Bismuth-based quadruple therapy modified with moxifloxacin for Helicobacter pylori eradication.

BACKGROUND: The aim of this study was to evaluate the efficacy, tolerability and safety of modified bismuth-based quadruple therapy for the second-line eradication treatment of Helicobacter pylori (H. pylori) infection. METHODS: Out of 758 patients treated between January 2010 and December 2015, 155 patients (20.45%) remained H. pylori positive after the first line treatment and received the second-line treatment consisting of colloidal bismuth subcitrate (240 mg twice daily), pantoprazole (40 mg twice daily), metronidazole (500 mg twice daily) and moxifloxacin (400 mg once daily) for 14 days. Six weeks after the completion of treatment patients were retested for the presence of H. pylori infection with 13C urea breath test. RESULTS: Out of 155 patients, 142 patients completed their second-line regimens. 13 patients were excluded from the study: 4 experienced adverse effects that have led to discontinuation of treatment, 5 were lost to follow-up and 4 complied poorly with medication. The eradication rates were 80.64% (125/155) and 88.02% (125/142) according to intention-to-treat and per-protocol analyses. Compliance with the therapy was 89%. CONCLUSIONS: Moxifloxacin in modified bismuth-based quadruple therapy was found to be effective and safe with good drug compliance; therefore it may be an acceptable alternative to other second-line eradication protocols.

Do gender and age influence the frequency of Helicobacter pylori infection?

BACKGROUND: (13)C urea breath test (UBT) is a noninvasive method for detection of Helicobacter pylori (H. pylori) infection. The aim of this study was to determine age and gender differences in patients with positive UBT. PATIENTS AND METHODS: During the period 2008-2011, a total of 3,000 patients, who did not receive Hp eradication therapy before our study, underwent UBT in Laboratory of Clinical Hospital Sveti Duh. Data were analyzed according to age and gender. RESULTS: A total of 1,400 patients were positive (47 %), 670 males and 730 females (the male/female ratio for positive UBT was 0.92). The male predominance was found in people born between 1930 and 1939, 1940 and 1949, and 1960 and 1969, respectively. The majority infected are born between from 1940 and 1979, with the highest point from 1950-1969. CONCLUSIONS: Our study results confirm the importance of epidemiologic characteristics of Hp infection in our region.

The effectiveness of systemic eradication therapy against oral Helicobacter pylori.

BACKGROUND: Helicobacter pylori infection is associated with numerous gastroduodenal diseases. The oral cavity could be a potential extragastric reservoir for H. pylori, and oral H. pylori might cause gastric reinfection after the eradication therapy. The aim of the study was to evaluate the presence of H. pylori in oral cavity of patients with gastric H. pylori infection and to examine the effectiveness of the eradication therapy against H. pylori in stomach and in the oral cavity. METHODS: Fifty-six patients with chronic periodontitis and gastric H. pylori were enrolled in the study. Gastric H. pylori infection was determined using (13) C-urea breath test before and 3 months after eradication therapy. The presence of the oral H. pylori was assessed using polymerase chain reaction before and 3 months after eradication therapy. The 1-week eradication therapy consisted of amoxycilin 1 g, clarithromycin 500 mg, and proton pump inhibitor 20 mg twice a day. RESULTS: Of 56 subjects with gastric infection, 23 (41.1%) harbored H. pylori in the oral cavity. Eradication rate in stomach was 78.3%, whereas in the oral cavity, H. pylori was not detected from any sample after the eradication therapy. CONCLUSION: Almost half of the patients with gastric H. pylori harbored the bacterium in the oral cavity. After the eradication therapy, H. pylori was not detected in the oral cavity, what suggests high effectiveness of the therapy protocol in the oral cavity, or it is possible that oral H. pylori is of a transient character.

Antimicrobial resistance of H. pylori to the outcome of 10-days vs. 7-days Moxifloxacin based therapy for the eradication: a randomized controlled trial.

INTRODUCTION: Antibiotic resistance decreases success of Helicobacter pylori (Hp) eradication. Recently published results show low rate of resistance and better compliance with moxifloxacin based regiments. AIMS&METHODS: Whether 7 days moxifloxacin with lansoprasole and amoxycillin can be compared with 10 days moxifloxacin with lansoprasole and amoxycillin according to moxifloxacin resistance. Patients with non-ulcer dyspepsia who had culture and histology positive Hp infection (n = 150) were randomly assigned into two groups. The first group (n = 75) received moxifloxacin 400 mg/d during 7 days and the other (n = 75) received moxifloxacin 400 mg/d during 10 days. All patients received amoxycillin 1 g twice daily, lansoprasole 30 mg twice daily. All Hp cultures were tested for sensitivity to moxifloxacin. RESULTS: 138 patients (92%) completed the study, 68 in the first group and 70 in the second. Eradication rates were 84% (57/68) and 76% (57/75) in the 7 days moxifloxacin group and 90% and 84% in the second group (63/70, 63/75) according to the PP and ITT analysis; p = n.s. Among 129 patients (86% of study group), 6% of strains were primary resistant to moxifloxacin. Eradication of moxifloxacin sensitive/resistant strains was 98%/66%, p < 0.05. CONCLUSION: According to our results we recommend 7 days moxiflixacin based triple therapy.

Second-line treatment for Helicobacter pylori infection based on moxifloxacin triple therapy: a randomized controlled trial.

BACKGROUND: In eradication of Helicobacter pylori infection, standard quadruple second-line therapy consisting of proton pump inhibitor (PPI), bismuth, metronidazole and tetracycline often fails and shows poor patient compliance. The aim of our study was to evaluate the efficacy and tolerability of moxifloxacin-based triple therapy as an alternative second-line protocol. METHODS: A total of 160 patients, in whom the initial standard PPI triple therapy had failed to eradicate H. pylori infection, were included in the study. The initial H. pylori status was assessed using the (13)C-urea breath test. Patients were randomized to one of the following 7-day treatment regimens: (1) OMM: omeprazole 20 mg twice a day, moxifloxacin 400 mg/day, metronidazole 500 mg three times a day; and (2) OBMT: omeprazole 20 mg twice a day, colloidal bismuth subcitrate 120 mg four times a day, metronidazole 500 mg three times a day, tetracycline 500 mg four times a day. Patient compliance and adverse events were evaluated one week after completion of therapy. H. pylori status was re-assessed with the (13)C-urea breath test six weeks after the end of therapy. RESULTS: The eradication rates were 73.2% (60/82) and 78.9% (60/76) with moxifloxacin-based triple therapy, and 53.8% (42/78) and 64.6% (42/65) with bismuth-based quadruple therapy, by intention-to-treat (p = 0.018) and per-protocol (p = 0.088) analyses, respectively. Adverse events/intolerability were described in 12/82 patients in the OMM group and 18/78 patients in the OBMT group. Compliance with treatment was 92.7% in the OMM group and 83.3% in the OBMT group. CONCLUSION: Moxifloxacin-based triple therapy is a highly effective second-line eradication treatment in H. pylori infection. Because of its high levels of safety and tolerability, this protocol represents an adequate alternative to the standard bismuth-based quadruple therapy.

High eradication rate of H. pylori with moxifloxacin-based treatment: a randomized controlled trial.

INTRODUCTION: Eradication of Helicobacter pylori remains a problematic treatment issue in clinical practice. The intention is to find a treatment that achieves a high rate of eradication at a low price and treatment options that are now used give us the opportunity to achieve this goal. Recently published results showing a low rate of resistance and better compliance with moxifloxacin-based treatment regimens indicate the need to investigate its efficacy in H. pylori eradication. This study is based on proving the efficacy of moxifloxacin in H. pylori eradication within the triple therapy. AIMS AND METHODS: The aim of the study was to compare the efficacy of one week of moxifloxacin-based treatment with the standard treatment for H. pylori eradication. Patients with H. pylori infection and non-ulcer dyspepsia (n = 277) were randomly divided into four groups to receive: moxifloxacin 400 mg/d, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (MML group); moxifloxacin 400 mg/d, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (MAL group); clarithromycin 500 mg twice daily, metronidazole 400 mg twice daily, lansoprazole 30 mg twice daily (CML group); clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily, lansoprazole 30 mg twice daily (CAL group). The patients were assessed for prevalence of H. pylori using the CLO test, histology and culture on gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomization and 4-6 weeks after completion of treatment. Bacterial sensitivity to clarithromycin and moxifloxacin was determined with the E-test. RESULTS: 265 (95.6%) patients completed the study forming the basis for PP analysis. Eradication rates of H. pylori in ITT and in PP analyses were: in the MML group 93.5% (58/62) and 96.7% (58/60), respectively; in the MAL group 86.4% (57/66) and 90.5% (57/63); in the CML group 70.4% (50/71) and 75.8% (50/66); and in the CAL group 78.2% (61/78) and 80.2% (61/76). Moxifloxacin treatment protocols were significantly more effective on both ITT and PP analyses than the clarithromycin based protocols with only one exception (MAL vs. CAL on ITT analysis). Among 238 patients (86% of the entire study group), strains showing primary resistance to clarithromycin were found in 10.8% and to moxifloxacin in 5.9%. Eradication of moxifloxacin sensitive/resistant strains was 98.1%/75% for MML (p < 0.01) and 91.1%/66.7% for MAL (p = n.s.); comparison of eradication of sensitive strains in MML and MAL regimens was 98.1%/91.1% (p < 0.05), and for resistant strains 75%/66.7% (p = n.s.). CML and CAL protocols did not differ in efficacy of eradication of clarithromycin sensitive or resistant strains. CONCLUSION: Moxifloxacin-based triple therapies showed higher eradication rates with few side effects and good drug compliance when compared with standard H. pylori treatments. Moreover, the increased prevalence of clarithromycin resistance suggests that moxifloxacin-based regimens could be safe and effective options in treatment of H. pylori infection.

Comparison of the efficacy of 250 mg and 500 mg clarithromycin used with lansoprazole and amoxicillin in eradication regimens for Helicobacter pylori infection.

AIMS AND METHODS: The aim of this study was to compare the efficacy of 250 mg and 500 mg clarithromycin used with lansoprazole and amoxicillin in eradication of H. pylori infection. 235 patients with H. pylori infections and non-ulcer dyspepsia were randomly assigned to one of the following regimens: lansoprazole 30 mg, amoxicillin 1000 mg, clarithromycin 250 mg (LAC250) and lansoprazole 30 mg, amoxicillin 1000 mg, clarithromycin 500 mg (LAC500). All drugs were given twice daily for 7 days. The patients were assessed for prevalence of H. pylori with the CLO test. Gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomization and 4-6 weeks after completion of therapy were used for histology and culture. Bacterial sensitivity to clarithromycin and amoxicillin was determined with the E-test. RESULTS: 101 patients in the LAC250 mg group and 102 in the LAC500 group completed the study. On intention-to-treat analysis, eradication rates were 81% with LAC250 and 82% with LAC500 (p=0.88). On per-protocol analysis, eradication rates were 92% with LAC250 and 96% with LAC500 (p=0.23). Among the 203 patients (86% of the entire study group) for whom H. pylori antibiotic-sensitivity testing was technically feasible, primary resistance to clarithromycin was found in 9% and to amoxicillin in 0%. Eradication of clarithromycin sensitive/resistant strains was 94%/38% for LAC250 (p < 0.001) and 93%/40% for LAC500 (p < 0.001). CONCLUSIONS: The cure rates for the two regimens were similar, although adverse effects were more frequent with the LAC500 regimen, suggesting that 250 mg of clarithromycin b.d. may be sufficient in our patient population.

The impact of primary antibiotic resistance on the efficacy of ranitidine bismuth citrate- vs. omeprazole-based one-week triple therapies in H. pylori eradication--a randomised controlled trial.

AIMS: To compare ranitidine bismuth citrate with omeprazole as to their efficacy to eradicate H. pylori in two different treatment schedules both consisting of a combination of either of above with two antibiotics for 1 week, and to relate these treatment results to primary antibiotic resistance. METHODS: 256 H. pylori positive patients with non-ulcer dyspepsia were randomised to one of the following four treatment groups: omeprazole 20 mg + clarithromycin 500 mg + amoxycillin 1000 mg (OCA); ranitidine bismuth citrate 400 mg + clarithromycin 500 mg + amoxycillin 1000 mg (RBCCA); omeprazole 20 mg + clarithromycin 500 mg + metronidazole 500 mg (OCM); ranitidine bismuth citrate 400 mg + clarithromycin 500 mg + metronidazole 500 mg (RBCCM). All drugs were given twice daily for one week. The patients were assessed for prevalence of H. pylori by CLO test, histology and culture on gastric biopsy samples obtained during upper gastrointestinal endoscopy before randomisation and 4-6 weeks after completion of therapy. Bacterial sensitivity to clarithromycin, metronidazole and amoxycillin was determined by E-test. RESULTS: On per-protocol analysis, overall eradication rates were 96% for RBCCA vs. 85% for OCA (p = 0.03), and 95% for RBCCM vs. 79% for OCM (p = 0.01). Amongst the 196 patients (77% of the entire study group) in whom antibiotic sensitivity testing was technically feasible, primary resistance was found in 8% for clarithromycin, in 33% for metronidazole, and in 0% for amoxycillin. Eradication of clarithromycin sensitive/resistant strains was 89%/40% for OCA (p = 0.0042) and 98%/80% for RBCCA (p = 0.0428). When strains were sensitive to both antibiotics, cure rates with OCM/RBCCM were 87%/96% respectively (p = 0.39), for strains resistant to clarithromycin only, eradication was achieved in 82% with OCM vs. 94% with RBCCM (p = 0.2), and in the case of metronidazole resistance in 85% with OCM vs. 94% with RBCCM (p = 0.09). CONCLUSIONS: Ranitidine bismuth citrate in combination with clarithromycin and either metronidazole or amoxycillin produced higher eradication rates than omeprazole co-administered with the same antibiotics. This appeared especially prominent in the subgroups with clarithromycin resistance without, however, reaching statistical significance. Efficacy of neither eradication regimen was influenced by metronidazole sensitivity to a significant degree.