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A. Leodolter [1] D. Vaira [2] F. Bazzoli [3] A. Hirschl [4] F. Megraud [5] P. Malfertheiner [1] [16/01] [*] European Multicentre Validation Trial of two new Non-invasive Tests for [...]

[15/27] A Validation of Questionnaire for Measuring the Presence and Severity of Dyspepsia Background: There is not currently validated questionnaire to assess presence and severity of dyspepsia. Aim: evaluate reproducibility, [...]

F. Bazzoli [1] R. Zagari [1] R. Albanese [2] P. Pozzato [1] S. Fossi [1] D. Berretti [1] C. Martuzzi [1] V. Lunedei [1] F. Antonini [1] E. Roda [1] [...]

F. Bazzoli [1] M. De Rosa [2] R. Zagari [1] E. Rossi [2] V. Lunedei [1] F. Antonini [1] E. Roda [1] [11/07] Pharmacoepidemiology Profile of Helicobacter pylori Regimens in [...]

Background: the presence of alarm symptoms (AS) such as anorexia, weight loss, signs of gastrointestinal bleeding is believed to discriminate between upper gastrointestinal (UGI) organic lesions and functional dyspepsia, but evidence in the literature is limited. Aim: To evaluate the prevalence of AS in a sample of the general population undergoing upper gastrointestinal endoscopy (OGD), in order to determine their value in predicting the presence of endoscopic lesions (EL). Methods: In the frame of the ongoing Loiano-Monghidoro project (APT 2001;15:1001-7), inhabitants of Loiano-Monghidoro commons are being re-invited to undergo OGD, and a previously validated detailed symptom questionnaire. 892 subjects have been evaluated during the period of time from January 2000 — October 2001 (442 males, 450 females, age range 18-86 years, mean age 54.4). The presence of AS was defined by at least one of the following symptoms: weigh loss, GI bleeding, anaemia, persisting vomiting, dysphagia, anorexia, pain radiating to the back. The presence of EL was defined by at least one of the following findings: oesophagitis, gastric and duodenal ulcers, erosive duodenitis, malignancies. All, but one, subjects completed the symptom questionnaire. Chi-square and Fischer exact tests were used for statistical analysis. Results: The prevalence of AS was 6.6% (59/892 subjects, 33 females, 26 males, age range 21-84 years, mean age 52.5) and the prevalence of EL was 16.7% (149/892) subjects, 60 females, 89 males, age range 19-86 years, mean age 56.7). AS were reported by 19/149 (12.8%) subjects with EL and by 40/743 (5.4%) of those without EL (OR = 2.6; 95% CI = 1.48-4.7; p < 0.001). Conclusions: In this large sample of the general population the presence of AS increased by almost three fold the risk of having major UGI endoscopic lesions. This finding might be relevant in planning management strategies for UGI disorders in the general population. [ABSTRACT FROM AUTHOR]

Background: HP infection and family history (FH) of gastric cancer (GC) seem to be risk factors for GC. Aim and methods: to study if Hp infection is associated with an increased risk of intestinal metaplasia (IM)in relatives of GC patients. In the frame of the ongoing Loiano-Monghidoro Project (APT 2001; 15:10017), inhabitants are re-invited to undergo upper gastrointestinal endoscopy with biopsies, [sup 13]C-UBT, medical interview and questionnaire. Odds ratio (OR), as an estimate of the relative risk for IM, was calculated by logistic regression analysis. Results: of 892 subjects enrolled histological evaluation is available for 672 subjects. 104 subjects had FH+ and 568 subjects had a FH-. The prevalence of IM was 32% (140/437) vs 17.4% (41/235), (p<0.0001), in HP+ and HP- subjects, respectively (OR= 2.2, 95% CI 1.5-3.3); the risk however appeared to be greater in HP+ FH+ (OR= 2.6, 95% CI 1.0-7.3) than HP+ FH- subjects (OR= 2.0, 95% CI 1.3-3.2). The prevalence of IM was 36.5% (38/104) vs. 25.2% (143/568) (p< 0.02)in FH+ and FHsubjects respectively(OR=1.7, 95% CI 1.1-2.6). The prevalence of IM was 42.1%(32/76) vs 29.9%(108/361), (p< 0.04), in HP+ FH+ and HP+FHsubjects respectively (OR= 1.7, 95% CI 1.0-2.8). Differently the prevalence of IM was similar in HP- FH+ 21.4% (6/28) and HP- FH- 16.9% (35/207) (p= ns) (OR= 1.3, 95% CI 0.5-3.5). Conclusions: The risk of developing IM associated with HP infection is increased in first-degree relatives of GC patients and a FH+ for GC is a risk factor of IM only in HP+ subjects. [ABSTRACT FROM AUTHOR]

Background: H. pylori infection is associated with peptic ulcer disease and gastric cancer and has also been implicated as a possible cause of extraintestinal disorders such as skin diseases. There are a few case reports on patients with skin diseases, such as prurigo nodularis that are associated with gastric cancer. Aims: The aim of this study was to examine the prevalence of H. pylori infection and the gastric cancer in patients with pruritic skin diseases. Methods: All patients were examined for circulating specific IgG antibodies against H. pylori in sera using ELISA. H. pylori-positive selected patients who were more than 50 years old underwent upper gastrointestinal endoscopy for confirmation of infection and screening of gastric cancer. Results: Seventy five patients with pruritic skin diseases were examined including 43 cases of pruritus cutaneous, 15 cases of nummular dermatitis, 17 cases of prurigo chronica multiforme. The prevalence of H. pylori infection was 70% in pruritus cutaneous, 73% in nummular dermatitis and 76% in pmrigo chronica multiforme. Early gastric cancer was detected in 3 of 30 patients with pruritus cutaneous, 1 of 11 with nummular dermatitis, 1 of 11 with pmrigo chronica multiforme. The prevalence of early gastric cancer was 9.6% which was much higher than the prevalence among patients having general endoscopic screening for gastric cancer. Two patients underwent endoscopic mucosal resection; the others had partial gastrectomy. Conclusions: These results suggest H. pylori -positive patients with pruritic skin diseases are a high risk group of gastric cancer and endoscopic screening is recommended. [ABSTRACT FROM AUTHOR]

Background and Aims: Upper gastrointestinal endoscopy (UGIE) and biopsies are needed for diagnosis of atrophic gastritis. Serum levels of Pepsinogen I (PGI) are used as a non-endoscopic test for atrophic corpus gastritis but non-endoscopic diagnosis of atrophic antrum gastritis has not been possible. The aim was to study whether the test panel composed of Elisa assays of Gastrin17 (sG17), PGI after a prandial protein stimulus and Hp antibodies (IgG) can be used as a tool for diagnosis of atrophic gastritis. Material and Methods: 104 subjects(M/F 56/48, mean age 55 yrs) was enrolled. A blood sample was collected for measurement of basal-G17, PGI and Hp IgG serum level; a second blood sample was collected 20 minutes after a prandial peptic stimulus evaluating sG17 serum level. Subjects were grouped according to five histological features, 1) Normal mucosa Hp- (N), 2) Non atrophic antrum gastritis Hp+ (S), 3) Atrophic gastritis of antrum Hp+ (A), 4) Atrophic gastritis of corpus Hp+/- (C), 5) Atrophic gastritis of antrum and corpus Hp+/- (AC). Results: sG17 serum level was higher in subjects with S (12,0 pmol/l) respect to subjects with A (1 pmol/l) (p<0,001) and with N (2,5 pmol/l)(p<0,001).PGI serum level was higher in subjects S and A (117,2µg/l and 119,7 µg/l) compared to subjects with atrophic corpus gastritis C (43,9µg/l)(p<0,001)and normal mucosa N (89,9 µg/l) (p<0,009).Combination of these three serological tests showed a sensitivity of 91% (32/35) and a specificity of 88%(61/69) in evaluating atrophic gastritis, overall accuracy of 87,5% (91/104) in identifying specific histological pattern using the test panel. Conclusions: Serum levels of sG17 and PGI combined with evaluation of Hp status by Hp IgG antibody represent a good non-invasive method to evaluate gastric atrophy and may use in a population screening program for gastric cancer to identify subjects at risk to be referred for upper-GI-endoscopy. [ABSTRACT FROM AUTHOR]

Background: Data on the prevalence of endoscopic lesions of the UGI tract in asymptomatic subjects are lacking. Aim: To evaluate the prevalence of endoscopic lesions of the UGI tract and their association with dyspeptic symptoms in the general population. Methods: In the frame of the ongoing Loiano-Monghidoro project (APT 2001;15:1001-7), inhabitants of the Loiano and Monghidoro commons are being re-invited to undergo UGI endoscopy and [sup 13]C-urea breath test. During UGI endoscopy gastric biopsies are obtained for histology and rapid urease test. Dyspeptic symptoms are evaluated by a previously validated questionnaire. Results: 892 subjects (442 males, 450 females, age range 18-86 years, mean age 54.4 years) were enrolled. The prevalence of endoscopic lesions of UGI tract was 16.7%: erosive esophagitis 8.2%, gastric ulcer 1.3%, duodenal ulcer 2%, concomitant esophagitis + gastric or duodenal ulcer 0.7%, erosive duodenitis 3.6%, gastric neoplasia 0.9%. Overall, 24.8% (37/149) of subjects with endoscopic lesions was asymptomatic. In particular, no symptoms were reported by 23.2% of subjects with esophagitis (20% with esophagitis of grade I and 31.4% of grade II), 33.3% of subjects with gastric ulcer, 33.3% with duodenal ulcer, 25% with erosive duodenitis and 25% with gastric neoplasia. H. pylori infection was present in 54.8%, 83.3%, 100%, 100%, 87.5%, and 100% of the subjects with esophagitis, gastric ulcer, duodenal ulcer, concomitant esophagitis + peptic ulcer, erosive duodenitis end gastric neoplasia, respectively. Conclusions: Endoscopic lesions of UGI tract are observed in 16% of this population and their association with H. pylori infection is as one would expect. Although not supporting the need of endoscopic screening of the general population, these results do support the need of defining high risk groups of asymptomatic subjects in whom endoscopic screening might prevent the development of advanced disease or severe complications. [ABSTRACT FROM AUTHOR]

Objective: Endoscopic submucosal dissection (ESD) aims to achieve en bloc resection of non-pedunculated colorectal adenomas which might be indicated in cases with superficial submucosal invasive cancers (SMIC), but the procedure is time consuming and complex. The prevalence of such cancers is not known but may determine the clinical necessity for ESD as opposed to the commonly used piecemeal mucosal resection (endoscopic mucosal resection) of colorectal adenomas. The main aim was to assess the prevalence of SMIC SM1 (ie, invasion ≤1000 µm or less than one-third of the submucosa) on colorectal lesions removed by ESD., Design: A literature review was conducted using electronic databases (up to March 2017) for colorectal ESD series reporting the histology of the dissected lesions., Results: 51 studies with data on 11 260 colorectal dissected lesions were included. Most resected lesions (82.2%; 95% CI 78.8% to 85.3%) were adenomas (low- and high-grade dysplasia, 26.8% and 55.4%, respectively). Overall, 15.7% were submucosal cancers, but only slightly more than half (8.0%; 95% CI 6.1% to 10.3%) had an infiltration depth of ≤1000 µm, providing a number needed to treat (NNT) to avoid one surgery of 12.5. Estimating an oncologically curative (R0; G1/2; L0/V0) resection rate of 75.3% (95% CI 52.2% to 89.4%) for malignant lesions, the prevalence of curative resection lowered to 6% (95% CI 4.2% to 7.2%) with an NNT of 16.7., Conclusion: The low prevalence of SMIC SM1 in lesions selected for ESD as well as the even lower rate of curative resection limits the clinical applicability of endoscopic en bloc resection. This calls for caution over an indiscriminate use of this technique in the resection of colorectal neoplasia., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: Gastro-oesophageal reflux symptoms are common in the community, but there has been no definitive systematic review and meta-analysis of data from all studies to estimate their global prevalence, or potential risk factors for them., Design: Medline, Embase and Embase Classic were searched (until September 2016) to identify population-based studies that reported the prevalence of gastro-oesophageal reflux symptoms in adults (≥15 years); gastro-oesophageal reflux was defined using symptom-based criteria or questionnaires. The prevalence was extracted for all studies, and according to the criteria used to define it. Pooled prevalence, according to study location and certain other characteristics, OR and 95% CIs were calculated., Results: Of the 14 132 citations evaluated, 102 reported the prevalence of gastro-oesophageal reflux symptoms in 108 separate study populations, containing 460 984 subjects. Prevalence varied according to country (from 2.5% in China to 51.2% in Greece) and criteria used to define gastro-oesophageal reflux symptoms. When only studies using a weekly frequency of heart burn or regurgitation to define presence were considered, pooled prevalence was 13.3% (95% CI 12.0% to 14.6%). Prevalence was higher in subjects ≥50 years (OR 1.32; 95% CI 1.12 to 1.54), smokers (OR 1.26; 95% CI 1.04 to 1.52), non-steroidal anti-inflammatory drug (NSAID)/aspirin users (OR 1.44; 95% CI 1.10 to 1.88) and obese individuals (OR 1.73; 95% CI 1.46 to 2.06)., Conclusions: The prevalence of gastro-oesophageal reflux symptoms varied strikingly among countries, even when similar definitions were used to define their presence. Prevalence was significantly higher in subjects ≥50 years, smokers, NSAID users and obese individuals, although these associations were modest., Competing Interests: Competing interests: None declared., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Objective: Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS., Design: We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time., Results: A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule., Conclusions: Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy., Trial Registration Number: ClincialTrials.gov number, NCT00626288., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)