Modified quadruple therapy versus bismuth-containing quadruple therapy in first-line treatment of Helicobacter pylori infection in Korea; rationale and design of an open-label, multicenter, randomized controlled trial

Abstract

Background:Clarithromycin-containing triple regimen for eradication of Helicobacter pylori is no longer acceptable in Korea due to high clarithromycin resistance. Concomitant therapy or bismuth-containing quadruple therapy is recommended as an alternative regimen. A recent study in Korea has shown that modified quadruple therapy has comparable efficacy and safety to concomitant therapy as a first-line regimen. However, there has been no comparative study of modified quadruple therapy with bismuth-containing quadruple therapy. The aim of this study is to compare the efficacy and safety of modified quadruple therapy with those of bismuth-containing quadruple therapy as a first-line regimen and to present the phenotypic and genotypic antibiotic resistance profile of H pylori.Methods:This study is an open-label, multicenter, randomized controlled trial. We are recruiting subjects endoscopically diagnosed with H pylori infection from 2 hospitals in Korea. Subjects will be randomly allocated either to modified quadruple therapy (proton-pump inhibitor bid, amoxicillin 1 g bid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid daily) or bismuth-containing quadruple therapy (proton-pump inhibitor bid, tetracycline 500 mg qid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid daily) for 14 days. The rate of eradication success and adverse events will be checked at least 4 weeks after the treatment. Antibiotic resistance will be established using both a bacterial culture with agar dilutions and DNA sequencing of the clarithromycin resistance point mutations in the 23S rRNA gene of H pylori.Conclusion:The results of this study will provide solid evidence for determining the optimal treatment regimen for first-line H pylori eradication in Korea.

Nationwide antibiotic resistance mapping of Helicobacter pylori in Korea: A prospective multicenter study

“…Although it is not clear why this rate seems to have decreased, the high MIC point in our current histogram was 2 µm/mL, which compared very favorably with previous results (4 µm/mL in 1987, 32 µm/mL in 1994, and 64 µm/mL in 2003) . Bismuth‐based quadruple therapy including metronidazole is an accepted alternative treatment to clarithromycin‐based triple therapy for H. pylori in Korea as it has shown favorable outcomes in recent studies …”

“…10 Bismuth-based quadruple therapy including metronidazole is an accepted alternative treatment to clarithromycin-based triple therapy for H. pylori in Korea as it has shown favorable outcomes in recent studies. [24][25][26] We analyzed the MIC level of two quinolones in our present investigations, levofloxacin and ciprofloxacin, and a high H. pylori resistance rate to these antibiotics was found (37.0%). Previous studies on the quinolone resistance rate of H. pylori in Korea reported an increase and a corresponding shift to a higher value on the MIC histogram.…”

Amoxicillin or tetracycline in bismuth-containing quadruple therapy as first-line treatment for Helicobacter pylori infection

“…The detailed inclusion and exclusion criteria is described in the protocol of this trial. 17 Outcome measurement H. pylori infection was diagnosed using one or more of the following methods: rapid urease test, UBT, or histological examination. Two specimens from the gastric corpus and two specimens from the antrum were taken during endoscopy for the rapid urease test (Pronto Dry New®; Medical Instruments Corp., Herford, Germany) or histological assessment using Giemsa staining.…”

“…Delta over baseline >2.5‰ was considered positive. 17 All the subjects were educated about adverse events related to the eradication medications, and they were asked to submit self-reported questionnaires at the first visit (2 weeks after ending the eradication regimen) and at the second visit (6 weeks after enrollment). The severity of the adverse events was classified as 'mild' (transient and well-tolerated), 'moderate' (causing discomfort and partially interfering with daily activities), or 'severe' (causing considerable interference with daily activities).…”

Differentiated approach to eradication therapy in patients with chronic pancreatitis

“…Комплекс уреазы А, р26, р19, р17 ассоциировался с р33 у 38,1% больных с ХП и у 6,7% больных контрольной группы (χ2 13,83, р<0,01), а с р30 -у 44,4% больных с ХП и у 15,6% больных контрольной группы (χ2 10,00, р<0,01 В настоящее время в научных кругах активно обсуждаются висмутсодержащие схемы антихеликобактерной терапии [15,16,17]. Ряд авторов проводят рандомизированные исследования по эффективности различных висмутсодержащих схем в качестве терапии первой линии [18]. В проведенном нами исследовании элиминация H. pylori достигнута при эрадикации по протоколу ЭТ-1+ВТД у 92,6% больных, тогда как при использовании схемы ЭТ-1 -лишь у 77,8% больных (р<0,05).…”