Background/Aim: The primary aim of this study was to assess the efficacy of a bismuth-based quadruple regimen as first-line therapy for Helicobacter pylori (HP) eradication in diabetes mellitus (DM) patients. The secondary aim was to study the effect of HP eradication on dyspeptic symptoms in DM patients. Method: Eighty-nine consecutive type 2 DM and 48 non-diabetic age- and sex-matched patients were enrolled in this study. Diabetic patients were randomized to receive either pantoprazole (40 mg b.i.d.), clarithromycin (500 mg b.i.d.), and amoxicillin (1 g b.i.d., PCA-DM group) for 14 days, or pantoprazole (40 mg b.i.d.), bismuth citrate (400 mg b.i.d.), tetracycline (500 mg q.i.d.), and metronidazole (500 mg b.i.d., PBTM-DM group) for 14 days as the eradication regimen. All non-diabetic patients were treated by quadruple therapy (PBTM-non-DM group) for 14 days. We used the validated Leeds Dyspepsia Questionnaire (LDQ) to assess dyspeptic symptoms at baseline and 6 weeks after the end of treatment. Results: The HP eradication rates with intention-to-treat (ITT) and per-protocol (PP) analyses were 51% (for both) in the PCA-DM group; 81 and 85% in the PBTM-DM group, and 85 and 87% in the PBTM-non-DM group. The eradication rates are not different between the PBTM-DM and PBTM-non-DM groups (p > 0.05). The eradication rate was significantly lower in the PCA-DM group with both ITT and PP analysis than in the PBTM-DM and PBTM-non-DM groups (p < 0.05). LDQ score was 4.53 ± 7.7 in DM patients with successful eradication and 14.68 ± 5.9 in DM patients without successful eradication (p < 0.05). Conclusion: The bismuth-based quadruple eradication regimen as first-line therapy is safe, tolerable and achieves a high cure rate in patients with DM, and successful eradication may be beneficial on dyspeptic symptoms.

Keywords:
Helicobacter pylori, Diabetes mellitus, Bismuth
1.
Suerbaum S, Michetti P: Helicobacter pylori infection. N Engl J Med 2002;347:1175–1186.
2.
Gasbarrini A, Ojetti V, Pitocco D, Franceschi F, Candelli M, Torre ES, et al: Insulin-dependent diabetes mellitus affects eradication rate of Helicobacter pylori infection. Eur J Gastroenterol Hepatol 1999;11:713–716.
3.
Gasbarrini A, Ojetti V, Pitocco D, Armuzzi A, Silveri NG, Pola P, el al: Efficacy of different Helicobacter pylori eradication regimens in patients affected by insulin-dependent diabetes mellitus. Scand J Gastroenterol 2000;35:260–263.
4.
Bégué RE, Gómez R, Compton T, Vargas A: Effect of Helicobacter pylori eradication in the glycemia of children with type 1 diabetes: a preliminary study. South Med J 2002;95:842–845.
5.
Sargýn M, Uygur-Bayramicli O, Sargýn H, Orbay E, Yavuzer D, Yayla A: Type 2 diabetes mellitus affects eradication rate of Helicobacter pylori. World J Gastroenterol 2003;9:1126–1128.
6.
Moayyedi P, Duffett S, Braunholtz D, Mason S, Richards ID, Dowell AC, el al: The Leeds Dyspepsia Questionnaire: a valid tool for measuring the presence and severity of dyspepsia. Aliment Pharmacol Ther 1998;12:1257–1262.
7.
Rokkas T, Sechopoulos P, Robotis I, Margantinis G, Pistiolas D: Cumulative H. pylori eradication rates in clinical practice by adopting first and second-line regimens proposed by the Maastricht III consensus and a third-line empirical regimen. Am J Gastroenterol. 2009;104:21–25.
8.
Selgrad M, Malfertheiner P: New strategies for Helicobacter pylori eradication. Curr Opin Pharmacol 2008;0 8:593–597.
9.
Unger RH, Foster DW: Diabetes mellitus; in Wilson JD, Foster DW (eds): Williams’ Textbook of Endocrinology, ed 8. Philadelphia, Saunders, 1992, pp 1255–1333.
10.
Marhoffer W, Stein M, Maeser E, Federlin K: Impairment of polymorphonuclear leukocyte function and metabolic control of diabetes. Diabetes Care 1992;15:256–260.
11.
Mégraud F: Resistance of Helicobacter pylori to antibiotics. Aliment Pharmacol Ther 1997;11(suppl 1):43–53.
12.
Sezgin O, Aslan G, Altintaş E, Tezcan S, Serin MS, Emekdaş G: Detection of point mutations on 23S rRNA of Helicobacter pylori and resistance to clarithromycin with PCR-RFLP in gastric biopsy specimens in Mersin, Turkey. Turk J Gastroenterol 2008;19:163–167.
13.
Gerrits MM, Schuijffel D, Van Zwet AA, Kuipers EJ, Vandenbroucke-Grauls CM, Kusters JG: Alterations in penicillin-binding protein 1A confer resistance to beta-lactam antibiotics in Helicobacter pylori. Antimicrob Agents Chemother 2002;46:2229–2233.
14.
Kwon DH, Kim JJ, Lee M, Yamaoka Y, Kato M, Osato MS, et al: Isolation and characterization of tetracycline-resistant clinical isolates of Helicobacter pylori. Antimicrob Agents Chemother 2000;44:3203–3205.
15.
Dore MP, Graham DY, Mele R, Marras L, Nieddu S, Manca A, et al: Colloidal bismuth subcitrate-based twice-a-day quadruple therapy as primary or salvage therapy for Helicobacter pylori infection. Am J Gastroenterol 2002;97:857–860.
16.
Graham DY: Antibiotic resistance in Helicobacter pylori: implications for therapy. Gastroenterology 1998;115:1272–1277.
17.
Debets-Ossenkopp YJ, Herscheid AJ, Pot RG, Kuipers EJ, Kusters JG, Vandenbroucke-Grauls CM: Prevalence of Helicobacter pylori resistance to metronidazole, clarithromycin, amoxicillin, tetracycline and trovafloxacin in The Netherlands. J Antimicrob Chemother 1999;43:511–515.
18.
Malfertheiner P, Megraud F, O’Morain C, Bazzoli F, El-Omar E, Graham D, et al: Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut 2007;56:772–781.
19.
Demir M, Gokturk HS, Ozturk NA, Kulaksizoglu M, Serin E, Yilmaz U: Helicobacter pylori prevalence in diabetes mellitus patients with dyspeptic symptoms and its relationship to glycemic control and late complications. Dig Dis Sci 2008;53:2646–2649.
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2010
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