A comparative study of eradication of H. pylori infection in dyspepsy patients using a low dose and a high dose triple therapy with clarithromycin, amoxicillin and Omeprazole

Background: Helicobacter Pylori is a major cause of diseases of the upper gastrointestinal tract. Having considered the high prevalence of the infection, an ideal regimen has been a matter of debate by the scientists for many years. This study evaluates the efficacy of the more tolerable regimens in the eradication of the bacteria and the effect of the treatment on the gastric symptoms.

Methods: This parallel randomized control trial study included 560 patients with dyspepsia admitted to Imam Reza hospital, Kermanshah University of Medical Sciences between 2006-2007. Patients who were identified with dyspepsia based on Rome II and were candidate for endoscopy were examined for H.pylori infection through rapid urease test and histology. Those proven positive were assigned at random to one of the two groups of high dose (Omeprazole 20mg, Clarithromycin 500 mg, and Amoxicillin 1000mg) and low dose (Omeprazole 20mg, clarithromycin 250 mg, Amoxicillin 500 mg) treatment regimens. They all went under treatment every 12 hours for a period of seven days. 4 weeks after the therapy, eradication success rate and gastric symptoms were evaluated using the same protocol. Side effects were recorded through a questionnaire.

Results: From the total of 560, 480 were proven positive for H. pylori (85.7%). Eradication success rate was the same for the two groups (87.5%). History of pyrosis before the treatment was statistically associated with eradication failure at the end of the treatment. Symptoms such as pyrosis were significantly reduced. General well being was also improved but the improvement was not statistically significant. Mild side effects were observed in 11% of high and 8% of low dose treatment regimens. However they were well tolerated and did not result in drug withdrawal.

Conclusion: Eradication success rate of one-week low dose treatment regimen was within the acceptable level. Eradication also reduced pyrosis episodes. Symptoms were improved even when the therapy did not result in eradication.