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Validation of the reflux symptom questionnaireHardtke Cyndy L, Romero Yvonne MD, Cameron Alan J MD*, SchaidDaniel J PhD, Murray Joseph A MD, Conio Massimo MD, BurgartLawrence J MD, Locke Giles R III MD. Mayo Clinic, Rochester,Minnesota, United States.

Purpose: To prospectively validate theReflux Symptom Questionnaire(RSQ) developed by Locke, et al. (Mayo Clin Proc 1994; 69: 539–547).Background: The RSQ has 17 items, of which 11 concern the type,frequency and duration of gastroesophageal reflux disease (GERD) symp-toms, medications taken for GERD and any prior esophageal diagnoses orsurgery. This instrument was developed using validated items from theGastroesophageal Reflux Questionnaire(GERQ).Methods: The RSQ was prospectively administered to potential subjectsprior to endoscopy (EGD). Subjects were either first degree relatives ofindex patients with Barrett’s esophagus (BE)(Relatives), or patients whodenied a family history of BE or esophageal cancer referred by theirphysicians for EGD (Controls). Criteria for GERD symptoms includedheartburn at least once per week in the past year with at least one of thefollowing criteria: relief with antacids, night awakening or radiation towardthe neck, OR acid regurgitation at least once per week. Subjects wereexcluded if they had previous EGD. The gold standard for GERD waserosive changes of the esophagus or BE at EGD.Results:294 subjects participated: 136 of 212 (63%) Relatives and 158 of160 (99%) Controls. Participants included 178 males (88 Relatives, 90Controls) and 116 females (48 Relatives, 68 Controls) of whom 113Relatives and 151 Controls met criteria for GERD symptoms as per theRSQ. Relatives were younger, median age 47 versus 55 years (p50.007).

EGD GERD 1 EGD GERD 2

RSQ GERD1 152 112RSQ GERD2 16 14Total 168 126

The overall sensitivity and specificity of the RSQ for erosive refluxdisease is 90% and 11%, respectively. Among persons without a familyhistory of BE, the respective sensitivity and specificity of the RSQ forerosive reflux is 97% and 6%. Data not shown.Conclusions: Preliminary analysis suggests that the RSQ is a sensitiveinstrument for the detection of GERD symptoms.

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Yield of screening colonoscopy in persons aged 40 to 49 yearsImperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, RansohoffDF. Indiana University School of Medicine, IndianapolisGastroenterology Research Foundation, Eli Lilly & Co. Inc.,Indianapolis, IN, and University of North Carolina, Chapel Hill, NC.

Background: Approximately 7% of colorectal cancers (CRC) occur inpersons aged, 50 years. Although screening colonoscopy (CY) has beenadvocated for people$ age 50 based on indirect evidence, there are nopublished data on the yield of CY for detection of neoplasia in persons40–49 years old.Methods: Eli Lilly & Co, Inc. provide screening CY to employees, retirees,and their dependents aged 40 years and older. We reviewed procedurereports and histologic findings from consecutive persons aged 40–49 whounderwent screening CY. Colorectal pathology was characterized accord-ing to the most advanced lesion proximally (splenic flexure) and distally.An advanced lesion was defined as villous histology, dysplasia or cancer.Findings in men vs. women were compared with relative risks (RR) and95% confidence intervals (CI).Results: From 9/95 to 4/00, 906 persons aged 40–49 were screened withCY (mean age 44.8 years; 61% men, 77% Caucasian). Overall, 79% had nopolyps, 10% had hyperplastic polyps, 9% had tubular adenomas, and 21(2%) had advanced lesions, none of which were cancers (95% CI for

cancer: 0–0.4%). Fourteen (64%) of 22 advanced lesions were distal andwithin reach of the sigmoidoscope. Of 8 advanced proximal neoplasms(APN), 6 had no distal sentinel polyp; 120 screening CYs (CI 69–454)would be needed to detect one APN among persons with no distal neo-plasm. Women were less likely to have any polyp (16% vs 24%; RR50.67;CI 0.43–0.86) and any neoplasm (8% vs 12%; RR50.66; CI 0.40–0.99).Conclusion: CRC is very rare in persons aged 40–49 years and is sub-stantially lower than in older persons. Advanced neoplasia is uncommonand tends to be distal in location. The low yield of screening CY in this agegroup supports current recommendations about when to begin CRC screen-ing. Identification of risk factors for ‘early‘ CRC and isolated advancedproximal neoplasms would be useful in order to target screening CY foryounger age groups.

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Impact of Lotronex on time lost from work in female patients withdiarrhea-predominant IBSJhingran P. Ph.D., Decker C. M.S., Ricci JF M.B.A., Watson M. Ph.D.,Northcutt A. M.S. Glaxo Wellcome Inc., Research Triangle Park, NC,USA.

Purpose: IBS is characterized by recurrent abdominal pain, discomfort,and alterations in bowel function. Previous studies have shown that mul-tiple and debilitating symptoms of IBS can impact daily life, functionalstatus, direct medical costs, and productivity. The objective of the studywas to assess the impact of Lotronex on the time lost from work in femalepatients with diarrhea-predominant IBS who were working full-time ($30hours a week).Methods: Time lost from work was measured at baseline and at Week12/Final Visit in two identically designed, double-blind, placebo-con-trolled, 12-week randomized clinical trials of Lotronex 1 mg twice daily infemales with diarrhea predominant IBS. Measures of time lost included thenumber of days over the preceding 4 weeks that subjects 1) were unable toattend work or 2) needed to reduce the length of their workday because oftheir IBS symptoms. Treatment groups were compared using a rank anal-ysis of covariance adjusting for baseline. The economic implications ofmeasured productivity changes were estimated using 1999 wage data fromthe US Bureau of Labor Statistics. Data from the 2 trials were combined forall analyses.Results: Of 903 subjects enrolled in the two trials, 397 (44%) wereworking full-time at baseline and study end. Analysis of combined studieson the 397 patients showed that at baseline, Lotronex and placebo diarrhea-predominant subjects missed 1.25 days and 1 day (median) over thepreceding 4 weeks, respectively. At Week 12/Final visit, Lotronex andplacebo patients missed 0 and 0.5 day (median), respectively (p,0.001).Assuming an 8-hour workday and total hourly benefits of $20.29, theadditional half day reduction in productivity loss for Lotronex patientstranslates into a $81-savings to employers. Constipation was the onlyadverse event reported more frequently with Lotronex than with placebo,39% versus 14%, respectively.Conclusion: Lotronex reduces time lost from work in diarrhea predomi-nant IBS females working full-time by half-a-day, translating into a $81savings per month for their employers.

This study was sponsored by Glaxo Wellcome, Inc.

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Patient satisfaction in Lotronex® (Aloseton HCl) treatednonconstipated irritable bowel syndrome (IBS) femalesJhingran P. Ph.D., Bagby BA M.B.A, Decker C. M.S., Gordon S.M.S.N., Markowitz MA M.D., Carter E. M.D. Glaxo Wellcome Inc.,RTP, NC, USA.

Purpose: Traditional medications have not shown consistent benefits inaddressing the multiple symptoms of IBS and may cause unwanted sideeffects resulting in lower patient satisfaction. This study evaluated patient

2631AJG – September, 2000 Abstracts