Helicobacter pylori eradication using one-week low-dose lansoprazole plus amoxycillin and azithromycin: failure of a "promising" association.
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Publications and source records attributed to A Pera.
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BACKGROUND: Mesalazine enemas are of well proven efficacy for the topical treatment of distal ulcerative colitis. Although new rectal formulations of mesalazine are not expected to be superior in efficacy and tolerability to standard formulations, they may offer secondary advantages in terms of overall acceptability. AIM: To compare the efficacy, tolerability and overall acceptability of a new mesalazine rectal foam (Salofalk foam) with mesalazine enema in the treatment of active distal ulcerative colitis. PATIENTS AND METHODS: A multicentre study was carried out in patients with active proctitis, proctosigmoiditis and left-sided ulcerative colitis as evaluated by the Clinical Activity Index (CAI > or =4) and Endoscopic Index (EI > or =6). Patients were randomly assigned to receive, in open-label fashion, either mesalazine foam 2 g twice a day or mesalazine enema (2 g/60 ml twice a day) for 3 weeks. Patients who did not achieve remission (defined as CAI <4 and EI <6) after 3 weeks continued the study receiving the alternative galenic formulation for a further 3 weeks. RESULTS: A total of 195 patients were enrolled. Characteristics at baseline were similar except for concomitant therapy with oral 5-ASA products: during the 1st treatment phase, 41% of patients on enema received such treatment vs only 29% of those on foam. Patients with at least one post-treatment efficacy evaluation were included in the intent-to-treat analysis (n=89 foam, n=96 enema). After 3 weeks of treatment, 112 patients were in remission and only 59 patients entered the 2nd treatment phase thus providing data on acceptability. Remission was achieved after 3 weeks in 54% of patients treated with foam and in 67% of those treated with enema. The 90% confidence interval for the difference in remission rates was 0 to 24 and thus within the clinically acceptable range of therapeutic equivalence. At the end of the 2nd phase, 70% of patients switched to foam were in remission vs 65% to the enema. Two patients discontinued treatment with foam prematurely due to anal burning. No clinically important changes were seen in the laboratory tests. CONCLUSIONS: Salofalk foam and enema are equally effective for the treatment of proctitis, proctosigmoiditis and left-sided ulcerative colitis. The new foam preparation is as well tolerated and accepted as enemas and can be used as a therapeutic alternative to conventional mesalazine enema formulations.
OBJECTIVES: A multicenter double-blind placebo-controlled clinical study was conducted to evaluate the efficacy and tolerability of two different therapeutic schedules of mesalazine suppositories in patients with ulcerative proctitis. METHODS: From 1990 to 1993, 111 patients with ulcerative proctisis in remission, limited to the rectum (< or = 15 cm from anus), were enrolled. After obtaining informed consent, patients were randomized to three treatment groups: 500 mg mesalazine b.i.d. (36 patients), 500 mg mesalazine u.i.d. (40 patients), and placebo (35 patients). The treatment lasted 1 yr. Follow-up consisted of periodic clinical, endoscopic, and histological assessments. An endoscopic score > 1 according to the Baron scale defined relapse occurrence. The three groups were homogeneous as regards main demographic, diagnostic, and prognostic features. RESULTS: The cumulative relapse rates at 12 months were 10% (95% confidence interval [CI]: 0-21) in the mesalazine b.i.d. group, 32% (95% CI: 16-49) in the mesalazine u.i.d. group, and 47% (95% CI: 29-65) in the placebo group. The comparison between the mesalazine b.i.d. group and the mesalazine u.i.d. group cumulative relapse rates gave a p value of 0.0334, whereas the corresponding comparison between the mesalazine b.i.d. group and the placebo group gave a p value of 0.007 (log-rank test). The dose-response relationship was statistically significant (p = 0.008 by Cox analysis). Two patients in the mesalazine b.i.d. group, two patients in the mesalazine u.i.d. group, and one patient in the placebo group withdrew from the study due to nonserious adverse events; four, three, and four patients per group, respectively, dropped out because of poor compliance. Two patients in the mesalazine u.i.d. group and two in the placebo group were lost to follow-up. CONCLUSIONS: The results of this study confirm the therapeutic efficacy of mesalazine suppositories in the maintenance treatment of ulcerative proctitis. According to our experience the most effective therapeutic schedule is 500 mg mesalazine b.i.d.
BACKGROUND: Chronic diarrhoea is the clinical hallmark of patients presenting with idiopathic bile acid malabsorption. Its pathogenesis is unknown; colonic water secretion can be induced by dihydroxy bile acids, but it is not known whether enrichment of the bile acid pool with these bile acids occurs in such patients. Furthermore, bile acid malabsorption is known to affect biliary lipid composition, but no information is available for the idiopathic type. AIMS: To verify: (a) whether diarrhoea in patients with idiopathic bile acid malabsorption is associated with enrichment of the bile acid pool with dihydroxy bile acids; and (b) whether supersaturation with cholesterol of duodenal bile occurs in such patients as a result of chronic bile acid depletion. PATIENTS: Thirteen patients with idiopathic bile acid malabsorption diagnosed according to abnormal 75SeHCAT test and absence of other organic diseases, and 23 control subjects. METHODS: Bile rich duodenal fluid was collected during intravenous ceruletide infusion in the fasting state. Biliary lipids were analysed by enzymatic assays and bile acids by high performance liquid chromatography. RESULTS: Patients with idiopathic bile acid malabsorption had a cholesterol saturation index similar to controls. Bile acid composition showed only a decrease in percentage cholic acid (29 (2)% versus 36 (2)%; p<0.05); the dihydroxy:trihydroxy bile acid ratio was similar to controls. CONCLUSIONS: Patients with idiopathic bile acid malabsorption do not have an increased risk of forming cholesterol gallstones. The mechanism of diarrhoea does not seem to depend on an enrichment of the bile acid pool with dihydroxy bile acids.
BACKGROUND AND AIMS: To investigate the effects and tolerance of amantadine in chronic hepatitis C patients. PATIENTS AND METHODS: Forty consecutive patients, with biopsy proven chronic active hepatitis, were treated with amantadine 200 mg daily in the morning for two months. Nineteen patients were previous non responders to alpha-interferon, nine patients experienced hepatitis relapse after interferon treatment, and twelve patients had never been treated with antiviral drugs. Complete blood count, liver and renal function tests were performed two months before, at baseline, end of therapy and two months after its completion. RESULTS: None of the patients experienced significant side effects. Twenty-four patients (60%) showed a reduction of serum aminotransferase levels (twelve patients > 30% and twelve patients < 30% of their basal levels). The analysis of variance showed a significant reduction in aminotransferase levels at the end of treatment (F = 11, p < 0.0001). In four patients, aminotransferases returned to normal, but none of them cleared HCV-RNA. After the end of treatment, serum ALT returned to baseline values in all patients. CONCLUSIONS: Amantadine is well tolerated in chronic hepatitis C patients. The time-relation between therapy and reduction of serum aminotransferase levels in 60% of patients suggests a potential anti-inflammatory activity of the drug without an effect on viraemia.
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AIM: The purpose of our study was to examine measles IgM immunoreactivity in patients with inflammatory bowel disease. PATIENTS AND METHODS: In an International collaborative study, serum measles IgM immunoreactivity was assayed in consecutive outpatients with Crohn's disease (n = 95), ulcerative colitis (n = 79), viral hepatitis (n = 63) and blood donors (n = 30). Two commercial measles assays--enzyme linked immunosorbent assay and indirect fluorescence assay--and a Public Health Laboratory Service (PHLS) "in house" antibody capture radioimmunoassay were used. Results were compared with serum rubella and Epstein-Barr virus-specific IgM immunoreactivity, total serum IgM, and measles IgG immunoreactivity. Twenty patients with inflammatory bowel disease were studied serially over a 4-month period. RESULTS: By enzyme linked immunosorbent assay, the prevalence of raised serum measles IgM immunoreactivity was significantly greater in patients with Crohn's disease 23/95 (24%) and ulcerative colitis 20/79 (27%) compared with hepatitis patients 2/63 (3%) and normal controls 0/30 (0%) (p < 0.001). Indirect fluorescence assay produced significantly more positive results than enzyme linked immunosorbent assay in both Crohn's disease (50/87; 57%) and ulcerative colitis (35/68; 51%) but not in controls (0%) (p < 0.001). In contrast, no sera were positive using MCRIA. In the enzyme linked immunosorbent assay, measles IgM immunoreactivity did not correlate with either total IgM, rubella or Epstein-Barr virus IgM immunoreactivities-which were not raised-measles IgM immunoreactivity, or disease activity. Patients not receiving steroids were more likely to have raised measles IgM immunoreactivity (p < 0.5). All sera tested for Rheumatoid factor were negative. Of 20 patients with inflammatory bowel disease studied by ELISA over a 4-month period, 50% showed raised measles IgM immunoreactivity at some stage. CONCLUSION: The data suggest a specific and fluctuating immune response to measles virus in patients with Crohn's disease and ulcerative colitis, that may be modified by corticosteroid therapy.
BACKGROUND: Recent data indicate that 5-aminosalicylic acid (5-ASA) is most effective in preventing relapse of Crohn's disease in patients with a short duration of remission before enrollment. AIM: To evaluate the efficacy of oral 5-ASA treatment, started immediately after achieving steroid-induced remission, in preventing clinical relapses of Crohn's disease. METHODS: Patients with active Crohn's disease, achieving remission on steroids, were randomized to oral 5-ASA 3 g/day or placebo, while steroids were tapered over 6 weeks. The trial was terminated after interim analysis showed a slightly higher relapse rate in the 5-ASA group, and the calculated probability of seeing a statistically significant difference by completing the study was minimal. RESULTS: Final analysis included 117 patients (58 taking 5-ASA and 59 taking placebo; follow-up 9.2 +/- 6.5 months). Cumulative relapse rates at 6 and 12 months were 34% and 58% in 5-ASA patients and 31% and 52% in placebo patients, respectively (rate difference +0.095; 95% CI = -0.085 to +0.274). Subgroups analysis showed that 5-ASA was equally ineffective in patients with ileal, colonic or ileocolonic disease. CONCLUSIONS: Contrary to previous results, in our study early introduction of treatment with oral 5-ASA did not prevent relapse in Crohn's disease patients treated with steroids to induce remission.
OBJECTIVES: To investigate the relationship between pre-treatment levels of anti-hepatitis C virus (HCV) immunoglobulin M (IgM) antibodies and the outcome of interferon therapy, and also the relationship with genotypes and quantitative viraemia. PATIENTS: One hundred and four patients with biopsy-proven chronic hepatitis C without cirrhosis, consecutively enrolled in three general hospitals in Turin, Italy, and treated according to the same interferon schedule (3 MU of recombinant alpha-2b interferon three times a week for 6 months). Anti-HCV IgM were measured by a second-generation enzyme-linked immunoassay and results expressed as sample-cutoff ratio. In 30 patients, determination of viraemia by branched DNA (bDNA) and genotyping were performed and the correlation with anti-HCV IgM ratios was assessed. RESULTS: According to univariate analysis, anti-HCV IgM ratios, age, serum gamma-glutamyltranspeptidase (gamma-GT) and ferritin levels were significantly associated with sustained response to therapy. A log-linear model, testing the effect of these variables on response to therapy, showed that anti-HCV IgM ratio was the only independently associated variable (P=0.00057). Anti-HCV IgM were associated with viraemia levels (r=0.57), but not with genotype distribution. Patients with anti-HCV IgM ratio less than 1 were sustained responders to the 'standard therapy' in 65% of cases. By contrast, among patients with a ratio greater than 3, sustained response was achieved in only one patient (3%), while 73% were non-responders; the majority of relapsers were found among patients with a ratio between 1 and 3. CONCLUSION: Anti-HCV IgM antibodies provide an easily accessible and cheap serological marker of active viral replication, and are significantly related to the outcome of interferon therapy in patients with chronic hepatitis C.
OBJECTIVE: Viral infections of the mesenteric microvascular endothelium have been hypothesized as pathogenetic factors in inflammatory bowel diseases. The aim of this study was to determine whether immunoglobulin M (IgM) antibody against measles virus is associated with disease. PATIENTS AND METHODS: The IgM antibody was detected by indirect antibody test in 36 patients with evidence of Crohn's disease (23 males and 13 females, median age 40 years, range 20-66), 22 patients with ulcerative colitis (14 males and 8 females, median age 42 years; range 19-65), 59 patients with a chronic active hepatitis (35 males and 24 females, median age 56 years, range 38-77) and 30 blood donors (20 males and 10 females, median age 45 years, range 29-62). RESULTS: Twenty-eight of 36 patients (78%) with Crohn's disease and 13 of 22 patients (59%) with ulcerative colitis tested positive as compared to only 3 of 89 (3.3%) controls (P < or = 0.001). CONCLUSION: The detection of IgM anti-measles virus in the majority of patients with Crohn's disease and in about half of ulcerative colitis patients as compared to a very low prevalence in patients with other chronic inflammatory disease is consistent with the hypothesis that the measles virus has pathogenetic implications in inflammatory bowel diseases.
Lymphocytic colitis is a clinicopathological entity, characterized by chronic watery diarrhea, not bloody. Previously termed microscopic, it is now named lymphocytic for histological features, the most important seems to be the diffuse infiltration of intraepithelial lymphocytes, that must be investigated in multiple biopsies during colonoscopy. This review evidences that during endoscopy the mucosa is normal, but this does not exclude a biopsy, only way for take a diagnosis. Ethiologies are unknown too although a correlation with autoimmune diseases as possible. Lymphocytic colitis is a definition histological entity, while the term ''microscopic'' includes different histological entities under the same ''umbrella'', in relation to the concept of no macroscopic changes and multiple different histological specimens. The treatment is based for the first time on mesalazine or sulphasalazine and then in case of non responders, on corticosteroids.
The association of primary sclerosing cholangitis and renal disease is not frequent, and is limited to a few reported cases of immune complex glomerulonephritis. We report the case of a 34-year-old patient with sclerosing cholangitis diagnosed 5 years earlier, with well preserved liver function and no clinical manifestations of cholestasis, who developed minimal change nephropathy. During the nephrotic phase of the disease, the peripheral blood lymphocyte count was normal, with a relative increase in percent CD4+ and an increase in the CD4+: CD8+ ratio. CD4+ cells showed immunoactivation. The HLA-DR expression on T-cells was 59%, and 16.5% of CD3+ cells were CD25+. A course of prednisone therapy induced long-lasting remission of the nephrotic syndrome. Peripheral blood lymphocyte count and subtyping were normal 7 months after prednisone withdrawal. We conclude that primary sclerosing cholangitis can be associated with minimal change nephropathy; underlying cell-mediated immunity may be the common pathogenic mechanism.
BACKGROUND: Patients with Crohn's disease may have periods of remission, interrupted by relapses. Because fish oil has antiinflammatory actions, it could reduce the frequency of relapses, but it is often poorly tolerated because of its unpleasant taste and gastrointestinal side effects. METHODS: We performed a one-year, double-blind, placebo-controlled study to investigate the effects of a new fish-oil preparation in the maintenance of remission in 78 patients with Crohn's disease who had a high risk of relapse. The patients received either nine fish-oil capsules containing a total of 2.7 g of n-3 fatty acids or nine placebo capsules daily. A special coating protected the capsules against gastric acidity for at least 30 minutes. RESULTS: Among the 39 patients in the fish-oil group, 11 (28 percent) had relapses, 4 dropped out because of diarrhea, and 1 withdrew for other reasons. In contrast, among the 39 patients in the placebo group, 27 (69 percent) had relapses, 1 dropped out because of diarrhea, and 1 withdrew for other reasons (difference in relapse rate, 41 percentage points; 95 percent confidence interval, 21 to 61; P < 0.001). After one year, 23 patients (59 percent) in the fish-oil group remained in remission, as compared with 10 (26 percent) in the placebo group (P = 0.003). Logistic-regression analysis indicated that only fish oil and not sex, age, previous surgery, duration of disease, or smoking status affected the likelihood of relapse (odds ratio for the placebo group as compared with the fish-oil group, 4.2; 95 percent confidence interval, 1.6 to 10.7). CONCLUSIONS: In patients with Crohn's disease in remission, a novel enteric-coated fish-oil preparation is effective in reducing the rate of relapse.
OBJECTIVE: To evaluate the utility of stool water analysis in the management of patients with chronic diarrhea. DESIGN: Retrospective analysis of 6 years of experience. SETTING: A specialized laboratory in a major referral center. PATIENTS: 325 patients with diarrhea who were referred for stool chemistry analysis. Fecal analysis was requested by many internists and gastroenterologists. Patient records were reviewed to establish the final and most likely cause of diarrhea. RESULTS: One third of patients provided samples that were inappropriate for analysis, but data from 202 persons were available. The usefulness of the general separation of cases of chronic diarrhea into those in which patients had predominantly osmotic pathophysiologies and those in which patients had predominantly secretory pathophysiologies was confirmed, but overlap and intra-individual variability limited the usefulness of this approach in individual patients. Thirty-five patients (17%) had a diagnosis of factitial diarrhea (30 because of laxative use and 5 because of fluid added to stools). CONCLUSIONS: Among selected subpopulations, the chemical analysis of fresh stools has a role in the evaluation of obscure examples of chronic diarrhea. It is especially useful in identifying factitial diarrhea.
PURPOSE: Management of perianal Crohn's disease is still controversial, and reports on large series are very few in the literature. The aim of this multicenter study was to investigate the outcome of both medical and surgical treatment in 225 patients. METHODS: Patients cared for at different institutions were followed up for a median of six years. Most of them had either anal fistula or an abscess (86 percent and 43 percent, respectively), but fissures were also present in 26 percent of the cases. Diarrhea and anal pain were the most common symptoms. Anal lesions preceded the onset of intestinal symptoms in 19 percent of cases. RESULTS: Medical treatment was curative only in 21 of 123 patients. Overall, medical and surgical treatment either cured or improved 62 percent of the cases. Fifty percent had an intestinal resection. Abscess drainage and fistulotomy were the most common anal surgeries. Rectovaginal fistulas (n = 30) required intestinal surgery in 36 percent and anal surgery in 20 percent of the cases, 50 percent with good results. Of 166 patients who had anal surgery, 97 (58 percent) had a positive outcome. Recurrence of anal disease requiring further surgery occurred in 24.5 percent of the cases. CONCLUSIONS: Limited surgeries seem to achieve satisfactory results in more than one-half of the patients affected by perianal Crohn's lesions, whereas medical treatment alone is curative in a small portion of them.
BACKGROUND/AIMS: Recurrence of lesions of Crohn's disease of the ileum within 1 year after so-called curative resection was well documented by endoscopy in 73%-93% of cases. This study investigated the efficacy of mesalamine in reduction of endoscopic recurrence after surgery. METHODS: In a double-blind, multicenter clinical trial, 87 patients were treated with 3 g/day mesalamine (Pentasa) or with placebo within 1 month after surgery. After 12 months of treatment, severity of endoscopic lesions was recorded with a five-point score; when it was not possible to reach the anastomosis by endoscopy, a barium enema was performed. RESULTS: Seventeen clinical relapses (seven in the mesalamine group) were recorded. After 12 months, the endoscopic lesions were less frequent and less severe in the mesalamine group than were those in the placebo group (chi 2, 13.5; P < 0.008). The overall rate of severe recurrence (score of 3-4 on endoscopy or radiological documentation) was 24% in the mesalamine group and 56% in the placebo group (chi 2, 8.57; P < 0.004; difference 32%; 95% confidence interval, 22-52). The odds ratio for active treatment was 4.1. CONCLUSIONS: This study shows that mesalamine is useful in decreasing the rate and severity of endoscopic recurrences after curative surgery for ileal Crohn's disease.
AIMS: This multicenter and prospective study was aimed at examining the appropriate use of upper gastrointestinal endoscopy in an open access system (primary endoscopy) using the American Society for Gastrointestinal Endoscopy (ASGE) guidelines. We also wished to see whether these guidelines can be easily used in clinical practice. MATERIALS AND METHODS: Three thousand four hundred fourteen upper gastrointestinal endoscopies performed in seven endoscopy units of different size were studied prospectively. The real indication, to be with the guidelines, was determined by the endoscopist before performing the examination, based on a patient's history. RESULTS: Seven hundred eighty-one (23%) endoscopies were "generally not indicated," according to ASGE guidelines, and were distributed as follows: follow-up of duodenal ulcer healing (33%), follow-up of other healed benign diseases (24%), surveillance of gastric atrophy, pernicious anemia, metaplasia, treated achalasia, and prior gastric intervention (14%), diagnosis of dyspepsia considered functional in origin (13%), and uncomplicated heartburn responding to medical therapy (7%). Endoscopies "generally not indicated" accounted for 23% in the bigger endoscopy units, 24% in the average sized units, and 22% in the smaller ones. They accounted for 32% when the examination was prescribed by family doctors, 17% when prescribed by internists, 19% by surgeons, and 14% by gastroenterologists (p < 0.001). Eighty-six (2.5%) endoscopies were done for indications not provided in the guidelines. CONCLUSIONS: This study shows that ASGE guidelines are complete and easy to use and that the rate of inappropriate indications in an open access system can be considerable. They occurred mainly in the follow-up of healed benign disease and were more frequent when the examination was prescribed by the family doctor.
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