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Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome
Open accessAbstract
OBJECTIVE: To investigate whether placebo effects can experimentally be separated into the response to three components-assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship-and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components. DESIGN: A six week single blind three arm randomised controlled trial. SETTING: Academic medical centre. PARTICIPANTS: 262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of > or =150 on the symptom severity scale. INTERVENTIONS: For three weeks either waiting list (observation), placebo acupuncture alone ("limited"), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence ("augmented"). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks. MAIN OUTCOME MEASURES: Global improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life. RESULTS: At three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus "limited" versus "augmented," respectively (P<0.001 for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01). Results were similar at six week follow-up. CONCLUSION: Factors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component. TRIAL REGISTRATION: Clinical Trials NCT00065403.
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“For the four dependent variables (global improvement, adequate relief, symptom severity, and quality of life), the two sham acupuncture conditions were superior to treatment as usual.However, the augmented relationship condition was superior to the limited interaction condition, particularly for quality of life.”
From How important are the common factors in psychotherapy? An update (2015) · cites this paper as [44]
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Longstreth, G. F., Thompson, W. G., Chey, W. D., Houghton, L. A., Mearin, F., & Spiller, R. C. (2006) · Gastroenterology · doi:10.1053/j.gastro.2005.11.061 · Cited by 4,856
Functional bowel disorders and functional abdominal pain
Thompson, W. G., Longstreth, G. F., Drossman, D. A., Heaton, K. W., Irvine, E. J., & Müller-Lissner, S. A. (1999) · Gut · doi:10.1136/gut.45.2008.ii43 · Cited by 2,440
Self-citationFRANCIS, C. Y., MORRIS, J., & WHORWELL, P. J. (1997) · Alimentary Pharmacology & Therapeutics · doi:10.1046/j.1365-2036.1997.142318000.x · Cited by 1,708
Neurobiological Mechanisms of the Placebo Effect
Benedetti, F., Mayberg, H. S., Wager, T. D., Stohler, C. S., & Zubieta, J.-K. (2005) · Journal of Neuroscience · doi:10.1523/jneurosci.3458-05.2005 · Cited by 812
Treatment fidelity in outcome studies
Moncher, F. J., & Prinz, R. J. (1991) · Clinical Psychology Review · doi:10.1016/0272-7358(91)90103-2 · Cited by 797 · cited 1×
“The practitioners in this study consisted of four licensed acupuncturists, all of whom had participated in previous randomised placebo controlled trials on acupuncture. The practitioners’ training followed methods described in earlier studies of structured patient-physician interactions.”
MethodKaptchuk, T. J. (2002) · Annals of Internal Medicine · doi:10.7326/0003-4819-136-11-200206040-00011 · Cited by 619
Self-citationDrossman, D. A., Toner, B. B., Whitehead, W. E., Diamant, N. E., Dalton, C. B., Duncan, S., Emmott, S., Proffitt, V., Akman, D., Frusciante, K., et al. (2003) · Gastroenterology · doi:10.1016/s0016-5085(03)00669-3 · Cited by 614
Self-citationCamilleri, M., Northcutt, A. R., Kong, S., Dukes, G. E., McSorley, D., & Mangel, A. W. (2000) · The Lancet · doi:10.1016/s0140-6736(00)02033-x · Cited by 551
Sham device v inert pill: randomised controlled trial of two placebo treatments
Kaptchuk, T. J., Stason, W. B., Davis, R. B., Legedza, A., Schnyer, R. N., Kerr, C. E., Stone, D. A., Nam, B. H., Kirsch, I., & Goldman, R. H. (2006) · BMJ · doi:10.1136/bmj.38726.603310.55 · Cited by 535
Self-citationAdjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial
Lang, E. V., Benotsch, E. G., Fick, L. J., Lutgendorf, S., Berbaum, M. L., Berbaum, K. S., Logan, H., & Spiegel, D. (2000) · The Lancet · doi:10.1016/s0140-6736(00)02162-0 · Cited by 513
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- [7]7. PatelSM,StasonWB,LegedzaA,OckSM,KaptchukTJ,ConboyL,etal. The placebo effect irritable bowel syndrome trials: a meta-analysis. Neurogastroenterol Motil 2005;17:332-40.
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Colloca, L., Ludman, T., Bouhassira, D., Baron, R., Dickenson, A. H., Yarnitsky, D., Freeman, R. L., Truini, A., Attal, N., Finnerup, N. B., et al. (2017) · Nature Reviews Disease Primers · doi:10.1038/nrdp.2017.2 · Cited by 2,271
RELIEVING PAIN IN AMERICA: A BLUEPRINT FOR TRANSFORMING PREVENTION, CARE, EDUCATION, AND RESEARCH
Simon, L. S. (2012) · Journal of Pain & Palliative Care Pharmacotherapy · doi:10.3109/15360288.2012.678473 · Cited by 2,200
How important are the common factors in psychotherapy? An update
Wampold, B. E. (2015) · World Psychiatry · doi:10.1002/wps.20238 · Cited by 1,728
Biological, clinical, and ethical advances of placebo effects
Finniss, D. G., Kaptchuk, T. J., Miller, F. G., & Benedetti, F. (2010) · The Lancet · doi:10.1016/s0140-6736(09)61706-2 · Cited by 1,309
Self-citationPlacebos without Deception: A Randomized Controlled Trial in Irritable Bowel Syndrome
Kaptchuk, T. J., Friedlander, E., Kelley, J. M., Sanchez, M. N., Kokkotou, E., Singer, J. P., Kowalczykowski, M., Miller, F. G., Kirsch, I., & Lembo, A. J. (2010) · PLoS ONE · doi:10.1371/journal.pone.0015591 · Cited by 900
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Metadata
- Authors
- Kaptchuk, T. J., Kelley, J. M., Conboy, L. A., Davis, R. B., Kerr, C. E., Jacobson, E. E., Kirsch, I., Schyner, R. N., Nam, B. H., Nguyen, L. T., Park, M., Rivers, A. L., McManus, C., Kokkotou, E., Drossman, D. A., Goldman, P., & Lembo, A. J.
- Affiliations
- Harvard University (US)
- Endicott College (US)
- Beth Israel Deaconess Medical Center (US)
- University of Hull (GB)
- University of North Carolina at Chapel Hill (US)
- Corresponding author
- Kaptchuk, Ted J
- ORCID
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2008-04-03
- Volume
- 336
- Issue
- 7651
- Pages
- 999-1003
- ISSN
- 1756-1833 (ISSN-L)
- 0959-8138
- PMC
- PMC2364862
- OpenAlex
- W2038810061
- Cited by
- 1,196
- References
- 35
- Citations by year
- 2026: 32 · 2025: 48 · 2024: 49 · 2023: 53 · 2022: 56 · 2021: 78 · 2020: 70 · 2019: 78 · 2018: 75 · 2017: 80 · 2016: 72 · 2015: 66 · 2014: 77 · 2013: 76 · 2012: 60
- FWCI
- 38.88
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- BMJ (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Digital Access to Scholarship at Harvard (DASH) (Harvard University) (submittedVersion)
- HighWire Press Open Archive (submittedVersion)
- Funders
- Beth Israel Deaconess Medical Center
- Harvard University
- National Institutes of Health (5r21at002564-02)
- National Institute of Diabetes and Digestive and Kidney Diseases
- National Center for Complementary and Alternative Medicine
- National Center for Research Resources (RR 01032, M01RR001032)
- Office of Behavioral and Social Sciences Research
- National Center for Complementary and Integrative Health (R01AT004662, R21AT002860, 1R21 AT002564, K24AT004095, R01AT001414)
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Pain Management and Placebo Effect
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Health Sciences › Medicine › Complementary and alternative medicine › Acupuncture Treatment Research Studies
- Keywords
- placebo effect, irritable bowel syndrome, sham acupuncture, patient-practitioner relationship, healing rituals, non-specific effects, symptom severity, quality of life, symptom relief, placebo-controlled trial design
- MeSH terms
- Adult, Female, Humans, Male, Waiting Lists, Acupuncture Therapy, Placebo Effect, Single-Blind Method, Treatment Outcome, Irritable Bowel Syndrome
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