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Editorials |

Balancing Randomized Trials With Anecdote

Paul S. Phillips, MD
[+] Article and Author Information

From Scripps Mercy Hospital, San Diego, CA 92103.


Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Paul S. Phillips, MD, Scripps Mercy Hospital Catheterization Laboratories, 4077 5th Avenue, San Diego, CA 92103; e-mail, Phillips.Paul@scrippshealth.org.


Ann Intern Med. 2009;150(12):885-886. doi:10.7326/0003-4819-150-12-200906160-00014
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Anecdotes may be misleading. They are uncontrolled. Findings may be due to chance, not cause and effect. The anecdote may incorrectly dissuade us from proven therapies. Dispassionate and objective, the randomized, controlled trial has rightfully gained priority as the highest level of evidence when selecting therapy for our patients. Its methodology minimizes the effects of bias and is responsible for medicine's progress from unproven treatments to the current era of evidence-based medicine. However, when it comes to drug toxicity, anecdotal case reports have repeatedly demonstrated that medicines previously found safe in randomized, controlled efficacy trials have important adverse effects (1). Those of us who care for patients who cannot tolerate lipid-lowering therapy are often confronted by anecdotes that contradict the findings of well-designed trials. Our statin myopathy clinic, which now exceeds 600 patients (45 of whom have experienced statin-induced rhabdomyolysis), provides such an experience.

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Response Balancing Randomized Trials
Posted on July 30, 2009
Charles Grossman
Odense University
Conflict of Interest: None Declared

The editorial, by Phillips, "Balancing randomized trials with anecdote" is concerned with drug therapy (1). Published anecdotal reports unrelated to drug therapy have contributed to scientific knowledge for thousands of years. Many such are frequently not accepted for publication due to evaluation of importance by reviewers and editors, and space limitations. I recall one personal experience in 1974; when a case report I wrote with the unusual findings of ectopic bone formation in the ventricular myocardium (with active marrow cells) was found at post mortem 3 years after an acute injury in a motor vehicle accident. The patient 67 years of age suffered a rib fracture, acute chest pain, and ST + T wave abnormalities in V5 and V6 all of which resolved with time. The report was rejected by a number of journals, until the Journal of Trauma published it. This was an anecdotal report with new information.

References

1.) Phillips PS. Balancing randomized trials with anecdote. (Editorial). Ann Intern. Med. 2009; 150: 885-6.

2.) Grossman CM. Posttraumatic Ossification of the Myocardium. Jour. Of Trauma. 1974; 14:85-9.

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