Balancing Randomized Trials With Anecdote
Authors: Paul S. Phillips
Journal: Annals of Internal Medicine (2009)

Editorials16 June 2009Balancing Randomized Trials With AnecdotePaul S. Phillips, MDPaul S. Phillips, MDFrom Scripps Mercy Hospital, San Diego, CA 92103.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-150-12-200906160-00014 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail 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). ...References1. Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA. 1999;281:1728-34. [PMID: 10328074] CrossrefMedlineGoogle Scholar2. Cao P, Hanai JI, Tanksale P, Imamura S, Sukhatme VP, Lecker SH. Statin-induced muscle damage and atrogin-1 induction is the result of a geranylgeranylation defect. FASEB J. 2009;:. [PMID: 19406843] CrossrefMedlineGoogle Scholar3. Collins R, Armitage J, Parish S, Sleigh P, Peto R; Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5963 people with diabetes: a randomised placebo-controlled trial. Lancet. 2003;361:2005-16. [PMID: 12814710] CrossrefMedlineGoogle Scholar4. 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Google Scholar Author, Article, and Disclosure InformationAffiliations: From Scripps Mercy Hospital, San Diego, CA 92103.Disclosures: None disclosed.Corresponding Author: Paul S. Phillips, MD, Scripps Mercy Hospital Catheterization Laboratories, 4077 5th Avenue, San Diego, CA 92103; e-mail, Phillips.[email protected]org. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoRed Yeast Rice for Dyslipidemia in Statin-Intolerant Patients David J. Becker , Ram Y. Gordon , Steven C. Halbert , Benjamin French , Patti B. Morris , and Daniel J. Rader Narrative Review: Statin-Related Myopathy Tisha R. Joy and Robert A. Hegele Metrics Cited byThe pharmacology of statinsProoxidative toxicity and selenoprotein suppression by cerivastatin in muscle cellsThe Role of Red Yeast Rice for the PhysicianApproach to the Patient Who Is Intolerant of Statin Therapy 16 June 2009Volume 150, Issue 12Page: 885-886KeywordsClinical trialsCreatine kinaseLipidsMusclesRenal failureRhabdomyolysisSafetyStatinsSystematic reviewsToxicity ePublished: 16 June 2009 Issue Published: 16 June 2009 Copyright & PermissionsCopyright © 2009 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...