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Acetaminophen and Aminotransferase Elevations
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To the Editor: The study of aminotransferase levels by Dr Watkins and colleagues1 found a high incidence of alanine aminotransferase (ALT) elevations in healthy participants who were randomized to receive medications containing acetaminophen (paracetamol); this was not found in participants randomized to placebo. We have a number of concerns with the methods used in this study.
First, the statistical methods did not include a description of sample size determination or definition of the minimal clinically important difference that the study was designed to detect.
Second, we are concerned about allocation concealment throughout the study. For example, blinding of patients may not have been effective, since the drugs were commercial products; 3 groups used all tablets but 2 groups used both tablets and caplets. There is no description of blinding of data analysts. The analysis was not performed according to intention to treat. All of these have the potential to introduce . . . [Full Text of this Article]
Yuhong Yuan, MD, PhD;
Marroon Thabane, MLIS, MSc
Division of Gastroenterology
Lehana Thabane, MSc, PhD
Department of Epidemiology and Biostatistics
Richard H. Hunt, MB, FRCPC, FACG
huntr@mcmaster.ca
Division of Gastroenterology
McMaster University Health Science Centre
Hamilton, Ontario
RELATED LETTER
Acetaminophen and Aminotransferase Elevations—Reply
Paul B. Watkins, Neil Kaplowitz, Salvatore V. Colucci, Paul W. Stewart, and Stephen C. Harris
JAMA. 2006;296(23):2798-2799.
EXTRACT
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RELATED ARTICLE
Aminotransferase Elevations in Healthy Adults Receiving 4 Grams of Acetaminophen Daily: A Randomized Controlled Trial
Paul B. Watkins, Neil Kaplowitz, John T. Slattery, Connie R. Colonese, Salvatore V. Colucci, Paul W. Stewart, and Stephen C. Harris
JAMA. 2006;296(1):87-93.
ABSTRACT
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