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LETTERS TO THE EDITOR |
Department of Clinical Bioethics; National Institutes of Health; Bethesda, Maryland
Lee et al reported important findings from a study designed to investigate the placebo effect on cough (1). From an ethical perspective, however, their research raises significant issues. It illustrates how research subjects can be deceived by truthful information disclosure. A single dose of vitamin E was administered to half the subjects as a placebo treatment. The other half received no treatment. The two groups were compared with respect to cough frequency and cough-suppression time. The subjects were not told that they might receive a placebo. Instead, they were informed that "The treatment to be tested contains vitamin E 300iu. The study is designed to investigate the effect of vitamin E on cough associated with the common cold." It is therefore surprising that the authors described this disclosure as "accurate but not misleading." It may have been accurate in disclosing facts about the study, but it was certainly designed to mislead subjects about the purpose of the research and the use of vitamin E as a placebo. The report states that "All patients gave written informed consent for the study." However, it is doubtful that subjects who have the opportunity to read this report would regard their consent as informed in light of the deceptive disclosure. There is no mention of debriefing of subjects at the conclusion of the research, which is a standard practice for research that uses deception. The deceptive experimental design might have been presented to the subjects in a way that respected self-determination and the spirit of informed consent by disclosing that aspects of the study are described in a misleading way, but that subjects would be informed accurately about the purpose and methods of the research at the end of the experiment (2).
NOTES
The opinions expressed are the views of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the US Department of Health and Human Services.
REFERENCES
Common Cold Centre; Cardiff School of Biosciences; Cardiff University; Cardiff, U.K.
Miller and Wendler raise an important ethical issue regarding the information provided to participants in our recently published study on the effects of placebo treatment on cough (1). The study did involve some deception of subjects because they were told in the informed consent that the aim was to investigate the effects of treatment with vitamin E on cough when the true aim was to obtain new knowledge about the effects of placebo treatment on cough. Vitamin E is not known to have any effects on cough, and the short time allowed for absorption (15 minutes) meant that any pharmacological effect would not be apparent at this time point. In designing the study, the investigators considered that the use of a vitamin would be useful in demonstrating a placebo effect because most people know the term vitamin and associate it with positive therapeutic effects. The ethical problem associated with this study is common to many studies on the placebo effect because the placebo effect is influenced by the belief of the patients that they are receiving a beneficial treatment (2). In retrospect and with the benefit of the letter from Miller and Wendler, it would have been appropriate to debrief the participants at the end of the trial, and this is an important point to be included in any future trials. However, even a debriefing would not have addressed the intended deception in the design of the study. Inclusion of some explanation of the misleading information in the informed consent could have confounded the outcome of the study by destroying any belief in the placebo therapy. The use of any form of placebo therapy must involve some form of deception or misplaced belief in the efficacy of the therapy, and it is difficult to see how one can be completely transparent about the aims of placebo therapy without compromising the patient’s belief in the therapy. This is a dilemma that has confounded much of the research on the placebo effect and that has stimulated much ethical debate on deception and the use of placebo treatments (3).
DOI:10.1097/01.psy.0000172146.62930.e2
REFERENCES
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