Comparison Between 10- and 14-Day Hybrid Regimens for Helicobacter pylori Eradication: A Randomized Clinical Trial.
BACKGROUND
Helicobacter pylori (H. pylori) eradication has always been a concern. In our previous study, 14-day hybrid regimen showed ideal results. Based on these findings, we decided to compare the efficacy of 10- and 14-day hybrid regimens for H. pylori eradication.


METHODS
Two hundred and seventy patients with peptic ulcer disease and H. pylori infection were enrolled in the study. One hundred and thirty-four patients received 10-day hybrid regimen (PACT-10): pantoprazole, 40 mg, and amoxicillin, 1 g, both twice daily for 10 days; plus clarithromycin, 500 mg, and tinidazole, 500 mg, both twice daily just during the last 5 days. One hundred and thirty-six patients received 14-day hybrid regimen (PACT-14): pantoprazole, 40 mg, and amoxicillin, 1 g, both twice a day for 14 days; plus clarithromycin, 500 mg, and tinidazole, 500 mg, both twice daily just for the last 7 days. Eight weeks after treatment, (14) C-urea breath test was performed to evaluate H. pylori eradication.


RESULTS
Two hundred and fifty patients (124 patients in PACT-10 and 126 patients in PACT-14 regimens) completed the study. The intention-to-treat eradication rates were 77.6% (95% confidence interval (CI): 70.6-84.6%) and 86% (95% CI: 80-92%) for the two regimens, respectively (p = .17). Per-protocol eradication rates were 83.8% (95% CI: 80-86%) and 92.8% (95% CI: 88-96%), respectively (p < .01). There were no significant intergroup differences in compliance to treatment or discontinuation of therapy due to severe side effects.


CONCLUSIONS
Ten-day hybrid regimen could not achieve acceptable eradication rate. However, 14-day hybrid regimen seems to be an acceptable option for H. pylori eradication in Iran.
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Hassan Ali
HA
Metanat
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Seyed Mohammad
SM
Valizadeh
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Hafez
H
Fakheri
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Iradj
I
Maleki
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Tarang
T
Taghvaei
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Vahid
V
Hosseini
Inflammatory Diseases of Upper Gastrointestinal Tract Research Center, Department of Gastroenterology, Mazandaran University of Medical Sciences, Sari, Mazandaran, Iran.
Zohreh
Z
Bari
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use; D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use; D018432:Drug Resistance, Multiple; D004359:Drug Therapy, Combination; D004382:Duodenitis / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000254:growth & development; D006801:Humans; D007492:Iran; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D000077402:Pantoprazole; D010437:Peptic Ulcer / Q000188:drug therapy* / Q000382:microbiology; D014011:Tinidazole / Q000627:therapeutic use
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D014011:Tinidazole; D000658:Amoxicillin; D000077402:Pantoprazole; D017291:Clarithromycin
Helicobacter pylori; eradication; hybrid