Optimized sequential therapy vs 10- and 14-d concomitant therapy for eradicating Helicobacter pylori: A randomized clinical trial

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.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,clarith-romycin 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 rabe-prazole 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 statist-ically 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.

Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population:A prospective,multicenter,randomized,two-stage study

BACKGROUND The efficacy of Vonoprazan-amoxicillin dual therapy(VAT)in the treatment of Helicobacter pylori(H.pylori)is controversial.AIM To evaluate the efficacy of VAT in the Chinese population.METHODS This prospective,multicenter,randomized,open-label,and two-stage study was conducted at 23 centers in Fujian,China(May 2021-April 2022).H.pylori-infected patients were randomized to bismuth quadruple therapy(BQT),BQT-Vonoprazan(BQT-V),seven-day VAT(VAT-7),ten-day VAT(VAT-10),and fourteen-day VAT(VAT-14)groups.The primary endpoint was the H.pylori eradication rate.The secondary endpoint was the frequency of adverse events.This study was registered with the Chinese Clinical Trial Registry,ChiCTR2100045778.RESULTS In the first stage,VAT-7 and BQT-V groups were selected for early termination because less than 23 among 28 cases were eradicated.In the second stage,the eradication rates for BQT,VAT-10,and VA-14 were 80.2%[95%confidence interval(95%CI):71.4%-86.8%],93.2%(86.6%-96.7%),92.2%(85.3%-96.0%)in the intention-to-treat(ITT)analysis,and 80.9%(95%CI:71.7%-87.5%),94.0%(87.5%-97.2%),and 93.9%(87.4%-97.2%)in the per-protocol analysis.The ITT analysis showed a higher eradication rate in the VAT-10 and VAT-14 groups than in the BQT group(P=0.022 and P=0.046,respectively).The incidence of adverse events in the VAT-10 and VAT-14 groups was lower than in the BQT group(25.27%and 13.73%vs 37.62%,respectively;P<0.001).CONCLUSION VAT with a duration of 10 or 14 days achieves a higher eradication rate than the BQT,with a more tolerable safety profile in H.pylori-infected patients in Fujian.Huang XP et al.VAT for H.pylori eradication.

Efficacy and safety of low-dose tetracycline,amoxicillin quadruple therapy in Helicobacter pylori infection:A retrospective single center study

BACKGROUND Helicobacter pylori(H.pylori)eradication rates have declined with the rise of antibiotic-resistant strains in recent years.Although highly effective with a low prevalence of resistance,standard dose tetracycline is associated with frequent adverse events.The efficacy and safety of low-dose tetracycline as part of tetra-cycline and amoxicillin-containing bismuth quadruple therapy are not well described.AIM To compare the efficacy and safety of low-dose compared to standard dose tetracycline with combined amoxicillin-containing bismuth quadruple therapy in patients with H.pylori infection.METHODS Consecutive patients with H.pylori infection receiving tetracycline,amoxicillin,proton pump inhibitor,and bismuth for 14 days at Sir Run Run Shaw Hospital(1/2022-6/2023)were evaluated.The low-dose tetracycline group received tetracycline 500 mg twice daily(bid)while the standard dose group received 750 mg bid or 500 mg three times daily(tid).Primary endpoints were H.pylori eradication rate and treatment-related adverse events.

Metabolic dynamics in chronic gastritis:Examining urinary profiles post Helicobacter pylori eradication

Chronic gastritis is the persistent and insidious inflammation of the gastric lining.Helicobacter pylori(H.pylori)has been identified as the most common cause of chronic gastritis and consequently elimination of H.pylori can lead to its cure.This editorial explores the use of urinary metabolic profiles before and after eradication to identify biomarkers that can aid in prognosis and treatment.Despite providing promising insights,there are limitations such as a small sample size(17 patients),a narrow treatment period of 2 wk,and treatment heterogeneity,which raise concerns.Nevertheless,these findings have opened a gateway to enhancing the treatment and prognosis of chronic gastritis through urinary metabolomics.

A new look at anti-Helicobacter pylori therapy

With the rising prevalence of antimicrobial resistance,the treatment success of standard triple therapy has recently declined to unacceptable levels (i.e.,80% or less) in most countries.Therefore,several treatment regimens have emerged to cure Helicobacter pylori (H.pylori) infection.Novel first-line anti-H.pylori therapies in 2011 include sequential therapy,concomitant quadruple therapy,hybrid (dual-concomitant) therapy and bismuth-containing quadruple therapy.After the failure of standard triple therapy,a bismuth-containing quadruple therapy comprising a proton pump inhibitor (PPI),bismuth,tetracycline and metronidazole can be employed as rescue treatment.Recently,triple therapy combining a PPI,levofloxacin and amoxicillin has been proposed as an alternative to the standard rescue therapy.This salvage regimen can achieve a higher eradication rate than bismuth-containing quadruple therapy in some regions and has less adverse effects.The best second-line therapy for patients who fail to eradicate H.pylori with first-line therapies containing clarithromycin,amoxicillin and metronidazole is unclear.However,a levofloxacin-based triple therapy is an accepted rescue treatment.Most guidelines suggest that patients requiring third-line therapy should be referred to a medical center and treated according to the antibiotic susceptibility test.Nonetheless,an empirical therapy (such as levofloxacin-based or furazolidone-based therapies) can be employed to terminate H.pylori infection if antimicrobial sensitivity data are unavailable.

Furazolidone,amoxicillin,bismuth and rabeprazole quadruple rescue therapy for the eradication of Helicobacter pylori

AIM： To compare the efficacy and side effect profiles of three furazolidone and amoxicillin-based quadruple rescue therapies for the eradication of Helicobacter pylori （H pylonS. METHODS： Patients who failed in the Hpylori eradication therapy for at least one course were randomly allocated into three groups. Group A received rebaprazole 10 mg＋ amoxicillin 1 g ＋ furazolidone 100 mg, and bismuth subcitrate 220 mg, twice daily for 1 wk; group B received the same regimen of group A but for 2 wk; and group C received the same regimen of group B, but furazolidone was replaced by furazolidone 100 mg three times daily. To record the side effect profiles at the end of the treatment, Hpylori eradication was assessed with 13C-urea breath test 4 wk after therapy. RESULTS： Sixty patients were enrolled including 28 males, and 20 patients in each group. The average age of the patients was 49.2 years, ranging from 18 to 84 years. H pylori eradication rates with per-protocol analysis were 82%, 89% and 90% in the three groups, respectively. Side effects were found in 11 patients, including mild dizziness, nausea, diarrhea and increased bowel movement. None of the 11 patients needed treatment for their side effects. CONCLUSION： One- or two-week furazolidone and amoxicillin-based quadruple rescue therapy with a low dose furazolidone （100 mg bid） for the eradication of Hpylori is effective. Extending the antibiotic course to 14 d could improve the eradication rates.

Outcomes of furazolidone-and amoxicillin-based quadruple therapy for Helicobacter pylori infection and predictors of failed eradication

AIM To evaluate the outcomes of furazolidone-and amoxicillin-based quadruple therapy for treatment of Helicobacter pylori(H. pylori) infection and identify predictors of failed eradication.METHODS Patients with H. pylori infection treated with furazolidone, amoxicillin, bismuth, and proton pump inhibitor therapy(January 2015 to December 2015) who received the ^(13)C-urea breath test > 4 wk after treatment were evaluated. Demographic and clinical data including prior H. pylori treatment attempts, medication adherence, alcohol and cigarette consumption during therapy, and treatment-related adverse events were recorded by reviewing medical records and telephone surveys. H. pylori eradication rates for overall and subgroups were evaluated. Multivariate analysis was performed to identify independent predictors of failed H. pylori eradication.RESULTS Of the 992 patients treated and retested for H. pylori infection, the overall eradication rate was 94.5% [95% confidence interval(CI): 94.1%-95.9%]. H. pylori eradication rate of primary therapy was 95.0%(95%CI: 93.5%-96.5%), while that of rescue therapy was 91.3%(95%CI: 86.8%-95.8%). Among the 859 patients who completed the study protocol, 144(17%) reported treatment-related adverse events including 24(3%) leading to premature discontinuation. On multivariate analysis, poor medication adherence [adjusted odds ratio(AOR) = 6.7, 95%CI: 2.8-15.8], two or more previous H. pylori treatments(AOR = 7.4, 95%CI: 2.2-24.9), alcohol consumption during therapy(AOR = 4.4, 95%CI: 1.5-12.3), and possibly smoking during therapy(AOR = 1.9, 95%CI: 0.9-4.3) were associated with failed H. pylori eradication. CONCLUSION Furazolidone-and amoxicillin-based quadruple therapy for H. pylori infection in an area with a high prevalence of clarithromycin resistance demonstrated high eradication rates as primary and rescue therapies with a favorable safety profile. Patient education targeting abstinence from alcohol during therapy and strict medication adherence may further optimize H. pylori eradication.

Standard triple, bismuth pectin quadruple and sequential therapies for Helicobacter pylori eradication

AIM: To compare the effectiveness of standard triple, bismuth pectin quadruple and sequential therapies for Helicobacter pylori (H. pylori ) eradication in a randomized, double-blinded, comparative clinical trial in China. METHODS: A total of 215 H. pylori -positive patients were enrolled in the study and randomly allocated into three groups: group A (n = 72) received a 10-d bismuth pectin quadruple therapy (20 mg rabeprazole bid , 1000 mg amoxicillin bid , 100 mg bismuth pectin qid , and 500 mg levofloxacin qd ); group B (n = 72) received the sequential therapy (20 mg omeprazole bid , 1000 mg amoxicillin bid , in 5 d, followed by 20 mg omeprazole bid , 500 mg tinidazole bid , 500 mg clarithromycin bid , for another 5 d); group C (n = 71) received a standard 1-wk triple therapy (20 mg omeprazole bid , 1000 mg amoxicillin bid , 500 mg clarithromycin bid ). After all these treatments, 20 mg omeprazole bid was administrated for 3 wk. H. pylori status was assessed by histology, 13C-urea breath test and rapid urease test at baseline and 4-6 wk after completion of treatment. Ulcer cicatrization was assessed by gastroscopy. χ 2 test (P < 0.05) was used to compare the eradication rates and ulcer cicatrisation rates among the three groups. RESULTS: The eradication rate was 83.33% (60/72) in group A, 88.89% (64/72) in group B, and 80.56% (58/71) in group C. The ulcer cicatrisation rate was 86.44% (51/59) in group A, 90.16% (55/61) in group B, and 84.91% (45/53) in group C. The sequential therapy yielded a higher eradication rate and ulcer cicatrisation rate than the standard triple and bismuth pectin quadruple therapies. Statistically, the eradication rate of group B was significantly different from groups A and C (P < 0.05), but the difference of ulcer cicatrisation rate and side effects was not statistically significant among the three groups (P > 0.05). The three protocols were generally well tolerated. CONCLUSION: The sequential therapy has achieved a significantly higher eradication rate, and is a more suitable first-line alternative protocol for anti-H. pylori infection compared with the standard triple and bismuth pectin quadruple therapies.

Helicobacter pylori:Future perspectives in therapy reflecting three decades of experience

The rising prevalence of antibiotic resistance has created a need to reassess the established Helicobacter pylori(H.pylori)eradication protocols,and to develop new ones.Various bacterial and host factors are evaluated,and their contribution to eradication failure is estimated.For a long time being considered the cornerstone eradication scheme,the standard triple therapy has been replaced with novel,more efficient regimens,namely sequential and concomitant,along with the emergence of a new design of bismuth quadruple therapy.A rescue levofloxacin based regimen has overcome the fear of therapy failure due to higher prevalence of dual resistant(clarithromycin and metronidazole)H.pylori.Culture-free and efficient susceptibility test are reestablishing the concept of tailored therapy,making eradication success close to originally desirable rates.Alleviating therapy side effects and improving patient compliance are as important as choosing appropriate eradication schemes,so various probiotic compound supplements are taken into consideration.Finally,we summarize the emerging efforts and obstacles in creating efficientH.pylori vaccine.

Current status of Helicobacter pylori eradication and risk factors for eradication failure

BACKGROUND The Helicobacter pylori(H.pylori)eradication rate is decreasing in the general population of China.AIM To evaluate the H.pylori eradication status in real-world clinical practice and to explore factors related to eradication failure.METHODS Patients with H.pylori infection who were treated with standard 14-d quadruple therapy and received a test of cure at a provincial medical institution between June 2018 and May 2019 were enrolled.Demographic and clinical data were recorded.Eradication rates were calculated and compared between regimens and subgroups.Multivariate analysis was performed to identify predictors of eradication failure.RESULTS Of 2610 patients enrolled,eradication was successful in 1999(76.6%)patients.Amoxicillin-containing quadruple regimens showed a higher eradication rate than other quadruple therapy regimens(83.0%vs 69.0%,P<0.001).The quadruple therapy containing amoxicillin plus clarithromycin achieved the highest eradication rate(83.5%).Primary therapy had a higher eradication rate than rescue therapy(78.3%vs 66.5%,P<0.001).In rescue therapy,the amoxicillinand furazolidone-containing regimens achieved the highest eradication rate(80.8%).Esomeprazole-containing regimens showed a higher eradication rate than those containing other proton pump inhibitors(81.8%vs 74.9%,P=0.001).Multivariate regression analysis found that older age,prior therapy,and use of omeprazole or pantoprazole were associated with an increased risk of eradication CONCLUSION The total eradication rate is 76.6%.Amoxicillin-containing regimens are superior to other regimens.Age,prior therapy,and use of omeprazole or pantoprazole are independent risk factors for eradication failure.

Second-line rescue treatment of Helicobacter pylori infection: Where are we now?

At present, the best rescue therapy for Helicobacter pylori(H. pylori) infection following failure of firstline eradication remains unclear. The Maastricht Ⅴ/Florence Consensus Report recommends bismuth quadruple therapy, or fluoroquinolone-amoxicillin triple/quadruple therapy as the second-line therapy for H. pylori infection. Meta-analyses have shown that bismuth quadruple therapy and levofloxacin-amoxicillin triple therapy have comparable eradication rates, while the former has more adverse effects than the latter. There are no significant differences between the eradication rates of levofloxacin-amoxicillin triple and quadruple therapies. However, the eradication rates of both levofloxacin-containing treatments are suboptimal. An important caveat of levofloxacin-amoxicillin triple or quadruple therapy is poor eradication efficacy in the presence of fluoroquinolone resistance. High-dose dual therapy is an emerging second-line therapy and has an eradication efficacy comparable with levofloxacinamoxicillin triple therapy. Recently, a 10-d tetracyclinelevofloxacin(TL) quadruple therapy comprised of a proton pump inhibitor, bismuth, tetracycline and levofloxacin has been developed, which achieves a markedly higher eradication rate compared with levofloxacin-amoxicillin triple therapy(98% vs 69%) in patients with failure of standard triple, bismuth quadruple or non-bismuth quadruple therapy. The present article reviews current second-line anti-H. pylori regimens and treatment algorisms. In conclusion, bismuth quadruple therapy, levofloxacin-amoxicillin triple/quadruple therapy, high-dose dual therapy and TL quadruple therapy can be used as second-line treatment for H. pylori infection. Current evidence suggests that 10-d TL quadruple therapy is a simple and effective regimen, and has the potential to become a universal rescue treatment following eradication failure by all firstline eradication regimens for H. pylori infection.

Quadruple primary malignancy patient with survival time more than 20 years

Multiple primary carcinoma (MPC) is defined as two or more carcinomas without subordinate relationship detected in the same or other organs of an individual patient. The diagnosis of MPC must comply with the following standards: each of the tumors must present a definite picture of malignancy, each tumor must be histologically distinct, and the probability of one being a metastasis of the other must be excluded. MPC often occurs in the digestive system, but its pathogenesis remains unclear involving genetic susceptibility, tumor immunity and iatrogenic factors, including radiotherapy and chemotherapy. Most MPC patients are double primary malignancy; the occurrence of quadruple primary malignancy is below 0.1%. Here we present a rare case of quadruple primary malignancy involving the small intestine, descending colon, renal pelvis and pancreas. Due to its rarity, the relevant literature is also reviewed. In general, the incidence of MPC is rising, so prevention, early diagnosis and treatment will become necessary and important. Therefore, further research should focus on the etiology and mechanism of MPC.

Nonbismuth concomitant quadruple therapy for Helicobacter pylori eradication in Chinese regions: A meta-analysis of randomized controlled trials

AIM: To evaluate the applicability of nonbismuth concomitant quadruple therapy for Helicobacter pylori(H. pylori) eradication in Chinese regions.METHODS: A systematic review and meta-analysis of randomized controlled trials was performed to evaluate the efficacy of nonbismuth concomitant quadruple therapy between sequential therapy or triple therapy for H. pylori eradication in Chinese regions. The defined Chinese regions include China, Hong Kong, Taiwan, and Singapore. The primary outcome was the H. pylori eradication rate; the secondary outcome was the compliance with therapy. The Pub Med, Embase, Scopus, and Cochrane databases were searched for studies published in the period up to March 2016 with no language restriction.RESULTS: We reviewed six randomized controlled trials and 1616 patients. In 3 trials comparing concomitant quadruple therapy with triple therapy, the H. pylori eradication rate was significantly higher for 7-d nonbismuth concomitant quadruple therapy than for 7-d triple therapy(91.2% vs 77.9%, risk ratio = 1.17, 95%CI: 1.09-1.25). In 3 trials comparing quadruple therapy with sequential therapy, the eradication rate was not significant between groups(86.9% vs 86.0%). However, higher compliance was achieved with concomitant therapy than with sequential therapy.CONCLUSION: The H. pylori eradication rate was higher for nonbismuth concomitant quadruple therapy than for triple therapy. Moreover, higher compliance was achieved with nonbismuth concomitant quadruple therapy than with sequential therapy. Thus, nonbismuth concomitant quadruple therapy should be the first-line treatment in Chinese regions.

Levofloxacin/amoxicillin-based schemes vs quadruple therapy for Helicobacter pylori eradication in second-line

Worldwide prevalence of Helicobacter pylori(H.pylori) infection is approximately 50%,with the highest being in developing countries.We compared cure rates and tolerability(SE) of second-line anti-H.pylori levofloxacin/amoxicillin(LA)-based triple regimens vs standard quadruple therapy(QT).An English language literature search was performed up to October 2010.A meta-analysis was performed including randomized clinical trials comparing 7-or 10-d LA with 7-d QT.In total,10 articles and four abstracts were identified.Overall eradication rate in LA was 76.5%(95% CI:64.4%-97.6%).When only 7-d regimens were included,cure rate was 70.6%(95% CI:40.2%-99.1%),whereas for 10-d combinations,cure rate was significantly higher(88.7%;95% CI:56.1%-109.9%;P < 0.05).Main eradication rate for QT was 67.4%(95% CI:49.7%-67.9%).The 7-d LA and QT showed comparable efficacy [odds ratio(OR):1.09;95% CI:0.63-1.87],whereas the 10-d LA regimen was significantly more effective than QT(OR:5.05;95% CI:2.74-9.31;P < 0.001;I 2 = 75%).No differences were reported in QT eradication rates among Asian and European studies,whereas LA regimens were more effective in European populations(78.3% vs 67.7%;P = 0.05).Incidence of SE was lower in LA therapy than QT(OR:0.39;95% CI:0.18-0.85;P = 0.02).A higher rate of side effects was reported in Asian patients who received QT.Our findings support the use of 10-d LA as a simple second-line treatment for H.pylori eradication with an excellent eradication rate and tolerability.The optimal second-line alternative scheme might differ among countries depending on quinolone resistance.

Effect of gastric microbiota on quadruple Helicobacter pylori eradication therapy containing bismuth

BACKGROUND Helicobacter pylori(H.pylori)is an important pathogen that can cause a variety of diseases.Yet,full eradication of H.pylori remains a significant challenge in clinical practice.H.pylori and other microbial communities have complex interactions in the unique gastric microecological environment.However,it is not clear whether the interactions have any effect on the therapeutic effect of H.pylori.AIM The aim was to investigate the characteristics of the gastric microbiota with H.pylori infection and the influence on the H.pylori eradication treatment.METHODS Patients with H.pylori infection underwent gastroscopy and received treatment for eradication.The prescription included esomeprazole 20 mg bid,Livzon Dele 220 mg bid,amoxicillin 1000 mg bid,and clarithromycin 500 mg bid for 14 d.Patients who did not respond to treatment and failed eradication were compared with those who achieved eradication by 1:2 propensity matching.Highthroughput sequencing of the gastric mucosal microbiota was performed,and the results were evaluated by alpha diversity analysis,beta diversity analysis,species correlation analysis,and metabolic pathway correlation analysis.RESULTS The eradication rate of all the patients was 95.5%(171/179).Twenty-four patients were enrolled in the study after propensity-matched scoring.There were eight cases in the failure group(patients who did not respond well to therapy)and 16 cases in the success group.The majority phyla in the two groups were the same,and included Proteobacteria,Bacteroides,Firmicutes,Actinomycetes,and Fusobacteria.The microbial diversity in the failure group had a decreasing trend(P=0.092)and the species abundance was significantly lower(P=0.031)compared with the success group.The high rate of H.pylori eradication was associated with Rhodococcus,Lactobacillus,and Sphingomonas,as they were significantly enriched in the successful group(P<0.05).Veronococcus and Cilium were enriched in the mucosa of chronic atrophic gastritis patients compared with chronic superficial gastritis patients(P=0.0466 and 0.0122,respectively).In both study groups,H.pylori was negatively correlated with other bacterial genera.More bacterial genera were directly related to H.pylori in the successful group compared with the failure group.CONCLUSION The effectiveness of quadruple H.pylori eradication therapy containing bismuth depended on gastric microbiota,and the high rate of H.pylori eradication was associated with the presence of Rhodococcus,Lactobacillus,and Sphingomonas.

Modified sequential therapy vs quadruple therapy as initial therapy in patients with Helicobacter infection

AIM: To evaluate the efficacy and safety of modified sequential therapy and to compare modified sequential therapy with standard quadruple therapy for Helicobacter pylori(H. pylori) eradication.METHODS: In total, 200 consecutive patients who were diagnosed with H. pylori-infected chronic gastritis by electronic endoscopy and rapid urease testing from December 2012 to October 2013 were enrolled in this study. The patients had not previously received H. pylori eradication treatment, and were randomized into two groups. The patients in Group A(n = 101) were treated with ilaprazole + bismuth potassium citrate + amoxicillin and clavulanate potassium + levofloxacin, and the patients in Group B(n = 99) were administered a modified sequential therapy composed of ilaprazole at 5 mg bid and amoxicillin and clavulanate potassium at 914 mg for the first five days followed by ilaprazole at 5 mg bid, furazolidone at 100 mg bid and levofloxacin at 500 mg qid for the next five days. Four to six weeks after the end of treatment, a 14C-urea breath test was performed for all the subjects to confirm the eradication of H. pylori. The intention-to-treat and per-protocol eradication rates were determined.RESULTS: A total of 190 of the 200 patients completed the study. All 200 patients were included in the intention-to-treat analysis, whereas 190 patients were included in the per-protocol analysis. In the intentionto-treat analysis, the rates of H. pylori eradication in Groups A and B were 85.15%(86/101) and 81.82%(81/99), respectively. In the per-protocol analysis, the H. pylori eradication rates in Groups A and B were 88.66%(86/97) and 87.09%(81/93), respectively. No significant difference was observed(χ2 = 0.109, P = 0.741) in the eradication rate between Groups A and B. The rates of adverse effects observed in the groups were similar at 6.19%(6/97) for Group A and 7.53%(7/93) for Group B(P > 0.05). No mortality or major morbidities were observed in any of the patients. Symptomatic improvements in the presentation of stomachache, acid regurgitation, and burning sensation were not significantly different between the two groups.CONCLUSION: Ilaprazole-based 10-d standard quadruple therapy does not offer an incremental benefit over modified sequential therapy for the treatment of H. pylori infection, as both treatment regimens appear to be effective, safe, and well-tolerated as initial treatment options.

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.

Tailored eradication vs empirical bismuth-containing quadruple therapy for first-line Helicobacter pylori eradication: A comparative,open trial

BACKGROUND Few studies have compared the efficacy and safety profile of a tailored eradication(TR)strategy based on the presence of a 23S ribosomal RNA point mutation with those of empirical bismuth-based quadruple therapy(EBQT)for first-line eradication of Helicobacter pylori(H.pylori)in Korean patients.AIM To compare the efficacy and safety of a TR strategy and those of EBQT regimen as first-line eradication therapy for H.pylori.METHODS This is an open-label,comparative study in which we prospectively enrolled patients over 18 years of age with H.pylori infection and retrospectively reviewed their data.H.pylori-positive patients diagnosed by rapid urease test,Giemsa staining,or dual priming oligonucleotide polymerase chain reaction(DPO-PCR)were enrolled from May 2016 to September 2018 at Gil Medical Center.Patients with H.pylori infection received either a TR regimen or the EBQT regimen.In the tailored therapy group that underwent DPO-PCR testing,patients with A2142G and/or A2143G point mutations were treated with a bismuth-containing quadruple regimen.The eradication rate,patient-reported side effect rate,and H.pylori eradication success rate were evaluated and compared between the groups.RESULTS A total of 150 patients were assigned to the TR(n=50)or EBQT group(n=100).The first-line eradication rate of H.pylori did not differ between the groups(96.0%vs 95.7%,P=0.9).The rate of eradication-related side effects for TR was 12.0%,which differed significantly from that of EBQT(43.0%)for first-line treatment(P<0.001).CONCLUSION DPO-PCR-based TR for H.pylori eradication may be equally efficacious,with less treatment-related complications,compared to EBQT in Korea,where clarithromycin resistance is high.

Triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for H pylori eradication:A comparative three-armed randomized clinical trial

AIM： To compare the effectiveness of triple, standard quadruple and ampicillin-sulbactam-based quadruple therapies for Hpylori eradication in a comparative three-armed randomized clinical trial. METHODS： A total of 360 H pylori-positive patients suffering from dyspepsia and aging 24-79 years with a median age of 42 years were enrolled in the study and randomly allocated into the following three groups： group A （n = 120） received a standard 1-wk triple therapy （20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 500 mg clarithromycin b.i.d.）, group B （n = 120） received a 10-d standard quadruple therapy （20 mg omeprazole b.i.d., 1000 mg amoxicillin b.i.d., 240 mg colloidal bismuth subcitrate b.i.d., and 500 mg metronidazole b.i.d.）, group C （n = 120） received the new protocol, i.e. 375 mg sultamicillin （225 mg ampicillin plus 150 mg sulbactam） b.i.d. （before breakfast and dinner）, instead of amoxicillin in the standard quadruple therapy for the same duration. Chi-square test with the consideration of P 〈 0.05 as significant was used to compare the eradication rates by intention-to-treat and per-protocol analyses in the three groups.RESULTS： The per-protocol eradication rate was 91.81% （101 patients from a total of 110） in group A, 85.84% （97 patients from a total of 113） in group B, and 92.85% （104 patients from a total of 112） in group C. The intention-to-treat eradication rate was 84.17% in group A, 80.83% in group B, and 86.67% in group C. The new protocol yielded the highest eradication rates by both per-protocol and intention-to-treat analyses followed by the standard triple and quadruple regimens, respectively. However, the differences were not statistically significant between the three groups. CONCLUSION： The results of this study provide further support for the equivalence of triple and quadruple therapies in terms of effectiveness, compliance and sideeffect profile when administered as first-line treatment for H pylori infection. Moreover, the new protocol using ampicillin-sulbactam instead of amoxicillin in the quadruple regimen is a suitable first-line alternative to be used in regions with amoxicillin-resistant Hpylori strains.

Non-bismuth quadruple therapy for first-line Helicobacter pylori eradication:A randomized study in Japan

AIM:To find the way to improve the eradication rate of first-line therapy in Japanese patients.METHODS:We prospectively compared the effectiveness of 7-d quadruple therapy to standard 7 d triple therapy in Japanese patients infected with Helicobacter pylori(H.pylori).One hundred and nineteen patients were randomly assigned to receive 7-d non-bismuth quadruple therapy with lansoprazole,amoxicillin,clarithromycin and metronidazole(LACM7) or 7-d triple therapy with lansoprazole,amoxicillin and clarithromycin(LAC7).After three months,H.pylori status was analyzed by 13C-urea breath test.Incidence rates of adverse events were evaluated by use of questionnaires.RESULTS:By intention-to-treat(ITT) analysis,the eradication rate in the LACM7 group was 94.9%,which was significantly higher than the LAC7 group(68.3%,P < 0.001).Per protocol analysis also showed a significantly higher eradication rate in the LACM7 group(98.3%) than the LAC7 group(73.2%,P < 0.001).Nevertheless,the incidence of serious adverse events did not differ between the two groups(RR:1.10,95% CI:0.70-1.73,P = 0.67).CONCLUSION:Seven day non-bismuth quadruple therapy(LACM7) was superior to standard 7-d triple therapy(LAC7) for first-line eradication.