Abstract
BackgroundPlacebo 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 designThis 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.DiscussionOLP 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 registrationClinicalTrials.gov, identifier: NCT02802241. Registered on 14 June 2016.
Highlights
Placebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms
The current study aims to dramatically expand what we know about open-label placebo (OLP) by comparing, for the first time, OLP and double-blind placebo (DBP) administration
In our previous large Randomized controlled trial (RCT) (n = 262), testing components of placebo effects in irritable bowel syndrome (IBS) [31], we found that the number of methionine alleles in the catechol-O-methyltransferase (COMT) val158met polymorphism was associated with placebo response, especially when placebo was combined with a supportive patient-provider relationship [32]
Summary
By definition, are composed of inactive ingredients that have no physiological effect on symptoms. Though designed to be inactive and physiologically ineffective, rigorous evidence has demonstrated that treatment with placebo can produce effects beyond that which one would expect from spontaneous improvement or natural waxing and waning of symptoms [1]. These so-called “placebo effects” are believed to represent relief of symptoms in the context of the therapeutic encounter, complete with its symbols (e.g., white coats), rituals (e.g., taking pills), expectancies (e.g., “medication can make me feel better”), hope (e.g., “there are still possibilities”), and interactions (e.g., therapeutic relationship). We discuss the possible mechanisms of OLP and the ethical implications
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