Abstract:
:The success of a clinical trial is judged by achieving statistical and clinical significance on the primary endpoint. This is particularly relevant in those trials that are initiated to achieve regulatory approval of a new therapeutic agent. Selection of an endpoint for which statistical significance will be too difficult to achieve can result in clinical trial data that fails to meet regulatory requirements for product approval. Over the past decade, significant progress has been made in development and refinement of the study design for evaluating new therapeutic agents targeted for the treatment of irritable bowel syndrome. One aspect of trial design that has been advanced is recognition of the endpoint of 'Adequate Relief.' Adequate relief has been used as a primary endpoint in treatment trials with alosetron, cilansetron and dextofisopam. With each of these agents, statistically significant benefit was seen when compared to placebo. As an endpoint, adequate relief is responsive, reproducible and moves in the same direction as other meaningful measures, and, therefore, displays properties of a validated endpoint. Adequate relief should be considered an acceptable primary endpoint by regulatory agencies for use in clinical trials of novel therapeutic agents for irritable bowel syndrome.
journal_name
Aliment Pharmacol Therjournal_title
Alimentary pharmacology & therapeuticsauthors
Mangel AWdoi
10.1111/j.1365-2036.2006.02839.xsubject
Has Abstractpub_date
2006-04-01 00:00:00pages
879-81issue
7eissn
0269-2813issn
1365-2036pii
APT2839journal_volume
23pub_type
杂志文章,评审abstract:BACKGROUND:Non-alcoholic fatty liver disease (NAFLD) has become the most common chronic liver condition. A major current research effort is ongoing to find potential strategies to treat NAFLD-non-alcoholic steatohepatitis (NASH), with special attention to the gut microbiota. Multiple animal studies and pilot clinical t...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.15416
更新日期:2019-09-01 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:Irritable bowel syndrome is characterised by chronic abdominal pain and frequent comorbid anxiety. The substance P ⁄ neurokinin-1 receptor system is implicated in the regulation of both pain and anxiety, suggesting a potential therapeutic target in IBS. AIM:To determine whether inhibition of the neurokinin-...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1111/j.1365-2036.2011.04958.x
更新日期:2012-02-01 00:00:00
abstract:BACKGROUND:We have observed an increase in hepatotoxicity (DILI) reporting related to the use of anabolic androgenic steroids (AAS) for bodybuilding. AIM:To characterise phenotype presentation, outcome and severity of AAS DILI. METHODS:Data on 25 cases of AAS DILI reported to the Spanish (20) and Latin-American (5) D...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.13023
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:Liver transplantation (LT) offers a possible cure for carefully selected patients with hepatocellular carcinoma (HCC). Studies report that preoperative alpha-fetoprotein (AFP) is a prognostic indicator that can predict survival and recurrence in these patients. AIM:To undertake a systematic review of availa...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2036.2012.05060.x
更新日期:2012-05-01 00:00:00
abstract:BACKGROUND:The low Fermentable Oligo-, Di- Monosaccharides, and Polyoles (FODMAP) diet is a new treatment option for irritable bowel syndrome (IBS). Experts refer to the diet as supported by high level of evidence, but an evaluation of the quality of trials is lacking. AIM:To provide a systematic review of the quality...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.14065
更新日期:2017-06-01 00:00:00
abstract:BACKGROUND:Attachment of Giardia lamblia trophozoites to enterocytes is essential for colonization of the small intestine and is considered a prerequisite for Giardia-induced enterocyte damage. Inhibition of attachment may therefore have therapeutic potential. METHODS:Enterocyte-like differentiated Caco-2 cells were u...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2036.1994.tb00277.x
更新日期:1994-04-01 00:00:00
abstract:BACKGROUND:Real-life long-term data on infliximab treatment in ulcerative colitis are limited. AIM:To study the long-term efficacy and safety of infliximab in chronic active ulcerative colitis and possible predictors of colectomy and response were also examined. METHODS:A retrospective multi-centre study of inflixima...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1111/apt.13893
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND:The new tablet formulation of omeprazole (Losec MUPS), is thought to have a stronger acid inhibition than the previously marketed capsules. METHODS:The effects of the proton pump inhibitors lansoprazole and omeprazole tablets on pentagastrin-stimulated acid secretion were compared in Helicobacter pylori-neg...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2036.2000.00823.x
更新日期:2000-09-01 00:00:00
abstract:BACKGROUND:With the global efforts to eradicate hepatitis C virus (HCV), treatment during pregnancy is becoming a priority for research as this, and maternal cure should reduce vertical transmission. However, as information on the efficacy and safety of direct-acting antivirals (DAAs) in pregnancy is generally lacking,...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.15476
更新日期:2019-10-01 00:00:00
abstract:BACKGROUND:Restriction of dietary FODMAP intake can alleviate symptoms in patients with irritable bowel syndrome. Because many FODMAPs have prebiotic actions, there is concern that their dietary restriction leads to dysbiosis with health consequences, and their intake is being encouraged by addition to foods and via su...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.15818
更新日期:2020-07-01 00:00:00
abstract:BACKGROUND:Programmed cell death protein-1-targeted immunotherapy has shown promising results in phase II studies of hepatocellular carcinoma. AIM:To evaluate safety and efficacy of nivolumab and pembrolizumab in an international, multicentre, real-world cohort of patients with advanced hepatocellular carcinoma. METH...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1111/apt.15245
更新日期:2019-05-01 00:00:00
abstract:BACKGROUND:Nonsteroidal anti-inflammatory drugs (NSAIDs) are a leading cause of drug-induced liver injury (DILI) across the world. Ibuprofen is one of the most commonly used and safest NSAIDs, nevertheless reports on ibuprofen-induced hepatotoxicity are available. AIM:To analyse previously published information on ibu...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.15645
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:Anti-tumour necrosis factor α (anti-TNF) agents have been implicated in drug-induced liver injury. There is minimal data on this occurrence in inflammatory bowel disease (IBD) patients. AIM:To identify the characteristics of liver enzyme elevations following anti-TNF therapy initiation in IBD. METHODS:A re...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.13159
更新日期:2015-05-01 00:00:00
abstract:BACKGROUND:Patient-reported outcome (PRO) measures historically used in inflammatory bowel disease have been considered inadequate to support future drug labelling claims by regulatory agencies. AIMS:To develop PRO tools for use in Crohn's disease (CD) and ulcerative colitis (UC) following guidance issued by the US FD...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.15726
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:Patients with chronic hepatitis B (CHB) need long-term antiviral treatment with nucleos(t)ide analogues (NA). Animal studies suggest that some NA may increase cancer risk, but human data are lacking. AIM:To investigate cancer risks in patients with or without NA treatment. METHODS:We conducted a territory-...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.14015
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND:In patients with pruritus of cholestasis, response to conventional drug treatment may be unsatisfactory. Activation of 5-hydroxytryptamine receptors on dermal sensory nerve-endings plays a role in the perception of pruritus. The 5-hydroxytryptamine(3) receptor antagonist, ondansetron, has been used in the tr...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2036.2005.02430.x
更新日期:2005-04-15 00:00:00
abstract:BACKGROUND:Butyrate, propionate and acetate are short chain fatty acids (SCFA), important for maintaining a healthy colon and are considered as protective in colorectal carcinogenesis. However, they may also regulate immune responses and the composition of the intestinal microbiota. Consequently, their importance in a ...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/apt.14689
更新日期:2018-07-01 00:00:00
abstract:BACKGROUND:Locally acquired hepatitis E is an emerging infection in developed countries and can be misdiagnosed as drug-induced liver injury. AIM:To study the role of hepatitis E virus (HEV) testing in drug-induced liver injury. METHODS:Retrospective review of a cohort of patients with suspected drug-induced liver in...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1111/j.1365-2036.2007.03504.x
更新日期:2007-11-15 00:00:00
abstract:BACKGROUND:Obeticholic acid (OCA) was recently approved as the only on-label alternative for patients with primary biliary cholangitis (PBC) with intolerance or suboptimal response to ursodeoxycholic acid (UDCA). However, few data are available outside clinical trials. AIM:To assess the effectiveness and safety of OCA...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.16181
更新日期:2020-12-12 00:00:00
abstract:BACKGROUND:Prior studies suggest that histamines may modulate the development of colorectal neoplasia. AIM:To assess whether histamine receptor antagonist use was associated with adenoma formation. METHODS:Patients (n = 2366) were drawn from three adenoma chemoprevention trials. All underwent baseline colonoscopy wit...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,meta分析
doi:10.1111/j.1365-2036.2005.02529.x
更新日期:2005-07-15 00:00:00
abstract:BACKGROUND:The effects of proton pump inhibitors and Helicobacter pylori infection on the distribution of drugs used for the eradication of the bacteria are poorly understood. AIM:The aim of this study was to investigate the effects of a 7-day administration of 20 mg of omeprazole on the pharmacokinetics of amoxicilli...
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.1365-2036.2002.01262.x
更新日期:2002-06-01 00:00:00
abstract:BACKGROUND:Irritable bowel syndrome (IBS) has been associated with microbial dysbiosis. AIM:To investigate the efficacy of faecal microbiota transplantation (FMT) in the treatment of IBS. METHODS:Forty-nine IBS patients were randomised to receive autologous or allogenic FMT via colonoscopy. The primary endpoint was a...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1111/apt.15740
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:In rheumatoid arthritis and psoriasis female sex has been shown to be associated with discontinuation of anti-tumour necrosis factor-α (TNF-α) therapy. AIM:To retrospectively assess the association between sex and TNF-α drug persistence in patients with inflammatory bowel disease (IBD). METHODS:All IBD pat...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.15380
更新日期:2019-08-01 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::Unfractioned heparin was recently reported to be beneficial in the treatment of inflammatory bowel disease. The available uncontrolled data show that it may be effective in steroid-resistant ulcerative colitis with a percentage of complete clinical remission of over 70% after an average of 4-6 weeks of therapy. The ad...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,评审
doi:10.1046/j.1365-2036.2000.00860.x
更新日期:2000-11-01 00:00:00
abstract:BACKGROUND:[corrected] A predictable consequence of cholestasis is malabsorption of fat-soluble factors, (vitamins A, D, E, K) and other free radical scavengers, such as carotenoids. It has been suggested that oxygen-derived free radicals may be involved in the pathogenesis of chronic liver damage. AIMS:(i) To evaluat...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2036.2000.00729.x
更新日期:2000-03-01 00:00:00
abstract:BACKGROUND:Online psychotherapy has been successfully used as supportive treatment in many chronic illnesses. However, there is a lack of evidence on its role in the management of gastrointestinal (GI) diseases. AIMS:To examine whether online psychological interventions improve mental and physical outcomes in gastroin...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章,meta分析
doi:10.1111/apt.14840
更新日期:2018-08-01 00:00:00
abstract:BACKGROUND:Orlistat reduces energy uptake by the impairment of fat digestion and some evidence indicates it also lowers plasma cholesterol. AIM:To examine total, low-density lipoprotein- and high-density lipoprotein cholesterol during a weight reducing regimen, and assess the effect of orlistat in lowering cholesterol...
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.1365-2036.2004.01966.x
更新日期:2004-06-01 00:00:00
abstract:BACKGROUND:Approximately one third of patients with acute severe ulcerative colitis (ASUC) fail response to steroids. Ciclosporin and anti-TNFα are proven second-line therapies, but evidence of their efficacy has come mainly from tertiary centres and/or selective clinical trial recruitment. AIM:To assess ASUC outcomes...
journal_title:Alimentary pharmacology & therapeutics
pub_type: 杂志文章
doi:10.1111/apt.12473
更新日期:2013-10-01 00:00:00