Background:Increasing Helicobacter pylori resistance has led to decreases in treatment effectiveness.Aim: To test the effectiveness of susceptibility-guided therapy vs a locally highly effective empiric modified bismuth quadruple therapy for first-line H pylori treatment in a region with high antimicrobial resistance. Methods:We compared 14-day susceptibility-guided with empiric therapy using a multicentre superiority-design trial, which randomised H pylori infected subjects 3:1 to (a) susceptibility-guided therapies contained esomeprazole 20 mg and amoxicillin 1 g b.d. plus clarithromycin 500 mg, metronidazole 400 mg b.d., or levofloxacin 500 mg daily for susceptible infections or bismuth 220 mg b.d. and metronidazole 400 mg q.d.s. for triple-resistant infections; (b) Empiric therapy contained esomeprazole 20 mg, bismuth 220 mg b.d., amoxicillin 1 g and metronidazole 400 mg t.d.s.Primary outcome was H pylori eradication. Results: Between February 2017 and March 2018, 491 subjects were screened and 382 were randomised. Both the susceptibility-guided and the empiric regimens were highly successful with per-protocol eradication rates of 97.7% (250/256) vs 97.6% (81/83, P = 1.00) and intent-to-treat eradication rates of 91.6% (262/286) vs 85.4%(82/96, P = 0.12). Overall, susceptibility-guided therapy was not superior to empiric therapy with 0.1% per-protocol (95% CI −3.1% to 3.2%) and 6.2% intent-to-treat (−0.3% to 12.7%) eradication difference. Both approaches had high adherence and low adverse event rates.Conclusions: Both susceptibility-guided and empiric therapies provided excellent eradication rates. Clinically, the choice would hinge on availability of susceptibility testing and/or a locally highly effective empiric therapy. S U PP O RTI N G I N FO R M ATI O NAdditional supporting information will be found online in the Supporting Information section at the end of the article.How to cite this article: Chen Q, Long X, Ji Y, et al.Randomised controlled trial: susceptibility-guided therapy versus empiric bismuth quadruple therapy for first-line Helicobacter pylori treatment. Aliment Pharmacol Ther.

Background A reliably highly effective high‐dose proton‐pump inhibitor plus amoxicillin (dual Helicobacter pylori therapy) has remained elusive. We compared whether the addition of bismuth to high‐dose dual therapy would improve the efficacy of high‐dose dual therapy as first‐line treatment. Methods This was an open‐label, randomized single‐center study of 160 treatment‐naive patients with H. pylori infection who were randomly assigned to 14‐day therapy with esomeprazole 40 mg twice a day plus amoxicillin 1 g three times a day with or without bismuth potassium citrate 600 mg (elemental bismuth 220 mg) twice a day. Antibiotic resistance was determined by agar dilution method and eradication by 13C‐urea breath test. Results The per‐protocol eradication rates were 96.1%; 95% CI = 88.9%‐99.2% (73/76) without bismuth vs 93.3%; 95% CI = 85.1%‐97.8% (70/75) with bismuth (P = 0.494). The intention‐to‐treat eradication rates were 92.5%; 95% CI = 84.4%‐97.2% (74/80) without bismuth and 88.8%; 95% CI = 79.7%‐94.7% (71/80) with bismuth (P = 0.416). Resistance to amoxicillin, clarithromycin, metronidazole, and levofloxacin was 0%, 31.7%, 81.4%, and 40.7%, respectively. Smoking reduced treatment effectiveness limited to those not receiving bismuth. The per‐protocol eradication rates were 70% (7/10) vs 100% (66/66) in smokers vs non‐smokers without bismuth (P = 0.002), and 100% (10/10) in smokers vs 92.3% (60/65) in non‐smokers with bismuth (P = 1.0). The adverse event rates were 7.5% (6/80) without bismuth vs 11.3% (9/80) with bismuth (P = 0.416). Conclusions Fourteen‐day high‐dose dual therapy was both effective and safe for first‐line treatment in a region of high prevalence antibiotic resistance. Adding bismuth only improved treatment effectiveness among smokers.

This prospective trial demonstrated that while high-dose metronidazole could not completely overcome metronidazole resistance, bismuth was additive and improved the overall cure rates by 21%-26%.

Background The high prevalence of Helicobacter pylori (H pylori) infection in China results in a substantial public health burden. Medical experts have not agreed on the best solution of population intervention for this problem. We presented a health economic evaluation of a population‐based H pylori screen‐and‐treat strategy for preventing gastric cancer, peptic ulcer disease (PUD), and nonulcer dyspepsia (NUD). Materials and Methods Decision trees and Markov models were developed to evaluate the cost‐effectiveness of H pylori screening followed by eradication treatment in asymptomatic Chinese. The modeled screen‐and‐treat strategy reduced the risk of gastric cancer, PUD, and NUD. The main outcomes were the costs, effectiveness, and the incremental cost‐effectiveness ratio. Uncertainty was explored by one‐way and probabilistic sensitivity analyses. Results For preventing gastric cancer, PUD, and NUD together in a cohort of 10 million asymptomatic Chinese at the age of 20 years, the H pylori screen‐and‐treat strategy saved 288.1 million dollars, 28 989 life years, and 111 663 quality‐adjusted life years, and prevented 11 611 gastric cancers, 5422 deaths from gastric cancer, and 1854 deaths from PUD during life expectancy. Uncertainty of screening age from 20 to 60 did not affect the superiority of the screen‐and‐treat strategy over the no‐screen strategy. The one‐way and probabilistic sensitivity analyses confirmed the robustness of our study's results. Conclusions Compared with the no‐screen strategy, population‐based screen‐and‐treat strategy for H pylori infection proved cheaper and more effective for preventing gastric cancer, PUD, and NUD in Chinese asymptomatic general population.

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Background The Helicobacter pylori (H. pylori) infection‐related diseases, peptic ulcer, and gastric cancer are frequently asymptomatic until the onset of complications. This study aimed to investigate the prevalence of H. pylori, erosive esophagitis, peptic ulcer, and precancerous lesions such as atrophic gastritis, intestinal metaplasia, gastric dysplasia, and upper gastrointestinal (GI) malignancy in asymptomatic Chinese. Methods From January to December 2017, a questionnaire was administered to consecutive asymptomatic patients undergoing routine physical examination, which included their first screening esophagogastroduodenoscopy. H. pylori infection was determined by one of positive 13C urea breath tests or rapid urease test and histology. The presence of H. pylori infection, erosive esophagitis, peptic ulcer, precancerous gastric histology, and upper GI malignancy was analyzed in relation to demographic factors. Results A total of 1108 subjects (mean age: 48, range 21 to 79, 39.5% men) were included. The findings were: erosive esophagitis 7.8%, active H. pylori infection 44%, peptic ulcer 9.1% (duodenal 5.8%, gastric 2.5% or both 0.8%); 0.5% had gastric cancer. Male, smoking history, and current H. pylori infection were all significantly related to the presence of peptic ulcer. Totally, 1095 patients had gastric histopathology and premalignant gastric lesions were present in 67.4%; atrophic gastritis (67.4%), intestinal metaplasia (27.4%), and gastric dysplasia (0.5%). Age, current and previous H. pylori infection were risk factors significantly associated with precancerous lesions. Conclusions Upper GI pathology as a sequelae of H. pylori infection is common in asymptomatic Chinese. These findings support institution of a nationwide test and treat program to eradicate H. pylori in China.

Background: Empirical therapy of Helicobacter pylori frequently results in treatment failure due to unrecognized antimicrobial resistance. The aim of this study was to investigate the effectiveness of susceptibility-guided therapy for rescue treatment of H. pylori infection in China. Methods: This was a prospective study of consecutive 200 patients infected with H. pylori with one or more treatment failures. The therapy chosen was susceptibility based using the most effective, best-tolerated regimens first and a locally proven, reliably effective regimen for multidrug-resistant infections. All patients received 14-day triple therapy, i.e. esomeprazole 20 mg and amoxicillin 1 g twice a day plus clarithromycin 500 mg twice a day, metronidazole 400 mg twice a day, or levofloxacin 500 mg daily, or, for multidrug-resistant infections, amoxicillin-containing bismuth quadruple therapy with esomeprazole 20 mg twice a day, bismuth 220 mg twice a day, amoxicillin 1 g three times a day, and metronidazole 400 mg four times a day. Antibiotic resistance was determined by agar dilution. Results: The eradication rate of susceptibility-guided therapy overall was 94.5% (189/200, 95% confidence interval: 90.4–97.2%). Around 28% (56/200) of patients carried strains susceptible to one of the tested antibiotics and were prescribed the triple therapy. A total of 144 multidrug-resistant patients received bismuth quadruple therapy. The eradication rates were all greater than 90%, i.e. 91.7% (11/12), 92.3% (12/13), and 93.5% (29/31) in those who received clarithromycin, metronidazole, and levofloxacin-containing triple therapy and 95.1% (137/144) for the bismuth quadruple therapy. There were no differences in eradication rates between the subgroups. Conclusions: Although susceptibility-guided therapy proved high efficacious despite the high proportion of multidrug-resistant strains, the strategy suggested the best approach for this population would be empirical amoxicillin-containing bismuth quadruple therapy. ClinicalTrials.gov identifier: NCT03413020.