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

Chieh-Chang Chen, Jiing-Chyuan Luo, Yu-Jen Fang, Ji-Yuh Lee, Chia-Chi Kuo, Tsung-Hua Yang, Min-Chin Chiu, Jian-Jyun Yu, Ming-Jong Bair, Po-Yueh Chen, Chu-Kuang Chou, Chi-Yi Chen, Chi-Yang Chang, Yao-Chun Hsu, Cheng-Hao Tseng, Wen-Feng Hsu, Wen-Hao Hu, Min-Horn Tsai, Cheng-Lin Hsieh, Mei-Jyh Chen, Chia-Tung Shun, Tzeng-Ying Liu, Yi-Chia Lee, Jyh-Ming Liou, Ming-Shiang Wu, and for the Taiwan Gastrointestinal Disease and Helicobacter Consortium, Chieh-Chang Chen, Jiing-Chyuan Luo, Yu-Jen Fang, Ji-Yuh Lee, Chia-Chi Kuo, Tsung-Hua Yang, Min-Chin Chiu, Jian-Jyun Yu, Ming-Jong Bair, Po-Yueh Chen, Chu-Kuang Chou, Chi-Yi Chen, Chi-Yang Chang, Yao-Chun Hsu, Cheng-Hao Tseng, Wen-Feng Hsu, Wen-Hao Hu, Min-Horn Tsai, Cheng-Lin Hsieh, Mei-Jyh Chen, Chia-Tung Shun, Tzeng-Ying Liu, Yi-Chia Lee, Jyh-Ming Liou, Ming-Shiang Wu, and for the Taiwan Gastrointestinal Disease and Helicobacter Consortium

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].

Keywords: Helicobacter pylori; N-acetylcysteine; community setting; dexlansoprazole; eradication; triple therapy.

Conflict of interest statement

Conflict of interest statement: The authors declare that there is no conflict of interest.

© The Author(s), 2020.

Figures

Figure 1.
Figure 1.
Study flow diagram. ITT, intention to treat; NAC-T14, N-acetylcysteine with adjunctive triple therapy for 14 days; PP, per protocol; T14, triple therapy alone for 14 days.

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