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26/09/2014 1 The dirty drug Never say never again Elena’s spider diagram Kelley JM, Kraft-Todd G, Schapira L, et al. The Influence of the Patient-Clinician Relationship on Healthcare Outcomes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS ONE 2014;9(4):e94207. 13 RCTs Random-effects-model “Small but significant effect on health outcomes” (p = 0.02) Kelley, J. M., et al. (2009). "Patient and Practitioner Influences on the Placebo Effect in Irritable Bowel Syndrome." Psychosomatic Medicine: SY. Perfectmatch.com Witt, C. M., et al. (2012). "Can I help you? Physicians' expectations as predictor for treatment outcome." European Journal of Pain 16(10): 1455-1466. Witt, C. M., et al. (2010). "Physician Characteristics and Variation in Treatment Outcomes: Are Better Qualified and Experienced Physicians More Successful in Treating Patients With Chronic Pain With Acupuncture?" The Journal of Pain 11(5): 431-435. Witt, C. M., et al. (2011). "Patient Characteristics and Variation in Treatment Outcomes: Which Patients Benefit Most From Acupuncture for Chronic Pain?" Clin J Pain. Conboy, L. A., et al. (2010). "Which patients improve: characteristics increasing sensitivity to a supportive patient-practitioner relationship." Soc Sci Med. 70(3): 479-484. doi: 410.1016/j.socscimed.2009.1010.1024. Epub 2009 Nov 1010. Suarez-Almazor, M. E., et al. (2010). "A randomized controlled trial of acupuncture for osteoarthritis of the knee: Effects of patient- provider communication." Arthritis Care & Research 62(9): 1229-1236. Kelley, J. M., et al. (2009). "Patient and Practitioner Influences on the Placebo Effect in Irritable Bowel Syndrome." Psychosomatic Medicine: SY. White, P., et al. (2012). "Practice, practitioner, or placebo? A multifactorial, mixed-methods randomized controlled trial of acupuncture." PAIN 153(2): 455-462.

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Page 1: (non)specific effects 2014 9 15oialliance.org/.../10/Foell-nonspecific-effects.pdf · Ballatt, J. and P. Campling(2011). Intelligent kindness - Reforming the culture of healthcare

26/09/2014

1

The dirty drug

Never say never again

Elena’s spider diagram

Kelley JM, Kraft-Todd G, Schapira L, et al. The Influence of the Patient-Clinician Relationship on Healthcare Outcomes:

A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS ONE 2014;9(4):e94207.

• 13 RCTs

• Random-effects-model

• “Small but significant effect on health outcomes” (p =

0.02)

Kelley, J. M., et al. (2009). "Patient and Practitioner Influences on the Placebo Effect in Irritable Bowel Syndrome." Psychosomatic

Medicine: SY.

Perfectmatch.com

Witt, C. M., et al. (2012). "Can I help you?

Physicians' expectations as predictor for

treatment outcome." European Journal of

Pain 16(10): 1455-1466.

Witt, C. M., et al. (2010). "Physician Characteristics and Variation in

Treatment Outcomes: Are Better Qualified and Experienced Physicians More

Successful in Treating Patients With Chronic Pain With Acupuncture?" The

Journal of Pain 11(5): 431-435.

Witt, C. M., et al. (2011). "Patient Characteristics and

Variation in Treatment Outcomes: Which Patients Benefit

Most From Acupuncture for Chronic Pain?" Clin J Pain.

Conboy, L. A., et al. (2010). "Which patients

improve: characteristics increasing sensitivity to a

supportive patient-practitioner relationship." Soc

Sci Med. 70(3): 479-484. doi:

410.1016/j.socscimed.2009.1010.1024. Epub 2009

Nov 1010.

Suarez-Almazor, M. E., et al. (2010). "A

randomized controlled trial of acupuncture for

osteoarthritis of the knee: Effects of patient-

provider communication." Arthritis Care &

Research 62(9): 1229-1236.

Kelley, J. M., et al. (2009).

"Patient and Practitioner

Influences on the Placebo Effect

in Irritable Bowel Syndrome."

Psychosomatic Medicine: SY.

White, P., et al. (2012).

"Practice, practitioner, or

placebo? A multifactorial,

mixed-methods randomized

controlled trial of

acupuncture." PAIN 153(2):

455-462.

Page 2: (non)specific effects 2014 9 15oialliance.org/.../10/Foell-nonspecific-effects.pdf · Ballatt, J. and P. Campling(2011). Intelligent kindness - Reforming the culture of healthcare

26/09/2014

2

Efficacy/effectiveness

Witt, C. (2011). "Clinical research on acupuncture — Concepts and guidance on efficacy and effectiveness research." Chinese

Journal of Integrative Medicine 17(3): 166-172.

Linde, K., K. Niemann, et al. (2010). "How large are the nonspecific effects of acupuncture? A meta-analysis of randomized

controlled trials." BMC Medicine 8(1): 75.

Components of the patients' benefit

and aspects of efficacy and effectivenessn= 800 needed for efficacy study

Individual patient data meta-analysis

17 922

patients

Vickers A CAMMAC, et al. Acupuncture for chronic pain: Individual patient data meta-analysis. Archives of Internal Medicine 2012;172(19):1444-53

Background

Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain.

Methods

We conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible RCTs, with a total of 17 922 patients analyzed.

Cure

Effect size 1

Comfort

“Moderate effect”

ES 0.5 - 0.8

“Mild effect “

ES 0.3 – 0.5

Consolation

“Small effect “

ES < 0.3

“Cure

sometimes,

comfort often,

console

always”

Individual metaanalysis n=17922

Acupuncture vs usual care Acupuncture vs sham

Vickers A CAMMAC, et al. Acupuncture for chronic pain: Individual patient data meta-analysis. Archives of Internal Medicine 2012;172(19):1444-53

0.55 (95% CI, 0.51-0.58)

0.57 (95% CI, 0.50-0.64)

0.42 (95% CI, 0.37-0.46)

0.23 (95% CI, 0.13-0.33)

0.16 (95% CI, 0.07-0.25)

0.15 (95% CI, 0.07-0.24)

Individual metaanalysis n=17922

Acupuncture vs usual care Acupuncture vs sham

Vickers A CAMMAC, et al. Acupuncture for chronic pain: Individual patient data meta-analysis. Archives of Internal Medicine 2012;172(19):1444-53

Comfort Consolation

Page 3: (non)specific effects 2014 9 15oialliance.org/.../10/Foell-nonspecific-effects.pdf · Ballatt, J. and P. Campling(2011). Intelligent kindness - Reforming the culture of healthcare

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The acupuncture trialists state:

“However, these differences are

relatively modest, suggesting

that factors in addition to the

specific effects of needling are

important contributors to the

therapeutic effects of

acupuncture.”

“About a half of the reviewed trials showed superiority of the surgical procedure over placebo intervention, but the magnitude of the effect directly related to the crucial surgical element was generally small. The majority of the trials showed an improvement in the surgical group as

well as in the placebo group, which would suggest that some surgical procedures may have a placebo effect and that some of the benefits of surgery are related to factors other than the crucial surgical element.”

Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."

BMJ: British Medical Journal 348.

Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."

BMJ: British Medical Journal 348.

Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."

BMJ: British Medical Journal 348.

Wartolowska, K., et al. (2014). "Use of placebo controls in the evaluation of surgery: systematic review."

BMJ: British Medical Journal 348.

Nocebo effect

• “Voodoo death is most

extreme form of nocebo

effect

“Not to Charing

Cross, the hospital

of death ! ”

Baumeister, R. F., et al. (2001). "Bad is stronger than good." Review of General Psychology 5(4): 323-370.

Page 4: (non)specific effects 2014 9 15oialliance.org/.../10/Foell-nonspecific-effects.pdf · Ballatt, J. and P. Campling(2011). Intelligent kindness - Reforming the culture of healthcare

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The overall magnitude of the nocebo effect was moderate to large (lowestg = 0.62 [0.24–1.01] and highest g = 1.03 [0.63–1.43]) and highly variable (range of g = −0.43 to 4.05). The magnitudes and range of effect sizes was similar to those of placebo effects (d = 0.81) in mechanistic studies. In studies in which nocebo effects were induced by a combination of verbal suggestions and conditioning, the effect size was larger (lowest g = 0.76 [0.39–1.14] and highest g = 1.17 [0.52–1.81]) than in studies in which nocebo effects were induced by verbal suggestions alone (lowest g = 0.64 [−0.25 to 1.53] and highest g = 0.87

[0.40–1.34]). These findings are similar to those in the placebo literature. As the magnitude of the nocebo effect is variable and sometimes large, this meta-analysis demonstrates the importance of minimizing nocebo effects in clinical practice.

Petersen, G. L., et al. (2014). "The magnitude of nocebo effects in pain: A meta-analysis." PAIN® 155(8): 1426-1434. James Bond “Never say never again”

James Bond “Never say never again” James Bond “Never say never again”

“emotional labor as the

process of regulating

experienced and displayed

emotions to present a

professionally desired

image during interpersonal

transactions at work”

Larson, E. B. and X. Yao (2005). "Clinical Empathy as Emotional Labor in the Patient-Physician

Relationship." JAMA: The Journal of the American Medical Association 293(9): 1100-1106.

Organisational climate

Team dynamics

Self in role

Ballatt, J. and P. Campling (2011). Intelligent kindness - Reforming the culture of healthcare. London RCPsych Publications.

Sense of autonomy bear the patient in mind understanding of own role/input skillful and compassionate work

Brutality Perversity Coercion Suspicion Disengagement Anxiety Preoccupation Disempowerment Fragmentation Distraction

Organisation

Team

Role

Self

Page 5: (non)specific effects 2014 9 15oialliance.org/.../10/Foell-nonspecific-effects.pdf · Ballatt, J. and P. Campling(2011). Intelligent kindness - Reforming the culture of healthcare

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