PMID- 38463026 OWN - NLM STAT- MEDLINE DCOM- 20240312 LR - 20240312 IS - 2219-2840 (Electronic) IS - 1007-9327 (Print) IS - 1007-9327 (Linking) VI - 30 IP - 6 DP - 2024 Feb 14 TI - Optimized sequential therapy vs 10- and 14-d concomitant therapy for eradicating Helicobacter pylori: A randomized clinical trial. PG - 556-564 LID - 10.3748/wjg.v30.i6.556 [doi] AB - BACKGROUND: A cure for Helicobacter pylori (H. pylori) remains a problem of global concern. The prevalence of antimicrobial resistance is widely rising and becoming a challenging issue worldwide. Optimizing sequential therapy seems to be one of the most attractive strategies in terms of efficacy, tolerability and cost. The most common sequential therapy consists of a dual therapy [proton-pump inhibitors (PPIs) and amoxicillin] for the first period (5 to 7 d), followed by a triple therapy for the second period (PPI, clarithromycin and metronidazole). PPIs play a key role in maintaining a gastric pH at a level that allows an optimal efficacy of antibiotics, hence the idea of using new generation molecules. AIM: To compare an optimized sequential therapy with the standard non-bismuth quadruple therapies of 10 and 14 d, in terms of efficacy, incidence of adverse effects (AEs) and cost. METHODS: This open-label prospective study randomized 328 patients with confirmed H. pylori infection into three groups (1:1:1): The first group received quadruple therapy consisting of twice-daily (bid) omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for 10 d (QT-10), the second group received a 14 d quadruple therapy following the same regimen (QT-14), and the third group received an optimized sequential therapy consisting of bid rabeprazole 20 mg plus amoxicillin 1 g for 7 d, followed by bid rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg for the next 7 d (OST-14). AEs were recorded throughout the study, and the H. pylori eradication rate was determined 4 to 6 wk after the end of treatment, using the 13C urea breath test. RESULTS: In the intention-to-treat and per-protocol analysis, the eradication rate was higher in the OST-14 group compared to the QT-10 group: (93.5%, 85.5% P = 0.04) and (96.2%, 89.5% P = 0.03) respectively. However, there was no statistically significant difference in eradication rates between the OST-14 and QT-14 groups: (93.5%, 91.8% P = 0.34) and (96.2%, 94.4% P = 0.35), respectively. The overall incidence of AEs was significantly lower in the OST-14 group (P = 0.01). Furthermore, OST-14 was the most cost-effective among the three groups. CONCLUSION: The optimized 14-d sequential therapy is a safe and effective alternative. Its eradication rate is comparable to that of the 14-d concomitant therapy while causing fewer AEs and allowing a gain in terms of cost. CI - (c)The Author(s) 2024. Published by Baishideng Publishing Group Inc. All rights reserved. FAU - Seddik, Hassan AU - Seddik H AD - Department of Gastroenterology II, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco. AD - Department of Gastroenterology, Mohammed V University in Rabat, Rabat 10100, Morocco. FAU - Benass, Jihane AU - Benass J AD - Department of Gastroenterology II, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco. AD - Department of Gastroenterology, Mohammed V University in Rabat, Rabat 10100, Morocco. jihane.benass@gmail.com. FAU - Berrag, Sanaa AU - Berrag S AD - Department of Gastroenterology, Mohammed V University in Rabat, Rabat 10100, Morocco. AD - Department of Gastroenterology I, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco. FAU - Sair, Asmae AU - Sair A AD - Department of Gastroenterology II, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco. AD - Department of Gastroenterology, Mohammed V University in Rabat, Rabat 10100, Morocco. FAU - Berraida, Reda AU - Berraida R AD - Department of Gastroenterology II, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco. AD - Department of Gastroenterology, Mohammed V University in Rabat, Rabat 10100, Morocco. FAU - Boutallaka, Hanae AU - Boutallaka H AD - Department of Gastroenterology II, Mohammed V Military Teaching Hospital of Rabat, Rabat 10100, Morocco. AD - Department of Gastroenterology, Mohammed V University in Rabat, Rabat 10100, Morocco. LA - eng PT - Clinical Trial PT - Randomized Controlled Trial PL - United States TA - World J Gastroenterol JT - World journal of gastroenterology JID - 100883448 RN - 140QMO216E (Metronidazole) RN - H1250JIK0A (Clarithromycin) RN - 32828355LL (Rabeprazole) RN - 0 (Anti-Bacterial Agents) RN - 804826J2HU (Amoxicillin) RN - 0 (Proton Pump Inhibitors) SB - IM MH - Humans MH - Metronidazole/adverse effects MH - Clarithromycin/adverse effects MH - *Helicobacter pylori MH - Rabeprazole/adverse effects MH - Prospective Studies MH - Drug Therapy, Combination MH - Anti-Bacterial Agents/adverse effects MH - *Helicobacter Infections/diagnosis/drug therapy MH - Amoxicillin/adverse effects MH - Proton Pump Inhibitors/adverse effects PMC - PMC10921140 OTO - NOTNLM OT - Helicobacter pylori OT - Optimization OT - Proton-pump inhibitor OT - Quadruple therapy OT - Sequential COIS- Conflict-of-interest statement: The authors report having no relevant conflicts of interest for this article. EDAT- 2024/03/11 06:43 MHDA- 2024/03/12 06:42 PMCR- 2024/02/14 CRDT- 2024/03/11 04:15 PHST- 2023/10/06 00:00 [received] PHST- 2023/11/26 00:00 [revised] PHST- 2023/12/29 00:00 [accepted] PHST- 2024/03/12 06:42 [medline] PHST- 2024/03/11 06:43 [pubmed] PHST- 2024/03/11 04:15 [entrez] PHST- 2024/02/14 00:00 [pmc-release] AID - 10.3748/wjg.v30.i6.556 [doi] PST - ppublish SO - World J Gastroenterol. 2024 Feb 14;30(6):556-564. doi: 10.3748/wjg.v30.i6.556.