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Background: Early endoscopy, Helicobacter pylori eradication and empirical acid suppression are commonly used dyspepsia management strategies in primary care but have not been directly compared in a single trial., Aim: To compare endoscopy, H. pylori test and refer, H. pylori test and treat and empirical acid suppression for dyspepsia in primary care., Methods: Patients presenting to their general practitioner with dyspepsia were randomized to endoscopy, H. pylori'test and treat', H. pylori test and endoscope positives, or empirical therapy with symptoms, patient satisfaction, healthcare costs and cost effectiveness at 12 months being the outcomes., Results: At 2 months, the proportion of patients reporting no or minimal dyspeptic symptoms ranged from 74% for those having early endoscopy to 55% for those on empirical therapy (P = 0.009), but at 1 year, there was little difference among the four strategies. Early endoscopy was associated with fewer subsequent consultations for dyspepsia (P = 0.003). 'Test and treat' resulted in fewer endoscopies overall and was most cost-effective over a range of cost assumptions. Empirical therapy resulted in the lowest initial costs, but the highest rate of subsequent endoscopy. Gastro-oesophageal cancers were found in four patients randomized to the H. pylori testing strategies., Conclusions: While early endoscopy offered some advantages 'Test and treat' was the most cost-effective strategy. In older patients, early endoscopy may be an appropriate strategy in view of the greater risk of malignant disease., (© 2008 The Authors. Journal compilation © 2008 Blackwell Publishing Ltd.)

Background: Which of Helicobacter pylori'test and treat' or empirical acid suppression should be preferred for the initial management of uncomplicated dyspepsia is controversial. Aim To conduct an individual patient data meta-analysis of randomized controlled trials (RCTs) of 'test and treat' vs. empirical acid suppression in adults with uncomplicated dyspepsia in primary care., Methods: Investigators provided original data sets for analysis. Effect of management strategy on symptom status and dyspepsia-related resource use at 12-month follow-up was examined by pooling symptom and cost data to obtain relative risk (RR) of remaining symptomatic at 12 months and weighted mean difference (WMD) in costs between the two strategies with 95% confidence intervals (CI)., Results: We identified three eligible RCTs containing 1547 patients, 791 (51%) of whom were assigned to 'test and treat'. There was no difference detected in symptom-cure at 12 months (RR = 0.99; 95% CI: 0.95-1.03). There was a nonsignificant trend towards cost-savings with 'test and treat' (WMD in costs = - 28.91 pound; 95% CI: - 68.48 pound to 10.65 pound)., Conclusions: There was little difference in symptom-resolution or costs between the two strategies. A combination of patient and physician preference should determine the initial approach to the management of uncomplicated dyspepsia.

Objective: To determine the cost effectiveness of Helicobacter pylori "test and treat" compared with empirical acid suppression in the initial management of patients with dyspepsia in primary care., Design: Randomised controlled trial., Setting: 80 general practices in the United Kingdom., Participants: 699 patients aged 18-65 who presented to their general practitioner with epigastric pain, heartburn, or both without "alarm symptoms" for malignancy., Intervention: H pylori 13C urea breath test plus one week of eradication treatment if positive or proton pump inhibitor alone; subsequent management at general practitioner's discretion., Main Outcome Measures: Cost effectiveness in cost per quality adjusted life year (QALY) (EQ-5D) and effect on dyspeptic symptoms at one year measured with short form Leeds dyspepsia questionnaire., Results: 343 patients were randomised to testing for H pylori, and 100 were positive. The successful eradication rate was 78%. 356 patients received proton pump inhibitor for 28 days. At 12 months no significant differences existed between the two groups in QALYs, costs, or dyspeptic symptoms. Minor reductions in costly resource use over the year in the test and treat group "paid back" the initial cost of the intervention., Conclusions: Test and treat and acid suppression are equally cost effective in the initial management of dyspepsia. Empirical acid suppression is an appropriate initial strategy. As costs are similar overall, general practitioners should discuss with patients at which point to consider H pylori testing., Trial Registration: Current Controlled Trials ISRCTN87644265.

Background & Aims: Helicobacter pylori "test and treat" has been recommended for the management of young dyspeptic patients without alarm symptoms, and trials have suggested that it is as effective as endoscopy. However, none of these trials have had sufficient sample size to confirm that "test and treat" costs less or to detect small differences in effect. A collaborative group has prospectively registered trials comparing prompt endoscopy with a "test and treat" approach, with the aim of performing an individual patient data meta-analysis of both effect and resource utilization data., Methods: Researchers provided data for meta-analysis, pooling effects of interventions on individual dyspepsia symptoms. Standardized unit costs were applied to resource utilization, and net benefit was calculated at patient level. Effects, costs, and net benefit were then pooled at study level., Results: Five trials were identified, containing 1924 patients (946 endoscopy [mean age, 40 years], 978 "test and treat" [mean age, 41 years]). The relative risk (RR) of remaining symptomatic after 1 year was reduced with endoscopy compared with "test and treat" (RR = 0.95; 95% confidence interval [CI]: 0.92-0.99). "Test and treat" cost 389 dollars less per patient (95% CI: 275-502 dollars). Using the net benefit approach, at no realistic level of willingness to pay per patient symptom-free did prompt endoscopy become cost-effective., Conclusions: Prompt endoscopy confers a small benefit in terms of cure of dyspepsia but costs more than "test and treat" and is not a cost-effective strategy for the initial management of dyspepsia.

Aim: To investigate the role of Helicobacter pylori, expressing the virulence marker CAGA (cytotoxin associated gene product A) in ulcer complications and its interaction with nonsteroidal anti-inflammatory drugs (NSAIDs) and other risk factors., Design: Case control study using conditional logistic regression analysis., Setting: University and City Hospitals, Nottingham., Subjects: 203 consecutive patients with ulcer bleeding and 203 age- and sex-matched controls., Results: Ulcer bleeding was more likely with positive H. pylori serology (odds ratio = 3.3, 95% CI: 1.7--6.6 for CagA positive, but only OR = 1.6, 95% CI: 0.7-3.7 for CagA negative serology), current smoking (OR 2.2, 95% CI: 1.04-4.7), aspirin < or = 300 mg daily (OR 7.7, 95% CI: 2.8-20.6), all other nonsteroidal anti-inflammatory drugs (NSAIDs: OR 10.6, 95% CI: 3.1-35.7 for < or = 1 defined daily dose lower and OR 22.6, 95% CI: 6.2-82.0 for higher doses) and past ulcer history (OR 5.6, 95% CI: 2.3-14.1). Aspirin < or = 300 mg daily was used by 25.1% of patients vs. 7.4% of controls. Smoking only enhanced risk in the presence of H. pylori, with a synergistic interaction (interaction odds ratio = 4.9, 2.4-9.9, P=0.002). Conversely, risks with non-aspirin NSAIDs were reduced in the presence of H. pylori, particularly if CagA-positive (interaction odds ratio=0.21, 0.05-0.9, P=0.03)., Conclusions: CagA positive H. pylori infection is associated with an increased risk of ulcer bleeding. The risk from non-aspirin NSAIDs is even higher, but is less in H. pylori infected people. Low-dose aspirin is now commonly associated with ulcer bleeding.

Objectives: To determine the prevalence of Helicobacter pylori (Hp) infection in Kenyan schoolchildren aged 3-15 years and the risk factors for infection., Design: A cross-sectional survey and study of risk factors., Subjects: Primary-school children in Trans Nzoia district, Kenya., Methods: Hp status was determined using the 13C-urea breath test. Risk factors were assessed using a structured interview schedule., Results: Of 205 children interviewed, valid breath test results were obtained for 192 (93.7%), of whom 155 (80.7% (95% CI 75.2-86.3)) were infected. Univariate analysis showed weak associations between Hp infection and rural areas (location of home, Relative Risk (RR)= 1.2 (1.0-1.4); location of school, RR = 1.2 (1.0-1.3)) and lower socio-economic status (RR = 1.2 (1.0-1.4)). Access to only a pit-latrine in the home (RR = 1.2 (1.0-1.4)) and plate-sharing with other family members in the home also increased the likelihood of Hp infection (RR = 1.3 (1.1 -1.6)). However, after logistic regression modelling only plate-sharing in the home remained as an independent risk factor (odds ratio (OR) = 2.8 (1.3-6.3))., Conclusions: The prevalence of Hp infection in Kenyan schoolchildren aged 3-15 years is already high, suggesting that most acquisition occurs before age 3 years. Children who normally shared a plate with other family members during meals in the home had a higher prevalence of infection, suggesting that oro-oral transmission may be important in this population. Future studies in developing countries should focus on younger children (before age 3 years), and consider the possibility of adult-child, oro-oral transmission in order to establish likely modes of transmission.

Objective: To evaluate the performance of a near patient test for Helicobacter pylori infection in primary care., Design: Validation study performed within a randomised trial of four management strategies for dyspepsia., Setting: 43 general practices around Nottingham., Subjects: 394 patients aged 18-70 years presenting with recent onset dyspepsia., Main Outcome Measures: Results of the FlexSure test compared with an enzyme linked immunosorbent assay (ELISA; HM-CAP) with an identical antigen profile and with results of an earlier validation study in secondary care. Diagnostic yield of patients undergoing endoscopy on the basis of their FlexSure result compared with those of patients referred directly for endoscopy., Results: When used in primary care FlexSure test had a sensitivity and specificity of 67% (95% confidence interval 59% to 75%) and 98% (95% to 99%) compared with a sensitivity and specificity of 92% (87% to 97%) and 90% (83% to 97%) when used previously in secondary care. Of the H pylori test and refer group 14% (28/199) were found to have conditions for which H pylori eradication was appropriate compared with 23% (39/170) of the group referred directly for endoscopy., Conclusions: When used in primary care the sensitivity of the FlexSure test was significantly poorer than in secondary care. About a third of patients who would have benefited from H pylori eradication were not detected. Near patient tests need to be validated in primary care before they are incorporated into management policies for dyspepsia.

Aims: To examine the relation between inflammatory bowel disease and appendicectomy, childhood domestic hygiene, and Helicobacter pylori infection., Methods: Case control study involving 213 patients with ulcerative colitis, 110 with Crohn's disease, and 337 controls having elective surgery., Results: Nine patients with ulcerative colitis (4.5%) reported a previous appendicectomy compared with 57 controls (19%) (odds ratio (OR) 0.20, 95% confidence interval (CI) 0. 1-0.4, p<0.0001). The inverse association was unaffected by excluding operations performed after the age of onset of ulcerative colitis and was stronger for appendicectomy performed before age 20 (OR 0.14). No association with appendicectomy was found for Crohn's disease and no associations with tonsillectomy for either disease. The availability of a fixed hot water supply in early childhood (before age 11) was associated with Crohn's disease (OR for hot water not always versus always available 0.56, 95% CI 0.3-0.9, p=0. 02) but not with ulcerative colitis. No other aspect of domestic hygiene before or after age 11 was associated with either Crohn's disease or ulcerative colitis. Although H pylori seroprevalence was positively associated with overcrowding (p<0.001) and the absence of running hot water in childhood it was not associated with the presence of either Crohn's disease or ulcerative colitis. H pylori seroprevalence was no lower in patients who had been exposed to sulphasalazine than in controls or those not exposed., Conclusions: Our findings confirm the strong inverse association between previous appendicectomy and the development of ulcerative colitis and suggest that the protective effect is greater for appendicectomy performed in childhood.

Objective: To determine how small differences in the efficacy and cost of two antibiotic regimens to eradicate Helicobacter pylori can affect the overall cost effectiveness of H pylori eradication in duodenal ulcer disease., Design: A decision analysis to examine the cost effectiveness of eight H pylori eradication strategies for duodenal ulcer disease with and without 13C-urea breath testing to confirm eradication., Main Outcome Measures: Cumulative direct treatment costs per 100 patients with duodenal ulcer disease who were positive for H pylori., Results: In model 1 the strategy of omeprazole, clarithromycin, and metronidazole alone was the most cost effective of the four strategies assessed. The addition of the 13C-urea breath test and a second course of omeprazole, clarithromycin, and metronidazole achieved the highest eradication rate (97%) but was the most expensive (62.63 pounds per patient). The cost of each additional effective eradication was 589.00 pounds (incremental cost per case) when compared with the cost of treating once only with omeprazole, clarithromycin, and metronidazole; equivalent to the cost of a patient receiving ranitidine for duodenal ulcer relapse for more than 15 years. Eradication strategies of omeprazole, amoxycillin, and metronidazole were less cost effective than omeprazole, clarithromycin, and metronidazole alone. In model 2 the addition of the 13C-urea breath test after treatment, and maintenance treatment, increased the cost of all the strategies and reduced the cost advantage of omeprazole, clarithromycin, and metronidazole alone., Conclusion: Small differences in efficacy can influence the comparative cost effectiveness of strategies for eradicating H pylori. Of the strategies tested the most cost effective (omeprazole, clarithromycin, and metronidazole alone) was neither the least expensive (omeprazole, amoxycillin, and metronidazole alone) nor the most effective (omeprazole, clarithromycin, and metronidazole with further treatment for patients found positive for H pylori on 13C-urea breath testing). Cost effectiveness should be an important part of choosing an eradication strategy for H pylori.

Background: Most ulcers are caused, one can deduce, by Helicobacter pylori or by use of non-steroidal anti-inflammatory drugs (NSAIDs). Whether both together are worse than one alone is something that is quite unknown., Aim: To study both factors in order to see wither they interact together positively., Method: A case control study of ulcer bleeding in elderly patients chosen without weeding., Results: NSAID usage increased risk substantially. So did H pylori infection (but relative risk less than three). Neither seemed to interact. Their actions were discretely intact., Conclusion: H pylori effects ulcer bleeding in an adverse manner but does not make the risk of NSAIDs worse.