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When a Placebo Causes Illness

Picture this surprising but realistic, documented patient care scenario: You have a patient that presents who is currently in a clinical trial for treatment of depression. She has intentionally overdosed on her study medication. After she overdoses, she begins to feel pre-syncopal and calls 911. EMS arrives to find that her blood pressure is 70/40 and has to institute standard ALS protocols including a substantial fluid bolus to normalize her vital signs. A through inpatient hospital evaluation fails to determine any pathophysiological diagnosis. Ultimately it is determined that her pills were placebos.

The positive influences of doctor–patient communication, treatment expectations, and sham treatments (termed the placebo effect), have been demonstrated scientifically for subjective symptoms such as pain and nausea. Many of us have seen the efficacy of a placebo.

As Emergency Medicine Physicians or Hospitalists, patient self-induced illnesses caused by internet medical care recommendations and treatment/medication noncompliance are etiologies that may cause these patients to seek medical evaluations. Then there’s the nocebo effect defined as the induction of a symptom perceived as negative by sham treatment or by the suggestion of negative treatment expectations. A nocebo response is a negative symptom caused by the patient’s own negative expectations or by negative suggestions from clinicians in the absence of any treatment. In fact, information about possible complications and negative expectations on the patient’s part has been found to increase the likelihood of adverse effects.

A recently published study from Germany was designed to determine the impact of nocebo effects on adverse events (AEs) in drug trials for fibromyalgia syndrome (FMS) and painful diabetic peripheral neuropathy (DPN). There were a total of 5065 patients in the placebo groups. The pooled estimate of the event dropout rate due to AEs in placebo groups was 9.6 in placebo and 16.3 in true drug groups of FMS trials; and was 5.8 in placebo and 13.2 in true drug groups of DPN trials. The investigators concluded that nocebo effects accounted for substantial numbers of AEs in drug trials of FMS and DPN. They recommended the need for development of strategies to minimize nocebo effects in both clinical trials and clinical practice. With any acute patient complaint presentation, our job is to rule out an emergency medical condition without introducing personal biases, minimizing the chief complaint or attributing the problem to potential nocebo effects.

Care standard requires us to inform patients of the potential complications of our proposed treatments. Concurrently we should make a conscious effort to minimize the likelihood of complications caused by a potential nocebo effect. When we place a patient on a new medication, it has been suggested that we should emphasize the fact that the proposed treatment is usually well tolerated. Another suggestion is to obtain the patient’s permission to incompletely inform them about the treatments’ possible side effects.

Words are one of the most powerful tools we have in our armamentarium. Communication lessons provided during training and with continuing medical education are ways that we can learn to more effectively utilize the spoken word. We need to remember that doctor–patient communications and the patient’s treatment expectations can influence the course of their medical therapy.

References:
1. Häuser, W et.al. Adverse Events Attributable to Nocebo in Randomized Controlled Drug Trials in Fibromyalgia Syndrome and Painful Diabetic Peripheral Neuropathy: Systematic Review, June 2012 – Volume 28 – Issue 5 l
2. Häuser, W et.al. Review Article Nocebo Phenomena in Medicine Their Relevance in Everyday Clinical Practice; Dtsch Arztebl Int. 2012 June; 109(26): 459–465. Published online 2012 June 29.

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