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1. Reply to Dr. Gatta and colleagues

   • Colin W Howden, MD
   • Nadim S. Jafri, Colin W. Howden

   Northwestern University Feinberg School of Medicine, Chicago, IL
   Dear Sir: We thank Dr. Gatta and colleagues for their comments. Our rationale for including the trial that had used a ranitidine bismuth citrate-containing regimen (1) is given in our paper. However, a sensitivity analysis had excluded that trial by examining only those that had compared 10 days of sequential treatment with 7 days of triple therapy (Table 3). Inclusion or exclusion of that trial did not substantially alter our results. Regarding the issue of clarithromycin-resistant strains in the study by de Francesco et al (2), the authors are correct. We regret our error in the transcription of these data. The corrected analysis still demonstrates an advantage of sequential over triple therapy. We apologize for the erroneous assumption that two trials (3, 4) had included patients from a U.S. site. The fact that none of the trials had included U.S. patients underscores our recommendation that sequential treatment should be studied in U.S.-based randomized controlled trials. Nadim S. Jafri, MD Division of Gastroenterology, Baylor College of Medicine, Houston, TX Colin W. Howden, MD Division of Gastroenterology, Northwestern University Feinberg School of Medicine, Chicago, IL REFERENCES 1. De Francesco V, Zullo A, Hassan C, Faleo D, Ierardi E, Panella C, Morini S. Two new treatment regimens for Helicobacter pylori eradication: a randomised study. Dig Liv Dis 2001; 33: 676-679. 2. De Francesco V, Margiotta M, Zullo A, Hassan C, Troiani L, Burattini O, Stella F, Di Leo A, Russo F, Marangi S, Monno R, Stoppino V, Morini S, Panella C, Ierardi E. Clarithromycin-resistant genotypes and eradication of Helicobacter pylori. Ann Intern Med 2006; 144: 94-100. 3. Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, and Morini S. Sequential therapy versus standard triple- drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med 2007; 146: 556-563. 4. Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadìa C, Fornari F, Pilati S, Mete LS, Merla A, Potì R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, and Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Alimen Pharmacol Ther 2003; 17: 719-726. Conflict of Interest: Colin W Howden has served as a consultant for Meretek, TAP, Takeda, Santarus and Novartis, and has received speakinh honoraria from AstraZeneca, Meretek and Santarus, and research grant support from AstraZeneca
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   Published July 21, 2008
2. Sequential Treatment for Helicobacter pylori infection

   • Luigi Gatta, M.D.
   • Angelo Zullo, Francesco Di Mario, Dino Vaira

   Section of Gastroenterology, Dept. of Clinical Science, University of Parma, Italy

   Dear Sir, we read with great interest the meta-analysis of Jaffri et al. (1) on sequential treatment. However, we would like to point out some points. We disagree with the choice of the Authors to include in the pooled analysis the data of De Francesco et al.(2) as it compared the sequential treatment to a 5 days therapy with ranitidine bismuth citrate which cannot be considered a “standard triple therapy” (3). Concerning the clarithromycin resistant issue, the data coming from the study of De Francesco et al. (4) are on 22 patients (instead of 81 as reported from the Authors) harbouring strains resistant to clarithromycin treated with the sequential treatment and 16 patients (instead of 75) harbouring strains resistant to clarithromycin treated with the standard triple therapy. When this data are pooled with those on resistant strains coming from the study of Vaira et al. (5), the eradication rate obtained in patients with strains resistant to clarithromycin treated with the sequential is 83.9% (95%CI: 67.4 to 92.9) instead of 82.2% as reported from the Authors, and 35.1% (95%CI: 21.8 to 51.2) instead of 40.6%, with a difference between the 2 treatments of 48.7% (95%CI: 25.7 to 64.8) favouring the sequential treatment. Finally, the manuscripts published by Vaira et al.(5) and by Zullo et al. (6) are multicentre studies that enrolled patients only in Italy and not in the U.S., and therefore it can not be stated that these studies recruited patients also in the U.S.

   Luigi Gatta, M.D. Versilia Hospital, Lido di Camaiore, Italy. Section of Gastroenterology, Dept. of Clinical Science, University of Parma, Italy.

   Angelo Zullo, M.D. Gastroenterologia ed Endoscopia Digestiva, Ospedale "Nuovo Regina Margherita, Rome, Italy

   Francesco Di Mario, M.D. Section of Gastroenterology, Dept. of Clinical Science, University of Parma, Italy.

   Dino Vaira, M.D. Dept. of Internal Medicine and Gastroenterology, S.Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy

   References

   1) Jafri NS, Hornung CA, Howden CW. Meta-analysis: Sequential Therapy Appears Superior to Standard Therapy for Helicobacter pylori Infection in Patients Naive to Treatment. Ann Intern Med 2008; 148: 923-931.

   2) De Francesco V, Zullo A, Hassan C, Faleo D, Ierardi E, Panella C, Morini S. Two new treatment regimens for Helicobacter pylori eradication: a randomised study. Dig Liv Dis 2001; 33: 676-679.

   3) Malfertheiner P, Megraud F, O'Morain C, Bazzoli F, El-Omar E, Graham D, Hunt R, Rokkas T, Vakil N, Kuipers EJ. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut 2007; 56: 772-81.

   4) De Francesco V, Margiotta M, Zullo A, Hassan C, Troiani L, Burattini O, Stella F, Di Leo A, Russo F, Marangi S, Monno R, Stoppino V, Morini S, Panella C, Ierardi E. Clarithromycin-resistant genotypes and eradication of Helicobacter pylori. Ann Intern Med 2006; 144: 94-100.

   5) Vaira D, Zullo A, Vakil N, Gatta L, Ricci C, Perna F, Hassan C, Bernabucci V, Tampieri A, and Morini S. Sequential therapy versus standard triple- drug therapy for Helicobacter pylori eradication: a randomized trial. Ann Intern Med 2007; 146: 556-563.

   6) Zullo A, Vaira D, Vakil N, Hassan C, Gatta L, Ricci C, De Francesco V, Menegatti M, Tampieri A, Perna F, Rinaldi V, Perri F, Papadìa C, Fornari F, Pilati S, Mete LS, Merla A, Potì R, Marinone G, Savioli A, Campo SM, Faleo D, Ierardi E, Miglioli M, and Morini S. High eradication rates of Helicobacter pylori with a new sequential treatment. Alimen Pharmacol Ther 2003; 17: 719-726.

   Conflict of Interest:

   None declared

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   Published July 7, 2008