"Pre-cebo": An unrecognized issue in the interpretation of adequate relief during irritable bowel syndrome drug trials

Journal of Clinical Gastroenterology

Volumn 46, Issue 8, 2012, Pages 686-690

  Kim, Sharon E ^a   Kubomoto, Scott ^a   Chua, Kathleen ^a   Amichai, Meridythe M ^a   Pimentel, Mark ^a  

^a CEDARS SINAI MEDICAL CENTER   (United States)

Author keywords

alosetron; desipramine; IBS; placebo; rifaximin

Indexed keywords

ALOSETRON; DESIPRAMINE; RIFAXIMIN;

ADULT; ARTICLE; CONTROLLED STUDY; DIARRHEA; DRUG SCREENING; FEMALE; GENDER; HUMAN; INFORMED CONSENT; IRRITABLE COLON; MALE; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; VISUAL ANALOG SCALE;

ADULT; CARBOLINES; DESIPRAMINE; DIARRHEA; FEMALE; GASTROINTESTINAL AGENTS; HUMANS; IRRITABLE BOWEL SYNDROME; MALE; MIDDLE AGED; PLACEBO EFFECT; QUESTIONNAIRES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RIFAMYCINS; TREATMENT OUTCOME;

EID: 84865460330     PISSN: 01920790     EISSN: 15392031     Source Type: Journal    
DOI: 10.1097/MCG.0b013e31825828a7     Document Type: Article

References (23)

1. Bommelaer G, Poynard T, Le Pen C, et al. Prevalence of irritable bowel syndrome (IBS) and variability of diagnostic criteria. Gastroenterol Clin Biol. 2004;28:554-561.
2. Wilson S, Roberts L, Roalfe A, et al. Prevalence of irritable bowel syndrome: A community survey. Br J Gen Pract. 2004; 54:495-502.
3. Gwee KA, Wee S, Wong ML, et al. The prevalence, symptom characteristics, and impact of irritable bowel syndrome in an Asian urban community. Am J Gastroenterol. 2004;99:924-931.
4. El-Serag HB. Impact of irritable bowel syndrome: Prevalence and effect on health-related quality of life. Rev Gastroenterol Disord. 2003;3(suppl 2):S3-S11.
5. Hungin AP, Whorwell PJ, Tack J, et al. The prevalence, patterns and impact of irritable bowel syndrome: An international survey of 40,000 subjects. Aliment Pharmacol Ther. 2003;17:643-650.
6. Talley NJ, Boyce PM, JonesM. Predictors of health care seeking for irritable bowel syndrome: A population based study. Gut. 1997;41:394-398.
7. Whitehead WE, Burnett CK, Cook EW III, et al. Impact of irritable bowel syndrome on quality of life. Dig Dis Sci. 1996;41:2248-2253.
8. Drossman DA, Patrick DL, Whitehead WE, et al. Further validation of the IBS-QOL: A disease-specific quality-of-life questionnaire. Am J Gastroenterol. 2000;95:999-1007.
9. Thompson WG, Longstreth GF, Drossman DA, et al. Functional bowel disorders and functional abdominal pain. Gut. 1999;45:II43-II47.
10. Drossman DA, Toner BB, Whitehead WE, et al. Cognitivebehavioral therapy versus education and desipramine versus placebo for moderate to severe functional bowel disorders. Gastroenterology. 2003;125:19-31.
11. Camilleri M, Chey WY, Mayer EA, et al. A randomized controlled clinical trial of the serotonin type 3 receptor antagonist alosetron in women with diarrhea-predominant irritable bowel syndrome. Arch Intern Med. 2001;161:1733-1740.
12. Camilleri M, Northcutt AR, Kong S, et al. Efficacy and safety of alosetron in women with irritable bowel syndrome: A randomised, placebo-controlled trial. Lancet. 2000;355:1035-1040.
13. Pimentel M, Park S, Mirocha J, et al. The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome. Ann Intern Med. 2006;145:557-563.
14. Pimentel M, Lembo A, Chey WD, et al. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011;364:22-32.
15. Rome Foundation. Guidelines - Rome III diagnostic criteria for functional gastrointestinal disorders. J Gastrointest Liv Dis. 2006;15:301-312.
16. Spiegel BM, Farid M, Esrailian E, et al. Is irritable bowel syndrome a diagnosis of exclusion?: A Survey of Primary Care Providers, Gastroenterologists, and IBS Experts. Am J Gastroenterologist . 2010;105:848-858.
17. Beecher HK. The powerful placebo. JAMA. 1955;159: 1602-1606.
18. Lasagna L. The placebo effect. J Allergy Clin Immunol. 1986;78:161-165.
19. Brown WA. The placebo effect. Sci Am. 1998;278:90-95.
20. Kienle GS, Kiene H. The powerful placebo effect: fact or fiction? J Clin Epidemiol. 1997;50:1311-1318.
21. Benedetti F, Lanotte M, Lopiano L, et al. When words are painful: Unraveling the mechanisms of the nocebo effect. Neuroscience. 2007;147:260-271.
22. De Craen AJ, Aptchuk TJ, Tijssen JG, et al. Placebos and placebo effects in medicine: historical overview. J R Soc Med. 1999;92:511-515.
23. Stewart-Williams S, Podd J. The placebo effect: Dissolving the expectancy versus conditioning debate. Psychol Bull. 2004;130: 324-340.