The Southern Medical Journal (SMJ) is the official, peer-reviewed journal of the Southern Medical Association. It has a multidisciplinary and inter-professional focus that covers a broad range of topics relevant to physicians and other healthcare specialists.

SMJ // Article

Original Article

Effect of Sequential Treatment as a First-Line Therapy for Helicobacter pylori Eradication in Patients with Diabetes Mellitus

Authors: Hilmi Ataseven, MD, Mehmet Demir, MD, Ramazan Gen, MD

Abstract

Objectives: The Maastricht III Consensus agreed that effective treatment for Helicobacter pylori (HP) should achieve an intention-to-treat (ITT) eradication rate above 80%, which is still lacking in patients with type 2 diabetes mellitus (DM). This pilot study was designed to confirm the efficacy of a 14-day sequential treatment regimen in patients with type 2 DM.


Methods: This is a prospective, open-label, single-center pilot study. All patients included in this study underwent upper gastrointestinal endoscopy. HP status was evaluated in each patient by a rapid urease test and histopathologic examination. For seven days, all patients received pantoprazole 40 mg twice daily (b.i.d.) and amoxicillin 1000 mg b.i.d., followed by pantoprazole 40 mg b.i.d., metronidazole 500 mg b.i.d., and tetracycline 500 mg once each day for the remaining seven days. The study population consisted of 38 consecutive patients with type 2 DM (18 female, 20 male; mean age 48.0 ± 12.2 years), 30 of whom had non-ulcer dyspepsia, four had gastritis, one had gastric ulcer, and three had duodenal ulcer disease. Eradication was defined as the absence of HP as assessed with the 14C-urea breath test.


Results: Thirty-seven of 38 patients completed the study. All side effects were observed in eight patients (21.1%). None of the patients discontinued treatment because of side effects. The eradication rate in the DM group was 22/38 (57.9%) for the ITT analysis and 22/37 (59.5%) for the per-protocol (PP) analysis.


Conclusion: The results of 14-day sequential therapy for the first-line treatment of HP in patients with type 2 DM were disappointing. Further studies with new antibiotic combinations are needed to find better methods of eradicating HP in patients with type 2 DM.

This content is limited to qualifying members.

Existing members, please login first

If you have an existing account please login now to access this article or view purchase options.

Purchase only this article ($25)

Create a free account, then purchase this article to download or access it online for 24 hours.

Purchase an SMJ online subscription ($75)

Create a free account, then purchase a subscription to get complete access to all articles for a full year.

Purchase a membership plan (fees vary)

Premium members can access all articles plus recieve many more benefits. View all membership plans and benefit packages.

References

1. Dunn BE, Cohen H, Blaser MJ. Helicobacter pylori. Clin Microbiol Rev 1997;10:720–741.
 
2. Songer TJ, Zimmet PZ. Epidemiology of type II diabetes: an international perspective. Pharmacoeconomics 1995;8:1–11.
 
3. Güvener N, Akcan Y, Paksoy I, et al. Helicobacter pylori associated gastric pathology in patients with type II diabetes mellitus and its relationship with gastric emptying: the Ankara study. Exp Clin Endocrinol Diabetes 1999;107:172–176.
 
4. Gentile S, Turco S, Oliviero B, et al. The role of autonomic neuropathy as a risk factor of Helicobacter pylori infection in dyspeptic patients with type 2 diabetes mellitus. Diabetes Res Clin Pract 1998;42:41–48.
 
5. Demir M, Gokturk HS, Ozturk NA, et al. 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.
 
6. Candelli M, Rigante D, Marietti G, et al. Helicobacter pylori, gastrointestinal symptoms, and metabolic control in young type 1 diabetes mellitus patients. Pediatrics 2003;111:800–803.
 
7. Sargýn M, Uygur-Bayramicli O, Sargýn H, et al. Type 2 diabetes mellitus affects eradication rate ofHelicobacter pylori. World J Gastroenterol 2003;9:1126–1128.
 
8. Demir M, Gokturk HS, Ozturk NA, et al. Efficacy of two different Helicobacter pylori eradication regimens in patients with type 2 diabetes and the effect of Helicobacter pylori eradication on dyspeptic symptoms in patients with diabetes: a randomized controlled study. Am J Med Sci 2009;338:459–464.
 
9. Tong JL, Ran ZH, Shen J, et al. Sequential therapy vs. standard triple therapies for Helicobacter pylori infection: a meta-analysis. J Clin Pharm Ther 2009;34:41–53.
 
10. Malfertheiner P, Megraud F, O'Morain C, et al. Current concepts in the management of Helicobacter pylori infection: the Maastricht III Consensus Report. Gut 2007;56:772–781.
 
11. Gasbarrini A, Ojetti V, Pitocco D, et al. Insulin-dependent diabetes mellitus affects eradication rate of Helicobacter pylori infection. Eur J Gastroenterol Hepatol 1999;11:713–716.
 
12. Gasbarrini A, Ojetti V, Pitocco D, et al. Efficacy of different Helicobacter pylori eradication regimens in patients affected by insulin-dependent diabetes mellitus. Scand J Gastroenterol 2000;35:260–263.
 
13. Moayyedi P. Sequential regimens for Helicobacter pylori eradication. Lancet 2007;370:1010–1012.
 
14. Zullo A, De Francesco V, Hassan C, et al. The sequential therapy regimen for Helicobacter pylori eradication: a pooled-data analysis. Gut 2007;56:1353–1357.
 
15. Uygun A, Kadayifci A, Yesilova Z, et al. Comparison of sequential and standard triple-drug regimen for Helicobacter pylori eradication: a 14-day, open-label, randomized, prospective, parallel-arm study in adult patients with nonulcer dyspepsia. Clin Ther 2008;30:528–534.
 
16. De Francesco V, Margiotta M, Zullo A, et al. Clarithromycin-resistant genotypes and eradication of Helicobacter pylori.  Ann Intern Med 2006;144:94–100.
 
17. Marhoffer W, Stein M, Maeser E, et al. Impairment of polymorphonuclear leukocyte function and metabolic control of diabetes. Diabetes Care 1992;15:256–260.
 
18. Bessman AN, Sapico FL. Infections in the diabetic patient: the role of immune dysfunction and pathogen virulence factors. J Diabetic Complications 1992;6:258–262.
 
19. Mégraud F. Resistance of Helicobacter pylori to antibiotics. Aliment Pharmacol Ther 1997;11(suppl 1):43–53.
 
20. Demir M, Gokturk HS, Ozturk NA, et al. Clarithromycin resistance and efficacy of clarithromycin-containing triple eradication therapy for Helicobacter pylori infection in type 2 diabetes mellitus patients. South Med J 2009;102:1116–1120.
 
21. Gwilt PR, Nahhas RR, Tracewell WG. The effects of diabetes mellitus on pharmacokinetics and pharmacodynamics in humans. Clin Pharmacokinet 1991;20:477–490.
 
22. Keshavarzian A, Iber FL, Vaeth J. Gastric emptying in patients with insulin-requiring diabetes mellitus. Am J Gastroenterol 1987;82:29–35.
 
23. Horowitz M, Wishart JM, Jones KL, et al. Gastric emptying in diabetes: an overview [Review]. Diabet Med 1996;13:S16–S22.
 
24.Groop LC, Luzi L, DeFronzo RA, et al. Hyperglycaemia and absorption of sulphonylurea drugs. Lancet 1989;2:129–130.
 
25. Tooke JE. Microvascular haemodynamics in diabetes mellitus [Review]. Clin Sci (Lond)1986;70:119–125.
 
26. Zatz R, Brenner BM. Pathogenesis of diabetic microangiopathy. The hemodynamic view. Am J Med 1986;80:443–453.
 
27. Kong MF, Macdonald IA, Tattersall RB. Gastric emptying in diabetes. Diabet Med 1996;13:112–119.
 
28. Perri F, Villani MR, Festa V, et al. Predictors of failure of Helicobacter pylori eradication with the standard ‘Maastricht triple therapy.’ Aliment Pharmacol Ther 2001;15:1023–1029.
 
29. Huang JQ, Hunt RH. Treatment after failure: the problem of “nonresponders” [Review]. Gut1999;45(suppl 1):140–144.
 
30. Huang JQ, Zheng GF, Hunt RH, et al. Do patients with non-ulcer dyspepsia respond differently to Helicobacter pylori eradication treatments from those with peptic ulcer disease? A systematic review. World J Gastroenterol 2005;11:2726–2732.
 
31. Sezgin O, Aslan G, Altintaş E, et al. Detection of point mutations on 23S rRNA of Helicobacter pyloriand resistance to clarithromycin with PCR-RFLP in gastric biopsy specimens in Mersin, Turkey. Turk J Gastroenterol 2008;19:163–167.