bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis: a randomized, active‐controlled, double‐blind study
Authors: Kovacs T. O. G. , Wilcox C. M. , Devault K. , Miska D. , Bochenek W. ,   THE PANTOPRAZOLE US GERD STUDY GROUP B
Published: March 2003

SummaryBackground : Pantoprazole is a proton pump inhibitor approved for the treatment of erosive oesophagitis and gastro‐oesophageal reflux disease.Aim : To compare the efficacy and safety of pantoprazole vs. nizatidine for the treatment of symptomatic gastro‐oesophageal reflux disease and endoscopically documented erosive oesophagitis (grade ≥ 2).Methods : A multicentre, double‐blind, randomized, active‐controlled study (221 patients) was performed to compare 20 and 40 mg pantoprazole daily with nizatidine 150 mg b.d. (maximum, 8 weeks). The primary end‐point was endoscopic healing of erosive oesophagitis (grade 1 or 0). The secondary end‐point was symptomatic improvement.Results : Healing averaged 61%, 64% and 22% for pantoprazole 20 mg, pantoprazole 40 mg and nizatidine 150 mg, respectively, at 4 weeks, and 79%, 83% and 41% at 8 weeks (P < 0.05, differences between groups at both points). Starting on day 1 of symptom assessment, significantly fewer pantoprazole‐treated patients reported night‐time heartburn and regurgitation compared with nizatidine‐treated patients. Symptoms of gastro‐oesophageal reflux disease were completely eliminated in 68% and 65% of patients in the pantoprazole 20‐mg and 40‐mg groups and in 28% of patients in the nizatidine group at study completion. The difference between each pantoprazole group and the nizatidine group was significant (P < 0.05).Conclusions : Pantoprazole, at single daily doses of 20 mg and 40 mg for up to 8 weeks, provides more rapid relief of symptoms and superior healing of erosive oesophagitis than nizatidine 150 mg b.d., and is well tolerated.
Long‐term aminosalicylate therapy is under‐used in patients with ulcerative colitis: a cross‐sectional survey
Authors: Rubin G. , Hungin A. P. S. , Chinn D. , Dwarakanath A. D. , Green L. , Bates J. 
Published: March 2003

SummaryBackground : There is evidence from case–control studies that aminosalicylate drugs can reduce colorectal cancer risk by 75–81% in patients with ulcerative colitis. Patients may fail to comply with long‐term therapies, however, or may have been advised to discontinue treatment once in remission.Aim : To describe the usage of long‐term aminosalicylate therapy in patients with ulcerative colitis.Methods : A cross‐sectional study was performed using data extracted from general practitioner clinical records on demographic features, extent and duration of disease, use of aminosalicylate therapy and specialist care.Results : Three hundred and sixty‐three people had ulcerative colitis and no history of colorectal surgery. Ninety‐five of 175 (54%) patients with proctitis, 78 of 123 (63%) patients with left‐sided colitis and 28 of 45 (62%) patients with extensive colitis were currently taking an aminosalicylate drug. Those doing so were more likely to be under specialist care than to be definitely or possibly discharged (odds ratio, 4.9; 95% confidence interval, 2.9–8.4). The likelihood of current aminosalicylate therapy was not related to gender or the extent of disease, but was negatively related to the duration of disease.Conclusions : A substantial minority of patients with ulcerative colitis does not take long‐term aminosalicylate therapy. Those who do are more likely to be under specialist care, to be older or to have disease of shorter duration.
A randomized, double‐blind, placebo‐controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation
Authors: Novick J. , Miner P. , Krause R. , Glebas K. , Bliesath H. , Ligozio G. , Rüegg P. , Lefkowitz M. 
Published: March 2003

SummaryBackground : Irritable bowel syndrome is a common functional gastrointestinal disorder which affects up to 20% of the population, with a predominance in females.Aim : To evaluate the efficacy and safety of tegaserod in female patients with irritable bowel syndrome characterized by symptoms of abdominal pain/discomfort and constipation.Methods : In a randomized, double‐blind, multicentre study, 1519 women received either tegaserod, 6 mg b.d. (n = 767), or placebo (n = 752) for 12 weeks, preceded by a 4‐week baseline period without treatment and followed by a 4‐week open withdrawal period. The primary efficacy evaluation was the patient's symptomatic response as measured by the Subject's Global Assessment of Relief. Other efficacy variables included abdominal pain/discomfort, bowel habits and bloating.Results : Tegaserod produced significant (P < 0.05) improvements in the Subject's Global Assessment of Relief and other efficacy variables. These improvements were seen within the first week, and were maintained throughout the treatment period. After withdrawal of treatment, the symptoms rapidly returned. Overall, tegaserod was well tolerated. Diarrhoea was the most frequent adverse event; however, this led to discontinuation in only 1.6% of tegaserod‐treated patients.Conclusions : Tegaserod, 6 mg b.d., produced rapid and sustained improvement of symptoms in female irritable bowel syndrome patients and was well tolerated.
Oxidative stress as a pathogenic factor in inflammatory bowel disease — radicals or ridiculous?
Authors: Kruidenier L. , Verspaget H. W. 
Published: March 2003

SummaryVirtually all inflammatory mediators investigated to date seem to be dysregulated in the inflamed intestinal mucosa of patients with inflammatory bowel disease. However, which of these are actually involved in the initiation and perpetuation of intestinal tissue damage is still not fully understood. Amongst these mediators are the reactive oxygen metabolites, produced in large amounts by the massively infiltrating leucocytes. These reactive oxygen metabolites are believed to constitute a major tissue‐destructive force and may contribute significantly to the pathogenesis of inflammatory bowel disease.This paper provides a concise overview of reactive oxygen metabolite biochemistry, the types of cell and tissue damage potentially inflicted by them, and the endogenous antioxidants which should prevent these harmful effects. An up‐to‐date summary of the available human experimental data suggests that reactive oxygen metabolite‐mediated injury is important in both the primary and downstream secondary pathophysiological mechanisms underlying intestinal inflammation. Nonetheless, how the individual components of the mucosal antioxidant enzymatic cascade respond to inflammatory conditions is a neglected area of research. This particular aspect of intestinal mucosal oxidative stress therefore merits further study, in order to provide a sound, scientific basis for the design of antioxidant‐directed treatment strategies for inflammatory bowel disease patients.
High‐dose interferon α‐2a with ribavirin and amantadine in naïve chronic hepatitis C patients — results of a randomized, prospective, pilot study
Authors: Ullerich H. , Avenhaus W. , Poremba C. , Domschke W. , Menzel J. 
Published: March 2003

SummaryBackground : Hepatitis C viral kinetic studies have demonstrated the increased anti‐viral effect of higher than standard dosages of interferon and of daily treatment schedules.Aim : To compare, in a prospective, randomized, controlled trial, the efficacy and safety of high‐dose interferon‐α therapy vs. standard‐dosage interferon‐α therapy, in a triple therapy combination with ribavirin and amantadine.Methods : Previously untreated patients with chronic hepatitis C were randomized to the standard interferon‐α group (n = 15), receiving thrice weekly 6 MU interferon‐α for 12 weeks, followed by 3 MU interferon‐α for 36 weeks, or the high‐dose interferon‐α group (n = 15), receiving daily 9 MU interferon‐α for 4 weeks, followed by 6 MU (weeks 5–8), 3 MU (weeks 9–12) and 1.5 MU (weeks 13–48) interferon‐α. All patients were given ribavirin (1000–1200 mg) and amantadine (200 mg) daily for 48 weeks.Results : At the end of treatment and after the 24‐week follow‐up period, serum hepatitis C virus RNA was undetectable in eight (53%) and six (40%) patients treated with standard‐dosage interferon‐α, respectively, compared with 11 (73%) and 10 (67%) treated with high‐dose interferon‐α, respectively (not significant). The safety profile of both treatment regimens was similar. Severe adverse events leading to withdrawal from the study occurred in one patient (7%) in each group, and in both groups one patient (7%) was lost during therapy for unknown reasons.Conclusions : The findings suggest that, although the difference between the response rates of standard and high‐dose interferon‐α regimens (within a triple anti‐viral therapy combination) did not reach statistical significance, there was a clear trend towards a higher response with high‐dose interferon‐α therapy and an equal safety profile.
One‐week ranitidine bismuth citrate, amoxicillin and metronidazole triple therapy for the treatment of Helicobacter pylori infection in Chinese
Authors: Hung W. K. , Wong W. M. , Wong G. S. W. , Yip A. W. C. , Szeto M. L. , Lai K. C. , Hu W. H. C. , Chan C. K. , Xia H. H. X. , Yuen M. F. , Fung F. M. Y. , Tong T. S. M. , Ho V. Y. K. , Lam S. K. , Wong B. C. Y. 
Published: March 2003

SummaryBackground : We have previously shown that ranitidine bismuth citrate‐based, clarithromycin‐containing triple therapy achieves a higher eradication rate than proton pump inhibitor‐based regimens in areas with a high prevalence of metronidazole resistance.Aim : To evaluate whether this higher efficacy of ranitidine bismuth citrate over proton pump inhibitor can be extended to non‐clarithromycin‐containing regimens.Methods : Helicobacter pylori‐positive dyspeptic patients were randomized to receive either ranitidine bismuth citrate, 400 mg, amoxicillin, 1000 mg, and metronidazole, 400 mg, or omeprazole, 20 mg, amoxicillin, 1000 mg, and metronidazole, 400 mg, each given twice daily for 1 week. H. pylori eradication was confirmed by 13C‐urea breath test 5 weeks later. The side‐effects of the treatments were documented.Results : Two hundred and twenty‐nine patients were eligible for analysis. By intention‐to‐treat and per protocol analysis, the eradication rates were 77% and 79%, respectively, in the ranitidine bismuth citrate–amoxicillin–metronidazole group and 77% and 82%, respectively, in the omeprazole–amoxicillin–metronidazole group (P = 0.58 and P = 0.65). However, patients in the omeprazole–amoxicillin–metronidazole group reported a significantly higher incidence of minor side‐effects when compared to those in the ranitidine bismuth citrate–amoxicillin–metronidazole group (P = 0.001).Conclusions : Ranitidine bismuth citrate–amoxicillin–metronidazole was equally as effective as omeprazole–amoxicillin–metronidazole triple therapy, and may be considered as an alternative non‐clarithromycin‐based regimen in the Chinese population.
Reflux and Barrett's oesophagitis after gastric surgery — long‐term follow‐up and implications for the roles of gastric acid and bile in oesophagitis
Authors: Taha A. S. , Angerson W. J. , Morran C. G. 
Published: March 2003

SummaryBackground : The role of gastric acid is difficult to separate from that of bile in oesophageal reflux, and the complications of this can take many years to develop. Gastric surgery patients provide a good model for both significant bile reflux and marked gastric acid inhibition.Aim : To study the oesophageal abnormalities in gastric surgery patients undergoing long‐term follow‐up, compared with patients with intact stomachs.Methods : Two hundred and forty adult patients were endoscoped regardless of their age, sex or type of surgical procedure. Oesophageal damage was graded on a scale of 0–5, and biopsies were taken to exclude neoplasia, to diagnose Barrett's oesophagus and to identify Helicobacter pylori.Results : Of the 240 patients studied, 140 had undergone gastric surgery 27 years (19–31 years) [median (interquartile range)] prior to endoscopy, and these patients had milder oesophageal scores and fewer cases of Barrett's oesophagitis. Of the 119 patients with post‐surgical bile reflux gastritis, 31 (26%) had oesophagitis, two (1.7%) had Barrett's oesophagitis and oesophageal scores of 0 (0–1) were found. These results compared with corresponding values of 37 (37%; P = 0.11), 11 (11%; P = 0.007) and 0 (0–2) (P = 0.046), respectively, in 100 patients with intact stomachs. In addition, of the 83 patients with vagotomy, 19 had oesophagitis (23%; P = 0.05), none had Barrett's oesophagitis and lower oesophageal scores (P = 0.02) were found.Conclusions : The prevalence and severity of reflux and Barrett's oesophagitis are not increased in patients with a long history of gastric surgery, particularly after vagotomy, and despite being at risk of bile reflux.
Gastrointestinal transit and 5‐ASA release from a new mesalazine extended‐release formulation
Authors: Brunner M. , Assandri R. , Kletter K. , Tschurlovits M. , Corrado M. E. , Villa R. , Eichler H. G. , Müller M. 
Published: March 2003

SummaryBackground : Mesalazine (5‐aminosalicylic acid, 5‐ASA)‐containing formulations represent a cornerstone in the treatment of inflammatory bowel diseases. Recently, a new formulation has been developed to provide selective and more homogeneous release of 5‐ASA compared to traditional systems.Methods : In a first study, gastrointestinal transit was followed by gamma‐scintigraphy after single‐dose application of tablets containing 1200 mg mesalazine to 12 healthy male volunteers. 5‐ASA release was verified by the assessment of plasma pharmacokinetics. In a second, 7‐day, multiple‐dose study, the steady state plasma pharmacokinetics, urinary excretion and safety profile were characterized after twice‐daily tablet administration to 12 healthy volunteers.Results : Tablet erosion started after 6.9 ± 1.1 h in the ascending or transverse colon. Radioactivity spread homogeneously throughout the colon, indicating the sustained release of active 5‐ASA. Plasma kinetics indicated an earlier initial absorption of 5‐ASA, i.e. during transit of the small intestine and ileum. Mean Cmax values (350.6 ± 322.6 ng/mL) were observed during location in the ileo‐caecal region. The mean relative absorption of 5‐ASA was 19.9 ± 18.2% in the small intestine and ileum and 80.1 ± 18.2% in the colon.Conclusions : The administration of the new mesalazine formulation was well tolerated, and 5‐ASA was continuously released along the whole colon, a favourable prerequisite for the therapy of distally located inflammatory bowel disease.
Nutrition and adult inflammatory bowel disease
Authors: Goh J. , O'Morain C. A. 
Published: March 2003

SummaryMajor advances in the understanding of the aetio‐pathogenesis and genetics of inflammatory bowel disease have been accompanied by an escalation in the sophistication of immunomodulatory inflammatory bowel disease therapeutics. However, the basic ‘triple’ therapy (5‐aminosalicylates, corticosteroids, azathioprine) and nutrition have maintained their central role in the management of patients with inflammatory bowel disease over recent decades.This review provides an overview of the supportive and therapeutic perspectives of nutrition in adult inflammatory bowel disease.The objective of supportive nutrition is to correct malnutrition in terms of calorie intake or specific macro‐ or micronutrients. Of particular clinical relevance is deficiency in calcium, vitamin D, folate, vitamin B12 and zinc.There is justifiably a growing sense of unease amongst clinicians and patients with regard to the long‐term use of corticosteroids in inflammatory bowel disease. This, rather than arguments about efficacy, should be the catalyst for revisiting the use of enteral nutrition as primary treatment in Crohn's disease.Treatment failure is usually related to a failure to comply with enteral nutrition. Potential factors that militate against successful completion of enteral nutrition are feed palatability, inability to stay on a solid‐free diet for weeks, social inconvenience and transient feed‐related adverse reactions. Actions that can be taken to improve treatment outcome include the provision of good support from dietitians and clinicians for the duration of treatment and the subsequent ‘weaning’ period. There is evidence to support a gradual return to a normal diet through exclusion–re‐introduction or other dietary regimen following the completion of enteral nutrition to increase remission rates. We also review the evidence for emerging therapies, such as glutamine, growth factors and short‐chain fatty acids.The future may see the evolution of enteral nutrition into an important therapeutic strategy, and the design of a ‘Crohn's disease‐specific formulation' that is individually tailored, acceptable to patients, cost‐effective, free from adverse side‐effects and combines enteral nutrition with novel pre‐ and pro‐biotics and other factors.
Effect of food and gender on the pharmacokinetics of tucaresol in healthy volunteers
Authors: Peck R. W. , Wootton R. , Wiggs R. , Layton G. , Posner J. 
Published: March 2003

Aims
The potential effects of food and gender on the pharmacokinetics of tucaresol were investigated in healthy volunteers.
Methods
Ten males (mean weight 76.5 kg, age 27–42 years) and eight females (mean weight 58.9 kg, age 18–44 years) received a single oral dose of 200 mg tucaresol on two occasions in random order. On one occasion, tucaresol was given after an overnight fast and on the other, immediately after ingestion of a standard breakfast.
Results
There were no significant differences in standard pharmacokinetic parameters between the two occasions but the rate of tucaresol absorption was faster after food intake. Female subjects had higher Cmax (ratio 1.25 with 95% CI 1.10–1.44) and AUC (ratio 1.25 with 95% CI 1.05–1.49) values than males but the differences were due to the higher body weights of the males; weight‐adjusted apparent total clearance values (CL/F ) were not different between genders (ratio 1.03 with 95% CI 0.87–1.21).
Conclusions
Food intake and gender have no significant effect on the exposure to orally administered tucaresol.
Lung delivery of non‐CFC salbutamol via small volume metal spacer and large volume plastic spacer devices compared with an open vent jet nebulizer
Authors: Lipworth B. J. , Clark D. J. 
Published: March 2003

Aims
To compare the lung delivery of salbutamol from a commonly used constant output open vent jet nebuliser (Sidestream) with use of both a conventional large volume plastic spacer (Volumatic) and a novel small volume metal spacer (NebuChamber). This was assessed using the early lung absorption profile of salbutamol over the first 20 min after inhalation.
Methods
Twelve healthy volunteers were studied in a randomized single (investigator) blind crossover design. Single 1200 μg nominal doses salbutamol from a CFC‐free metered‐dose inhaler (12 sequential 100 μg puffs of Airomir) were delivered via the Volumatic and NebuChamber spacers. A single 1200 μg nominal dose of salbutamol was given as a 4ml fill volume from a Sidestream nebuliser with mouthpiece. Mouth rinsing was performed after each drug sequence. Plasma salbutamol was measured at 5, 10, 15 and 20 min after the last dose of each inhalation sequence, with calculation of maximal concentration (Cmax ) and average concentration over 20 min (Cav ). Systemic β2‐responses were measured as plasma potassium, tremor and heart rate.
Results
Both the Volumatic and the NebuChamber spacers produced significantly greater salbutamol concentration than the Sidestream nebuliser. For Cav this amounted to a 7.34‐fold difference (95%CI 5.31 to 9.38) between Volumatic vs Sidestream, and a 7.04‐fold difference (95%CI 4.91 to 9.17) for NebuChamber vs Sidestream. Similar differences were found for the extrapulmonary β2‐responses. There were no significant differences in either salbutamol concentration or extrapulmonary β2‐responses between the Volumatic and NebuChamber spacers.
Conclusions
We found that, in vivo, both the Volumatic and the NebuChamber spacers produced seven‐fold greater lung delivery of salbutamol than the Sidestream nebuliser when comparing microgram equivalent nominal doses, in terms of the early lung absorption profile.
Increases in metabolism of valproate and excretion of 6β‐hydroxycortisol in patients with traumatic brain injury
Authors: Anderson Gail D. , Awan Asaad B. , Adams Carlyn A. , Temkin Nancy R. , Winn H. Richard 
Published: March 2003

Aims
The objectives of this study were to determine the effect of brain trauma on the multiple pathways of metabolism of valproate and to evaluate the use of the urinary 6β‐hydroxycortisol to cortisol ratio in predicting changes in hepatic metabolism induced by brain injury.
Methods
Fourteen patients with severe head injuries received a 15 mg kg−1 loading dose and a maintenance dose of valproate to maintain therapeutic plasma concentrations. A minimum of one steady state trough blood sample and one dosage interval urine were collected during days 3–6 and during days 7–14 post‐injury. Total and unbound valproate plasma concentrations were determined by gas chromatography‐flame ionization detection (GC‐FID) with and without ultrafiltration. Urinary valproate metabolites were measured by gas chromatography|mass spectrometry (GC‐MS) (n=10). Urinary 6β‐hydroxycortisol and cortisol concentrations were determined by high performance liquid chromatography (h.p.l.c.) (n=14). Total intrinsic clearance (CLint ) for valproate and individual formation clearances (CLf ) to its major metabolites were calculated. Data obtained during baseline (days 3–6) were averaged for each patient and were compared with averaged data obtained from days 7 to 14 using a paired t‐test.
Results
Statistically significant increases in the CLint, CLf of VPA glucuronide, 2‐ene‐VPA, and 4‐OH‐VPA pathways and the 6β‐hydroxycortisol to cortisol ratio were found. The percent change in the 6β‐hydroxycortisol to cortisol ratio correlated significantly with the changes in the CLint of valproate.
Conclusions
Brain trauma results in induction of multiple pathways of valproate metabolism and increases in the 6β‐hydroxycortisol to cortisol ratio, suggesting a non‐specific enzyme induction in response to head injury.
Loratadine‐pseudoephedrine in children with allergic rhinitis, a controlled double‐blind trial
Authors: Serra Héctor Alejandro , Alves Oscar , Rizzo Leonardo Francisco Luis , Devoto Flavio Marcelo , Ascierto Héctor 
Published: March 2003

Aims
To conduct a randomized placebo controlled double‐blind crossover trial in order to evaluate a loratadine‐pseudoephedrine combination (L+PS) in children with seasonal allergic rhinitis.
Methods
Forty children (15 males; 25 females), aged 3–15 years, were included in this study. They were randomized to receive L+PS (0.2 mg kg−1 body weight–2.4 mg kg−1 body weight respectively) or placebo (PLA) for 14 days. After 7 days of washout, patients were shifted to the other treatment for a further 14 days. Nasal symptoms (sneezing/itching, congestion, nasal dripping) and signs (turbinal swelling, retronasal drainage), rated on a scale ranging from: 1. absent to 5. very intense, and their sum or mean total symptom score (MTSS) were used as efficacy measurement.
Results
Significant relief was observed; post‐treatment MTSS difference and its percent change were respectively; L+PS=−4.29; 95% CI: −3.64 and −4.94 (27.8%), and PLA=−1.63; 95% CI: −0.95 and −2.31 (10.7%) (P<0.001 baseline vs endpoint and between treatments). Furthermore, L+PS and PLA significantly modified symptoms, but only L+PS significantly modified signs. No clinical changes were observed during the trial; only one patient showed slight transient insomnia when receiving L+PS.
Conclusions
It is concluded that L+PS is useful and well tolerated in children with seasonal allergic rhinitis. However, elements such as placebo effect must be taken into account for planning future trials.