Placebo Control Groups Arguments Pro and

As we have seen, the arguments against the use of placebo control groups are seldom absolute. Few would argue against using placebo control groups when the usual treatment is no treatment. Few would argue against using placebo control groups when a new treatment is tested as a supplement to an old treatment. The general argument against the use of placebo control groups can be summarized as: There are often better alternatives for a control group than placebo control subjects, alternatives that are better clinically and ethically, and often the scientific quality and clinical impact of RCTs using alternative control groups are preferable.

On the other hand, Leber (2000, p. 699), for example, has argued that "in the evaluation of drugs intended for the management of psychiatric illness, placebo control groups are indispensable, a fact that has been recognized for almost half a century by literally generations of investigators working in the fields of clinical pharmacology and psychopharmacology." Yet A. Bradford Hill (1963), often recognized as the father of RCTs, stated the following: "Is it ethical to use a placebo? The answer to this question will depend, I suggest, upon whether there is already available an orthodox treatment of proved or accepted use." The arguments about placebo control groups among those most knowledgeable about RCTs have been around as long as RCTs have been around (Rothman and Michels 1994).

Arguments for the necessity of placebo control groups are often made on philosophical grounds (Leber 2000) or in terms of convenience to researchers because placebo-controlled RCTs take less time and effort and require less funding (with their smaller sample sizes). However, RCTs are clinical trials proposed to address clinical issues, not philosophical or logistical ones. To benefit clinical decision making, hence medical consumers and clinicians, the crucial question is this: Is T clinically preferable to C in the population studied? If physicians in the community are using a range of treatments that they believe to be effective, there is little value in demonstrating that a new treatment is better than withholding treatment altogether (as in a placebo control group).

Others argue, not for the necessity of placebo control groups but for their acceptability, that placebos do no lasting or irrevocable harm. For example, numerous studies have demonstrated that the suicide risk among psychiatric patients receiving a placebo is not such as to preclude the ethical use of placebos in that context (Khan et al. 2000, 2001, 2006; Storosum et al. 2005). However, the Hippocratic oath's requirement to "do no harm" is not restricted to lasting or irrevocable harm. It is not the prerogative of the medical researcher to stipulate how much potential harm to a patient is acceptable. Rather, it is the duty of the medical researcher to assure patients that, to the best of current medical knowledge, the harm that may occur if they participate in the RCT would not be greater than if they chose not to participate in the RCT, and may well be less.

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