APS position statement on the use of placebos in pain management

Sullivan, Mark D.; Terman, Gregory W.; Peck, Brian; Correll, Darin; Rich, Ben A.; Clark, W. Crawford; Latta, Kenneth S; Lebovits, Allen H.; Gebhart, G. F.

doi:10.1016/j.jpain.2005.01.347

Cited by 36 publications

(29 citation statements)

References 20 publications

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“…We are not condoning the use of sham interventions or those known to be ineffective or inert in clinical practice as the ethics of such a recommendation are arguably questionable. 69 We do suggest that placebo as a mechanism likely plays a role in the outcomes of manual therapy interventions and believe that clinicians should attempt to maximize the hypoalgesic effect of placebo within (1) ethically accepted parameters (for example, stating a 'guarantee' for pain relief would not be ethically appropriate) and (2) accepted interventions for musculoskeletal pain conditions. We offer the following suggestions to manual therapists to enhance corresponding placebo-related hypoalgesia.…”

Section: Placebo In Clinical Practicementioning

confidence: 99%

“…Subsequently, placebos are ethical with informed consent in studies to establish efficacy or safety of an intervention; however, their use in clinical care is questionable. 69 The Declaration of Helsinki mandates the use of placebo in clinical trials in only two specific situations: (1) when no proven intervention exists; and 2) when use of placebo is necessary to establish the efficacy or safety of a studied intervention and provides no risk to the participant. 68 A primary concern for the use of placebo in clinical practice is for loss of trust between patient and provider; 70 however, adverse effects resulting from the disclosure of having received a placebo are speculative and have not been systematically studied.…”

Section: Ethical Considerationsmentioning

confidence: 99%

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Placebo response to manual therapy: something out of nothing?

Bialosky

Bishop

George

et al. 2011

Journal of Manual & Manipulative Therapy

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The mechanisms through which manual therapy inhibits musculoskeletal pain are likely multifaceted and related to the interaction between the intervention, the patient, the practitioner, and the environment. Placebo is traditionally considered an inert intervention; however, the pain research literature suggests that placebo is an active hypoalgesic agent. Placebo response likely plays a role in all interventions for pain and we suggest that the same is true for the treatment effects associated with manual therapy. The magnitude of a placebo response may be influenced by negative mood, expectation, and conditioning. We suggest that manual therapists conceptualize placebo not only as a comparative intervention, but also as a potential active mechanism to partially account for treatment effects associated with manual therapy. We are not suggesting manual therapists include known sham or ineffective interventions in their clinical practice, but take steps to maximize placebo responses to reduce pain.

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Section: Placebo In Clinical Practicementioning

confidence: 99%

Section: Ethical Considerationsmentioning

confidence: 99%

Placebo response to manual therapy: something out of nothing?

Bialosky

Bishop

George

et al. 2011

Journal of Manual & Manipulative Therapy

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show abstract

“…105 In a position statement issued in April 2005, American Pain Society recommended the use of placebo in clinical trials when there is limited harm to patients from delayed treatment, when the alternative active treatment is unproved, when there is a substantial potential benefit to future patients in establishing the efficacy of a treatment and/or avoiding side effects of a treatment. 106,107 Wendler and Miller argued that "authorized deception" may be another way to resolve the dilemma. 104 Subjects are informed of the deception and asked to consent to it without being informed of the nature of deception.…”

Section: Ethical Implicationsmentioning

confidence: 99%

Placebo Theory and Its Implications for Research and Clinical Practice: A Review of the Recent Literature

2007

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Although placebo effect is a common phenomenon in medicine and research, its mechanisms are not well understood. With the advent of modern medicine, placebo became a symbol for an outdated, morally questionable practice implying deceit and paternalism. However, in recent years, there has been an increasing amount of rigorous research into the mechanisms of placebo response and placebo analgesia with most studies coming from the field of pain medicine. New theories on placebo mechanisms have shown that placebo represents the psychosocial aspect of every treatment and the study of placebo is essentially the study of psychosocial context that surrounds the patient. Therefore, its understanding is essential for researchers and all medical practitioners, particularly those dealing with patients suffering from pain, depression, and motor disorders. In this article, we review the theories on placebo mechanisms and discuss their implications for clinical practice and the design of clinical trials.

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“…Participants in placebo controlled research studies provide informed consent with the knowledge of potentially receiving a placebo treatment. Subsequently, placebos are considered ethical with informed consent in studies to establish efficacy or safety of an intervention; however, their use in clinical care is questionable [20].…”

Section: Attitudes Towards Health Care and The Providermentioning

confidence: 99%

Placebo disclosure does not result in negative changes in mood or attitudes towards health care or the provider

Bialosky

2017

Journal of Manual & Manipulative Therapy

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: The purposes of this study were to (1) determine whether disclosure of having received a placebo treatment following participation in a randomized manual therapy trial resulted in changes in negative mood or attitudes towards health care and the provider and (2) examine the association between changes in mood or attitude and changes in clinical outcomes over the two-week study period. : Participants with low back pain ( = 110) were randomly assigned to receive a spinal manipulative therapy (SMT), a standard placebo SMT in which participants were aware of a chance of receiving a placebo, an enhanced placebo SMT in which participants were instructed 'the manual therapy technique you will receive has been shown to significantly reduce low back pain in some people,' or no treatment. Outcomes included pain (Numeric Rating Scale), disability (Oswestry Disability Index), and negative mood and attitudes towards health care and the provider (visual analog scales). Pain and disability were obtained at baseline and two weeks. Mood and attitude measures were assessed at baseline, at the start of the final session, and upon completion of the final session following disclosure of group assignment. : Disclosure of having received a placebo treatment was not associated with worsening of mood or attitudes towards health care or the provider ( > 0.05). A small, but significant ( < 0.05) association was observed between two-week changes in disability and immediate changes in mood ( = 0.31-0.36) upon disclosure of having received a placebo. This analysis indicates an association between larger improvements in disability and more positive changes in mood. : Placebo treatment use in clinical practice is common yet controversial due to the deceptive nature. Our findings suggest disclosure of having received a placebo treatment is not associated with adverse changes in negative mood or attitudes towards health care or the provider.

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APS position statement on the use of placebos in pain management

Cited by 36 publications

References 20 publications

Placebo response to manual therapy: something out of nothing?

Placebo response to manual therapy: something out of nothing?

Placebo Theory and Its Implications for Research and Clinical Practice: A Review of the Recent Literature

Placebo disclosure does not result in negative changes in mood or attitudes towards health care or the provider

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