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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Nam, Bong Hyun Kirsch, Irving Schyner, Rosa N. Kaptchuk, Ted J. Nguyen, Long T. Rivers, Andrea L. Kelley, John M. Lembo, Anthony J. Goldman, Peter Conboy, Lisa A. Kokkotou, Efi Park, Min Kerr, Catherine E. Mcmanus, Claire Davis, Roger B. Drossman, Douglas A. Jacobson, Eric E. |
| Description | Author Affiliation: Kaptchuk TJ ( Osher Research Center, Harvard Medical School, 401 Park Drive, Boston, MA 02215, USA. ted_kaptchuk@hms.harvard.edu); |
| 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 ≥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. |
| ISSN | 09598138 |
| e-ISSN | 17561833 |
| Journal | BMJ (British Medical Journal) |
| Issue Number | 7651 |
| Volume Number | 336 |
| Language | English |
| Publisher | British Medical Journal Publishing Group |
| Publisher Date | 2008-05-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Acupuncture Therapy Irritable Bowel Syndrome Therapy Placebo Effect Adverse Effects Single-Blind Method Waiting Lists Randomized Controlled Trial Research Support, N.I.H., Extramural Medicine |
| Content Type | Text |
| Resource Type | Article |
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