bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effect of asimadoline, a κ opioid agonist, on pain induced by colonic distension in patients with irritable bowel syndrome
Authors: Delvaux M. , Beck A. , Jacob J. , Bouzamondo H. , Weber F. T. , Frexinos J. 
Published: July 2004

SummaryBackground : Visceral hypersensitivity plays a major role in irritable bowel syndrome pathophysiology. Opioid κ receptors on afferent nerves may modulate it and be the target for new irritable bowel syndrome treatments.Aim : This study evaluated the effect of the κ opioid agonist asimadoline on perception of colonic distension and colonic compliance in irritable bowel syndrome patients.Method : Twenty irritable bowel syndrome female patients (Rome II criteria; 40 ± 13 years) and hypersensitivity to colonic distension (Pain threshold ≤32 mmHg) were included in a randomized double‐blind cross‐over trial comparing the effect of a single oral dose of asimadoline 0.5 mg or placebo on sensory thresholds (defined as a constant and sustained sensation) elicited by left colon phasic distension (5 mmHg steps, 5 min) up to a sensation of abdominal pain. Colonic compliance was compared by the slope of the pressure–volume curves.Results : On asimadoline, pain threshold (mean ± s.d.) (29.8 ± 7.2 mmHg) was higher than on placebo (26.3 ± 7.8 mmHg), difference not statistically significant (P = 0.1756, anova). Area under curve of pain intensity rated at each distension step was significantly lower on asimadoline (89.3 ± 33.9, anova) than on placebo (108.1 ± 29.7) (P = 0.0411). Thresholds of perception of nonpainful distensions were not altered on asimadoline, as compared with placebo. Colonic compliance was not different on placebo and asimadoline.Conclusion : Asimadoline decreases overall perception of pain over a wide range of pressure distension of the colon in irritable bowel syndrome patients, without altering its compliance. These data suggest that further studies should explore the potential benefit of asimadoline in treatment of pain in irritable bowel syndrome patients.
Six‐month trial of on‐demand rabeprazole 10 mg maintains symptom relief in patients with non‐erosive reflux disease
Authors: Bytzer P. , Blum A. , De Herdt D. , Dubois D. ,   the trial investigators
Published: July 2004

SummaryBackground : Compliance studies have shown that patients with reflux symptoms generally take their medication only when experiencing these symptoms.Aim : To evaluate the efficacy of on‐demand rabeprazole maintenance therapy in patients with non‐erosive reflux disease.Methods : This multicentre, randomized, double‐blind, placebo‐controlled, withdrawal study compared 6 months of on‐demand treatment with rabeprazole 10 mg vs. placebo. Adults with a history of reflux symptoms, a negative endoscopy, and ≥3 days of moderate to very severe heartburn in the 7 days before enrolment (N = 535) entered 4 weeks of open‐label, acute treatment with rabeprazole 10 mg once daily. Patients with complete symptom relief then entered the on‐demand phase. The primary end‐point was discontinuation due to lack of heartburn control during the on‐demand phase.Results : Eighty‐three percent (432 of 523) of patients reported complete symptom relief at the end of the acute phase. During on‐demand treatment, rates of discontinuation because of inadequate heartburn control were 20% (28 of 139) for placebo vs. 6% (16 of 279) for rabeprazole (P < 0.00001). Antacid use was twofold higher in the placebo group vs. the rabeprazole group (P = 0.0009).Conclusions : Rabeprazole 10 mg once daily is highly effective in acute symptom relief and as on‐demand long‐term maintenance therapy in non‐erosive reflux disease patients.
Improvement in quality of life of children with acute Crohn's disease does not parallel mucosal healing after treatment with exclusive enteral nutrition
Authors: Afzal N. A. , Van Der Zaag‐Loonen H. J. , Arnaud‐Battandier F. , Davies S. , Murch S. , Derkx B. , Heuschkel R. , Fell J. M. 
Published: July 2004

SummaryBackground : Crohn's disease is a chronic debilitating disorder affecting a child's physical and emotional well‐being. Recent emphasis on ‘quality of life’ (QOL) has led to re‐evaluation of available medical treatments.Aim : To assess prospectively change in QOL, clinical disease activity and intestinal mucosal inflammation in active paediatric Crohn's disease after treatment with exclusive enteral nutrition. In addition, we evaluated whether change in QOL could predict changes in paediatric Crohn's disease activity index (PCDAI) and mucosal inflammation (endoscopic and histologic).Methods : The IMPACT II questionnaire was used prospectively and longitudinally in 26 consecutively recruited children [16 males (67%), median 14 years, s.d. = 1.7 years] with active Crohn's disease (PCDAI > 20). They were treated with a new polymeric enteral feed (ACD004, Nestle) for a period of 8 weeks. All had PCDAI, QOL and endoscopic assessment at the time of diagnosis and after 8 weeks of treatment.Results : Twenty‐three of 26 children achieved a clinical remission at 8 weeks, with improvement in the QOL scores (P < 0.05). The change in QOL score after treatment was predictive of achieving a clinical remission, but not of histological improvement.Conclusions : Although children may find dietary restrictions difficult, this study confirms a clear improvement in QOL after treatment with exclusive enteral nutrition. However, improvement in QOL scores is not reflected by improvement in mucosal inflammation. Whilst improving QOL remains a core principal in patient management, the long‐term consequences of ongoing mucosal inflammation must be better understood before relying only on short‐term QOL measures to dictate treatment choices.
How effective are the usual treatments for ulcerative colitis?
Authors: Bebb J. R. , Scott B. B. 
Published: July 2004

SummaryBackground : Details of the efficacy of the drugs used in ulcerative colitis are not readily available.Methods : We have reviewed all placebo‐controlled trials of the commonly used drugs for both induction and maintenance of remission to determine the efficacy and to calculate the numbers needed to treat (NNTs) to achieve a specified benefit for each drug.Results : The drug response rates and the NNTs (with 95% CI) are tabulated for each drug.Conclusion : Corticosteroids give a remission rate of 68% in mild or moderate disease and an NNT for remission of 2 (95% CI 1.4–5) in mild disease. Intravenous hydrocortisone gives a remission rate of 60–73%. Aminosalicylates are relatively ineffective in inducing remission with an NNT of 10 (95% CI 7–21) improving to 8 (95% CI 5–20) if the dose ≥3 g daily. They are better at maintenance (NNT = 6; 95% CI 4–8). Intravenous ciclosporin is very effective in achieving remission in severe colitis with an NNT of 1.2 (95% CI 1–2.5). Although there is fairly good evidence that azathioprine is effective in maintaining remission and is used widely, there are no suitable placebo‐controlled trials to calculate the NNT.
Efficacy and safety of thiopurinic immunomodulators (azathioprine and mercaptopurine) in steroid‐dependent ulcerative colitis
Authors: Lopez‐Sanroman A. , Bermejo F. , Carrera E. , Garcia‐Plaza A. 
Published: July 2004

SummaryBackground : The efficacy of azathioprine in the management of steroid‐dependent ulcerative colitis is taken for granted. However, study populations frequently include together steroid‐dependent and refractory patients.Aim : To assess the efficacy and safety of thiopurinic immunomodulators in strictly defined steroid‐dependent ulcerative colitis.Methods : Survey of 34 patients with steroid‐dependent ulcerative colitis, treated with azathioprine according to protocol. Therapeutical success: glucocorticoid withdrawal within 12 months, without steroid requirements during another year.Results : Mean age was 39.1 ± 17 years. Pancolitis and extensive colitis accounted for 50% of cases. Therapeutic success of immunomodulator treatment reached 70.6%, intention to treat analysis (confidence interval 95%: 52–84%) and 72.7%, as per protocol (confidence interval 95%: 54–86%). Mean time to steroid withdrawal was 4.6 months. In therapy successes, mean corpuscular volume and total serum bilirubin increased with treatment time (P = 0.0001). Fifteen adverse effects were observed in 13 patients (38%). Azathioprine was withdrawn in seven cases (20.6%); in four of them (with liver toxicity), treatment with mercaptopurine was indicated.Conclusions : Therapy with thiopurinic immunomodulators (azathioprine) represents the first option in the management of steroid‐dependent ulcerative colitis. Its efficacy (70%) and its acceptable safety support this view. Increasing mean corpuscular volume and serum bilirubin values may be a surrogate marker of a beneficial effect.
Alosetron repeat dose pharmacokinetics, effects on enzyme activities, and influence of demographic factors
Authors: Koch K. M. , Corrigan B. W. , Manzo J. , James C. D. , Scott R. J. , Stead A. G. , Kersey K. E. 
Published: July 2004

SummaryAim : To assess the pharmacokinetics of alosetron, its effect on in vivo enzyme activities, and influence of demographic factors during repeated dosing.Methods : Thirty healthy men and women received 1 mg oral alosetron twice‐daily for 29.5 days and a single oral dose of a metabolic probe cocktail before and on the last day of alosetron dosing. Serum alosetron concentrations were measured on days 1, 8, 15, 22 and 29. Probe‐substrate and metabolite concentrations were measured after each cocktail dose.Results : Alosetron accumulation in serum was negligible. Exposure to alosetron did not alter probe‐metabolite/substrate ratios associated with CYP2C19, 2E1, 2C9, or 3A4 activity, but modestly decreased those associated with CYP1A2 and N‐acetyltransferase activity. Systemic exposure to alosetron was higher in women, positively correlated with age and body mass index, and negatively correlated with CYP1A2 activity. Incidence of constipation was higher in women, but not associated with alosetron concentration.Conclusions : Single dose data can reliably predict the pharmacokinetics of alosetron after repeated doses. Alosetron exhibits limited potential for inhibition of cytochrome P450‐mediated metabolism. Interindividual differences in alosetron pharmacokinetics associated with demographic factors may be related to strong dependence on metabolism by CYP1A2.
The effects of withdrawing tegaserod treatment in comparison with continuous treatment in irritable bowel syndrome patients with abdominal pain/discomfort, bloating and constipation: a clinical study
Authors: Bardhan K. D. , Forbes A. , Marsden C. L. , Mason T. , Short G. 
Published: July 2004

SummaryBackground : The post‐withdrawal characteristics of tegaserod treatment in patients with irritable bowel syndrome with constipation remain undefined.Aim : To evaluate the effects of continuous tegaserod treatment, versus intermittent or withdrawal of treatment in patients with irritable bowel syndrome with constipation.Methods : In a randomized, open‐label trial, all patients initially received tegaserod 6 mg b.d. Responders were randomized to continue or withdraw from treatment for 8 weeks and symptom recurrence was assessed. Tegaserod was re‐introduced in withdrawal patients who experienced symptom recurrence, allowing an assessment of intermittent treatment. Two separate analyses assessed the effects of intermittent and withdrawal of treatment on symptom recurrence.Results : Five hundred irritable bowel syndrome with constipation patients initially received tegaserod; 410 completed treatment. Time to symptom recurrence was shorter in withdrawal patients than those maintained on tegaserod. Significantly more patients maintained on tegaserod had not experienced symptom recurrence by week 8, compared with intermittent (86.5% vs. 58.1%, respectively) or withdrawal of treatment (69.2% vs. 11.3%, respectively) (P < 0.0001 for both). Significant treatment effects were observed for bloating (P < 0.01) and abdominal pain/discomfort (P < 0.02). Most adverse events were mild to moderate.Conclusions : Irritable bowel syndrome with constipation patients who receive continuous or intermittent tegaserod are less likely to experience symptom recurrence than patients withdrawn from treatment.
The cost‐effectiveness of high‐dose oral proton pump inhibition after endoscopy in the acute treatment of peptic ulcer bleeding
Authors: Barkun A. N. , Herba K. , Adam V. , Kennedy W. , Fallone C. A. , Bardou M. 
Published: July 2004

SummaryBackground : Recent data suggest a role for high‐dose oral proton pump inhibition in ulcer bleeding.Aim : To compare the cost‐effectiveness of oral high‐dose proton pump inhibition to both high‐dose intravenous proton pump inhibition and placebo administration.Methods : The model adopted a 30‐day time horizon, and focused on patients with ulcer haemorrhage initially treated endoscopically for high‐risk stigmata. Re‐bleeding rates were set a priori based on non‐head‐to‐head data from the literature, and charges and lengths of stay from a national American database. Sensitivity analyses were carried across a broad range of clinically relevant assumptions.Results : Re‐bleeding rates for patients receiving intravenous, oral, or placebo therapies were 5.9%, 11.8%, and 27%, respectively. The mean lengths of stay and costs for admitted patients with and without re‐bleeding were 4.7 and 3 days; $11 802, and $7993, respectively. High‐dose intravenous proton pump inhibition was more effective and less costly (dominant) than high‐dose oral proton pump inhibition with incremental savings of $136.40 per patient treated. The oral high‐dose strategy in turn dominated placebo administration. Results remained robust according to one‐ and two‐way sensitivity analyses.Conclusion : In patients undergoing endoscopic haemostasis, subsequent high‐dose intravenous proton pump inhibition is more cost‐effective than high‐dose oral proton pump inhibition, which in turn dominates placebo. The results from this exploratory‐type cost analysis require confirmation by head‐to‐head prospective trials performed in Western populations.
Wireless capsule endoscopy in patients with obscure gastrointestinal bleeding: a comparative study with push enteroscopy
Authors: Mata A. , Bordas J. M. , Feu F. , Ginés A. , Pellisé M. , Fernández‐Esparrach G. , Balaguer F. , Piqué J. M. , Llach J. 
Published: July 2004

SummaryBackground : The identification and treatment of lesions located in the small intestine in obscure gastrointestinal bleeding is always a clinical challenge.Aim : To examine prospectively the diagnostic precision and the clinical efficacy of capsule endoscopy compared with push enteroscopy in obscure gastrointestinal bleeding.Methods : Forty‐two patients (22 men and 20 women) with obscure gastrointestinal bleeding (overt bleeding in 26 cases and occult blood loss with chronic anaemia in 16) and normal oesophagogastroduodenoscopy and colonoscopy were analysed. All patients were instructed to receive the capsule endoscopy and push enteroscopy was performed within the next 7 days. Both techniques were blindly performed by separate examiners. The diagnostic yield for each technique was defined as the frequency of detection of clinically relevant intestinal lesions carrying potential for bleeding.Results : A bleeding site potentially related to gastrointestinal bleeding or evidence of active bleeding was identified in a greater proportion of patients using capsule endoscopy (74%; 31 of 42) than enteroscopy (19%; eight of 42) (P = 0.05). The most frequent capsule endoscopy findings were: angiodysplasia (45%), fresh blood (23%), jejunal ulcers (10%), ileal inflammatory mucosa (6%) and ileal tumour (6%). No additional intestinal diagnoses were made by enteroscopy. In seven patients (22%), the results obtained with capsule endoscopy led to a successful change in the therapeutic approach.Conclusions : Compared with push enteroscopy, capsule endoscopy increases the diagnosis yield in patients with obscure gastrointestinal bleeding, and allows modification on therapy strategy in a remarkable proportion of patients.
Hyperamylasaemia and acute pancreatitis in paracetamol poisoning
Authors: Schmidt L. E. , Dalhoff K. 
Published: July 2004

SummaryBackground : Hyperamylasaemia and even acute pancreatitis have been reported in patients with paracetamol poisoning.Aims : To describe the incidence, clinical characteristics, and prognostic implications of hyperamylasaemia in paracetamol poisoning.Patients : Six hundred and two patients transferred to a specialized unit with severe paracetamol poisoning and 212 unselected patients admitted from the local region.Methods : Retrospective study based on hospital charts. The optimum threshold of serum amylase to discriminate non‐survivors was identified.Results : An elevated serum amylase (>100 U/L) occurred in 28 of the unselected patients (13%), in 218 of the transferred patients (36%), and in 118 of 148 patients (80%) with fulminant hepatic failure. Only 33 cases of paracetamol‐associated acute pancreatitis were diagnosed. A threshold serum amylase of 150 U/L to discriminate non‐survivors had sensitivity 76%, specificity 85%, positive predictive value 33%, and negative predictive value 97%. In a logistic regression analysis, a serum amylase > 150 U/L was associated with an excess mortality (odds ratio 5.0, 2.6–9.7).Conclusions : Hyperamylasaemia is frequent in patients with paracetamol poisoning, whereas clinical acute pancreatitis occurs rarely. The incidence of hyperamylasaemia increases with the degree of hepatic dysfunction. A serum amylase exceeding 1.5 times the upper normal limit indicates a poor prognosis.
Insulin reduces apoptosis and increases DNA synthesis and cell size via distinct signalling pathways in Drosophila Kc cells
Authors: Bikopoulos G. , Ceddia R. B. , Sweeney G. , Hilliker A. J. 
Published: July 2004

Abstract.  During development of Drosophila, cell proliferation and size are known to be regulated by insulin. Here we use Drosophila Kc cells to examine the molecular basis for the control of cell growth by insulin. Growing cells in the presence of insulin increased cell number above control levels at 16, 24, 48 and 72 h. We have demonstrated a novel anti‐apoptotic effect of insulin (∼50%) in these cells, measured by caspase 3‐like activity, which contributed to the increase in cell number. The anti‐apoptotic effect was observed both in control cells and those in which apoptosis was induced by ultraviolet irradiation. An approximately 2‐fold stimulation of bromodeoxyuridine incorporation demonstrated that insulin also increased Kc cell proliferation by stimulating new DNA synthesis. The ability of insulin to increase cell number, stimulate bromodeoxyuridine incorporation and reduce caspase 3‐like activity was prevented by PD98059, which inhibits activation of the Drosophila extracellular signal regulated kinase (DERK) pathway, and was unaffected by wortmannin, an inhibitor of Drosophila phosphatidylinositol 3‐kinase (DPI3K). Insulin also increased cell size approximately 2‐fold and this was prevented by wortmannin and rapamycin, an inhibitor of Drosphilia target of rapamycin (DTOR). In summary, we show that DERK plays an important role in mediating the effect of insulin to reduce apoptosis and increase DNA synthesis whereas the DPI3K/DTOR/Dp70S6 kinase pathway mediates effects of insulin on cell size in Drosophila Kc cells.
How many do I need? Basic principles of sample size estimation
Authors: Devane Declan , Begley Cecily M. , Clarke Mike 
Published: July 2004

Background.  In conducting randomized trials, formal estimations of sample size are required to ensure that the probability of missing an important difference is small, to reduce unnecessary cost and to reduce wastage. Nevertheless, this aspect of research design often causes confusion for the novice researcher.Aim.  This paper attempts to demystify the process of sample size estimation by explaining some of the basic concepts and issues to consider in determining appropriate sample sizes.Method.  Using a hypothetical two group, randomized trial as an example, we examine each of the basic issues that require consideration in estimating appropriate sample sizes. Issues discussed include: the ethics of randomized trials, the randomized trial, the null hypothesis, effect size, probability, significance level and type I error, and power and type II error. The paper concludes with examples of sample size estimations with varying effect size, power and alpha levels.Conclusion.  Health care researchers should carefully consider each of the aspects inherent in sample size estimations. Such consideration is essential if care is to be based on sound evidence, which has been collected with due consideration of resource use, clinically important differences and the need to avoid, as far as possible, types I and II errors. If the techniques they employ are not appropriate, researchers run the risk of misinterpreting findings due to inappropriate, unrepresentative and biased samples.
A theoretical model of job retention for home health care nurses
Authors: Ellenbecker Carol Hall 
Published: July 2004

Background.  Predicted severe nursing shortages and an increasing demand for home health care services have made the retention of experienced, qualified nursing staff a priority for health care organizations.Aims.  The purpose of this paper is to describe a theoretical model of job retention for home health care nurses.Methods.  The theoretical model is an integration of the findings of empirical research related to intent to stay and retention, components of Neal's theory of home health care nursing practice and findings from earlier work to develop an instrument to measure home health care nurses’ job satisfaction.Discussion.  The theoretical model identifies antecedents to job satisfaction of home health care nurses. The antecedents are intrinsic and extrinsic job characteristics. The model also proposes that job satisfaction is directly related to retention and indirectly related to retention though intent to stay. Individual nurse characteristics are indirectly related to retention through intent to stay. The individual characteristic of tenure is indirectly related to retention through autonomy, as an intrinsic characteristic of job satisfaction, and intent to stay.Conclusions.  The proposed model can be used to guide research that explores gaps in knowledge about intent to stay and retention among home health care nurses.