Abstract:
:This review focuses on the methodology and interpretation of drug trials in peptic ulcer disease. The problems of planning and conduct that are discussed include the ethics of using placebo, eligibility criteria, estimations of sample size, stopping rules, randomization, blinding, and efficacy criteria, that is, ulcer healing and pain relief in the short term and prevention of relapse and complications in the long term. Statistical topics covered include confidence intervals, evaluation of survival type data, post-stratification, and sub-group analysis. The difference between clinical and statistical significance is discussed, major problems being overemphasis on P-value, type II errors, and post hoc power determinations. Explanatory and pragmatic questions are based on compliance-to-protocol and intention-to-treat cohorts, respectively, and involve problems of compliance testing, evaluation of withdrawals, and the use of fixed-dose regimens. The rather slow process for clinical trials to gain acceptance is described, and it is proposed to rely on disease-related and behavioural barriers, lack of knowledge of the inherent limitations of methodology, and overemphasis on the subject of peptic ulcer healing, in addition to some concern at the relevance of assessing long-term drug intervention by repeated endoscopies rather than by studying symptoms and the incidence of complications. We foresee an increased impact of clinical trials on ulcer research and therapeutic decision making, provided physicians are able to develop the proper methodology to answer the relevant questions.
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Lauritsen K,Rask-Madsen Jdoi
10.1111/j.1365-2036.1987.tb00610.xsubject
Has Abstractpub_date
1987-04-01 00:00:00pages
91-123issue
2eissn
0269-2813issn
1365-2036journal_volume
1pub_type
杂志文章,评审abstract::Haemochromatosis was first recognized as a disease entity over a century ago and its hereditary nature recognized over 60 years ago. However it was only in late 1996 that the haemochromatosis gene was cloned and a single C282Y mutation confirmed as being the cause of all HLA-linked iron overload in Caucasian populatio...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1046/j.1365-2036.1997.00197.x
更新日期:1997-08-01 00:00:00
abstract::Coeliac disease is a chronic inflammatory condition associated with small intestinal injury that results in the malabsorption of different nutrients. The damaging factor is gluten present in wheat, barley and rye. The diagnosis relies on the clinical picture of the patient, serological markers for coeliac disease, cha...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1046/j.1365-2036.2003.01442.x
更新日期:2003-04-01 00:00:00
abstract:BACKGROUND:The incidence of 'true' re-infection with Helicobacter pylori after successful eradication remains uncertain. AIM:To determine the worldwide rates, risk factors and clinical implications of 'true' re-infection of Helicobacter pylori. 'True' re-infection of H. pylori is defined as the situation where tests f...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2036.2008.03873.x
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Limited therapeutic options exist for severe gastroparesis, where severe nausea and vomiting can lead to weight loss, dehydration and malnutrition due to inadequate caloric and fluid intake. TZP-101 (ulimorelin) is a ghrelin receptor agonist that accelerates gastric emptying and improves upper gastrointestin...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1111/j.1365-2036.2010.04567.x
更新日期:2011-03-01 00:00:00
abstract::The present study examined whether histamine could affect the growth of the enterochromaffin-like (ECL) cell and the parietal cell. The effects of the unsurmountable histamine H2-receptor antagonist loxtidine (80 mg/kg) and the H+, K(+)-ATPase inhibitor omeprazole (100 mumol/kg) were compared in female Sprague-Dawley ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.1992.tb00055.x
更新日期:1992-06-01 00:00:00
abstract:BACKGROUND:Proton pump inhibitors (PPIs) are potent inhibitors of gastric acid secretion and give hypergastrinemia secondary to gastric hypoacidity. PPI treatment therefore induces enterochromaffin-like (ECL) cell hyperplasia. Long-term hypergastrinemia in rodents and man also leads to ECL cell neoplasia. Whether long-...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12012
更新日期:2012-10-01 00:00:00
abstract:BACKGROUND:Factors associated with mortality and disease progression in non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) are poorly understood. AIMS:To assess the impact of liver disease severity, demographics and comorbidities on all-cause mortality and liver disease progression in a...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.16016
更新日期:2020-10-01 00:00:00
abstract:BACKGROUND:The diagnosis of covert hepatic encephalopathy (CHE) by means of portosystemic encephalopathy syndrome (PSE) test is costly and therefore infrequently performed. AIM:To determine the ability of critical flicker frequency (CFF) alone or in combination with laboratory findings, as an initial test to pre-selec...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.13721
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Patients with thalassaemia major depend on blood transfusions. In Italy, up to 80% of thalassaemia patients bear HCV antibodies due to HCV contaminated transfusions before 1990. Thalassaemia patients with HCV infection have high risk of developing HCC. Treatment based on Pegylated-IFN (Peg-IFN) and Ribavirin...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1111/apt.14197
更新日期:2017-08-01 00:00:00
abstract:BACKGROUND:Hepatitis C virus (HCV) genotype 6 is common among patients from Southeast Asia and the surrounding regions, where HCV prevalence is also high. HCV genotype 6 has great genetic diversity and different response to antiviral therapy compared with the more commonly known genotype 1. AIM:Our goal was to provide...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2036.2011.04714.x
更新日期:2011-08-01 00:00:00
abstract:BACKGROUND:Infection is the most common cause of mortality in end-stage liver disease (ESLD). The impact of obesity on infection risk in ESLD is not established. AIM:To characterise the impact of obesity on infection risk in ESLD. METHODS:We evaluated the association between infection and obesity in patients with ESL...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.13426
更新日期:2015-12-01 00:00:00
abstract:BACKGROUND:This randomized, double-blind, multicentre study compared lansoprazole with placebo for symptomatic relief of patients with non-erosive gastro-oesophageal reflux disease (GERD). METHODS:214 patients with symptomatic, non-erosive GERD (moderate to severe daytime and/or night-time heartburn greater than half ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1046/j.1365-2036.1999.00558.x
更新日期:1999-06-01 00:00:00
abstract:BACKGROUND:In developed countries, hepatitis E is a porcine zoonosis caused by hepatitis E virus (HEV) genotype 3. In developing countries, hepatitis E is mainly caused by genotype 1, and causes increased mortality in patients with pre-existing chronic liver disease (CLD). AIM:To determine the role of HEV in patients ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.13309
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Sulfasalazine is accepted therapy for active ulcerative colitis, but side-effects and intolerance are common. Balsalazide is an azo-bonded pro-drug which also releases 5-aminosalicylic acid into the colon, but uses an inert carrier molecule. AIM:To compare the safety and efficacy of sul- fasalazine, 3 g, wi...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1046/j.1365-2036.2002.01151.x
更新日期:2002-01-01 00:00:00
abstract:BACKGROUND:Omeprazole has become available in a tablet formulation, a Multiple Unit Pellet System (MUPS) containing a large number of small individually enteric-coated micropellets. AIM:To compare the acid-inhibitory effect of omeprazole MUPS 20 mg with pantoprazole 40 mg and to describe the pharmacokinetics of both d...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2036.2000.00806.x
更新日期:2000-08-01 00:00:00
abstract:BACKGROUND:Hepatitis B (HBV)-infected patients have a higher morbidity and mortality when super-infected by hepatitis A (HAV). AIM:To evaluate the immunogenicity and safety of a commercial inactivated HAV vaccine in Chinese patients with chronic HBV infection. METHODS:Sixty-five HBV-infected patients (30 carriers, 22...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2036.1999.00628.x
更新日期:1999-11-01 00:00:00
abstract:BACKGROUND:Combined treatment using an acid-inhibiting drug with antibiotics can cure Helicobacter pylori infection. However, eradication rates are highly variable, especially if a proton pump inhibitor is used with amoxycillin. Therefore it is important to define factors/predictors of the clinical outcome. METHODS:In...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2036.1997.00210.x
更新日期:1997-08-01 00:00:00
abstract:BACKGROUND:Five oral nucleos(t)ide analogues are available to treat chronic hepatitis B (CHB). With the availability of newer agents, their efficacy on incidence of hepatocellular carcinoma (HCC) is not well described. AIM:To determine the efficacy of oral anti-viral agents in reducing HCC risk in relationship with ot...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,meta分析
doi:10.1111/apt.12344
更新日期:2013-07-01 00:00:00
abstract:BACKGROUND:Hepatocellular carcinoma is the leading cause of death in cirrhosis. A majority of patients present at an advanced stage with poor prognosis. AIM:To review the current screening, diagnosis and management strategies involved in hepatocellular carcinoma. METHODS:A literature search was performed using PubMed...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2036.2009.04200.x
更新日期:2010-02-15 00:00:00
abstract:BACKGROUND:Infection with the hepatitis C virus (HCV) has been considered a major cause of mortality, morbidity and resource utilisation in the US. In addition, HCV is the main cause of hepatocellular cancer (HCC) in the US. Recent developments in the diagnosis and treatment of HCV, including new recommendations pertai...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12625
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:There is no consensus on the standard treatment of gastric mucosa-associated lymphoid tissue (MALT) lymphoma for Helicobacter pylori-negative patients and for patients with persistent disease despite H. pylori eradication. AIM:To evaluate the comparative efficacy and safety of alkylating agents and rituxima...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12635
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:The widespread use of eradication therapy for Helicobacter pylori in Japan has led to an increase in antibiotic-resistant strains and the problem of re-treatment in cases of eradication failure. AIM:To perform drug sensitivity testing for metronidazole in 92 H. pylori-positive patients who had failed eradic...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2036.2003.01401.x
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Treatment with a continuous i.v. proton pump inhibitor is presumed to promote clot formation and stability by sustaining intragastric pH > or = 6. AIM:We postulated that very frequent oral dosing of proton pump inhibitors should simulate i.v. infusion and achieve similar pH control. METHODS:Twenty healthy ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.2006.02933.x
更新日期:2006-06-01 00:00:00
abstract:BACKGROUND:In the absence of prior gastrointestinal infection, the risk factors for irritable bowel syndrome (IBS) are not well established. AIM:To identify the incidence and risk factors for IBS in general population samples METHODS: Narrative review of population-based studies. Electronic databases were searched usi...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.15396
更新日期:2019-09-01 00:00:00
abstract:BACKGROUND:The rs738409 GG variant in patatin-like phospholipase 3 (PNPLA3) is associated with non-alcoholic fatty liver disease (NAFLD) and disease severity. However, it remains unclear if it contributes to the development of NAFLD through affecting dietary pattern. AIM:To examine the association among PNPLA3 gene po...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12609
更新日期:2014-03-01 00:00:00
abstract:BACKGROUND:In view of the high diagnostic accuracy of immunoglobulin-A-tissue transglutaminase antibodies for detecting coeliac disease, we have explored whether a small bowel biopsy is always required to establish the diagnosis. AIM:To define the transglutaminase antibody level giving a positive predictive value for ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.2008.03609.x
更新日期:2008-04-01 00:00:00
abstract:BACKGROUND:Vitamin D has immune-regulatory functions in experimental colitis, and low vitamin D levels are present in Crohn's disease. AIM:To assess the effectiveness of vitamin D3 treatment in Crohn's disease with regard to improved disease course. METHODS:We performed a randomized double-blind placebo-controlled tr...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1111/j.1365-2036.2010.04355.x
更新日期:2010-08-01 00:00:00
abstract:AIM:To develop general rules on how to pursue a therapeutic goal of interventional endoscopy without getting lost in abundant details. METHODS:The influences of various medical interventions on the survival of a patient with gastrointestinal haemorrhage are modelled by an influence diagram. Survival is the focal point...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2036.2002.01233.x
更新日期:2002-05-01 00:00:00
abstract:BACKGROUND:Pantoprazole is a new substituted benzimidazole that blocks the H+/K(+)-ATPase in the gastric mucosa and thus inhibits acid secretion. METHODS:Efficacy and tolerability of pantoprazole (40 mg at breakfast) and ranitidine (300 mg at bedtime) in the treatment of uncomplicated acute duodenal ulcer were compare...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1111/j.1365-2036.1994.tb00163.x
更新日期:1994-02-01 00:00:00
abstract:BACKGROUND:The effects of lactulose and polyethylene glycol on colonic transit are poorly established. AIM:To assess the effects of these laxatives on colonic transit in normal subjects. METHODS:Colonic transit (mean residence time, cumulative counts in stool, counts remaining in the proximal or distal colon) was mea...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1111/j.1365-2036.2005.02244.x
更新日期:2005-02-01 00:00:00