Correspondence

Itopride for Functional Dyspepsia

N Engl J Med 2006; 354:2392June 1, 2006

Article

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

5 References

1. 1

   Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med 2006;354:832-840
   Full Text | Web of Science | Medline

2. 2

   Leodolter A, Wolle K, Malfertheiner P. Current standards in the diagnosis of Helicobacter pylori infection. Dig Dis 2001;19:116-122
   CrossRef | Web of Science | Medline

3. 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;89:524-528
   Web of Science | Medline

4. 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;40:1345-1350
   CrossRef | Web of Science | Medline

5. 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;158:1427-1433
   CrossRef | Web of Science | Medline

Author/Editor Response

status was assessed according to current recommendations for the diagnosis of the infection.1,2 In 453 patients a rapid urease test or histologic analysis was used to diagnose H. pylori. In the remainder, a carbon-13 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

5 References

1. 1

   Talley NJ, Silverstein MD, Agreus L, Nyren O, Sonnenberg A, Holtmann G. Evaluation of dyspepsia. Gastroenterology 1998;114:582-595
   CrossRef | Web of Science | Medline

2. 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;39:937-956
   CrossRef | Web of Science | Medline

3. 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;123:1451-1458
   CrossRef | Web of Science | Medline

4. 4

   Talley NJ, O'Keefe EA, Zinsmeister AR, Melton LJ III. Prevalence of gastrointestinal symptoms in the elderly: a population-based study. Gastroenterology 1992;102:895-901
   Web of Science | Medline

5. 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
   CrossRef | Web of Science | Medline

Citing Articles (1)

Citing Articles

1. 1

   Jing Yuan FANG, Wen Zhong LIU, Yao SHI, Zhi Zheng GE, Shu Dong XIAO. (2007) Consensus on chronic gastritis in China ? Second National Consensus Meeting on Chronic Gastritis (14?16 September 2006 Shanghai, China). Journal of Digestive Diseases 8:2, 107-119
   CrossRef