Intentional Ignorance: A History of Blind Assessment and Placebo Controls in Medicine

Kaptchuk, Ted J.

doi:10.1353/bhm.1998.0159

Cited by 251 publications

(130 citation statements)

References 100 publications

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“…The implicit assumption of this 'additive model' [9,10] is that in both the drug and the placebo arm, the drug-unspecific responses (which include the placebo response) are equal. This model reflects a general assumption in almost all placebo-controlled drug trials that have been performed since its dawn in the 1940s [7,8,11] (figure 2). Interestingly, the underlying hypothesis that the placebo response is equal in size irrespective of whether an active drug or a placebo was given has never been tested thoroughly.…”

Section: Are the Placebo Response Rates In The Drug Arm And In The Plmentioning

confidence: 74%

The placebo response in clinical trials: more questions than answers

Enck¹,

Klosterhalfen

Weimer³

et al. 2011

Phil. Trans. R. Soc. B

135

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Meta-analyses and re-analyses of trial data have not been able to answer some of the essential questions that would allow prediction of placebo responses in clinical trials. We will confront these questions with current empirical evidence. The most important question asks whether the placebo response rates in the drug arm and in the placebo arm are equal. This 'additive model' is a general assumption in almost all placebo-controlled drug trials but has rarely been tested. Secondly, we would like to address whether the placebo response is a function of the likelihood of receiving drug/placebo. Evidence suggests that the number of study arms in a trial may determine the size of the placebo and the drug response. Thirdly, we ask what the size of the placebo response is in 'comparator' studies with a direct comparison of a (novel) drug against another drug. Metaanalytic and experimental evidence suggests that comparator studies may produce higher placebo response rates when compared with placebo-controlled trials. Finally, we address the placebo response rate outside the laboratory and outside of trials in clinical routine. This question poses a serious challenge whether the drug response in trials can be taken as evidence of drug effects in clinical routine.

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Section: Are the Placebo Response Rates In The Drug Arm And In The Plmentioning

confidence: 74%

The placebo response in clinical trials: more questions than answers

Enck¹,

Klosterhalfen

Weimer³

et al. 2011

Phil. Trans. R. Soc. B

135

View full text Add to dashboard Cite

show abstract

“…However, when a curtain was placed between the magnetiseur and the test person, nothing happened. The committee concluded that animal magnetism was not proved as such, but that the phenomenon was obviously owing to the rapport between the magnetiseur and his patient [7][8][9][10].…”

Section: History Of the Notionmentioning

confidence: 99%

Placebo controls: historical, methodological and general aspects

Walach

2011

Phil. Trans. R. Soc. B

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Control conditions were introduced through the trial of Mesmerism in Paris. Placebo controls became codified standard in 1946. Although seemingly unchallenged, there are various problems with this received view. The notion of a placebo is only defined from the negative. A positive notion proposed that placebo effects are effects owing to the meaning an intervention has for an individual. Thus, placebo effects are individualized, whereas standard research paradigms reveal only grossly averaged behaviour. Also, placebo effects are context sensitive, dependent on psychological factors such as expectancy, relief of stress and anxiety, and hence can generate strong and long-lasting treatment effects. These, however, are not predictable. Such a situation can lead to the efficacy paradox: sometimes, sham interventions can be more powerful than proved, evidence-based treatments. This situation has methodological consequences. Placebo-controlled randomized trials reveal only part of the answer, whether an intervention is effective. This is valuable information for regulators, but not necessarily also for patients and of limited value for providers. Hence, I have argued that we need to complement the hierarchical model of evidence by a circular one, in which various methods are employed on equal footing to answer different questions.

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“…His research was nevertheless largely descriptive, with the accompanying risk that Stieve sometimes may have seen what he wanted to see in his microscopic slides. It should be kept in mind, however, that ''blinded'' research designs were not the standard of the time, with the first truly randomized controlled trial being published in 1948 (Kaptchuk, 1998). Knaus (1950) was probably correct to assess Stieve as representative of a purely anatomical approach with a range of limitations in interpreting processes as dynamic as ovulation and fertilization.…”

Section: Stieve's Scientific Methodsology Findings and Impactmentioning

confidence: 99%

Hermann Stieve's clinical‐anatomical research on executed women during the “Third Reich”

Winkelmann

Schagen

2009

Clinical Anatomy

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Hermann Stieve (1886–1952) was Director of the Berlin Institute of Anatomy from 1935 to 1952. His research on the female reproductive system is controversial, as some of his scientific insights derived from histological investigations on the genital organs of executed women. These investigations were made possible by the sharp increase in executions during the “Third Reich.” Stieve's research was methodologically accurate and contributed significantly to contemporary scientific debates. Nevertheless, his use of the organs of execution victims, some of them resistance fighters, benefited from the Nazi justice system. He thus indirectly supported this system of injustice. The allegation, however, that Stieve “ordered” the death of prison inmates according to their menstrual cycle, appears to be incorrect. An appraisal of Stieve's research should avoid traditional black‐and‐white classifications of research during Nazi times. In our opinion, Stieve was neither a murderer nor a fervent Nazi. Nevertheless, his research results were flawed by their ethical and political context. Stieve will remain a somber footnote in the biographies of many execution victims. Clin. Anat. 22:163–171, 2009. © 2009 Wiley‐Liss, Inc.

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Intentional Ignorance: A History of Blind Assessment and Placebo Controls in Medicine

Cited by 251 publications

References 100 publications

The placebo response in clinical trials: more questions than answers

The placebo response in clinical trials: more questions than answers

Placebo controls: historical, methodological and general aspects

Hermann Stieve's clinical‐anatomical research on executed women during the “Third Reich”

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