The Placebo as a Therapeutic Intervention

Employing the placebo effect as a therapeutic intervention is controversial. Some clinicians argue that the benefits of the placebo effect might be quite useful in treating patients with conditions that are refractory to standard medical therapy. Others argue that the use of a placebo in the guise of therapy is deceptive, unethical practice and undermines the physician-patient relationship of trust.

Nevertheless, it appears that nationwide the practice of prescribing placebo treatments is quite pervasive. In 2009, Tilburt et al. published the results of a survey of 1200 internists and rheumatologists in the United States regarding their attitudes toward placebo therapy (Tilburt et al. 2008). Over 60% of respondents agreed that it is permissible to prescribe placebo therapy primarily to promote patients' expectations. When then queried if this permissive attitude toward prescribing placebo treatment applied to clinical practice, almost half of all respondents stated that they had recommended placebo treatment for patients at least once in the past year. Moreover, when placebo treatments were prescribed, 68% of prescribers described the proposed therapy as "medicine not typically used for your condition but might benefit you."

Interestingly, the authors found that the type of placebo prescribed was varied, but that purely inert substances such as sugar pills or saline were prescribed less than 5% of the time. The most frequently prescribed placebo treatments included multivitamins and over-the-counter analgesics. Alarmingly, more than one-quarter of prescribed placebo treatments were sedatives or antibiotics - medicines with potentially deleterious effects. Thus, practice patterns alone suggest that using the placebo effect as a therapeutic intervention is quite widespread.

Given the ubiquitous nature of placebo treatment in clinical practice, determining the beneficial effect of this form of therapy is paramount. Clearly this task is difficult. As noted earlier, since the publication of Beecher's landmark article, "The Powerful Placebo," the placebo effect has been reported to be effective in 30-40% of cases. However, differentiating the improvement in a clinical condition due to the placebo itself, as opposed to improvement due to the natural course of the disease or other factors, is challenging.

In 2001, Hrobjartsson et al. attempted to answer the question of whether placebo treatment conferred therapeutic benefit by systematically reviewing 130 clinical trials in which patients were assigned to either placebo or no treatment. They looked at the difference in outcome between the placebo and the no-treatment groups, rather than looking at the effect of the intervention arm of each trial. The underlying disease processes in each trial were diverse and involved 40 clinical conditions, such as asthma, schizophrenia, and chronic pain syndromes. In their analysis, they found no significant placebo effect in trials with binary outcomes, either subjective or objectively measured, nor in trials with continuous, objective outcomes. However, they did find a significant difference in trials with continuous subjective outcomes and in trials where pain was investigated (Hróbjartsson and G0tzsche 2001). The authors acknowledged several limitations to their study, including the inability to blind the untreated group, the effects of reporting bias, and the inability to assess the effects of the physician-patient relationship independent from the placebo itself. Moreover, critics contend that the ability to find a placebo effect in subgroup analysis was limited due to sample size, and in fact, the authors did show statistical significance of the placebo effect in one important group - chronic pain patients. Critics also report that some of the referenced trials were methodologically poor or were studying serious conditions, whose outcomes may have masked any placebo effect (Bailar 2001). However, in general the authors make a powerful argument that the clinical effect of placebo therapy may be less impressive than generally thought.

The questionable efficacy of the placebo effect must be considered when deciding whether the benefits outweigh the risks of placebo therapy. As previously mentioned, some placebo therapy may cause deleterious effects, such as a sedative prescription leading to delirium, respiratory compromise, and addiction, or inappropriate antibiotic therapy leading to further antibiotic resistance. Yet, other risks of placebo therapy may be more subtle though just as dangerous. In an accompanying editorial, Bailar writes with respect to placebos that "they may divert patients from seeking more effective treatments, they may mask symptoms that need attention, they may add to the cost of treatment.. .this deception may damage the doctor patient relationship in subtle ways (Bailar 2001)."

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