Two-week bismuth-containing quadruple therapy and concomitant therapy are effective first-line treatments for Helicobacter pylori eradication: A prospective open-label randomized trial

BACKGROUND Increasing levels of antibiotic resistance have reduced the Helicobacter pylori(H.pylori)eradication rates afforded by the standard triple therapy.Thus,2-wk firstline four-drug regimens must be considered.AIM To analyze the eradication rates of modified bismuth-containing quadruple therapy(mBCQT)and concomitant therapy(CT),the associated adverse events,and compliance.METHODS Patients infected with H.pylori were prospectively randomized to receive mBCQT or CT for 2 wk.mBCQT featured a proton pump inhibitor(PPI),bismuth,metronidazole,and tetracycline,taken twice daily.CT included a PPI,clarithromycin,metronidazole,and amoxicillin,taken twice daily.The 13C-urea breath test was performed no earlier than 4 wk after therapy concluded to confirm eradication.If either the histological or rapid urease test was positive,H.pylori infection was diagnosed.RESULTS The demographic characteristics of 68 patients who received mBCQT and 68 who received CT did not differ significantly.On intention-to-treat analysis,the eradication rate was 88.2%(60/68)in the mBCQT group and 79.4%(54/68)in the CT group(P=0.162).By per-protocol analysis,the respective eradication rates were 98.4%(60/61)and 93.1%(54/58)(P=0.199).More CT than mBCQT patients experienced adverse events[33.8%(23/68)mBCQT vs 51.5%(35/58)CT patients,respectively,P=0.037].All patients showed good compliance[85.3%(58/68)mBCQT vs 82.4%(56/68)CT patients,P=0.641].CONCLUSION The H.pylori eradication rates of the 2-wk mBCQT and CT regimens are high.Most patients show good compliance,and more CT than mBCQT patients experience adverse events.

Is tailored therapy based on antibiotic susceptibility effective?A multicenter,open-label,randomized trial

An effective eradication therapy of Helicobacter pylori(H.pylori)should be used for the first time.In this study,we assessed whether tailored therapy based on antibiotic susceptibility testing is more effective than traditional therapy.We also evaluated the factors that cause treatment failure in high-resistance areas.For this multicenter trial,we recruited 467 H.pylori-positive patients.The patients were randomly assigned to receive tailored triple therapy(TATT),tailored bismuth-containing quadruple therapy(TABQT),or traditional bismuthcontaining quadruple therapy(TRBQT).For the TATT and TABQT groups,antibiotic selection proceeded via susceptibility testing using an agar-dilution test.The patients in the TRBQT group were given amoxicillin,clarithromycin,esomeprazole,and bismuth.Successful eradication was defined as a negative 13C-urea breath test at least eight weeks after the treatment ended.Susceptibility testing was conducted using an agar-dilution test.The eradication rate was examined via intention-to-treat(ITT)and per-protocol(PP)analyses.The clarithromycin,levofloxacin,and metronidazole resistance rates were 26.12%,28.69%,and 96.79%,respectively.Resistance against amoxicillin and furazolidone was rare.The eradication rates for TATT,TRBQT,and TABQT were 67.32%,63.69%,and 85.99%in the ITT analysis(P<0.001)and 74.64%,68.49%,and 91.22%in the PP analysis(P<0.001),respectively.The efficacy of TABQTwas affected by clarithromycin resistance,and bismuth exerted a direct influence on TATT failure.TABQT was the most efficacious regimen for use in high-resistance regions,especially among clarithromycin-susceptible patients.

Efficacy and safety of high-dose esomeprazole–amoxicillin dual therapy for Helicobacter pylori rescue treatment:a multicenter,prospective,randomized,controlled trial

Background:High-dose dual therapy(HDDT)with proton pump inhibitors(PPIs)and amoxicillin has attracted widespread attention due to its favorable efficacy in eradicating Helicobacter pylori(H.pylori).This study aimed to compare the efficacy and safety of high-dose PPI-amoxicillin dual therapy and bismuth-containing quadruple therapy for H.pylori rescue treatment.Methods:This was a prospective,randomized,multicenter,non-inferiority trial.Patients recruited from eight centers who had failed previous treatment were randomly(1:1)allocated to two eradication groups:HDDT(esomeprazole 40 mg and amoxicillin 1000 mg three times daily;theHDDTgroup)and bismuth-containing quadruple therapy(esomeprazole 40 mg,bismuth potassium citrate 220 mg,and furazolidone 100 mg twice daily,combined with tetracycline 500 mg three times daily;the tetracycline,furazolidone,esomeprazole,and bismuth[TFEB]group)for 14 days.The primary endpoint was the H.pylori eradication rate.The secondary endpoints were adverse effects,symptom improvement rates,and patient compliance.Results:A total of 658 patients who met the criteria were enrolled in this study.The HDDT group achieved eradication rates of 75.4%(248/329),81.0%(248/306),and 81.3%(248/305)asdetermined by the intention-to-treat(ITT),modified intention-totreat(MITT),and per-protocol(PP)analyses,respectively.The eradication rates were similar to those in the TFEB group:78.1%(257/329),84.2%(257/305),and 85.1%(257/302).The lower 95%confidence interval boundary(9.19%in the ITT analysis,9.21%in the MITT analysis,and9.73%in the PP analysis)was greater than the predefined non-inferiority margin of10%,establishing a non-inferiority of the HDDT group vs.the TFEB group.The incidence of adverse events in the HDDT group was significantly lower than that in the TFEB group(11.1%vs.26.8%,P<0.001).Symptom improvement rates and patients’compliance were similar between the two groups.Conclusions:Fourteen-day HDDT is non-inferior to bismuth-containing quadruple therapy,with fewer adverse effects and good treatment compliance,suggesting HDDT as an alternative for H.pylori rescue treatment in the local region.Trial registration:Clinicaltrials.gov,NCT04678492.