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We read the study by Janatuinen et al (Gut 2002;50:332–5) with great interest. However, we would like to highlight some concerns.
The initial study1 included 92 patients randomised to two groups—oats and gluten free diet, 45 and 47 patients respectively—however, these numbers do not correspond to those in figure 1 of their paper.
Patients were verbally consenting volunteers, thus introducing selection bias to compliance. The number of dropouts, especially in the control group, was surprisingly high (41 in total). Were there so many dropouts because of the unpalatability of oats or concerns over their safety? If the latter, then surely this would be greater in the oats group.
It is not clear whether patients were followed up in the interim period between 12 months and five years. It would be important to ascertain objectively whether the oats group were in fact including oats in their diet, as omission would not address their long term safety. Assessment of compliance and food diary are very subjective, introducing bias towards dietary compliance. How was this done? We were surprised to see that one third of the oats group did not in fact take oats at all, so only one third of patients were ingesting oats on a daily …