Clarithromycin versus furazolidone for naïve Helicobacter pylori infected patients in a high clarithromycin resistance area.

BACKGROUND AND AIM: The increase in antibiotic resistance makes the eradication of Helicobacter pylori more difficult. Considering the limitations of the application of susceptibility-guided therapy, it is important to find an effective empirical regimen. The aim of the study is to compare the efficacy, safety, and cost-effectiveness of clarithromycin-based bismuth-containing quadruple therapy (C-BQT) and furazolidone-based bismuth-containing quadruple therapy (F-BQT) in naïve H. pylori positive patients. METHODS: This was an open-label, randomized controlled, crossover trial. The trial comprised two phases. In C-F group, patients received C-BQT in the first phase; those who were still positive for H. pylori infection after the first phase entered the second phase to receive F-BQT as rescue treatment. In F-C group, patients were treated with F-BQT firstly and rescued with C-BQT. RESULTS: As first-line treatments, the eradication rates of C-BQT and F-BQT were 89.7% (157/175) and 92.0% (161/175) (P = 0.458) in intention-to-treat analysis and 93.4% (156/167) and 95.8% (161/168) (P = 0.327) in per-protocol analysis, respectively. The cumulative eradication rates of the C-F group and the F-C group were both 94.3% in intention-to-treat analysis (P = 1.000). Cost-effectiveness indexes of F-BQT and C-BQT were 0.54 and 1.24 in first-line treatments. Frequencies of adverse events in F-BQT and C-BQT had no differences (36.0% in C-BQT vs 32.6% in F-BQT, P = 0.499). CONCLUSIONS: Furazolidone-based bismuth-containing quadruple therapy should be preferred for its excellent cost-effectiveness and acceptable safety.

Bismuth salicylate for diarrhea in children.

QUESTION: Recently, I had a visit from a 5-year-old patient who had been given bismuth subsalicylate for a diarrheal illness by a local family physician during a trip to South America. Is this a practice we should encourage? ANSWER: Research from developing countries has found the use of bismuth subsalicylate to be effective in shortening the duration of diarrheal illness. Despite these findings, its limited effectiveness and concerns about it potentially causing Reye syndrome, compliance, and cost are the key reasons it is not routinely recommended for children.

[Efficacy of bismuth-based quadruple therapy as first-line treatment for Helicobacter pylori infection].

OBJECTIVE: To evaluate the efficacy of bismuth-based quadruple therapy as the first-line treatment for H.pylori infection. METHODS: A total of 136 patients with H.pylori related peptic ulcer or chronic gastritis were randomized into two groups: 67 patients in bismuth-based quadruple group received esomeprazole 20 mg, clarithromycin 0.5 g,amoxicillin 1.0 g,and bismuth potassium citrate 220 mg for 7 d; 69 patients in standard triple group received esomeprazole 20 mg, clarithromycin 0.5 g and amoxicillin 1.0 g for 7 d. Outcome of eradication therapy was assessed by (14)C-UBT. On ITT and PP analysis, calculating the cost-effectiveness ratio (C/E) and the incremental cost-effectiveness ratio (delta C/delta E). RESULT: On ITT and PP analysis, the eradication rates of the quadruple therapy group were 82.09% and 88.71%, and those of the triple therapy group were 66.67% and 73.02% (P<0.05). The cost-effectiveness ratio of two groups was 4.15 and 4.82; The incremental cost-effectiveness ratio of quadruple therapy group was 1.02 as against triple therapy group. CONCLUSION: Compared to the standard triple therapy regimen, the bismuth-containing quadruple therapy regimen has higher eradication rate and cost-effectiveness, which can be recommended as the fist-line treatment for H.pylori infection.

Comparative chemical study of MTA and Portland cements.

Portland cement has been analyzed and compared to mineral trioxide aggregate (MTA) because of their chemical similarity. The possibility of using this material as a less expensive alternative to MTA in dental practice should be considered. In view of this, the present study compared the components of a Portland cement (Votoran) to two commercial brands of MTA (Pro-Root and MTA-Angelus). Twelve specimens of each material were fabricated and examined by scanning electron microscopy (SEM) with energy dispersive spectroscopy (EDS) to obtain their percentage of chemical elements. The means of the chemical elements found in each material was compared by descriptive statistics. Bismuth was present only in MTA cements to provide radiopacity. In conclusion, the tested cements have similar components, which supports, as far as composition is concerned, the possible clinical use of Portland as an option to MTA.

Comparative chemical study of MTA and portland cements

Portland cement has been analyzed and compared to mineral trioxide aggregate (MTA) because of their chemical similarity. The possibility of using this material as a less expensive alternative to MTA in dental practice should be considered. In view of this, the present study compared the components of a Portland cement (Votoran®) to two commercial brands of MTA (Pro-Root™ and MTA-Angelus®). Twelve specimens of each material were fabricated and examined by scanning electron microscopy (SEM) with energy dispersive spectroscopy (EDS) to obtain their percentage of chemical elements. The means of the chemical elements found in each material was compared by descriptive statistics. Bismuth was present only in MTA cements to provide radiopacity. In conclusion, the tested cements have similar components, which supports, as far as composition is concerned, the possible clinical use of Portland as an option to MTA.

O cimento Portland tem sido analisado e comparado com o agregado trióxido mineral (MTA) devido a sua similaridade química. Dada à possibilidade de uso na Odontologia como uma alternativa menos onerosa ao MTA, realizou-se uma análise comparativa dos componentes do cimento Portland (Votoran®) com os constituintes de dois cimentos MTA (Pro-Root™-MTA e Angelus®-MTA). Para tanto, foram confeccionados 12 corpos-de-prova de cada um dos materiais (n=36), e estes foram analisados em microscopia eletrônica de varredura (MEV) pela técnica de espectroscopia por dispersão de energia (EDS), que fornece o percentual dos componentes químicos encontrados nos corpos-de-prova. As médias dos elementos químicos encontrados nos três cimentos foram comparadas por meio de análise estatística descritiva. O bismuto estava presente somente nos cimentos MTA. Concluiu-se que os cimentos testados apresentaram similaridade em seus constituintes, o que indica, considerando-se a composição, a possibilidade de futura utilização clínica do cimento Portland como alternativa ao MTA.

Impact of Helicobacter pylori eradication on dyspepsia, health resource use, and quality of life in the Bristol helicobacter project: randomised controlled trial.

OBJECTIVE: To determine the impact of a community based Helicobacter pylori screening and eradication programme on the incidence of dyspepsia, resource use, and quality of life, including a cost consequences analysis. DESIGN: H pylori screening programme followed by randomised placebo controlled trial of eradication. SETTING: Seven general practices in southwest England. PARTICIPANTS: 10,537 unselected people aged 20-59 years were screened for H pylori infection (13C urea breath test); 1558 of the 1636 participants who tested positive were randomised to H pylori eradication treatment or placebo, and 1539 (99%) were followed up for two years. INTERVENTION: Ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily for two weeks or placebo. MAIN OUTCOME MEASURES: Primary care consultation rates for dyspepsia (defined as epigastric pain) two years after randomisation, with secondary outcomes of dyspepsia symptoms, resource use, NHS costs, and quality of life. RESULTS: In the eradication group, 35% fewer participants consulted for dyspepsia over two years compared with the placebo group (55/787 v 78/771; odds ratio 0.65, 95% confidence interval 0.46 to 0.94; P = 0.021; number needed to treat 30) and 29% fewer participants had regular symptoms (odds ratio 0.71, 0.56 to 0.90; P = 0.05). NHS costs were 84.70 pounds sterling (74.90 pounds sterling to 93.91 pounds sterling) greater per participant in the eradication group over two years, of which 83.40 pounds sterling (146 dollars; 121 euro) was the cost of eradication treatment. No difference in quality of life existed between the two groups. CONCLUSIONS: Community screening and eradication of H pylori is feasible in the general population and led to significant reductions in the number of people who consulted for dyspepsia and had symptoms two years after treatment. These benefits have to be balanced against the costs of eradication treatment, so a targeted eradication strategy in dyspeptic patients may be preferable.

Helicobacter pylori-positive duodenal ulcer: three-day antibiotic eradication regimen.

BACKGROUND: The most widely used treatments for ulcer healing and Helicobacter pylori eradication consist of a 1-2 week regimen of a proton pump inhibitor plus two or three antimicrobials. AIMS: To evaluate the efficacy, safety, cost, and tolerance of a three-day regimen with three antibiotics vs. a 10-day treatment with a proton pump inhibitor or vs. a ranitidine bismuth citrate triple therapy. METHODS: Two hundred and twenty-one patients with endoscopically-proven H. pylori-positive duodenal ulcers were recruited to the study. Recruited patients were assigned to one of the following four regimens: (I) omeprazole 40 mg o.m. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 10 days (OAC: 55 patients); (ii) omeprazole 40 mg o.m. on days 1-5, plus amoxycillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. on days 3-5 (OACM: 56 patients); (iii) ranitidine bismuth citrate 400 mg b.d. plus amoxycillin 1 g b.d. and clarithromycin 500 mg b.d. for 10 days (RAC: 54 patients); (iv) ranitidine bismuth citrate 400 mg b.d. on days 1-5, plus amoxycillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. on days 3-5 (RACM: 56 patients). Fisher's exact test was used to compare data regarding healing and eradication in the four groups. RESULTS: The intention-to-treat eradication and ulcer healing rates for the RACM regimen were 95% and 98%, respectively. Statistically significant differences were observed, relating to the eradication and healing of ulcers, between RACM and either the RAC or OAC regimens. CONCLUSION: The three-day antibiotic therapy with amoxycillin, clarithromycin and metronidazole in addition to ranitidine bismuth citrate is a very effective anti-H. pylori regimen.

Helicobacter pylori eradication in clinical practice: retreatment rates and costs of competing regimens.

OBJECTIVE: To measure outcomes for eradication regimens for Helicobacter pylori infection in routine clinical practice. DESIGN: Retrospective analysis of an integrated medical and pharmacy claims database identified patients treated from June 1, 1995 through May 31, 1996, and followed the patients' claims until December 31, 1996. SETTING: The database represented multiple health plans throughout the US. PATIENTS: Patients were > or = 16 years old, continuously enrolled from April 1, 1995, to December 31, 1996, and met clinical (diagnostic or procedural) criteria. INTERVENTION: Patient cohorts were treated with bismuth-based triple (n = 98), proton-pump inhibitor (PPI)-based triple (n = 180), or PPI-based dual (n = 337) regimens. OUTCOME MEASURES: Retreatment; monthly postregimen medical expense, controlling for preregimen expense; and drug cost per successfully treated patient. Cox regression (retreatment analysis) and ANCOVA (postregimen expense analysis) adjusted for age, gender, diagnostic/procedural criteria met by patient, and specialty physician use. RESULTS: Retreatment rates were higher (p < 0.05) for PPI-based dual than bismuth-based or PPI-based triple-therapy cohorts. Retreatment rates for bismuth- and PPI-based triple-therapy cohorts were not significantly different. Total and follow-up (excluding the first 2 wk of treatment) expenses were higher for retreated than nonretreated patients (p < 0.01). Total expenses were higher for the PPI-dual cohort (p < 0.05) than for triple cohorts. Drug costs per successfully treated patient were $30 for bismuth-based, $172 for PPI-based triple, and $208 for PPI-based dual-therapy regimens. CONCLUSIONS: PPI-based dual-therapy regimens are not cost-effective in H. pylori treatment. Further study should compare more costly (PPI-based) versus less costly (bismuth-based) triple-therapy regimens.

How to treat Helicobacter pylori. First-line, second-line, and future therapies.

Numerous trials were performed in the 1990s to define the optimal therapy for Helicobacter pylori infections. The proposed proton-pump inhibitor (PPI)-based and ranitidine bismuth citrate (RBC)-based triple therapies led to satisfactory results. Their first drawback is cost, and, for this reason, many people worldwide cannot benefit from these regimens. Failures of first-line therapies essentially are because of antimicrobial resistance, which increases with the selection pressure resulting from the use of these drugs. Second-line treatments using antimicrobial agents for which H. pylori resistance is low or nonexistent are being tested to find alternatives to the quadruple therapy. There is a need for new drugs, which should be highly effective, nonselective of resistant strains, and without side effects, to improve current regimens. These drugs may be the results of postgenomic studies.

The pharmacoeconomic impact of antimicrobial therapy for peptic ulcer disease in a large urban jail.

PURPOSE: To determine the pharmacoeconomic impact of antimicrobial treatment of peptic ulcer disease (PUD) in a large urban jail. PATIENTS AND METHODS: Retrospective comparison of PUD-related pharmacy and laboratory expenditures over a 2-year period before and after the institution of a PUD treatment protocol with the priority of Helicobacter pylori eradication for inmates in Rikers Island Correctional Facility. RESULTS: After the protocol was adopted, total pharmacy-related and laboratory-related expenses for PUD care decreased by 40.2%, and expenditures for ranitidine declined by 52.2%. There was an increase in spending for antimicrobial agents and H. pylori antibody testing, but this was insignificant compared to the savings generated by decreased ranitidine usage. Annual savings in our facility as a result of this intervention were $123,449. CONCLUSIONS: Modern therapeutic strategies for PUD aimed at eradicating H. pylori can result in significant savings in the institutional setting; these savings are largely attributable to the decreased usage of histamine-2 receptor antagonists.

Pharmacoeconomic comparison of treatments for the eradication of Helicobacter pylori.

BACKGROUND: Patients with Helicobacter pylori-induced duodenal ulcer should have their infection eradicated. The optimal choice of antibiotic therapy, however, is less clear. OBJECTIVE: To evaluate costs and outcomes of treatment with 8 antibiotic regimens with documented activity against H pylori vs maintenance therapy with histamine2-receptor antagonists (H2RA). METHODS: A meta-analysis for 119 studies enrolling 6416 patients to determine aggregate eradication rates. The complexity of each regimen was used to determine the anticipated compliance rate and actual effectiveness. A decision analytic model with Monte Carlo simulation determined annual costs and health outcomes. RESULTS: Average annual total costs of testing for H pylori infection and antibiotic treatment ranged from $223 to $410 and prevented ulcer recurrence in 70% to 86% of patients. The H2RA maintenance therapy cost $425 and prevented recurrence in 72% of patients. The lowest costs and recurrence rates were achieved by 3 regimens: standard triple therapy (a combination of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride) for 14 days ($223, with 18% recurrence); a combination of clarithromycin, metronidazole, and a proton pump inhibitor for 7 days ($235, with 15% recurrence); and standard triple therapy with a proton pump inhibitor for 7 days ($236, with 14% recurrence). CONCLUSION: Treatment with any regimen resulted in lower costs compared with H2RA maintenance therapy. Three antibiotic regimens had consistently lower costs and better outcomes: standard triple therapy for 14 days, metronidazole, clarithromycin, and a proton pump inhibitor for 7 days, and standard triple therapy plus a proton pump inhibitor for 7 days.

Cost-effectiveness of Helicobacter pylori eradication therapy in duodenal ulcer disease.

A model analysis applied to Helicobacter pylori eradication found that, following successful healing with omeprazole and H. pylori eradication, virtually all patients were cured and experienced no relapse during the next 5 years. In contrast, almost all of the patients receiving episodic therapy relapsed and, during maintenance therapy with H2-receptor antagonists, most experienced at least one relapse. Although H. pylori eradication initially resulted in higher costs than the alternative therapies, it reduced the risk of recurrence and, for most patients, no future costs were incurred. Even with a worst case scenario, such as an H. pylori eradication rate of only 50%, the H. pylori eradication therapy had a pay-off period of less than 1.3 years compared with maintenance treatment and 3 years compared with episodic treatment. A preliminary analysis also compared the cost-effectiveness of three different H. pylori eradication therapies: omeprazole plus one or two antibiotics, ranitidine plus two antibiotics, and ranitidine plus bismuth triple therapy. The highest eradication rates (in excess of 90%) were achieved using 1-week regimens including omeprazole in combination with either clarithromycin or amoxycillin and a nitroimidazole. These regimens were also shown to be the most cost-effective. As the difference in costs between the therapies is small compared with the savings that can be achieved by successful H. pylori eradication, it is logical that the eradication strategy with the highest eradication rate is the most cost-effective. The model analysis concludes that H. pylori eradication in patients with duodenal ulcer disease is cost-effective in comparison to episodic therapy with omeprazole or maintenance therapy with ranitidine.