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To the Editor: The study of treatment of Crohn disease by Dr Feagan and colleagues¹ is important because smaller clinical trials are more susceptible to bias, are often less methodologically rigorous, and produce relatively less precise estimates of the true effect of treatment than large multicenter studies. However, the methodology of this study overlooked 2 potential sources of type II error.

First, no measurements were made of essential fatty acid status at the start or end of the trial. It is not possible to assess the quality of the randomization for either the baseline omega-3 status, the baseline intake of the proinflammatory omega-6 fatty acids, or the baseline ratios of omega-6 to omega-3. Additionally, the quality of the intervention cannot be assessed, including omega-3 fatty acid absorption in these patients or their actual adherence to the protocol.

Second, no measurements were made of the vitamin D status in this population. . . . [Full Text of this Article]

Gregory A. Plotnikoff, MD, MTS
gregory.plotnikoff@allina.com
Institute for Health and Healing
Abbott Northwestern Hospital
Minneapolis, Minnesota

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RELATED ARTICLE

Omega-3 Free Fatty Acids for the Maintenance of Remission in Crohn Disease: The EPIC Randomized Controlled Trials
Brian G. Feagan, William J. Sandborn, Ulrich Mittmann, Simon Bar-Meir, Geert D’Haens, Marc Bradette, Albert Cohen, Chrystian Dallaire, Terry P. Ponich, John W. D. McDonald, Xavier Hébuterne, Pierre Paré, Pavel Klvana, Yaron Niv, Sandro Ardizzone, Olga Alexeeva, Alaa Rostom, Gediminas Kiudelis, Johannes Spleiss, Denise Gilgen, Margaret K. Vandervoort, Cindy J. Wong, Guang Yong Zou, Allan Donner, and Paul Rutgeerts
JAMA. 2008;299(14):1690-1697.
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RELATED LETTER

Fatty Acid and Vitamin D Status in the EPIC Trials of Crohn Disease Treatment—Reply
Brian G. Feagan
JAMA. 2008;300(6):650.
EXTRACT | FULL TEXT