Reduced symptoms and need for antisecretory therapy in veterans 3 years after Helicobacter pylori eradication with ranitidine bismuth citrate/amoxicillin/clarithromycin

OBJECTIVE: The most effective combination therapy to eradicate Helicobacter pylori has not yet been found. The perfect combination would be effective, relatively free of side effects, and easy to comply with. We studied a 14- day course of three medications taken twice daily by H. pylori-infected pat ients who were enrolled in the outpatient Veterans Affairs (VA) clinics. Th e two major objectives were 1) to determine the effectiveness of the combin ation therapy and 2) to determine the compliance of patients in a VA popula tion. METHODS: Fifty-two male patients were identified with H. pylori infection b y positive CLO (Rapid Urease Test) test, positive Giemsa stain, or positive serology. Active infection was confirmed by a positive C-13 urea breath te st (UBT). Patients were treated for 14 days with open-label triple-combinat ion therapy of ranitidine bismuth citrate (RBC; 400 mg b.i.d.), amoxicillin (1000 mg b.i.d.), and clarithromycin (500 mg b.i.d.). Successful eradicati on of H. pylori was confirmed by repeat UBT at 6-8 wk after the final dose of therapy. RESULTS: Of the 52 enrolled patients, 49 (94.2%) met the criteria for succe ssful completion of the study (par protocol analysis based on compliance wi th at least 80% of medication and performance of both UBTs). Of the three p atients who did not successfully complete, one was cured (after 6 days of t reatment), and two remained infected (after 3 days and 9 days of treatment) . Of the 49 completed patients, 45 (91.8%) were cured, and four remained in fected. Overall, regardless of compliance (intent-to-treat analysis)? 46 of the 52 (88.4%) patients had documented cure of H. pylori infection as dete rmined by the posttreatment UBT. By 3 yr after H. pylori eradication, two o f 15 (13.3%) patients who were not on baseline medications had developed th e need for antisecretory therapy, but 18 of 31 (58.1%) who were on baseline medications were able to stop therapy. Thus, at 3 yr, successful H. pylori eradication decreased the need for antisecretory therapy from 67.4% of the H. pylori-infected population to 43% of the PI. pylori-eradicated populati on. The effect of H. pylori eradication in improving symptoms at 3 yr was s tatistically significant in both the ulcer population and the nonulcer popu lation. Adverse events were mild, and included diarrhea (26 patients), bad taste in mouth (24 patients), nausea/upset stomach (nine patients), and hea dache (two patients). The diarrhea was self-limiting in 25 of the 26 patien ts. Only two patients discontinued medication because of adverse events. CONCLUSION: The RBC/amoxicillin/clarithromycin combination was, in our VA p opulation, an easily complied with, highly effective, and safe triple thera py with a 90% PI. pylori eradication rate. Successful eradication of Ii. py lori leads to a dramatic decrease in upper-gut symptoms and decreased need for antisecretory therapy. (C) 2001 by Am. Cell. of Gastroenterology.