A Prospective Study to Compare a Symptom-Based Reflux Disease Questionnaire to 48-h Wireless pH Monitoring for the Identification of Gastroesophageal Reflux Brian E. Lacy, PhD, MD, FACG, Robert Chehade, MD 1 and Michael D. Crowell, PhD, FACG The American Journal of GASTROENTEROLOGY VOLUME 106 : R1 Lee Tae-In / Prof. Cho Joon-Hyung

 Gastroesophageal reflux disease (GERD) The most common out-patient gastroenterology diagnosis in the United States Controversy exists over how best to diagnose GERD  The gastroesophageal reflux disease questionnaire (GerdQ) Validated questionnaire that identifies patients with GERD  The aim of this study INTRODUCTION To assess GerdQ scores in relationship to 48-h wireless pH monitoring To determine the performance of the GerdQ in patients studied on/off acid suppression

 Inclusion criteria 18 years of age or older with symptoms thought secondary to GERD for 48-h wireless pH capsule testing 1 October 2008 ~ 31 October 2009  Exclusion criteria Dominant symptom of patients was chest pain, chronic cough, asthma, or ENT symptoms (e.g., hoarseness, globus, sore throat, post-nasal drip) Known or suspected esophageal varices, a cardiac defibrillator or other device inserted state  Asked to stop the medication during 7 days in advance of the pH study if on PPI 5 days in advance of the pH study if on anti-histamine METHODS Patients

 The two standardized methods for the deployment of the wireless pH capsule Endoscopic placement or trans-orally guided by manometric criteria  Asked to keep a diary Symptoms and activity, including body position(supine vs upright) during the 48-h recording period  Symptom association probability(SAP) scores were calculated at the 95% level for symptoms of heartburn and regurgitation  Premature detachment of the capsule an abrupt drop and rise in pH (pH 7.0) METHODS Wireless pH capsule placement

For the next 6 questions please think about your symptoms over the past 7 days… A. 1. How often did you have a burning feeling behind your breastbone (heartburn)? 1. 0 days 2. 1 day days days 2. How often did you have stomach contents (liquid or food) moving upwards to your throat or mouth (regurgitation)? 1. 0 days 2. 1 day days days B. 1. How often did you have pain in the center of the upper stomach? 1. 0 days 2. 1 day days days 2. How often did you have nausea? 1. 0 days 2. 1 day days days C. 1. How often did you have difficulty getting a good night’s sleep because of your heartburn and/or regurgitation? 1. 0 days 2. 1 day days days 2. How often did you take additional medications for your heartburn and/or regurgitation other than what your physician t old you to take? 1. 0 days 2. 1 day days days METHODS Questionnaires Supplementary appendix addendum

RESULTS

RESULTS Demographics

RESULTS Wireless pH capsule placement EndoscopicOrally Wireless pH capsule placement 202 patients (56%)156 patients (44%)  Premature detachment or loss of signal resulted in the exclusion of six studies (1.7%)

 The 48-h wireless pH study either off(n=178) or on(n=180) acid suppression  Patients studied on acid suppression 48%(daily qd PPI), 49%(daily bid PPI), 3%(anti-histamine or combination)  The odds of an abnormal study were 5.04(95% CI, ) times greater in patients studied off PPI compared with patients studied on PPI OR : 4.09 (95% CI, ; P <0.001) on daily PPI OR : 6.08 (95% CI, 3.29 – ; P < 0.001) on twice-daily PPI  The odds of the SAP being >95% was 5.69 (95% CI, 3.36 – 9.64 ; P < 0.001) for patients studied off PPI compared with on PPI RESULTS pH recordings and SAP

EsophagitisBx-proven Barrett’s esophagus Hiatal herniaEsophageal stricture (non-occluding) 17%12%69%3% RESULTS Endoscopic findings  Upper endoscopy findings were not significantly related to whether or not the patient was on PPI(n=86; 70%) or off PPI (n=73; 64%; OR 1.31; 95% CI, ; P=0.34)

RESULTS GerdQ scores

 Each of six individual GerdQ questions was analyzed separately  Only the GerdQ subscale for regurgitation was positively associated with an abnormal pH study (OR, 1.43; 95% CI, 1.01 – 2.03) RESULTS GerdQ scores

 Elevated GerdQ scores were associated with increased likelihood of an abnormal 48-h pH study  GerdQ subscale scores for regurgitation were associated with an abnormal wireless pH study  The GerdQ performed more robustly for patients studied off acid suppressants  Overall, the GerdQ cannot accurately diagnose acid reflux when compared with 48-h wireless pH testing CONCLUSION