April 2000 AGAA219

Vitamin 8'2atentry and last visit after ARS orduring treatment with OME. (pmoln)( Mean±SD)

1332

PATIENT SATISFACTION WITH ALOSETRON FOR THETREATMENT OF IRRITABLE BOWEL SYNDROME (IBS).Maria E. Watson, Loretto A. Lacey, Dave McSorley, Ning S. Kong,Allison R. Northcutt, Allen W. Mangel, GlaxoWellcome, RTP, NC; GlaxoWellcome, Greenford, United Kingdom.

Alosetron, a potent and selective 5-RT3 receptor antagonist, is safe andeffective for the treatment of IBS in non-constipated women. Objective: Todetermine patient satisfaction with alosetron in non-constipated womenwith IB5. Methods: In each of two multicenter, double-blind, placebo­controlled studies (S3BA3001, S3BA3002) of alosetron Img BID, patientsatisfaction with treatment was evaluated at the end of 12 weeks oftreatment or, for subjects who withdrew prematurely, at the time ofwithdrawal. Two questions were used to measure satisfaction. First, sub­jects were asked how satisfied they were with the drug they took during thestudy. Seven possible response options ranged from "extremely satisfied"to "extremely dissatisfied". Second, subjects were asked whether theywould use the study drug again. The five response options were "Yes, Iwould ask my doctor for it", "Yes, if my doctor thought I should take it","Not sure", "No, even if my doctor thought I should take it", and "No, Iwould ask my doctor for something else". For each of the two satisfactionquestions, responses between treatment groups were compared using theWilcoxon rank-sum test. Results: The subject satisfaction questions wereadded to the study protocol through an amendment implemented after thestudy began; thus only 38 % (235/626) and 48 % (312/647) of subjects inthe two studies had the opportunity to complete them. In both studies,patient satisfaction was significantly higher in the alosetron groups(p<O.OOI), with 57% and 58% reporting that they were either satisfied orextremely satisfied with the treatment, compared with 38% and 41% in theplacebo groups. In addition, a greater proportion of the alosetron groupsindicated that they would take the drug again (p <0.02). Of those subjectstreated with alosetron, 70 % and 73 % would either ask their doctor for thedrug again or would take the drug at their doctor's suggestion, comparedwith 62 % and 55% in the placebo groups, respectively. Conclusion:Results from two separate studies indicate that a majority of the womenwho received alosetron for IBS were satisfied with their treatment andwould ask for it again.

1331

VITAMIN B12 LEVELS DURING LONG·TERM TREATMENTWITH OMEPRAZOLE OR AFTER ANTI·REFLUX SURGERY INPATIENTS WITH GERD. RESULTS OF A RANDOMISED STUDY.Anders Walan, Niilo Havu, Lars Lundell, Pekka Miettinen, Helge Myr­void, Sven-Arne Pedersen, Jan Hatlebakk, Risto Julkunen, KristinaLevander, Martha Lamm, Jonas Carlsson, Per Lundborg, AstraZenecaR&D, Molndal, Sweden; AstraZeneca R&D, Sodertalje, Sweden; Sahlg­renska Univ Hosp, Gothenburg, Sweden; Univ Hosp, Kuopio, Finland;Univ of Trondheim,Trondheim, Norway; Univ Hosp, Odense, Denmark;Haukeland Hosp, Bergen, Norway; Ersta Hosp, Stockholm, Sweden; As­traZeneca, Molndal, Sweden.

Aim: To study whether there is any difference in vitamin B12 values inpatients with GERD, who are randomised to anti-reflux surgery (ARS) orcontinuous maintenance treatment with omeprazole (OME). Methods: 310patients with esophagitis and chronic GERD were enrolled. 155 patientswere randomised to ARS, of whom 144 subsequently underwent surgeryand 155 to OME - 154 treated. The mean age in the ARS group was 50years and in the OME group 52 years. Laboratory analyses and biopsiesfrom the corpus mucosa (analysed according to the Sydney system) weretaken at baseline and after 12, 36 and 60 months. Differences between firstand last value between the groups were tested with a t-test. Results:Vitamin B12 values at entry and last visit are presented in the table. At entry15 patients (12 OME and 3 ARS) had serum vitamin B\2levels below thelower reference value of 180 pmolll. At the last visit 14 OME patients hadvalues below the reference range, 5 of these had low values also at entry.In the ARS group II patients had values below 180 pmolll at the last visit,one of whom had a low value also at entry. Biopsies from the corpusmucosa showed some degree of atrophy of the mucosal glands at the lastbiopsy in 9 patients in the OME group and 10 patients in the ARS group.The last B12 values among these patients were in the OME group 282 ::'::110 pmol/l and in the ARS group 319::':: 135 pmolll (ns). There was neitherany difference at entry nor at last value between Helicobacter pylorinegative and Helicobacter pylori positive patients irrespective of treatmentgroup and also when the first and last values were compared. Conclusion:In patients with GERD who were randomised to continuous treatment withOME or ARS, no difference was observed in vitamin B\2 values during the5 year study period (p=0.51) and an equal number of patients in bothgroups had values below the lower reference range at the last value. Nopatient developed signs or symptoms of vitamin B12 deficiency during thecourse of the study.

(39.1%). Patients where endoscopy revealed a putative cause of melaenahad experienced symptoms for a shortertime (4.1 +/-5.0 vs 6.6+1-9.9 days,not significant (NS)) and, once referred, had a shorter mean wait forendoscopy (2.9+/-4.5 vs 6.9+1-11.9 days, NS). The median urea:creati­nine (U:C) ratio was also higher (1.12 vs 0.77, NS). In those cases whereupper gastrointestinal endoscopy did not reveal a cause of melaena (n= 56),65% had further investigations: 21 colonoscopies, 9 barium enemas and 6small bowel bariums. In only one case was a putative cause for melaenafound (1.78% of cases with a negative upper gastrointestinal endoscopy).Rates of clinically significant re-bleeding were low. These data demon­strate that: (i) a history of melaena is unreliable unless the haemoglobin islow or the U:C ratio is > 1; (ii) the U:C ratio is useful in the assessment ofpatients with melaena; (iii) colonoscopy has a very low yield in patientspresenting with melaena in whom upper GI endoscopy is negative.

1329LIMITED SUCCESS OF H. PYLORI EDUCATION INTERVEN·TIONS IN PRIMARY CARE.Nimish B. Vakil, Kelly Sutton, Univ of Wisconsin Med Sch, Milwaukee,WI; Aurora Health Care, Milwaukee, WI.

The aim of this study was to determine the impact of a H. pylori educationprogram on the management of peptic ulcer disease by primary carephysicians. Methods: We studied three health care facilities in Wisconsinbelonging to the same health care network: (1) an inner-city hospital clinicstaffed by residents, supervised by full-time faculty of the University ofWisconsin, (2) a free-standing clinic staffed by family practice physicianslocated in a suburban area and (3) a multi-specialty clinic with 7 satellitesin central Wisconsin. Baseline Measurement: During the control phase(June 1, 1996 - May 31, 1997), a trained chart abstractor from the ClinicalQuality department reviewed all patient records coded with or document­ing peptic ulcer disease for testing and treatment for H pylori. Interven­tions: Clinic specific data from the chart abstraction and the currentfindings from scientific literature on the testing and treatment of H. pyloriin peptic ulcer disease were presented and focus group discussions wereheld with physicians to review the rationale and results of H pyloritreatment. Written guidelines (ACG &AGA) and printed laminated pocketcards, containing a summary of the testing and treatment strategies (in­cluding dose and duration) for H. pylori in peptic ulcer disease, weredeveloped and distributed to the primary care physicians at each facility.Patient waiting areas in each clinic carried informational posters designedfor patients. Follow Up Measurement: Medical records from March 1998­February 1999 were examined in the same manner as at baseline. Results:The total number of clinic visits at each site did not change significantly inthe 2 periods. Of 202 patients diagnosed with PUD in the control period,55% were tested for H pylori. Of those tested, 32% tested positive, and92% of those found positive for H. pylori were treated. DUring the fol­lOW-Up study period, 121 patients were identified with a diagnosis of pepticulcer disease. Of these 62% were tested for H pylori (ns) and 38% werenot. Of those tested, 31% were infected with H pylori and 91% of themwere treated using one of eight different treatment regimens. Of the eightregimens, five were not effective against H. pylori and were used to treat34% of the study population. Conclusions: Interventions to improve com­pliance with H pylori guidelines have limited success in primary care.Unconventional and ineffective regimens continue to be used despitestructured education programs.

1330

SHORT·TERM TREATMENT WITH PROTON PUMP INHIBI·TORS, H2-RECEPTOR ANTAGONISTS AND PROKINETICS INGASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATICREVIEW.Bart van Pinxteren, Mattijs E. Numans, Julius Ctr, Univ Med Ctr, Utrecht,Netherlands.

Objective To determine short term clinical improvement by use of protonpump inhibitors, H2-receptor antagonists and prokinetics in empiricaltreatment of Gastro Esophageal Reflux Disease (GERD) and in treatmentof Endoscopy Negative Reflux Disease (ENRD). Design Included wererandomised controlled trials, studying clinical outcome after short-term useof proton pump inhibitors, H2-receptor antagonists and prokinetics inadults with symptomatic GERD. Studies not using Esophago Gastro Du­odenoscopy (EGD) or including patients irrespective of EGO-findings orlimiting inclusion to endoscopy negative reflux disease were all eligible.Subjects The electronic databases of MEDLINE, EMBASE and the Co­chrane Controlled Trials Register were searched for English and non­English references. Bibliographies were screened for missing publications.Main outcome measures Dichotomous outcome data were extracted onpatients gaining partial or complete symptom relief. Treatment succes wasdefined as no more than one day with mild heartburn per week. Quality oflife scores and methodological characteristics were extracted. Results Atotal of 19 trials was included. In empirical treatment of GERD odds ratio(OR) for treatment success when H2RA was compared with placebo was0.50 (95% CI 0.36 - 0.69), for PPI versus H2RA OR was 0.40 (95%CI 0.26- 0.60). In ENRD both PPI and H2RA were significantly superior toplacebo (OR 0.29 and 0.53). When directly compared difference in efficacywas not significant. Conclusion In short term treatment of GERD PPItherapy is superior to placebo and H2RA, in ENRD PPI seems to beequally effective to H2RA. Current evidence supports short term empiricaltreatment with PPI provided the diagnostic probability of GERD is high.

OMEARS

n

142127

AtenlJy

339±128347±118

Last value

329±123327±135