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
Randomized Controlled Trial
. 2017 May 25;18(1):234.
doi: 10.1186/s13063-017-1964-x.

Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial

Sarah Ballou  1 , Ted J Kaptchuk  2   3 , William Hirsch  4 , Judy Nee  4 , Johanna Iturrino  4 , Kathryn T Hall  2   5 , John M Kelley  2   6 , Vivian Cheng  4 , Irving Kirsch  2 , Eric Jacobson  3 , Lisa Conboy  2   7 , Anthony Lembo  4   2 , Roger B Davis  2   7
Affiliations
Randomized Controlled Trial

Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial

Sarah Ballou et al. Trials. .

Abstract

Background: Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment.

Methods and design: This paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants' experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup.

Discussion: OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the "culture" of the trial as well as potential mechanisms of OLP and ethical implications.

Trial registration: ClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016.

Keywords: Irritable bowel syndrome; Multi-disciplinary models; Open-label placebo; Peppermint oil; Placebo effects; Research methods.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Treatment arms and sample sizes
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments
See this image and copyright information in PMC

References

    1. Kaptchuk TJ, Miller FG. Placebo effects in medicine. N Engl J Med. 2015;373(1):8–9. doi: 10.1056/NEJMp1504023. - DOI - PubMed
    1. Finniss DG, Kaptchuk TJ, Miller F, Benedetti F. Biological, clinical, and ethical advances of placebo effects. Lancet Lond Engl. 2010;375(9715):686–95. doi: 10.1016/S0140-6736(09)61706-2. - DOI - PMC - PubMed
    1. Wager TD, Atlas LY. The neuroscience of placebo effects: connecting context, learning and health. Nat Rev Neurosci. 2015;16(7):403–18. doi: 10.1038/nrn3976. - DOI - PMC - PubMed
    1. Tilburt JC, Emanuel EJ, Kaptchuk TJ, Curlin FA, Miller FG. Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists. BMJ. 2008;337:a1938. doi: 10.1136/bmj.a1938. - DOI - PMC - PubMed
    1. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med. 2000;133(6):455–63. doi: 10.7326/0003-4819-133-6-200009190-00014. - DOI - PubMed

Publication types

Associated data

LinkOut - more resources