Use of imidazole-based eradication regimens for Helicobacter pylori should be abandoned in North India regardless of in vitro antibiotic sensitivity.
OBJECTIVE
The purpose of this study was to compare the efficacy of tinidazole- versus clarithromycin-based triple regimens for eradication of Helicobacter pylori in North Indian patients of peptic ulcer disease, and to correlate the outcome with in vitro antibiotic susceptibility.


METHODS
One hundred and forty-six H. pylori-infected patients with active ulcer were included in the prospective, randomized study. A total of 70 patients received lansoprazole 30 mg b.d., amoxycillin 1000 mg b.d. and tinidazole 500 mg b.d. (LAT), and 76 patients received lansoprazole 30 mg b.d., amoxycillin 1000 mg b.d. and clarithromycin 500 mg b.d. (LAC) for 14 days. The H. pylori status was assessed by urea breath test, rapid urease test, and histology and antibiotic sensitivity pattern by Epsilometer test.


RESULTS
In per-protocol analysis of 112 patients the H. pylori eradication rate was 42.3% (95% confidence interval (CI): 0.29-0.56) in LAT, and 64.8% (95%CI: 0.52-0.78) in LAC (95%CI of difference of proportions: 0.13-0.33, P = 0.01). Ulcer healed in 69.2% in the LAT group (95%CI: 0.57-0.82) and 81.7% in the LAC group (95%CI: 0.72-0.92; P = 0.02). Antibiotic susceptibility testing was done in 31 patients. Metronidazole resistance was present in 41.9% isolates but was unrelated to the outcome of the LAT regimen.


CONCLUSIONS
Imidazole-based eradication regimens should be abandoned in North India regardless of in vitro susceptibility results.
Bhatia
Vikram
V
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
Ahuja
Vineet
V
Das
Bimal
B
Bal
Chandrasekhar
C
Sharma
Mahesh P
MP
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000658:Amoxicillin; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000494:pharmacology / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D007194:India; D064747:Lansoprazole; D008795:Metronidazole / Q000494:pharmacology; D008826:Microbial Sensitivity Tests; D009853:Omeprazole / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000382:microbiology / Q000503:physiopathology; D011446:Prospective Studies; D014011:Tinidazole / Q000627:therapeutic use*; D016896:Treatment Outcome; D014945:Wound Healing
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D014011:Tinidazole; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole