bluuebunny/crossref_metadata_2025_split huggingface dataset:
A dose‐ranging, placebo‐controlled, randomized trial of alosetron in patients with functional dyspepsia
Authors: Talley N. J. , Van Zanten S. V. , Saez L. R. , Dukes G. , Perschy T. , Heath M. , Kleoudis C. , Mangel A. W. 
Published: March 2003

Background:Functional dyspepsia is characterized by upper abdominal pain or discomfort.Aim:To assess the benefit of the 5‐HT3‐receptor antagonist alosetron in a pilot, dose‐ranging, placebo‐controlled, multicentre, randomized clinical trial.Methods:A total of 320 functional dyspepsia patients received placebo (n=81), or alosetron 0.5 mg b.d. (n=77), 1.0 mg b.d. (n=79) or 2.0 mg b.d. (n=83) for 12 weeks, followed by 1 week of follow‐up. Primary efficacy was the 12‐week average rate of adequate relief of upper abdominal pain or discomfort. Secondary endpoints assessed pain and upper gastrointestinal symptoms.Results:Twelve‐week average rates of adequate relief of pain or discomfort were 46% (95% CI: 37–54%), 55% (95% CI: 46–63%), 55% (95% CI: 47–64%) and 47% (95% CI: 38–55%) in the placebo, 0.5 mg, 1.0 mg and 2.0 mg alosetron groups, respectively. Alosetron 0.5 mg or 1.0 mg showed potential benefit over placebo for early satiety and postprandial fullness. Females showed greater responses compared to males. Patients with adequate relief had significantly (P < 0.001) greater reductions in severity and frequency of functional dyspepsia symptoms than those without adequate relief. Constipation was the most commonly reported adverse event.Conclusions:Alosetron showed potential benefit in relieving functional dyspepsia symptoms compared to placebo. Patients with adequate relief of upper abdominal pain or discomfort showed improvements in multiple functional dyspepsia symptoms.
Effect of nabumetone and aspirin on colonic mucosal bleeding time
Authors: Basson M. D. , Panzini L. , Palmer R. H. 
Published: March 2003

Background:The management of patients taking aspirin or non‐steroidal anti‐inflammatory drugs (NSAIDs) who require colonoscopy remains controversial because of concerns over bleeding after biopsy or polypectomy.Aim:To determine whether patients using the NSAID nabumetone, a non‐acidic prodrug with mixed activity against cyclooxygenase‐1 (COX‐1) and COX‐2, exhibited prolonged mucosal bleeding times and how this might compare with mucosal bleeding times in patients using aspirin.Methods:We assessed triplicate mucosal bleeding times in patients undergoing screening flexible sigmoidoscopy. We compared 90 patients who had taken no aspirin or NSAIDs within the previous 2 weeks, to 60 patients who had received nabumetone 1 g b.d. by mouth for the previous 2 weeks, and 30 patients who had taken 325 mg aspirin daily for the previous 2 weeks. In each case, the investigator performing the study was blinded to the patient’s medication.Results:Mucosal bleeding times did not differ significantly among control or nabumetone‐using patients. However, the patients receiving aspirin exhibited significant prolongation. Mucosal bleeding time correlated statistically significantly, but weakly, with skin bleeding time.Conclusions:Nabumetone does not appear to prolong mucosal bleeding time after mucosal pinch biopsy, and skin bleeding time does not reliably screen for prolonged mucosal bleeding time.
Rapid detection of anti‐Helicobacter pylori IgG in urine using immunochromatography
Authors: Graham D. Y. , Reddy S. 
Published: March 2003

Background:Non‐invasive methods to detect the presence of H. pylori infection continue to be refined.Aim:To evaluate a new 20‐min immunochromatography method (RAPIRUN H. pylori Antibody) for the presence of anti‐H. pylori IgG in urine.Methods:We used the 13C‐urea breath test to establish H. pylori status. We evaluated the urine test among 104 subjects including 43 with H. pylori infection confirmed by repeatedly positive urea breath tests and 61 H. pylori‐negative subjects with repeatedly negative urea breath tests. Forty‐one of the 43 subjects with H. pylori infection had a positive rapid urine test with two false negative tests. There were two false positive tests among the 61 with repeatedly negative urea breath tests. The sensitivity, specificity, positive and negative predictive values for the rapid urine test were 95.3%, 96.7%, 95.3%, and 96.7%, respectively. The kit was easy to use and required no special equipment.Conclusions:The rapid immunochromatography method for determination of anti‐H. pylori IgG proved to be reliable with excellent sensitivity and specificity and is likely to be useful for both clinical and epidemiological studies.
Surveillance colonoscopy or chemoprevention with COX‐2 inhibitors in average‐risk post‐polypectomy patients: a decision analysis
Authors: Arguedas M. R. , Heudebert G. R. , Wilcox C. M. 
Published: March 2003

Objectives:Clinical trials are currently underway evaluating the efficacy of COX‐2 inhibitors in decreasing the incidence of adenomas and colorectal carcinoma in ‘average’ risk individuals.Aim:To use decision analysis to compare the cost‐effectiveness of celecoxib to surveillance colonoscopy in ‘average’ risk patients who had undergone prior adenoma resection.Methods:A model of the natural history of adenomas after endoscopic polypectomy was constructed using probabilities from the literature. Cost estimates were obtained from available Medicare reimbursement rates and supplemented by the literature. Three strategies were evaluated: (i) no surveillance; (ii) colonoscopic surveillance; and (iii) celecoxib chemoprevention. We compared total costs and performed cost‐effectiveness analysis between these strategies. The outcome measures were years of life saved and ‘high‐grade’ adenoma prevented. Sensitivity analyses were performed on selected variables.Results:Our base‐case analysis assumed a 50% risk reduction in the incidence of adenomas among patients using celecoxib. No surveillance was associated with a cost of $1014 per patient, and colonoscopic surveillance with a cost of $1572 per patient, whereas celecoxib use was associated with a total cost of $11 503. Ten years after the index colonoscopy, 15% of patients in the no surveillance strategy developed ‘high‐grade’ lesions compared to 13% of patients in the colonoscopic surveillance group and 6% in the celecoxib group. There was a small gain in years of life saved (0.006) favouring celecoxib over colonoscopic surveillance. The incremental cost‐effectiveness ratio of celecoxib vs. colonoscopy was $141 871 per ‘high‐grade’ adenoma prevented and $1 715 199 per year of life saved. The most important variables in determining the cost‐effectiveness of celecoxib were its cost and its efficacy.Conclusion:Chemoprevention with COX‐2 inhibitors in ‘average‐risk’ postpolypectomy patients is a more expensive strategy compared to colonoscopic surveillance.
A randomized controlled crossover study comparing synthetic porcine and human secretins with biologically derived porcine secretin to diagnose Zollinger–Ellison Syndrome
Authors: Metz D. C. , Buchanan M. , Purich E. , Fein S. 
Published: March 2003

Background:Although biologically‐derived porcine secretin is approved for the diagnosis of Zollinger–Ellison Syndrome, it is no longer available in the United States. Pure human and porcine secretins have now been synthesized and new drug applications have been filed with the Federal Drug Administration (FDA).Methods:In the current study we compared secretin testing results in six confirmed Zollinger–Ellison Syndrome patients using the biologically‐derived product and both synthetic products (human and porcine) in a three‐way, randomized, single‐blind Latin‐squares crossover study.Results:Using the FDA‐approved criterion for positive secretin testing (i.e. a serum gastrin concentration increase of > 110 pg/mL), there was complete agreement between all three agents for all patients. With the more stringent NIH criterion (i.e. a serum gastrin concentration increase of > 200 pg/mL), positive results persisted in five out of six, six out of six and four out of six patients using biologically‐derived secretin, synthetic porcine secretin, and synthetic human secretin, respectively (six out of six, six out of six and four out of six if a positive test was defined as a 50% increase in serum gastrin concentration). The time to peak serum gastrin concentration after secretin injection occurred within 15 min in all studies (in 94% by 10 min and in 77% by 5 min). Three‐way comparisons of serum gastrin concentrations showed a single statistically significant difference (the change from baseline at 15 min between synthetic human and synthetic porcine secretin, P=0.0274). Statistically significant changes from baseline occurred at 1, 2 and 5 min for biologically‐derived porcine secretin and at 2 and 5 min for both synthetic porcine and synthetic human secretin, in keeping with the expected time curve for positive tests. All three agents were well‐tolerated.Conclusions:These data suggest that either synthetic secretin product, when released onto the United States market, can be used to confirm Zollinger–Ellison Syndrome.
Bolus somatostatin but not octreotide reduces hepatic sinusoidal pressure by a NO‐independent mechanism in chronic liver disease
Authors: Matrella E. , Valatas V. , Notas G. , Roumpaki H. , Xidakis C. , Hadzidakis A. , Mouzas I. , Kouroumalis E. 
Published: March 2003

Background:Evidence exists that somatostatin and octreotide might have different effects on hepatic haemodynamics.Aim:The investigation of the effects of somatostatin and its octapeptide analogue, octreotide, on sinusoidal pressure measured by the wedged hepatic venous pressure in patients with cirrhosis or chronic hepatitis and the correlation with the levels of hepatic vein NO.Methods:Patients were randomly assigned to receive an injection of either 250 μg somatostatin (n=14: cirrhosis six, chronic hepatitis eight) or an injection of 125 μg octreotide (n=19: cirrhosis nine, chronic hepatitis 10) during hepatic vein catheterization. Baseline wedged hepatic venous pressure was measured, followed by measurements at 2, 5, 10 and 15 min after the injection of the drug. Nitrites/nitrates of the hepatic vein were measured before the injection and after 15 min.Results:Both agents showed a similar qualitative but a different quantitative haemodynamic profile. No change in the wedged hepatic venous pressure was observed during the first 2 min after the injection of both drugs. This was followed by a decrease: 18% at 5 min (N.S.), 23% at 10 min (P < 0.01) and 24% at 15 min (P < 0.01) for somatostatin. Octreotide induced a relatively smaller decrease in the wedged hepatic venous pressure: 8% at 5 min (N.S.), 20% at 10 min (P < 0.01) and 16% at 15 min (N.S.). Further analysis of the sub‐groups of cirrhotic and chronic hepatitis patients revealed a different effect. In the sub‐group of cirrhotic patients, somatostatin caused a maximum decrease of 34% at 15 min post‐injection (P < 0.01), but octreotide failed to produce a significant change on the wedged hepatic venous pressure. In contrast, no change was observed in chronic hepatitis patients with either drug. No change in the hepatic vein concentration of NO after treatment was observed with either somatostatin or octreotide. Moreover, no correlation of the levels of NO with the wedged hepatic venous pressure values was found.Conclusions:This study shows that somatostatin is more effective than octreotide in acutely reducing the wedged hepatic venous pressure after bolus injection and the observed change is probably mediated by a NO‐independent mechanism.
What is the optimal length of proton pump inhibitor‐based triple therapies for H. pylori? A cost‐effectiveness analysis
Authors: Calvet X. , Gené E. , LÓpez T. , Gisbert J. P. 
Published: March 2003

Background:Triple therapy with a proton pump inhibitor, clarithromycin and amoxicillin is widely used for H. pylori infection. The appropriate length of treatment remains controversial.Aim:To determine whether length of treatment has an impact on the cost‐effectiveness of triple therapy.Methods:The study took the form of a cost‐effectiveness analysis spanning 2 years. The perspective was societal and the setting, ambulatory care. Subjects were Helicobacter pylori‐positive patients with a duodenal ulcer. The triple therapy trials spanned 7, 10 or 14 days and the main outcome measures were cost per patient and marginal cost for additional cured patient calculated for a low cost‐of‐care setting (Spain), for a high‐cost setting (USA), and for two follow‐up strategies: (i) systematic 13C‐urea breath test after eradication; (ii) clinical follow‐up, breath‐test if symptoms recurred.Results:Base‐case analysis showed that for both the 13C‐UBT and the clinical follow‐up branches, lowest costs were obtained with 7‐day schedules both in Spain and the USA. Sensitivity analysis showed that in Spain, 10‐day therapies would have to increase 7‐day cure rates by 10–12% to become cost‐effective. In contrast, in the USA only a 3–5% increase was needed. The corresponding figures for 14‐day therapy were 25–35% and 8–11%, respectively.Conclusions:Seven‐day therapies seem the most cost‐effective strategy. However, in high‐cost areas the differences were less evident.
Influence of anti‐Helicobacter triple‐therapy with metronidazole, omeprazole and clarithromycin on intestinal microflora
Authors: Bühling A. , Radun D. , Müller W. A. , Malfertheiner P. 
Published: March 2003

Background:Proton pump inhibitor‐based therapy including two antibiotics is the treatment of choice for Helicobacter pylori infection. Oral antibiotic treatment can lead to intestinal overgrowth of potentially pathogenic bacteria.Aim:To investigate the intestinal microflora before and at different times after H. pylori treatment with omeprazole, clarithromycin and metronidazole.Methods:Bacterial growth in faecal samples from 51 patients infected with H. pylori was determined qualitatively and quantitatively. During the same period of time, stool samples from 27 H. pylori‐negative controls were taken and investigated at the same intervals.Results:The microflora of H. pylori‐infected patients was different from that in H. pylori negative controls. It was characterized by a high concentration of lactobacilli, mainly Lactobacillus acidophilus. Immediately after therapy there was an increased colonization with yeasts, while the growth of lactobacilli and other species was inhibited. Clostridium difficile was cultured from three cases, but without clinical manifestations of pseudomembranous colitis. After 4 weeks of therapy, the microflora returned to normal and was not different from that of the H. pylori‐negative control group.Conclusions:In H. pylori‐positive patients the intestinal flora is characterized by an increase in growth of acid‐tolerant L. acidophilus. Eradication therapy exerts only a short‐term influence on intestinal flora, whereas in the long term, the intestinal microflora is restored to a pattern similar to that of the control group.
A study of fructo oligosaccharides in the prevention of travellers’ diarrhoea
Authors: Cummings J. H. , Christie S. , Cole T. J. 
Published: March 2003

Background: Prebiotic carbohydrates selectively stimulate the growth of bifidobacteria and lactobacilli in the human colon. These bacteria form part of the gut’s inherent defence against invading pathogens.Aim: To test the effectiveness of fructo oligosaccharides in preventing travellers’ diarrhoea.Methods: A total of 244 healthy subjects, travelling to high and medium risk destinations for travellers’ diarrhoea, took part in a randomized, double‐blind, placebo‐controlled study. The protocol comprised a preliminary week for recording bowel habit by diary, a 2‐week pre‐holiday period with the diary and consumption of 10 g of fructo oligosaccharides or placebo daily, followed by a 2‐week holiday with continuation of treatment and diary. A post‐study questionnaire was completed by all subjects on their return to the UK.Results: The consumption of fructo oligosaccharides led to a small (6%; P < 0.02) increase in stool frequency in the pre‐holiday period and gave a significantly better sense of ‘well‐being’ during the holiday, although subjects reported more flatulence. There were non‐significant decreases in episodes of diarrhoea with 20% on placebo and 11% on fructo oligosaccharides recording episodes in the post‐study questionnaire (P=0.08) and 46% placebo, 38% fructo oligosaccharides recording episodes in the diary (P > 0.1). No change in bowel frequency, consistency or stool size was recorded.Conclusion: Travel to high risk areas increases diarrhoea. Fructo oligosaccharides alone are not sufficient to prevent this, although do have some benefits for the subjects.
Alternative antibacterial agents for Helicobacter pylori eradication
Authors: Guslandi M. 
Published: March 2003

Standard eradication therapies against Helicobacter pylori appear to be effective in most cases, but in clinical practice a failure rate higher than the 5–10% reported in clinical trials is often observed. Among the various reasons responsible for therapeutic failure, antibiotic resistance is becoming a major issue in some countries. A range of different antibacterial agents is currently under investigation: several macrolides, new fluoroquinolones, furazolidone and rifabutin.Although not formally tested in refractory cases, azithromycin, spiromycin, levofloxacin and furazolidone represent the most promising antibacterial agents for possible inclusion in eradication regimens.Rifabutin has been evaluated in H. pylori infections resistant to standard therapies. Although very effective, the drug is expensive and its use should be restricted to the most difficult cases to avoid the development of rifabutin resistance in Mycobacterium spp.
Intragastric distribution of Helicobacter pylori during short‐term omeprazole therapy: study using Carnoy’s fixation and immunohistochemistry for detection of bacteria
Authors: Ishihara S. , Okuyama T. , Ishimura N. , Ono M. , Hashimoto T. , Kazumori H. , Kaji T. , Sato H. , Fujishiro H. , Adachi K. , Fukuda R. , Kinoshita Y. 
Published: March 2003

Background:There is controversy about the effect of acid‐suppressive therapy on Helicobacter pylori density and the severity of histological gastritis in the corpus.Aim:To evaluate the precise distribution of H. pylori, both on the surface mucus cells and in the surface mucus gel layer, by using Carnoy’s fixation and immunostaining for the detection of bacteria.Methods:A total of 19 peptic ulcer patients with H. pylori infection were studied. All patients received a 6‐week course of treatment with omeprazole (20 mg/day). Before and after the therapy, H. pylori density in Carnoy‐fixed tissue sections was examined immunohistochemically. The effect of omeprazole therapy on the severity of gastritis was also evaluated.Results: H. pylori density and the grade of gastritis significantly decreased in the antrum after omeprazole therapy. In the corpus, however, there were no significant changes in H. pylori density or the severity of gastritis after omeprazole therapy.Conclusion:Carnoy’s fixation and immunostaining was found to be useful for the detection of H. pylori in the surface mucus gel layer as well as on the surface mucus cells in biopsy tissue sections. By using this method, H. pylori density decreased in the antrum, but remained unchanged in the corpus after a 6‐week course of omeprazole therapy.
Influence of pantoprazole on oesophageal motility, and bile and acid reflux in patients with oesophagitis
Authors: Netzer P. , Gut A. , Brundler R. , Gaia C. , Halter F. , Inauen W. 
Published: March 2003

Background:Reflux of duodeno‐gastric juice into the oesophagus appears to be involved in the pathogenesis of both reflux oesophagitis and oesophageal adenocarcinoma. Although proton pump inhibitors have been shown to decrease acid reflux and heal oesophagitis, their effect on biliary reflux and motility is less clear.Aim:To investigate whether pantoprazole also reduces bile reflux and whether this is paralleled by a change in oesophageal motility.Methods:Combined 24‐h measurements of intraoesophageal bilirubin concentration, pH and pressure were performed in 18 symptomatic patients with endoscopically proven reflux oesophagitis before and on day 28 of treatment with pantoprazole, 40 mg/day, under standardized conditions. A reflux symptom score was determined initially and every 2 weeks thereafter. After 56 days on medication, a control endoscopy was performed.Results:The symptom score and the acid and bile reflux improved significantly, whereas the motility parameters did not change during the study period. Helicobacter pylori‐positive patients had a significantly higher bile reflux time (32.1 ± 4.3%) than H. pylori‐negative patients (16.3 ± 3.1%) (P=0.009). The endoscopic healing rate was 89%. The cough symptoms disappeared in three of four patients.Conclusions:The proton pump inhibitor pantoprazole decreases both acid and bile reflux. The decrease of bile reflux cannot be explained by increased oesophageal clearance as oesophageal motility did not improve with therapy. Interestingly, H. pylori infection of the stomach was associated with higher levels of oesophageal bile reflux.
Octreotide increases the proportions of arachidonic acid‐rich phospholipids in gall‐bladder bile
Authors: Pereira S. P. , Hussaini S. H. , Murphy G. M. , Wass J. A. H. , Dowling R. H. 
Published: March 2003

Background and aims:Octreotide treatment of acromegalic patients induces cholesterol gallstone formation, in part by impairing cholecystokinin release and gall‐bladder contraction. However, there are few data on the effect of octreotide on biliary arachidonic acid‐rich phospholipids or mucin glycoprotein, factors which also influence cholesterol gallstone formation.Methods:In acromegalic patients studied before and during 3 months of octreotide treatment, we measured mucin glycoprotein concentrations and the molecular species of phosphatidylcholine, and related the results to the cholesterol saturation and percentage of deoxycholic acid in gall‐bladder bile.Results:The relative proportions of the major arachidonic acid‐rich phosphatidylcholine species, PC 16:0–20:4 and PC 18:0–20:4, increased significantly during octreotide treatment. These changes were associated with a rise in the cholesterol saturation index and a non‐significant twofold increase in mucin glycoprotein concentration. There were significant correlations between PC 16:0–20:4 and the cholesterol saturation index, percentage of vesicular cholesterol and percentage of deoxycholic acid in gall‐bladder bile.Conclusions:In acromegalic patients, octreotide increases the proportions of arachidonic acid‐rich phospholipids, with associated rises in: (a) the cholesterol saturation index and percentage of vesicular cholesterol, and (b) the percentage of deoxycholic acid in gall‐bladder bile—changes similar to those found in patients with cholesterol‐rich gall‐bladder stones.