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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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Project description:ObjectiveTo assess the effects and safety of berberine combined with triple therapy on Helicobacter pylori (H. pylori) eradication in adults.MethodsPubMed, MEDLINE, EMBASE, Cochrane Library, and Chinese databases including China National Knowledge Infrastructure (CNKI), Wanfang data, Chinese Technology Journal Full-text Database (VIP), and China biomedical literature database (CBM) were searched to obtain the eligible studies published up to October 10, 2017. The primary outcome was eradication rate of H. pylori. The secondary outcome was incidence of adverse effects. Data analysis was conducted by RevMan5.2 and Stata V.9.0 software. Trial sequential analysis (TSA) was performed to assess the risk of random error and the validity of conclusion with TSA program version 0.9 beta.ResultsThe meta-analysis results indicated berberine combined with triple therapy could improve the eradication rates of H. pylori (urea breath test subgroup: RR=1.18, 95%CI=(1.12,1.24), P < 0.00001, biopsy subgroup: RR=1.23, 95%CI=(1.13,1.34), P < 0.00001) and reduce the total occurrence of adverse effects (OR=0.59, 95%CI(0.46, 0.75), P < 0.0001) when compared with only using triple therapy. Besides, the incidence of nausea (OR=0.59, 95%CI(0.41, 0.86), P < 0.05) and diarrhea (OR=0.41, 95%CI(0.24, 0.71) was remarkably lower in experimental group while that of abdominal distention (OR=0.64, 95%CI(0.40,1.04), P > 0.05) and vomiting (OR=0.65, 95%CI(0.37, 1.15), P > 0.05) had no significant change. TSA of H. pylori eradication rates and adverse effects incidence illustrated that the cumulative value of Z-curve went across the conventional boundary value, trial sequential monitoring boundary for benefit, and required information size, suggesting the results were stable.ConclusionEvidence from meta-analysis suggested that berberine combined with triple therapy can be an option for increasing H. pylori eradication rates and reducing overall therapy-related adverse effects incidence, particularly nausea and diarrhea, whereas more randomized controlled trials designed according to CONSORT statement are demanded to support the efficacy in further studies.

Dataset Information

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

Publications

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.

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