American Journal of Gastroenterology ISSN 0002-9270 C  2005 by Am. Coll. of Gastroenterology doi: 10.1111/j.1572-0241.2005.50019.x Published by Blackwell Publishing Seven versus Ten Days of Rabeprazole Triple Therapy for Helicobacter pylori Eradication: A Multicenter Randomized Trial X. Calvet, M.D., 1 J. Ducons, M.D., 2 L. Bujanda, M.D., 3 F. Bory, M.D., 4 A. Montserrat, M.D., 1 and J.P.Gisbert, M.D., 5 on behalf of the Hp Study Group of the Asociaci ´ on Espa ˜ nola de Gastroenterolog´ ıa 1 Digestive Diseases Unit, Hospital de Sabadell, Barcelona, Spain; 2 Gastroenterology Unit, Hospital de San Jorge, Huesca, Spain; 3 Gastroenterology Department, Hospital Donosti, San Sebasti´ an, Spain; 4 Gastroenterology Department, Hospital del Mar, Barcelona, Spain; and 5 Gastroenterology Department, Hospital de la Princesa, Madrid, Spain BACKGROUND: Ten-day triple therapy is somewhat more effective than 7-day treatment for curing Helicobacter pylori infection. Recent studies have suggested that rabeprazole—a proton pump inhibitor with fast onset of acid inhibition—could raise the efficacy of 7-day therapies to the levels obtained with 10-day treatment. OBJECTIVE: To compare the efficacy of 7- and 10-day rabeprazole-based triple therapy for H. pylori eradication. PATIENTS Four hundred and fifty-eight patients were randomized to 7 or 10 days of triple therapy, including AND METHODS: rabeprazole 20 mg, clarithromycin 500 mg, and amoxicillin 1 g, all twice a day. Cure rates were evaluated by urea breath test. RESULTS: Two hundred and thirty-seven patients received 7-day and 221 received 10-day therapy. Groups were comparable in terms of demographic variables. Intention to treat cure rates were 73.8% (95% CI: 67–79%) for 7-day and 79.6% (95%: CI:74–85%) for 10-day therapy (p = 0.09). Per-protocol cure rates were 81.8% (95% CI:76–o86%) and 89.3% (95% CI: 84–93%), p = 0.02, respectively. Cure rates were similar in peptic ulcer patients but in subjects without ulcer they were clearly lower for 7-day therapy: 66% versus 77% by intention to treat (p = 0.08) and 73% versus 91% in the per-protocol analysis (p = 0.004). Side effects and compliance in the two groups were comparable. CONCLUSIONS: Seven- and 10-day triple therapies seem equally efficient in peptic ulcer patients. In contrast, 7-day therapy is significantly less effective in nonulcer dyspepsia patients. Ten-day therapy, therefore, seems preferable when treating nonulcer patients. (Am J Gastroenterol 2005;100:1696–1701) INTRODUCTION Although triple therapy combining a proton pump inhibitor and two antibiotics is the standard care for Helicobacter py- lori infection treatment, the ideal length of therapy has been a matter of debate for several years. The most frequently rec- ommended length of treatment in Europe is 1 wk (1, 2). In contrast, in the United States, 10–14 day treatment is rec- ommended because the results of 7-day therapies are incon- sistent (3–6). In a previous metaanalysis, we observed that lengthening triple therapy slightly enhanced cure rates; im- provement was 3–6% when therapy was increased from 7 to 10 days and 2–4% when increased from 10 to 14 days. The improvements in cure rates reached statistical significance only in the comparison of 7- and 14-day therapies (7). A later cost-effectiveness analysis of the two therapies favored the 7-day regimen (8). However, other aspects have emerged since these studies were published, that have aroused controversy. First, some studies have suggested that short treatment regimens may be effective in patients with ulcer disease, but that eradication rates may be lower in patients with H. pylori infection with- out ulcer disease and that these patients may require longer courses of therapy (9–11). Since current guidelines recom- mend noninvasive testing and argue against the use of en- doscopy to treat dyspeptic patients (1, 5, 6, 12–14), the un- derlying disease (peptic ulcer disease or nonulcer dyspepsia) is frequently unknown and the treatment cannot be tailored accordingly. Second, some proton pump inhibitors such as rabeprazole have proved more effective than omeprazole in inhibiting acid secretion in the first days of treatment (15–17). It has been hypothesized that this rapid onset of action means that shorter regimens may be possible (18). In fact, a recent paper 1696