Balancing Randomized Trials With Anecdote

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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Prasad GV, Wong T, Meliton G, Bhaloo S. Rhabdomyolysis due to red yeast rice (Monascus purpureus) in a renal transplant recipient. Transplantation. 2002;74:1200-1. PMID: 12438974 CrossrefMedlineGoogle Scholar21. Rhabdomyolysis linked to Chinese red yeast rice. Prescrire Int. 2008;17:64. PMID: 18516816 MedlineGoogle Scholar22. Phillips PS, Haas RH. Observations from a statin myopathy clinic Letter. Arch Intern Med. 2006;166:1232-3; author reply 1233. PMID: 16772252 Google Scholar23. U.S. Food and Drug Administration. FDA warns consumers to avoid red yeast rice products promoted on internet as treatments for high cholesterol: products found to contain unauthorized drug new release. Rockville, MD: U.S. Food and Drug Administration; 2007. Accessed at www.fda.gov/bbs/topics/NEWS/2007/NEW01678.html on 13 May 2009. 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 protectedorg. 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. 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