Bismuth-based first-line therapy for Helicobacter pylori eradication in type 2 diabetes mellitus patients.
OBJECTIVE
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.


METHODS
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).


CONCLUSIONS
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.
Demir
Mehmet
M
Department of Gastroenterology, Baskent University Faculty of Medicine, Konya, Turkey. drmehmetdemir@yahoo.com
Göktürk
Savaş
S
Oztürk
Nevin Akçaer
NA
Serin
Ender
E
Yilmaz
Uğur
U
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000658:Amoxicillin / Q000627:therapeutic use; D000863:Antacids / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use; D001729:Bismuth / Q000627:therapeutic use*; D016022:Case-Control Studies; D016009:Chi-Square Distribution; D017291:Clarithromycin / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000150:complications* / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D000077402:Pantoprazole; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D013752:Tetracycline; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000863:Antacids; D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D000077402:Pantoprazole; D013752:Tetracycline; D017291:Clarithromycin; D001729:Bismuth