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Clinicians should use
dexlansoprazole-based triple therapy to eradicate H. pylori
as adding NAC does not have an additive effect.
A recent study illustrated that for the first-line management of Helicobacter pylori (H. pylori)- infected patients, adding N-acetylcysteine (NAC), a biofilm destabilizing agent in dexlansoprazole triple therapy did not portray superiority to the standard dexlansoprazole delayed release-based triple therapy.
For eliminating H. pylori, the empirical dexlansoprazole delayed release-based triple therapy for 14 days is well-tolerated and effective compared to the triple therapy using twice-daily proton-pump inhibitor (PPI).
Between 1 January 2014 and 30 June 2018, a randomized, multicenter, open-label analysis was carried out to comparatively evaluate the efficacy of 14-day triple therapy with or without NAC for managing H. pylori-infected subjects. Both community-based and hospital-based H. pylori-infected individuals naïve to treatment were actively recruited.
Overall, 680 participants were randomized to either N-acetylcysteine adjunctive triple therapy for 14 days (NAC-T14) arm [60 mg dexlansoprazole four times daily (q.d.); 1 g amoxicillin twice daily (b.i.d.), 500 mg clarithromycin b.i.d., 600 mg NAC b.i.d.] (n=340), or triple therapy alone for 14 days (T14) arm [60 mg dexlansoprazole q.d.; 1 g amoxicillin b.i.d., 500 mg clarithromycin b.i.d.) (n=340).
The eradication rates as per intention to treat (ITT) analysis was the primary outcome parameter. Compliance and the frequency of noxious effects were the secondary outcome parameters. The study also investigated CYP2C19 gene polymorphism and antibiotic resistance.
Considering the ITT analysis, the H. pylori eradication rates were more in the T14 group compared to the NAC-T14 group. In subjects who adhered to their assigned therapy (per-protocol [PP] analysis), the eradication rates were greater in the T14 group than the NAC-T14 group, as shown in the following table:
No vital differences were observed in adverse effects or compliance. The H.pylori eradication rates in participants with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains for NAC-T14 and for T14 is illustrated in the following table:
The CYP2C19 polymorphism did not affect the efficacy of NAC-T14 and T14. Thus, for the first-line treatment of H. pylori infection, NAC containing 14-day triple therapy is not better than standard 14-day triple therapy.
Therapeutic Advances in Gastroenterology
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 et al.
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