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

被引:49
作者
Ballou, Sarah [1 ]
Kaptchuk, Ted J. [2 ,3 ]
Hirsch, William [1 ]
Nee, Judy [1 ]
Iturrino, Johanna [1 ]
Hall, Kathryn T. [2 ,4 ]
Kelley, John M. [2 ,5 ]
Cheng, Vivian [1 ]
Kirsch, Irving [2 ]
Jacobson, Eric [3 ]
Conboy, Lisa [2 ,6 ]
Lembo, Anthony [1 ,2 ]
Davis, Roger B. [2 ,6 ]
机构
[1] Beth Israel Deaconess Med Ctr, Dept Med, Div Gastroenterol, 330 Brookline Ave, Boston, MA 02215 USA
[2] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Program Placebo Studies, 330 Brookline Ave, Boston, MA 02215 USA
[3] Harvard Med Sch, Dept Global Hlth & Social Med, 641 Huntington Ave, Boston, MA 02115 USA
[4] Harvard Med Sch, Brigham & Womens Hosp, Div Prevent Med, 900 Commonwealth Ave, Boston, MA 02215 USA
[5] Endicott Coll, Dept Psychol, 376 Hale St, Beverly, MA 01915 USA
[6] Beth Israel Deaconess Med Ctr, Dept Med, Div Gen Med & Primary Care, 330 Brookline Ave, Boston, MA 02215 USA
关键词
Placebo effects; Open-label placebo; Irritable bowel syndrome; Research methods; Multi-disciplinary models; Peppermint oil; INFORMED-CONSENT; NONCONSCIOUS ACTIVATION; ALTERNATIVE MEDICINE; CONDITIONED PLACEBO; CLINICAL-TRIALS; ACUPUNCTURE; REWARD; PAIN; PERSPECTIVES; EXPERIENCES;
D O I
10.1186/s13063-017-1964-x
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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.
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页数:15
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