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Biomedical subjects

Anthony Lembo

Publications and source records attributed to Anthony Lembo.

10 recordsLinked to original sources

Endoscopic full-thickness plication for the treatment of GERD: a multicenter trial.

BACKGROUND: A novel endoscopic full-thickness plication device has been designed to inhibit gastroesophageal reflux by placing a transmural plication near the gastroesophageal junction under direct endoscopic visualization. This study assessed the safety and efficacy of endoscopic full-thickness plication in the treatment of patients with symptoms caused by GERD. METHODS: Patients with chronic heartburn requiring maintenance therapy with antisecretory medication were recruited. Exclusion criteria were the following: hiatal hernia (>2 cm), grade III and IV esophagitis, and Barrett's esophagus. The following were assessed over a follow-up period of 6 months: GERD-Health-Related Quality of Life, Gastrointestinal Symptom Rating Scale, and SF-36 Health Survey, medication use, 24-hour esophageal pH monitoring and esophageal manometry. Patients underwent a single, full-thickness plication in the gastric cardia just distal to the gastroesophageal junction. Re-treatment was not permitted. RESULTS: A total of 64 patients (mean age 46.3 years, range 23-71 years) underwent endoscopic full-thickness plication (mean procedure time 17.2 minutes). At 6 months after plication, proton pump inhibitor therapy had been eliminated in 74% of previously medication-dependent patients. Median GERD-Health-Related Quality of Life scores improved 67% (19.0 vs. 5.0; p<0.001). Improvements also were observed in median Gastrointestinal Symptom Rating Scale and SF-36 Health Survey mental and physical composite scores. Median esophageal acid exposure improved significantly (10 vs. 8; p<0.008) with normalization of pH noted in 30% of patients. No significant change in esophageal manometry was noted. One gastric perforation occurred and was managed conservatively without sequelae. CONCLUSIONS: In this study, a single full-thickness plication placed at the gastroesophageal junction reduced symptoms, medication use, and esophageal acid exposure associated with GERD.

Adult↗

Irritable bowel syndrome medications side effects survey.

OBJECTIVES: This study was conducted to determine the frequency and severity of side effects (SEs) experienced during treatment with standard medications used to treat patients with irritable bowel syndrome (IBS) with constipation (IBS-C). METHODS: In January of 2002, 668 subjects responded to a survey addressed to an online panel of 25,000 physician-diagnosed IBS sufferers. Of the survey respondents, 504 had constipation as a predominant bowel habit (median age 45 years, and 88% were women). Respondents answered questions about the therapies they used to relieve their IBS symptoms and about any SEs they experienced while taking these therapies; they were also asked to rate their satisfaction with their current/past medications. To gauge IBS impact, respondents were also asked about the number of times they either visited or called their health-care provider about their IBS symptoms and approximately how many days of work or school they missed because of their IBS symptoms. RESULTS: Subjects reported having tried an average of 3.9 +/- 3.3 medications for their IBS-C symptoms with virtually all subjects (99%) having tried at least 1 medication. Subjects reported an average of 3.3 +/- 2.7 SEs. Nearly three quarters reported discontinuing treatment because of SEs, and many sought medical help or missed work, school, or social activities because of SEs. CONCLUSIONS: Traditional therapies for IBS-C, including laxatives, fiber, and stool softeners, are associated with SEs that negatively affect the lives of IBS sufferers.

Abdominal Pain↗

Tegaserod does not alter fasting or meal-induced biliary tract motility.

OBJECTIVE: Tegaserod is a 5-HT(4) receptor partial agonist that increases peristaltic activity of the intestinal tract. It is approved for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). IBS is a chronic gastrointestinal disorder of function that is reported to be associated with an increased incidence of abdominal surgery including cholecystectomy. The effect of tegaserod on nongut digestive organs, such as the gallbladder and biliary tract, has not been previously investigated. Therefore, this study aimed to evaluate the effects of tegaserod on gallbladder contractility and on functional status of the sphincter of Oddi during both the interdigestive and the digestive periods in healthy female subjects and in female patients with IBS-C. METHODS: During a 6-wk, double-blind, placebo-controlled crossover study, gallbladder contractility and concomitant change in luminal diameter of the common hepatic duct (CHD) and the common bile duct (CBD, both proximal and distal) in response to a standard liquid meal were quantified using real-time ultrasonography. Changes in luminal diameter of the CHD and the CBD were used as a surrogate marker for sphincter of Oddi function. Ultrasound measurements were conducted every 15 min from 45 min before, to 60 min after the test meal to observe the impact of tegaserod on gallbladder volume and any concomitant change in the diameters of the CHD and the CBD that developed in response to gallbladder contraction. The ultrasound measurements of gallbladder contractility, along with the CHD and the CBD diameters, were repeated after each of the two 2-wk periods of treatment with tegaserod or placebo. The recommended dose of tegaserod (6 mg b.i.d.) for IBS-C patients was used in healthy female subjects (n = 13) and female patients with IBS-C (n = 20). Twice this dose (12 mg b.i.d.) was also evaluated in an additional 20 female patients with IBS-C. Statistical evaluations were conducted using a two-sided analysis of variance (ANOVA). RESULTS: Gallbladder contractility variables including ejection fraction, ejection rate and ejection period, fasting and residual volume, and maximal emptying, were similar after 2 wk of treatment with tegaserod 6 mg b.i.d. and placebo in healthy female subjects and female patients with IBS-C. There were no significant changes in the luminal diameters of the CHD or the CBD after tegaserod compared to placebo in any cohort. Additionally, no significant dilation (> or =7 mm in diameter) of the CHD or CBD was observed during maximal gallbladder emptying. Similar results were also observed when tegaserod was given at 12 mg b.i.d. in patients with IBS-C. Tegaserod treatment had no significant effect on plasma CCK concentration in response to the test meal. No significant abdominal pain or unexpected adverse events were reported during the study. CONCLUSIONS: This study showed no significant pharmacodynamic effect of tegaserod on gallbladder contractility or on CBD and CHD diameters as a surrogate marker of sphincter of Oddi function during both the interdigestive (fasting) and the digestive (postprandial) periods in healthy female subjects and female patients with IBS-C.

Biliary Tract↗

A novel endoscopic full-thickness plicator for the treatment of GERD: A pilot study.

BACKGROUND: The novel full-thickness plication described in this study was designed to inhibit gastroesophageal reflux by placement of a transmural plication near the gastroesophageal junction under direct endoscopic visualization. The resulting serosa-to-serosa tissue union is thought to accentuate and restore the valvular mechanism of the gastroesophageal junction. The aim of this study was to assess the safety and feasibility of endoscopic full-thickness plication for the treatment of patients with GERD symptoms. METHODS: A pilot study was performed in patients with chronic heartburn and pathologic reflux requiring maintenance antisecretory therapy. A single full-thickness plication was placed in the gastric cardia within 1 to 2 cm of the gastroesophageal junction. The primary end points of the study were procedure safety and feasibility, as well as long-term durability of the full-thickness tissue fixation. Secondary end points included medication use and the GERD-Health Related Quality of Life questionnaire and Gastrointestinal Symptom Rating Scale. RESULTS: Full-thickness plication was performed successfully in 6 of 7 patients, with one procedure aborted because of difficulty in sedating the patient. Mean procedure time was 21 minutes. Mild epigastric pain was reported by two patients and difficulty with eructation by one patient; all symptoms resolved spontaneously within 7 days of the procedure. Endoscopy at 6 months revealed an intact plication in all patients. At 1 year after the procedure, patients reported sustained reduction in heartburn scores. One patient, who did not experience significant relief of symptoms, ultimately underwent successful laparoscopic Nissen fundoplication at 6 months after the procedure. At 1 year after the procedure, 3 of 5 patients were not taking anti-GERD medications. CONCLUSIONS: Endoscopic full-thickness plication is feasible, safe and, in this pilot study, appeared to reduce symptoms and medication use associated with GERD.

Adult↗

Irritable bowel syndrome: evaluation and treatment.

Irritable bowel syndrome is a common gastrointestinal disorder characterized by abdominal pain, bloating, and disturbed defecation in the absence of other medical conditions with similar presentations. Because physical findings and currently available diagnostic tests lack sufficient specificity for clinical use, the diagnosis of IBS is based on characteristic symptoms as outlined in several symptom-based criteria for IBS. When used in combination with a detailed history, physical examination, and limited diagnostic testing, these criteria are a valid method of diagnosing IBS. Once a confident diagnosis of IBS has been made, treatment of IBS should be based on the predominant symptom while taking into account the severity of symptoms and the degree of functional impairment both physically and psychologically. Most patients with IBS have mild symptoms and education, reassurance, dietary and lifestyle changes, and a therapeutic physician-patient relationship form the backbone of treatment. A smaller number of patients have moderate symptoms, which are typically intermittent, but may at times interrupt their normal activities. In addition to dietary and lifestyle modifications, pharmacologic intervention based on the predominant symptom (diarrhea, constipation, or pain) may be used to relieve symptoms. Finally, a small subset of patients has severe or intractable symptoms. These patients, often seen in tertiary referral centers, often have constant pain symptoms and psychosocial impairments. A multidisciplinary approach including pharmacologic treatments, psychologic treatments, and possibly a mental health or pain center involvement may be beneficial.

Colonic Diseases, Functional↗

Alosetron in irritable bowel syndrome: strategies for its use in a common gastrointestinal disorder.

Irritable bowel syndrome (IBS) is a common gastrointestinal disorder characterised by recurrent abdominal pain and altered bowel habits in the absence of any discernible structural, biochemical and physiological abnormalities. Although there is no specific biological marker for the diagnosis of this disorder, recently developed symptom-based criteria provide the tools necessary to make a diagnosis. The precise underlying pathophysiology of IBS remains unknown. However, disturbances in the brain-gut axis involving the central nervous system and the enteric nervous system have emerged as an underlying concept for IBS. In this regard, conventional treatment has been recognised as unsatisfactory for many patients with IBS and novel, neuroenteric modulatory compounds have been introduced for use by clinicians. Specifically, compounds interacting with the 5-hydroxytryptamine (5-HT, serotonin) receptors of the 5-HT3 and 5-HT4 subtype have been demonstrated of benefit in some patients for the treatment of IBS. In this leading article, we present the current data on the pharmacology, clinical trials, indications and adverse effects of alosetron, a potent and selective 5-HT3 antagonist. As a result of the recognition of serious adverse effects, the indication for alosetron has been restricted and it is now indicated only for women with severe diarrhoea-predominant IBS who have symptoms for at least 6 months and who have failed to respond to conventional therapy. Prescribing restrictions and the risk-management programme implemented as required by the US FDA is reviewed along with a summary of the studies to be performed after reintroduction of alosetron to monitor safety.

Carbolines↗