Susceptibility‐guided quadruple therapy is not superior to medication history‐guided therapy for the rescue treatment of Helicobacter pylori infection: A randomized controlled trial

Abstract

In this study we aimed to compare the efficacy and safety of two personalized rescue therapies for Helicobacter pylori infection. Methods: An open-label, single-center, randomized controlled trial was conducted. Patients who had failed one or two regimens for H. pylori infection were randomized to receive a 14-day bismuth-containing quadruple therapy guided by antimicrobial susceptibility testing (AST) or personal medication history (PMH). In the AST group, either two of amoxicillin, clarithromycin, metronidazole or levofloxacin were prescribed according to the AST. In the PMH group, amoxicillin plus either levofloxacin or furazolidone were prescribed based on the patient's history of quinolone use. The primary outcomes were eradication rates confirmed by an urea breath test 6 weeks after treatment. The secondary outcomes were adherence, incidence of adverse events (AE) and cost-effectiveness. Results: Altogether 164 with a positive culture received AST-guided therapy and 192 received PMH-guided therapy, respectively. Both AST-and PMH-guided therapies achieved comparable eradication rate (intention-to-treat analysis: 78.10% vs 74.29%, P = 0.42; per-protocol analysis: 87.10% vs 88.64%, P = 0.80). The AST clarithromycin regimen had a lower per-protocol eradication rate than the levofloxacin (75.47% vs 96.30%, P = 0.03) or furazolidone-containing regimen (75.47% vs 92.75%, P = 0.02). Both groups had high compliance with low incidences of AE, and PMH-guided therapy had a lower medical cost. Conclusions: AST-guided therapy was not superior to PMH-guided therapy as a second-or third-line treatment for H. pylori infection. Considering the cost-effectiveness, PMH therapy is clinically more favorable.

Two Different 1-Week Quadruple Therapies Given Back-to-Back Consecutive Therapy for Difficult-to-Treat Helicobacter pylori Infection: A Pilot Study

“…Of these, 14 patients (21.5%) have experienced failed regimens containing amoxicillin, tetracycline, and a PPI. In China, the resistant rates of H. pylori to amoxicillin, tetracycline, and furazolidone are lower than 5% ( 14 , 17 ), and reuse of these antibiotics rarely results in subsequent resistance. The consecutive regimen includes 3 antibiotics known to have the highest resistance barrier to achieve satisfactory efficacy in a difficult-to-treat group.…”

“…We conducted a randomized controlled trial (RCT) for the second-line or third-line therapy of H. pylori to compare the efficacy of antimicrobial susceptibility-guided with empirical BQTs. The eradication rates in both groups were <80% in intention-to-treat (ITT) analysis ( 14 ). However, antimicrobial susceptibility testing is time-consuming, expensive, and has certain technical prerequisites.…”

Helicobacter pylori culture: from bench to bedside

“…The same phenomenon is expected when antibiotic susceptibility is genetically assessed using a culture-free, polymerase chain reaction (PCR)-based tool, that overcomes the culture limitation of difficult bacterial growth [ 27 ]. On the other hand, a recent randomized controlled trial found that, as second- or third-line treatment, therapy guided by antimicrobial susceptibility testing was not significantly superior to the costless therapy guided by personal medication history, according to the intention to treat analysis (78.1% vs. 74.3%) [ 28 ].…”

Susceptibility testing alone will not reliably achieve high Helicobacter pylori cure rates: A systematic review and meta‐analysis

“…As with other infectious diseases, it was postulated that susceptibility‐guided therapy would improve outcomes as it avoided use of antibiotics the infection was resistant to 3 . However, experience showed that susceptibility‐guided studies did not uniformly produce eradication rates ≥ 90% 4,5 or were uniformly superior to empirical rescue treatment 6,7 …”

“…3 However, experience showed that susceptibility-guided studies did not uniformly produce eradication rates ≥ 90% 4,5 or were uniformly superior to empirical rescue treatment. 6,7 The aim of the present study was to perform a systematic review and meta-analysis to identify the optimal regimen for H. pylori treatment based on antibiotic susceptibility and to help identify the reasons why susceptibility-guided therapy has failed to achieve its potential.…”