The ethics of the placebo in clinical practice

Lichtenberg, Pesach; Heresco-Levy, Uriel; Nitzan, Uri

doi:10.1136/jme.2002.002832

Cited by 97 publications

(59 citation statements)

References 20 publications

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“…The practice of start-low-and-go-slow-psychiatrists often start patients on an ineffective dose of medication that they intend to gradually increase, but some patients display improvement at doses that remain far below a standard pharmacological threshold (for example, prescribing 25 mg of chlorpromazine while the recommended dose is 600 to 1000 mg). 58 2. Receiving new patients that are already taking subtherapeutic doses of medication, the receiving psychiatrist continues to prescribe the same low dose because the patient appears to benefi t.…”

Section: Discussionmentioning

confidence: 99%

“…32 Publications concerning placebos now span research studies, 12 reviews, 33,34 books, 8,35 and popular media coverage, 36,37 including legal scholarship 29 and social science. [38][39][40][41] The widespread use of placebos in clinical practice has been demonstrated in a recent survey of internists and rheumatologists in the United States 42 revealing that of the 679 physicians who replied, more than one-half said they prescribed placebo treatments every now and then, and that they deemed the practice ethical.…”

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confidence: 99%

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Placebos in Clinical Practice: Comparing Attitudes, Beliefs, and Patterns of Use between Academic Psychiatrists and Nonpsychiatrists

et al. 2011

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Controversial and ethically tenuous, the use of placebos is central to medicine but even more pivotal to psychosocial therapies. Scholars, researchers, and practitioners largely disagree about the conceptualization of placebos. While different professionals often confound the meanings of placebo effects with placebo responses, physicians continue to prescribe placebos as part of clinical practice. Our study aims to review attitudes and beliefs concerning placebos outside of clinical research. Herein we compare patterns of placebo use reported by academic psychiatrists with those reported by physicians from different specialties across Canadian medical schools. Using a web-based tool, we circulated an online survey to all 17 Canadian medical schools, with a special emphasis on psychiatry departments therein and in university-affi liated teaching hospitals. A variation on earlier efforts, our 5-minute, 21-question survey was anonymous. Among the 606 respondents who completed our online survey, 257 were psychiatrists. Our analysis revealed that psychiatrists prescribed signifi cantly more subtherapeutic doses of medication than physicians in other specialties, although about 20% of both psychiatrists and nonpsychiatrists prescribed placebos regularly as part of routine clinical practice. However, compared with 6% of nonpsychiatrists, only 2% of psychiatrists deemed placebos of no clinical benefi t. In addition, more than 60% of psychiatrists either agreed or strongly agreed that placebos had therapeutic effects relative to fewer than 45% of other practitioners. Findings from this pan-Canadian survey suggest that, compared with other physicians, psychiatrists seem to better value the infl uence placebos wield on the mind and body and maintain more favourable beliefs and attitudes toward placebo phenomena. Can J Psychiatry. 2011;56(4):198-208. Highlights• Most physicians acquiesce to the effects of placebos, yet they seem equivocal regarding a common placebo description.• Probably because they construe them as therapeutic, psychiatrists seem to administer signifi cantly more subtherapeutic doses of medication, compared with nonpsychiatrists.• Our fi ndings likely represent a valuable contribution to preliminary investigations of placebo use among physicians and their beliefs about placebo mechanisms and effectiveness.

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Placebos in Clinical Practice: Comparing Attitudes, Beliefs, and Patterns of Use between Academic Psychiatrists and Nonpsychiatrists

et al. 2011

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“…We focus on classical trials possessing perfect validity that compare alternative treatments relevant to clinical practice. Treatments may include placebo if it is a relevant clinical option or if it is considered equivalent to prescribing no treatment (28,29). In particular, we study trials that draw subjects at random within groups of predetermined size stratified by covariates and treatments.…”

Section: Introductionmentioning

confidence: 99%

Sufficient trial size to inform clinical practice

Manski

Tetenov

2016

Proc. Natl. Acad. Sci. U.S.A.

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Medical research has evolved conventions for choosing sample size in randomized clinical trials that rest on the theory of hypothesis testing. Bayesian statisticians have argued that trials should be designed to maximize subjective expected utility in settings of clinical interest. This perspective is compelling given a credible prior distribution on treatment response, but there is rarely consensus on what the subjective prior beliefs should be. We use Wald's frequentist statistical decision theory to study design of trials under ambiguity. We show that e-optimal rules exist when trials have large enough sample size. An e-optimal rule has expected welfare within e of the welfare of the best treatment in every state of nature. Equivalently, it has maximum regret no larger than e. We consider trials that draw predetermined numbers of subjects at random within groups stratified by covariates and treatments. We report exact results for the special case of two treatments and binary outcomes. We give simple sufficient conditions on sample sizes that ensure existence of e-optimal treatment rules when there are multiple treatments and outcomes are bounded. These conditions are obtained by application of Hoeffding large deviations inequalities to evaluate the performance of empirical success rules.clinical trials | sample size | medical decision making | near optimality A core objective of randomized clinical trials (RCTs) comparing alternative medical treatments is to inform treatment choice in clinical practice. However, the conventional practice in designing trials has been to choose a sample size that yields specified statistical power. Power, a concept in the statistical theory of hypothesis testing, is at most loosely connected to effective treatment choice. This paper develops an alternative principle for trial design that aims to directly benefit medical decision making. We propose choosing a sample size that enables implementation of near-optimal treatment rules. Near optimality means that treatment choices are suitably close to the best that could be achieved if clinicians were to know with certainty mean treatment response in their patient populations. We report exact results for the case of two treatments and binary outcomes. We derive simple formulas to compute sufficient sample sizes in clinical trials with multiple treatments.Whereas our immediate concern is to improve the design of RCTs, our work contributes more broadly by adding to the reasons why scientists and the general public should question the hegemony of hypothesis testing as a methodology used to collect and analyze sample data. It has become common for scientists to express concern that evaluation of empirical research by the outcome of statistical hypothesis tests generates publication bias and diminishes the reproducibility of findings. See, for example, ref. 1 and the recent statement by the American Statistical Association (2). We call attention to a further deficiency of testing. In addition to providing an unsatisfactory basis for evalu...

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“…Can it be ethical for physicians to recommend placebo treatments in a deceptive way or should placebos be recommended or administered only transparently? The benevolent use of deception to invoke a placebo effect in clinical practice has been the object of philosophical analyses (Foddy, 2009;Lichtenberg et al, 2004). Some argue that the use of placebo treatments in clinical practice must be consistent with the professional integrity of clinicians and respect for patients' values and preferences.…”

Section: Placebo Interventions In the Practice Of Medicinementioning

confidence: 98%

Ethics of Placebos

Colloca¹

2014

Reference Module in Biomedical Sciences

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The ethics of the placebo in clinical practice

Cited by 97 publications

References 20 publications

Placebos in Clinical Practice: Comparing Attitudes, Beliefs, and Patterns of Use between Academic Psychiatrists and Nonpsychiatrists

Placebos in Clinical Practice: Comparing Attitudes, Beliefs, and Patterns of Use between Academic Psychiatrists and Nonpsychiatrists

Sufficient trial size to inform clinical practice

Ethics of Placebos

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