bluuebunny/crossref_metadata_2025_split huggingface dataset:
Domperidone is more effective than cisapride in children with diabetic gastroparesis
Authors: Franzese A. , Borrelli O. , Corrado G. , Rea P. , Di Nardo G. , Grandinetti A. L. , Dito L. , Cucchiara S. 
Published: March 2003

Background:Disorders of gastrointestinal motility are commonly detected in patients with insulin‐dependent diabetes mellitus and are associated with significant morbidity. They contribute to poor metabolic control of diabetes.Aim:To assess the effect of an 8‐week course of domperidone or cisapride on gastric electrical activity, gastric emptying time and dyspeptic symptoms in children with insulin‐dependent diabetes mellitus and gastroparesis.Methods:Dyspeptic symptoms were assessed by a score system, gastric emptying time was measured by ultrasonography and gastric electrical activity was obtained by electrogastrography. Fourteen children received domperidone and 14 received cisapride. The median (range) ages were 11.6 years (5–15 years) and 12 years (6–16.9 years), respectively. Symptom assessment, ultrasonography and electrogastrography were repeated at the end of the trial. Fasting and fed (180 min after feeding) glycaemia and haemoglobin A, C (HbA1c) levels were also measured.Results:At the end of the trial both groups showed a significant decrease in symptomatic score; however, the score was markedly lower in the domperidone group than in the cisapride group (P < 0.01). Domperidone was significantly more effective than cisapride in reducing the gastric emptying time (P < 0.05), normalizing gastric electrical activity (P < 0.05) and decreasing the prevalence of episodes of gastric dysrhythmia (P < 0.01). Domperidone was also more effective than cisapride in improving diabetic metabolic control. No potentially drug‐related adverse effects occurred.Conclusions:In children with insulin‐dependent diabetes mellitus complicated by dyspeptic symptoms and gastroparesis, domperidone is superior to cisapride in reversing gastric emptying delay and gastric electrical abnormalities, as well as in improving dyspeptic symptoms and diabetic metabolic control.
Effectiveness of Helicobacter pylori eradication treatments in a primary care setting in Italy
Authors: Monica P. Della , Lavagna A. , Masoero G. , Lombardo L. , Crocellá L. , Pera A. 
Published: March 2003

Aim:To evaluate the choice and relative effectiveness of Helicobacter pylori eradication regimens in a primary care setting.Patients and methods:Patients referred to our department, who had been treated for H. pylori infection during the preceding 6 months, were enrolled between September 1998 and July 1999. H. pylori status was assessed by urea breath test. Information on the drugs administered, compliance and side‐effects was recorded.Results:The mean eradication rate was 72% in patients receiving their first course of treatment (1863 cases; 45% male; mean age, 53 ± 14 years); a double therapy regimen was prescribed to 14% of patients, triple therapy to 85% and quadruple therapy to 1%. Maastricht Consensus proton pump inhibitor‐based regimens were prescribed in 80% of cases, with a mean eradication rate of 73%. No statistically significant correlation was found between eradication failure and sex, age, endoscopic findings or administered treatment.Conclusions:In Italy, in a primary care setting, first‐line H. pylori eradication therapies reflect international guidelines. The efficacy of such regimens is lower than that reported by controlled trials. These results are relevant when making pharmacoeconomic evaluations of H. pylori management.
Safety and efficacy of two reduced dosing regimens of sodium phosphate tablets for preparation prior to colonoscopy
Authors: Rex D. K. , Chasen R. , Pochapin M. B. 
Published: March 2003

Objectives:To evaluate the safety and efficacy of two reduced dosing regimens of sodium phosphate tablets (Visicol, InKine Pharmaceutical Co. Inc., Blue Bell, PA, USA) for colon cleansing prior to colonoscopy.Methods:In a randomized, multicentre, endoscopist‐blinded clinical study, adults undergoing colonoscopy received either 28 tablets (42 g) or 32 tablets (48 g) of sodium phosphate for colon cleansing. The endoscopist used a validated four‐point scale to rate the overall quality of colon cleansing, as well as cleansing in the ascending colon. Adverse events were collected and evaluated.Results:The quality of overall colon cleansing was `excellent' or `good' in 84% or more of both groups, with no significant difference between the two doses. No patient had a preparation rated as `inadequate' or required a repeat procedure. All patients were able to complete the assigned dose of tablets, and there were no deaths, serious adverse events or dropouts from the study.Conclusions:A reduced tablet regimen for sodium phosphate tablets, using either 28 or 32 tablets, is well tolerated and effective for colon cleansing prior to colonoscopy.
Effects of anti‐tumour necrosis factor‐α therapy on the quality of life in Crohn's disease
Authors: Van Balkom B. P. J. , Schoon E. J. , Stockbrügger R. W. , Wolters F. L. , Van Hogezand R. A. , Van Deventer S. J. H. , Oldenburg B. , Van Dullemen H. M. , Russel M. G. V. M. 
Published: March 2003

SummaryBackground : Infusion of anti‐tumour necrosis factor‐α appears to be highly effective in patients with Crohn's disease.Aim : To assess the effect of infliximab on the quality of life in patients with active or fistulizing disease, as measured by the inflammatory bowel disease questionnaire, and to examine the impact on its four dimensions.Methods : An observational study was conducted in 65 patients. An infusion of 5 mg/kg infliximab was given at week 0 in patients with active disease and at week 0, 2 and 6 in fistulizing disease. Changes from baseline in the total and dimensional inflammatory bowel disease questionnaire scores were calculated and compared between the patient groups. Potential predictors of change in the quality of life were identified.Results : In the active disease group, at week 4, the mean total and dimensional inflammatory bowel disease questionnaire scores improved compared to baseline (P < 0.001). In the fistulizing group, at week 6, all scores changed from baseline (P < 0.05). Improvement in the total inflammatory bowel disease questionnaire score correlated well with the improvement of the Crohn's disease activity index. Systemic and social scores improved more than bowel and emotional scores. Inflammatory Crohn's disease and a young age at diagnosis were predictors for a better response to infliximab therapy.Conclusions : Infliximab therapy improves all dimensions of the quality of life in patients with Crohn's disease.
Prucalopride, a systemic enterokinetic, for the treatment of constipation
Authors: Emmanuel A. V. , Roy A. J. , Nicholls T. J. , Kamm M. A. 
Published: March 2003

SummaryBackground : Laxatives are frequently ineffective in treating constipation. An alternative therapeutic approach is to target serotonin‐4 receptors, which are involved in initiating peristalsis.Aim : In a double‐blind, placebo‐controlled trial, to assess the efficacy and safety of a systemically active serotonin‐4 agonist, prucalopride.Methods : Seventy‐four women with constipation were stratified into slow or normal transit groups, and each group was randomized to receive either placebo or 1 mg prucalopride daily for 4 weeks. A bowel function diary was maintained. Whole‐gut and orocaecal transit, visceral sensitivity, quality of life and psychological state were assessed before and after treatment.Results : Prucalopride, not placebo, increased spontaneous stool frequency (P=0.008) and reduced time to first stool (P < 0.001). Prucalopride reduced the number of retained markers in all patients compared to placebo (P=0.004). Prucalopride reduced the mean number of retained markers in slow transit (P=0.069), but did not alter the marker count in normal transit (P=0.86). Orocaecal transit was accelerated by prucalopride, not placebo (P=0.004). Prucalopride, notplacebo, increased rectal sensitivity to distension (urge volume, P=0.01) and electrical stimulation (P=0.001). Prucalopride significantly improved several domains of the Short Form Health Status Survey and the disease‐specific quality of life. Adverse effects were similar for prucalopride and placebo.Conclusions : Prucalopride improves symptoms, upper gut transit and gut sensitivity in constipated patients with both slow and normal transit. It improves transit in patients with slow transit. These changes are associated with improved well‐being.
One‐week triple vs. quadruple therapy for Helicobacter pylori infection — a randomized trial
Authors: Calvet X. , Ducons J. , Guardiola J. , Tito L. , Andreu V. , Bory F. , Guirao R. ,   The Group for Eradication Studies from Catalonia and Aragón (Gresca)
Published: March 2003

SummaryBackground : Seven‐day triple therapy including omeprazole, clarithromycin and amoxicillin has become the treatment of choice for Helicobacter pylori infection. However, 7 days of classical quadruple therapy combining omeprazole, tetracycline, metronidazole and bismuth may be an alternative to triple therapy.Aim : To compare triple vs. quadruple therapy for H.pylori eradication.Methods : Three hundred and thirty‐nine patients with peptic ulcer and H. pylori infection were included in the study. Patients were randomized to receive omeprazole,20 mg, amoxicillin, 1 g, and clarithromycin, 500 mg, all b.d., or omeprazole, 20 mg b.d., tetracycline chloride, 500 mg, metronidazole, 500 mg, and bismuth subcitrate, 120 mg, all t.d.s. Cure was defined as a negative urea breath test at least 2 months after treatment.Results : Per protocol and intention‐to‐treat cure rates were 86%[95% confidence interval (CI), 80–91%] and 77% (95% CI, 70–83%) for triple therapy, and 89% (95% CI, 82–93%) and 83% (95% CI, 76–88%) for quadruple therapy. No significant differences between the groups were found in the cure rates, compliance or side‐effects.Conclusion : One‐week triple and quadruple therapy show similar results when used as first‐line eradication treatment.
The use of ciclosporin in paediatric inflammatory bowel disease: an Italian experience
Authors: Barabino A. , Torrente F. , Castellano E. , Gandullia P. , Calvi A. , Cucchiara S. , De 'Angelis G. L. , Fontana M. , Lionetti P. , De Giacomo C. , Gissi A. 
Published: March 2003

SummaryAim : To asses the efficacy and safety of ciclosporin in a paediatric population with inflammatory bowel disease.Patients and methods : Twenty‐three Italian children treated with ciclosporin were studied retrospectively. The indications for treatment were severe unresponsive colitis, chronic active colitis or severe fistulizing Crohn's disease. The treatment duration, follow‐up and causes of drug discontinuation were assessed.Results : Sixteen patients were treated intravenously for a mean time of 10 ± 7 days (1–24 days) and 19 orally for a mean time of 133 days (17–660 days). The mean follow‐up of all patients was 13.2 months. Ciclosporin was totally ineffective, being discontinued for surgery, in nine of 23 patients (39%); it was discontinued for partial response in three patients (13%). During treatment, clinical remission was achieved in eight children (35%) and maintained after drug withdrawal in four (17%). In severe unresponsive colitis, urgent colectomy was avoided in 12 (85%) of 14 patients who tolerated the drug. Side‐effects appeared in six of 23 patients (26%), and three (13%) required ciclosporin to be discontinued due to neurotoxicity.Conclusions : Ciclosporin shows disappointing long‐term results in the treatment of refractory inflammatory bowel disease, but can play an important role in preventing urgent surgery in unresponsive severe colitis. Severe side‐effects can occur.
The effect of baclofen on gastro‐oesophageal reflux, lower oesophageal sphincter function and reflux symptoms in patients with reflux disease
Authors: Van Herwaarden M. A. , Samsom M. , Rydholm H. , Smout A. J. P. M. 
Published: March 2003

SUMMARYBackground : Baclofen decreases gastro‐oesophageal reflux episodes in healthy subjects by reducing the incidence of transient lower oesophageal sphincter relaxations.Aim : To investigate the effect of baclofen on reflux symptoms, oesophageal pH and lower oesophageal sphincter manometry in patients with gastro‐oesophageal reflux disease.Methods : A double‐blind, placebo‐controlled, two‐way crossover design was used to study the effect of baclofen on heartburn and regurgitation 3 h after a provocation test meal in 37 patients with gastro‐oesophageal reflux disease. Additionally, in 20 of these patients, the effect of baclofen on oesophageal pH, transient lower oesophageal sphincter relaxations and basal lower oesophageal sphincter pressure was studied.Results : Baclofen significantly decreased the acid reflux time and the incidence of gastro‐oesophageal reflux episodes (8.3 ± 8.8% vs. 12.4 ± 12.0%, P = 0.03 and 10.9 ± 7.3 per 3 h vs. 18.7 ± 12.4 per 3 h). The incidence of transient lower oesophageal sphincter relaxations was significantly lower with baclofen than with placebo (15.1 ± 6.4 per 3 h vs. 22.8 ± 5.4 per 3 h, P < 0.0001). Lower oesophageal sphincter pressure and the percentage of transient lower oesophageal sphincter relaxations associated with reflux were not affected by baclofen. No significant effect on symptom scores was observed.Conclusions : Baclofen decreases post‐prandial acid reflux in patients with gastro‐oesophageal reflux disease by reducing the incidence of transient lower oesophageal sphincter relaxations. No effect of a single dose of baclofen on reflux symptoms could be demonstrated in this 3‐h post‐prandial study.
Colonic delivery of 4‐aminosalicylic acid using amylose–ethylcellulose‐coated hydroxypropylmethylcellulose capsules
Authors: Tuleu C. , Basit A. W. , Waddington W. A. , Ell P. J. , Newton J. M. 
Published: March 2003

SummaryBackground : 4‐Aminosalicylic acid has the potential for use in the treatment of diseases of the colon.Aim : To assess the feasibility of delivering 4‐aminosalicylic acid directly to the colon using a hydroxypropylmethylcellulose capsule coated with a mixture of amylose, a polysaccharide metabolized by bacterial enzymes in the colon, and ethylcellulose.Methods : Seven healthy male volunteers received, on three separate occasions, an uncoated or amylose–ethylcellulose‐coated hydroxypropylmethylcellulose capsule containing 4‐aminosalicylic acid Na (550 mg), or an intravenous injection of 4‐aminosalicylic acid Na (135 mg). The capsules were radiolabelled with 99mTc to allow their positions in the gastrointestinal tract to be followed using a gamma camera. Plasma and urine samples were collected and assayed for 4‐aminosalicylic acid and metabolite concentrations.Results : The uncoated capsules broke down within 10 min in the stomach, allowing rapid and complete absorption of the drug. The coated capsules remained intact in the upper gastrointestinal tract, and had a median gastric emptying time of 61 min (interquartile range, 77 min) and a median colon arrival time of 363 min (interquartile range, 185 min). For the coated capsules, only the metabolite was detected in the plasma and/or urine after the capsules had reached the colon.Conclusions : The specific coating protected the drug until the capsule reached the colon, where 4‐aminosalicylic acid was slowly released and absorbed. Thus, such a formulation has the potential for use in the treatment of inflammatory bowel disease.
Terlipressin in acute oesophageal variceal haemorrhage
Authors: Ioannou G. N. , Doust J. , Rockey D. C. 
Published: March 2003

SummaryBackground : Controversy exists surrounding pharmacological therapy in acute variceal bleeding.Aim : To determine the efficacy and safety of terlipressin.Methods : Randomized trials were identified and duplicate, independent, review identified 20 randomized trials involving 1609 patients that compared terlipressin with placebo, balloon tamponade, endoscopic treatment, octreotide, somatostatin or vasopressin for treatment of acute oesophageal variceal haemorrhage.Results : Meta‐analysis showed that compared to placebo, terlipressin reduced mortality (relative risk 0.66, 95% CI 0.49–0.88), failure of haemostasis (relative risk 0.63, 95% CI 0.45–0.89) and the number of emergency procedures per patient required for uncontrolled bleeding or rebleeding (relative risk 0.72, 95% CI 0.55–0.93). When used as an adjuvant to endoscopic sclerotherapy, terlipressin reduced failure of haemostasis (relative risk 0.75, 95% CI 0.58–0.96), and had an effect on reducing mortality that approached statistical significance (relative risk 0.74, 95% CI 0.53–1.04). No significant difference was demonstrated between terlipressin and endoscopic sclerotherapy, balloon tamponade, somatostatin or vasopressin. Haemostasis was achieved more frequently with octreotide compared to terlipressin (relative risk 1.62, 95% CI 1.05–2.50), but this result was based on unblinded studies. Adverse events were similar between terlipressin and the other comparison groups except for vasopressin, which caused more withdrawals due to adverse events.Conclusions : Terlipressin is a safe and effective treatment for acute oesophageal variceal bleeding, with or without adjuvant endoscopic sclerotherapy. Terlipressin appears to reduce mortality in acute oesophageal variceal bleeding compared to placebo, and is the only pharmacological agent shown to do so. Future studies will be required to detect potential mortality differences between terlipressin and other therapeutic approaches.
The pharmacokinetic profiles of oral mesalazine formulations and mesalazine pro‐drugs used in the management of ulcerative colitis
Authors: Sandborn W. J. , Hanauer S. B. 
Published: March 2003

SummaryAim : To quantify through systematic review the pharmacokinetic profiles of the oral delayed release and sustained release mesalazine (5‐aminosalicylate, 5ASA) formulations (Asacol, Salofalk, Mesasal, Claversal, Pentasa) and pro‐drugs (sulfasalazine, olsalazine, balsalazide) used in the management of ulcerative colitis.Methods : Selected articles had: (1) adult healthy volunteers or patients with ulcerative colitis and (2) quantification of pharmacokinetic data to include, at a minimum, urinary excretion of total 5ASA [5ASA plus N‐Acetyl‐5ASA (N‐Ac‐5ASA)].Data collection and analysis : Pharmacokinetic data (Tmax, Cmax, AUC, urinary excretion, faecal excretion) of 5ASA, its major metabolite N‐Acetyl‐5ASA, total 5ASA, and the parent pro‐drug compounds was extracted.Main results : The summary results for urinary excretion of total 5ASA over 24–96 h in all subjects (either mean or median) were: sulfasalazine mean 11–33% or median 22%; olsalazine mean 14–31% or median 16–27%; balsalazide mean 12–35% or median 20%; Asacol mean 10–35% or median 18–40%; Pentasa mean 15–53% or median 23–34%; Salofalk, Mesasal and Claversal mean 27–56% or median 31–44%. The summary results for faecal excretion of total 5ASA over 24–96 h in all subjects (either mean or median) were: sulfasalazine mean 23–75% or median 38%; olsalazine mean 47–50% or median 17–36%; balsalazide mean 46% or median 22%; Asacol mean 40–64% or median 20–56%; Pentasa mean 12–51% or median 39–59%; Salofalk, Mesasal and Claversal mean 37–44% or median 23–35%.Conclusions : The systemic exposure to 5ASA, as measured by urinary excretion of total 5ASA, and the faecal excretion of total 5ASA is comparable for all oral mesalazine formulations and pro‐drugs. Thus, selection of a mesalazine therapy for the treatment of ulcerative colitis should be based on other factors such as efficacy, dose–response, toxicity of the parent compound and its metabolites, compliance issues related to dose forms and dosing schedules, and costs.
Infusion reactions to infliximab in children and adolescents: frequency, outcome and a predictive model
Authors: Crandall W. V. , Mackner L. M. 
Published: March 2003

SummaryBackground : Crohn's disease commonly affects children and adolescents, however the majority of research into the safety and efficacy of therapies for inflammatory bowel disease, including infliximab, has occurred only in adults.Aim : To determine the rate of reactions in children following infliximab infusions, and to identify variables that might be predictive of those reactions.Methods : We performed a retrospective review of all infliximab infusions performed at Columbus Children's Hospital from December 1998 through September 2001.Results : Fifty‐seven children received 361 infusions. Three hundred and fifty‐five of the 361 infusions (98.3%) were completed. Fifty children had 304 repeat infusions. There were a total of 35 infusion related reactions. Female gender and the use of immunosuppressive medications for less than 4 months were risk factors for a reaction to infusion number 2. A reaction to infusion 2 and immunosuppressive use for less than 4 months were risk factors for infusion number 3.Conclusions : The rate of infusion reactions in children receiving infliximab is similar to that in adults. Female gender, immunosuppressive use for less than 4 months and prior infusion reactions may be risk factors for subsequent infusion reactions in children.
A pharmacoscintigraphic evaluation of oral budesonide given as controlled‐release (Entocort) capsules
Authors: Edsbäcker S. , Bengtsson B. , Larsson P. , Lundin P. , Nilsson Å. , Ulmius J. , Wollmer P. 
Published: March 2003

SummaryAims : To investigate the gastrointestinal pharmacokinetics of controlled‐release (Entocort) and standard budesonide capsules.Methods : Six Crohn's disease patients and eight healthy controls were given controlled‐release capsules containing budesonide and an inert 111In label, following breakfast. In the patients, a standard capsule containing deuterium‐labelled budesonide was given simultaneously. In the controls, on a separate occasion, the controlled‐release capsules were given in the fasting state. Gastrointestinal transit was recorded by a gamma camera. Plasma budesonide and deuterium‐labelled budesonide were used to estimate drug release, and urine cortisol was used to assess systemic effects.Results : Budesonide delivery to the ileo‐colonic region was significantly greater after the intake of the controlled‐release capsules [69%; 95% confidence interval (CI), 54–84] than after the standard capsules (30%; 95% CI, 15–45) (P = 0.005). Fasting had little impact on uptake. The transit and pharmacokinetics of budesonide were similar in both subject groups, although systemic availability was higher in patients (21%; 95% CI, 13–33) than in controls (12%; 95% CI, 10–14) (P = 0.009). Urinary cortisol was, however, similar in both groups.Conclusions : A major fraction of budesonide is released in the ileum and throughout the colon, the intended target for the controlled‐release formulation. The prandial state has little effect on budesonide uptake.