Are twelve days of omeprazole, amoxicillin and clarithromycin better than six days for treating H-pylori infection in peptic ulcer and in non-ulcer dyspepsia?

Background/Aims: To evaluate whether omeprazole, amoxicillin and clarithrom ycin for 12 days is more effective for Helicobacter pylori eradication than the same regimen for only 6 days; and to verify whether these eradication regimens are more effective in peptic ulcer disease than in non-ulcer dyspe psia. Methodology: We studied 411 patients in whom a gastroscopy was carried out due to symptoms related to the upper gastrointestinal tract and who were di agnosed with duodenal ulcer (175 patients, 43%), gastric ulcer (42 patients , 10%, or non-ulcer dyspepsia (194 patients, 47%), and concomitant infectio n by H. pylori. At endoscopy, biopsies were obtained for rapid urease test, and a C-13-urea breath test was carried out. Urea breath test was repeated four weeks after completing eradication treatment with 1) omeprazole (20mg b.i.d.), amoxicillin (1g b.i.d.) and clarithromycin (500mg b.i.d.) for six days (239 patients), or 2) the same regimen for 12 days (172 patients). Results: H. pylori eradication was achieved in 73.6% (95% Cl, 68-79%) of th e patients treated during 6 days, and in 84.3% (79-90%) of those receiving 12 days of therapy (P < 0.01). The overall eradication rate with both regim ens (6 plus 12 days), respectively in patients with duodenal ulcer, gastric Weer and non-Weer dyspepsia, was 84.6% (79-90%), 75.6% (61-86%), and 72.8% (67-79%) (P < 0.01 when comparing duodenal ulcer vs. non-ulcer dyspepsia). Twelve-day regimen was more effective than 6-day regimen only in non-ulcer dyspepsia (62% vs. 83%, P < 0.01), but not in duodenal or gastric ulcer. I n the multivariate analysis the duration (6 vs. 12 days) of eradication the rapy (odds ratio: 2.2; 1.3-3.7) and the type of disease (duodenal ulcer vs. non-ulcer dyspepsia; odds ratio: 2.3; 1.3-3.8) were the only variables whi ch influenced on H. pylori eradication efficacy (<chi>(2) model, 17; P < 0. 001). Conclusions: Efficacy with omeprazole-amoxicillin-clarithromycin regimen in patients with duodenal ulcer is higher than in those patients with non-ulc er dyspepsia. The increase of H. pylori eradication rate by 21% in our non- ulcer dyspepsia patients justifies the prolongation from 6 to 12 days of om eprazole-amoxicillin-clarithromycin therapy, whilst the increase of cure ra tes in duodenal or gastric ulcer patients with a 12-day therapy would not b e cost-effective.