bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ferric trimaltol corrects iron deficiency anaemia in patients intolerant of iron
Authors: Harvey R. S. J. , Reffitt D. M. , Doig L. A. , Meenan J. , Ellis R. D. , Thompson R. P. H. , Powell J. J. 
Published: March 2003

Background:Oral iron supplements, which are usually in the form of ferrous (Fe2+) salts, are toxic to the gastrointestinal mucosa, and so intolerance is common, resulting in poor compliance and failure of treatment. The sugar derivative maltol strongly chelates iron, rendering it available for absorption and stabilized in the less toxic ferric (Fe3+) form.Aim:To test whether ferric trimaltol could correct iron deficiency anaemia in patients intolerant of ferrous sulphate.Methods:Twenty‐three patients were recruited from gastroenterology clinics, of whom 15 had inflammatory bowel disease, a group often difficult to treat with oral iron. Patients with iron deficiency anaemia and documented intolerance to ferrous sulphate were given 3 months of treatment with ferric trimaltol.Results:Nineteen of 23 patients completed the treatment and anaemia was fully corrected in 14 of these, mean haemoglobin increased from 106 ± 15 to 126 ± 16 g/L, and there was a particularly low incidence of side‐effects. Of 11 patients with inflammatory bowel disease who completed the study, nine fully corrected their anaemia.Conclusion:The results demonstrate that in patients intolerant of ferrous compounds, ferric trimaltol corrects iron deficiency and has a low incidence of side‐effects.
Review article: the use of biotherapeutic agents in the prevention and treatment of gastrointestinal disease
Authors: Lewis S. J. , Freedman A. R. 
Published: March 2003

There is presently a lack of well conducted clinical trials demonstrating any significant benefits of probiotics in humans. With the exception of diarrhoea due to rotavirus infection in children there is little evidence from randomized, double‐blind, placebo‐controlled studies that bacterial probiotics have a significant beneficial action in preventing diarrhoea of any cause. The yeast Saccharomyces boulardii has been shown to be of benefit in the prevention of antibiotic‐associated diarrhoea but not in preventing infection with Clostridium difficile. S. boulardii may also be of benefit in preventing relapse of C. difficile infection. Because of the simplicity of in vitro systems and some animal models, beneficial characteristics of probiotics such as the ability of bacteria to bind to epithelial surfaces are not always transferable to humans. Thus any postulated benefit from consumption of probiotic bacteria should only be accepted as fact after testing in clinical studies.This review outlines our present knowledge of the mode of action of probiotics and presents the data from clinical trials on their use.
Octreotide in the prevention of pancreatic injury associated with endoscopic cholangiopancreatography
Authors: Tulassay  , Döbrönte  , Prónai  , Zágoni  , Juhász  
Published: March 2003

Background:Data on whether long‐acting somatostatin analogue octreotide causes or prevents pancreatic injury following endoscopic retrograde cholangiopancreatography (ERCP) are controversial.Aim:This multicentre, prospective trial studied the effect of octreotide on pancreatic injury in a large unselected group of patients after ERCP and endoscopic sphincterotomy.Methods:The study was carried out in a prospective random manner on 2102 patients in 11 endoscopic centres. Patients in the study received 0.1 mg octreotide acetate and those in the control group received isotonic sodium chloride, subcutaneously before and 45 min after ERCP. Pancreatic injury was assessed by clinical symptoms such as pain, fever and abdominal tenderness. Serum amylase and blood sugar were determined prior to, and 6 and 24 h after the endoscopic procedure.Results:Data from 599 patients in the study group and 600 in the control group were included in the final evaluation. When all the patients were considered, octreotide did not induce pancreatic injury as assessed by clinical symptoms, and diminished the increase of serum amylase levels following ERCP. However, when subgroups of patients were studied, the frequency of increased amylase levels decreased significantly in patients with chronic obstructive pancreatitis and in patients who underwent endoscopic sphincterotomy (P < 0.01). The peak serum glucose level was higher in the treated group when compared to the controls.Conclusion:The prophylactic use of long‐acting somatostatin does not alter the frequency of post‐ERCP pancreatic injury, but it may diminish the rate of increased serum amylase levels in patients with chronic obstructive pancreatitis and also in those with an endoscopic sphincterotomy.
Low‐ versus high‐dose azithromycin triple therapy for Helicobacter pylori infection
Authors: Chey  , Fisher  , Barnett  , Delvalle  , Elta  , Hasler  , Nostrant  , Palaniappan  , Scheiman  
Published: March 2003

BackgroundWe report a clinical trial which evaluated the effectiveness of triple therapy containing low‐ and high‐dose azithromycin to treat Helicobacter pylori infection.MethodsFrom March 1997 to March 1998, patients infected with H. pylori were assigned to receive either: Treatment 1: ranitidine bismuth citrate (RBC) (400 mg b.d.) and amoxycillin (1 g b.d.) for 10 days with azithromycin 500 mg o.m. for 3 days; or Treatment 2: RBC and amoxycillin for 10 days with azithromycin 1 g o.m. for 3 days. H. pylori eradication was established by a urea breath test at least 4 weeks after therapy. Side‐effects and compliance were assessed using a diary.ResultsSixty‐eight patients were enrolled. Fifty‐seven per cent of patients were treated for active peptic ulcer disease or a history of peptic ulcer disease. Treatment 1 cured H. pylori in 44% and 44% by per protocol and intention‐to‐treat analysis, respectively. The corresponding eradication rates for Treatment 2 were 79% and 75%. Two patients taking Treatment 2 dropped out of the study because of side‐effects.ConclusionsWith RBC and amoxycillin for 10 days, azithromycin at a dose of 1 g/day for 3 days was significantly better at curing H. pylori infection than azithromycin 500 mg/day for 3 days.
Nocturnal gastric acidity and acid breakthrough on different regimens of omeprazole 40 mg daily
Authors: Hatlebakk  , Katz  , Kuo  , Castell  
Published: March 2003

BackgroundOn chronic intake of omeprazole, most healthy volunteers and patients still have nocturnal acid breakthrough (NAB), defined as night‐time periods with gastric pH < 4.0 lasting for longer than 1 h. Gastro‐oesophageal reflux during NAB may be particularly injurious to the oesophageal mucosa, contributing to the chronic lesions complicating the condition.AimTo compare the effect of three different dosing regimens of omeprazole 40 mg daily with regard to suppressing nocturnal gastric acidity and avoiding NAB.MethodsEighteen healthy volunteers were given three different regimens of omeprazole for 7 days each in randomized order: 40 mg before breakfast (qAM), 40 mg before dinner (qPM) and 20 mg before breakfast and dinner (b.d.). On day 7, 24‐h intragastric and intra‐oesophageal pH‐metry was performed. Tracings were analysed for the period from 22.00 h until 06.00 h with regard to the percentage of time at which gastric pH was below 4.0, 3.0 and 2.0, and also the occurrence and duration of NAB.ResultsNocturnal acid breakthrough was significantly more common on qAM than on qPM and b.d. (P < 0.05) dosing. The percentage of time gastric pH was less than 4.0 overnight was significantly lower on qPM (median 31.3) and b.d. (median 20.5) than on qAM (median 66.3) dosing (P = 0.01 and P < 0.02, respectively). A pH threshold of 3 and 4 showed the same differences, as did median 24‐h gastric pH. Daytime acidity was not significantly different.ConclusionsIn healthy volunteers, dinner time or split dosing of omeprazole 40 mg daily is significantly more effective than dosing before breakfast in preventing NAB and controlling gastric acidity. These regimens should be preferred in patients in whom suppression of nocturnal gastric acidity is desirable.
Development of a new dyspepsia impact scale: the Nepean Dyspepsia Index
Authors: Talley  , Haque  , Wyeth  , Stace  , Tytgat  , Stanghellini  , Holtmann  , Verlinden  , Jones  
Published: March 2003

Background:There is not at present a suitable disease‐specific health‐related quality of life instrument for uninvestigated dyspepsia and functional (non‐ulcer) dyspepsia.Aim:To develop a new multi‐dimensional disease‐specific instrument.Methods:The Nepean Dyspepsia Index (NDI) was designed to measure impairment of a subject’s ability to engage in relevant aspects of their life and also their enjoyment of these aspects; in addition, the individual importance of each aspect is assessed. A 42‐item quality of life measure was developed and tested, both in out‐patients presenting to general practice with upper gastrointestinal complaints (n = 113) and in a randomly chosen population‐based sample (n = 347).Results:Adequate face and content validity was documented by an expert panel. Factor analysis identified four clinically relevant subscales: interference with activities of daily living, work, enjoyment of life and emotional well‐being; lack of knowledge and control over the illness; disturbance to eating or drinking; and disturbance to sleep because of dyspepsia. These scales had high internal consistency. Both symptoms and the quality of life scores discriminated dyspepsia from health.Conclusion:The Nepean Dyspepsia Index is a reliable and valid disease‐specific index for dyspepsia, measuring symptoms and health‐related quality of life.
Helicobacter pylori eradication with proton pump inhibitor‐based triple therapies and re‐treatment with ranitidine bismuth citrate‐based triple therapy
Authors: Rinaldi  , Zullo  , Francesco  , Hassan  , Winn  , Stoppino  , Faleo  , Attili  
Published: March 2003

Background:It has been suggested that short‐term triple therapy comprising a proton pump inhibitor, plus clarithromycin and amoxycillin be used as first choice in treating H. pylori infection, while eradication failure patients should be further treated with a quadruple therapy. Nevertheless, conflicting results have been reported using these treatment regimens in different countries.Methods:A total of 278 patients with H. pylori infection were randomised to receive one‐week triple therapy, comprising clarithromycin 500 mg b.d., amoxycillin 1 g b.d., and either omeprazole 20 mg b.d. (OAC; 90 patients), or pantoprazole 40 mg b.d. (PAC; 95 patients), or lansoprazole 30 mg b.d. (LAC; 93 patients). H. pylori infection at entry, and eradication 4–6 weeks after therapy had ended, were assessed by rapid urease test and histology on biopsies from the antrum and the corpus. When eradication did not occur, patients were given a 2‐week treatment comprising ranitidine bismuth citrate 400 mg b.d., tetracycline 500 mg t.d.s. and tinidazole 500 mg b.d. (RBTT). Eradication in these patients was assessed 4–6 weeks after conclusion of treatment by a further endoscopy.Results:Six patients were lost to the follow‐up. At the end of the first course of treatment, the overall H. pylori eradication rate was 78% (95% CI: 73–83) and 79% (95% CI: 75–84) at ‘intention‐to‐treat’ (ITT) and ‘per protocol’ (PP) analysis, respectively, without any statistically significant difference between treatment regimens, although a trend for better results with the omeprazole combination was observed. Moreover, H. pylori eradication was achieved in 82% (95% CI: 75–97) (ITT) and 86% (95% CI: 69–94) (PP) of 38 patients re‐treated with RBTT regimen.Conclusions:Our data found that this short‐term triple therapy is not a satisfactory treatment (< 80% eradication rate) for H. pylori infection. The 2‐week triple therapy used as re‐treatment in eradication failure patients yielded more promising results.
The colonic mesenteric margin is most susceptible to injury in an experimental model of colonic ulceration
Authors: ANTHONY  , DHILLON  , POUNDER  , WAKEFIELD  
Published: March 2003

Background: Crohn's disease ileal ulcers and indomethacin‐induced jejunal ulceration in the rat tend to occur in the mucosa nearest to the mesentery (mesenteric margin), an area of the bowel wall that has a critical blood supply. Mercuric chloride induces caecal and colonic ulceration in the Brown Norway rat.Aim: To examine whether the mesenteric margin is more sensitive to injury by a substance known to be vasculotoxic in the caecum and colon.Methods: Brown Norway rats received a single subcutaneous dose of either mercuric chloride 1 mg/kg or saline. The gastrointestinal tract was examined macro‐ and microscopically for lesions 48 h later. The vascular anatomy of the normal rat colon and caecum was also examined using the carbon ink perfusion technique.Results: Mercuric chloride induced caecal and colonic ulceration preferentially along the mesenteric margin of the bowel wall. Histologically, the lesions showed mucosal necrosis and neutrophil infiltration. There was also extensive vascular degeneration/necrosis with microaneurysm formation and extensive submucosal haemorrhage. Cellular infiltration of the vasculature was not a feature. The caecal and colonic mesenteric margins in control rats were supplied by small end arteries.Conclusions: The colonic and caecal mesenteric margins are susceptible to injury by mercuric chloride, a chemical known to induce haemorrhagic vasculopathy in the rat gastrointestinal tract. The large bowel mesenteric margin may be susceptible to injury by mercuric chloride because of the critical blood supply to that side of the bowel wall.
Impact of rabeprazole, a new proton pump inhibitor, in triple therapy for Helicobacter pylori infection—comparison with omeprazole and lansoprazole
Authors: Miwa H. , Ohkura R. , Murai T. , Sato K. , Nagahara A. , Hirai S. , Watanabe S. , Sato N. 
Published: March 2003

Background: A recent trend in curative therapy for Helicobacter pylori infection is the so‐called triple therapy, which consists of a proton pump inhibitor (PPI) and two different antimicrobials. Various regimens employing this triple therapy have been reported. However, little is known about the effectiveness of rabeprazole, a recently developed proton pump inhibitor, when used in the triple therapy.Aim: To validate its usefulness by comparing rabeprazole with omeprazole and lansoprazole, in combination with amoxycillin and clarithromycin.Patients and methods: 221 H. pylori‐positive patients with peptic ulcer disease were randomized to receive one of three different proton pump inhibitor/amoxycillin–clarithromycin (PPI/AC) regimens for 7 days. (i) OAC regimen (n = 75): omeprazole 20 mg b.d., amoxycillin (AMOX) 500 mg t.d.s. and clarithromycin (CAM) 200 mg b.d.; (ii) LAC regimen (n = 74): lansoprazole 30 mg b.d., AMOX 500 mg t.d.s. and CAM 200 mg b.d.; and (iii) RAC regimen (n = 72): rabeprazole 20 mg b.d., AMOX 500 mg t.d.s. and CAM 200 mg b.d. Cure of the infection was determined by the 13C urea breath test 1 month after completion of the treatment.Results: Intention‐to‐treat based cure rates for OAC, LAC and RAC regimens were 85% (95% CI, 75–92), 84% (95%, CI 73–91) and 88% (95% CI, 78–94), respectively, and per protocol based cure rates of these regimens were 88% (95% CI, 78–94), 91% (95%, CI 82–99) and 93% (95% CI, 84–98), respectively. Adverse effects in the entire study population, which included diarrhoea, glossitis or skin rash, were reported by 15% of the patients, and complete compliance was achieved in 95% of these patients.Conclusion: 1‐week proton pump inhibitor/AC regimens for H. pylori infection were effective in the Japanese population. Rabeprazole can be considered as equivalent to omeprazole and lansoprazole in the PPI/AC triple therapy.
Short‐term triple therapy with lansoprazole 30 mg or 60 mg, amoxycillin and clarithromycin to eradicate Helicobacter pylori
Authors: Sieg  , Sellinger  , Schlauch  , HÖrner  , Fuchs  
Published: March 2003

Background: We investigated the efficacy of 30 vs. 60 mg lansoprazole daily in a 1‐week triple therapy for eradication of Helicobacter pylori in a prospective randomized study.Methods: Two hundred and fifteen consecutive out‐patients with peptic ulcer disease or non‐ulcer dyspepsia, in whom H. pylori infection was confirmed by histology and/or a urease biopsy test, were randomly assigned to a 1‐week treatment with either 15 mg lansoprazole b.d. (LAC15 group) or 30 mg lansoprazole b.d. (LAC30 group) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d.Results: Eradication of H. pylori was successful in 87% (per protocol) and 82% (intention‐to‐treat) of the patients with LAC15 and in 94% (per protocol) and 87% (intention‐to‐treat) of the patients with LAC30. The difference was not significant. In both treatment groups, all peptic ulcers were healed at the check‐up. Adverse effects were seen in 11 patients of the LAC15 group and 10 patients of the LAC30 group: they caused discontinuation of the therapy in four of the LAC15 group and two patients of the LAC 30 group.Conclusions: A 7‐day triple therapy using lansoprazole (LAC15) is an efficient and economical regimen for the eradication of H. pylori.
The effect of Helicobacter pylori eradication on gastro‐oesophageal reflux
Authors: Tefera  , Hatlebakk  , Berstad  
Published: March 2003

Background: Increased prevalence of oesophagitis has been reported following eradication of Helicobacter pylori. We hypothesized that H. pylori eradication might increase gastro‐oesophageal acid reflux in patients with reflux oesophagitis.Methods: Twenty‐five consecutive patients (13 male, 12 female) with H. pylori infection and reflux oesophagitis grade I (22 patients) or II (three patients) were enrolled; mean age 49.9 (range 33–75) years. Twenty‐four hour intra‐oesophageal pH recording was performed before and 12 weeks after eradication of H. pylori, which was achieved using bismuth subnitrate suspension 150 mg q.d.s., oxytetracycline 500 mg q.d.s. and metronidazole 400 mg t.d.s. for 10 days. Eradication was confirmed by 14C‐urea breath test 12 weeks after completion of treatment. The patients did not receive acid‐suppressive medication.Results: All patients had abnormal gastro‐oesophageal reflux before anti‐H. pylori treatment. After treatment, there was no significant change in the percentage of total time oesophageal pH < 4 (P=0.46) in the 23 patients in whom the infection had been cured. Nine of the cured patients had increased acid exposure, whereas 14 had decreased acid exposure. No significant change in reflux symptom scores was found. There was no relationship between change in acid exposure and symptom improvement.Conclusions: Twelve weeks after H. pylori eradication there was no consistent change in gastro‐oesophageal acid reflux in patients with mild or moderate reflux oesophagitis.
Randomized trial of omeprazole and clarithromycin combined with either metronidazole or amoxycillin in patients with metronidazole‐resistant or ‐susceptible Helicobacter pylori strains
Authors: Houben  , Hensen  , Rauws  , Hulst R. W. M. Van Der , Hoff B. W. M. Van‘T , Ende A. Van Der , Kate F. J. W. Ten , Tytgat  
Published: March 2003

Background: The impact of metronidazole resistance on the efficacy of proton pump inhibitor based triple therapies remains unclear.Aim: To study whether metronidazole resistance affects Helicobacter pylori eradication rates in patients treated for 1 week with either omeprazole 20 mg b.d., metronidazole 400 mg b.d. and clarithromycin 250 mg b.d. (OMC), or omeprazole 20 mg b.d., amoxycillin 1000 mg b.d. and clarithromycin 500 mg b.d. (OAC).Methods: A randomized, single blind, single centre study with parallel groups was conducted. H. pylori positive patients were enrolled in a metronidazole‐resistant (MR; MIC > 8 μg/mL) or a metronidazole‐susceptible group (MS; MIC < 4 μg/mL), as determined by E‐test. Within the strata patients were randomized to either OAC or OMC.Results: One hundred and twenty‐two patients were included. The per protocol cure rate for OAC was 52 out of 57 (91%) (MS 23 out of 26 (89%); MR 29 out of 31 (94%)) and for OMC 46 out of 55 (84%) (MS 19 out of 22 (86%); MR 27 out of 33 (82%)).Conclusions: One‐week OAC and OMC are effective therapies. OAC and OMC were equally effective in patients with metronidazole‐susceptible strains of H. pylori. Using the OMC regimen, neither equality nor significant differences in treatment outcome could be shown between patients with metronidazole‐resistant or –susceptible strains of H. pylori.
A double‐blind, randomized, multicentre, crossover study to prove equivalence of pancreatin minimicrospheres versus microspheres in exocrine pancreatic insufficiency
Authors: Halm  , LÖser  , LÖhr  , Katschinski  , MÖssner  
Published: March 2003

Background: Modern pancreatin preparations consist of enteric‐coated microspheres to protect the enzymes from gastric acid. There are, however, no clinical trials comparing different sizes of pancreatin microspheres with regard to fat excretion and fat intake.Aim: To prove both equivalent efficacy and safety of conventional pancreatin microspheres and smaller pancreatin minimicrospheres in patients with exocrine insufficiency due to chronic pancreatitis.Methods: In this prospective, randomized, double‐blind, multicentre, crossover trial, patients with a stool fat excretion of > 7.5 g/day during a placebo period were randomly assigned either to the minimicrosphere/microsphere treatment sequence or vice versa. The primary end‐point was the coefficient of fat absorption, which was calculated from fat excretion and fat intake during the course of a standardized diet. Stool weight, clinical symptoms and the safety of the preparations were also evaluated.Results: Thirty‐seven patients entered the study, of whom 23 fulfilled the criteria for the crossover period. In the per protocol analysis (n=18), the 90% confidence intervals for the coefficient of fat absorption of both crossover periods lay entirely within the equivalence range (P=0.02). The intention‐to‐treat analysis revealed similar results, but the equivalence range was slightly missed (P=0.07). Similar results were obtained for the secondary parameters and the reported adverse events.Conclusions: Pancreatin minimicrospheres have been shown to be equally effective as microspheres in improving the coefficient of fat absorption in patients with exocrine insufficiency due to chronic pancreatitis.
Double‐blind comparison of lansoprazole 15 mg, lansoprazole 30 mg and placebo as maintenance therapy in patients with healed duodenal ulcers resistant to H2‐receptor antagonists
Authors: Kovacs  , Campbell  , Richter  , Haber  , Jennings  , Rose  
Published: March 2003

Background: Maintenance antisecretory therapy is often used to prevent duodenal ulcer recurrence and control symptoms. This study compared the efficacy and safety of lansoprazole 15 mg and 30 mg daily with placebo in preventing ulcer recurrence in patients with a recent history of duodenal ulcer disease.Methods: Fifty‐six patients were treated with either lansoprazole 15 mg, 30 mg or placebo o.m.Results: Within 1 month of study initiation, 27% (four out of 15) of placebo‐treated patients experienced ulcer recurrence as compared to 13% (two out of 15) and 6% (one out of 18) of lansoprazole 15 mg and 30 mg treated patients, respectively. Median time to first ulcer recurrence was > 12 months in lansoprazole patients. At Month 12, significantly (P < 0.001) more lansoprazole 15 mg patients (70%) and lansoprazole 30 mg patients (85%) remained healed. Eighty‐two per cent of lansoprazole 15 mg and 76% of lansoprazole 30 mg patients remained asymptomatic during the entire study period. All placebo patients became symptomatic, experienced ulcer recurrence, or withdrew from the study by month six. The incidence of adverse events was comparable among the three treatment groups.Conclusions: Lansoprazole safely and effectively reduces duodenal ulcer recurrence and ulcer‐related symptoms.