Use of imidazole-based eradication regimens for Helicobacter pylori should be abandoned in North India regardless of in vitro antibiotic sensitivity

BACKGROUND AND AIM: The purpose of this study was to compare the efficacy of tinidazole- versus clarithromycin-based triple regimens for eradication of Helicobacter pylori in North Indian patients of peptic ulcer disease, and to correlate the outcome with in vitro antibiotic susceptibility. METHODS: One hundred and forty-six H. pylori-infected patients with active ulcer were included in the prospective, randomized study. A total of 70 patients received lansoprazole 30 mg b.d., amoxycillin 1000 mg b.d. and tinidazole 500 mg b.d. (LAT), and 76 patients received lansoprazole 30 mg b.d., amoxycillin 1000 mg b.d. and clarithromycin 500 mg b.d. (LAC) for 14 days. The H. pylori status was assessed by urea breath test, rapid urease test, and histology and antibiotic sensitivity pattern by Epsilometer test. RESULTS: In per-protocol analysis of 112 patients the H. pylori eradication rate was 42.3% (95% confidence interval (CI): 0.29-0.56) in LAT, and 64.8% (95%CI: 0.52-0.78) in LAC (95%CI of difference of proportions: 0.13-0.33, P = 0.01). Ulcer healed in 69.2% in the LAT group (95%CI: 0.57-0.82) and 81.7% in the LAC group (95%CI: 0.72-0.92; P = 0.02). Antibiotic susceptibility testing was done in 31 patients. Metronidazole resistance was present in 41.9% isolates but was unrelated to the outcome of the LAT regimen. CONCLUSION: Imidazole-based eradication regimens should be abandoned in North India regardless of in vitro susceptibility results.     

Treatment of Helicobacter pylori in surgical practice： A randomised trial of triple versus quadruple therapy in a rural district general hospital

AIM： To compare a lansoprazole-based triple versus quadruple therapy for Helicobacter pylori （H pylori） eradication with emphasis on side effect profile, patient compliance and eradication rate at a rural district general hospital in Wales, United Kingdom. METHODS： One hundred one patients with H pylori infection were included in the study. Patients were randomised to receive triple therapy comprising of lansoprazole 30 mg, amoxycillin 1 g, clarithromycin 500 mg, all b.d. （LAC）, or quadruple therapy comprising of lansoprazole 30 mg b.d., metronidazole 500 mg t.d.s., bismuth subcitrate 240 mg b.d., and tetracycline chloride 500 mg q.d.s. （LMBT）. Cure was defined as a negative 13C urea breath test 2 mo after treatment. RESULTS： Seven patients were withdrawn after randomisation. Fifty patients were assigned to LAC group and 44 to LMBT group. The intention-to-treat cure rates were 92% and 91%, whereas the perprotocol cure rates were 92% and 97%, respectively. Side effects were common, with 56% experiencingmoderate to severe symptoms in the LAC group and 59% in the LMBT group. Symptoms of vomiting, diarrhoea and black stools were significantly more common in the LMBT group. Patient compliance was 100% for triple therapy and 86% for quadruple therapy （P 〈 0.01）. One-third of patients in both groups were still taking acid-reducing medications at six-month follow-up. CONCLUSION： One-week triple and quadruple therapies have similar intention-to-treat eradication rates. Certain side effects are more common with quadruple therapy, which can compromise patient compliance. Patient education or modifications to the regimen are alternative options to improve compliance of the quadruple regimen.     

Eradication rates of helicobacter pylori infection with second-line treatment: non-ulcer dyspepsia compared to peptic ulcer disease

BACKGROUND/AIMS: Initial proton pump inhibitor (PPI)-based triple therapy for Helicobacter pylori (H. pylori) infection is less effective in patients with nonulcer dyspepsia (NUD) than those with peptic ulcer disease (PUD). To date, there have been no studies on the difference in eradication rates in NUD compared to PUD with regard to second-line therapy. Therefore, we retrospectively analyzed the difference in eradication rates of a second-line quadruple therapy for NUD and PUD patients. METHODOLOGY: Between June 2003 and December 2005, patients who failed to respond to initial PPI-based triple therapy, received 7 days of quadruple therapy (PPI b.i.d., bismuth 300mg q.i.d., metronidazole 500mg t.i.d., tetracycline 500mg q.i.d.) as a second-line treatment regimen. Four weeks after the completion of the course of medication, a 13C-urea breath test was performed for detection of H. pylori. RESULTS: A total of 87 patients received second-line quadruple therapy. Of these, 43 patients had NUD and 44 patients had PUD (19 gastric ulcers, 23 duodenal ulcers, 2 both ulcers). The eradication rates were 76.7% (33/43) in the NUD group and 90.9% (40/44) in the PUD group by per-protocol analysis. Therefore, the eradication rates in the NUD group were significantly lower than those in the PUD group (p = 0.034). CONCLUSIONS: A 7-day bismuth-based second-line quadruple therapy for H. pylori infection was less effective in patients with NUD than those with PUD. Therefore, a more potent second-line treatment regimen or extension of treatment duration of quadruple therapy should be considered for the eradication of H. pylori in patients with NUD.     

Helicobacter pylori eradication using tetracycline and furazolidone versus amoxicillin and azithromycin in lansoprazole based triple therapy: an open randomized clinical trial

BACKGROUND: Optimal anti-Helicobacter pylori treatment has not yet been established. AIM: To evaluate H. pylori eradication using tetracycline and furazolidone versus amoxicillin and azithromycin in lansoprazole based triple therapy in northeastern of Brazil. PATIENTS AND METHODS: One hundred and four patients with H. pylori infection, as determined by rapid urease testing and histology, were randomly assigned to receive either: lansoprazole (30 mg q.d.), tetracycline (500 mg q.i.d.), and furazolidone (200 mg t.i.d.) for 7 days (LTF; n = 52); or lansoprazole (30 mg b.i.d.) and amoxicillin (1 g b.i.d.) for 1 week, plus azithromycin (500 mg q.d.) for the first 3 days (LAAz; n = 52). H. pylori eradication was assessed 3 months following completion of therapy by means of rapid urease testing, histology and a 14C-urea breath test. RESULTS: H. pylori eradication was achieved in 46 of 52 (88.4%, 95% CI: 77.5%-95.1%) patients in LTF group and in 14 of 52 (26.9%, 95% CI: 16.2%-40,1%) patients in LAAz group. On a per-protocol analysis, eradication rates were 91.8% (95% CI: 81.4%-97.3%) and 28.5% (95% CI: 17.2%-42.3%), respectively in LTF and LAAz groups. CONCLUSION: The LAAz regimen yielded unacceptably low eradication rates. On the other hand, the LTF scheme represents a suitable alternative for H. pylori eradication.     

Levofloxacin-based triple therapy versus bismuth-based quadruple therapy for persistent Helicobacter pylori infection: a meta-analysis

BACKGROUND: Levofloxacin-based triple therapy has been suggested as an alternative salvage therapy to bismuth-based quadruple therapy for persistent Helicobacter pylori (H. pylori) infection.METHODS: A search of PUBMED, EMBASE, EBM Review databases and abstracts from recent Digestive Disease Week, United European Gastroenterology Week, and European Helicobacter Study Group conferences was performed. Randomized controlled trials (RCTs) comparing levofloxacin-based triple salvage therapy (levofloxacin + amoxicillin + PPI) to bismuth-based quadruple salvage therapy (bismuth + tetracycline + metronidazole + PPI) were selected for meta-analysis. Additionally, all prospective trials evaluating this levofloxacin-based triple therapy as salvage therapy were pooled to analyze optimal levofloxacin treatment duration and dosing. All selected trials confirmed prior treatment failure and post-salvage treatment eradication.RESULTS: Four RCTs compared a 10-day regimen of levofloxacin-based triple therapy to 7-day bismuth-based quadruple therapy (n = 391 patients). Levofloxacin-based triple therapy was superior to quadruple therapy (RR = 1.41 [95% CI: 1.25-1.59]). Levofloxacin-based triple therapy was better tolerated than quadruple therapy with a lower incidence of side effects (RR = 0.51 [95% CI: 0.34-0.75]) and side effects prompting discontinuation of therapy (RR = 0.30 [95% CI: 0.10-0.89]). Eleven trials (n = 547 patients) evaluating levofloxacin-based triple therapy demonstrated higher eradication rates with 10-day versus 7-day regimen (87%[95% CI: 82%-92%]vs 68%[95% CI: 62%-74%]) yet eight trials (n = 477 patients) demonstrated no difference with 500 mg daily versus 250 mg b.i.d. dosing of levofloxacin (81%[95% CI: 78%-89%]vs 84%[95% CI: 66%-97%]).CONCLUSIONS: A 10-day course levofloxacin triple therapy is more effective and better tolerated than 7-day bismuth-based quadruple therapy in the treatment of persistent H. pylori infection.     

Pre-treatment urea breath test results predict the efficacy of Helicobacter pylori eradication therapy in patients with active duodenal ulcers

AIM: To evaluate the association of pre-treatment ^13C-urea breath test (UBT) results with H pylori density and efficacy of eradication therapy in patients with active duodenal ulcers. METHODS: One hundred and seventeen consecutive outpatients with active duodenal ulcer and H pylori infection were recruited. H pylori density was histologically graded according to the Sydney system. Each patient received lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) for i week. Acoording to UBT values, patients were allocated into low (<16‰), intermediate (16-35‰), and high (>35‰) UBT groups. RESULTS: A significant correlation was found between pre-treatment UBT results and Hpylori density (P<0.001). H pylori eradication rates were 94.9%, 94.4% and 81.6% in the low, intermediate and high UI3T groups, respectively (per protocol analysis, P=0.11). When patients were assigned into two groups (UBT results ≤35 and >35‰), the eradication rates were 94.7% and 81.6%, respectively (P=0.04). CONCLUSION: The intragastric bacterial load of H pylori can be evaluated by UBT, and high pre-treatment UBT results can predict an adverse outcome of eradication therapy.     

Ranitidine Bismuth Citrate With Clarithromycin Given Twice Daily Effectively Eradicates Helicobacter pylori and Heals Duodenal Ulcers

Objective : Ranitidine bismuth citrate (RBC) b.i.d. with Clarithromycin q.i.d. eradicates Helicobacter pylori (H. pylori ) in 82–94% of patients, and heals duodenal ulcers in 88–90% of patients. This double blind, placebo-controlled study examines the efficacy of a simpler b.i.d. treatment regimen, and examines the potential benefit of including a second antibiotic, metronidazole, to the b.i.d. treatment regimen. Methods : A total of 648 patients with active duodenal ulcer received RBC 400 mg b.i.d. for 4 wk, coprescribed with Clarithromycin 250 mg q.i.d. , Clarithromycin 500 mg b.i.d. , or Clarithromycin 500 mg b.i.d. with metronidazole 400 mg b.i.d. for the first 2 wk of treatment. Endoscopies were performed prestudy, after 4 wk of treatment, and at least 4 wk posttreatment. H. pylori status was assessed by CLOtest, ¹³C-urea breath test (UBT), and histology prestudy, and by UBT and histology at least 4 wk posttreatment. Adverse events were recorded at each visit. Results : All three regimens were highly effective and well tolerated. H. pylori eradication rates were 84–94% and duodenal ulcer healing rates were 92–96% (observed data). Highest H. pylori eradication and ulcer healing rates were achieved with RBC 400 mg b.i.d. with Clarithromycin 500 mg b.i.d. Conclusion : Ranitidine bismuth citrate with Clarithromycin 500 mg b.i.d. provides an effective, simple and well tolerated regimen for the eradication of H. pylori and healing of duodenal ulcers.     

Rabeprazole in a one-week eradication therapy of Helicobacter pylori: comparison of different dosages

AIM: Many data regarding omeprazole-, lanzoprazole- and pantoprazole-based triple therapy for Helicobacter pylori (H. pylori) eradication have been reported, but there is few data present regarding rabeprazole (R). We report the efficacy and tolerability of rabeprazole in different dosages in association with clarithromycin (C)and tinidazole (T) in H. pylori eradication. DESIGN AND METHODS: Ninety-four H. pylori-positive patients with dyspeptic symptoms were enrolled and randomly allocated to eradication therapy in two different one-week regimens. In regimen A, 47 patients received R 20 mg b.i.d, C 500 mg b.i.d and T 500 mg b.i.d, while in regimen B, 47 patients received R 10 mg b.i.d, C 500 mg b.i.d and T 500 mg b.i.d. Eradication of H. pylori was evaluated by a 13C urea breath test (UBT) two months after the end of the therapy. RESULTS: Four patients (two in each regimen) did not complete treatment. The H. pylori eradication rate was 91.4% in group A compared to 89.3% in group B (P-value not significant). Minor side-effects were reported in 4.2% of group A and 6.4% of group B patients. CONCLUSION: Rabeprazole showed good efficacy and tolerability in one-week H. pylori therapy at 20 mg b.i.d and 10 mg b.i.d, suggesting the use of the lower dosage.     

Poor efficacy of ranitidine bismuth citrate-based triple therapies for Helicobacter pylori eradication.

BACKGROUND: Helicobacter pylori eradication rates have tended to decrease recently possibly related with increasing antibiotic resistance. The present study investigated the efficacy of three different ranitidine bismuth citrate (RBC) based triple regimens in a population with high prevalence of H. pylori. METHODS: 300 consecutive H. pylori positive patients with non-ulcer dyspepsia were randomized into three regimens: (1) RBC 400 mg, amoxicillin 1000 mg and tetracycline 500 mg [RBC-AT], (2) RBC 400 mg, amoxicillin 1000 mg and clarithromycin 500 mg [RBC-AC], (3) RBC 400 mg, metronidazole 500 mg and tetracycline 500 mg [RBC-MT]. Tetracycline was given q.i.d, all other drugs were given b.i.d. for 14 days. Gastroscopy and (14)C-Urea breath test (UBT) were performed before enrollment and UBT only was repeated 6 weeks after the end of treatment. RESULTS: 274 patients completed the protocols. The overall 'intention to treat' and 'per protocol' H. pylori eradication rates in all subjects were 57.6% (95% CI: 52-63) and 63.1% (95% CI: 57-68), respectively. The eradication rates achieved in the groups (RBC-AT, RBC-AC and RBC-MT) were 64.4% (95% CI: 54-74), 66.2% (95% CI: 56-76), and 58.9% (95% CI: 49-68) on 'per protocol' analyses, respectively. There was no difference in eradication rates, compliance and major side effects between the groups. CONCLUSION: The current RBC-based H. pylori eradication therapy is not adequately effective.     

Efficacy of short‐course lansoprazole with clarithromycin and amoxicillin in the eradication of Helicobacter pylori in South‐East Asian patients: 5‐day t.d.s. versus 7‐day b.d. treatment regimens

OBJECTIVE : To determine and compare the efficacy of 5‐day t.d.s and 7‐day b.d. treatment regimens comprising lansoprazole, clarithromycin and amoxicillin in the eradication of Helicobacter pylori. METHODS : Patients with unequivocal evidence of H. pylori infection based on histology and rapid urease tests of both antrum and corpus biopsies were recruited for the study. The study was a randomized, investigator‐blind, comparative study. Patients received either 500 mg clarithromycin t.d.s. and 500 mg amoxicillin t.d.s. for 5 days (LAC5) or 500 mg clarithromycin b.d. and 500 mg amoxicillin b.d. for 7 days (LAC7) together with 30 mg lansoprazole (both groups) daily for either 5 or 7 days, depending on the treatment group. Patients were assessed for the successful eradication of H. pylori, defined as the absence of bacteria based on histology and urease tests on both antral and corporeal biopsies, carried out at least 4 weeks after completion of the therapy. RESULTS : One hundred and eight patients were recruited for the study. In the LAC5 treatment group, four patients failed to return for follow up and in the LAC7 group, two failed to return for follow up and two were not compliant with medications. Eradication rates based on an intention‐to‐treat analysis were: 46/54 for LAC5 (85.2%; 95% CI = 72.9–93.4) and 47/54 for LAC7 (87.0%; 95% CI = 75.1–94.6). Based on a per protocol analysis, the rates were: 46/50 for LAC5 (92.0%; 95% CI = 80.8–97.8) and 47/50 for LAC7 (94.0%; 95% CI = 83.5–98.7). Both treatment regimens were convenient for patients and except for two patients in the LAC7 group, all patients reported taking 100% of all prescribed medications. The side‐effects encountered were uniformly mild and no patient discontinued treatment because of intolerance to medications. The most common side‐effects were altered taste (LAC5 64.7%; LAC7 78.8%). Diarrhea, nausea and anorexia were reported in a minority of patients. CONCLUSIONS : Both the LAC5 t.d.s. and the LAC7 b.d. treatment regimens were well tolerated by patients and were highly effective in the eradication of H. pylori.     

Randomized Comparison of Ranitidine Bismuth Citrate-Based Triple Therapies for Helicobacter pylori

Objectives: In an attempt to increase the efficacy and simplicity of FDA-approved regimens for Helicobacter pylori , we studied (1) addition of an inexpensive antibiotic (amoxicillin) to twice-daily ranitidine bismuth citrate (RBO-clarithromycin dual therapy, and (2) substitution of RBC for bismuth subsalicylate + H2-receptor antagonist in bismuth-based triple therapy. Methods : Subjects with previously untreated Helicobacter pylori infection documented by ¹³C-urea breath test plus either endoscopic biopsy or serology were randomly assigned to a 2-wk course of (1) RBC 400 mg b.i.d. , amoxicillin 1 g b.i.d. , and clarithromycin 500 mg b.i.d. (RAC), or (2) RBC 400 mg b.i.d. , metronidazole 250 mg t.i.d. , and tetracycline 500 mg t.i.d. (RMT). Repeat breath test was performed 4 wk after the completion of therapy. Results : Intent-to-treat and per-protocol cure rates for RAC were 46 of 50 patients (92%) and 45 of 47 patients (96%); for RMT they were 40 of 50 patients (80%) and 37 of 42 patients (88%). Study drugs were stopped due to side effects in three patients (6%) taking RAC and six patients (12%) taking RMT. Conclusions : Twice-daily RBC-based triple therapy with clarithromycin and amoxicillin produces Helicobacter pylori eradication rates over 90%, which is comparable to rates seen with proton pump inhibitor-based triple therapies. RBC also may be substituted for bismuth subsalicylate and an + H2-receptor antagonist in standard bismuth-based triple therapy.     

A randomized controlled comparison of three quadruple therapy regimens in a population with low Helicobacter pylori eradication rates

BACKGROUND AND AIM: We sought to compare the efficacy and tolerability of an omeprazole/clarithromycin/bismuth/tetracycline-based quadruple therapy to that of a ranitidine/metronidazole/bismuth/tetracycline-based quadruple therapy of 2 or 3 weeks duration in a population with a high prevalence of metronidazole-resistant Helicobacter pylori and low triple therapy eradication rates. METHODS: Two hundred and twenty-one patients who presented endoscopically proven duodenal ulcers and a positive rapid urease test were randomized to receive either: (i) omeprazole 20 mg b.i.d., clarithromycin 250 mg b.i.d., bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d (OCBT) for 2 weeks; (ii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT2) for 2 weeks; or (iii) ranitidine 300 mg b.i.d., metronidazole 500 mg b.i.d, bismuth subcitrate 240 mg b.i.d. and tetracycline 500 mg b.i.d. (RMBT3) for 3 weeks. Patients were interviewed 2 weeks after the completion of therapy to review compliance and side-effects. Eradication of H. pylori was assessed 8 weeks after the completion of therapy with the use of a 14C-urea breath test. RESULTS: The per-protocol eradication rate was significantly higher with OCBT (88%) than RMBT2 (73%) or RMBT3 (71%) (P<0.05). The intent-to-treat eradication rate was numerically higher with OCBT (80%) than RMBT2 (68%) or RMBT3 (68%), although this difference did not reach statistical significance (P=0.09). Per-protocol or intent-to-treat eradication rates were similar with RMBT2 and RMBT3. There were significantly greater side-effects with the RMBT2 regimen. CONCLUSIONS: The omeprazole/clarithromycin/bismuth/tetracycline-based quadruple therapy provides higher H. pylori eradication rates than the ranitidine/metronidazole/bismuth/tetracycline-based quadruple therapy when administered per protocol. The prolongation of the latter regimen from 2 to 3 weeks did not increase eradication rates.     

Recent success of pantoprazole -or lansoprazole- based clarithromycin plus amoxicillin treatment in the eradication of Helicobacter pylori.

BACKGROUND/AIMS: There are some reports showing that resistance of Helicobacter pylori (H. pylori) to clarithromycin has increased in recent years. We aimed to investigate the current success of a most popular first-line eradication regimen by using two different proton pump inhibitors: lansoprazole and pantoprazole. METHODS: Ninety patients with H. pylori-positive functional dyspepsia were randomized to receive pantoprazole 40 mg b.i.d. or lansoprazole 30 mg b.i.d. in addition to amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 14 days in a multicenter study. H. pylori infection was determined by histological examination and a rapid urease test. A follow-up endoscopy was performed to assess the H. pylori eradication six weeks after the end of therapy. RESULTS: Seventy-nine patients completed the study protocol properly. The H. pylori eradication rates according to per protocol analysis were 70% in group pantoprazole, amoxicillin and clarithromycin (28/40) and 69.2% in group pantoprazole, amoxicillin and clarithromycin (27/39). The eradication rates according to intention to treat analysis were 62.2% and 60% in lansoprazole, amoxicillin, clarithromycin, pantoprazole, amoxicillin, clarithromycin groups, respectively. The eradication rates were similar in both protocols (p>0.05). CONCLUSIONS: The most popular first-line eradication protocols of H. pylori achieved only a moderate success in the current study. Alternative therapy options are needed instead of clarithromycin-based triple treatment for eradication of H. pylori. The choice of proton pump inhibitor is not important in the eradication rate of H. pylori.     

Efficacy of levofloxacin-based triple therapy as second-line Helicobacter pylori eradication]

BACKGROUND/AIMS: Bismuth-based quadruple therapy for second-line eradication treatment achieves the eradication rate ranging from 70% to 81% due to antimicrobial resistance and poor compliance. The aim of this study was to compare the eradication rate of levofloxacin-based triple therapy with that of bismuth-based quadruple therapy in second-line Helicobacter pylori (H. pylori) eradication therapy. METHODS: Seventy-six outpatients with persistent H. pylori infection after first-line triple therapy were enrolled in this prospective randomized trial. The subjects were randomized to receive levofloxacin 300 mg, amoxicillin 1 g, and pantoprazole 20 mg, given twice daily for 7 days (LAP group), or metronidazole 500 mg twice, tetracycline 500 mg four times, and pantoprazole 20 mg twice, bismuth subcitrate 600 mg twice daily for 7 days (MTPB group). Eradication was confirmed with (13)C-urea breath test or rapid urease test 4 weeks after the cessation of therapy. RESULTS: Among Seventy-six patients initially included, eleven were lost during follow-up. The eradication rates, expressed as intention to treat (ITT) and per protocol (PP) analyses, were 51.6% and 53.3% in the LAP group, and 48.9% and 62.9% in the MTPB group, respectively. There was no significant difference in H. pylori eradication rates between the two groups (p=0.815 by ITT, p=0.437 by PP). LAP regimen was better tolerated than MTPB regimen with lower incidence of side effects (10.0% versus 31.4%, p=0.03). CONCLUSIONS: H. pylori eradication rates of levofloxacin-based triple therapy and bismuth-based quadruple therapy were not significantly different in second-line H. pylori eradication therapy, and low incidence of side effects was observed in levofloxacin-based triple therapy.     

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.     

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.     

Moxifloxacin-containing triple therapy after non-bismuth quadruple therapy failure for Helicobacter pylori infection

AIM: To assess the efficacy of moxifloxacin-containing triple therapy after non-bismuth quadruple therapy failure for Helicobacter pylori(H. pylori) eradication.METHODS: Between January 2010 and December 2012,we screened individuals who were prescribed non-bismuth quadruple therapy for H. pylori eradication. Among them,a total of 98 patients who failed non-bismuth quadruple therapy received 1-wk or 2-wk moxifloxacin-containing triple therapy(400 mg moxifloxacin once daily,and 20 mg of rabeprazole and 1 g of amoxicillin twice daily). H. pylori status was evaluated using the 13C-urea breath test 4 wk later,after treatment completion. The eradication rates were determined by intention-to-treat and per-protocol analyses.RESULTS: In total,60 and 38 patients received 1-wk and 2-wk moxifloxacin-containing triple therapy,respectively. The intention-to-treat and per-protocol eradication rates were 56.7%(95%CI: 45.0-70.0) and 59.6%(95%CI: 46.6-71.7) in the 1-wk group and 76.3%(95%CI: 63.2-89.5) and 80.6%(95%CI: 66.7-91.9) in the 2-wk group(P = 0.048 and 0.036,respectively). All groups had good compliance(95% vs 94.9%). Neither group showed serious adverse events,and the proportions of patients experiencing mild side effects were not significantly different(21.1% vs 13.9%). Clinical factors such as age,sex,alcohol and smoking habits,comorbidities,and presence of gastric or duodenal ulcer did not influence the eradication therapy efficacy. The efficacy of second-line eradication therapy did not differ significantly according to the firstline regimen.CONCLUSION: Two-week moxifloxacin-containing triple therapy showed better efficacy than a 1-wk regimen after non-bismuth quadruple therapy failure.Key words: Helicobacter pylori; Moxifloxacin-based triple; Non-bismuth quadruple; Second-line; Eradication     

Helicobacter pylori eradication with either quadruple regimen with lactoferrin or levofloxacin-based triple therapy: A multicentre study

BACKGROUND: Helicobacter pylori eradication rate following standard triple therapy is decreasing worldwide. A quadruple therapy with lactoferrin and a levofloxacin-based triple therapy has been found to achieve a very high (>90%) cure rate. This study aimed to confirm these encouraging results. METHODS: This was a prospective, open-label, randomised, multicentre, Italian study enrolling consecutive H. pylori infected patients. The infection at entry was assessed by endoscopy and biopsies (histology plus rapid urease test) in all patients, whilst bacterial eradication was assessed by 13C-urea breath test 4-6 weeks after therapy ended. Patients were randomised to receive either a 7-day, triple therapy with rabeprazole 20mg o.d., levofloxacin 500 mg o.d., and amoxycillin 1g b.i.d. (4 tablets/day) or a 7-day quadruple therapy comprising of rabeprazole 20mg, clarithromycin 500 mg, tinidazole 500 mg plus bovine lactoferrin 200mg, all given twice daily (10 tablets/day). RESULTS: Overall, 144 consecutive patients were enrolled in the study. Following the triple therapy, H. pylori infection was cured in 49 out of 72 (68.1%; 95% CI=57-79) patients and in 49 out of 71 (69.1%; 95% CI=58-80) at intention-to-treat and per protocol analyses, respectively. Following the quadruple regimen, the infection was cured in 52 out of 72 (72.2%; 95% CI=62-83) and in 52 out of 68 (76.5; 95% CI=66-87) patients at intention-to-treat and per protocol analyses, respectively. No statistically significant difference emerged between the two therapy regimens. CONCLUSIONS: H. pylori eradication rate following both quadruple therapy with lactoferrin and a low-dose PPI, triple therapy with levofloxacin is disappointingly low.     

Density of Helioobacterpylo／Ymay affect the efficacy of eradication therapy and ulcer healing in patients with active duodenal ulcers

AIM: To evaluate the association of pre-treatment Helicobacter pylori (H. pylori) density with bacterial eradication and ulcer healing rates in patients with active duodenal ulcer. METHODS: One hundred and four consecutive duodenal ulcer outpatients with H. pylori infection ascertained by gastric histopathology and (13)C-urea breath test (UBT) were enrolled in this study. H. pylori density was graded histologically according to the Sydney system (normal, mild, moderate, and marked). In each patient, lansoprazole (30 mg b.i.d.), clarithromycin (500 mg b.i.d.) and amoxicillin (1 g b.i.d.) were used for 1 week, then 30 mg lansoprazole once daily was continued for an additional 3 weeks. Follow-up endoscopy was performed at 4 weeks after completion of the therapy, and UBT was done at 4 and 8 weeks after completion of the therapy. RESULTS: The H. pylori eradication rates were 88.9 %/100.0 %, 94.3 %/100.0 %, and 69.7 %/85.2 %; and the ulcer healing rates were 88.9 %/100.0 %, 94.3 %/100.0 %, and 63.6 %/77.8 % (intention-to-treat/per protocol analysis) in the mild, moderate, and marked H. pylori density groups, respectively. The association of pretreatment H. pylori density with the eradication rate and ulcer healing rate was both statistically significant (P=0.013/0.006 and 0.002/<0.001, respectively; using results of intention-to-treat/per protocol analysis). CONCLUSION: Intragastric bacterial load may affect both the outcome of eradication treatment and ulcer healing in patients with active duodenal ulcer disease.     

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 H pylori eradication in a comparative threearmed 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 intentionto-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 side-effect 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 H pylori strains.