Determination of four-drug regime effectiveness of Amoxicillin, Tetracycline, Omeprazole and Bismuth in eradicating Helicobacter pylori in patients with dyspepsia

Abstract

Introduction Helicobacter pylori is one of the most common human infections and about half of the world’s populations carry this microorganism. Mentioned bacteria are difficult to treat, and successful treatment requires prescription of combining two or more antibiotics. The most effective treatment regime can be seen in Iranian studies, four-drug regimes were based on Clarithromycin or Furazolidone. Instead of this, as regard to common side effects of the Furazolidone and the high cost of Clarithromycin and tendency of Iranian physicians to Metronidazole that have great resistance, as well as low resistance and side effect reported to tetracycline and amoxicillin, hence we intended to carry out this drug regime in a group of Iranian patients with H pylori-positive dyspepsia. Materials and Methods This clinical trial study carried out on 188 patients with dyspepsia complaints were referred to the clinic of Imam Khomeini Hospital in Ardabil. Patients were enrolled after the diagnosis of infection (Pathology and RUT). During 14 days was prescribed daily four-drug regime of tetracycline (1000mg), bismuth subcitrate (498mg), amoxicillin (2000mg) and Pantoprazole (40 mg BD). Patients received maintenance treatment with Pantoprazole (40 mg BD) during 4 weeks and 2 weeks after discontinuation; all patients underwent Urea Breath Test (UBT) with carbon-13. Patients were requested to inform significant side effects to the doctor. Data were analyzed by statistical software SPSS v16. Results Among 188 patients, 74 )39.4%) and 114 patients (60.6%) were men and female; respectively and the age average was 42.59±12.32 years. Before administration, endoscopic gastritis was most common between 148 patients (78.72%) who underwent endoscopic findings. 185 patients (98.5%) completed the study whereas 3 patients (1.5%) left the treatment period due to severe abdominal pain and headache. Intolerable side effects were observed in 15 patients that nausea was common. Successful eradication of infection was observed in 170 patients (91.89%), and percentage of eradication was calculated by analyzing 91.89% per protocol and 90.42 % intention to treat. Conclusion This study showed that four-drug regime with a high eradication rate, low cost and side effects can be used as a first-line regime in eradicating the infection