Only 50% of them had alarm symptoms and positive urease test for H pylonn. Serious pathology in the racial sub-groups were as follows: 12% Chinese, 7% Indians and 5% of Malays. The incidence of li. pylori in the racial sub-groups was as follows: - Indians 32%, Chinese 23%and Malays 13%. Multivariate regression analysis revealed the following risk factors as independent predictors for serious pathology: age > 45 years (p=0.O01, OR 3.97), male gender (p=0.001, OR 2.78), Chinese race (p=0.046, OR 2.39), smoking (p = 0.008, OR 2.68) and H.pylori infection (p < 0.001, OR 5.46). CONCLUSION A subset of our dyspeptics over 45 years is at a higher risk of serious upper gastrointestinal pathology. Although the numbers for malignancy were small, all cases occurred in patients > 45 years of age, who were of predominant Chinese ethnicity. A non-invasive screening policy for patients <45 years with lower risk factors may be feasible in this South East Asian population. $1252 A Systematic Review and Economic Analysis of the Cost-effectiveness of Proton Pump Inhibitor Therapy in Non-Ulcer Dyspepsia Paul Moayyedi, Nimish Vakil, Brendan C. Delaney Introduction: The efficacy of proton pump inhibitor (PPI) therapy in non-ulcer dyspepsia (NUD) is controversial. We have conducted a Cochrane systematic review of the literature and evaluated the cost-effectiveness of this strategy. Methods: The Cochrane Controlled Trials Register, Medline, EMBASE,and C1NAHL electronic databases were searched for RCTs evaluating PPIs in NUD until September 2002. Experts in the field and pharmaceutical companies were contacted for information on unpublished RCTs. A single investigator reviewed papers generated from this search according to predeflned eligibility and validity criteria. Outcomes were dichotomised into dyspepsia minimal/resolved versus same/worse. The results were entered into a Markov model (Tree Age Data Pro) that compared US retail costs and effects of PP1 with antacid therapy over a 12-month period from a health service perspective. Full dose PP1 was assumed to cost $120/month, antacid $7.16/month and a family practice visit = $42. A second order Monte Carlo simulation of 5000 patients was performed using distributions to represent the meta-analysis data to give an estimate of uncertainty around cost-effectiveness. Results: Seven RCTs evaluating 3,031 patients for 2- 8 weeks were eligible for the review. PPl therapy was significantly superior to placebo in treating NUD (relative risk (RR) of remaining dyspeptic = 0.86; 95% CI = 0.80-0.93, p<0.0001 - random effects model). There was significant heterogeneity between the studies. The number needed to treat to cure one case of dyspepsia = 9 (95% C1 = 6 to 26). Six RCTs evaluating 2,032 patients compared high versus low dose PPI with no statistical difference in curing NUD symptoms (RR=0.98; 95% C1 = 0.92 to 1.05). The Markov model suggested full dose PP1 cost $319/month free from dyspepsia (95% CI = $220 to $723). A recent study suggested patients would be willing to pay $182 for relief of symptoms. If this is the case then our model suggests PPI therapy is not cost-effective for the treatment of NUD at current retail prices. A threshold analysis suggests PPI therapy needs to cost $40/ month before we can be 95% certain that the incremental cost-effectiveness ratio lies below $182/month. Conclusions: PPI is modestly effective in NUD even at low doses. These drugs need to be substantially cheaper before we can be confident PPls are cost-effective in NUD. Recommendations for over the counter PPIs, shortly to be released in the USA, will depend to a significant extent on their cost. $1253 Functional Dyspepsia and Irritable Bowel Syndrome - Treatment Effects of Artichoke-Leaf-Extract: A Placebo-Controlled, Randomised, Multicenter Trial Gerald Holtmann, Tobias Liebregts, Winfried Collet, Timo Windeck Background: Artichoke leaf extracts are a well recognized remedy for the treatment of dyspeptic symptoms. However, no studies have formally tested efficacy Aim: To assess the efficacy of a commercially available artichoke preparation for the treatment of patients with functional dyspepsia in a prospective, randomised, double blind, placebo controlled trial of 6 weeks treatment with ALE LI 220 (640 mg plant extract rid) or placebo. Patients and Methods: 247 patients were enrolled with functional dyspepsia (ROME [I criteria, but concomitant IBS symptoms, not dominating the clinical picture were allowed), with at least moderate intensity of the main symptom. Patients with predominant reflux- or IBS-symptoms were excluded. The primary efficacy variable was the sum score of the patients weekly rating of the overall change in dyspeptic symptoms (4 point scale). Secondary vanables were e.g. the score of each dyspeptic symptom and the quality of life (QoL) questionnaire Nepean Dyspepsia Index (NDI). Results: Data from 244 patients (129 active treatment, 115 placebo) were available for data analysis (intention to treat) Treatment with ALE L1220 resulted in a significant better improvement of the symptom score (8,3, -+4.6) compared to placebo (6.7 +-4.8, p<0.01). Similarly active treatment yielded significant superiority for the secondary outcome parameters (i.e. ND1 total QoL score active treatment vs. placebo group -41.1 _+47.6 vs. -24.8 _+35.6 respectively (p<0,01)). The best response to treatment (global symptom score) was found in patients without concomitant IBS symptoms (improvement of symptom score 9.0 _+4.6 vs. 6.3 _+4.9; p<O,O01). Safety parameters were comparable between both groups. Conclusions: The artichoke leaf extract was significantly better than placebo for the improvement of symptoms and disease specific quality of life in patients with functional dyspepsia. Further studies are needed to elucidate the precise mechanisms of action. $1254 Short-term Effect of Strategies Based on Empirical Antisecretory Therapy and Helicobaeter Pylori Status in Management of Upper Dyspepsia in General Practice Dorte Jarbol, Jakob Kragstrup, Troels Havelund, Ore B. Sehaffalitzky de Muckadell Background: Decision analysis models have indicated that empirical antisecretory therapy alone or combined with screening and treatment for Helicohacter pylon (Hp) is effective in the management of patients with uninvestigated dyspepsia. However, the optimal approach has not been established. Aim/purpose: To compare the effect of three strategies for manage- ment of upper dyspepsia in a randomised controlled trial in general practice. Methods: 722 patients presenting in primary care with upper dyspepsia (more than two weeks of epigastric pain or discomfort, no alarm symptoms), where the general practitioner (GP) finds indication for investigation or treatment. Patients are initially treated according to one of three manage- ment strategies, all carried out in general practice. Practice is the unit of randomisation (cluster randomisation). Strategy 1: Proton pump inhibitor (esomeprazole 40 mg bid) for one week followed by Hp-testing if symptoms improve. Hp-infected patients to receive eradication treatment. Strategy 2: Hp-testing. Hp-infected patients to receive eradication treatment. Strategy 3: Proton pump inhibitor (esomeprazole 40 mg bid) for one week. Follow-up for one year. Outcome measures are symptoms, quality of life, drug consumption and use of health care services (visits to GP, out-patient clinics, hospitalisations etc.). The 6 weeks follow-up is now completed and we present patient statements on changes in gastrointestinal symptoms. Results: The median age was 44 years (range 18-89) and female:- male ratio 59:41. In strategies 1 and 2, 23% and 24% of the patients tested Hp-positive. At the 6 weeks follow-up patients managed according to strategy 3 improved more (Table) than patients managed according to strategies 1 or 2. P = 0048 (ordered logit model adjusted for clustering) Conclusion: In the short term, a strategy based on empincal antisecretory therapy improves symptoms more than strategies based on Hp-teat and eradicate. TaMe: Overall improvementof gastrointestinal symptoms 6 weeks after inclusion Improvements No symptoms Improved Unchanged Worse Strategy I (n=226) 33 (14.6%) 117 (51.8%) 70 (31%) 6 (2,7%) SttaterM 2 (n:2t8) 34 (15.6%) 98 (45%) 77 (35.3%) 9 (4.1%) Strategy 3 (n=t86) 32 (17.2%) 106 (57%) 41 (22%} 7 (3.8%) S1255 The Effect of Saccharomyces boulardii on Gastrointestinal Symptoms and Helicobacter pylori Eradication in Patients with Functional Dyspepsia irfan Soykan, Murat Toruner, Aysegul Temizkan, All Ozden Introduction: Saccharomyces boulardii is used in the prevention and treatment of diarrhea due to various causes and of various forms. Heficobacter pylori (lip) infection is the com- monest cause of gastritis in humans and is found in the majority of patients with functional dyspepsia Hp eradmation is a treatment option and should be considered for patients who have not responded to other treatments. Therefore, the aims of this study were to identify whether Saccharomyces boulardii could improve gastrointestinal (GI) symptoms and enhance Hp eradication rate in patients with functional dyspepsia. Methods: 63 patients (mean age: 43.7, 41 women) with functional dyspepsia diagnosed according to the Rome-II, criteria were studied. All patients were positive for Hp infection. Patients were stratified into two groups: control (n = 31) and medication (n = 32) group. Control group received amoxicillin 1 gr bid, elarithromycin 500 mg bid, and lansoprazole 30 mg bid while medication group received amoxicillin 1 gr bid, clarithromycin 500 mg bid, and lansoprazole 30 mg bid and Saccharomyces boulardii 500 mg bid (Sanofi AS, Istanbul, Turkey) for 14 days. G1 symptom scores of abdominal pain, nausea, vomiting, abdominal distention, belching and epigastnc burning sensation were obtained before therapy, at the end of the 45th day and at the end of the 180th day. All symptoms were graded from 0 to 3 (0 = none, 3 = severe), kip status was detected at 45 and 180th days. Results: 52 patients (28 from the control and 24 from the medication group) completed the study period. The median symptom scores of patients in the control group was 8.2 and 8.6 in the medication group (p =ns) before treatment. GI symptom scores were significantly reduced to 2.5 and 3.2 at the end of the 45th day and reduced to 2.0 and 3.1 at the end of the 180th day in control and medication groups respectively. There was no significance by means of symptom improvement in both groups. As for lip eradication rates, 18 patients (64.2%) from the control group and 14 patients from the medication group (58.3%) were negative fbr Hp at the end of the study period (p = ns) During the study period, antibiotic-associated diarrhea was occurred in 6 patients in the control group and 4 patients in the medication group (p=ns). Conclusions: In functional dyspepsia patients infected with Hp, Saccharomyces boulardii therapy does not improve GI symptoms, has no effect on Hp eradication rate and has limited efficacy in preventing antibiotic-associated diarrhea $1256 Efficacy of Antidepressant in Functional Dyspepsia Michiro Otaka, Mario Jni, Sumio Watanabe Background: Functional dyspepsia (FD) is common clinical entity classified to a functional upper G1disorder. As the pathogenesis of FD, abnormality of upper G1motility, hypersensitiv- ity of visceral nerves of the gastric mucosa, or H. pylori infection have been studied and discussed. The symptoms of FD sometimes do not easily disappeared by drugs such as 5- HT4 agonist (5-HT4A), H2 receptor antagonist (H2RA) or proton pump inhibitor (PPI). Irritable bowel syndrome (IBS) is also a functional disorder with abnormality in bowel movements and lower abdominal symptoms. Both FD and IBS, there are no small extent of contributions of psychosomatic factors including anxiety, depression, or neurosis. As a therapy for IBS patients, the effectiveness of antidepressant has been reported. However, no large scale study has been reported to evaluate the effectiveness of antidepressant for the therapy of FD. In this study, we evaluated the efficacy of antidepressant (amitriptyline) for the therapy of FD patients. Materials and Methods: Forty four patients complaining upper- G1 symptoms were diagnosed as FD ruling out organic diseases with ultrasonography and upper GI-endoscopy. As the first step therapy, patients received H2RA (40rag of lamotidine/ day) for 4 weeks (Step 1 therapy). When symptoms remained, patients received 5-HT4A (mosapride citrate, 15mg/day) as the second step therapy (Step 2 therapy) for 4 weeks. When symptoms still remained, patients received antidepressant (amitriptyline 30mg/day) as the third step therapy (Step 3 therapy). Alteration of upper G1 symptoms was recorded daily by patients using analog scale Patients who had abnormality in psychological test (SDS and CMI) were omitted in this study. Results: Eleven patients (2 cases of ulcer-like type, 3 cases of dysmotility-type, and 6 cases of idiopathic type) were untried to the Step AGA Abstracts A-182