Philip O. Katz

Gastroesophageal reflux disease and obesity.

Gastroesophageal reflux disease (GERD) is a common condition, with multifactorial pathogenesis, affecting up to 40% of the population. Obesity is also common. Obesity and GERD are clearly related, both from a prevalence and causality association. GERD symptoms increase in severity when people gain weight. Obese patients tend to have more severe erosive esophagitis and obesity is a risk factor for the development of Barretts esophagus and adenocarcinoma of the esophagus. Patients report improvement in GERD when they lose weight and there are several reports suggesting a decrease in GERD symptoms after bariatric surgery. At present, there is little evidence that obesity has any effect on the efficacy of antisecretory therapy, with conflicting data on surgical outcomes. This review attempts to put in perspective the relationship of these two common entities.

A Dual-Action, Low-Volume Bowel Cleanser Administered the Day Before Colonoscopy: Results From the SEE CLEAR II Study

OBJECTIVES:Optimal bowel preparation is vital for the efficacy and safety of colonoscopy. The inconvenience, discomfort, required consumption of large volumes of product, and potential adverse effects associated with some bowel preparations deter patients from colonoscopy and may provide inadequate cleansing. A dual-action, non-phosphate, natural orange-flavored, low-volume preparation containing sodium picosulfate and magnesium citrate (P/MC) is currently being reviewed for bowel cleansing.METHODS:This was a phase 3, randomized, multicenter, assessor-blinded, prespecified non-inferiority, head-to-head study to investigate the efficacy, safety, and tolerability of day-before administration of P/MC vs. 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG-3350 and bisacodyl tablets (HalfLytely and Bisacodyl Tablets Bowel Prep Kit)) in adult patients preparing for colonoscopy (SEE CLEAR II Study). The primary objective of the study was to demonstrate the non-inferiority of P/MC to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing using a modified Aronchick scale. In addition, efficacy in the ascending, mid (transverse and descending), and recto-sigmoid segments of colon was evaluated using a modified Ottawa scale. Patient acceptability and tolerability of the bowel preparations were assessed via a standard questionnaire. Safety was assessed based on the monitoring of adverse events (AEs) and meaningful findings on clinical evaluations including physical examinations, vital sign measurements, and electrocardiograms (ECGs).RESULTS:A total of 603 patients were randomized to receive either P/MC (n=300) or 2L PEG-3350 and bisacodyl tablets (n=303). Based on the Aronchick scale, successful overall cleansing was similar in patients receiving P/MC (83.0%) and patients receiving 2L PEG-3350 and bisacodyl tablets (79.7%). P/MC demonstrated non-inferiority to 2L PEG-3350 and bisacodyl tablets in overall cleansing of the colon, as measured by the Aronchick scale. Similarly, the efficacy of P/MC, as measured by the Ottawa scale, was non-inferior to 2L PEG-3350 and bisacodyl tablets in cleansing the ascending, mid, and recto-sigmoid segments of the colon. Patient-reported acceptability and tolerability for each item examined on the questionnaire was significantly greater for P/MC compared with 2L PEG-3350 and bisacodyl tablets (P<0.0001).Treatment-emergent AEs related to the bowel preparation reported by 1% of patients receiving P/MC or 2L PEG-3350 and bisacodyl tablets were nausea (3.0% vs. 4.3%), vomiting (1.4% vs. 2.0%), and headache (2.7% vs. 1.7%). No clinically meaningful changes were noted in either treatment arm in data collected from physical examinations, vital sign measurements, and ECGs.CONCLUSIONS:When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets.

Split-dose administration of a dual-action, low-volume bowel cleanser for colonoscopy: the SEE CLEAR I study

BACKGROUNDnNew bowel cleansers for colonoscopy that lead to improved efficacy, safety, and tolerability are needed.nnnOBJECTIVEnThis study evaluated a nonphosphate, dual-action, low-volume, orange-flavored preparation containing sodium picosulfate and magnesium citrate (P/MC).nnnDESIGNnMulticenter, assessor-blinded, randomized, noninferiority study.nnnSETTINGnUniversity hospitals, academic medical centers, and private clinics across the United States.nnnPATIENTSnAdults preparing for colonoscopy.nnnINTERVENTIONSnP/MC versus 2 L of polyethylene glycol solution (2L PEG-3350) and two 5-mg bisacodyl tablets.nnnMAIN OUTCOME MEASUREMENTSnThis phase 3 study investigated the efficacy, safety, and tolerability of split-dose administration of P/MC versus day-before dosing of 2L PEG-3350 and two 5-mg bisacodyl tablets (SEE CLEAR I study). Efficacy was evaluated by using the Aronchick and Ottawa scales; noninferiority and superiority analyses were performed. Safety was assessed by monitoring adverse events (AEs). Tolerability was measured via a patient questionnaire.nnnRESULTSnThe intent-to-treat population consisted of 601 patients who self-administered P/MC (nxa0= 304) or 2L PEG-3350 and bisacodyl tablets (nxa0= 297). P/MC was superior to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing (84.2% vs 74.4%; 1-sided 97.5% confidence interval [CI], 3.4) (Aronchick scores of excellent or good) and in cleansing of the ascending (89.5% vs 78.8%; 1-sided 97.5% CI, 4.9), mid (transverse and descending) (92.4% vs 85.9%; 1-sided 97.5% CI, 1.6), and rectosigmoid (92.4% vs 87.2%; 1-sided 97.5% CI, 0.4) segments of the colon (Ottawa scores of excellent, good, or fair). Commonly reported AEs related to the bowel preparations were nausea, vomiting, headache, and chills. Patient-reported tolerability, including ease of consumption and taste, was significantly higher for P/MC than 2L PEG-3350 and bisacodyl tablets (Pxa0< .0001).nnnLIMITATIONSnBecause of differences in administration and volume of the bowel preparations, the study was designed to be a single-assessor, blinded study.nnnCONCLUSIONSnThe bowel-cleansing effects and patient acceptability of split-dose P/MC were superior to day-before dosing with 2L PEG-3350 and bisacodyl tablets.

GERD: GERD and insomnia—first degree relatives or distant cousins?

Two population-based studies highlight the detrimental role of night-time GERD symptoms on sleep quality. The studies reinforce the observation that loss of sleep is associated with night-time GERD symptoms, and that sleep loss from GERD is associated with decreased work production, increased use of health-care resources, and an overall reduction in quality of life for patients.

Use of an electronic stimulator for the treatment of dry mouth

This paper presents an innovative approach to the treatment of xerostomia through normal physiologic mechanisms with a device that provides electrical stimulation to the oral and pharyngeal afferent nervous system; the result is a reflex volley of efferent impulses to the salivary glands, causing salivation. The device has been successful in treating xerostomic patients regardless of the etiology of their dry mouths.

Prevalence, knowledge and care patterns for gastro‐oesophageal reflux disease in United States minority populations

Aliment Pharmacol Ther 2010; 32: 645–654

Functional esophageal disorders: a review of diagnosis and management.

Functional esophageal disorders are a group of conditions that present with symptoms presumed to originate in the esophagus and otherwise not detected in an objective manner with available diagnostic tests. The diagnosis is typically made after the exclusion of gastroesophageal reflux disease and a primary esophageal motility abnormality such as achalasia or distal esophageal spasm. Functional heartburn, functional chest pain of presumed esophageal origin, functional dysphagia and globus are the four functional esophageal disorders as defined in the ROME III consensus criteria. The dietary, pharmacological and psychological therapies that are used for managing these difficult-to-treat conditions are based on limited evidence as of this date. Although diagnostic algorithms can separate hypersensitive esophagus from functional esophageal disorders, a therapeutic and most likely a pathophysiologic overlap between these conditions may exist. In this comprehensive review, the authors present an overview of diagnostic approaches to each of these functional esophageal disorders and summarize available evidence on existing management strategies.

Clinical Implications of Emerging Data on the Safety of Proton Pump Inhibitors

Opinion statementProton pump inhibitors (PPI) are among the safest class of drugs used by all care providers, including gastroenterologists. They are the mainstay in treatment of acid-related disease, in particular, gastroesophageal reflux disease. Without them, many patients would experience a major decrement in their quality of life. However, no drug is without side effects or adverse events. In the past decade, numerous reports, principally case control studies and meta-analyses, have raised questions about important adverse events related to the use of PPIs. This has affected not only physicians’ prescribing habits but patients’ concerns about using these medications, particularly long term. Several FDA warnings are listed including those related to long bone fractures, interaction with clopidogrel, enteric infections, and hypomagnesaemia. More recently, concerns regarding PPIs and cardiovascular events have resurfaced as have issues related to kidney disease and dementia. The methodology of these studies allows us to find an association with these events but does not provide us with sufficient evidence to determine causality. In general, the findings of the available studies do not fit with our clinical experience nor is the magnitude of the association sufficient to result in a major change in our practice. Nevertheless, the recent literature has resulted in our careful reevaluation of PPI use across both FDA indications and in general. This article will critically review the literature regarding potential PPI adverse events and attempt to place them in perspective for the practicing physician.

Identification of Quality Measures for Performance of and Interpretation of Data From Esophageal Manometry

BACKGROUND & AIMSnEsophageal manometry is the standard for the diagnosis of esophageal motility disorders. Variations in the performance and interpretation of esophageal manometry result in discrepant diagnoses and unnecessary repeated procedures, and could have negative effects on patient outcomes. We need a method to benchmark the procedural quality of esophageal manometry; as such, our objective was to formally develop quality measures for the performance and interpretation of data from esophageal manometry.nnnMETHODSnWe used the RAND University of California Los Angeles Appropriateness Method (RAM) to develop validated quality measures for performing and interpreting esophageal manometry. The research team identified potential quality measures through a literature search and interviews with experts. Fourteen experts in esophageal manometry ranked the proposed quality measures for appropriateness via a 2-round process on the basis of RAM.nnnRESULTSnThe experts considered a total of 29 measures; 17 were ranked as appropriate and were as follows: related to competency (2), assessment before the esophageal manometry procedure (2), the esophageal manometry procedure itself (3), and interpretation of data (10). The data interpretation measures were integrated into a single composite measure. Eight measures therefore were found to be appropriate quality measures for esophageal manometry . Five other factors also were endorsed by the experts, although these were not ranked as appropriate quality measures.nnnCONCLUSIONSnWe identified 8 formally validated quality measures for the performance and interpretation of data from esophageal manometry on the basis of RAM. These measures represent key aspects of a high-quality esophageal manometry study and should be adopted uniformly. These measures should be evaluated in clinical practice to determine how they affect patient outcomes.

Development of Quality Measures for the Care of Patients with Gastroesophageal Reflux Disease

BACKGROUND & AIMSnGastroesophageal reflux disease (GERD) is a common and costly disorder. Symptoms attributed to GERD have a wide spectrum of presentations and complications that have led to complex diagnostic and management algorithms. As such, there is considerable variation in clinical approaches to GERD. In contrast to multiple published guidelines for the management of GERD, there are few validated GERD quality measures. The objective of this study was to use a well-described, formal methodology to develop valid, physician-led quality measures for all aspects of care for patients with GERD.nnnMETHODSnQuality measures were identified from the literature, consensus guidelines, and GERD experts. Eight clinical experts ranked potential measures for validity on the basis of the RAND/University of California, Los Angeles Appropriateness Methodology.nnnRESULTSnOf the 52 proposed quality measures, 24 were rated as valid, and 1 new measure was developed. These valid measures were related to initial diagnosis and management (9), monitoring (3), further diagnostic testing (4), proton pump inhibitor refractory symptoms (2), symptoms of chest pain (1), erosive esophagitis (3), esophageal stricture or ring (1), and surgical therapy (2). Fifteen of these measures were ranked with the highest validity. Twenty-seven measures were determined to be equivocal; 89% of these were extracted from guidelines that were based on low or moderate level evidence.nnnCONCLUSIONSnWe used RAND/University of California, Los Angeles Appropriateness Methodology to develop quality measures for GERD care. By examining performance on these valid, formally developed quality measures, clinical practices and individual providers can assess their adherence with them and direct quality improvement efforts accordingly.