Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate,metronidazole, and tetracycline given with omeprazole versus omeprazole,amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: a prospective,randomized, multicenter,North American trial

OBJECTIVES: This multicenter, randomized, active-controlled trial assessed efficacy of bismuth-based quadruple therapy with omeprazole, bismuth biskalcitrate, metronidazole, and tetracycline (OBMT) using a single-triple capsule of BMT compared with triple therapy with omeprazole, amoxicillin, and clarithromycin (OAC) in treatment of patients with Helicobacter pylori infection and duodenal ulcers. METHODS: Patients with active duodenal ulcer or diagnosed within the past 5 yr and with infection documented by (13)C-urea breath test plus histology or culture were randomly assigned to 10-day course of OBMT using a single-triple capsule containing bismuth biskalcitrate 140 mg, metronidazole 125 mg, and tetracycline 125 mg given as three capsules q.i.d. with omeprazole 20 mg b.i.d., or a 10-day course of OAC, omeprazole 20 mg plus amoxicillin 1 g plus clarithromycin 500 mg, all b.i.d. Eradication was confirmed by two negative urea breath tests at >1 month and >2 months after therapy. RESULTS: One hundred thirty-eight patients received OBMT and 137 OAC. Modified intent-to-treat eradication rates were 87.7% for OBMT and 83.2% for OAC (95% CI = -3.9%-12.8%; p = 0.29). OBMT eradicated 91.7% metronidazole-sensitive and 80.4% metronidazole-resistant strains (p = 0.06). OAC eradicated 92.1% clarithromycin sensitive and 21.4% clarithromycin-resistant strains (p < 0.001). Adverse events occurred in 58.5% of OBMT patients and 59.0% of OAC patients. CONCLUSIONS: OBMT regimen using the single-triple capsule is as efficacious and well-tolerated as the widely used OAC regimen for H. pylori eradication. This OBMT therapy largely overcomes H. pylori metronidazole resistance, present in 40% of patients in this study.     

Efficacy of 14 day OBMT therapy as a second-line treatment for Helicobacter pylori infection]

BACKGROUND/AIMS: As a second-line treatment for H. pylori eradication in the case of first-line OAC (omeprazole, amoxicillin, clarithromycin) treatment failure, a minimum of one-week OBMT quadruple therapy composed of omeprazole, bismuth, metronidazole, tetracycline has been recommended in European countries and one or two weeks in USA. In Korea, one-week OBMT quadruple therapy is recommended for the case of first-line OAC treatment failure. Because H. pylori eradication rate of one-week OBMT therapy in Korea is about 80%, the eradication rate of one week therapy is not satisfactory. We analyzed the effect of two-week second-line OBMT therapy. METHODS: Between June 2002 and June 2003, 107 patients who were H. pylori positive (44 males and 63 females: mean age 51.8 years) after primary eradication therapy received two-week OBMT therapy. Four weeks after completion of therapy, 13C-urea breath test was performed to detect H. pylori. RESULTS: After two weeks of OBMT therapy, eradication was achieved in 103 of 107 patients (96.3%) and in 68 of 71 peptic ulcer patients (95.8%). CONCLUSIONS: Two-week OBMT therapy should be considered as a retreatment regimen with the eradication rate more than 90%.     

Antimicrobial susceptibility testing before first-line treatment for Helicobacter pylori infection in patients with dual or triple antibiotic resistance

AIM To evaluate the efficacy of antimicrobial susceptibilityguided therapy before first-line treatment for infection in patients with dual or triple antibiotic resistance.METHODS A total of 1034 patients infected by Helicobacter pylori(H. pylori) during 2013-2014 were tested for antimicrobial susceptibility. 157 of 1034(15%) patients showed resistance to two(127/1034; 12%) and to three(30/1034; 3%) antibiotics. Sixty-eight patients with dual H. pylori-resistance(clarithromycin, metronidazole or levofloxacin) were treated for 10 d with triple therapies: OAL(omeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and levofloxacin 500 mg b.i.d.) 43cases, OAM(omeprazole 20 mg b.i.d., amoxicillin 1 g b.i.d., and metronidazole 500 mg b.i.d.) 12 cases and OAC(omeprazole 20 mg b.id., amoxicillin 1 g b.i.d., and clarithromycin 500 mg b.i.d.) 13 cases based on the antimicrobial susceptibility testing. Twelve patients showed triple H. pylori-resistance(clarithromycin, metronidazole and levofloxacin) and received for 10 d triple therapy with OAR(omeprazole 20 mg b.id., amoxicillin 1 g b.i.d., and rifabutin 150 mg b.i.d.). Eradication was confirmed by 13C-urea breath test. Adverse effects and compliance were assessed by a questionnaire. RESULTS Intention-to-treat eradication rates were: OAL(97.6%), OAM(91.6%), OAC(92.3%) and OAR(58.3%). Cure rate was significantly higher in na?ve patients treated with OAR-10 compared to patients who had two or three previous treatment failures(83% vs 33%). Adverse events rates for OAL, OAM, OAC and OAR were 22%, 25%, 23% and 17%, respectively, all of them mild-moderate. CONCLUSION Antimicrobial susceptibility-guided triple therapies during 10 d for first-line treatment leads to an eradication rate superior to 90% in patients with dual antibiotic H. pylori resistance.     

Comparison of 1 and 2 weeks of omeprazole, amoxicillin and clarithromycin treatment for Helicobacter pylori eradication: the HYPER Study

BACKGROUND: Triple therapy is recommended for Helicobacter pylori eradication, yet consensus on the duration of treatment is lacking. AIM: To compare the efficacy and safety of 1- and 2-week regimens of omeprazole, amoxicillin and clarithromycin in a large, multicentre, double-blind and randomised study. METHODS: A total of 909 H pylori-positive patients with duodenal ulcer, enrolled in 81 endoscopy units in Italy, were randomised to receive omeprazole, amoxicillin and clarithromycin for either 1 week (OAC1W) or 2 weeks (OAC2W) or omeprazole and amoxicillin for 2 weeks. H pylori eradication was assessed by histological examination and carbon-13 urea breath test 4 weeks after treatment. RESULTS: Both the intention-to-treat (ITT; n = 907) and per protocol (PP; n = 661) analyses showed no significant differences between the eradication rates of OAC1W (ITT 79.7%; PP 83.6%) and OAC2W (ITT 81.7%; PP 84.9%; ITT p = 0.53; PP p = 0.71). Both triple omeprazole, amoxicillin and clarithromycin regimens gave significantly higher eradication rates compared with omeprazole and amoxicillin treatment (ITT 44.6%; PP 42.8%; p<0.001). Poor compliance was reported in 18.6%, 17.3% and 15.1% (p = 0.51) of patients for OAC2W, OAC1W and omeprazole and amoxicillin, respectively. Adverse events occurred in 9.9% and 9.6% (p = 0.88) of patients for OAC2W and OAC1W, respectively, and in 5.9% for omeprazole and amoxicillin (p = 0.11). CONCLUSIONS: 1-week and 2-week triple treatments for H pylori eradication are similar in terms of efficacy, safety and patient compliance.     

One-week therapy with pantoprazole versus ranitidine bismuth citrate plus two antibiotics for Helicobacter pylori eradication

AIM: A combination of omeprazole plus amoxycillin (Amo) and clarithromycin (CIa) for 7 days has been studied extensively. However, the role of other proton pump inhibitors, such as pantoprazole (Pan), in this therapy is not well known. On the other hand, ranitidine bismuth citrate (RBC) also seems to be effective when combined with Amo and CIa. Our aim was to evaluate and to compare these two novel short-term triple therapies (Pan+Amo+Cla and RBC+Amo+Cla) for treatment of Helicobacter pylori. METHODS: In a randomized clinical trial 150 consecutive patients (38 with duodenal ulcer, 112 with non-ulcer dyspepsia) infected by H. pylori were studied prospectively. Exclusion criteria were: previous H. pylori eradication therapy, gastroerosive drug use, gastric surgery, and associated diseases. One of two regimens was given for 7 days: Pan (40 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group Pan+Amo+Cla, n = 75); or RBC (400 mg b.i.d.), Amo (1 g b.i.d.), Cla (500 mg b.i.d.) (group RBC+Amo+Cla, n = 75). All drugs were administered together after meals. Compliance was evaluated by return tablet count. Data were analysed by univariate (chi2) and multivariate (multiple logistic regression) analysis. Eradication was defined as a negative 13C-urea breath test 1 month after completing therapy. RESULTS: The distribution of studied variables (age, gender, smoking, duodenal ulcer/non-ulcer dyspepsia) was similar in both therapy groups. Per-protocol eradication was achieved in 48/71 (68%) in group Pan+Amo+Cla, and in 61/70 (87%) in group RBC+Amo+Cla (P= 0.01). Intention-to-treat (ITT) eradication was achieved in, respectively, 48/ 75 (64%) and in 61/75 (81%) (P= 0.03). The RBC+ Amo+Cla regimen was more effective than Pan+Amo+Cla in non-ulcer dyspepsia patients (ITT, 84% vs 58%; P = 0.005), but statistically significant differences were not demonstrated in duodenal ulcer patients (72% vs 80%). In the multivariate analysis the odds ratio for the effect of the type of therapy on H. pylori eradication in patients with non-ulcer dyspepsia was 3.8 (95% Cl, 1.6-9.3; P = 0.003). No relevant adverse effects were reported with any regimen. CONCLUSION: A RBC+Amo+Cla regimen for only 1 week is a promising therapy for H. pylori infection, due to its high efficacy, simple posology, and excellent tolerability. Combination of Pan with Amo and Cla, although effective in duodenal ulcer patients, but in non-ulcer dyspepsia has not achieved the favourable results previously reported with other proton pump inhibitors.     

Esomeprazole versus omeprazole for the eradication of Helicobacter pylori infection: results of a randomized controlled study

BACKGROUND: Esomeprazole has higher oral bioavailability and increased antimicrobial activity against Helicobacter pylori than omeprazole. GOALS: To compare 7 days esomeprazole with 7 days of omeprazole based triple therapies for the eradication of H. pylori, and to assess whether the administration of higher dose of esomeprazole leads to improved eradication rates. STUDY: One hundred and fifty-six dyspeptic patients with H. pylori received either: (1) 1-week treatment including esomeprazole 40 mg once daily, amoxicillin 1 g, and clarithromycin 500 mg, both twice daily (EAC1 group, n = 52); (2) 1-week treatment of omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, all administered twice daily (OAC group, n = 52); or (3) 1-week treatment with esomeprazole 40 mg, amoxicillin 1 g, and clarithromycin 500 mg, all given twice daily (EAC2 group, n = 52). RESULTS: H. pylori was eradicated in 37 of 52 patients in the OAC group (Intension to treat [ITT] 71%), and in 42 patients in the EAC1 group (ITT 81%). High eradication rate was achieved by the EAC2 regimen (ITT; 96%), but more patients reported unwanted effects. CONCLUSION: Seven days of esomeprazole based triple therapy is a satisfactory eradication regimen for H. pylori infection. Higher doses of esomeprazole have excellent eradication rates, but they may lead to increased side effects.     

Optimal treatment for duodenal ulcer disease: a cost-decision analysis in Malaysian patients

The aim of the present study was to determine the cost-efficiency of different duodenal ulcer disease treatment practices in Malaysia. Six Malaysian gastroenterologists met to discuss the direct costs related to Helicobacter pylori (HP) eradication treatment. Five treatment strategies were compared: (i) histamine H2 receptor antagonists (H2RA), acid suppression therapy for 6 weeks followed by maintenance therapy as needed; (ii) bismuth triple + proton pump inhibitor (PPI), bismuth (120 mg, q.i.d.), metronidazole (400 mg; t.i.d.), tetracycline (500 mg, q.i.d.) for 7 days and PPI, b.i.d., for 7 days; (iii) OAC, omeprazole (20 mg, b.i.d.), amoxycillin (1000 mg, b.i.d.) and clarithromycin (500 mg, b.i.d.) for 7 days; (iv) OMC, omeprazole (20mg, b.i.d.), metronidazole (400mg, b.i.d.) and clarithromycin (500 mg, b.i.d.) for 7 days; and (v) OAM, omeprazole (20 mg, b.i.d.), amoxycillin (1000 mg, b.i.d.) and metronidazole (400 mg, b.i.d.) for 7 days. A decision tree model was created to determine which therapy would be the most cost-effective. The model considered eradication rates, resistance to anti-microbial agents, compliance and cost implications of treatment regimens, physician visits and ulcer recurrences during a 1 year time period assumption. The H2RA maintenance therapy was the most expensive treatment at Malaysian Ringgit (MR) 2335, followed by bismuth triple therapy (MR 1839), OMC (MR 1786), OAM (MR 1775) and OAC, being the most cost-effective therapy, at MR 1679. In conclusion, HP eradication therapy is superior to H2RA maintenance therapy in the treatment of duodenal ulcer disease. Of the HP eradication regimens, OAC is the most cost-effective.     

Twice-daily, 10-day triple therapy with omeprazole, amoxicillin, and clarithromycin for Helicobacter pylori eradication in duodenal ulcer disease: results of three multicenter, double-blind, United States trials

Objective: We assessed the safety and efficacy of 10-day twice-daily triple therapy for Helicobacter pylori ( H. pylori ) in three double-blind, controlled trials in patients with duodenal ulcer disease.
Methods: H. pylori -infected patients with one or more duodenal ulcer(s) at endoscopy (studies 1, 2) or with a documented duodenal ulcer history and no duodenal ulcer or erosions at endoscopy (study 3) were randomly assigned to 10-day courses of omeprazole 20 mg b.i.d . plus amoxicillin 1 g b.i.d . plus clarithromycin 500 mg b.i.d . (OAC) or placebo plus amoxicillin 1 g b.i.d . plus clarithromycin 500 mg b.i.d . (AC). In studies 1 and 2, patients received an additional 18 days of omeprazole 20 mg q.d . (OAC group) or placebo (AC group). Endoscopy was repeated 4 wk after therapy in studies 1 and 2 and 4–6 wk after therapy in study 3. At baseline, H. pylori was diagnosed by CLOtest plus histology, or by culture. Eradication was defined as no positive biopsy test and two or more negative tests. Patients were defined as compliant if they took 75% or more of each study drug and missed ≤ 3 consecutive days of the 10-day therapy.
Results: Intent-to-treat populations of the three studies combined were 241 patients for OAC and 266 for AC. Of all OAC patients combined, 2% stopped study medications due to adverse events, and 93% were compliant. Per-protocol cure rates were 78% to 90% (all studies combined, 84%) for OAC vs 33% to 45% (combined, 39%) for AC (   p < 0.001  , OAC vs AC); intent-to-treat eradication rates were 69% to 83% (combined, 75%) for OAC vs 32% to 37% (combined, 35%) for AC; (   p < 0.001  , OAC vs AC).
Conclusion: Rigorously designed studies indicate that 10 days of twice-daily triple therapy with omeprazole, amoxicillin, and clarithromycin achieves per-protocol eradication rates of approximately 80% to 90% in the U.S.     

Efficacy of 1 week omeprazole or lansoprazole-amoxycillin-clarithromycin therapy for Helicobacter pylori infection in the Japanese population

BACKGROUND: The effectiveness of curative therapy for Helicobacter pylori may vary according to the geographic region and patient population, thus the efficacy of each treatment regimen should be determined according to the specific patient population. However, there is no literature available concerning the efficacy of 1 week omeprazole-amoxycillin-clarithromycin (OAC) regimens for the cure of H. pylori infection in Japan. METHODS: Helicobacter pylori-positive patients (224) with peptic ulcer disease or non-ulcer dyspepsia were randomized to receive one of three different omeprazole or lansoprazole-amoxycillin-clarithromycin (PPI/AC) regimens for 7 days: (1) OAC 20 regimen (n = 76), omeprazole (OPZ) 20 mg daily, amoxycillin (AMOX) 500 mg t.d.s. and clarithromycin (CAM) 200 mg b.d.; (2) LAC 30 regimen (n = 73), Lansoprazole (LPZ) 30 mg daily, AMOX 500 mg t.d.s. and CAM 200 mg b.d.; and (3) OPZ 40 regimen (n = 75), OPZ 20 b.d., AMOX 500 mg t.d.s. and CAM 200 mg b.d. Cure of the infection was determined by the [13C]-urea breath test, 1 month after completion of the treatment. RESULTS: Intention-to-treat based cure rates for OAC 20, LAC 30 and OAC 40 regimens were 75.0% (95% CI, 64-84%), 82.2% (95%, CI 72-90), and 80.0% (95% CI, 69-88), respectively and per-protocol based cure rates of these regimens were 79.2% (95% CI, 68-88%), 83.3% (95%, CI 73-91), and 83.1% (95% CI, 72-91%), respectively. Adverse effects, which included diarrhoea, glossitis or skin rash, were reported by 26.1% of the patients. However, these were mild and did not affect compliance. CONCLUSION: One week PPI/AC regimens for H. pylori infection with smaller proton pump inhibitors and antimicrobial dosages compared to regimens used in Western countries were revealed to provide sufficient cure rate (more than 80% by ITT analysis) with mild adverse effects in the Japanese population.     

细胞色素P450 2C19基因多态性对埃索美拉唑三联疗法根除幽门螺杆菌疗效的影响

目的 前瞻性对比埃索美拉唑和奥美拉唑三联疗法根除幽门螺杆菌(Hp)的疗效,及细胞色素P450(CYP)2C19基因多态性对根除Hp疗效的影响.方法 240例Hp阳性消化性溃疡患者,随机分为EAC组(埃索美拉唑、阿莫西林和克拉霉素)和OAC组(奥美拉唑、阿莫西林和克拉霉素),每组120例,疗程7 d.继后埃索美拉唑或奥美拉唑巩固治疗3周.胃镜观察2周溃疡愈合情况,结束治疗4周后进行13C尿素呼气试验.利用聚合酶链反应(PCR)及限制片段长度多态性(RFLP)分析技术,测定所有患者的CYP2C19基因型,分为强代谢型(Ems)和弱代谢型(PMs),强代谢型包括纯合子(homEM)和杂合子(hetEM).结果 240例患者中225例完成疗效观察.Hp根除率按意向处理分析(ITT),EAC组为88.3%,OAC组为79.2%(P>0.05);按方案分析(PP)EAC组为91.4%,OAC组为87.2 oA(P>0.05).ITT分析显示,在CYP2C19 homEM基因型中,EAC和OAC组Hp根除率分别为91.9%和71.8%,两组间差异有统计学意义(P=0.037).PP分析显示,在homEM基因型中,EAC组和OAC组Hp根除率分别为97.1%和77.8%,两组间差异也有统计学意义(P=0.028).ITT分析显示,EAC组和OAC组2周溃疡愈合率分别为79.2%和69.2%(P>0.05);PP分析显示分别为81.9%和76.1%(P>0.05).EAC组和OAC组不良反应均较少(分别为3.3%和7.5%,P>0.05).结论 EAC方案Hp根除率较高,尤其在CYP2C19 homEM基因型患者,埃索美拉唑优于奥美拉唑.     

细胞色素P450 2C19基因多态性对埃索美拉唑三联疗法根除幽门螺杆菌疗效的影响

目的 前瞻性对比埃索美拉唑和奥美拉唑三联疗法根除幽门螺杆菌(Hp)的疗效,及细胞色素P450(CYP)2C19基因多态性对根除Hp疗效的影响.方法 240例Hp阳性消化性溃疡患者,随机分为EAC组(埃索美拉唑、阿莫西林和克拉霉素)和OAC组(奥美拉唑、阿莫西林和克拉霉素),每组120例,疗程7 d.继后埃索美拉唑或奥美拉唑巩固治疗3周.胃镜观察2周溃疡愈合情况,结束治疗4周后进行13C尿素呼气试验.利用聚合酶链反应(PCR)及限制片段长度多态性(RFLP)分析技术,测定所有患者的CYP2C19基因型,分为强代谢型(Ems)和弱代谢型(PMs),强代谢型包括纯合子(homEM)和杂合子(hetEM).结果 240例患者中225例完成疗效观察.Hp根除率按意向处理分析(ITT),EAC组为88.3%,OAC组为79.2%(P>0.05);按方案分析(PP)EAC组为91.4%,OAC组为87.2 oA(P>0.05).ITT分析显示,在CYP2C19 homEM基因型中,EAC和OAC组Hp根除率分别为91.9%和71.8%,两组间差异有统计学意义(P=0.037).PP分析显示,在homEM基因型中,EAC组和OAC组Hp根除率分别为97.1%和77.8%,两组间差异也有统计学意义(P=0.028).ITT分析显示,EAC组和OAC组2周溃疡愈合率分别为79.2%和69.2%(P>0.05);PP分析显示分别为81.9%和76.1%(P>0.05).EAC组和OAC组不良反应均较少(分别为3.3%和7.5%,P>0.05).结论 EAC方案Hp根除率较高,尤其在CYP2C19 homEM基因型患者,埃索美拉唑优于奥美拉唑.     

Effects of a specially designed fermented milk product containing probiotic Lactobacillus casei DN-114 001 and the eradication of H. pylori in children: a prospective randomized double-blind study

GOALS: To determine the efficacy of triple therapy supplemented with a specially designed fermented milk product containing specific probiotic Lactobacillus casei (L. casei) DN-114 001 strain on Helicobacter pylori eradication in children. BACKGROUND: Lactobacillus species possess in vitro activity against H. pylori. There are no consistent data on the impact of eradication therapy supplemented with probiotics on H. pylori cure rates in childhood in vivo. STUDY: Multicenter, prospective, randomized, double-blind controlled study. Eighty-six symptomatic H. pylori-positive children were randomized either to receive the control treatment of omeprazole, amoxicillin, and clarithromycin (OAC) for 7 days or the test treatment of omeprazole, amoxicillin, and clarithromycin for 7 days supplemented with fermented milk (Actimel) containing L. casei DN-114 001 (OAC-LC), for 14 days. H. pylori status was assessed at 4 weeks following therapy using two noninvasive tests. RESULTS: Intention-to-treat (ITT) based eradication rates for the OAC-LC group were 84.6% (95% CI, 71.2%-95.5%), and 91.6% (95% CI, 76.9%-98.2%) by per-protocol (PP) analysis. Eradication in the OAC group was 57.5% (95% CI, 42.2%-72.3%) in the ITT set and 61.3% (95% CI, 44.4%-75.0%) in the PP group. Eradication success was higher in the OAC-LC group compared with the OAC group in both ITT (P=0.0045) and PP analysis (P=0.0019). Primary resistance for clarithromycin could be determined in 21.2%. Side effects were infrequent. Drug compliance was good throughout the study. CONCLUSION: Supplementation with fermented milk, containing live special probiotic L. casei DN-114 001, confers an enhanced therapeutic benefit on H. pylori eradication in children with gastritis on triple therapy.     

Clinical evaluation of four one-week triple therapy regimens in eradicating Helicobacter pylori infection

AIM: To evaluate clinical efficacy of four one-week triple therapies in eradicating Helicobacter pylori infection. METHODS: In this clinical trial, 132 patients with duodenal ulcer and chronic gastritis were randomly divided into four groups, and received treatment with OAC (omeprazole 20 mg + amoxicillin 1 000 mg + clarithromycin 250 mg), OFC (omeprazole 20 mg + furazolidone 100 mg + clarithromycin 250 mg), OFA (omeprazole 20 mg + furazolidone 100 mg + amoxicillin 1 000 mg) and OMC (omeprazole 20 mg + metronidazole 200 mg + clarithromycin 250 mg), respectively. Each drug was taken twice daily for one week. The (13)C urea breath test was carried out 4-8 weeks after treatment to determine the success of H pylori eradication. RESULTS: A total of 127 patients completed the treatment. The eradication rate for H pylori infection was 90.3%, 90.9%, 70.9% and 65.6%, respectively in OAC, OFC OMC and OFA groups. CONCLUSION: A high eradication rate can be achieved with one-week OAC or OFC triple therapy. Thus, one-week triple therapies with OAC and OFC are recommended for Chinese patients with duodenal ulcers and chronic gastritis.     

One week of treatment with esomeprazole-based triple therapy eradicates Helicobacter pylori and heals patients with duodenal ulcer disease.

BACKGROUND: Proton pump inhibitor (PPI) monotherapy is commonly continued for 3 weeks after Helicobacter pylori eradication with PPI-based triple therapy regimens to ensure duodenal ulcer (DU) healing. This randomized, double-blind, multicentre study evaluated whether only 1 week of triple therapy with the new PPI esomeprazole was sufficient to ensure high rates of ulcer healing and H. pylori eradication. METHODS: A total of 446 H. pylori-positive patients with active DU received twice daily treatment with esomeprazole 20 mg (n = 222) or omeprazole 20 mg (n = 224) in combination with amoxicillin 1 g and clarithromycin 500 mg for 1 week (EAC and OAC, respectively). Patients in the OAC group then received 3 weeks' monotherapy with omeprazole 20 mg once daily; those treated with EAC received placebo. Ulcer healing was assessed by endoscopy on completion of therapy and H. pylori status was assessed by (13)C-urea breath testing and histology 4-6 weeks later. RESULTS: Ulcer healing rates (95% CI) for intention-to-treat and per-protocol populations were: EAC + placebo 91% (87-95%) and 94% (90-97%); OAC + omeprazole 92% (88-95%) and 96% (92-98%). Corresponding H. pylori eradication rates were: EAC + placebo 86% (81-90%) and 89% (84-93%); OAC + omeprazole 88% (83-92%) and 90% (85-93%). Both eradication regimens were well tolerated, and patient compliance was high. CONCLUSIONS: A 1-week regimen of esomeprazole-based triple therapy is sufficient for DU healing and H. pylori eradication in patients with DU disease.     

Quadruple therapy with lactoferrin for Helicobacter pylori eradication: A randomised, multicentre study

BACKGROUND: Helicobacter pylori eradication rate with standard triple therapies is decreasing. Recently, lactoferrin administration has been shown to significantly increase the cure rate of 7-day rabeprazole, clarithromycin and tinidazole triple therapy. We assessed whether lactoferrin also increases the eradication rate of 7-day esomeprazole, clarithromycin and amoxycillin triple therapy as first-line treatment. METHODS: Overall, 133 consecutive patients with non-ulcer dyspepsia and H. pylori infection were randomised to receive either a standard 7-day triple therapy with esomeprazole 20mg b.i.d., clarithromycin 500 mg b.i.d. and amoxycillin 1g b.i.d. (68 patients) or a quadruple therapy comprising of the same regimen plus lactoferrin 200mg b.i.d. (65 patients). H. pylori at entry was assessed by endoscopy, while bacterial eradication was checked by (13)C urea breath test 4-6 weeks after treatment. RESULTS: H. pylori eradication following standard triple therapy was achieved in 53/68 (77.9%; 95% CI = 68-88) and in 53/66 (80.3%; 95% CI = 71-89) patients at ITT and PP analyses, respectively. Following the quadruple regimen, the infection was cured in 50/65 (76.9%; 95% CI = 67-87) and 50/64 (78.1%; 95% CI = 68-88) patients at ITT and PP analyses, respectively. No statistically significant difference emerged between the two therapeutic regimens, both at ITT (p = 0.9) and PP analyses (p = 0.9). Side effects were complained by seven (10.3%) patients and six (9.2%) patients following the triple and quadruple regimens, respectively (p = 0.9), with only one patient in the quadruple group interrupting the treatment due to side effects. CONCLUSIONS: Quadruple therapy with lactoferrin did not significantly increase the H. pylori cure rate of standard 7-day clarithromycin-amoxycillin based triple therapy in non-ulcer dyspepsia patients.     

A randomized trial comparing seven-day ranitidine bismuth citrate and clarithromycin dual therapy to seven-day omeprazole, clarithromycin and amoxicillin triple therapy for the eradication of Helicobacter pylori.

OBJECTIVE: To assess Helicobacter pylori eradication after one week dual ranitidine bismuth citrate-clarithromycin (RBC-C) or triple omeprazole, clarithromycin and amoxicillin (OCA) therapy. METHODS: In this multicentre Canadian trial, H pylori-positive patients with functional dyspepsia or inactive peptic ulcer disease were randomized to open-label treatment with RBC-C (ranitidine bismuth citrate 400 mg plus clarithromycin 500 mg) or OCA (omezaprole 20 mg, clarithromycin 500 mg and amoxicillin 1000 mg), given twice a day for seven days. Treatment allocation was randomly assigned. H pylori infection was confirmed by positive 13C-urea breath test (13C-UBT). H pylori status was reassessed by UBT at least four and 12 weeks after treatment (negative: d13CO2 below 3.5 per mil). Intention-to-treat (ITT) eradication rates were determined for all patients with confirmed H pylori infection. Per protocol (PP) rate was determined for all patients treated with at least two evaluable follow-up visits. RESULTS: Three hundred five patients were included in the ITT and 222 in the PP analysis. The ITT eradication rates were 66% for RBC-C and 78% for OCA. The PP success rates were 84% for RBC-C and 96% for OCA. The difference for both ITT 12% (95% CI 2 to 22) and PP 12% (95% CI 4 to 19) were statistically significant, P=0.030 and P=0.007, respectively. Treatment was generally well tolerated. CONCLUSION: The eradication rate for the seven-day dual RBC-C regimen was lower than that for OCA.     

Comparison of the effectiveness of quadruple salvage regimen for Helicobacter pylori infection according to the duration of treatment]

BACKGROUND/AIMS: At present, triple therapy schemes are recommended by national and international consensus conferences for the treatment of Helicobacter pylori (H. pylori) infection. However, even with the most effective current treatment regimens, about 10-20% of patients fail to eradicate H. pylori, necessitating alternative strategy to eradicate H. pylori in primary treatment failure. Therefore, we performed this study to evaluate the efficacy of quadruple therapy and to compare 1 and 2-week quadruple regimen as a second-line therapy. METHODS: The hospital records of 155 patients who failed to the standard triple therapy (proton pump inhibitor, amoxicillin, clarithromycin) were reviewed retrospectively, and divided the 1 or 2 weeks OBMT regimen (omeprazole 20 mg bid, bismuth salt 120 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid). Presence of H. pylori infection and side-effects of the treatment regimen were assessed 4 weeks after the cessation of treatment. RESULTS: One hundred and eight male and 47 female (mean age, 52.2+/-15.4) patients were enrolled. The overall eradication rate of H. pylori with quadruple therapy was 83.9% and the eradication rate was similar between 1 and 2 weeks of OBMT regimen (76.8% in OBMT 1 week, 87.9% in OBMT 2 weeks, respectively p=0.110). CONCLUSIONS: Quadruple therapy is an effective salvage regimen for H. pylori eradication after the failure of standard triple therapy. One week quadruple therapy is not significantly different from 2-weeks regimen as the second-line option for H. pylori eradication.     

Two-day quadruple therapy for cure of helicobacter pylori infection: a comparative, randomized trial

Objective: We sought to compare a 2-day quadruple therapy with a 14-day triple therapy in the treatment of Helicobacter pylori infection.
Methods: Eighty-one consecutive patients with an endoscopically diagnosed peptic ulcer and demonstrated infection by H. pylori were included in the study. Patients were randomized to receive omeprazole 40 mg b.i.d. , amoxicillin 2.5 g once daily, metronidazole 500 mg t.i.d. , and bismuth subcitrate 360 mg t.i.d. for 2 days, followed by omeprazole 20 mg once daily for 6 additional days (Group 1) or a 14-day course of omeprazole 20 mg b.i.d. , amoxicillin 1 g t.i.d. , and metronidazole 500 mg t.i.d. (Group 2). Eradication was evaluated by antral biopsy and rapid urease test at 2 months after therapy and by C¹³-urea breath test after a year.
Results: Two patients were lost to follow-up at 2 months. Intention-to-treat analysis showed that H . pylori infection was cured in 29 of 42 patients (69%; 95% CI: 53–82%) in Group 1 versus 36 of 39 (92%; 95% CI: 78–98%) of patients in Group 2 (   p = 0.009  ). Per-protocol analysis showed a cure rate of 71% (95% CI: 55–84%) (29/41 patients) and 95% (95% CI: 81–99%) (36/38 patients), respectively (   p = 0.007  ). Fifty-five of 65 cured patients returned 1 year after treatment (26 in Group 1, 29 in Group 2). All but one in Group 2 remained cured. There were no significant differences in compliance (88% in Group 1 versus 92% in Group 2) or in the presence of side effects (27%; 95% CI: 15–43% versus 41%; 95% CI: 26–58%; ns).
Conclusion: Two-day quadruple therapy is significantly less effective than 2-wk triple treatment.     

Third-line rescue therapy with levofloxacin after two H. pylori treatment failures

AIM: Eradication therapy with proton pump inhibitor, clarithromycin and amoxicillin fails in a considerable number of cases. A rescue therapy still fails in more than 20% of the cases. Our aim was to evaluate the efficacy and tolerability of a third-line levofloxacin-based regimen in patients with two consecutive Helicobacter pylori eradication failures. METHODS: Design: Prospective multicenter study. Patients: In whom a first treatment with omeprazole-clarithromycin-amoxicillin and a second with omeprazole-bismuth-tetracycline-metronidazole (or ranitidine bismuth citrate with these antibiotics) had failed. Intervention: A third eradication regimen with levofloxacin (500 mg b.i.d.), amoxicillin (1 g b.i.d.), and omeprazole (20 mg b.i.d.) was prescribed for 10 days. Outcome: Eradication was confirmed with 13C-urea breath test 4-8 wk after therapy. RESULTS: One-hundred patients were initially included, and nine were lost for follow-up. All patients but five took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 66% (95% CI = 56-75%) and 60% (50-70%). Adverse effects were reported in 25% of the patients, mainly including metallic taste (8%), nausea (8%), myalgia/arthralgia (5%), and diarrhea (4%); none of them were severe. CONCLUSION: Levofloxacin-based rescue therapy constitutes an encouraging empirical third-line strategy after multiple previous H. pylori eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole, and tetracycline.     

The efficacy of bismuth containing quadruple therapy as a first-line treatment option for Helicobacter pylori

BACKGROUND: Helicobacter pylori eradication rates have tended to decrease recently, mostly due to increasing antibiotic-resistance. The present study aimed to compare the efficacy of bismuth-based quadruple regimen with proton pump inhibitor-based triple regimen for eradication of H. pylori. METHODS: Consecutive H. pylori-positive patients with non-ulcer dyspepsia were randomized into one of two regimens: (i) bismuth subsalicylate 300 mg q.i.d., lansoprazole 30 mg b.i.d., tetracycline 500 mg q.i.d. and metronidazole 500 mg t.i.d. (BLTM group) for 14 days; (ii) lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d. (LAC) for 14 days. Gastroscopy and (14)C-Urea breath test (UBT) were performed before enrollment, and UBT only was repeated for 6 weeks after treatment. RESULTS: A total of 240 patients were randomized into groups and 212 of them completed the protocols. The 'intention-to-treat' (ITT) and 'per protocol' (PP) H. pylori eradication rates were 70% (95%CI 61-78) and 82.3% (95%CI 74-89) in the BLTM group, and 57.5% (95%CI 48-66) and 62.7% (95%CI 53-71) in the LAC group. The BLTM treatment achieved a significantly better eradication rate compared with LAC treatment in PP analysis (82.3% vs. 62.7%, P = 0.002). Mild to severe side-effects, which were more frequent in the BLTM group, were reported in 18.2% of the patients. CONCLUSION: The bismuth-based quadruple regimen achieved a better eradication rate compared with proton pump inhibitor-based triple regimens as a first-line eradication option for H. pylori in our population.