bluuebunny/crossref_metadata_2025_split huggingface dataset:
Triple therapy for Helicobacter pylori eradication: a comparison of pantoprazole once versus twice daily
Authors: Bardhan  , Dillon  , Axon  , Cooper  , Tildesley  , Wyatt  , Gatz  , Braun  
Published: March 2003

Background:Proton pump inhibitor‐based triple therapy is recommended as treatment for Helicobacter pylori eradication. The proton pump inhibitor may be given once or twice daily. However, little information is available on how these two treatment strategies compare.Methods: H. pylori‐positive patients (two positive test results) with endoscopy‐proven healed duodenal ulcer or non‐ulcer dyspesia were randomly allocated to 1 week of double‐blind treatment with pantoprazole 40 mg once or twice daily, plus clarithromycin 250 mg and metronidazole 400 mg twice daily. Eradication was defined as a negative 13C‐urea breath test (13C‐UBT) and histology, 4–5 weeks post‐treatment. The follow‐up phase comprised 12 months off therapy, with 13C‐UBT at 6 and 12 months.Results:Two hundred and four patients received treatment: pantoprazole once daily (×1), n=104; twice daily (×2), n=100. Eradication rates were 84% in both the pantoprazole ×1 and pantoprazole ×2 groups by modified intention‐to‐treat analysis and 89% and 87%, respectively, by per protocol analysis. Metronidazole resistance was found in 44% of pre‐treatment cultures of H. pylori. Eradication rates were similar in susceptible (72%) and resistant (75%) strains. During follow‐up, recrudescence of infection occurred in 3/118 patients.Conclusion:When using pantoprazole plus clarithromycin and metronidazole, the proton pump inhibitor can be used once daily without loss of efficacy.
The effects of 1‐year gluten withdrawal on bone mass, bone metabolism and nutritional status in newly‐diagnosed adult coeliac disease patients
Authors: Sategna‐Guidetti  , Grosso  , Grosso  , Mengozzi  , Aimo  , Zaccaria  , Di Stefano  , Isaia  
Published: March 2003

Objectives:To evaluate the impact of a 1‐year gluten‐free diet on bone metabolism and nutritional status in coeliac disease.Methods:Bone mineral density, serum indices of bone remodelling, clinical and biochemical nutritional assessment were evaluated in 86 consecutive newly‐diagnosed, biopsy proven, coeliac disease patients (untreated). A complete revaluation, including intestinal biopsy, was repeated within 1 year of dietary treatment (treated).Results:Untreated: according to WHO criteria, 34% of patients had a normal bone mineral density, 40% had osteopenia and 26% osteoporosis. Between males and females there were no statistical differences in bone metabolism or in most of the nutritional indices, while, between fertile and postmenopausal women, bone mineral density and several bone metabolism markers were significantly different. Compared to subjects with a normal bone mineral density, osteopenics had higher bone specific alkaline phosphatase (BAP) and Bone‐Gla‐protein (BGP) values. In patients with a concomitant BAP increase and 25OH vitamin D serum level reduction, bone mineral density and several bone turnover markers were statistically different compared to patients without such a serological pattern. Treated: notwithstanding intestinal biopsy which showed a mucosal recovery in only 57%, gluten‐free diet led, even in postmenopausal women, to a significant improvement in bone mineral density, bone metabolism and nutrition, except for folic acid, albumin and pre‐albumin serum levels which persisted as abnormal in patients with obdurate mucosal impairment.Conclusions:Coeliac disease patients are at high risk for developing a low bone mineral density and bone turnover impairment. A gluten‐free diet can improve this situation even in postmenopausal women and in patients with incomplete mucosal recovery.
Low‐dose intravenous erythromycin: effects on postprandial and fasting motility of the small bowel
Authors: Medhus  , Bondi  , Gaustad  , Husebye  
Published: March 2003

Background: Erythromycin is a motilin agonist and its effects on gastrointestinal motility are dependent on both dose and whether it is administered during the postprandial or fasting state.Aim: To study the motility response of the small bowel to a low dose of intravenous erythromycin after meal intake and during fasting.Methods: Eighteen healthy subjects with mean age of 25 years were studied by small bowel manometry. Erythromycin was administered intravenously (0.75 mg per kg body weight) during 20 min in the postprandial (n=9) and the fasting state (n=9), and the motility response was recorded.Results: Erythromycin significantly reduced the frequency of propagated contractions (P < 0.001) and the amplitude of contractions (P < 0.02) in the small bowel during established postprandial motility. During the fasting state, erythromycin invariably initiated a phase III‐like activity, which was similar to the spontaneous nocturnal phase III and migrated significantly more slowly than the diurnal phase III (P < 0.01).Conclusions: A low dose of erythromycin administered intravenously during the postprandial state significantly inhibits small bowel motility, whereas administration during the fasting state initiates a phase III resembling the nocturnal rather than the diurnal phase III. These effects of erythromycin may indicate interference with vagal pathways. Due to its inhibitory effects, the clinical use of erythromycin in patients with hypomotility should be reconsidered, and the potential usefulness of these effects in patients with exaggerated intestinal motility deserves further attention.
Gastrointestinal spread of oral prolonged‐release mesalazine microgranules (Pentasa) dosed as either tablets or sachet
Authors: Wilding  , Kenyon  , Hooper  
Published: March 2003

Background: There is increasing interest in using higher dosages of mesalazine for the treatment of inflammatory bowel disease; however, with current mesalazine products this involves the use of 8–16 tablets per day.Aim: To evaluate the disposition, dispersion and movements of Pentasa prolonged‐release microgranules following single dosing of either tablets (2 × 500 mg) or a new 1 g sachet (unit dose, microgranules in a foil bag).Methods: A randomized crossover study in eight healthy volunteers was undertaken. Both formulations were radiolabelled by neutron activation and dosed in the fasted state. Location of the preparations in the bowel was assessed over 24 h by scintigraphy.Results: Dissolution testing at pH 7.5 showed comparable in vitro mesalazine release properties for the tablet and sachet preparations. In vivo disposition of the microgranules administered as either tablets or sachet was comparable in terms of gastric emptying, small intestinal transit and colon arrival.Conclusions: Pentasa sachets 1 g unit dose offers the same release of mesalazine as Pentasa 500 mg tablets. Drug release occurs throughout the gastrointestinal tract from stomach to colon, with the advantage of fewer oral doses and ease of swallowing.
Clinical and fiscal impact of lansoprazole intolerance in veterans with gastro‐oesophageal reflux disease
Authors: Gerson  , Hatton  , Ryono  , Jones  , Pulliam  , Sampliner  , Triadafilopoulos  , Fass  
Published: March 2003

Background:Omeprazole was replaced by lansoprazole as the only proton pump inhibitor on the Veterans Affairs (VA) formulary in February 1997. We aimed to assess the clinical and fiscal impact of this conversion at two VA hospitals.Methods:We identified lansoprazole intolerant patients using pharmacy databases. We reviewed medical records to obtain data regarding reasons for lansoprazole intolerance. The costs of the formulary change and the savings to the VA were calculated.Results:A total of 3833 patients required long‐term proton pump inhibitor therapy; 2224 (58%) were started on lansoprazole and 1479 (39%) were converted from omeprazole to lansoprazole. The remaining 130 (3.4%) patients were never converted from omeprazole to lansoprazole. Of the 3833 patients, 325 (8.5%) currently receive omeprazole therapy; of these, 195 out of 3703 (5.3%) patients are true lansoprazole failures; 172 of these 195 patients completed the study. Most (87%) of the lansoprazole intolerant patients received prior omeprazole. Discontinuation of lansoprazole was due to poor symptom control in 69% and/or side‐effects (22%) including diarrhoea (10%), abdominal pain (5%), or hives (1%). The 1‐year cost of managing lansoprazole failure in 195 patients was $61 690. However, the savings to the VA during the same time period, which totalled $321 360, more than offset the costs associated with the conversion.Conclusions:Lansoprazole intolerance requiring omeprazole conversion occurred in 5% of veterans on proton pump inhibitor therapy for chronic gastro‐oesophageal reflux disease (GERD) symptoms and in 10% of patients with prior omeprazole success. The VA realized substantial cost savings in association with the formulary change.
Diagnostic accuracy of a new non‐invasive enzyme immunoassay for detecting Helicobacter pylori in stools after eradication therapy
Authors: Ishihara  , Kaji  , Kawamura  , Rumi  , Sato  , Okuyama  , Adachi  , Fukuda  , Watanabe  , Hashimoto  , Hirakawa  , Matsushima  , Chiba  , Kinoshita  
Published: March 2003

Background: Helicobacter pylori eradication therapy has been commonly performed for patients with peptic ulcer. An inexpensive, reliable, non‐invasive test would be useful for evaluation of the effectiveness of eradication therapy.Aim:To evaluate the diagnostic potential of a new non‐invasive enzyme immunoassay (HpSA) for H. pylori antigen in stools.Methods:A total of 112 peptic ulcer patients with H. pylori infection (82 male, 30 female; age range 22–81 years, mean 54 years) received a course of eradication therapy. Four weeks after the end of the therapy, stool samples were collected from all patients and tested using the HpSA. The diagnostic accuracy of the HpSA EIA was evaluated in comparison with the results of a 13C‐urea breath test.Results:The diagnostic sensitivity of HpSA EIA after eradication therapy was 90%, the specificity 98%, the positive predictive value 82% and the negative predictive value 99%.Conclusion:The HpSA stool test is potentially useful for the diagnosis of H. pylori infection 4 weeks after the end of eradication therapy.
Rifaximin versus chlortetracycline in the short‐term treatment of small intestinal bacterial overgrowth
Authors: Di Stefano  , Malservisi  , Veneto  , Ferrieri  , Corazza  
Published: March 2003

Background:Bacterial overgrowth of the small intestine is a condition characterized by nutrient malabsorption due to an excessive number of bacteria in the lumen of the small intestine. Current treatment is based on empirical courses of broad spectrum antibiotics; few controlled data, with respect to the duration and choice of antibiotic drug, exist at present. The recent availability of rifaximin, a non‐absorbable rifamycin derivative, highly effective against anaerobic bacteria, prompted us to carry out a randomized, double‐blind controlled trial in order to compare its efficacy and tolerability to those of tetracycline, currently considered the first‐choice drug.Methods:In 21 patients affected by small intestinal bacterial overgrowth, fasting, peak and total H2 excretion after ingestion of 50 g glucose and severity of symptoms were evaluated before and after a 7‐day course of rifaximin, 1200 mg/day (400  mg t.d.s.), or chlortetracycline, 1 g/day (333 mg␣t.d.s.).Results:Fasting, peak and total H2 excretion decreased significantly in the group of patients treated with rifaximin whereas chlortetracycline did not modify these parameters. The H2 breath test normalized in 70% of patients after rifaximin and in 27% of patients after chlortetracycline. The improvement in symptoms was significantly higher in patients treated with rifaximin.Conclusions:Rifaximin is a promising, easily‐handled and safe drug for the short‐term treatment of small intestinal bacterial overgrowth.
Pharmacokinetics of Lactobacillus plantarum NCIMB 8826, Lactobacillus fermentum KLD, and Lactococcus lactis MG 1363 in the human gastrointestinal tract
Authors: Vesa  , Pochart  , Marteau  
Published: March 2003

Objectives:Genetically modified lactic acid bacteria may be a way to deliver vaccinal epitopes in the gastrointestinal tract.Aim:Three strains of lactic acid bacteria were studied for their pharmacokinetics in the human gastrointestinal tract.Methods:The survival of the strains was studied up to the ileum in six subjects each, after ingestion of 150 g of fermented milk. The strains and their concentrations in the products were Lactobacillus fermentum KLD (107 cfu/g), Lactobacillus plantarum NCIMB 8826 (108 cfu/g), and Lactococcus lactis MG 1363 (108 cfu/g). Ileal fluid was aspirated by intestinal intubation and immediately cultured. L. plantarum NCIMB 8826, which was found in high concentrations in the ileum, was studied for its survival in the faeces after consumption of 150 g of fermented milk three times daily for 7 days. Faecal samples were collected for culture.Results:The concentration of L. plantarum NCIMB 8826 in the ileum reached 108 cfu/mL after a single dose, with a survival of 7%. L. fermentum KLD and Lc. lactis MG 1363 had lower (0.5 and 1.0%, respectively) and shorter (4 h) survival in the ileum. During the 7‐day ingestion period, L. plantarum NCIMB 8826 reached high concentrations (108 cfu/g) in the faeces, with a survival of 25 ± 29%. None of the strains colonized.Conclusions: L. plantarum NCIMB 8826 has a promising pharmacokinetic profile as a candidate vaccine vehicle.
Nitric oxide formation in the dog sphincter of Oddi from nitric oxide donors as measured with in vivo micro‐dialysis
Authors: Yamamoto I. , Fujimura M. , Kihara N. , Kumano K. , Yamada T. , Yamamoto H. , Fujimiya M. 
Published: March 2003

Background:Nitric oxide (NO) is known to play an important role in neurally mediated relaxation of the sphincter of Oddi.Aim:We investigated whether NO donors, such as nitroglycerin or zwitterionic polyamine/NO, applied into the common bile duct or intravenously, may induce the relaxation of the sphincter of Oddi by producing NO in the anaesthetized dog.Methods:NO production in the sphincter of Oddi was measured by detecting NO oxidation products (NO2– and NO3–) using micro‐dialysis methods.Results:Zwitterionic polyamine/NO and nitroglycerin applied into the common bile duct induced a marked increase in NO2– but not NO3–, in the sphincter of Oddi. Intravenous infusion of zwitterionic polyamine/NO and nitroglycerin induced little or no increase in NO2– formation. Nitroglycerin infused into either the common bile duct or intravenously administered produced relaxation of the sphincter of Oddi, but zwitterionic polyamine/NO had no effect on the sphincter of Oddi in spite of the increase in NO2– levels.Conclusions:Locally or systemically applied NO donors induce relaxation of the sphincter of Oddi by producing NO, although their mode of action differs in different analogues.
Gastric damage in the rat with nitrogen‐containing bisphosphonates depends on pH
Authors: Blank  , Gibson  , Myers  , Dierckman  , Phipps  , Smith  
Published: March 2003

Background:The use of nitrogen‐containing bisphosphonates (N‐BPs) has been reported to be associated with gastrointestinal intolerance. The fasted, indomethacin‐treated rat provides a model for assessing the gastrointestinal effects of these compounds.Aims:The aims of this study were to elucidate the effect of pH on N‐BP‐induced gastric damage, and to evaluate the structure–activity relationship between N‐BP anti‐resorptive and gastric effects.Methods:Fasted rats were dosed concomitantly with indomethacin (40 mg/kg, subcutaneously) and an N‐BP (pamidronate, alendronate, or risedronate at 150 or 300 mg/kg, orally), with the N‐BP dosing solutions adjusted to pH 2, 4 or 7. The aminopentane and aminohexane N‐BPs (150, 225 or 300 mg/kg, orally) were only tested at pH 4 only.Results:Nitrogen‐containing bisphosphonate‐induced gastric damage was pH‐dependent, with increased damage at increasing pH.Conclusions:Gastric damage potential did not correlate with bone anti‐resorptive effects, and the more potent anti‐resorptive N‐BPs were not necessarily more damaging to the stomach.
Changes in Helicobacter pylori‐induced gastritis in the antrum and corpus during long‐term acid‐suppressive treatment in Japan
Authors: Uemura N. , Okamoto S. , Yamamoto S. , Matsumura N. , Yamaguchi S. , Mashiba H. , Sasaki N. , Taniyama K. 
Published: March 2003

Background:Several studies have shown that acid‐suppressive therapy aggravates corpus gastritis in patients with Helicobacter pylori infection, promoting the development of atrophic gastritis.Aim:To study the effects of long‐term use of antisecretory agents on the H. pylori‐positive gastric mucosa in Japan, a country with a high incidence of gastric cancer.Methods:A total of 141 H. pylori‐positive patients who had peptic ulcers or reflux oesophagitis were treated for 3 years with either omeprazole (20 mg/day) alone (n=7) or with omeprazole for primary therapy (8 weeks), followed by famotidine (40 mg/day) for maintenance therapy (n=134). Endoscopy was performed before, during, and after treatment. Biopsy specimens were taken from the greater curvature of the antrum and corpus and were examined histologically.Results:The long‐term use of famotidine after 8 weeks of treatment with omeprazole distinctly decreased H. pylori density and neutrophil infiltration in the antrum, but did not change H. pylori density in the corpus. The gastritis score increased in patients who had no, or only mild corpus gastritis before treatment (n=74), and significantly decreased in those who had moderate or severe gastritis before treatment (n=60). In four of the seven patients who received long‐term treatment with omeprazole alone, neutrophil infiltration and H. pylori density decreased not only in the antrum but also in the corpus. There was no increase in intestinal metaplasia or mucosal atrophy as assessed endoscopically during follow‐up.Conclusion:Changes in corpus gastritis in response to acid‐suppressive therapy depend on the severity of gastritis before treatment. Long‐term use of acid‐suppressive therapy apparently does not accelerate the development of atrophy or intestinal metaplasia in Japanese patients.
Lower‐dose 13C‐urea breath test to detect Helicobacter pylori infection—comparison between infrared spectrometer and mass spectrometry analysis
Authors: Sheu B.‐S. , Lee S.‐C. , Yang H.‐B. , Wu H.‐W. , Wu C.‐S. , Lin X.‐Z. , Wu J.‐J. 
Published: March 2003

Background:The expense of the 13C‐urea breath test (UBT) to detect Helicobacter pylori infection is mainly due to the cost of 13C‐urea and the analysis using isotope ratio mass spectrometry (IRMS).Aim:To test whether a UBT, using a lower dose of urea and lower‐priced isotope‐selective nondispersive infrared spectrometry (INIS), can preserve diagnostic efficacy in clinical practice.Methods:A total of 177 dyspeptic patients received endoscopy for H. pylori culture and histology. All of them received a UBT in which the duplicate baseline, 10 min, and 15 min breath samples after ingestion of 50 mg 13C‐urea were collected to analyse the excess 13CO2/12CO2 ratio (ECR) by IRMS (ABCA, Europa Scientific, UK) and INIS (UBiT‐IR200, Photal Otsuka Electronics, Japan), respectively.Results:Of the 177 patients, 84 were infected and 93 were uninfected with H. pylori. A close correlation of ECR was found between IRMS and INIS (r=0.9829 at 10 min; r=0.9918 at 15 min, P < 0.0001). Analysing the 15‐min samples, UBT by both IRMS and INIS achieved the same sensitivity (96.4%) and specificity (98.9%).Conclusions:INIS is as effective as IRMS for UBT, and can use a lower dose of 13C‐urea. This can provide an economic UBT, using the lower‐priced INIS and a low dose of 13C‐urea.
Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial
Authors: Kahrilas P. J. , Falk G. W. , Johnson D. A. , Schmitt C. , Collins D. W. , Whipple J. , D'Amico D. , Hamelin B. , Joelsson B. ,   FOR THE ESOMEPRAZOLE STUDY INVESTIGATORS
Published: March 2003

Background:The pharmacologic profile of the new proton pump inhibitor esomeprazole has demonstrated advantages over omeprazole that suggest clinical benefits for patients with acid‐related disease.Methods:1960 patients with endoscopy‐confirmed reflux oesophagitis (RO) were randomized to once daily esomeprazole 40 mg (n=654) or 20 mg (n=656), or omeprazole 20 mg (n=650), the standard recommended dose for RO, for up to 8 weeks in a US, multicentre, double‐blind trial. The primary efficacy variable was the proportion of patients healed at week 8. Secondary variables included healing and heartburn resolution at week 4, time to first resolution and sustained resolution of heartburn, and per cent of heartburn‐free days and nights. Safety and tolerability were also evaluated.Results:Significantly more patients were healed at week 8 with esomeprazole 40 mg (94.1%) and 20 mg (89.9%) vs. omeprazole 20 mg (86.9%), using cumulative life table estimates, ITT analysis (each P < 0.05). Esomeprazole 40 mg was also significantly more effective than omeprazole for healing at week 4 and for all secondary variables evaluating heartburn resolution. The most common adverse events in all treatment groups were headache, abdominal pain and diarrhoea.Conclusion:Esomeprazole was more effective than omeprazole in healing and symptom resolution in GERD patients with reflux oesophagitis, and had a tolerability profile comparable to that of omeprazole.
Triple therapy with clarithromycin, omeprazole, and amoxicillin for eradication of Helicobacter pylori in duodenal ulcer patients in Asia and Africa
Authors: Wong B. C. Y. , Chang F. Y. , Abid S. , Abbas Z. , Lin B. R. , Van Rensburg C. , Chen P. C. , Schneider H. , Simjee A. E. , Hamid S. S. , Seebaran A , Zhang J. , Destefano M. , Lam S. K. 
Published: March 2003

Background:Studies assessing the efficacy of triple therapy containing clarithromycin and amoxicillin for the eradication of Helicobacter pylori infection and healing of duodenal ulcers in Asian and African countries are limited.Aim:To determine the efficacy and safety of 1‐week triple therapy with omeprazole, amoxicillin and clarithromycin for eradicating H. pylori infection in patients with active duodenal ulcer living in Asian and African regions.Methods:This was an open‐label, multicentre study in 11 centres in Asia and Africa. Patients with endoscopy‐proven duodenal ulcer and who were H. pylori‐positive were treated with clarithromycin 500 mg, omeprazole 20 mg, and amoxicillin 1000 mg, all given twice daily for 7 days. Upper endoscopy was repeated at week 6 to check for ulcer healing and H. pylori status.Results:A total of 117 patients were recruited. H. pylori eradication rates were 85% by per protocol analysis and 80% by intention‐to‐treat analysis. Ulcer healing was found in 94% of subjects (per protocol analysis). Clinical success, measured by change of pre‐treatment ulcer symptoms, was strongly supported by complete resolution or improvement in 100% of the evaluable patients (per protocol analysis). Since treatment‐related adverse events, when present, were largely mild or moderate, the triple therapy regimen was considered safe.Conclusion:Seven‐day triple therapy with omeprazole, amoxicillin, and clarithromycin was efficacious for treating Asian and African patients with duodenal ulcer disease associated with H. pylori infection, and the treatment regimen was well‐tolerated.