Bismuth‐containing quadruple therapy versus concomitant quadruple therapy as first‐line treatment for Helicobacter Pylori infection in an area of high resistance to clarithromycin: A prospective, cross‐sectional, comparative, open trial

Abstract

Background Concomitant quadruple (CQT) or bismuth‐containing quadruple therapy (BQT) is recommended as first‐line treatment for Helicobacter pylori infection depending on antibiotic resistance. Aim To compare the efficacy, safety, and compliance of CQT and BQT as first‐line therapy for H. pylori eradication in real clinical practice in an area of high resistance to clarithromycin. Methods A prospective, open, comparative cross‐sectional study including dyspeptic patients >18 years with H. pylori infection and with no previous eradication treatment was performed. CQT (omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1 g + metronidazole 500 mg, all given twice daily, for 14 days) or BQT (omeprazole 20 mg twice daily + 3 capsules of Pylera® 4 times a day, for 10 days) was prescribed at the discretion of the prescribing physician. Eradication was tested by 13C‐urea breath test. Efficacy was assessed by intention‐to‐treat (ITT) and per‐protocol (PP) analyses. Results One hundred and four consecutive patients were included (64.4% female, age 52.9 years). Fifty patients received CQT and 54 BQT. Eradication rate was similar with both therapies at the PP (CQT 97.9%, 95% CI: 93.9‐100 vs BQT 96.2%, 95% CI: 90.9‐100, P = 0.605) and ITT analyses (CQT 98.0%, 95% CI: 94‐100 vs BQT 94.4%, 95% CI: 88.1‐100, P = 0.346). The rate of adverse events was also similar with CQT (56%) and BQT (46.3%). One patient in each group discontinued the treatment due to significant adverse events. Conclusion The use of CQT and BQT as first‐line treatment against H. pylori is similarly effective and safe strategy in an area of high clarithromycin resistance.

Antimicrobial and Antibiofilm Activities of New Synthesized Silver Ultra-NanoClusters (SUNCs) Against Helicobacter pylori

“…The increase of the failure rates of the triple therapy recorded in many countries such as those in Europe, as well as Korea, Japan, and China, has been due to an excessive use of antibiotics as well as to the empirical prescription of drugs (Ko et al, 2019). Therefore, both a bismuth-containing quadruple therapy has been recently recommended or clinical studies involving novel potassium-competitive acid blockers (P-CABs instead of PPIs) have been carried out (Mori and Suzuki, 2019) as the first-line treatment of multidrug-resistant H. pylori strains, particularly in areas of high clarithromycin resistance (Macías-García et al, 2019). In 2017, the WHO classified the H. pylori resistance to clarithromycin as "a high priority for antibiotic research and development" (Savoldi et al, 2018).…”

Best Helicobacter pylori Eradication Strategy in the Era of Antibiotic Resistance

“…A Spanish study demonstrated that concomitant therapy was significantly better than triple therapy (92% vs. 70% (ITT), p = 0.02 and 92% vs. 74% (PP), p = 0.05), and the eradication rate of concomitant therapy was superior to that of sequential therapy for antibiotic-resistant strains [59]. In addition, concomitant therapy and BQT as first-line regimens have shown similar H. pylori eradication rates in PP (97.7% vs. 96.2%, p = 0.605) and ITT (98.0% vs. 94.4%, p = 0.346) analyses [43]. Moreover, network meta-analyses have shown that concomitant therapy has superior efficacy to several other regimens [40,60].…”

“…A randomized controlled trial (RCT) in Taiwan yielded a 96.0% eradication rate in patients who received BQT, although the rate of adverse events was 47.7% [42]. BQT was highly effective as the first-line regimen for H. pylori eradication in a prospective study in Spain (94.4% (ITT) and 96.2% (PP)) [43]. BQT has an excellent H. pylori eradication rate, but patient compliance may be reduced because of the large number of drugs.…”

Review: Treatment of Helicobacter pylori Infection 2019

“…A systematic review and meta-analysis on concomitant therapy vs triple therapy for first-line treatment looked at 23 randomized controlled trials and 6632 patients and found that concomitant therapy given for 5 or 10 days was superior to 5-or 7-, or 10-day triple therapy with PPI, amoxicillin, and clarithromycin, but not to 14-day therapy. 17 As a rescue therapy for third line in a highly resistant set of cases (79% resistant to clarithromycin, 95% to levofloxacin, and 67% to metronidazole), eradication rates of only 52% were seen for 14-day quadruple therapy, compared to 81% for susceptibilityguided treatment. The reverse hybrid therapy (PPI plus amoxicillin for 14 days, and clarithromycin plus metronidazole for the initial 7 days) has been proposed as a means of simplifying it.…”

“…16 A prospective cross-sectional study conducted in Spain found very impressive eradication rates of 98% for concomitant quadruple therapy compared to 94% for bismuth-based quadruple therapy. 17 As a rescue therapy for third line in a highly resistant set of cases (79% resistant to clarithromycin, 95% to levofloxacin, and 67% to metronidazole), eradication rates of only 52% were seen for 14-day quadruple therapy, compared to 81% for susceptibilityguided treatment. 18 Regarding the sequential therapy, which was proposed as a means of overcoming antibiotic resistance, an interesting study from Italy where H pylori primary resistance to antimicrobials tested is high showed eradication rates for 10-day sequential therapy of 97% in strains susceptible to clarithromycin and metronidazole, 96% in strains resistant to metronidazole, 93% in strains resistant to clarithromycin, and surprisingly even 83% in strains resistant to both clarithromycin and metronidazole.…”