BMJ  2008;336:999-1003 (3 May), doi:10.1136/bmj.39524.439618.25 (published 3 April 2008)

Research

Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome

Ted J Kaptchuk, associate professor of medicine1, John M Kelley, assistant professor of psychology and statistics2, Lisa A Conboy, instructor of medicine1, Roger B Davis, associate professor of medicine and biostatistics3, Catherine E Kerr, instructor of medicine1, Eric E Jacobson, lecturer4, Irving Kirsch, professor of psychology5, Rosa N Schyner, research associate1, Bong Hyun Nam, research fellow1, Long T Nguyen, research fellow1, Min Park, research coordinator1, Andrea L Rivers, research coordinator1, Claire McManus, research coordinator1, Efi Kokkotou, assistant professor of medicine3, Douglas A Drossman, professor of medicine6, Peter Goldman, professor emeritus 7, Anthony J Lembo, assistant professor of medicine3

1 Osher Research Center, Harvard Medical School, 401 Park Drive, Boston, MA 02215, USA, 2 Endicott College, 376 Hale Street, Beverly, MA 01915, USA, 3 Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA, 4 Department of Social Medicine, Harvard Medical School, 641 Huntington Avenue, Boston, MA 02215, USA, 5 Department of Psychology, University of Hull, Hull HU6 7RX, 6 Center for Functional GI and Motility Disorders, University of North Carolina School of Medicine, Chapel Hill, NC 27699, USA, 7 Harvard Medical School, 25 Shattuck Street, Boston, MA 02115, USA

Correspondence to: T J Kaptchuk ted_kaptchuk{at}hms.harvard.edu

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 [ClinicalTrials.gov] .


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to StumbleUpon StumbleUpon   Add to Technorati Technorati    What's this?

Relevant Articles

Escaping from placebo prison
Jeremy Howick
BMJ 2009 338: b1898. [Extract] [Full Text]

Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups
Matias Vested Madsen, Peter C Gøtzsche, and Asbjørn Hróbjartsson
BMJ 2009 338: a3115. [Abstract] [Full Text] [PDF]

Illusion is disease mongering
Alain Braillon and Aurore Bernardy-Prud’homme
BMJ 2008 337: a2686. [Extract] [Full Text]

Placebo pills for children
Douglas Kamerow
BMJ 2008 336: 1339. [Extract] [Full Text] [PDF]

Reconceptualising placebo
G Lorimer Moseley
BMJ 2008 336: 1086. [Extract] [Full Text] [PDF]

Helping patients feel better
T Everett Julyan
BMJ 2008 336: 1086-1087. [Extract] [Full Text] [PDF]

Reclaiming the placebo effect
Fiona Godlee
BMJ 2008 336: 0. [Extract] [Full Text]

What is the placebo worth?
David Spiegel and Anne Harrington
BMJ 2008 336: 967-968. [Extract] [Full Text] [PDF]

Sham device v inert pill: randomised controlled trial of two placebo treatments
Ted J Kaptchuk, William B Stason, Roger B Davis, Anna R T Legedza, Rosa N Schnyer, Catherine E Kerr, David A Stone, Bong Hyun Nam, Irving Kirsch, and Rose H Goldman
BMJ 2006 332: 391-397. [Abstract] [Full Text] [PDF]

Related external webpages:

Student BMJ: Critical appraisal

This article has been cited by other articles:

  • Tough, E. A, White, A. R, Richards, S. H, Lord, B., Campbell, J. L (2009). Developing and validating a sham acupuncture needle. Acupuncture in Medicine 27: 118-122 [Abstract] [Full text]  
  • (2009). Summaries and commentaries by editor Adrian White on a selection of recent acupuncture research studies. Acupuncture in Medicine 27: 138-142 [Full text]  
  • Bradley, E., Finlay, F. (2009). QUESTION 1. Arch. Dis. Child. 94: 555-556 [Full text]  
  • Lundeberg, T., Lund, I., Sing, A., Naslund, J. (2009). Is Placebo Acupuncture What It is Intended to Be?. Evid Based Complement Alternat Med 0: nep049v1-nep049 [Abstract] [Full text]  
  • Latimer, N. (2009). NICE guideline on osteoarthritis: is it fair to acupuncture? Yes. Acupuncture in Medicine 27: 72-75 [Abstract] [Full text]  
  • Howick, J. (2009). Escaping from placebo prison. BMJ 338: b1898-b1898 [Full text]  
  • Cherkin, D. C., Sherman, K. J., Avins, A. L., Erro, J. H., Ichikawa, L., Barlow, W. E., Delaney, K., Hawkes, R., Hamilton, L., Pressman, A., Khalsa, P. S., Deyo, R. A. (2009). A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain. Arch Intern Med 169: 858-866 [Abstract] [Full text]  
  • Caspi, O., Shalom, T., Holexa, J. (2009). Informed Consent in Complementary and Alternative Medicine. Evid Based Complement Alternat Med 0: nep032v1-nep032 [Abstract] [Full text]  
  • Treasure, T. (2009). Are randomised trials needed in the era of rapidly evolving technologies?. Eur. J. Cardiothorac. Surg. 35: 474-478 [Abstract] [Full text]  
  • Madsen, M. V., Gotzsche, P. C, Hrobjartsson, A. (2009). Acupuncture treatment for pain: systematic review of randomised clinical trials with acupuncture, placebo acupuncture, and no acupuncture groups. BMJ 338: a3115-a3115 [Abstract] [Full text]  
  • Chong, L.-Y., Treasure, T. (2008). Acupuncture to relieve the pain of thoracotomy: commentary on randomized, controlled trial.. J. Thorac. Cardiovasc. Surg. 136: 1470-1471 [Full text]  
  • Braillon, A., Bernardy-Prud'homme, A. (2008). Illusion is disease mongering. BMJ 337: a2686-a2686 [Full text]  
  • (2008). How Does a Placebo Really Work?. JWatch Psychiatry 2008: 2-2 [Full text]  
  • Moseley, G L. (2008). Reconceptualising placebo. BMJ 336: 1086-1086 [Full text]  
  • Julyan, T E. (2008). Helping patients feel better. BMJ 336: 1086-1087 [Full text]  
  • Spiegel, D., Harrington, A. (2008). What is the placebo worth?. BMJ 336: 967-968 [Full text]  

Rapid Responses:

Read all Rapid Responses

Self-deception in healing processes; is it ethical?
Paul Vaucher
bmj.com, 12 Apr 2008 [Full text]
There is a far way to go.
Yun Hyung Koog, et al.
bmj.com, 14 Apr 2008 [Full text]
Let us call it “Curabo effect”
Bertrand Graz, et al.
bmj.com, 15 Apr 2008 [Full text]
Placebo-effect or social desirability?
Edzard Ernst
bmj.com, 15 Apr 2008 [Full text]
Basic skills of CBT
Dirk Van Duppen
bmj.com, 16 Apr 2008 [Full text]
Placebo
John M.S. PEARCE
bmj.com, 2 May 2008 [Full text]
Physicians are placebo !
Josef Panasoff
bmj.com, 4 May 2008 [Full text]
Helping patients feel better
T Everett Julyan
bmj.com, 6 May 2008 [Full text]
Placebo or nocebo?
W Grant Thompson, et al.
bmj.com, 13 May 2008 [Full text]
Doctor-patient interaction is not an element of the placebo effect
Simon J Heyland, et al.
bmj.com, 14 May 2008 [Full text]
The Limits of Positivism
Pat Bracken
bmj.com, 29 May 2008 [Full text]
Authors Response
Ted J Kaptchuk
bmj.com, 4 Jun 2008 [Full text]
Placebo needle
Nobuari Takakura, et al.
bmj.com, 5 Jun 2008 [Full text]
Which are the placebo effects - comment on Kaptchuk et al’s IBS placebo study
Stephen Birch, et al.
bmj.com, 30 Jun 2008 [Full text]



Access jobs at BMJ Careers
Whats new online at Student 

BMJ