The

n e w e ng l a n d j o u r na l

of

m e dic i n e

Itopride for Functional Dyspepsia

To the Editor: We have three questions for Holtmann et al. (Feb. 23 issue).1 First, could they clarify the methods used to determine Helicobacter pylori status that is, was the gold-standard combination of histologic analysis, culture, and rapid urease testing of gastric-biopsy specimens used? 2 Second, was there control for cigarette smoking or the use of aspirin or nonaspirin nonsteroidal antiinflammatory drugs (NSAIDs)? We appreciate that the association between these factors and functional dyspepsia is controversial,3,4 but dyspeptic symptoms have been linked to smoking and the use of NSAIDs and aspirin.3,5 Finally, the mean ages were similar among the four groups of patients studied, but the ranges were wide and included not only octogenarians but also a patient who was 94 years of age. It is most unusual to diagnose functional dyspepsia in elderly patients. Do the authors agree that their study population may not be representative of general practice? Kirstin M. Taylor, M.B., B.S. Adam W. Harris, M.B., B.S., M.D.
Kent and Sussex Hospital Tunbridge Wells TN4 8AT, United Kingdom kirstin_taylor@hotmail.com
1. Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C.

rapid urease test or histologic analysis was used to diagnose H. pylori. In the remainder, a carbon13 urea breath test was performed. Regular intake of NSAIDs can cause dyspepsia3 and was an exclusion criterion. However, treatment with up to 100 mg of aspirin per day was considered acceptable. All patients underwent endoscopy before recruitment to exclude relevant mucosal lesions. Treatment groups were similar with regard to smoking, alcohol consumption, and treatment with low-dose aspirin. Functional dyspepsia affects patients with a wide range of ages.4 It is noteworthy that the onset of functional dyspepsia occurs even in the very elderly (>90 years of age).5 For this reason, it is not justifiable to exclude patients from a trial just because of an arbitrary age limit. However, we screened patients for criteria (e.g., dementia) that would preclude them from participating. Therefore, we believe that our sample mirrors the population of patients with functional dyspepsia seeking medical treatment. Gerald Holtmann, M.D., Ph.D. Tobias Liebregts, M.D.
Royal Adelaide Hospital Adelaide SA 5000, Australia gholtman@mail.rah.sa.gov.au

Nicholas J. Talley, M.D., Ph.D.

Mayo Clinic College of Medicine Rochester, MN 55905
1. Talley NJ, Silverstein MD, Agreus L, Nyren O, Sonnenberg A,

A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med 2006;354:832-40. 2. Leodolter A, Wolle K, Malfertheiner P. Current standards in the diagnosis of Helicobacter pylori infection. Dig Dis 2001;19:116-22. 3. Talley NJ, Weaver AL, Zinsmeister AR. Smoking, alcohol, and nonsteroidal anti-inflammatory drugs in outpatients with functional dyspepsia and among dyspepsia subgroups. Am J Gastroenterol 1994;89:524-8. 4. Talley NJ, Evans JM, Fleming KC, Harmsen WS, Zinsmeister AR, Melton LJ III. Nonsteroidal antiinflammatory drugs and dyspepsia in the elderly. Dig Dis Sci 1995;40:1345-50. 5. Nandurkar S, Talley NJ, Xia H, Mitchell H, Hazel S, Jones M. Dyspepsia in the community is linked to smoking and aspirin use but not to Helicobacter pylori infection. Arch Intern Med 1998;158:1427-33.

The authors reply: H. pylori status was assessed according to current recommendations for the diagnosis of the infection.1,2 In 453 patients a

Holtmann G. Evaluation of dyspepsia. Gastroenterology 1998;114: 582-95. 2. Malfertheiner P, Holtmann G, Peitz U, et al. Guidelines of the German Society of Digestive and Metabolic Diseases for treatment of dyspepsia. Z Gastroenterol 2001;39:937-56. (In German.) 3. Holtmann G, Gschossmann JM, Buenger L, Gerken G, Talley NJ. Do changes in visceral sensory function determine the development of dyspepsia during treatment with aspirin? Gastroenterology 2002;123:1451-8. 4. Talley NJ, OKeefe EA, Zinsmeister AR, Melton LJ III. Prevalence of gastrointestinal symptoms in the elderly: a populationbased study. Gastroenterology 1992;102:895-901. 5. Mearin F, Perez-Oliveras M, Perello A, et al. Dyspepsia and irritable bowel syndrome after a Salmonella gastroenteritis outbreak: one-year follow-up cohort study. Gastroenterology 2005; 129:98-104.

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