A Multicenter, Randomized, Double-Blind, 8-Week Comparative Trial of Low-Dose Esomeprazole (20 mg) and Standard-Dose Omeprazole (20 mg) in Patients with Erosive Esophagitis

The objective of this trial was to compare the efficacy of esomeprazole, 20 mg, with that of omeprazole, 20 mg, in patients with erosive esophagitis (EE). In this multicenter, double-blind, parallel-group trial, 1176 patients with EE confirmed by endoscopy (Helicobacter pylori-negative by serology) were randomized to once-daily treatment with 20 mg esomeprazole or 20 mg omeprazole for 8 weeks. The primary outcome was the proportion of patients with healed EE through week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. Cumulative life-table healing rates at week 8 were similarly high for 20 mg esomeprazole (90.6%; 95% confidence interval, 88.1%–93%) and 20 mg omeprazole (88.3%; 95% confidence interval, 85.5%–91.0%). The two treatments were comparable for other secondary measures and had similar tolerability profiles.     

Twice-Daily Standard Dose of Omeprazole Achieves the Necessary Level of Acid Inhibition for <Emphasis Type="Italic">Helicobacter pylori</Emphasis> Eradication. A Randomized Controlled Trial Using Standard and Double Doses of Omeprazole in Triple Therapy

Antibiotic resistances and level of acid inhibition may affect the outcome of eradicating regimens for H. pylori. To evaluate the impact of different degrees of acid inhibition on the efficacy of triple treatment, we treated 323 patients with H. pylori infection with clarithromycin and tinidazole plus omeprazole, either 20 mg bid or 40 mg bid. Gastric biopsies and antimicrobial susceptibility testing were performed. Eradication was evaluated by means of breath test. Eradication rates were (intention to treat and per protocol) 83.3 and 84.3% in patients receiving 40 mg omeprazole and 81.9 and 84.1% in those receiving 80 mg omeprazole. Culture was successful in 218 patients (68.7%). Resistance to clarithromycin and metronidazole were found in 13.7 and 20.6%, respectively. Eighteen further patients (8.2%) presented double resistance. Resistance was comparable across the two groups. In resistant patients the eradication rate was significantly lower (66.6% [95% CI, 56–76%], vs 86% [95% CI, 78–91%]; P = 0.001). Antibiotic resistance (OR, 2.73; 95% CI, 1.4–5.3) and smoking (OR, 2.68; 95% CI, 1.4–5.2) were independent predictors of eradication failure. Omeprazole, 20 mg bid, achieves the optimal acid inhibition in H. pylori eradication. Increasing antisecretory activity does not significantly enhance cure rates.     

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.     

A Multicenter, Randomized, Double-Blind, 8-Week Comparative Trial of Standard Doses of Esomeprazole (40 mg) and Omeprazole (20 mg) for the Treatment of Erosive Esophagitis

To compare esomeprazole with omeprazole for healing erosive esophagitis (EE), 1148 patients with endoscopically confirmed EE were randomized to once-daily esomeprazole, 40 mg, or omeprazole, 20 mg, for 8 weeks in this multicenter, double-blind, parallel-group trial. The primary outcome was the proportion of patients with healed EE at week 8. Secondary outcomes included diary and investigator assessments of heartburn symptoms. At week 8, estimated healing rates were 92.2% (95% CI, 89.9%–94.5%) with esomeprazole and 89.8% (95% CI, 87.2%–92.4%) with omeprazole. Healing rates with esomeprazole were significantly higher than those with omeprazole at weeks 8 (88.4% vs 77.5%; P = 0.007) and 4 (60.8% vs 47.9%; P = 0.02) in patients with moderate to severe (Los Angeles grade C or D) EE at baseline but were not significantly different for patients with mild (Los Angeles grade A or B) EE. Both treatments were comparable for other secondary measures and had similar tolerability profiles.An erratum to this article can be found at     

Azithromycin for the Cure of Helicobacter pylori Infection

Objectives: Azithromycin, a new antibiotic chemically related to erythromycin, has been proposed for the cure of Helicobacter pylori , achieving high gastric tissue levels (above the MIC for H. pylori ) after oral administration. The aim of the study was to establish whether azithromycin plus metronidazole in association with either omeprazole or bismuth subcitrate is useful in curing H. pylori infection of the stomach. Patients and Methods: The study involved 132 dispeptic patients who proved to be H. pylori infected by antral and corpus histology (Giemsa, modified) and rapid urease test (CLO test); the Sydney system was used to classify the gastritis. Sixty-three patients received bismuth subcitrate 120 mg q.i.d. for 14 days plus azithromycin 500 mg o.d. for the first 3 days plus metronidazole 250 mg q.i.d. for the first 7 days; 69 patients received omeprazole 40 mg for 14 days plus azithromycin 500 mg o.d. for the first 3 days plus metronidazole 250 mg q.i.d. for the first 7 days. Patients were well matched for common clinical variables. Cure of H. pylori infection was assessed by the same methods 2 months after completion of treatment. Results: Eleven patients dropped out of the study, only one reporting side effects (nausea, vomiting, and epigastric pain). Cumulative "per protocol" cure rate was 66.1% (CI 95%, 58.5–75.3%). There was no statistically significant difference between the two treatment groups: 58.9% (CI 95% 48.4–74.6%) versus 72.3% (CI 95%, 60.7–82.5%). Intention to treat does not substantially modify results. Few side effects were recorded. Cured patients showed a significant reduction in the activity of gastritis. Conclusion: azithromycin, combined with omeprazole and metronidazole, the cure rate of H. pylori was about 70%. The cure of H. pylori infection improves the activity of gastritis.     

Second-line treatment for Helicobacter pylori infection in Japan: proton pump inhibitor-based amoxicillin and metronidazole regimen

Background Recent studies have reported that proton pump inhibitor (PPI)/amoxicillin (A) metronidazole (M) therapy for Helicobacter pylori infection provides a sufficient cure rate in Japan in patients who have failed first-line treatment with PPI/amoxicillin and clarithromycin (AC). To validate the efficacy of this regimen as second-line therapy, our experience with second-line treatment using a PPI/AM regimen was reviewed.Methods We analyzed data on 151 patients who had been prescribed a 10-day PPI/AM re-treatment regimen after eradication failure of 1 to 2 weeks first-line PPI/AC therapy. The PPI/AM regimen was given according to results of susceptibility testing (S+) in 31 patients. The group that had undergone susceptibility testing was further divided into two subgroups according to dosage: standard dose of omeprazole (O)/AM (n = 11) and double dose of lansoprazole (L)/AM (n = 20). The PPI/AM regimen was given without susceptibility testing (S–) to 120 patients. These patients were also divided into two subgroups according to whether they received omeprazole or lansoprazole: OAM (n = 61) and LAM (n = 59). Cure rates and adverse effects in each group were analyzed.Results The intention-to-treat (ITT)-based cure rate with/without susceptibility testing was 93.5% (95% confidence interval [CI], 79%–99%) and 87.5% (95% CI, 80%–93%), respectively (not significant [NS]). The ITT-based cure rate in S+/S– for OAM and S+/S– for LAM was 90.9% (95% CI, 59%–100%)/82% (95% CI, 70%–91%), and 95% (95% CI, 75%–100%)/93.2% (95% CI, 84%–98%), respectively (NS). Adverse effects were seen in 26.3% and 32.5% of patients in the OAM group and the LAM group, respectively (NS).Conclusions The 10-day PPI/AM re-treatment regimen is safe and effective, suggesting its usefulness as second-line treatment in Japan in patients who have failed initial treatment with the PPI/AC regimen.     

Fourteen-day optimized levofloxacin-based therapy versus classical quadruple therapy for Helicobacter pylori treatment failures: a randomized clinical trial

Abstract

Objective. To test the efficacy of lansoprazole, bismuth, levofloxacin, and amoxicillin therapy compared to bismuth metronidazole tetracycline (BMT) quadruple therapy for second-line treatment of Helicobacter pylori infection. Methods. A total of 284 patients who failed prior H. pylori eradication were randomized to receive 14-day regimens containing lansoprazole 30 mg twice a day (b.i.d.), bismuth subcitrate 240 mg b.i.d., and either amoxcillin, 1 g b.i.d. and levofloxacin 500 mg once daily (qd) (levofloxacin/bismuth therapy) or metronidazole 400 mg four times daily (q.i.d.) and tetracycline, 500 mg q.i.d. (BMT quadruple therapy). Endoscopy and culture were performed before treatment. Antimicrobial susceptibility was by agar dilution. H. pylori status was determined 6 weeks after the end of therapy using a ¹³C-urea breath test. Results. The metronidazole, levofloxacin, tetracycline, and amoxicillin resistance rates were 85.3%, 40.2%, 1.1%, and 0.5%, respectively. The intention-to-treat and per-protocol (PP) eradication rates were 83% (95% confidence interval [CI]: 75.9–88.3%) and 88.1% (95% CI: 81.2–92.4%) (p = 0.22) for levofloxacin-bismuth (levo-bismuth) versus BMT quadruple, respectively, and PP rates were 85.4% (95% CI: 78.5–90.3%) and 90.6% (95% CI: 84.6–94.5%) (p = 0.18). Moderate and severe side effects were significantly higher with BMT quadruple than levo-bismuth (22.4% vs. 5%, p < 0.001) and higher in women (28.4%) than men (10.4%) in BMT quadruple therapy group (p = 0.015). Conclusion. Increasing fluoroquinolone resistance has undermined levo-bismuth quadruple therapy making BMT quadruple therapy a better choice empiric second-line therapy for H. pylori infection. However, compliance was significantly higher with levo-bismuth quadruple therapy, especially among women.     

Interpretation of the 13C-urea breath test in the choice of second- and third-line eradication of Helicobacter pylori infection

Background The urea breath test (UBT) is one of the most accurate methods of assessing Helicobacter pylori status. The predictive value of the test is, however, uncertain. This study was a serial, prospective analysis of the change over time of UBT values after first-, second- and third-line treatments of patients with failed eradication therapy. Methods One hundred thirty-four duodenal ulcer patients with persisting H. pylori infection after first-line triple therapy were enrolled in a cross-over manner to receive either pantoprazole (40 mg twice daily), amoxicillin (1000 mg twice daily), and clarithromycin (500 mg) or ranitidine bismuth citrate (400 mg twice daily), metronidazole (250 mg twice daily), and clarithromycin (500 mg twice daily) for 7 days. Forty-one patients with failed second-line treatment were randomized to receive third-line quadruple therapies with pantoprazole + amoxicillin and tetracycline (500 mg four times daily) and either nitrofurantoin (100 mg three times daily) or bismuth subsalicylate (120 mg four times daily). Breath tests were performed 6 weeks after therapy. The δ¹³CO₂ values (‰) after primary, secondary, and tertiary treatment were analyzed, and the correlation between pretreatment values and the rate of H. pylori eradication was assessed. Results In patients with successful second-line treatment, UBT values decreased from 12.4‰ [confidence interval (CI), 9.7–15.7)] to 2.8‰ (CI, 0.9–2.5) (P = 0.001), and in those with persistent infection, they increased from 13.2‰ (CI, 7.3–19.1) to 19.2‰ (CI, 13.4–25.0) (P = 0.03). After a failed quadruple regimen, UBT values increased from 19.3‰ (CI, 16.2–22.4) to 25.8‰ (CI, 19.8–312.8) (P = 0.03). The correlation between the pretreatment UBT values and the rate of eradication was negative for both second- and third-line therapies. Conclusions Serial assessment showed that UBT values after successive treatments showed a marked tendency to increase over time in failed cases. The significance of this phenomenon must be further studied. It might indicate increased colonization, ongoing resistance, or urease gene overexpression. Higher pretreatment UBT values were associated with lower (<60%) eradication rates. In these cases, alternative/rescue therapies should be chosen.     

Comparison of the efficacy of 1‐day high‐dose quadruple therapy versus 7‐day triple therapy for treatment of Helicobacter pylori infection

BACKGROUND: The proton pump inhibitor (PPI)‐based 7‐day triple therapy is the regimen with the highest cure rates for eradication of Helicobacter pylori infection and has been recommended as the first‐line regimen in the world. It had been reported that a 1‐day quadruple therapy could also successfully cure 95% of the H. pylori infected patients. OBJECTIVES: To observe the efficacy of 1‐day high‐dose quadruple therapy versus 7‐day triple therapy for treatment of H. pylori infection, and to observe side‐effects of the two different regimens. METHODS: This randomized, open, parallel‐controlled study was conducted at Renji Hospital between November 2004 to March 2005. A total of 80 consecutive patients with non‐ulcer dyspepsia, who were H. pylori positive proven by both rapid urease test and histology were included and randomly assigned to 1‐day quadruple therapy or 7‐day triple therapy. Thirty‐nine patients were administered with 1‐day high‐dose quadruple therapy including esomeprazole 40 mg b.i.d., colloidal bismuth subcitrate 440 mg q.i.d., amoxicillin 2 g q.i.d. and metronidazole (400 mg q.i.d.) for 1 day. Forty‐one patients received a standard 7‐day triple therapy consisting of esomeprazole 20 mg b.i.d., clarithromycin 500 mg b.i.d. and amoxicillin 1 g b.i.d. for 7 days. The eradication rates were evaluated by the ¹³C‐urea breath test at least 4 weeks after completion of a course treatment. RESULTS: Seventy‐seven patients completed the trial and three patients dropped out. The eradication rates in the 1‐day therapeutic group and the 7‐day therapeutic group were 39.5% (15/38) and 84.6% (33/39), respectively. There was a statistically significant difference between the two groups (P < 0.0001). Short‐lasting and self‐limiting side effects including thirst, a metallic taste, diarrhea and abdominal pain were reported in three patients (7.9%) in the 1‐day group and seven patients (18%) in the 7‐day group (P = 0.31). CONCLUSIONS: A 1‐day high‐dose quadruple therapy with amoxicillin, metronidazole, bismuth salt, and esomeprazole is not effective for eradication of H. pylori compared with the standard 7‐day triple therapy.     

A prospective randomized study of amoxycillin and omeprazole with and without metronidazole in the eradication treatment of Helicobacter pylori

A combination of amoxycillin and omeprazole is often used to treat Helicobacter pylori infection. A three-drug regimen comprising metronidazole, amoxycillin and omeprazole has been proposed as an alternative therapy. In a prospective, randomized, comparative study, we evaluated these two regimens with respect to safety and ef?cacy in patients with H. pylori infection. Sixty patients with peptic ulcer (gastric, 32 patients; duodenal, 28 patients) who had a history of ulcer recurrence were randomly assigned to dual therapy with amoxycillin (500 mg three times daily for 2 weeks) and omeprazole (20 mg once daily for 8 weeks) or to triple therapy with metronidazole (500 mg twice daily for 2 weeks) plus amoxycillin and omeprazole, given in the same dosages as dual therapy. Forty-eight patients completed the protocol; treatment was discontinued because of side effects in nine patients, and three patients dropped out of the study. On the basis of all patients treated, the rate of H. pylori eradication was signi?cantly higher for triple therapy 20/23 cases, 87.0%; 95% con?dence interval (CI), 0.664–0.972) than for dual therapy 13/25, 52.0%; 0.313–0.722; P < 0.05). On an intention-to-treat basis, the difference between the groups in the rate of H. pylori eradication was marginally signi?cant (P= 0.06 [0.028–0.512]). Side effects were reported by ?ve patients receiving triple therapy (skin rash, one; nausea, two; headache, one; abdominal pain, one), and four patients receiving dual therapy (skin rash, two; abdominal pain, one; diarrhoea, one). All side effects resolved spontaneously after termination of treatment. There was no signi?cant difference in safety between the two regimens. Triple therapy with metronidazole, amoxycillin, and omeprazole was signi?cantly more effective for the eradication of H. pylori than dual therapy with amoxycillin and omeprazole alone. The safety of these regimens was similar, and triple therapy was found to be clinically acceptable.     

Comparison of four-day and seven-day pantoprazole-based quadruple therapy as a routine treatment for Helicobacter pylori infection

BACKGROUND: H. pylori eradication is usually performed with three or four drugs for at least seven days. Recently four reports have shown a cure rate of approximately 90% using a four-day quadruple therapy. The objectives of this prospective study were: 1) to evaluate the efficacy of pantoprazole-based quadruple therapy, and 2) to compare the efficacy and tolerability of four-day with seven-day quadruple therapy. METHODS: The study was performed in a single centre. The first 56 consecutive patients with nonulcer dyspepsia or peptic ulcer disease and proven H. pylori infection received seven days of quadruple therapy (pantoprazole, bismuth, tetracycline and metronidazole). At least six weeks after treatment, endoscopy was repeated with six biopsies of the antrum and corpus for histology, urease test and culture. The next 59 consecutive patients followed the same protocol but received four-day quadruple therapy. RESULTS: Using an intention-to-treat analysis, the cure rate in the seven-day treatment group was 54/56 (96.4%, 95% confidence interval (CI) 87.7-99.6%). In the per protocol analysis the cure rate was 53/55 (96.3%, 95% CI 87.5-99.6%). Primary metronidazole resistance was observed in seven patients. All were cured. Using an intention-to-treat analysis, the cure rate in the four-day treatment group was 51/59 (86.4%, 95% CI 75.0-94.0%). In the per protocol analysis the cure rate was 50/58 (86.2%, 95% CI 74.6-93.8%). Primary metronidazole resistance was observed in seven patients, four of whom were cured. In three out of eight patients in whom four-day treatment failed, secondary metronidazole resistance was induced. Both treatment regimens were well tolerated. The difference between cure rates of both regimens did not reach statistical significance (p=0.0585). CONCLUSION: Routine use of both four-day and seven-day pantoprazole-based quadruple anti-H. pylori treatment is effective and well tolerated. The results of both regimens reach the required eradication standard, but results with the seven-day regimen were slightly but not significantly better. Seven-day treatment may be superior, especially in case of metronidazole resistance, and should be preferred.     

Limited usefulness of a seven-day twice-a-day quadruple therapy

OBJECTIVE: To test the usefulness of a twice-a-day, simplified quadruple therapy to cure Helicobacter pylori infection. DESIGN: Helicobacter pylori-positive ulcer patients were treated with omeprazole 20 mg twice a day (b.d.), amoxicillin 1 g b.d., tinidazole 500 mg b.d. and bismuth subcitrate 240 mg b.d. for 7 days in an experimental, noncomparative pilot study. SETTING: The gastroenterology unit of a county hospital. PARTICIPANTS: Forty-four consecutive patients with peptic ulcer disease and H. pylori infection. MEASUREMENTS: Cure was tested by either endoscopy or breath test after 2 months, and by urea breath test 6 months after therapy. RESULTS: One patient was lost to follow-up. Of the remaining 43, 37 were cured at the first control, giving an intention-to-treat cure rate of 84.1% (95% CI 69-93%) and a per protocol cure rate of 86% (95% CI 71-94%). Thirty-three cured patients agreed to return for a six-month breath test. All but one were cured (long-term per protocol cure rate 82.1%; 95% CI 66-92%). CONCLUSIONS: This particular quadruple therapy is well tolerated and easy to comply with. However, cure rates did not reach 90%.     

Efficacy of the Standard Quadruple Therapy Versus Triple Therapies Containing Proton Pump Inhibitor Plus Amoxicillin and Clarithromycin or Amoxicillin-Clavulanic Acid and Metronidazole for Helicobacter pylori Eradication in Children

Objectives Helicobacter pylori (H. pylori) cure rates vary in different geographical regions because of differences in hosts as well as in H. pylori strains. In this study we evaluated the efficacy of different treatment regimens for eradication of H. pylori infection in children, in order to select a treatment regimen that is most effective with the least adverse effects and cost. Method Through a randomized clinical trial study we enrolled 120 pediatric patients (age ≤ 18 years) with H. pylori infection confirmed through histopathological examination of their upper endoscopic findings and positive rapid urease test. Patients were randomized into three groups: group A received omeprazole, amoxicillin, metronidazole, and bismuth subcitrate; group B received omeprazole, amoxicillin, and clarithromycin; and group C the most recent regime of omeprazole, amoxicillin-clavulanic acid, and metronidazole. Subjects were followed 6 weeks after completing the antimicrobial therapy and H. pylori eradication was assessed with urea breath test. Results A total of 117 patients with a mean age of 12 ± 4 years completed the study. Eradication rate was 91.9% in group A, compared with 82.1% in group B, and 80.5% in group C (P = 0.33). Conclusion Considering these data we suggest quadruple therapy as the first line of therapy for eradication of H. pylori infection in children in our geographic area (Iran).     

Dual therapy versus triple therapy forHelicobacter pylori-associated duodenal ulcers

We compared the ulcer healing effect and eradication ofH. pylori by one-week triple therapy of bismuth, metronidazole, and tetracycline with two-week dual therapy of amoxicillin and omeprazole. One hundred twelve patients with confirmedH. pylori infection and duodenal ulcers were recruited in a prospective, randomized, single-blinded trial. Ulcer healing, eradication ofH. pylori in the stomach six weeks after randomization, and side effects reported by patients during the therapy. Duodenal ulcers were healed in 44 of 49 (89.8%, 95% CI 81.3–98.3%) patients receiving triple therapy and in 44 of 53 (83.0%, 95% CI 72.9–93.1%) patients receiving dual therapy (P=0.32).H. pylori was successfully eradicated in 41 of 49 (83.6%, 95% CI 73.4–94%) patients and in 40 of 53 (75.5%, 95% CI 63.9–87.1%) patients in the triple therapy group and the dual therapy group respectively (P=0.31). Side effects experienced by patients who received triple therapy were significantly more frequent than those who received dual therapy (P=0.0076). In conclusion, a two-week course of omeprazole and amoxicillin achieves a comparable rate ofH. pylori eradication and ulcer healing with fewer side effects.     

Comparison of a monoclonal with a polyclonal antibody-based enzyme immunoassay stool test in diagnosing Helicobacter pylori infection after eradication therapy

Background  Recently, a novel Helicobacter pylori stool antigen test (Testmate pylori antigen EIA) using monoclonal antibodies against H. pylori catalase has been developed commercially. This study assessed the diagnostic usefulness of the stool antigen test compared with a polyclonal enzyme immunoassay (HpSA test) after H. pylori eradication. Methods  A total of 150 patients with H. pylori infection were treated by triple therapy with PPI and amoxicillin with either clarithromycin or metronidazole. H. pylori stool antigen was tested 4 and 8 weeks after eradication. The outcome of H. pylori eradication was assessed by urea breath test (UBT) 8 weeks after the end of therapy. Discordant results were followed by endoscopic examination. Results  Of 150 patients enrolled, H. pylori status was negative in 122 cases and positive in 28 cases, assessed by the ¹³C-UBT. On the other hand, the monoclonal stool antigen test results were negative in 126 cases and positive in 24. The polyclonal stool test results were negative in 126 cases and positive in 22. The overall sensitivity and specificity of the monoclonal stool antigen test were 91.6% (95% CI 85.9–97.3%) and 98.4% (95% CI 97.3–99.5%). The overall sensitivity and specificity of the polyclonal stool antigen test were 87.0% (95% CI 86.9–94.0%) and 97.5% (95% CI 96.1–98.9%). Conclusion  The new stool antigen test using monoclonal antibody is useful for the diagnosis of H. pylori eradication 4 weeks after the end of treatment.     

Short duration therapy for Helicobacter pylori in Western Australia: the impact of metronidazole resistance

Background: Limited Australian data are available on either short duration therapy for Helicobacter pylori infection, or the impact of metronidazole resistance on the outcome of treatment. Aim: To compare the efficacy of two treatment regimens and determine the influence metronidazole resistance has on clearing H. pylori infection. Methods: Eighty patients with H. pylori infection proven at upper gastrointestinal endoscopy, none of whom had previously received therapy for H. pylori, were randomised to one week therapy with either bismuth subcitrate one tablet qid, tetracycline 500 mg qid and metronidazole 400 mg tds (BTM), or lansoprazole 30 mg bd, amoxycillin 500 mg qid and metronidazole 400 mg tds (LAM). Effectiveness of therapy was measured by C14-urea breath test at six weeks. Results: On an intention-to-treat basis, clearance of infection was achieved in 17 of 32 (53%; 95% CI: 35–71%) evaluable patients receiving BTM and 32 of 46 (70%, 54–182%) patients receiving LAM (p=0.16). Metronidazole resistance was found in 32 of 65 (49%) patients in whom H. pylori was isolated by culture. On a per-protocol basis, of patients who had metronidazole sensitive strains of H. pylori 23 of 24 (96%) cleared infection after therapy with either BTM or LAM, compared with 14 of 24 (58%) who were metronidazole resistant (p=0.004). Clarithromycin resistance was not found in 45 patients tested. Conclusions: In Western Australia clearance rates H. pylori infection, after one week of BTM or LAM, are lower than in other published series. The high incidence of metronidazole resistance is the main determinant of our relatively poor eradication rates.     

Efficacy of quadruple therapy for Helicobacter pylori eradication after failure of proton pump inhibitor‐based triple therapy in Singapore

BACKGROUND: Helicobacter pylori eradication is the mainstay in the treatment of H. pylori‐associated peptic ulcer disease. Current standard eradication therapy consists of 1 week of treatment with a proton pump inhibitor (PPI) and two antibiotics selected from amoxicillin, metronidazole and clarithromycin. In this study we aimed to assess the efficacy of quadruple therapy consisting of a PPI, bismuth, tetra‐cycline and metronidazole in patients for whom initial H. pylori eradication using a triple therapy regimen consisting of a PPI, amoxicillin and clarithromycin was unsuccessful. METHODS: Consecutive patients with H. pylori‐associated peptic ulcer disease, in whom H. pylori with triple therapy had been unsuccessful, were included in the study. These patients had been treated with a regimen that included a PPI (standard dose twice daily), amoxicillin (1 g twice daily) and clarithro­mycin (500 mg twice daily) for 1 week during 1997?2001. Diagnosis of peptic ulcer disease was made at esophagogastroduodenoscopy. Helicobacter pylori infection was considered to be present on the basis of either a positive rapid urease test, positive histo­logical identification of H. pylori or both. Failure of initial H. pylori eradication was established with either a rapid urease test, a ¹³C urea breath test or histology. Quadruple therapy consisted of a PPI (standard dose twice daily), metronidazole (400 mg three times daily), tetracycline (500 mg four times daily) and bismuth subcitrate (240 mg twice daily). Failure of quadruple therapy was diagnosed on the basis of a positive ¹³C urea breath test. RESULTS: Fifty‐three patients received quadruple therapy. The median age was 52 years (range 20?74) and the male to female ratio was 42 : 11. On an intent‐to‐treat basis, the eradication rate was 69.8%, whereas on a per‐protocol basis, the eradication rate was 82.2%. CONCLUSION: We conclude that a 1‐week quadruple therapy regime consisting of a PPI, bismuth, tetracycline and metronidazole was effective in 82.2% of patients who experienced an unsuccessful initial H. pylori eradication attempt with PPI, amoxicillin and clarithromycin.     

Treatment of Helicobacter pylori Infection in Clinical Practice in the United States

Our objectives were to define treatment success, compliance, and side effects for treatment of Helicobacter pylori in clinical practice. In all, 224 consecutive patients received Helicobacter pylori treatment: 97 received two weeks of bismuth subsalicylate, metronidazole, tetracycline four times a day with a H₂-receptor antagonist twice a day (BMT); 89 received one week of metronidazole, lansoprazole, and clarithromycin twice a day (MLC); and 38 received one week of BMT with lansoprazole twice a day (BMT-PPI). Cure rates were: BMT 81% (95% CI 74–89%), MLC 90% (95% CI 84–96%) BMT-PPI 87% (95% CI 81–92%). More patients prescribed a bismuth-based regimen discontinued medications due to side effects compared to MLC (P = 0.049). Nausea was more common for BMT compared to MLC (P = 0.04). In conclusion, treatment of Helicobacter pylori infection with a one-week course of MLC achieves a high rate of cure in clinical practice. Significantly fewer patients prescribed PPI-based therapy discontinue medications due to side effects as compared to bismuth-based triple therapy.     

A randomized controlled trial comparing sequential with triple therapy for Helicobacter pylori in an Aboriginal community in the Canadian North

BACKGROUND:

Helicobacter pylori infection occurs more frequently in Arctic Aboriginal settings than elsewhere in North America and Europe. Research aimed at reducing health risks from H pylori infection has been conducted in the Aboriginal community of Aklavik, Northwest Territories.

OBJECTIVE:

To compare the effectiveness of the Canadian standard therapy with an alternative therapy for eliminating H pylori infection in Aklavik.

METHODS:

Treatment-naive H pylori-positive individuals were randomly assigned to a 10-day regimen (oral twice-daily doses) with rabeprazole (20 mg): standard triple therapy (proton pump inhibitor, added clarithromycin [500 mg] and amoxicillin [1 g] [PPI-CA]); sequential therapy (ST) added amoxicillin (1 g) on days 1 to 5, and metronidazole (500 mg) and clarithromycin (500 mg) on days 6 to 10. Participants with clarithromycin-resistant H pylori were randomly assigned to ST or quadruple therapy. Treatment effectiveness was estimated as per cent (95% CI) with a negative urea breath test at least 10 weeks after treatment.

RESULTS:

Of 104 (53 PPI-CA, 51 ST) randomized participants, 89 (49 PPI-CA, 40 ST) had post-treatment results. Per-protocol treatment effectiveness was 59% (95% CI 45% to 73%) for PPI-CA and 73% (95% CI 58% to 87%) for ST. Based on intention to treat, effectiveness was 55% (95% CI 41% to 69%) for PPI-CA and 57% (95% CI 43% to 71%) for ST. Of 77 participants (43 PPI-CA, 34 ST) with 100% adherence, effectiveness was 63% (95% CI 43% to 82%) for PPI-CA and 81% (95% CI 63% to 99%) for ST.

CONCLUSIONS:

While additional evidence is needed to confirm that ST is more effective for Arctic Aboriginal communities than the Canadian standard H pylori treatment, these results show standard PPI-CA treatment to be inadequate for communities such as Aklavik.     

A 10-day levofloxacin-based therapy in patients with resistant Helicobacter pylori infection: a controlled trial.

BACKGROUND & AIMS: Antibiotic resistance is a major issue in anti- Helicobacter pylori treatment. This study was aimed at assessing the efficacy of 2 therapies in patients with resistant H pylori infection. METHODS: Patients who had failed 1 or more eradication regimens underwent upper gastrointestinal endoscopy and 2 antral and 2 corpus biopsy specimens were taken for histology and culture. Metronidazole, clarithromycin, and amoxicillin resistance were determined by E-test. Patients were randomly assigned to 2 therapies: 1 group received pantoprazole 40 mg, amoxicillin 1 g, levofloxacin 250 mg, all twice daily for 10 days, and the other group was treated with omeprazole 20 mg twice daily for the first week and omeprazole 20 mg twice daily, tetracycline 250 mg 4 times daily, metronidazole 500 mg twice daily, and bismuth subcitrate 240 mg twice daily for the second week. Therapeutic success was evaluated by 13C urea breath test after 4 weeks of treatment. RESULTS: We enrolled 44 patients in the levofloxacin-based regimen and 46 patients in the quadruple therapy. The former was successful in 31 of 44 (70%; 95% confidence interval: 53-87) and the latter in 17 of 46 (37%; 95% confidence interval: 23-47) patients, using intention-to-treat (ITT) analysis (P < .001). The rates of H pylori resistance to metronidazole, clarithromycin, and amoxicillin were 46%, 12%, and 0%, respectively. Resistance to both metronidazole and clarithromycin was found in 10% of cases. CONCLUSIONS: Triple therapy containing levofloxacin was better than quadruple therapy. The 70% success rate observed indicates that 10 days of pantoprazole, amoxicillin, and levofloxacin should be considered in patients who had failed 1 or more eradication regimens.