PMID- 16684262 OWN - NLM STAT- MEDLINE DCOM- 20060712 LR - 20131121 IS - 1083-4389 (Print) IS - 1083-4389 (Linking) VI - 11 IP - 3 DP - 2006 Jun TI - Efficacy of metronidazole as second-line drug for the treatment of Helicobacter pylori Infection in the Japanese population: a multicenter study in the Tokyo Metropolitan Area. PG - 152-8 AB - BACKGROUND: With the increase in the frequency of clarithromycin-resistant Helicobacter pylori (H. pylori), there is rising concern about the decline of the eradication rate of this infection following treatment. The Tokyo Hp Study Group examined the eradication rate in response to a second-line regimen consisting of proton pump inhibitor (PPI), amoxicillin, and metronidazole by conducting a multicenter study in the Tokyo Metropolitan Area. MATERIALS AND METHODS: Two hundred and twenty-eight patients with H. pylori infection, in whom the first-line therapy with a PPI, amoxicillin, and clarithromycin administered for 1 week had failed to eradicate the infection, were enrolled in this study. These cases were randomly assigned to one of the two second-line regimens containing metronidazole (PPI/AM500 or PPI/AM750) administered for 1 week. 13C-urea breath test was performed as a diagnostic method test for H. pylori infection not earlier than 8 weeks after the second-line therapy. RESULTS: Intention-to-treat (ITT) and per-protocol (PP) analyses revealed an eradication rate of 87.6 and 90.6%, respectively, following PPI/AM500 treatment, and 86.9 and 88.6%, respectively, following PPI/AM750 treatment. Neither analysis revealed any significant difference in the eradication rate between PPI/AM500 and PPI/AM750 (p = .876 and .621, respectively). According to ITT and PP analyses, the eradication rates following treatment with PPI/AM500 were 85.2 and 88.5% with the use of lansoprazole, 62.5 and 62.5% with the use of omeprazole, and 93.2 and 96.5% with the use of rabeprazole, respectively. There was a significant difference in the eradication rates between PPI (omeprazole)/AM500 and PPI (rabeprazole)/AM500. In the case of PPI/AM750, the corresponding eradication rates were 84.8 and 87.0% with the use of lansoprazole, 92.9 and 92.9% with the use of omeprazole, and 92.9 and 92.9% with the use of rabeprazole, respectively. There were no significant differences in the eradication rates obtained with the use of the three PPIs. CONCLUSIONS: Both PPI/AM500 and PPI/AM750 administered for 1 week appeared to be highly effective second-line regimens for the treatment of H. pylori infection in Japanese patients. From the viewpoint of adverse events, PPI/AM500 appeared to be safe compared with PPI/AM750. FAU - Matsuhisa, Takeshi AU - Matsuhisa T AD - Tokyo Hp Study Group, Division of Gastroenterology, National Hospital Organization, Tokyo Medical Center, 2-5-1 Higashigaoka, Meguro-ku, Tokyo 152-8902 [corrected] Japan. matuhisa@nms.ac.jp FAU - Kawai, Takashi AU - Kawai T FAU - Masaoka, Tatsuhiro AU - Masaoka T FAU - Suzuki, Hidekazu AU - Suzuki H FAU - Ito, Masayoshi AU - Ito M FAU - Kawamura, Yo AU - Kawamura Y FAU - Tokunaga, Kengo AU - Tokunaga K FAU - Suzuki, Masayuki AU - Suzuki M FAU - Mine, Tetsuya AU - Mine T FAU - Takahashi, Shin-ichi AU - Takahashi S FAU - Sakaki, Nobuhiro AU - Sakaki N LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - England TA - Helicobacter JT - Helicobacter JID - 9605411 RN - 0 (Anti-Bacterial Agents) RN - 0 (Anti-Ulcer Agents) RN - 0 (Proton Pump Inhibitors) RN - 140QMO216E (Metronidazole) RN - 804826J2HU (Amoxicillin) SB - IM EIN - Helicobacter. 2006 Aug;11(4):306 MH - Adult MH - Aged MH - Amoxicillin/administration & dosage/adverse effects/therapeutic use MH - Anti-Bacterial Agents/administration & dosage/adverse effects/*therapeutic use MH - Anti-Ulcer Agents/administration & dosage/therapeutic use MH - Drug Administration Schedule MH - Drug Therapy, Combination MH - Female MH - Helicobacter Infections/*drug therapy/microbiology MH - Helicobacter pylori/*drug effects MH - Humans MH - Male MH - Metronidazole/administration & dosage/adverse effects/*therapeutic use MH - Middle Aged MH - Proton Pump Inhibitors MH - Retreatment MH - Tokyo MH - Treatment Outcome EDAT- 2006/05/11 09:00 MHDA- 2006/07/13 09:00 CRDT- 2006/05/11 09:00 PHST- 2006/05/11 09:00 [pubmed] PHST- 2006/07/13 09:00 [medline] PHST- 2006/05/11 09:00 [entrez] AID - HEL394 [pii] AID - 10.1111/j.1523-5378.2006.00394.x [doi] PST - ppublish SO - Helicobacter. 2006 Jun;11(3):152-8. doi: 10.1111/j.1523-5378.2006.00394.x.