Improving Medication Tolerance: A Pilot Study in Disorders of Gut-brain Interaction Treated With Tricyclic Antidepressants.


Journal

Journal of clinical gastroenterology
ISSN: 1539-2031
Titre abrégé: J Clin Gastroenterol
Pays: United States
ID NLM: 7910017

Informations de publication

Date de publication:
Historique:
received: 28 01 2021
accepted: 10 05 2021
pubmed: 7 6 2021
medline: 16 4 2022
entrez: 6 6 2021
Statut: ppublish

Résumé

Tricyclic antidepressants (TCAs) are commonly used to treat disorders of gut-brain interaction (DGBI). However, these medications are often associated with side effects that lead to early treatment discontinuation. Research in other chronic medical conditions suggests that many TCA side effects may be caused by nocebo (negative placebo) effects. The current study tests a brief, verbal intervention aimed at improving tolerance of TCAs in DGBI by providing education about nocebo effects. This pilot randomized controlled trial was performed in a tertiary care gastroenterology clinic. Participants with DGBI were randomized "standard information," describing the benefits and risks of TCAs, or "augmented information," which included an additional <30-second education about nocebo effects. Two weeks after their visit, participants were emailed a survey evaluating the number and bothersomeness of side effects, adequate relief, global improvement, and treatment satisfaction. Thirty-one patients were randomized and 22 responded to the survey. The average age was 40% and 59% were women. Although not statistically significant, the augmented group attributed nominally fewer symptoms to TCAs than the standard group, with a medium effect size (1.5 vs. 4.2, effect size d=0.56, P=0.212) and reported being significantly less bothered by those symptoms (13.4 vs. 38.1, P=0.037). A nominally larger percentage of the augmented group reported adequate relief of symptoms after 2 weeks of treatment compared with the standard group (55% vs. 27%, respectively). This pilot study demonstrates that a brief (≈30 s) clinical intervention addressing nocebo effects may improve tolerance of TCAs. These findings provide support for future, fully powered studies to evaluate the impact of framing on clinical outcomes, especially in chronic conditions.

Identifiants

pubmed: 34091518
doi: 10.1097/MCG.0000000000001575
pii: 00004836-202205000-00014
doi:

Substances chimiques

Antidepressive Agents, Tricyclic 0

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

452-456

Informations de copyright

Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.

Références

Barsky AJ, Saintfort R, Rogers MP, et al. Nonspecific medication side effects and the nocebo phenomenon. JAMA. 2002;287:622–627.
Sperber AD, Bangdiwala SI, Drossman DA, et al. Worldwide prevalence and burden of functional gastrointestinal disorders: results of Rome Foundation Global Study. Gastroenterology. 2020;160:99.e3–114.e3.
Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014;40:1023–1034.
Whitehead WE, Levy RL, Von Korff M, et al. The usual medical care for irritable bowel syndrome. Aliment Pharmacol Ther. 2004;20:1305–1315.
Lembo A. Irritable bowel syndrome medications side effects survey. J Clin Gastroenterol. 2004;38:776–781.
Rief W, Nestoriuc Y, von Lilienfeld-Toal A, et al. Differences in adverse effect reporting in placebo groups in SSRI and tricyclic antidepressant trials: a systematic review and meta-analysis. Drug Saf. 2009;32:1041–1056.
Amanzio M, Corazzini LL, Vase L, et al. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain. 2009;146:261–269.
Häuser W, Bartram C, Bartram-Wunn E, et al. Adverse events attributable to nocebo in randomized controlled drug trials in fibromyalgia syndrome and painful diabetic peripheral neuropathy: systematic review. Clin J Pain. 2012;28:437–451.
Rief W, Avorn J, Barsky AJ. Medication-attributed adverse effects in placebo groups: implications for assessment of adverse effects. Arch Intern Med. 2006;166:155–160.
Drossman DA, Toner BB, Whitehead WE, et al. Cognitive-behavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. Gastroenterology. 2003;125:19–31.
O’Connor AM, Pennie RA, Dales RE. Framing effects on expectations, decisions, and side effects experienced: the case of influenza immunization. J Clin Epidemiol. 1996;49:1271–1276.
Varelmann D, Pancaro C, Cappiello EC, et al. Nocebo-induced hyperalgesia during local anesthetic injection. Anesth Analg. 2010;110:868–870.
Heisig SR, Shedden-Mora MC, Hidalgo P, et al. Framing and personalizing informed consent to prevent negative expectations: an experimental pilot study. Health Psychol. 2015;34:1033–1037.
Faasse K, Huynh A, Pearson S, et al. The influence of side effect information framing on nocebo effects. Ann Behav Med. 2019;53:621–629.
Myers MG, Cairns JA, Singer J. The consent form as a possible cause of side effects. Clin Pharmacol Ther. 1987;42:250–253.
Lang EV, Hatsiopoulou O, Koch T, et al. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005;114:303–309.
Wells RE, Kaptchuk TJ. To tell the truth, the whole truth, may do patients harm: the problem of the nocebo effect for informed consent. Am J Bioeth. 2012;12:22–29.
Häuser W, Hansen E, Enck P. Nocebo phenomena in medicine: their relevance in everyday clinical practice. Dtsch Arztebl Int. 2012;109:459–465.
Bingel U. Placebo Competence Team. Avoiding nocebo effects to optimize treatment outcome. JAMA. 2014;312:693–694.
Rief W, Barsky AJ, Glombiewski JA, et al. Assessing general side effects in clinical trials: reference data from the general population. Pharmacoepidemiol Drug Saf. 2011;20:405–415.
Cohen J. A power primer. Psychol Bull. 1992;112:155–159.
Thiwan S, Drossman DA, Morris CB, et al. Not all side effects associated with tricyclic antidepressant therapy are true side effects. Clin Gastroenterol Hepatol. 2009;7:446–451.
Taft TH, Keefer L, Artz C, et al. Perceptions of illness stigma in patients with inflammatory bowel disease and irritable bowel syndrome. Qual Life Res. 2011;20:1391–1399.
Yan X-J, Luo Q-Q, Qiu H-Y, et al. The impact of stigma on medication adherence in patients with functional dyspepsia. Neurogastroenterol Motil. 2021;33:e13956.
Feingold JH, Drossman DA. Deconstructing stigma as a barrier to treating DGBI: lessons for clinicians. Neurogastroenterol Motil. 2021;33:e14080.
Olshansky B. Placebo and nocebo in cardiovascular health: implications for healthcare, research, and the doctor-patient relationship. J Am Coll Cardiol. 2007;49:415–421.

Auteurs

Sarah Ballou (S)

Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.
Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School.

Johanna Iturrino (J)

Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.

Vikram Rangan (V)

Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.

Vivian Cheng (V)

Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.

John M Kelley (JM)

Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School.
Psychology Department, Endicott College, Beverly, MA.

Anthony Lembo (A)

Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.
Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School.

Ted J Kaptchuk (TJ)

Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.
Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School.
Department of Global Health and Social Medicine, Harvard Medical School, Boston.

Judy Nee (J)

Department of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center.

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