Bismuth-based quadruple therapy for Helicobacter pylori - a single triple capsule plus lansoprazole.

BACKGROUND: Recently a new 'all in one' single capsule with the three components of bismuth-based triple therapy became available in trials for treating Helicobacter pylori. AIM: To investigate the efficacy and tolerability of this new capsule when combined with lansoprazole. METHODS: A total of 66 consecutive infected patients from a single centre received two single triple capsules four times daily and lansoprazole 30 mg b.d. for 7 days. Each capsule contained 60 mg of bismuth subcitrate, 125 mg of tetracycline and 125 mg of metronidazole. Endoscopy with biopsies for CLO-test, histology and culture from antrum and corpus was performed before and at least 5 weeks after treatment. RESULTS: The per protocol cure rate was 56/64 (88%, 95% CI: 79-95%); by intention-to-treat 56/65 (86%, 95% CI: 78-95%). The per protocol cure rate in metronidazole sensitive strains was 40/43 (93%, 95% CI: 85-100%); in resistant strains 5/9 (56%, 95% CI: 23-88%). There was one drop-out due to adverse events. CONCLUSIONS: It is possible to combine the components of bismuth-based triple therapy into a single capsule. Based on the results it can be assumed that the capsule releases its content in the stomach. When combined with lansoprazole it reaches high cure rates, especially in metronidazole sensitive strains. This new approach simplifies bismuth-based anti-Helicobacter therapy.

Usefulness of the 14C urea breath test as a semi-quantitative monitoring instrument after therapy for Helicobacter pylori infection.

BACKGROUND: We evaluated the reliability and usefulness of the 14C urea breath test (UBT) in confirming eradication of Helicobacter pylori 4 to 6 weeks after cessation of antimicrobial therapy. METHODS: We investigated 57 patients, who underwent both an upper endoscopy with multiple biopsy specimens taken for histopathology, culture and/or CLO test, and a 14C UBT. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the breath test were calculated against the combined biopsy-based test results. Values for sensitivity, specificity, PPV, and NPV were also calculated after excluding results in a grey zone containing equivocal test results. RESULTS: Sensitivity, specificity, PPV, and NPV of the 14C UBT were 92%, 78%, 52%, and 97%, respectively. After introduction of a grey zone concept, these values were 89%, 100%, 100%, and 97% respectively. CONCLUSIONS: We conclude that for research, upper gastrointestinal endoscopy with multiple biopsy specimens and using different diagnostic techniques should remain the 'gold standard' to test for cure.

Effectiveness of quadruple therapy using lansoprazole, instead of omeprazole, in curing Helicobacter pylori infection.

BACKGROUND: Omeprazole enhances the efficacy of bismuth-based triple therapy. It is unknown whether the same is true for other proton pump inhibitors. Lansoprazole has superior anti-Helicobacter activity in vitro and possibly also in vivo; therefore we investigated quadruple therapy with lansoprazole. MATERIALS AND METHODS: In two studies performed in separate hospitals, a total of 67 Helicobacter pylori-positive patients were treated with 7-day quadruple therapy (lansoprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole) after 3 days of lansoprazole pretreatment. Testing for cure was done by endoscopy in study 1 and by breath test in study 2. RESULTS: Cure rates per protocol were 31 of 31 (100%) in study 1 and 30 of 32 (94%) in study 2. Intention-to-treat cure rates were 31 of 35 (89%) in study 1 and 30 of 32 (94%) in study 2. Cured overall were 32 of 34 with a metronidazole sensitive strain and 3 of 3 with a metronidazole-resistant strain. Data on side effects were collected from 51 patients. Twelve (21%) had no side effects, 27 (53%) had mild side effects, 10 (20%) had moderate side effects, but only 2 (4%) had severe side effects. Side effects, never were the reason that a patient stopped taking the medication. CONCLUSIONS: The results with lansoprazole-quadruple therapy are comparable to the historic control group treated with omeprazole-quadruple therapy. The cure rare is very high, and although mild to moderate side effects occurred in many patients, everybody finished the treatment regime.

Comparison of three commercially available enzyme-linked immunosorbent assays and biopsy-dependent diagnosis for detecting Helicobacter pylori infection.

We evaluated the performance of three enzyme-linked immunosorbent assays (ELISAs) in detecting serum immunoglobulin G (IgG) and IgA antibodies to Helicobacter pylori; two were new ones from Pyloriset (Pyloriset EIA-G update and Pyloriset EIA-A update; Orion Diagnostica, Espoo, Finland), and the third was the Malakit EIA-G (Biolab, Limal, Belgium). Serum samples from 154 dyspeptic patients were collected. As a reference method, multiple biopsy specimens from different anatomical areas of the stomach were obtained by endoscopy and were analyzed by culture and/or histology and direct urease testing. Accordingly, 126 patients (82%) were found to be H. pylori positive and 28 patients (18%) were found to be H. pylori negative. To validate serology as a predictor of H. pylori infection, sensitivity, specificity, positive and negative predictive values, and accuracy of the assays were calculated against the H. pylori status as determined by the reference method. The corresponding data for the different ELISAs were 100%, 79%, 95%, 100%, and 96% for the Pyloriset ELA-G update, 81%, 89%, 97%, 52%, and 82% for the Pyloriset EIA-A update, and 87%, 86%, 96%, 60%, and 87% for the Malakit EIA-G, respectively. We conclude that the Pyloriset EIA-G update is a reliable and accurate test and that because of its 100% sensitivity, conjunctional IgA testing is not necessary. Its 100% negative predictive value makes it a very useful screening test. For purposes of excluding infection with H. pylori, the performance of the Malakit EIA-G is moderate but can be improved by conjunctional IgA testing. The Pyloriset EIA-A update can be useful as such a conjunctional test.

Serodiagnosis of Helicobacter pylori infection: an evaluation of a commercially available ELISA-IgG.

BACKGROUND: Our aim was to evaluate a commercially available ELISA (Pyloriset IgG, Orion diagnostica, Imphos B.V.) for detection of serum IgG antibodies to Helicobacter pylori. METHODS: Serum samples were taken from 154 Dutch patients. As a reference method several biopsy specimens were taken from different gastric areas for histological analysis, bacterial culture and direct urease testing. The sensitivity, specificity, positive and negative predictive values of the Pyloriset IgG were calculated as compared to the reference method. RESULTS: Of 154 patients 126 were found to be H. pylori positive (82%), 28 were H. pylori negative (18%). Using a cut-off value at a titre of 500 U/l (as advised by the manufacturer) we found a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 81, 89, 97 and 51%, respectively. Lowering the cut-off value to 350 U/l and excluding patients aged above 70 years optimalized the performance of the Pyloriset IgG to a sensitivity, specificity, PPV and NPV of 92, 96, 99 and 72%, respectively. In the subgroup of 54 patients under the age of 45 years a sensitivity, specificity, PPV and NPV of 92, 100, 100 and 82% was found. CONCLUSIONS: The Pyloriset IgG is a simple and accurate method for detecting H. pylori infection in dyspeptic Dutch patients. The performance of this assay is improved by lowering the cut-off value (test becomes predominantly more sensitive) and excluding older patients (test becomes predominantly more specific). Therefore serology might eventually replace endoscopy or breath tests in the detection of H. pylori infection, especially in the younger age groups.