Multicenter Randomized Trial of 10-French versus 11.5-French Plastic Stents for Malignant Biliary Obstruction.

Background. There is little prospective data on whether bigger plastic stents are better for patients with malignant biliary obstruction with jaundice. Goals.

Effect of endoscopic stenting of malignant bile duct obstruction on quality of life.

Background And Goals: Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. Although endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear.

OTC polyethylene glycol 3350 and pharmacists' role in managing constipation.

Objectives: To define constipation, assess the pharmacist's role in identifying and treating constipation, and review clinical evidence for the efficacy, safety, and tolerability of polyethylene glycol (PEG) 3350 (MiraLAX-Merck Consumer Care), an osmotic laxative now available over the counter (OTC), across a variety of patient populations routinely encountered in pharmacy settings.

Data Sources: Systematic PubMed search of the primary literature for constipation treatment guidelines and clinical trial results for PEG 3350.

Data Synthesis: Pharmacists have a unique role in assisting patients with identifying and managing constipation.

Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation.

Background: Lubiprostone helps relieve constipation in short-term 4-week studies. There are limited data on long-term pharmacological treatment with lubiprostone for chronic idiopathic constipation.

Aims: To examine the long-term safety and effectiveness of lubiprostone in patients with chronic idiopathic constipation.

Over-the-counter laxative polyethylene glycol 3350: an evidence-based appraisal.

Objective: To explore the clinical dimensions of chronic constipation and the role played in its treatment by laxatives in general and by polyethylene glycol 3350 (MiraLAX * ) in particular. * MiraLAX is a registered trade name of Schering-Plough HealthCare Products, Inc., Memphis, TN, USA, a subsidiary of Merck & Co.

Efficacy and safety of lubiprostone in patients with chronic constipation.

Aims: The aim of this study is to assess the efficacy and safety of lubiprostone in adults with chronic constipation.

Methods: This multicenter, parallel-group trial enrolled 237 patients with chronic constipation and randomized them to 4 weeks of double-blind treatment with oral lubiprostone 24 mcg or placebo twice daily. The primary efficacy endpoint was the number of spontaneous bowel movements (SBMs) after 1 week of treatment.

Review of the treatment options for chronic constipation.

Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives, and is associated with high healthcare costs. There is a considerable range of treatment modalities available for patients with constipation; however, the clinical evidence supporting their use varies widely. Nonpharmacologic modalities, such as increased exercise or fluid intake and bowel habit training, are generally recommended as first-line approaches, but data on the effectiveness of these measures are limited.

Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of lubiprostone, a locally-acting type-2 chloride channel activator, in patients with chronic constipation.

Objectives: To assess the efficacy and safety of lubiprostone in adults with chronic constipation.

Methods: This multicenter, parallel-group, double-blind controlled trial enrolled 242 patients with constipation and randomized them to receive oral lubiprostone 24 mcg or placebo twice daily for 4 wk. The primary efficacy end point was the number of spontaneous bowel movements (SBMs; those occurring without use of constipation relieving medications) after 1 wk of double-blind treatment.

A randomized, multicenter study comparing the safety and efficacy of sodium phosphate tablets with 2L polyethylene glycol solution plus bisacodyl tablets for colon cleansing.

Objective: The safety and efficacy of NaP tablets have not been compared with 2L PEG lavage solution. A multicenter, investigator-blinded study was conducted to compare the colon-cleansing efficacy of a new NaP tablet formulation with that of 2L PEG solution plus bisacodyl tablets in adults undergoing colonoscopy.

Methods: A total of 481 patients were randomized to receive either 32 tablets (48 g) of NaP or 2L PEG solution plus 4 (20 mg) bisacodyl tablets.

Colonoscopic withdrawal times and adenoma detection during screening colonoscopy.

Background: Colonoscopy is commonly used to screen for neoplasia. To assess the performance of screening colonoscopy in everyday practice, we conducted a study of the rates of detection of adenomas and the amount of time taken to withdraw the colonoscope among endoscopists in a large community-based practice.

Methods: During a 15-month period, 12 experienced gastroenterologists performed 7882 colonoscopies, of which 2053 were screening examinations in subjects who had not previously undergone colonoscopy.

Efficacy of tegaserod in chronic constipation in men.

Objectives: Chronic constipation/idiopathic constipation is highly prevalent in western countries and traditional treatments are suboptimal. This multicenter study evaluated the efficacy and safety of tegaserod, a selective 5-HT(4) agonist and promotility agent, in men with chronic constipation.

Methods: After screening and baseline phases, men with chronic constipation were randomized to receive either tegaserod 6 mg twice daily or placebo in a double-blind manner for 12 wk.

Maintenance of healed erosive esophagitis: a randomized six-month comparison of esomeprazole twenty milligrams with lansoprazole fifteen milligrams.

Background And Aims: The aim was to compare esomeprazole with lansoprazole for the maintenance of healed erosive esophagitis and resolution of gastroesophageal reflux disease-related symptoms in a United States population.

Methods: Patients who entered this double-blind, randomized, parallel-group, multicenter, maintenance trial had been treated and healed (no endoscopic evidence of erosive esophagitis) with esomeprazole 40 mg or lansoprazole 30 mg once daily (patients with Los Angeles grades C and D erosive esophagitis at baseline) or esomeprazole 40 mg (patients with Los Angeles grades A and B erosive esophagitis at baseline) and had no heartburn or acid regurgitation symptoms during the previous week. Patients were randomized to maintenance once-daily therapy with esomeprazole 20 mg (n = 512) or lansoprazole 15 mg (n = 514) for up to 6 months.

Fiber for the treatment of hemorrhoids complications: a systematic review and meta-analysis.

Objectives: To evaluate the impact of laxatives on a wide range of symptoms in patients with symptomatic hemorrhoids.

Methods: We searched using the following sources: MEDLINE, EMBASE, CINAHL and CENTRAL, BIOSIS, AMED, Papers First and Proceedings; study authors, industry, and experts in the field. We included all published and unpublished parallel group randomized controlled trials comparing any type of laxative to placebo or no therapy in patients with symptomatic hemorrhoids.

Healing of gastric ulcers with esomeprazole versus ranitidine in patients who continued to receive NSAID therapy: a randomized trial.

Objective: To compare orally administered esomeprazole 40 mg once daily and 20 mg once daily with ranitidine 150 mg twice daily for the healing of gastric ulcers (GUs) during 8 wks in patients who continued to receive daily nonsteroidal anti-inflammatory drug (NSAID) therapy.

Methods: This multicenter, randomized, double-blind, parallel-group trial included patients who were receiving nonselective or cyclo-oxygenase-2 (COX-2)-selective NSAIDs and had at least one GU >or=5 mm but no gastric or duodenal ulcer >25 mm in diameter at the baseline esophagogastroduodenoscopy (EGD). After 4 and 8 wks of treatment, ulcer-healing status was confirmed by EGD.

Effect of tegaserod in chronic constipation: a randomized, double-blind, controlled trial.

Background And Aims: Chronic constipation is a common gastrointestinal disorder. The aim of this study was to evaluate the efficacy, safety, and tolerability of tegaserod, a serotonin subtype 4 receptor partial agonist in patients with chronic constipation.

Methods: This was a randomized, double-blind, placebo-controlled study.

Epidemiology of constipation in North America: a systematic review.

Objective: The aim of this study was to systematically review the published literature regarding prevalence, risk factors, incidence, natural history, and the effect on quality of life of constipation in North America.

Methods: A computer-assisted search of MEDLINE, EMBASE, and Current Contents databases was performed independently by two investigators. Study selection criteria included the following: (1) North American population-based sample of adults with constipation; (2) publication in full manuscript form in English; and (3) report on the prevalence, incidence, and natural history of constipation or impact of constipation on quality of life.

Obscure gastrointestinal bleeding.

This is one of a series of statements discussing the utilization of GI endoscopy in common clinical situations. The Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text. In preparing this guideline, a MEDLINE literature search was performed, and additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants.

Rabeprazole improves health-related quality of life in patients with erosive gastroesophageal reflux disease.

The purpose of this study was to assess the effect of rabeprazole 20 mg once a day on patient-reported health-related quality of life in routine clinical practice. Patients with erosive gastroesophageal reflux disease participating in an open-label, 8-week study completed the SF-36 Health Survey before and after treatment with rabeprazole. For all SF-36 scales, there was a statistically significant (p < or = 0.