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Comparison of the effect of clarithromycin triple therapy with or without N-acetylcysteine in the eradication of Helicobacter pylori: a randomized controlled trial.

ABSTRACT:

Background

Whether adjunctive N-acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of Helicobacter pylori infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of H. pylori.

Material and methods

Between 1 January 2014 and 30 June 2018, 680 patients with H. pylori infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC [NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d.] for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and CYP2C19 gene polymorphism were determined.

Results

The ITT analysis demonstrated H. pylori eradication rates in NAC-T14 and T14 were 81.7% [276/338, 95% confidence interval (CI): 77.5-85.8%] and 84.3% (285/338, 95% CI 80.4-88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by CYP2C19 polymorphism.

Conclusion

Add-on NAC to triple therapy was not superior to triple therapy alone for first-line H. pylori eradication [ClinicalTrials.gov identifier: NCT02249546].

SUBMITTER: Chen CC

PROVIDER: S-EPMC7406927 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Comparison of the effect of clarithromycin triple therapy with or without <i>N</i>-acetylcysteine in the eradication of <i>Helicobacter pylori</i>: a randomized controlled trial.

Chen Chieh-Chang CC Luo Jiing-Chyuan JC Fang Yu-Jen YJ Lee Ji-Yuh JY Kuo Chia-Chi CC Yang Tsung-Hua TH Chiu Min-Chin MC Yu Jian-Jyun JJ Bair Ming-Jong MJ Chen Po-Yueh PY Chou Chu-Kuang CK Chen Chi-Yi CY Chang Chi-Yang CY Hsu Yao-Chun YC Tseng Cheng-Hao CH Hsu Wen-Feng WF Hu Wen-Hao WH Tsai Min-Horn MH Hsieh Cheng-Lin CL Chen Mei-Jyh MJ Shun Chia-Tung CT Liu Tzeng-Ying TY Lee Yi-Chia YC Liou Jyh-Ming JM Wu Ming-Shiang MS

Therapeutic advances in gastroenterology 20200731

<h4>Background</h4>Whether adjunctive <i>N</i>-acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of <i>Helicobacter pylori</i> infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of <i>H. pylori</i>.<h4>Material and methods</h4>Between 1 January 2014 and 30 June 2018, 680 patients with <i>H. pylori</i> infection naïve to treatment were enrolled in this multicenter, open- ...[more]

PMID: 32821287

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