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Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome.
BMJ 2008; 336(7651):999-1003BMJ

Abstract

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.

Authors+Show Affiliations

Osher Research Center, Harvard Medical School, 401 Park Drive, Boston, MA 02215, USA. ted_kaptchuk@hms.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

18390493

Citation

Kaptchuk, Ted J., et al. "Components of Placebo Effect: Randomised Controlled Trial in Patients With Irritable Bowel Syndrome." BMJ (Clinical Research Ed.), vol. 336, no. 7651, 2008, pp. 999-1003.
Kaptchuk TJ, Kelley JM, Conboy LA, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ. 2008;336(7651):999-1003.
Kaptchuk, T. J., Kelley, J. M., Conboy, L. A., Davis, R. B., Kerr, C. E., Jacobson, E. E., ... Lembo, A. J. (2008). Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ (Clinical Research Ed.), 336(7651), pp. 999-1003. doi:10.1136/bmj.39524.439618.25.
Kaptchuk TJ, et al. Components of Placebo Effect: Randomised Controlled Trial in Patients With Irritable Bowel Syndrome. BMJ. 2008 May 3;336(7651):999-1003. PubMed PMID: 18390493.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. AU - Kaptchuk,Ted J, AU - Kelley,John M, AU - Conboy,Lisa A, AU - Davis,Roger B, AU - Kerr,Catherine E, AU - Jacobson,Eric E, AU - Kirsch,Irving, AU - Schyner,Rosa N, AU - Nam,Bong Hyun, AU - Nguyen,Long T, AU - Park,Min, AU - Rivers,Andrea L, AU - McManus,Claire, AU - Kokkotou,Efi, AU - Drossman,Douglas A, AU - Goldman,Peter, AU - Lembo,Anthony J, Y1 - 2008/04/03/ PY - 2008/4/9/pubmed PY - 2008/5/20/medline PY - 2008/4/9/entrez SP - 999 EP - 1003 JF - BMJ (Clinical research ed.) JO - BMJ VL - 336 IS - 7651 N2 - 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. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/18390493/Components_of_placebo_effect:_randomised_controlled_trial_in_patients_with_irritable_bowel_syndrome_ L2 - http://www.bmj.com/cgi/pmidlookup?view=long&amp;pmid=18390493 DB - PRIME DP - Unbound Medicine ER -