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Background: Symptomatic uncomplicated diverticular disease (SUDD) is a recognized clinical condition characterized by abdominal pain and changes in bowel habits, attributed to diverticula but without macroscopic signs of diverticulitis. There is no consensus about the management of these patients. Enteroflegin ® , an association of natural active ingredients, could be effective in the treatment of those patients., Methods: We conducted a retrospective observational study to evaluate the performances of Enteroflegin ® in patients with SUDD. Patients were treated with Enteroflegin ® 2 cp/day for 10 days per month for 6 months. Primary endpoint was the clinical remission rate, defined as the absence of any symptoms; secondary endpoints were the impact of the treatment on reduction of symptoms, on fecal calprotectin (FC) expression, and the prevention of acute diverticulitis., Results: Three hundred and fifty patients were retrospectively enrolled (183 males, median age 64 years, IQR 54-70). Enteroflegin ® was effective in inducing remission in 9.34% and 17.64% of patients at 3 and 6 months respectively (P<0.001). Reduction of symptoms occurred in 92.3% and in 85.3% of patients at 3 and 6 months respectively (P<0.001), and symptoms' recurrence or worsening was recorded in only 1.71% of patients during the follow-up. FC expression dropped from 181.3 μg/g at baseline to 100.2 μg/g (P<0.001) and to 67.9 μg/g (P<0.001) at 3 and 6 months of follow-up respectively. No adverse event was recorded during the follow-up. Finally, acute diverticulitis occurred in just 2% of patients during the follow-up., Conclusions: Enteroflegin ® seems to be an effective nutraceutical compound in obtaining remission and symptom relief in SUDD patients. Further randomized, placebo-controlled clinical trials are needed to confirm these preliminary data.

Goals: The present survey from the Italian Society of Digestive Endoscopy (SIED-Società Italiana di Endoscopia Digestiva) was aimed at reporting infection control practice and outcomes at Digestive Endoscopy Units in a high-incidence area., Background: Lombardy was the Italian region with the highest coronavirus disease-2019 (COVID-19) prevalence, at the end of March 2020 accounting for 20% of all worldwide deaths. Joint Gastro-Intestinal societies released recommendations for Endoscopy Units to reduce the risk of the contagion. However, there are few data from high-prevalence areas on adherence to these recommendations and on their efficacy., Methods: A survey was designed by the Lombardy section of SIED to analyze (a) changes in activity and organization, (b) adherence to recommendations, (c) rate of health care professionals' (HCP) infection during the COVID-19 outbreak., Results: In total, 35/61 invited centers (57.4%) participated; most modified activities were according to recommendations and had filtering face piece 2/filtering face piece 3 and water-repellent gowns available, but few had negative-pressure rooms or provided telephonic follow-up; 15% of HCPs called in sick and 6% had confirmed COVID-19. There was a trend (P=0.07) toward different confirmed COVID-19 rates among endoscopists (7.9%), nurses (6.6%), intermediate-care technicians (3.4%), and administrative personnel (2.2%). There was no correlation between the rate of sick HCPs and COVID-19 incidence in the provinces and personal protective equipment availability and use, whereas an inverse correlation with hospital volume was found., Conclusions: Adherence to recommendations was rather good, though a minority were able to follow all recommendations. Confirmed COVID-19 seemed higher among endoscopists and nurses, suggesting that activities in the endoscopy rooms are at considerable viral spread risk., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Prospective studies about endoscopic retrograde cholangio-pancreatography (ERCP) in a community setting are rare., Aim: To assess success and complication rates of routinely-performed ERCP in a regional setting, and the priority quality indicators for ERCP practice., Methods: Prospective region wide observational study on consecutive patients undergoing ERCP during a 6-month period. A centralized online ERCP questionnaire was built and used for data storage. Primary quality indicators provided by the American Society of Gastrointestinal Endoscopy (ASGE) were considered., Results: 38 endoscopists from 18 centers performed a total of 2388 ERCP. The most common indication for ERCP was choledocholitiasis (54.8%) followed by malignant jaundice (22.6%). Cannulation of the desired duct was obtained in 2293 cases (96%) and ERCP was successful in 2176 cases (91.1%). Success and ERCP difficulty were significantly related to the experience of the operator (p = 0.001 and p < 0.001, respectively). ERCP difficulty was also significantly related to volume centers (p < 0.01). The overall complication rate was 8.4%: post-ERCP pancreatitis (PEP) occurred in 4.1% of procedures, bleeding in 2.9%, infection in 0.8%, perforation in 0.4%. Mortality rate was 0.4%. All the ASGE priority quality indicators for ERCP were confirmed., Conclusions: The procedural questionnaire proved to be an important tool to assess and verify the quality of routinely-performed ERCP performance in a community setting., (Copyright © 2019. Published by Elsevier Ltd.)

Background: Chronic constipation is a risk factor of inadequate bowel preparation for colonoscopy; however, no large clinical trials have been performed in this subgroup of patients., Aims: To compare bowel cleansing efficacy, tolerability and acceptability of 2-L polyethylene-glycol-citrate-simethicone (PEG-CS) plus 2-day bisacodyl (reinforced regimen) vs. 4-L PEG in patients with chronic constipation undergoing colonoscopy., Methods: Randomized, observer-blind, parallel group study. Adult outpatients undergoing colonoscopy were randomly allocated to 2-L PEG-CS/bisacodyl or 4-L PEG, taken as split regimens before colonoscopy. Quality of bowel preparation was assessed by the Ottawa Bowel Cleansing Scale (OBCS). The amount of foam/bubble interfering with colonic visualization was also measured., Results: 400 patients were enrolled. There was no significant difference in successful cleansing (OBCS score ≤6): 80.2% in the 2-L PEG-CS/bisacodyl vs. 81.4% in the 4-L PEG group. Significantly more patients taking 2L PEG-CS/bisacodyl showed no or minimal foam/bubbles in all colonic segments (80% vs. 63%; p<0.001). 2-L PEG-CS/bisacodyl was significantly more acceptable for ease of administration (p<0.001), willingness to repeat (p<0.001) and showed better compliance (p=0.002)., Conclusion: Split 2-L PEG-CS plus bisacodyl was not superior to split 4-L PEG for colonoscopy bowel cleansing in patients with chronic constipation; however, it performed better than the standard regimen in terms of colonic mucosa visualization, patient acceptance and compliance., (Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background and Aims: Subsite-specific incidence rates of colorectal cancer (CRC) and adenomas may vary considerably by race, sex and age as well as due to different screening strategies. We assessed variations in the anatomical distribution of adenomas according to age and sex in an average-risk screening cohort testing positive at immunological faecal occult blood test (i-FOBT) in northern Italy., Methods: Data from 2,281 consecutive asymptomatic i-FOBT-positive subjects ageing 50-70 years undergone colonoscopy were reviewed. Size, number, macroscopic and histological features of all adenomas found as well as their proximal or distal location in relation to the splenic flexure were examined. Odds ratios (OR) of proximal neoplasms, according to the presence of distal neoplasms and other selected covariates were assessed by multiple logistic regression analysis., Results: A total of 2,599 neoplasms were found in 1,396 patients. Of these, 116 (5 %) were colorectal cancers, diagnosed in 106 patients. Out of 2,483 adenomas found, 1,564 (63 %) were sessile, 795 (32 %) were peduncolated and 124 (5 %) were flat-type; 54 % of all adenomas were tubular, 36 % were tubulovillous or villous, and 10 % were serrated adenomas. The majority of neoplasms (66 %) were located in the distal colon. Tumour subsite distribution was consistent in both sexes, whereas significant proximal migration of neoplasms occurred in the older age cohort. Indeed, the rate of proximal neoplasms in patients aged ≥60 years was 37 % as compared with 29 % in those ageing 50-59 years. Male gender (OR 1.84), age of 60 years or older (OR 1.44), having a family history of colorectal neoplasms (OR 1.47) and presence of at least 1 distal advanced adenoma (OR 1.63) were all significant predictors of advanced proximal neoplasms., Conclusions: A left to right shift of colorectal adenomas with increasing age is evident in northern Italian asymptomatic i-FOBT-positive population. Advanced proximal neoplasms are not uncommon in subjects with or without distal adenomas, especially after 60 years of age. This should be carefully considered when implementing public screening strategies for CRC since the use of flexible sigmoidoscopy as a screening tool, particularly in older age groups, appears to be less effective.

Background and Aim: Recurrence of diverticulitis is frequent within 5 years from the uncomplicated first attack, and its prophylaxis is still unclear. We have undertaken a multicentre, randomised, double-blind, placebo-controlled pilot study in order to evaluate the role of mesalazine in preventing diverticulitis recurrence as well as its effects on symptoms associated to diverticular disease., Methods: Ninety-six patients with the recent first episode of uncomplicated diverticulitis were randomised to receive mesalazine 800 mg twice daily for 10 days every month or placebo for 24 months. The primary efficacy end point was the diverticulitis recurrence at intention to treat analysis. Clinical evaluations were performed using the Therapy Impact Questionnaire (TIQ) for physical condition and quality of life at admission and at 3-month intervals. Treatment tolerability and routine biochemistry parameters as well as the use of additional drugs were also evaluated., Results: Ninety-two patients (mean age, 61.5) completed the study, 45 of whom received mesalazine, and 47, placebo. Diverticulitis relapse incidence in mesalazine-treated group was 5/45 (11%) at the 12th month and 6/45 (13%) at the 24th month; in the placebo-treated group, the correspondent rates were 13% (6/47) and 28% (13/47), respectively. Mean values of TIQ at 24 months were significantly better in mesalazine-treated group than in placebo-treated group (p = 0.02); in addition, average additional drug consumption was significantly lower (-20.4%, p < 0.03) in mesalazine than in placebo., Conclusions: Diverticulitis recurrence occurred in as many as 28% of patients under placebo within 24 months from the initial episode. Intermittent prophylaxis with mesalazine did not significantly reduce the risk of relapse but induced a significant improvement of patients' physical conditions and significantly lowered the additional consumption of other gastrointestinal drugs.

Background: The results of a pilot colorectal cancer screening programme by biennial immunochemical faecal occult blood test (FOBT) are reported., Methods: All residents aged between 50 and 69 years in the Italian province of Lecco were invited to have a FOBT. Those with a positive result were offered colonoscopy. FOBT uptake and compliance with colonoscopy were assessed. Detection rate and positive predictive value (PPV) for cancer and adenoma were calculated. Tumour stages were compared between screen-detected cancers and other colorectal cancers diagnosed within the target age group., Results: Some 38,693 (49.6 per cent) of 78,083 individuals had a FOBT and 2392 (6.2 per cent) had a positive result. Colorectal cancer was diagnosed in 4.6 per cent and advanced adenoma in 32.7 per cent. PPVs were 4.0 per cent for cancer, 28.1 per cent for advanced adenoma and 36.6 per cent for any adenoma. There was a significant difference in incidence of stage III/IV disease between screened and non-screened cohorts. Compliance for colonoscopy was 92.0 per cent. Major determinants of compliance were age less than 59 years, female sex, high education level and non-manual work., Conclusion: These results justify extension of colorectal cancer screening to other regions of Italy., (2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.)

Unlabelled: The risk for gallstones (GD) in inflammatory bowel diseases and the factors responsible for this complication have not been well established. We studied the incidence of GD in a cohort of Crohn's disease (CD) and ulcerative colitis (UC) patients and investigated the related risk factors. A case-controlled study was carried out. The study population included 634 inflammatory bowel disease (IBD) patients (429 CD, 205 UC) and 634 age-matched, sex-matched, and body mass index (BMI)-matched controls free of GD at enrollment, who were followed for a mean of 7.2 years (range, 5-11 years). The incidence of GD was calculated by dividing the number of events per person-years of follow-up. Multivariate analysis was used to discriminate among the impact of different variables on the risk of developing GD. The incidence rates of GD were 14.35/1,000 persons/year in CD as compared with 7.75 in matched controls (P=0.012) and 7.48/1000 persons/year in UC patients as compared with 6.06 in matched-controls (P=0.38). Ileo-colonic CD location (OR, 2.14), disease duration>15 years (OR, 4.26), >3 clinical recurrences (OR, 8.07), ileal resection>30 cm (OR, 7.03), >3 hospitalizations (OR, 20.7), multiple TPN treatments (OR, 8.07), and long hospital stay (OR, 24.8) were significantly related to GD in CD patients., Conclusion: Only CD patients have a significantly higher risk of developing GD than well-matched hospital controls. Site of disease at diagnosis, lifetime surgery, extent of ileal resections, number of clinical recurrences, TPN, and the frequency and duration of hospitalizations are independently associated with GD.

Aim: To prospectively assess the impact of time of endoscopy and endoscopist's experience on the outcome of non-variceal acute upper gastrointestinal (GI) bleeding patients in a large teaching hospital., Methods: All patients admitted for non-variceal acute upper GI bleeding for over a 2-year period were potentially eligible for this study. They were managed by a team of seven endoscopists on 24-h call whose experience was categorized into two levels (high and low) according to the number of endoscopic hemostatic procedures undertaken before the study. Endoscopic treatment was standardized according to Forrest classification of lesions as well as the subsequent medical therapy. Time of endoscopy was subdivided into two time periods: routine (8 a.m.-5 p.m.) and on-call (5 p.m.-8 a.m.). For each category of experience and time periods rebleeding rate, transfusion requirement, need for surgery, length of hospital stay and mortality we compared. Multivariate analysis was used to discriminate the impact of different variables on the outcomes that were considered., Results: Study population consisted of 272 patients (mean age 67.3 years) with endoscopic stigmata of hemorrhage. The patients were equally distributed among the endoscopists, whereas only 19% of procedures were done out of working hours. Rockall score and Forrest classification at admission did not differ between time periods and degree of experience. Univariate analysis showed that higher endoscopist's experience was associated with significant reduction in rebleeding rate (14% vs 37%), transfusion requirements (1.8+/-0.6 vs 3.0+/-1.7 units) as well as surgery (4% vs 10%), but not associated with the length of hospital stay nor mortality. By contrast, outcomes did not significantly differ between the two time periods of endoscopy. On multivariate analysis, endoscopist's experience was independently associated with rebleeding rate and transfusion requirements. Odds ratios for low experienced endoscopist were 4.47 for rebleeding and 6.90 for need of transfusion after the endoscopy., Conclusion: Endoscopist's experience is an important independent prognostic factor for non-variceal acute upper GI bleeding. Urgent endoscopy should be undertaken preferentially by a skilled endoscopist as less expert staff tends to underestimate some risk lesions with a negative influence on hemostasis.

Background: Hepatitis C virus infection is more common in patients with inflammatory bowel disease than in general population. Limited data are available as to the safety and efficacy of alpha-interferon therapy for chronic active hepatitis C in patients with concomitant inflammatory bowel disease., Aim: To evaluate the efficacy and safety of alpha-interferon monotherapy in patients with chronic active hepatitis C and inactive or mildly active inflammatory bowel disease., Methods: A total of 513 consecutive inflammatory bowel disease patients at a single centre were tested for antibodies to hepatitis C virus (anti-hepatitis C virus) between 1995 and 2000. Twenty-one patients had detectable anti-hepatitis C virus Ab and were hepatitis C virus-RNA positive with histologically proved chronic active hepatitis. Each of these patients, whose inflammatory bowel disease was in clinical remission or mildly active, was sex- and age-matched to three controls with similar histological grade and stage of chronic hepatitis C virus but without inflammatory bowel disease; and all were treated with human leucocyte alpha-interferon 6 million units given thrice weekly for 12 months. Responses to treatment were classified as follows: complete response--persistently normal alanine aminotransferase and viral clearance (hepatitis C virus-RNA-ve) at the end-of-treatment, incomplete response--alanine aminotransferase normalization without viral clearance (hepatitis C virus-RNA+ve), and sustained response--alanine aminotransferase normalization and hepatitis C virus clearance 12 months after the end-of-treatment., Results: Twenty-one patients with chronic active hepatitis C and inflammatory bowel disease (10 with Crohn's disease and 11 with ulcerative colitis) and 63 sex- and age-matched controls with chronic hepatitis C virus alone received alpha-interferon monotherapy. Response rates to interferon were similar for inflammatory bowel disease patients compared with controls [CR 42% vs. 35% and SR 24% vs. 18% (P, not significant), respectively]. None of the 21 inflammatory bowel disease patients had severe adverse effects and the mild ones observed were comparable with those seen in the control group. No patients developed an inflammatory bowel disease relapse during the interferon treatment period or in the 12 months thereafter., Conclusions: The biochemical and virological response to a 12-month human leucocyte alpha-interferon treatment in patients with chronic active hepatitis C are similar to that observed in matched controls with chronic hepatitis C virus without inflammatory bowel disease. Adverse effects are similar in both groups of patients and unrelated to the underlying inflammatory bowel condition. This provides hepatologists with evidence that alpha-interferon can be safely administered to patients with chronic hepatitis C virus and inflammatory bowel disease provided that the inflammatory bowel condition is in clinical remission.

Hepato-biliary ascariasis is a rare condition in non-endemic areas; however, it should always be taken into account in patients with recurrent biliary colics and/or cholangitis, since these are among the most frequent modes of clinical presentation. We report a case of a young woman suffering from recurrent biliary colics in whom a diagnosis of biliary ascariasis was made. Endoscopic retrograde cholangiopancreatography with sphincterotomy and endoscopic extraction of the worm, using a Dormia basket, proved to be a safe and effective procedure for removing the living Ascaris from the biliary tree and relieving symptoms. In the era of worldwide travels, physicians in Western countries should be more aware of this infection especially in patients with biliary symptoms who have travelled to endemic areas or immigrant from endemic countries.

Background: Acid-suppressive medications are commonly used in hospitalized patients, but, to date, little is known about the overall use of these drugs in the hospital setting., Aim: To evaluate the appropriateness of acid-suppressive therapy in a large teaching hospital in northern Italy, and the fall-out of hospital prescription in general practice., Methods: The use of antisecretory agents was monitored for 1 month in adult patients consecutively admitted to L. Sacco University Hospital by reviewing their clinical charts. The appropriateness of each prescription was reviewed jointly by two consultant gastroenterologists., Results: A total of 46.8% of 799 hospitalized patients received acid-suppressive therapy. Ranitidine was the most frequently used drug (44.4%), followed by pantoprazole (31.8%) and omeprazole (23.0%). Stress ulcer prophylaxis and the prevention of non-steroidal anti-inflammatory drug-induced ulcer accounted for 60.4% of the indications for use. Overall, 68% of prescriptions were not appropriate as determined by consensus review; 56.4% of patients receiving unnecessary prophylactic treatment whilst in hospital were discharged on therapy, and 46% were still receiving the treatment 3 months later., Conclusions: Acid-suppressive agents are over-used in hospitalized patients. Most of the inappropriate hospital prescriptions are for ulcer prophylaxis in low-risk patients. This unnecessary use may also induce inappropriate drug consumption in general practice.

Goals: Inflammatory bowel diseases (IBDs) are associated with pathologic findings in the liver and biliary tract. Ultrasonography (US) represents a noninvasive means to study hepatobiliary abnormalities. This study evaluated the prevalence of US hepatobiliary changes and their relationship to clinical variables in a large IBD patient population followed in a single center., Study: Five hundred eighty-three consecutive IBD patients were studied with US. After excluding patients with preexisting acute or chronic hepatitis, metabolic disorders, or obesity, 511 patients were investigated for age, duration, site, and severity of the disease, history of surgery, and present medical treatment. At US, liver size, echogenicity (graded as mild-to-moderate or severe indicating a corresponding degree of hepatic steatosis), focal lesions of the liver and gallbladder, and biliary tract abnormalities were recorded., Results: Three hundred eleven patients with Crohn disease (CD) and 200 patients with ulcerative colitis (UC) were recruited for the study. Hepatobiliary abnormalities were found at US in 54.2% and 55.9% of CD and UC patients, respectively. Liver enlargement and mild-to-moderate to severe liver steatosis were found in 25.7% and 39.5% of CD patients and in 25.5% and 35.5% of UC patients, respectively, a higher prevalence than among healthy controls (P < 0.001). The prevalence of gallstones among CD patients was 11%, higher than that among UC patients (7.5%) and controls (5.5%) (P = 0.016). The higher risk of gallbladder stones in CD was related to age, female sex, and previous surgery., Conclusion: The prevalence of liver enlargement and liver steatosis was higher among IBD patients. The prevalence of gallstones was increased in CD patients only. This risk was related to age, female sex, and previous surgery.

Background: A regional initiative, called the 'three-day rule', has recently been introduced in Italy to facilitate the earlier diagnosis of malignancy. It requires patients with suspected severe diseases to have a diagnostic procedure performed within three working days of referral by a general practitioner., Aim: To assess prospectively the effectiveness and compliance with the three-day rule for upper digestive malignancies., Methods: We compared patients referred for gastroscopy under the three-day rule initiative with contemporaneous open access referrals over a 12-month period at a single large teaching hospital in west Milan. We compared the prevalence of malignancies and other serious non-neoplastic diseases as well as the waiting times in the two groups. The appropriateness of the indications for each referral was also reviewed by a gastroenterologist blind to the outcome of the test., Results: One hundred and forty-two patients referred for gastroscopy under the three-day rule scheme and 767 routine referrals were studied. Significantly more oesophageal/gastric cancers (6% vs. 1%) and serious benign gastrointestinal lesions (grade II-III oesophagitis or peptic ulcer) were diagnosed in three-day rule patients in comparison with routine referrals (P < 0.05). The rate of inappropriate referral was significantly lower in the three-day rule group than in the open access group (39% vs. 22%) (P < 0.01). The estimated cost of the three-day rule scheme (in extra list examinations alone) was 10 780 euros, with about 1198 euros per diagnosis of cancer, but only 229.5 euros per 'useful' diagnosis (including peptic ulcer disease and oesophagitis)., Conclusions: Significantly more upper gastrointestinal cancers and serious benign diseases can be found within a short period to comply with the three-day rule scheme. However, some general practitioners appear to over-interpret alarm symptoms, leading to some inappropriate referrals. Better awareness of appropriate urgent referral criteria is needed in order to ensure that the best use is made of the resources available.

Aim: To determine the prevalence of heterotopic gastric mucosa in the upper oesophagus (inlet patch) and the factors that may influence its finding. To study its macroscopic and microscopic characteristics and its relationship with symptoms and oesophago-gastroduodenal diseases., Patients and Methods: The study was carried out in two different prospective series of consecutive patients undergoing oesophagogastroduodenoscopy. The first 791 patients were examined by one medical practitioner who was aware of the existence of inlet patch entity and aimed to evaluate the prevalence of inlet patch. The second series of 687 patients was examined by another investigator who was aware of the existence of inlet patch entity and who was requested to refer all patients with inlet patch, but he was unaware of the existence of a study aimed at evaluating the prevalence of inlet patch. The heterotopic gastric mucosal patches identified in the upper oesophagus were photographed, biopsied and analysed according to the Sydney system score., Results: The presence of an inlet patch was found in 0.29% (operator unaware) and 2.27% (operator aware) of prospectively evaluated patients. Inlet patches appeared as single areas in 12 patients, as twin areas in five, and as multiple areas in one patient. Their diameters ranged approximately from 3 to 25 mm. The average age of the patients (13 men) was 52.5 +/- 16.8 years. Five patients had an active or healed peptic ulcer and only one patient had reflux oesophagitis. Dysphagia or throat discomfort/heartburn represented the symptoms leading to upper endoscopy in only one patient. Six of seven patients with Helicobacter pylori infection in the stomach also presented the infection in the heterotopic gastric mucosa., Conclusion: Heterotopic gastric mucosa in the upper oesophagus is not a rare condition. The frequency with which this condition is found during routine endoscopic examination is likely due to the reduced awareness of the examiner. The presence of inlet patches is scarcely correlated with specific symptoms and the patches are often infected by H. pylori, in patients with H. pylori positive gastritis.

Background/aims: Reduction of gastric acid secretion by maintenance treatment with antisecretory agents and eradication of H. pylori by antibiotics constitute the most effective therapeutic options in preventing duodenal ulcer relapse. The aim of this study was to compare the effect of a 12-month low-dose lansoprazole maintenance treatment with H. pylori eradication on the rate of ulcer relapse in H. pylori-positive duodenal ulcer patients., Methodology: After a healing phase with lansoprazole 30 mg/die or lansoprazole 30-60 mg/die plus antibiotics (amoxycillin, tinidazole and colloidal bismuth subcitrate), 84 patients with healed duodenal ulcer entered the follow-up phase. Thirty-eight patients with persistent H. pylori infection received lansoprazole 15 mg at bedtime, whereas 46 in whom H. pylori was eradicated during the acute phase received no active therapy during the 12-month follow-up. The two groups were well balanced concerning all demographic characteristics. Clinical controls were performed every 3 months or sooner in the event of symptomatic relapse., Results: In terms of per protocol analysis, the overall rate of ulcer relapse at 6 months was 5.5% (2/36) in the maintenance group and 0 (0/42) in the antibiotic group. The corresponding figures at 12 months were 20.5% (7/34) and 5.7% (2/35), respectively (p:ns, 95% CI for the difference -0.30+0.02). On intent to treat analysis, the rate of ulcer relapse at 6 months was 5.2% (2/38) in the first group and 0% (0/46) in the second group: at 12 months the corresponding figures were 19.4% (7/36) and 4.3% (2/46), respectively (p=0.06; CI 95%: +0.016+0.28). No significant side effects were observed during long-term maintenance with lansoprazole., Conclusions: Continuous maintenance with low-dose lansoprazole may constitute a valuable alternative to H. pylori eradication for the prevention of relapse and complications in duodenal ulcer patients not suitable for, or who have failed, H. pylori eradication.

Objective: The evolution of gastritis and the behavior of basal and meal-stimulated gastrin release, pepsinogen levels, and gastric emptying of solids were studied in a series of consecutive patients with Helicobacter pylori-positive, uncomplicated, non-NSAID-related type I gastric ulcer over a follow-up period of 3 months after eradication therapy was begun., Methods: Before starting treatment (consisting of omeprazole 40 mg a day for 1 month and amoxycillin 1 g three times daily for 14 days), and for 3 months after ulcer healing, 16 patients had a series of functional examinations, including basal and meal-stimulated serum gastrin concentration, serum pepsinogen I levels, evaluation of gastric emptying of solids by means of serial ultrasonographic measurement of the gastric antrum area, and histological assessment of antral and corpus gastritis., Results: Double therapy resulted in the successful eradication of H. pylori in eight of 16 evaluable patients. In the group of H. pylori-eradicated patients, the mean scores of gastritis activity and inflammation in the antrum and corpus had fallen, 3 months after eradication. No significant changes in mean gastritis scores were observed in the case and control group with regard to intestinal metaplasia and atrophy in the antrum and corpus. In H. pylori-eradicated patients, the integrated gastrin response to meal, but not fasting gastrin concentration, fell significantly during follow-up, and serum pepsinogen I levels significantly decreased, compared with baseline. In contrast, the fasting and maximal antral area and the gastric emptying of solids remained unchanged over time. In the control group (but not the H. pylori-eradicated group), no significant modifications of any of the above-mentioned parameters were observed during follow-up., Conclusion: Our findings suggest that in non-NSAID-related type I gastric ulcers, the eradication of H. pylori significantly reduces gastritis activity and inflammatory scores, but not atrophy and intestinal metaplasia, and modifies gastrin and pepsinogen I release in a short follow-up period. In contrast, H.pylori eradication does not significantly affect gastric emptying of solids, at least within a period of 3 months from therapy.

Background: Helicobacter pylori infection is associated with idiopathic gastric ulcer in about 90% of the cases, but only a few controlled studies aimed at evaluating gastric ulcer healing and the natural history after Helicobacter pylori-eradication have been carried out., Objective: The aim of the present study was to evaluate the efficacy of omeprazole coupled with amoxicillin in the eradication of Helicobacter pylori and healing and prevention of gastric ulcer recurrence., Patients: Fifty-nine patients with active gastric ulcer were randomized under double-blind conditions to receive either omeprazole 20 mg twice daily for four weeks plus amoxicillin 3 g daily during the first and second week (29 patients, Group A) or omeprazole .20 mg twice daily for 4 weeks plus placebo for two weeks (30 patients, Group B)., Methods: Endoscopic studies were carried out at the end of the 4 weeks treatment (or after 8 weeks in non-healed patients) as well as 2, 6 and 12 months later. A total of 3 biopsies in the antrum, 3 in the gastric body and at least seven at the edge of the crater were taken at each endoscopic control for exclusion, of malignancy, histological detection of Helicobacter pylori and for evaluation of gastric histology according to the Sydney system., Results: With intention to treat analysis, the percentage of healing after 4 and 8 weeks was 86% and 100% in Group A patients and 86% and 93% in Group B, respectively. Two patients dropped out in Group B for non medical reasons. The percentage of eradication was 63% in Group A and 7% in Group B. During a 12-month follow-up gastric ulcer relapsed in 20/32 (63%) of the persistently Helicobacter pylori positive patients. Only two out 20 (10%) Helicobacter pylori cured patients showed a gastric ulcer relapse and Helicobacter pylori reinfection. Twenty out of 30 patients, still healed after 12 months, underwent endoscopic control after two years. A gastric ulcer relapse was observed in three out of nine (33%) patients with persisting infection after treatment. No gastric lesions, but one case of erosive oesophagitis were observed in the 11 Helicobacter pylori-eradicated patients., Conclusions: In our experience, Helicobacter pylori eradication does not favour gastric ulcer healing but does positively influence the subsequent natural history.

Objective: The aim of this study was to verify the efficacy--in the cure of duodenal ulcer associated H. pylori infection--of ranitidine 300 mg taken late in the evening or lansoprazole 30 mg taken before breakfast, coupled with clarithromycin and metronidazole., Methods: Eighty patients with endoscopically proven active duodenal ulcer were randomized to take ranitidine or lansoprazole for 4-8 wk, together with clarithromycin 250 mg b.i.d. and metronidazole 500 mg b.id. for the first 2 wk. Endoscopic controls, as well as histological and urease tests for H. pylori, were performed at entry and after 4 and 8 wk., Results: According to intent-to-treat analysis, ulcers were healed after 4 wk in 36/40 patients (90%) with ranitidine and in 38/40 (95%) with lansoprazole. After 8 wk, the healing percentage with ranitidine and lansoprazole was 97% (39/40) and 95% (38/40), respectively. H. pylori was eradicated in 85% of the patients taking ranitidine and in 90% of those taking lanzoprazole. Side effects were reported in 25% of the patients in both groups., Conclusions: Our results confirm that the combination of ranitidine, clarithromycin, and metronidazole can be considered an alternative to proton pump inhibitors in terms of clinical efficacy and economy.

The aim of this study was to assess the effect of colloidal bismuth subcitrate (CBS) and metronidazole on Helicobacter pylori eradication and on the course of symptoms due to functional dyspepsia. Forty-one patients with functional dyspepsia were entered into the study and randomized to treatment with CBS (120 mg four times a day) for four weeks combined with metronidazole (250 mg four times a day) for one week (group A, N = 21) or matching placebo (group B, N = 20). The severity of gastritis and of bacterial colonization and the symptom score was assessed by endoscopy and clinical evaluation at baseline and after four, eight, and 24 weeks from the start of the treatment. With intent-to-treat analysis eradication was achieved in 16/25 (64%) patients in group A and in 6/24 (25%) in group B. At eight and 24 weeks the gastritis score was significantly lower only in those patients with eradication. No change was seen in patients in whom the bacteria was not eradicated. The symptom score at eight weeks was considerably lower both in patients with eradication and in those with infection. However, at 24 weeks a gradual decrease in the symptom score in patients with eradication and a worsening of symptoms in controls was observed. No differences were observed between patients with ulcerlike and those with dysmotility-like dyspepsia. The study confirms the need for a long observation period after antibacterial treatment in patients with functional dyspepsia and suggests that Helicobacter pylori-eradicating treatment improves the course of this functional syndrome.

Aim: To compare the eradicating capacity of two different antibiotic-lansoprazole combinations (amoxycillin vs. standard triple therapy) with that of lansoprazole alone in Helicobacter pylori-positive duodenal ulcer patients., Methods: Ninety-six out-patients with H. pylori-positive duodenal ulcer were randomly assigned to receive one of the following three antiulcer regimens: (1) lansoprazole 30 mg b.d. for 4 weeks plus amoxycillin 1 g t.d.s. during the last 2 weeks; or (2) lansoprazole 30 mg once daily for 4 weeks plus classical triple therapy (tripotassium dicitratobismuthate 240 mg b.d., amoxycillin 1 g t.d.s. and tinidazole 500 mg b.d.) for the last 2 weeks; or (3) lansoprazole 30 mg once daily for 4 weeks. Endoscopy was repeated at the end of treatment and 1 month later. A rapid urease test and histology were used to determine H. pylori status., Results: Duodenal ulcer healing rates at 4 weeks were 96% after both lansoprazole with amoxycillin, and lansoprazole with triple therapy, and 97% after lansoprazole alone. Eradication of H. pylori was significantly better with lansoprazole with triple therapy than with either lansoprazole with amoxycillin or lansoprazole alone (90% vs. 55% vs. 3%, respectively)., Conclusion: Classical triple therapy combined with lansoprazole is significantly more effective than the lansoprazole with amoxycillin combination for the eradication of H. pylori in duodenal ulcer patients pre-treated with lansoprazole.

Aim: To assess the usefulness of early evening administration of roxatidine 150 mg as an alternative to the traditional bedtime regimen., Methods: Twenty-four patients with healed duodenal ulcer were dosed according to a balanced incomplete-block design, with two of the following regimens: placebo, roxatidine 150 mg at 07.30 h (early evening) or roxatidine 150 mg at 22.00 h (bedtime). Twenty-four-hour intragastric pH-metry was started at 18.00 h on the first day of dosing. Median pH was determined for the 24-h period, and for the following time intervals: 20.00-00.00 h, 00.00-08.00 h and 08.00-18.00 h. Percentage time in the 24-h period with pH greater than 4.0 was also calculated., Results: The two roxatidine regimens proved significantly superior to the placebo, decreasing 24-h acidity for all the time intervals, except the 20.00-00.00 h period, when mean intragastric pH with the early evening regimen (4.5 +/- 1.1) proved significantly higher than after placebo (2.2 +/- 1.0) or when roxatidine was taken at bedtime (2.4 +/- 1.1)., Conclusion: Early evening administration of roxatidine may afford satisfactory control of 24-h acidity, offering a useful alternative to conventional bedtime administration.

Background: Numerous therapeutic trials aimed at eradicating Helicobacter pylori (HP) from the gastric mucosa and preventing ulcer recurrence have been carried out; however, an optimal treatment has not yet been established with carefully controlled randomized studies., Objective: The aim of our study was to evaluate the efficacy of an association of omeprazole (OM) coupled with two antibiotics in the eradication of HP and prevention of duodenal ulcer (DU) recurrence., Methods: One hundred and eighty three patients with active DU were randomized under double-blind conditions to receive either OM 20 mg for 4 wk plus amoxycillin 3 g daily and metronidazole 1 g daily during the 2nd and 3rd wk (91 patients, group A) or OM 20 mg for 4 wk plus matching placebo (92 patients, group B). Endoscopy was performed before and at the end of the 4-wk treatment as well as 2, 6, and 12 months later. Biopsies were taken from the duodenum, antrum, and gastric body at each endoscopic examination for HP histological detection and for evaluation of inflammatory changes according to the Sydney system., Results: After 4 wk, 84/86 patients (98%) of group A and 80/86 (93%) of group B were healed of their ulcers. The percentage of eradication was 90% in group A and 1% in group B. During a 12-month follow-up, DU relapsed in 4/63 (6%, including two of three reinfected cases) HP-eradicated group A patients, 4/8 (50%) HP-noneradicated group A patients, and 52/65 (80%) persistently HP-positive group B patients. Rapid, complete, and persistent suppression of gastroduodenitis activity and gastric surface epithelium lesions was observed in most HP-eradicated group A patients, whereas a transient decrease of bacterial colonization and inflammatory scores in the antrum and a transient worsening of corpus gastritis were found in group B patients., Conclusions: The combined therapy with amoxycillin, metronidazole, and omeprazole is highly effective in both HP eradication and prevention of duodenal ulcer recurrence.

Objective: To establish the efficacy of omeprazole combined with two antibiotics for Helicobacter pylori eradication and duodenal ulcer relapse., Patients: Thirty-seven patients with endoscopically proven duodenal ulcer and H. pylori infection., Methods: Treatment consisted of 20 mg omeprazole daily for 4 weeks with the addition, during the second and third weeks, of amoxycillin (1 g three times daily) and metronidazole (1 g daily) (group A) or placebo (group B). Endoscopy and biopsy to assess ulcer recurrence and H. pylori status were performed at entry to the study, after 4 weeks of therapy, and 1 and 6 months after treatment., Results: Duodenal ulcers healed in all patients. H. pylori infection was eradicated in 15 (79%) out of 19 patients in group A and one (6%) out of 16 patients in group B (P < 0.01). One patient in each of the groups was lost to follow-up after 6 weeks. During the 6 month follow-up period, duodenal ulcers recurred in three of the 16 patients with H. pylori eradication, compared with 16 of the 19 patients with persistent H. pylori infection (19 versus 84%; P < 0.01)., Conclusion: The combination of omeprazole with amoxycillin and metronidazole is effective in H. pylori eradication. This triple therapy, which eradicates H. pylori, also significantly reduced duodenal ulcer relapse.

The present study was designed to determine the effects of an antacid suspension containing magnesium hydroxide and aluminum hydroxide (30 ml of Maalox) on the oral bioavailability of rufloxacin (400 mg). Rufloxacin was administered orally to 12 healthy volunteers according to a randomized, balanced, crossover design. Three treatments were administered to each subject, with a 10-day washout period between treatments; the treatments included rufloxacin alone, rufloxacin taken 5 min after antacid, and rufloxacin taken 4 h before antacid. Administration of antacid within 5 min before the administration of rufloxacin resulted in a substantial decrease in rufloxacin absorption, with a mean percent relative bioavailability compared with control values of 64% (range, 42 to 77%). Administration of antacid 4 h after the administration of rufloxacin slightly affected the absorption of the quinolone (mean relative bioavailability, 87%; range, 51 to 110%). Antacids that contain magnesium and aluminum salts reduce the absorption of rufloxacin. The extent of this interaction depends on the time that elapses between administration of the two drugs.

The possibility to detect the antibody to hepatitis C virus (HCV) has allowed to estimate the prevalence of this virus in patients with hepatic disease, mostly in those with hepatitis considered non-A non-B. Literature shows that HCV causes about 75% of cases of cryptogenic hepatitis and more than the 90% of post-transfusional hepatitis. Circumstantial evidence suggests the existence of a relationship between parenterally-transmitted non-A non-B hepatitis (PTH) and primary liver cancer (PLC). With the advent of anti-HCV, it is now possible to assess directly whether or not there is a relationship between PTH and PLC. So anti-HCV was looked for in the sera of 365 patients with cirrhosis prospectively followed-up for early detection the development of PLC, using an enzymatic immunoassay (ELISA Ortho DS). At baseline anti-HCV was detected in 221 patients (60%). During 5-39 month 53 patients developed PLC and anti-HCV was detected in 68% of them. The univariate analysis demonstrated that alcohol abuse, anti-HBs and anti-HBc were the only covariates that were significantly associated with an increase risk of developing PLC. When these factors were introduced in the step wise regression analysis, age and alcohol were found to be the only independent risk factors. The high prevalence of anti-HCV found in patients with cirrhosis and PLC suggests that HCV might play a role in this tumor; the frequent co-occurrence of HCV and HBV markers suggests that HCV-HBV coinfection might be pathogenically important; alcohol was the most important non-viral risk factor for PLC.