , Brian M Quigley  1 , Sigal Zilcha-Mano  2 , Christopher Radziwon  1 , Susan S Krasner  1 , Gregory D Gudleski  1 , Paul Enck  3
Affiliations

Factors That Predict Magnitude, Timing, and Persistence of Placebo-Like Response in Patients With Irritable Bowel Syndrome

Jeffrey M Lackner et al. Gastro Hep Adv. 2024.

Abstract

Background and aims: Placebo response impedes the development of novel irritable bowel syndrome (IBS) therapies and the interpretability of randomized clinical trials. This study sought to characterize the magnitude, timing, and durability of IBS symptom relief in patients undergoing a non-drug placebo-like control.

Methods: One hundred forty-five Rome III-diagnosed patients (80% F, M age = 42 years) were assigned to education/nondirective support delivered over a 10-week acute phase. Treatment response was based on the IBS version of the Clinical Global Improvement Scale completed 2 weeks after treatment ended. Candidate predictors were assessed at baseline (eg, emotion regulation, pain catastrophizing, distress, neuroticism, stress, somatization, gastrointestinal-specific anxiety) or clinically relevant points during treatment (patient-provider relationship, treatment expectancy/credibility).

Results: Midtreatment response was associated with lower levels of stress and somatization at baseline and greater patient-provider agreement on treatment tasks (P < .001). Treatment response was associated with baseline gastroenterologist-rated IBS severity, anxiety, ability to reappraise emotions to reduce their impact [cognitive reappraisal], and agreement that provider and patient shared goals from provider perspective (P < .001). The day-to-day ability to reappraise emotions at baseline distinguished rapid from delayed placebo responders (P = .011).

Conclusion: Patient beliefs (eg, perceived stress, cognitive reappraisal) impacted the magnitude, timing, and persistence of placebo response measured at midway point of acute phase and 2 weeks after treatment discontinuation. Baseline beliefs that patients could alter the impact of stressful events by rethinking their unpleasantness distinguished rapid vs delayed placebo responders. Collaborative agreement between doctor and patient around shared tasks/goals from the clinician perspective predicted placebo response.

Keywords: Emotion Regulation; Expectancies; Placebo Effect; Randomized Clinical Trials.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: The authors disclose no conflicts.

Figures

None
Graphical abstract
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Staudacher H.M., Black C.J., Teasdale S.B., et al. Irritable bowel syndrome and mental health comorbidity - approach to multidisciplinary management. Nat Rev Gastroenterol Hepatol. 2023;20:582–596. - PMC - PubMed
    1. Ford A.C., Lacy B.E., Talley N.J. Irritable bowel syndrome. N Engl J Med. 2017;376(26):2566–2578. - PubMed
    1. Black C.J., Ford A.C. Best management of irritable bowel syndrome. Frontline Gastroenterol. 2021;12(4):303–315. - PMC - PubMed
    1. Camilleri M., Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008;135(6):1877–1891. - PMC - PubMed
    1. Enck P., Aziz Q., Barbara G., et al. Irritable bowel syndrome. Nat Rev Dis Primers. 2016;2 - PMC - PubMed