Effects of baseline abdominal pain and bloating on response to lubiprostone in patients with irritable bowel syndrome with constipation.


BACKGROUND:Lubiprostone (8 μg b.d.) received US Food and Drug Administration (FDA) approval in 2008 for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) in women aged ≥18 years. In 2012, the FDA issued new guidance for IBS-C clinical trials, recommending a composite endpoint incorporating both abdominal pain and stool frequency. AIM:In a post hoc analysis, similar criteria were applied to data from two pivotal, phase 3, double-blind, randomised trials of lubiprostone in patients with IBS-C. METHODS:Included patients had a baseline spontaneous bowel movement (SBM) frequency <3/week and abdominal pain or bloating ratings ≥1.36 on a 5-point scale [0 (absent) to 4 (very severe)]. Responders (composite endpoint) had a mean pain reduction ≥30% compared with baseline, and an increase from baseline of ≥1 SBM/week for ≥6 of the 12 treatment weeks. Lubiprostone effects on abdominal pain alone were also evaluated, as were bloating alone and in a composite endpoint with stool frequency. RESULTS:In pooled data, 325 patients received lubiprostone and 180 received placebo. Rates of response were higher with lubiprostone vs. placebo for the composite endpoint of improved pain and stool frequency (26.3% vs. 15.3%, respectively; P = 0.008) and the composite endpoint of improved bloating and stool frequency (23.8% vs. 12.6%, respectively; P = 0.012). Response rates were also higher with lubiprostone vs. placebo for abdominal pain alone (P = 0.005) and bloating alone (P = 0.012). CONCLUSION:Lubiprostone was significantly more effective than placebo in improving abdominal pain or bloating, and also in composite endpoints that included stool frequency.


Aliment Pharmacol Ther


Chang L,Chey WD,Drossman D,Losch-Beridon T,Wang M,Lichtlen P,Mareya S




Has Abstract


2016-11-01 00:00:00












  • Review article: prognosis of hepatorenal syndrome--has it changed with current practice?

    abstract::The Consensus Conference on Hepatorenal Syndrome (HRS) organized by the International Ascites Club in 1994 redefined HRS, introduced new diagnostic criteria that are now widely accepted, and proposed the distinction between two types of HRS: type 1 and type 2. Before the introduction of the new therapeutic options, th...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Angeli P

    更新日期:2004-09-01 00:00:00

  • The cost effectiveness of Helicobacter pylori population screening-economic evaluation alongside a randomised controlled trial with 13-year follow-up.

    abstract:BACKGROUND:Helicobacter pylori eradication improves dyspeptic symptoms in 8%-10%, prevents peptic ulcer and may reduce the risk of gastric cancer. Availability of a high quality diagnostic test and an effective treatment makes population screening and eradication of Helicobacter pylori an attractive option. AIM:To eva...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Høgh MB,Kronborg C,Hansen JM,Schaffalitzky de Muckadell OB

    更新日期:2019-04-01 00:00:00

  • Review article: from gastrin to gastro-oesophageal reflux disease--a century of acid suppression.

    abstract::To commemorate Edkins' discovery of gastrin in 1905, we review a century of progress in the physiology and pathobiology of gastrin and acid secretion especially as it pertains to clinical aspects of gastro-oesophageal reflux disease. Although initially ignored, Edkins' observations eventually led to the enthusiastic i...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Malfertheiner P,Fass R,Quigley EM,Modlin IM,Malagelada JR,Moss SF,Holtmann G,Goh KL,Katelaris P,Stanghellini V,Talley NJ,Tytgat GN,Wright NA

    更新日期:2006-03-15 00:00:00

  • An open trial of long-term therapy with lansoprazole in patients with peptic ulceration resistant to extended high-dose ranitidine treatment.

    abstract::Forty-two patients with peptic ulceration of the duodenum, stomach or oesophagus, who had not responded to 3 or more months of high-dose treatment with ranitidine (450 or 600 mg/day), were treated with oral lansoprazole at 30-60 mg daily. In 40 patients (95.2%) the ulcers healed within 2-12 weeks. In the remaining 2 p...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章


    authors: Brunner G,Arnold R,Hennig U,Fuchs W

    更新日期:1993-01-01 00:00:00

  • Scintigraphic assessment of the intragastric distribution and gastric emptying of an encapsulated drug: the effect of feeding and of a proton pump inhibitor.

    abstract:BACKGROUND:Local delivery of therapeutic agents to the stomach may be a useful strategy in the treatment of Helicobacter pylori infection. We aimed to see whether the intragastric distribution and gastric retention of a therapeutic agent could be improved, either by giving omeprazole or by dosing after a meal. METHODS...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Atherton JC,Washington N,Bracewell MA,Sutton LJ,Greaves JL,Perkins AC,Hawkey CJ,Spiller RC

    更新日期:1994-10-01 00:00:00

  • The impact of eosinophilia and hepatic necrosis on prognosis in patients with drug-induced liver injury.

    abstract:BACKGROUND:Drug-induced liver injury may be immunologically mediated or metabolically induced. Peripheral eosinophilia and liver eosinophilia in suspected drug-induced liver injury generally supports the role of drug aetiology. AIM:To assess the importance of eosinophilia and hepatic necrosis on outcome in patients wi...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Björnsson E,Kalaitzakis E,Olsson R

    更新日期:2007-06-15 00:00:00

  • Review article: the incidence and risk factors for irritable bowel syndrome in population-based studies.

    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


    authors: Creed F

    更新日期:2019-09-01 00:00:00

  • Double stenting of oesophagus and airways in palliative treatment of patients with oesophageal cancer is efficient but associated with a high morbidity.

    abstract:BACKGROUND:Double stenting of oesophagus and airways may be required in palliative treatment of patients with locally advanced oesophageal cancer. AIM:To assess feasibility, efficacy and complications occurring in patients with locally advanced oesophageal cancer receiving both oesophagus and airways stenting. METHOD...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Lecleire S,Antonietti M,Di Fiore F,Ben-Soussan E,Bota S,Hellot MF,Thiberville L,Michel P,Lerebours E,Ducrotté P

    更新日期:2007-04-15 00:00:00

  • New onset idiosyncratic liver enzyme elevations with biological therapy in inflammatory bowel disease.

    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


    authors: Shelton E,Chaudrey K,Sauk J,Khalili H,Masia R,Nguyen DD,Yajnik V,Ananthakrishnan AN

    更新日期:2015-05-01 00:00:00

  • Review article: the treatment of hepatitis C virus recurrence after liver transplantation.

    abstract:BACKGROUND:Recurrent hepatitis C represents a major challenge for the liver transplant community. Given the potentially significant impact that hepatitis C recurrence has on graft and patient survival, several treatment strategies have been utilized to prevent/slow the progression to hepatitis C-related graft failure. ...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Arjal RR,Burton JR Jr,Villamil F,Rosen HR

    更新日期:2007-07-15 00:00:00

  • Randomised clinical trial: preventive treatment with topical rectal beclomethasone dipropionate reduces post-radiation risk of bleeding in patients irradiated for prostate cancer.

    abstract:BACKGROUND:Radiotherapy is an established treatment modality for prostate cancer; however, up to a third of patients develops a radiation-induced proctopathy. AIM:To assess the effect of topical beclomethasone dipropionate (BDP) in the prevention of radiation-induced proctopathy in patients undergoing radiotherapy for...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Fuccio L,Guido A,Laterza L,Eusebi LH,Busutti L,Bunkheila F,Barbieri E,Bazzoli F

    更新日期:2011-09-01 00:00:00

  • Polycystic ovary syndrome with hyperandrogenism as a risk factor for non-obese non-alcoholic fatty liver disease.

    abstract:BACKGROUND:Non-alcoholic fatty liver disease (NAFLD) is known to be associated with polycystic ovary syndrome (PCOS). However, most studies investigated the prevalence of NAFLD in obese PCOS patients. AIM:To compare the prevalence of non-obese NAFLD in women with or without PCOS, and to assess an independent associati...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Kim JJ,Kim D,Yim JY,Kang JH,Han KH,Kim SM,Hwang KR,Ku SY,Suh CS,Kim SH,Choi YM

    更新日期:2017-06-01 00:00:00

  • Helicobacter pylori eradication: proton pump inhibitor vs. ranitidine bismuth citrate plus two antibiotics for 1 week-a meta-analysis of efficacy.

    abstract:OBJECTIVE:To compare the efficacy of proton pump inhibitor vs. ranitidine bismuth citrate (RBC) with two antibiotics for 1 week in Helicobacter pylori eradication. METHODS:Randomized trials comparing 1-week regimens with (i) proton pump inhibitor plus two antibiotics [clarithromycin (C) and amoxycillin (A) or a nitroi...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,meta分析


    authors: Gisbert JP,González L,Calvet X,Roqué M,Gabriel R,Pajares JM

    更新日期:2000-09-01 00:00:00

  • Systematic review: the prognostic role of alpha-fetoprotein following liver transplantation for hepatocellular carcinoma.

    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


    authors: Hakeem AR,Young RS,Marangoni G,Lodge JP,Prasad KR

    更新日期:2012-05-01 00:00:00

  • In-vitro cyclosporin sensitivity of proliferating lymphocytes is predictive of in-vivo therapeutic response in ulcerative colitis.

    abstract:BACKGROUND:The efficacy of cyclosporin in the management of ulcerative colitis is recognized. Not all patients respond to this treatment. Existing clinical and laboratory parameters are of little use in identifying those most likely to respond. AIMS:To determine whether in-vitro sensitivity to cyclosporin as measured ...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: McCormack G,O'Donoghue D,Baird A

    更新日期:2001-05-01 00:00:00

  • The effects of omeprazole and cimetidine on duodenal ulcer healing and the relief of symptoms.

    abstract::In a Swedish double-blind multicentre study, omeprazole (30 mg o.m.) was compared with the H2-receptor antagonist cimetidine (400 mg b.d.) in 152 patients. Clinical assessments and laboratory investigations were carried out at 2 and 4 weeks, and again at 6 weeks in unhealed patients. Endoscopy was performed at 2 weeks...

    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


    authors: Dahlgren S,Domellöf L,Hradsky M,Norryd C,Brunkwall J,Svensson G,Svensson JO,Karlsson J,Knutson U,Gasslander T

    更新日期:1988-12-01 00:00:00

  • Review article: intestinal failure.

    abstract::Intestinal failure is a specific disease entity resulting from intestinal resection or disease-associated malabsorption and characterized by the inability to maintain protein-energy, fluid, electrolyte or micronutrient balance. We performed a MEDLINE search (1966-2006) to identify relevant articles, using keywords int...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,评审


    authors: Lal S,Teubner A,Shaffer JL

    更新日期:2006-07-01 00:00:00

  • Randomised clinical trial: comparison of two everolimus dosing schedules in patients with advanced hepatocellular carcinoma.

    abstract:BACKGROUND:Deregulation of mammalian target of rapamycin (mTOR) signalling is common in human hepatocellular carcinoma (HCC). AIM:To determine the maximum tolerated dose (MTD) of the oral mTOR inhibitor everolimus in advanced HCC patients. METHODS:Patients with locally advanced or metastatic HCC (Child-Pugh class A o...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,随机对照试验


    authors: Shiah HS,Chen CY,Dai CY,Hsiao CF,Lin YJ,Su WC,Chang JY,Whang-Peng J,Lin PW,Huang JD,Chen LT

    更新日期:2013-01-01 00:00:00

  • Clinical and histological features of non-alcoholic fatty liver disease in Hong Kong Chinese.

    abstract:BACKGROUND:Non-alcoholic fatty liver disease is prevalent in affluent countries and is a cause of cirrhosis and possibly hepatocellular carcinoma. AIM:To examine the clinical and histological features of biopsy-proven non-alcoholic fatty liver disease and investigate the predictors of severe histological disease in Ch...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Wong VW,Chan HL,Hui AY,Chan KF,Liew CT,Chan FK,Sung JJ

    更新日期:2004-07-01 00:00:00

  • Occurrence and risk factors for benign epithelial gastric polyps in atrophic body gastritis on diagnosis and follow-up.

    abstract:BACKGROUND:Benign epithelial gastric polyps have been reported to be more common in atrophic body gastritis. The role of Helicobacter pylori infection in the induction of gastric atrophy is well-known. The development of hyperplastic polyps may be in relation to H. pylori infection. AIM:To investigate occurrence of be...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Di Giulio E,Lahner E,Micheletti A,Milione M,D'Ambra G,Bordi C,Delle Fave G,Annibale B

    更新日期:2005-03-01 00:00:00

  • Overlap of gastro-oesophageal reflux disease and irritable bowel syndrome: prevalence and risk factors in the general population.

    abstract:BACKGROUND:Gastro-oesophageal reflux disease (GERD) and irritable bowel syndrome may occur more often than expected by chance, but little community data exists and risk factors are unknown. AIM:To determine prevalence and risk factors for overlap of GERD and irritable bowel disease. METHODS:Population-based, cross-se...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,多中心研究


    authors: Jung HK,Halder S,McNally M,Locke GR 3rd,Schleck CD,Zinsmeister AR,Talley NJ

    更新日期:2007-08-01 00:00:00

  • Steroid dependency and trends in prescribing for inflammatory bowel disease - a 20-year national population-based study.

    abstract:BACKGROUND:It is unclear whether adherence to prescribing standards has been achieved in inflammatory bowel disease (IBD). AIM:To determine how prescribing of 5-aminosalicylates (5-ASAs), steroids and thiopurines has changed in response to emerging evidence. METHODS:We examined trends in oral and topical therapies in...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Chhaya V,Saxena S,Cecil E,Subramanian V,Curcin V,Majeed A,Pollok RC

    更新日期:2016-09-01 00:00:00

  • Review article: the screening, diagnosis and optimal management of haemochromatosis.

    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


    authors: George DK,Powell LW

    更新日期:1997-08-01 00:00:00

  • Redefining the intraepithelial lymphocytes threshold to diagnose gluten sensitivity in patients with architecturally normal duodenal histology.

    abstract:BACKGROUND:Accuracy of intraepithelial lymphocytes counts for diagnosing mild enteropathy coeliac disease in absence of villous atrophy can be limited by inappropriate controls included in the studies. AIM:To determine the diagnostic accuracy of intraepithelial lymphocytes counts utilising controls lacking HLA coeliac...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Pellegrino S,Villanacci V,Sansotta N,Scarfì R,Bassotti G,Vieni G,Princiotta A,Sferlazzas C,Magazzù G,Tuccari G

    更新日期:2011-03-01 00:00:00

  • A comparison between enprostil and ranitidine in the management of gastric ulceration.

    abstract::In a randomly allocated, double-blind, endoscopically controlled study, 98 patients with gastric ulcers were treated with either (a synthetic prostaglandin of E2-like structure) enprostil 70 micrograms b.d. or 150 mg ranitidine b.d. The healing rates at 4, 8 and 12 weeks were enprostil 57, 91 and 94% and for ranitidin...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章,随机对照试验


    authors: Morgan AG,Pacsoo C,Taylor P,McAdam WA

    更新日期:1990-12-01 00:00:00

  • Clinical trial: percutaneous acetic acid injection vs. percutaneous ethanol injection for small hepatocellular carcinoma--a long-term follow-up study.

    abstract:BACKGROUND:The long-term outcome of percutaneous acetic acid injection (PAI) and percutaneous ethanol injection (PEI) for treating small hepatocellular carcinoma (HCC) remains unclear. AIM:To compare the long-term outcome of PAI vs. PEI for treating small HCC. METHODS:From July 1998 to July 2004, 125 patients with sm...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Tsai WL,Cheng JS,Lai KH,Lin CP,Lo GH,Hsu PI,Yu HC,Lin CK,Chan HH,Chen WC,Chen TA,Li WL,Liang HL

    更新日期:2008-08-01 00:00:00

  • Misoprostol in the treatment of chronic refractory constipation: results of a long-term open label trial.

    abstract:BACKGROUND:Misoprostol is known to be effective in stimulating intestinal transit both in healthy individuals and in patients with chronic constipation when evaluated in short-term trials. The aim of this study was to determine the utility of misoprostol in the long-term management of patients with chronic refractory c...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章


    authors: Roarty TP,Weber F,Soykan I,McCallum RW

    更新日期:1997-12-01 00:00:00

  • Development and validation of the chronic hepatitis C virus treatment satisfaction (HCVTSat) instrument.

    abstract:BACKGROUND:While current medications used to treat patients with chronic hepatitis C virus (HCV) effectively produce sustained viral response (SVR), postponement of therapy is often times attributed to patient perceptions of unfavourable outcomes. However, an instrument to assess patient perceptions of therapy (i.e. tr...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章


    authors: Szeinbach SL,Baran RW,Dietz B,Gazzouola Rocca L,Littlefield D,Yawn BP

    更新日期:2013-03-01 00:00:00

  • Mucosal healing and a fall in mucosal pro-inflammatory cytokine mRNA induced by a specific oral polymeric diet in paediatric Crohn's disease.

    abstract:BACKGROUND:Although enteral nutrition is a recognized form of treatment for intestinal Crohn's disease, there are persisting problems with feed palatability and only limited data as to its mode of action. AIM:To assess the effects of a specific oral polymeric diet (CT3211; Nestle, Vevey, Switzerland), which is rich in...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 临床试验,杂志文章


    authors: Fell JM,Paintin M,Arnaud-Battandier F,Beattie RM,Hollis A,Kitching P,Donnet-Hughes A,MacDonald TT,Walker-Smith JA

    更新日期:2000-03-01 00:00:00

  • Acute pancreatitis in inflammatory bowel disease, with special reference to azathioprine-induced pancreatitis.

    abstract:BACKGROUND:Pancreatitis is a potentially severe condition. Patients with inflammatory bowel disease (IBD) seem to be at increased risk for acute pancreatitis. AIM:To describe the incidence, main causes and possible predictive factors of acute pancreatitis in inflammatory bowel disease. METHODS:Information was retrosp...

    journal_title:Alimentary pharmacology & therapeutics

    pub_type: 杂志文章,多中心研究


    authors: Bermejo F,Lopez-Sanroman A,Taxonera C,Gisbert JP,Pérez-Calle JL,Vera I,Menchén L,Martín-Arranz MD,Opio V,Carneros JA,Van-Domselaar M,Mendoza JL,Luna M,López P,Calvo M,Algaba A

    更新日期:2008-09-01 00:00:00