bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparable clinical efficacy and tolerability of 20 mg pantoprazole and 20 mg omeprazole in patients with grade I reflux oesophagitis
Authors: Bardhan K. D. , Van Rensburg C. ,   (on behalf of the investigators)
Published: March 2003

Background:Several clinical trials have shown that pantoprazole (40 mg) and omeprazole (40 or 20 mg) have similar efficacy and safety in the treatment of grade II–IV reflux oesophagitis (Savary–Miller classification).Aim:To compare the efficacy and safety of once‐daily doses of pantoprazole (20 mg) and omeprazole (20 mg) with respect to symptom relief and healing of patients with grade I reflux oesophagitis.Methods:Patients with endoscopically established grade I reflux oesophagitis (non‐confluent, patchy red lesions with/without white fibrin coating) were enrolled into this randomized, open, parallel‐group, multicentre study. A total of 328 patients (n=166 in the pantoprazole group, n=162 in the omeprazole group) were recruited in 23 centres. Patients received 4 weeks of treatment. If the reflux oesophagitis was not completely healed, the treatment was extended to 8 weeks.Results:After 2 and 4 weeks of treatment with either pantoprazole or omeprazole, the rate of symptom relief was similar (70% vs. 79% and 77% vs. 84%, respectively). High healing rates were observed after 4 and 8 weeks (pantoprazole: 84% and 90%, respectively; omeprazole: 89% and 95%, respectively). Both treatments were well tolerated. The most frequently reported adverse events on pantoprazole and omeprazole, respectively, were nausea (8% vs. 7%), diarrhoea (5% vs. 6%) and headache (6% vs. 3%).Conclusions:After 4 and 8 weeks of treatment with pantoprazole (20 mg) or omeprazole (20 mg), patients with mild gastro‐oesophageal reflux disease (grade I) showed comparably high rates of symptom relief and healing. Both treatments were safe and well tolerated.
Clinical use of Infliximab in Crohn’s disease: the Edinburgh experience
Authors: Arnott I. D. R. , McDonald D. , Williams A. , Ghosh S. 
Published: March 2003

Introduction:Infliximab is an established treatment for steroid‐resistant and fistulating Crohn’s disease. Although efficacy has been shown in clinical trials, financial implications often limit its use and limited data exist regarding clinical practice.Aims:To audit the clinical effectiveness of Infliximab.Methods:We prospectively audited 50 consecutive patients [28 females; median age, 34 years (17–70 years)]. Disease activity and response rates were assessed by the Harvey–Bradshaw index. Clinical and disease data were collected and blood was taken for inflammatory markers, complement and double‐stranded DNA antibodies. Patients received Infliximab at 5 mg/kg and were followed for 12 weeks.Results:Indications for Infliximab were refractory Crohn’s disease in 39 patients, fistulating Crohn’s disease in six, pyoderma gangrenosum in one, pouchitis in two and coeliac disease in two. Thirty‐one (79%) of the refractory Crohn’s disease patients and four (66%) of the fistulating patients responded at 4 weeks. Twenty‐one (54%) of the refractory Crohn’s disease patients had a continued response at 12 weeks. Perianal disease was more prevalent in non‐responders (7/8 vs. 12/31, P < 0.02).Conclusions:Response rates to Infliximab in our group are comparable to those of clinical trials. Despite the expense, it remains a useful adjunct to treatment in this otherwise difficult group of patients. Patients with perianal disease responded less well in our cohort.
Efficacy and safety of oral ridogrel in the treatment of ulcerative colitis: two multicentre, randomized, double‐blind studies
Authors: Tytgat G. N. J. , Van Nueten L. , Van De Velde I. , Joslyn A. , Hanauer S. B. 
Published: March 2003

Background:Ridogrel at low doses inhibits thromboxane synthase. Oral ridogrel, from 5 mg once daily to 150 mg twice daily, improves the endoscopic appearance of colonic mucosa and clinical manifestations in mild to moderate ulcerative colitis.Aim:One US trial and one international trial were conducted to determine the effect of ridogrel on mild to severe active ulcerative colitis.Methods:Two 12‐week, double‐blind, randomized, parallel‐group trials were conducted. A US trial compared 0.5 mg, 2.5 mg and 5 mg of ridogrel once daily with placebo. An international trial compared 0.5 mg of ridogrel once daily with 2.5 mg and 5.0 mg of ridogrel once daily and 800 mg of mesalazine (known as mesalamine in the USA) three times daily. The primary efficacy outcome measure was the rate of complete remission.Results:In the US trial, complete remission was achieved in 20.8% of patients in the 0.5 mg ridogrel group, 17.9% in the 2.5 mg ridogrel group, 20.6% in the 5.0 mg ridogrel group and 13.6% in the placebo group. In the international trial, 14.4% of patients in the 0.5 mg ridogrel group, 19.6% in the 2.5 mg ridogrel group, 19.4% in the 5.0 mg ridogrel group and 16.4% in the mesalazine group experienced complete remission. In the international trial, rates of complete remission at the end‐point were greater in the 2.5 mg and 5.0 mg ridogrel groups than in the 0.5 mg ridogrel group, but the differences were not statistically significant. In the US trial, rates of complete remission at the end‐point were greater in the 2.5 mg and 5.0 mg ridogrel groups than in the placebo group, but the differences were not statistically significant. Approximately 30% of the patients in each group discontinued treatment before the 12‐week end‐point owing to a lack of therapeutic response. All doses of ridogrel were well tolerated and comparable with placebo or mesalazine in terms of safety.Conclusions:No significant differences in the primary efficacy outcome measure were found between either the 2.5 mg or the 5.0 mg dose of ridogrel and placebo in the US trial and between either the 2.5 mg or the 5.0 mg dose of ridogrel and the 0.5 mg dose of ridogrel, a surrogate dose for placebo, in the international trial. There was no clear indication in either trial of an effective dose of ridogrel in the treatment of ulcerative colitis.
High rate of post‐therapeutic resistance after failure of macrolide–nitroimidazole triple therapy to cure Helicobacter pylori infection: impact of two second‐line therapies in a randomized study
Authors: Peitz U. , Sulliga M. , Wolle K. , Leodolter A. , Von Arnim U. , Kahl S. , Stolte M. , Börsch G. , Labenz J. , Malfertheiner P. 
Published: March 2003

Background:The optimal second‐line treatment after failed Helicobacter pylori therapy has not been established.Aims:To ascertain whether quadruple therapy or triple therapy with omeprazole, clarithromycin and amoxicillin is the superior re‐treatment after triple therapy containing a macrolide and a nitroimidazole, and to determine the impact of microbial in vitro resistance.Methods:Patients after failed triple therapy were randomly allocated to one of two 1‐week second‐line treatments: omeprazole, 40 mg, clarithromycin, 500 mg, and amoxicillin, 1 g, all b.d.; or omeprazole, 20 mg b.d., bismuth subsalicylate, 600 mg q.d.s., metronidazole, 400 mg t.d.s., and tetracycline, 500 mg q.d.s. Post‐therapeutic Helicobacter pylori status was assessed by 13C‐urea breath test at least 4 weeks after treatment.Results:The study was terminated after including 84 patients. H. pylori cure rates differed significantly: omeprazole–clarithromycin–amoxicillin: intention‐to‐treat, 43%; per protocol, 50%; omeprazole–bismuth subsalicylate–metronidazole–tetracycline: intention‐to‐treat, 68%; per protocol, 69%. The frequencies of resistance after first‐line therapy were: metronidazole, 90%; clarithromycin, 71%; both combined, 68%. For clarithromycin resistance, H. pylori cure with omeprazole–clarithromycin–amoxicillin was 30% vs. 83% for clarithromycin susceptibility.Conclusions:Omeprazole–bismuth subsalicylate–metron‐ idazole–tetracycline was superior to omeprazole–clarithromycin–amoxicillin, but both therapies yielded unsatisfactory results. The high rate of post‐therapeutic dual resistance has a negative impact on omepraz‐ ole–clarithromycin–amoxicillin, and probably also on omeprazole–bismuth subsalicylate–metronidazole–tetracycline, and limits the choice for second‐line treatment.
13C‐Aminopyrine breath test to evaluate severity of disease in patients with chronic hepatitis C virus infection
Authors: Giannini E. , Fasoli A. , Chiarbonello B. , Malfatti F. , Romagnoli P. , Botta F. , Testa E. , Polegato S. , Fumagalli A. , Testa R. 
Published: March 2003

Background:There are few data on the use of the 13C‐aminopyrine breath test to evaluate the severity of disease in patients with hepatitis C virus‐related chronic liver disease, although these patients represent one of the most important problems in clinical hepatology.Aims:To compare 13C‐aminopyrine breath test results of patients with hepatitis C virus‐related chronic hepatitis and Child–Pugh class A cirrhosis with those of normal subjects, and to evaluate different methods of expressing 13C‐aminopyrine breath test results.Methods:Twenty‐four patients with hepatitis C virus‐related chronic hepatitis and 17 patients with Child–Pugh class A cirrhosis underwent 13C‐aminopyrine breath test. Breath samples were collected every 30 min up to 2 h after 13C‐aminopyrine administration. 13C‐Aminopyrine breath test results were expressed as a percentage of the administered dose of 13C recovered per hour (% dose/h) and the cumulative percentage of administered dose of 13C recovered over time (% dose cum). Nineteen healthy subjects served as controls. Patients with hepatitis C virus‐related chronic hepatitis were divided into subgroups on the basis of histological staging and grading.Results:The 13C‐aminopyrine breath test result (% dose/h) at 30 min was significantly different among the three subgroups of subjects (normal subjects, 11.5 ± 3.5; chronic hepatitis patients, 8.1 ± 4.1; cirrhosis patients, 5.0 ± 3.1; P < 0.0005). Moreover, the differences between chronic hepatitis and cirrhosis patients were statistically significant (P < 0.03). The fibrosis score showed a significant inverse correlation with the 13C‐aminopyrine breath test result (% dose/h) at 30 min (rs=− 0.409, P=0.05). The 13C‐aminopyrine breath test result (% dose/h) at 30 min also allowed normal subjects and chronic hepatitis patients with low (≤ 2) or high (> 2) fibrosis scores to be distinguished. The 13C‐aminopyrine breath test results (% dose cum) at 30, 60 and 90 min allowed discrimination between normal subjects and chronic hepatitis and cirrhosis patients. The 13C‐aminopyrine breath test result (% dose cum) was also able to distinguish between normal subjects and chronic hepatitis patients with high but not low fibrosis scores. Both 13C‐aminopyrine breath test results (% dose/h and % dose cum) at 120 min allowed the differentiation between normal subjects and chronic hepatitis patients with high (≥ 6) necro‐inflammatory activity.Conclusions:In patients with hepatitis C virus‐related chronic liver disease, the 13C‐aminopyrine breath test proved to be safe and easy to perform, and was able to evaluate different degrees of liver function impairment which were partly correlated to clinical and histological evaluation. In future studies, 13C‐aminopyrine breath test results should be expressed in a standardized fashion to permit comparison.
A pilot study of treatment of active ulcerative colitis with natalizumab, a humanized monoclonal antibody to alpha‐4 integrin
Authors: Gordon F. H. , Hamilton M. I. , Donoghue S. , Greenlees C. , Palmer T. , Rowley‐Jones D. , Dhillon A. P. , Amlot P. L. , Pounder R. E. 
Published: March 2003

Background:Alpha‐4 integrins facilitate leucocyte migration across vascular endothelium.Aim:To assess the safety and efficacy of natalizumab (Antegren), a humanized antibody to alpha‐4 integrin, in patients with active ulcerative colitis.Methods:Ten patients with active ulcerative colitis, defined by a Powell‐Tuck activity score > 4, received a single 3 mg/kg natalizumab infusion. The primary end‐point was the change in Powell‐Tuck score at 2 weeks post‐infusion.ResultsSignificant decreases in the median Powell‐Tuck score were observed at 2 and 4 weeks post‐infusion (7.5 and 6, respectively) compared to the median baseline score (10). Five of 10 patients achieved a good clinical response at 2 weeks and one more patient by 4 weeks, defined by a Powell‐Tuck score of ≤ 5. Significant improvements in quality of life scores were found at week 4. Rescue medication was required by two (20%), three (30%) and eight (80%) patients by weeks 2, 4 and 8, respectively (median, 34 days; range, 8–43 days). One patient remained in remission at 12 weeks. The median C‐reactive protein at 2 weeks (6 mg/L) was lower than that pre‐treatment (16 mg/L).Conclusions:A single 3 mg/kg infusion of natalizumab was well tolerated by ulcerative colitis patients. The positive efficacy demonstrated in this study merits further investigation by randomized, placebo‐controlled trials.
The 13C‐urea breath test to detect Helicobacter pylori infection: a validated simple methodology with 50 mg 13C‐urea
Authors: Liao C.‐C. , Lee C.‐L. , Chiang T.‐C. , Lee S.‐C. , Huang S.‐H. , Tu T.‐C. , Chen T.‐K. , Wu C.‐H. 
Published: March 2003

Background:Several modifications of the 13C‐urea breath test have been published. For reasons of cost efficiency and practicability, the urea dose and measurement duration should be reduced while still maintaining excellent diagnostic accuracy.Aims:To establish a validated simple protocol for the urea breath test with 50 mg 13C‐urea and to compare this protocol with the conventional urea breath test with 100 mg 13C‐urea.Methods:Conventional urea breath test with 100 mg 13C‐urea was performed on 152 dyspeptic patients. Full‐cream cow's milk was used as the test meal. Breath tests were repeated using 50 mg 13C‐urea and the breath samples were collected at baseline and at 10 (protocol t10), 15 (protocol t15) and 30 min (protocol t30). Helicobacter pylori status was assessed by rapid urease test, histology and conventional urea breath test with 100 mg 13C‐urea.Results:With protocol t15, the best combination of sensitivity (99.1%), specificity (97.3%) and accuracy (98.7%) was obtained with a cut‐off of 2.5‰. There was an extremely high correlation coefficient between the three protocols and conventional 13C‐urea breath test (all P < 0.001).Conclusions:A urea breath test with 50 mg 13C‐urea using a simple test meal and a 15‐min sampling interval with a low cut‐off seems to be cost‐effective and convenient. In a well‐standardized laboratory, this modification is not associated with any loss of diagnostic accuracy.
Helicobacter pylori increases the risk of upper gastrointestinal bleeding in patients taking low‐dose aspirin
Authors: Lanas A. , Fuentes J. , Benito R. , Serrano P. , Bajador E. , Sáinz R. 
Published: March 2003

Aim:To evaluate the role of Helicobacter pylori infection and other clinical factors in the risk of upper gastrointestinal bleeding in patients taking low‐dose aspirin.Subjects and methods:A case–control study was carried out of consecutive current users of low‐dose aspirin admitted because of upper gastrointestinal bleeding. Within a cohort of 695 patients with upper gastrointestinal bleeding, 98 patients had taken low‐dose aspirin and no other non‐steroidal anti‐inflammatory drug. Controls were 147 low‐dose aspirin users without upper gastrointestinal bleeding of similar age, sex and extent of aspirin use as cases. H. pylori infection was determined by CagA/VacA serology and 13C‐urea breath test in all cases and controls. Adjusted odds ratios (OR) are provided.Results: H. pylori infection was identified as an independent risk factor of upper gastrointestinal bleeding in this population (OR, 4.7; 95% confidence interval (95% CI), 2.0–10.9), but the presence of CagA‐positive serology was not. Other risk factors identified were a previous ulcer history (OR, 15.2; 95% CI, 3.8–60.1), alcohol use (OR, 4.2; 95% CI, 1.7–10.4) and use of calcium channel blockers (OR, 2.54; 95% CI, 1.25–5.14). Antisecretory therapy (OR, 0.1; 95% CI, 0.02–0.3) and nitrovasodilators (OR, 0.2; 95% CI, 0.1–0.6) decreased the risk of bleeding.Conclusions: H. pylori infection is a risk factor for upper gastrointestinal bleeding in low‐dose aspirin users, which might have therapeutic implications in high‐risk patients.
P‐Glycoprotein‐170 inhibition significantly reduces cortisol and ciclosporin efflux from human intestinal epithelial cells and T lymphocytes
Authors: Farrell R. J. , Menconi M. J. , Keates A. C. , Kelly C. P. 
Published: March 2003

Aim:To assess the role of P‐glycoprotein‐170 (P‐gp) in transporting cortisol and ciclosporin from human intestinal epithelium and T lymphocytes.Methods:The effect of P‐gp inhibitors (verapamil, 0–100 μM; PSC 833, 0–20 μM) on the intracellular accumulation of 3H‐cortisol and 3H‐ciclosporin was studied in confluent layers of human Caco‐2 cells (n=6), a P‐gp‐dependent absorptive intestinal epithelial cell phenotype, and moderately resistant MDRhigh CEM/VBL 100 T cells (n=6). The transport of 3H‐vinblastine, a strong multidrug resistance (MDR) substrate, and 3H‐progesterone, a poor MDR substrate, was also studied.Results:Caco‐2 cells had a 2.4‐, 6.6‐, 6.7‐ and 1.03‐fold higher net basal to apical transport (efflux) of 3H‐cortisol, 3H‐ciclosporin, 3H‐vinblastine and 3H‐progesterone, respectively. PSC 833 (20 μM) reduced cortisol efflux by 69% (0.23 ± 0.04 to 0.07 ± 0.01 pmol/cm2/h, P < 0.05) and ciclosporin efflux by 76% (11.1 ± 1.4 to 2.7 ± 0.6 pmol/cm2/h, P < 0.001). MDRlow CEM T cells had a 1.4‐, 1.9‐, 3.2‐ and 1.02‐fold higher intracellular accumulation of cortisol, ciclosporin, vinblastine and progesterone than MDRhigh CEM/VBL 100 T cells. Increasing concentrations of PSC 833 (> 0.1 μM) and verapamil (> 1 μM) restored the intracellular level of 3H‐cortisol and 3H‐ciclosporin in MDRhigh CEM/VBL 100 T cells to that of MDRlow CEM cells with little change in accumulation in the MDRlow parental cell line.Conclusions:P‐gp inhibitors significantly increase intracellular cortisol and ciclosporin levels in human intestinal epithelium and T lymphocytes in a dose‐dependent manner, demonstrating a potential mechanism for overcoming poor response to immunosuppressant therapy in refractory inflammatory bowel disease.
Single vs. double dose of a proton pump inhibitor in triple therapy for Helicobacter pylori eradication: a meta‐analysis
Authors: Vallve M. , Vergara M. , Gisbert J. P. , Calvet X. 
Published: March 2003

Background:Triple therapies combining a double dose of proton pump inhibitor plus two antibiotics are the standard treatment for Helicobacter pylori infection. Some reports suggest that the use of half the dose of proton pump inhibitor is equally effective.Aim:To compare the efficacy of a single vs. double dose of proton pump inhibitor in triple therapy.Methods:We conducted a MEDLINE search. The search strategy included the words (pylori) AND (triple, PPI, proton pump, omeprazole, rabeprazole, pantoprazole, lansoprazole, clarithromycin, amoxicillin, amoxycillin or metronidazole). Abstracts of the articles obtained and papers presented at the European Helicobacter pylori Study Group and American Gastroenterological Association congresses from 1996 to 2001 were examined. Inclusion criteria were: (i) randomized studies with at least two branches of triple therapy including a proton pump inhibitor and two standard antibiotics; (ii) branches could differ only in terms of proton pump inhibitor dosage. A meta‐analysis was conducted using conventional shareware (Review Manager 4.1).Results:Thirteen studies met the inclusion criteria with a total of 2391 patients. Cure rates with double doses of proton pump inhibitor were higher in both the intention‐to‐treat analysis (83.9% vs. 77.7%; Peto odds ratio, 1.51; 95% confidence interval, 1.23–1.85; P < 0.01) and per protocol analysis (89% vs. 81%; Peto odds ratio, 1.96; 95% confidence interval, 1.55–2.47; P < 0.01).Conclusion:Triple therapies containing a single dose of proton pump inhibitor are less effective than those containing a standard double dose of proton pump inhibitor.
An open‐label study of thalidomide for maintenance therapy in responders to infliximab in chronically active and fistulizing refractory Crohn's disease
Authors: Sabate J. M. , Villarejo J. , Lemann M. , Bonnet J. , Allez M. , Modigliani R. 
Published: March 2003

SummaryBackground : Infliximab, a chimeric monoclonal antibody to tumour necrosis factor‐α, is a new potent therapy for active Crohn's disease, but induces short‐lived improvements.Aim : To evaluate the efficacy of thalidomide, a drug with anti‐tumour necrosis factor‐α activity, for the maintenance of infliximab‐induced response in refractory Crohn's disease.Methods : Fifteen patients with severe, refractory disease (10 females, five males; mean age, 40 years; eight with luminal disease, two with fistulizing disease and five with both luminal and fistulizing disease) were started on thalidomide (100 mg daily), 29 ± 10 days after they had responded to infliximab (5 mg/kg infusions).Results : The median follow‐up period was 238 days (range, 10–458 days) from the initiation of thalidomide and 265 days (range, 10–537 days) from the last infliximab infusion. The median Crohn's disease activity indices were 322 (range, 170–525), 119 (range, 24–503) and 35 (range, − 60–360) before infliximab, at the initiation of thalidomide and at the end of follow‐up, respectively. Remission rates on thalidomide were 92%, 83% and 83% at 3, 6 and 12 months, respectively, after the last infliximab infusion (Kaplan–Meier). Four patients (two in remission) stopped thalidomide for suspected adverse effects. Side‐effects (drowsiness, rash and peripheral neuropathy) were mild and mostly transient.Conclusions : Thalidomide appears to be an effective and relatively safe drug to maintain response to infliximab in chronically active and fistulizing refractory Crohn's disease.
Helicobacter pyloriinfection and gastric outlet obstruction — prevalence of the infection and role of antimicrobial treatment
Authors: Gisbert J. P. , Pajares J. M. 
Published: March 2003

SummaryThe prevalence of Helicobacter pylori infection in peptic ulcer disease complicated by gastric outlet obstruction seems to be, overall, lower than that reported in non‐complicated ulcer disease, with a mean value of 69%. However, H. pylori infection rates in various studies range from 33% to 91%, suggesting that differences in variables, such as the number and type of diagnostic methods used or the frequency of non‐steroidal anti‐inflammatory drug intake, may be responsible for the low prevalence reported in some studies.The resolution of gastric outlet obstruction after the eradication of H. pylori has been demonstrated by several studies. It seems that the beneficial effect of H. pylori eradication on gastric outlet obstruction is observed early, just a few weeks after the administration of antimicrobial treatment. Furthermore, this favourable effect seems to remain during long‐term follow‐up. Nevertheless, gastric outlet obstruction does not always resolve after H. pylori eradication treatment and an explanation for the failures is not completely clear, non‐steroidal anti‐inflammatory drug intake perhaps playing a major role in these cases. Treatment should start pharmacologically with the eradication of H. pylori even when stenosis is considered to be fibrotic, or when there is some gastric stasis.In summary, H. pylori eradication therapy should be considered as the first step in the treatment of duodenal or pyloric H. pylori‐positive stenosis, whereas dilation or surgery should be reserved for patients who do not respond to such medical therapy.