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Randomized controlled trial comparing esophageal dilation to no dilation among adults with esophageal eosinophilia and dysphagia.
Kavitt RT, Ates F, Slaughter JC, Higginbotham T, Shepherd BD, Sumner EL, Vaezi MF
(2016) Dis Esophagus 29: 983-991
MeSH Terms: Adult, Deglutition Disorders, Dexlansoprazole, Dilatation, Eosinophilic Esophagitis, Esophageal Stenosis, Esophagoplasty, Esophagoscopy, Esophagus, Female, Fluticasone, Glucocorticoids, Humans, Male, Proton Pump Inhibitors, Single-Blind Method, Treatment Outcome, Young Adult
Show Abstract · Added September 28, 2015
The role of esophageal dilation in patients with esophageal eosinophilia with dysphagia remains unknown. The practice of dilation is currently based on center preferences and expert opinion. The aim of this study is to determine if, and to what extent, dysphagia improves in response to initial esophageal dilation followed by standard medical therapies. We conducted a randomized, blinded, controlled trial evaluating adult patients with dysphagia and newly diagnosed esophageal eosinophilia from 2008 to 2013. Patients were randomized to dilation or no dilation at time of endoscopy and blinded to dilation status. Endoscopic features were graded as major and minor. Subsequent to randomization and endoscopy, all patients received fluticasone and dexlansoprazole for 2 months. The primary study outcome was reduction in overall dysphagia score, assessed at 30 and 60 days post-intervention. Patients with severe strictures (less than 7-mm esophageal diameter) were excluded from the study. Thirty-one patients were randomized and completed the protocol: 17 randomized to dilation and 14 to no dilation. Both groups were similar with regard to gender, age, eosinophil density, endoscopic score, and baseline dysphagia score. The population exhibited moderate to severe dysphagia and moderate esophageal stricturing at baseline. Overall, there was a significant (P < 0.001) but similar reduction in mean dysphagia score at 30 and 60 days post-randomization compared with baseline in both groups. No significant difference in dysphagia scores between treatment groups after 30 (P = 0.93) or 60 (P = 0.21) days post-intervention was observed. Esophageal dilation did not result in additional improvement in dysphagia score compared with treatment with proton pump inhibitor and fluticasone alone. In patients with symptomatic esophageal eosinophilia without severe stricture, dilation does not appear to be a necessary initial treatment strategy.
© 2015 International Society for Diseases of the Esophagus.
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18 MeSH Terms
Risk of recurrent Helicobacter pylori infection 1 year after initial eradication therapy in 7 Latin American communities.
Morgan DR, Torres J, Sexton R, Herrero R, Salazar-Martínez E, Greenberg ER, Bravo LE, Dominguez RL, Ferreccio C, Lazcano-Ponce EC, Meza-Montenegro MM, Peña EM, Peña R, Correa P, Martínez ME, Chey WD, Valdivieso M, Anderson GL, Goodman GE, Crowley JJ, Baker LH
(2013) JAMA 309: 578-86
MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles, Adult, Amoxicillin, Anti-Infective Agents, Bismuth, Breath Tests, Clarithromycin, Drug Administration Schedule, Drug Therapy, Combination, Enzyme Inhibitors, Female, Follow-Up Studies, Helicobacter Infections, Humans, Lansoprazole, Latin America, Male, Medication Adherence, Metronidazole, Middle Aged, Primary Prevention, Recurrence, Risk, Stomach Neoplasms, Young Adult
Show Abstract · Added September 3, 2013
IMPORTANCE - The long-term effectiveness of Helicobacter pylori eradication programs for preventing gastric cancer will depend on recurrence risk and individual and community factors.
OBJECTIVE - To estimate risk of H. pylori recurrence and assess factors associated with successful eradication 1 year after treatment.
DESIGN, SETTING, AND PARTICIPANTS - Cohort analysis of 1463 randomized trial participants aged 21 to 65 years from 7 Latin American communities, who were treated for H. pylori and observed between September 2009 and July 2011.
INTERVENTIONS - Randomization to 1 of 3 treatment groups: 14-day lansoprazole, amoxicillin, and clarithromycin (triple therapy); 5-day lansoprazole and amoxicillin followed by 5-day lansoprazole, clarithromycin, and metronidazole (sequential); or 5-day lansoprazole, amoxicillin, clarithromycin, and metronidazole (concomitant). Participants with a positive (13)C-urea breath test (UBT) 6 to 8 weeks posttreatment were offered voluntary re-treatment with 14-day bismuth-based quadruple therapy.
MEASUREMENTS - Recurrent infection after a negative posttreatment UBT and factors associated with successful eradication at 1-year follow-up.
RESULTS - Among participants with UBT-negative results who had a 1-year follow-up UBT (n=1091), 125 tested UBT positive, a recurrence risk of 11.5% (95% CI, 9.6%-13.5%). Recurrence was significantly associated with study site (P = .03), nonadherence to initial therapy (adjusted odds ratio [AOR], 2.94; 95% CI, 1.31-6.13; P = .01), and children in the household (AOR, 1.17; 95% CI, 1.01-1.35 per child; P = .03). Of the 281 with positive posttreatment UBT results, 138 completed re-treatment, of whom 93 tested UBT negative at 1 year. Among the 1340 who had a 1-year UBT, 80.4% (95% CI, 76.4%-83.9%), 79.8% (95% CI, 75.8%-83.5%), and 77.8% (95% CI, 73.6%-81.6%) had UBT-negative results in the triple, sequential, and concomitant groups, respectively (P = .61), with 79.3% overall effectiveness (95% CI, 77.1%-81.5%). In a single-treatment course analysis that ignored the effects of re-treatment, the percentage of UBT-negative results at 1 year was 72.4% (95% CI, 69.9%-74.8%) and was significantly associated with study site (P < .001), adherence to initial therapy (AOR, 0.26; 95% CI, 0.15-0.42; P < .001), male sex (AOR, 1.63; 95% CI, 1.25-2.13; P < .001), and age (AOR, 1.14; 95% CI, 1.02-1.27 per decade; P = .02). One-year effectiveness among all 1463 enrolled participants, considering all missing UBT results as positive, was 72.7% (95% CI, 70.3%-74.9%).
CONCLUSIONS AND RELEVANCE - One year after treatment for H. pylori infection, recurrence occurred in 11.5% of participants who had negative posttreatment UBT results. Recurrence determinants (ie, nonadherence and demographics) may be as important as specific antibiotic regimen in determining the long-term success of H. pylori eradication interventions. Study findings are relevant to the feasibility of programs for the primary prevention of gastric cancer in high-incidence regions of Latin America.
TRIAL REGISTRATION - clinicaltrials.gov Identifier: NCT01061437.
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25 MeSH Terms
14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial.
Greenberg ER, Anderson GL, Morgan DR, Torres J, Chey WD, Bravo LE, Dominguez RL, Ferreccio C, Herrero R, Lazcano-Ponce EC, Meza-Montenegro MM, Peña R, Peña EM, Salazar-Martínez E, Correa P, Martínez ME, Valdivieso M, Goodman GE, Crowley JJ, Baker LH
(2011) Lancet 378: 507-14
MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles, Adult, Aged, Amoxicillin, Anti-Bacterial Agents, Breath Tests, Clarithromycin, Drug Administration Schedule, Drug Therapy, Combination, Female, Helicobacter Infections, Helicobacter pylori, Humans, Lansoprazole, Latin America, Male, Metronidazole, Middle Aged, Proton Pump Inhibitors, Time Factors, Treatment Outcome, Urea
Show Abstract · Added May 18, 2016
BACKGROUND - Evidence from Europe, Asia, and North America suggests that standard three-drug regimens of a proton-pump inhibitor plus amoxicillin and clarithromycin are significantly less effective for eradication of Helicobacter pylori infection than are 5-day concomitant and 10-day sequential four-drug regimens that include a nitroimidazole. These four-drug regimens also entail fewer antibiotic doses than do three-drug regimens and thus could be suitable for eradication programmes in low-resource settings. Few studies in Latin America have been done, where the burden of H pylori-associated diseases is high. We therefore did a randomised trial in Latin America comparing the effectiveness of four-drug regimens given concomitantly or sequentially with that of a standard 14-day regimen of triple therapy.
METHODS - Between September, 2009, and June, 2010, we did a randomised trial of empiric 14-day triple, 5-day concomitant, and 10-day sequential therapies for H pylori in seven Latin American sites: Chile, Colombia, Costa Rica, Honduras, Nicaragua, and Mexico (two sites). Participants aged 21-65 years who tested positive for H pylori by a urea breath test were randomly assigned by a central computer using a dynamic balancing procedure to: 14 days of lansoprazole, amoxicillin, and clarithromycin (standard therapy); 5 days of lansoprazole, amoxicillin, clarithromycin, and metronidazole (concomitant therapy); or 5 days of lansoprazole and amoxicillin followed by 5 days of lansoprazole, clarithromycin, and metronidazole (sequential therapy). Eradication was assessed by urea breath test 6-8 weeks after randomisation. The trial was not masked. Our primary outcome was probablity of H pylori eradication. Our analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, registration number NCT01061437.
FINDINGS - 1463 participants aged 21-65 years were randomly allocated a treatment: 488 were treated with 14-day standard therapy, 489 with 5-day concomitant therapy, and 486 with 10-day sequential therapy. The probability of eradication with standard therapy was 82·2% (401 of 488), which was 8·6% higher (95% adjusted CI 2·6-14·5) than with concomitant therapy (73·6% [360 of 489]) and 5·6% higher (-0·04% to 11·6) than with sequential therapy (76·5% [372 of 486]). Neither four-drug regimen was significantly better than standard triple therapy in any of the seven sites.
INTERPRETATION - Standard 14-day triple-drug therapy is preferable to 5-day concomitant or 10-day sequential four-drug regimens as empiric therapy for H pylori infection in diverse Latin American populations.
FUNDING - Bill & Melinda Gates Foundation, US National Institutes of Health.
Copyright © 2011 Elsevier Ltd. All rights reserved.
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22 MeSH Terms
Proton pump inhibitor therapy improves symptoms in postnasal drainage.
Vaezi MF, Hagaman DD, Slaughter JC, Tanner SB, Duncavage JA, Allocco CT, Sparkman C, Clement LE, Wasden CM, Wirth D, Goutte M, McCafferty BA, Lanza DC
(2010) Gastroenterology 139: 1887-1893.e1; quiz e11
MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles, Adult, Chronic Disease, Education, Medical, Continuing, Enzyme Inhibitors, Esophageal pH Monitoring, Female, Gastroesophageal Reflux, Humans, Lansoprazole, Male, Middle Aged, Mucus, Nasal Mucosa, Proton Pump Inhibitors, Rhinitis, Treatment Outcome
Show Abstract · Added January 20, 2015
BACKGROUND & AIMS - Gastroesophageal reflux is common among patients with postnasal drainage. We investigated whether proton pump inhibitor therapy improved symptoms in patients with postnasal drainage without sinusitis or allergies.
METHODS - In a parallel-group, double-blind, multi-specialty trial, we randomly assigned 75 participants with continued symptoms of chronic postnasal drainage to groups that were given 30 mg of lansoprazole twice daily or placebo. Participants were followed up for 16 weeks. Symptoms were assessed at baseline and after 8 and 16 weeks. Ambulatory pH and impedance monitoring assessed presence of baseline reflux. The primary objective of the study was to determine if acid suppressive therapy improved postnasal drainage symptoms. The secondary objective was to assess if pH and impedance monitoring at baseline predicted response to treatment.
RESULTS - Postnasal drainage symptoms improved significantly among patients given lansoprazole compared with placebo. After 8 and 16 weeks, participants given lansoprazole were 3.12-fold (1.28-7.59) and 3.50-fold (1.41-8.67) more likely to respond, respectively, than participants given placebo. After 16 weeks, median (interquartile) percent symptom improvements were 50.0% (10.0%-72.0%) for participants given lansoprazole and 5.0% (0.0%-40.0%) for participants given placebo (P = .006). Neither baseline presence of typical reflux symptoms nor esophageal physiologic parameters predicted response to therapy.
CONCLUSIONS - Among participants with chronic postnasal drainage without evidence of sinusitis and allergies, twice-daily therapy with proton pump inhibitors significantly improved symptoms after 8 and 16 weeks. The presence of heartburn, regurgitation, abnormal levels of esophageal acid, or nonacid reflux did not predict response to therapy.
Copyright © 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.
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17 MeSH Terms
Dilated intercellular space in chronic laryngitis and gastro-oesophageal reflux disease: at baseline and post-lansoprazole therapy.
Vaezi MF, Slaughter JC, Smith BS, Washington MK, Jerome WG, Garrett CG, Hagaman D, Goutte M
(2010) Aliment Pharmacol Ther 32: 916-24
MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles, Adult, Anti-Infective Agents, Biopsy, Chronic Disease, Dilatation, Pathologic, Extracellular Space, Female, Gastroesophageal Reflux, Humans, Intercellular Junctions, Lansoprazole, Laryngitis, Longitudinal Studies, Male, Middle Aged, Prospective Studies, Statistics as Topic, Surveys and Questionnaires
Show Abstract · Added December 10, 2013
BACKGROUND - Dilation of intercellular spaces is reported to be an early morphological marker in gastro-oesophageal reflux. It remains unknown if this marker is useful in diagnosing reflux-related chronic laryngitis.
AIM - To determine histopathology and electron microscopic changes in oesophageal and laryngeal epithelium in chronic laryngitis.
METHODS - In this prospective blinded study, we enrolled 53 participants: 15 controls, 20 patients with GERD and 18 patients with chronic laryngitis. The latter two groups were subsequently treated with lansoprazole 30 mg bid for 12-weeks. Baseline and postacid suppressive therapy biopsies were obtained from distal oesophagus and laryngeal postcricoid areas. Biopsy specimens were evaluated for histopathology and dilated intercellular space changes.
RESULTS - There was no significant increase in oesophageal or laryngeal epithelium intercellular spaces among GERD or laryngitis patients compared with controls at baseline or postacid suppressive therapy. Only patients with GERD had significantly (P = 0.03) higher proportion of moderate-to-severe oesophageal spongiosis and basal cell hyperplasia, which normalized postacid suppressive therapy.
CONCLUSIONS - There was no increase in the width of intercellular spaces in the oesophagus or larynx in GERD or chronic laryngitis at baseline or postacid suppressive therapy. Our findings question the uniform presence of dilated intercellular space in patients with GERD.
2010 Blackwell Publishing Ltd.
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3 Members
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19 MeSH Terms
Clinical trial: gastric acid suppression in Hispanic adults with symptomatic gastro-oesophageal reflux disease - comparator study of esomeprazole, lansoprazole and pantoprazole.
Morgan D, Pandolfino J, Katz PO, Goldstein JL, Barker PN, Illueca M
(2010) Aliment Pharmacol Ther 32: 200-8
MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles, Adolescent, Adult, Aged, Anti-Ulcer Agents, Cross-Over Studies, Drug Therapy, Combination, Esomeprazole, Female, Gastric Acid, Gastroesophageal Reflux, Hispanic Americans, Humans, Lansoprazole, Male, Middle Aged, Pantoprazole, Patient Compliance, Treatment Outcome, United States, Young Adult
Show Abstract · Added May 20, 2016
BACKGROUND - Hispanic-Americans are a rapidly growing population in the United States, yet gastro-oesophageal reflux disease (GERD) is not well studied in this population.
AIM - To compare the efficacy of esomeprazole, lansoprazole and pantoprazole in suppressing gastric acid, including the area of the 'acid pocket,' in Hispanics with GERD.
METHODS - In this open-label, 3-way crossover study, 83 Hispanics with symptomatic GERD were randomized to 1 of 6 possible treatment sequences of three 5-7-day dosing periods with esomeprazole 40 mg, lansoprazole 30 mg and pantoprazole 40 mg daily separated by 10-17-day washout periods. Intragastric pH was measured for 24 h using dual probes with a distal and proximal (area of the 'acid pocket') electrode.
RESULTS - Esomeprazole suppressed intragastric acid (pH >4.0) significantly longer over 24 h (primary end point) compared with lansoprazole and pantoprazole (P < 0.0001), and proximal gastric acid (pH >4.0) significantly longer over 24 h compared with lansoprazole (P < 0.05) and pantoprazole (P < 0.0001).
CONCLUSIONS - Esomeprazole was more effective than lansoprazole and pantoprazole in suppressing gastric acidity at both intragastric distal and proximal (area of the acid pocket) sites in Hispanics with GERD. Future studies are warranted to understand better the role of the acid pocket in GERD (Clinical trial numbers: D9612L00106; ClinicalTrials.gov: NCT00410592).
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21 MeSH Terms
Effect of Helicobacter pylori eradication on gastric carcinogenesis.
Romero-Gallo J, Harris EJ, Krishna U, Washington MK, Perez-Perez GI, Peek RM
(2008) Lab Invest 88: 328-36
MeSH Terms: 2-Pyridinylmethylsulfinylbenzimidazoles, Adenocarcinoma, Amoxicillin, Animals, Animals, Outbred Strains, Anti-Bacterial Agents, Clarithromycin, Disease Models, Animal, Drug Administration Schedule, Drug Therapy, Combination, Gastritis, Gerbillinae, Helicobacter Infections, Helicobacter pylori, Interferon-gamma, Lansoprazole, Male, Specific Pathogen-Free Organisms, Stomach Neoplasms, Time Factors
Show Abstract · Added March 5, 2014
Chronic gastritis induced by Helicobacter pylori is the strongest known risk factor for gastric adenocarcinoma, yet the effects of bacterial eradication on carcinogenesis remain unclear. Animal models provide important insights into factors that are involved in gastric carcinogenesis, and we previously utilized such a model to demonstrate that an in vivo-adapted H. pylori strain, 7.13, rapidly and reproducibly induces inflammation-mediated gastric carcinoma. In the current study, we used this bacterial strain as a prototype to define the role of targeted antimicrobial therapy in gastric carcinogenesis. Mongolian gerbils were infected with H. pylori for 4 or 8 weeks, treated with antimicrobial agents or vehicle, and then euthanized at 8 weeks after the completion of therapy. All infected gerbils developed gastritis; however, inflammation was significantly attenuated in animals receiving antimicrobial therapy. Gastric dysplasia or cancer developed in >60% of the gerbils that remained persistently colonized with H. pylori, but in none of the animals treated with antibiotics following 4 weeks of infection. Infection with H. pylori for 8 weeks prior to therapy resulted in an attenuation, but not complete prevention, of pre-malignant and malignant lesions. Similarly, antibiotic therapy initiated at 4, but not 8, weeks after H. pylori challenge significantly reduced expression of the Th1 pro-inflammatory cytokine interferon-gamma within colonized gastric mucosa. These results indicate that treatment of H. pylori in this model decreases the incidence and severity of lesions with carcinogenic potential. The effectiveness of eradication is dependent upon the timing of intervention, providing insights into mechanisms that may regulate the development of malignancies arising within the context of inflammatory states.
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20 MeSH Terms