Sequential therapy for 10 days versus triple therapy for 14 days in the eradication ofHelicobacter pyloriin the community and hospital populations: a randomised trial

Abstract

ObjectiveSignificant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies.DesignWe conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test.ResultsThe eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism.ConclusionsS10 was not superior to T14 in areas with low clarithromycin resistance.Trial registration numberNCT01607918.

Screening and treating Helicobacter pylori infection for gastric cancer prevention on the population level

“…Asymptomatic carriers may be less likely to tolerate long and complex antimicrobial regimens. This is supported by our comparison between the community‐based and the hospital‐based studies in Taiwan . We found lower eradication rates from triple therapy for 14 days and sequential therapy for 10 days in the community population, even though they had a lower prevalence rate of antibiotic resistance strains.…”

“…In this program, the H. pylori antibiotic resistant pattern was investigated during 2012–2014, after two rounds of mass eradication. The results showed that the percentage of H. pylori strains resistant to clarithromycin, metronidazole, amoxicillin, and levofloxacin were 7.6%, 22.7%, 0.7%, and 3.9%, respectively . This is lower than the resistance rates from a hospital‐based study in Taiwan during the same period (11.5%, 28.6%, 1.3%, and 14.7%, respectively) and suggests that the routine retest‐and‐retreat practice limits the development of antibiotic‐resistant strains.…”

First-line therapies for Helicobacter pylori eradication: a critical reappraisal of updated guidelines

“…When considering only data from studies published in the last 5 years, the cure rate following sequential therapy was still 90-92.6% in 5 Italian studies with more than 1000 patients [26,38-41], and 73% in another study with 100 cases [42]. A similarly high success rate of sequential therapy has been observed in studies recently performed in Slovenia (94.2%) [43], Portugal (90%) [44], Belgium (90%) [3], Israel (95.9%) [45], Thailand (94%) [46], Taiwan (91.9%) [47], Singapore (90.3%) [48], and the United Arab Emirates (88.6%) [49], suggesting that this therapy is still effective in several countries. Based on these findings, Italian, Slovenian, or Portuguese physicians could inopportunely deprive their patients a priori of a still effective therapy by following the European guidelines.…”

Letter: could sequential therapy extended to 14 days replace prolonged triple regimens for Helicobacter pylori treatment? Authors' reply

“…[3][4][5] We did a systemic review of randomised control trials comparing 10 and 14 days as first-line treatment in adults, and identified four randomised trials comparing the efficacy of 10-day and 14/15-day sequential therapies. 4,[6][7][8] Meta-analysis of the four studies showed that 14/ 15-day sequential therapy was not significantly superior to 10-day sequential therapy [risk ratio 1.03, 95% confidence interval (CI) 0.96-1.12, P = 0.418; heterogeneity: Q = 4.2, I 2 = 28.6%, P = 0.241, Figure 1] using a random effects model.…”

“…However, the risk difference between 10 and 14 days might vary in regions with a different prevalence of antibiotic resistance. 4,5 The risk difference might be greater in regions with higher clarithromycin and higher metronidazole resistance and vice the versa. 4 For example, the predicted efficacy of 10 and 14 days would be 82.0% and 86.6%, respectively, in a region with clarithromycin resistance of 20% and metronidazole resistance of 40% according to our prediction model (http://hp-therapy.biomed.org.tw).…”