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Background and Aims: The quality of a colonoscopy is heavily reliant on the effectiveness of bowel cleansing. Various cleansing solutions are currently available, but their comparative efficacy remains uncertain. This systematic review and network meta-analysis aims to compare the performance of different bowel preparations for colonoscopy., Methods: MEDLINE, Embase, Scopus, and the Cochrane Library were systematically searched for randomized controlled trials (RCTs) comparing the efficacy of different bowel preparations. The primary outcome was cleansing success (CS), and the secondary outcome was adenoma detection rate (ADR)., Results: On network meta-analysis for CS (22 RCTs, 7179 patients, 14 bowel preparations), 2 L PEG + simethicone (RR = 1.25 [95 %CI = 1.13-1.37]), 2 L PEG + lactulose (RR = 1.22 [95 %CI = 1.10-1.38]) and 1 L PEG + ascorbate (ASC) (RR = 1.03 [95 %CI = 1.01-1.06]) were significantly superior to 2 L PEG + ASC. Overall, 2 L PEG + lactulose resulted as the best product (SUCRA 0.94), followed by 2 L PEG + simethicone (SUCRA 0.93). On network meta-analysis for ADR (17 RCTs, 6639 patients, 11 bowel preparations), only 2 L PEG + simethicone (RR = 1.60 [95 %CI = 1.05-2.43]) resulted significantly superior to 2 L PEG + ASC., Conclusions: 2 L PEG + simethicone, 2 L PEG + lactulose, and 1 L PEG + ASC seemed to provide high rates of CS, albeit only 2 L PEG + simethicone was associated with significantly higher ADR. Consequently, these products should be preferred for bowel preparation of colonoscopy. Further randomized studies with adequate sample sizes are needed for a more accurate comparison of these products on ADR., Competing Interests: Declaration of competing interest RV and LF received consultation fees from AlfaSigma and Norgine. MM, RDM and AR received consultation fees from Norgine. Other authors have no proprietary, financial, professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented in, or the review of this manuscript., (Copyright © 2024 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC)., Aim: To assess the safety and effectiveness of TOFA in clinical practice., Methods: TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with UC starting TOFA from its introduction in Sicily (July 2021) to July 2022 were included., Results: 111 patients were included (mean follow-up: 31.7 ± 14.9 weeks; biologic-experienced: 92.8%). Nineteen adverse events were reported (17.1%; incidence rate: 28.2 per 100 patient years), including 11 cases of hypercholesterolemia and 3 infections (no cases of herpes zoster reactivation. At week 8, the rates of clinical response, steroid free clinical remission, and CRP normalization were 74.8%, 45.0%, and 56.9%, respectively, and 68.5%, 51.4%, and 65.2%, respectively, at the end of follow-up. Eighteen patients experienced a loss of response after successful induction (21.7%; incidence rate: 33.2 per 100 patient years). Twenty-six patients (23.4%) discontinued TOFA over time, of whom 3 due to AEs, and 23 to non response or loss of response., Conclusions: TOFA is safe and effective in patients with UC, including those with history of multiple failures to biological therapies., Competing Interests: Conflict of interest Fabio Salvatore Macaluso served as an advisory board member and/or received lecture grants from Biogen, Ferring, Galapagos, Janssen, MSD, Pfizer, Samsung Bioepis, and Takeda Pharmaceuticals. Walter Fries served as an advisory board member and/or received lecture grants from Abbvie, MSD, Takeda, Pfizer, Biogen, Sandoz, Zambon, Ferring Italia, Sofar. Anna Viola received lecture grants from Pfizer. Maria Cappello served as an advisory board member for AbbVie, MSD, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Chiesi, and Takeda Pharmaceuticals. Filippo Mocciaro served as an advisory board member for Janssen and Galapagos, and received lecture grants from Takeda Pharmaceuticals. Antonino Carlo Privitera served as consultant to Mundipharma, Abbvie, MSD, Takeda, and Janssen, and received lecture fees from Abbvie, Sara Renna served as an advisory board member for AbbVie, Janssen, and MSD Pharmaceuticals, and received lecture grants from AbbVie, Janssen, MSD, Pfizer, and Takeda Pharmaceuticals. Ambrogio Orlando served as an advisory board member for AbbVie, Galapagos, MSD, Janssen, Pfizer, Samsung Bioepis, and Takeda Pharmaceuticals, and received lecture grants from AbbVie, Fresenius Kabi, Galapagos, MSD, Sofar, Chiesi, Janssen, Pfizer, and Takeda Pharmaceuticals., (Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: The role of Vedolizumab (VDZ) as therapeutic option for the postoperative recurrence of Crohn's disease (CD) following ileocolonic resection is unknown., Aims: To assess the effectiveness of VDZ in this setting., Methods: All consecutive CD patients with a baseline colonoscopy at 6-12 months from the ileocolonic resection showing postoperative recurrence (Rutgeerts score ≥i2) and treated with VDZ after the baseline colonoscopy were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD). The primary outcome was endoscopic success, assessed at the first colonoscopy following initiation of VDZ and defined as reduction of at least one point of Rutgeerts score. The secondary outcome was clinical failure, assessed at one year and at the end of follow-up., Results: Fifty-eight patients were included (mean follow-up: 24.8 ± 13.1 months). Endoscopic success was reported in 47.6% of patients. Clinical failure was reported in 19.0% of patients at one year, and in 32.8% of patients at the end of follow-up. A new resection was required in 7 patients (12.1%)., Conclusions: VDZ may be an effective option for the treatment of postoperative recurrence of CD., Competing Interests: Conflict of Interest None declared., (Copyright © 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Adalimumab is used to treat ulcerative colitis, but additional effectiveness and safety data are needed., Patients and Methods: This retrospective study considered adults with ulcerative colitis treated with adalimumab at 19 hospitals. Clinical data were collected from the start of treatment, after 2, 6 and 12 months, and at the last visit. Outcome measures of effectiveness were treatment duration, reasons for discontinuation and colectomy., Results: We studied 381 patients treated with adalimumab for a median of 12.1 months. Disease activity at the start of treatment was moderate to severe in 262 cases (68.8%) and endoscopic activity was moderate to severe in 339 cases (89.0%). At week 8, clinical responses were observed in 177 cases (46.5%) and clinical remission in 136 cases (35.7%). At 12 months, remission was observed in 128 cases (33.6%). Overall, 44 patients required colectomy, and 170 patients (44.6%) were still taking adalimumab when data were collected. Variables associated with adalimumab discontinuation were concomitant steroid treatment, severe clinical-endoscopic activity at baseline, need for adalimumab intensification and drug-related adverse events. Variables associated with colectomy were concomitant steroid treatment and high baseline C-reactive protein., Conclusion: Adalimumab is safe and effective for the treatment of ulcerative colitis., Competing Interests: Conflict of Interest None declared., (Copyright © 2021. Published by Elsevier Ltd.)

Background: No real-life study on the comparative effectiveness of Vedolizumab (VDZ), Adalimumab (ADA), and Golimumab (GOL) in ulcerative colitis (UC) is currently available., Aims: To compare the effectiveness of the three biologics in consecutive patients with UC., Methods: A three-arms propensity score-adjusted analysis was performed using the Inverse Probability of Treatment Weighting method., Results: 463 treatments (VDZ: n = 187; ADA: n = 168; GOL: n = 108) were included (median follow-up: 47.6 weeks). At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons). At 52 weeks (n = 377), a steroid-free remission was reported in 51.5% patients in the VDZ group, in 31.2% patients in the ADA group, and in 29.4% patients in the GOL group (p = 0.002 for VDZ vs. ADA, p = 0.001 for VDZ vs. GOL, p = n.s. for ADA vs. GOL). Cox survival analysis demonstrated that patients treated with VDZ had reduced probability of treatment discontinuation compared to those treated with ADA (HR: 0.42, 95% CI 0.28-0.64, p < 0.001) and GOL (HR: 0.30, 95% CI 0.19-0.46, p < 0.001), while patients treated with ADA had reduced risk of treatment discontinuation compared to those treated with GOL (HR: 0.71, 95% CI 0.50-1.00, p = 0.048)., Conclusions: VDZ was superior to ADA and GOL at 52 weeks and as treatment persistence, while ADA showed a superior treatment persistence compared to GOL., Competing Interests: Declaration of Competing Interest Fabio Salvatore Macaluso served as an advisory board member and/or received lecture grants from AbbVie, Biogen, MSD, and Takeda Pharmaceuticals. Maria Cappello served as an advisory board member for AbbVie, MSD, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Chiesi, and Takeda Pharmaceuticals. Filippo Mocciaro served as an advisory board member for AbbVie and MSD Pharmaceuticals, and received lecture grants from AbbVie, MSD and Takeda Pharmaceuticals. Sara Renna served as an advisory board member for AbbVie and MSD Pharmaceuticals, and received lecture grants from AbbVie, MSD and Takeda Pharmaceuticals Ambrogio Orlando served as an advisory board member for AbbVie, MSD, Janssen, Pfizer, Takeda Pharmaceuticals, and received lecture grants from AbbVie, MSD, Sofar, Chiesi, Janssen, Pfizer, and Takeda Pharmaceuticals., (Copyright © 2020 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Standard suction and slow-pull techniques have been utilized during endoscopic ultrasound-guided fine needle aspiration of pancreatic solid lesions, but the correct sampling technique remains unclear. New needles designed to obtain samples suitable for histological evaluation have become available. We performed a study comparing the two sampling methods during endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in patients with pancreatic solid lesions., Methods: We performed EUS-FNB with a 20 Gauge FNB needle using slow-pull or standard suction techniques in a prospective, randomized, multicenter study. The primary aim was bloodiness of the collected specimens. Secondary aims were technical success and performance of the two techniques., Results: 110 patients were included (55 per group). No difference in blood contamination was observed (slow-pull 80% vs. suction 74%, p = 0.917). Technical success was 95% (96% vs. 94%, p = 0315). Sensitivity (96% vs. 93%), specificity (100% vs. 100%), positive likelihood ratio (NA), negative likelihood ratio (0.04 vs. 0.07), diagnostic accuracy (96 vs. 93%) did not differ between the two groups., Conclusion: EUS-FNB with slow-pull and standard suction techniques are comparable in terms of blood contamination providing similar high diagnostic sensitivity and accuracy in pancreatic solid lesions. The use of the new generation FNB needle allows to reach such high level of diagnostic adequacy regardless of the technique utilized., (Copyright © 2019. Published by Elsevier Ltd.)

The first infliximab biosimilar for the treatment of inflammatory bowel disease (IBD) was introduced in 2013, and today eight anti-TNF alpha biosimilars (three for infliximab and five for adalimumab) have been approved and licensed by the European Medicines Agency. Biosimilars present great potential in terms of cost saving and possible consequential reinvestment in the health care system. The increasing knowledge about the process of biosimilar development and use in IBD and the publication of many prospective clinical studies and real-life clinical experiences have progressively changed the point of view of IBD physicians. In the present position paper, the Italian Group for the Study of Inflammatory Bowel Disease present and discuss their updated statements and positions on this topic, with emphasis on the concepts of biosimilarity and extrapolation across indications, safety and immunogenicity, interchangeability and switching, automatic substitution, and, finally, patient education about biosimilars., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Little is known about the unmet needs of physicians caring for patients with inflammatory bowel disease (IBD)., Aims: This study explored the practical difficulties and needs for professional updating of Italian IBD physicians., Methods: A questionnaire was distributed to 600 physicians attending IG-IBD meetings., Results: 280 physicians completed the questionnaire (46.7%). On a 5-point Likert scale (from 1, strongly disagree to 5, strongly agree), they identified the most problematic issues in managing IBD patients as increasing bureaucracy (3.9), lack of extra-gastroenterological IBD expertise (3.4), lack of diagnostic techniques (3.1) and budget limitations (2.9). The most lacking techniques, ranked from 1 (greatest need) to 9 (lowest need), were: anti-drug antibody and trough level assays (2.7), device-assisted enteroscopy (3.1), exploration under anaesthesia (3.2), MR enterography (3.2), and bowel ultrasonography (3.3). About professional updating, respondents indicated (on a 5-point Likert scale) that helpful topics were practical medicine (4.3), managing difficult patients (4.1), and guidelines (4.0). The most desired modality for updating was residential courses on clinical practice (4.3)., Conclusion: Several factors potentially limit the best management of IBD patients in Italy. Satisfying these unmet needs could improve care for IBD patients., (Copyright © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Adalimumab and golimumab are effective in the treatment of moderate to severe ulcerative colitis., Aims: We reported the comparative effectiveness of adalimumab and golimumab in ulcerative colitis., Methods: 118 patients treated with adalimumab and 79 treated with golimumab were included and evaluated at 8 weeks and at the end of follow up., Results: Overall clinical benefit was 72.6% at 8 weeks and 58.9% at the end of follow up. Patients with longer disease duration and those treated with adalimumab had a better outcome. Clinical benefit was 78.8% in adalimumab patients and 63.3% in golimumab patients (p = 0.026) after 8 weeks; it was 66.9% in adalimumab patients and 46.8% in golimumab patients (p = 0.008) at the end of follow up. These data were confirmed by propensity score analysis. A further analysis considering adalimumab optimization as treatment failure showed that the difference between adalimumab and golimumab was not significant., Conclusion: Adalimumab and golimumab are effective in the treatment of ulcerative colitis. Adalimumab seems to be more effective than golimumab. This difference is probably affected by the impossibility of golimumab to be optimized in Italy while adalimumab is., (Copyright © 2018. Published by Elsevier Ltd.)

Introduction: Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic, systemic Inflammatory Bowel Diseases (IBDs) that need a multidisciplinary approach involving not only different medical specialists but also qualified nurses., Aim: We evaluated the concordance between IBD-nurse and physician in computing Clinical Activity Scores in IBD-patients treated with biologics., Methods: We enrolled all consecutive IBD-patients treated with biologics in two referral centers for IBD-care. For each patient, a gastroenterologist and a nurse blindly filled-out a form to assess the Harvey-Bradshaw Index (HBI) in CD or the partial MAYO score in UC. All data were recorded to assess the beyond chance agreement (concordance) using the k statistic., Results: 87 patients were enrolled. The agreement in all patients by k value was substantial (66%), ranging from moderate to substantial (95% CI from 51% to 80%). The main reason of disagreement was about the scoring of remission versus mild activity, and that of mild versus moderate activity, both in CD and UC. For the HBI, the best agreement was for well-being on the previous day (k 62%) and the least one for abdominal mass (k 35%)., Conclusions: Our study shows an acceptable strength of agreement among nurse and gastroenterologist in evaluating the disease activity of IBD-patients through the calculation of clinical scores., (Copyright © 2017 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Adalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission., Aims: To assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment., Methods: The present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab., Results: Of the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16±10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events. We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome., Conclusions: This "real life" prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients., (Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Most inflammatory bowel disease patients miss follow-up visits and are non-adherent to therapy due to the lack of an engaging patient-physician relationship. Motivational interviewing is a patient-centred counselling method used to elicit/strengthen motivation towards change. The aim of this study was to assess the role of motivational interviewing in patients affected by inflammatory bowel disease., Methods: The study included consecutive patients with inflammatory bowel disease presenting for the first consultation (June 2012-February 2013). All consultations were carried out applying the motivational interviewing approach. After each consultation, patients filled out a questionnaire asking demographic data, and their past and current experience., Results: Overall, 23 males (51.1%) and 22 females (48.9%), mean age 36.1±15.2 years, were enrolled. Before and after experiencing the motivational interviewing approach (mean visit duration 41.5±8.7min) "overall satisfaction rate", "physician's communication skills", and "perceived empathy" were 60% vs 100%, 40% vs 95.6%, and 40% vs 100%, respectively. Satisfaction was lower in patients affected by indeterminate colitis (p=0.004), and of younger age (p=0.02)., Conclusion: The motivational interview approach is appreciated by inflammatory bowel disease patients. Despite being time-consuming, the motivational interview appears considerably worthwhile at the first visit and in younger patients. Motivational interviewing can help physicians to deal with their patients, moving from "cure" to "care"., (Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Endoscopic ultrasound fine needle aspiration has a central role in the diagnostic algorithm of solid pancreatic masses. Data comparing the fine needle aspiration performed with different aspiration volume and without aspiration are lacking. We compared endoscopic ultrasound fine needle aspiration performed with the 22 gauge needle with different aspiration volumes (10, 20 and 0 ml), for adequacy, diagnostic accuracy and complications., Methods: Prospective clinical study at four referral centres. Endoscopic ultrasound fine needle aspiration was performed with a 22G needle with both volume aspiration (10 and 20 cc) and without syringe, in randomly assigned sequence. The cyto-pathologist was blinded as to which aspiration was used for each specimen., Results: 100 patients met the inclusion criteria, 88 completed the study. The masses had a mean size of 32.21±11.24 mm. Sample adequacy evaluated on site was 87.5% with 20 ml aspiration vs. 76.1% with 10 ml (p=0.051), and 45.4% without aspiration (20 ml vs. 0 ml p<0.001; 10 ml vs. 0 ml p<0.001). The diagnostic accuracy was significantly better with 20 ml than with 10 ml and 0 ml (86.2% vs. 69.0% vs. 49.4% p<0.001)., Conclusions: A significantly higher adequacy and accuracy were observed with the 20 ml aspiration puncture, therefore performing all passes with this volume aspiration may improve the diagnostic power of fine needle aspiration., (Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Self-expandable metal stents are a non-surgical option for the treatment of symptomatic malignant colorectal obstruction as palliative treatment or as a bridge to surgery., Aims: To report data from a regional study on self-expandable metal stent (SEMS) placement for malignant colorectal obstruction., Methods: Two hundred and four patients (male 54.9%, mean age of 69.5 ± 14.2) were retrospectively evaluated and data on technical and clinical success, and complications, were analyzed., Results: Technical and clinical success rates were 99% and 94.6% respectively, with 36.7% treated on an emergency basis and 63.3% electively. Palliative treatment was administered to 70.1%, and as a bridge to surgery for 29.9%. Complications were 17 neoplastic ingrowths, 10 stent migrations, and 4 perforations. Palliative treatment was associated with a higher risk of stent ingrowth (p=0.003), and chemotherapy with a lower risk of stent ingrowth (p=0.009)., Conclusion: This regional study, although it has certain limitations, confirms the positive role of self-expandable metal stents in the treatment of symptomatic malignant colorectal obstruction, and that chemotherapy decreases the risk of ingrowth., (Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Endoscopic ultrasound-guided fine needle aspiration of pancreatic cystic lesions has been reported to have a higher complication rate than that of solid lesions, but the real complication rate is unknown. Aim of the study was to identify the complication rate of endoscopic ultrasound-guided fine needle aspiration and related risk factors., Methods: Prospective multicenter study at four referral centres. Data were collected from January 2010 to July 2012, searching for all adverse events related to guided fine needle aspiration. All complications occurring up to day 90 were recorded., Results: 298 patients (43.9% male, mean age 63.2 ± 15.4 years) underwent endoscopic ultrasound-guided needle aspiration of pancreatic cystic lesions. Mean size was 34.1 ± 9 mm. Adverse events occurred in 18 patients (6%): mild complications in 12/18 (66.6%), and moderate complications in 6/18 (33.3%). Seven were immediate, 6 early, and 5 late. All resolved with medical therapy., Conclusions: Endoscopic ultrasound-guided fine needle aspiration of pancreatic cystic lesions has been found to be associated with a higher complication rate than for solid lesions; however, the risk rate is acceptable considering the complication grade and the important diagnostic role of the technique in the management of pancreatic cystic lesions., (Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Aim: To evaluate prospectively the clinical efficacy and safety of endoscopic hydrostatic balloon dilation in a consecutive cohort of symptomatic intestinal Crohn's disease strictures., Methods: Between September 2003 and December 2008 we performed endoscopic balloon dilations in 37 Crohn's disease patients with 39 intestinal symptomatic strictures (4 naïve and 35 postoperative). Dilations were performed using a Rigiflex through-the-scope balloon. Clinical success rate was claimed if a patient remained asymptomatic and did not require surgery or further endoscopic dilation, following technical success. Actuarial curves of clinical, endoscopic (redilation) and surgical recurrence were obtained by Kaplan-Meier method. Demographic and disease variables were related to the main outcomes., Results: After a mean follow-up of 26.3 months (range, 2-61 months), the long-term global benefit rate was 89% (33/37). The 1-2-3 years cumulative symptom-free rates were respectively: 76%, 55% and 46%. Four patients were operated upon. Technical success predicts a lower rate of surgery. There were no complications related to the endoscopic procedures., Conclusions: Endoscopic balloon dilation of symptomatic Crohn's disease strictures may achieve clinical benefit in many patients and is a valid alternative to surgery in the management of the disease. Dilation may be repeated in recurrent intestinal obstructions and appears safe without morbidity., (Copyright © 2010 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Several methods have been reported to minimize patient discomfort during colonoscopy, none are currently recommended by clinical practice guidelines. We performed a single-blind randomized controlled trial to assess the efficacy of music for colonoscopy., Methods: 109 patients were randomized to music-delivering or mute headphones before and during colonoscopy. Physicians were blinded to the trial. Sedation was given on demand. Primary outcome was pain measured on linear analogue scale from 0 to 10. Secondary endpoints were the difficulty of the procedure, need of sedation, overall patient satisfaction and willingness to repeat the procedure., Results: Mean pain score was 5.9±2.2 in the control group vs. 3.8±1.9 in the music group (p<0.00001); correspondingly overall satisfaction and willingness to repeat the procedure were significantly improved by music and the difficulty perceived by physicians was significantly reduced. Total administered midazolam was 36mg in the control group vs. 13 in the music group (p<0.007), pethidine was 860mg vs. 465mg (p=0.07) and patients requiring sedation were 22 vs. 9, respectively (p=0.003). A multivariable analysis to adjust treatment effect for potential confounding factors confirmed the significant beneficial effect of music., Conclusions: Music significantly reduces discomfort and should be routinely offered to patients undergoing colonoscopy., (Copyright © 2010 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Infliximab is a widely used biological agent for the treatment of inflammatory bowel disease, and has a favorable risk/benefit ratio., Aim: It is useful to know that patients treated with infliximab are exposed to developing adverse events that could be reduced with a prudent and a rational clinical approach and by optimizing the treatment protocol., Methods: PubMed (including Epub) was searched in October 2006 and again in March 2007., Results: The high immunogenic potential of infliximab determines the antibodies that inhibit the effect of infliximab and the appearance of subsequent acute and delayed infusion reactions. Infliximab has an immunomodulatory effect, thus increasing the risk of serious and latent infections. Screening for tuberculosis, HBV, opportunistic or latent infections, heart failure, and haematological, neurological and hepatological disorders must be performed before infliximab therapy. There is no definitive evidence that infliximab increases the risk of neoplasia. Mortality in infliximab-treated patients does not appear increased compared to the controls., Conclusions: Infliximab safety is similar to that of conventional immunomodulators and patients treated had similar rates of mortality, neoplasm and lymphoma as patients not treated with infliximab. Patients treated with infliximab have an increased risk of serious infections but it is not related to infliximab therapy.

Aim: To provide a review of studies on prognosis in ulcerative colitis by reviewing the relevant population-based cohort studies. On the basis of incidence and population studies, ulcerative colitis has a favourable clinical course, with good quality of life, a chronic course characterized by at least one relapse, and a surgery rate of 30% after 10 years from diagnosis. Patients affected by severe ulcerative colitis have a higher risk of colectomy, and some clinical variables may predict the disease's clinical course. Most patients respond to steroids and only a low percentage become dependent, or non-responders to steroids. Patients who have a long-lasting ulcerative colitis (>10 years) or are affected by an extensive disease have an increased risk of developing colorectal cancer, while those treated with immunosuppressants for long period of time may have an increased risk of developing lymphomas. Data on mortality in ulcerative colitis patients are not homogeneous, but if a real risk exists it is in patients with extensive or severe disease. The evidence that patients with severe ulcerative colitis are often non-smokers may explain why in one study the mortality rate was lower.

Background: Almost 20% of patients with active Crohn's disease are refractory to conventional therapy. Infliximab is a treatment of proven efficacy in this group of patients and it is not clear which variables predict a good response. AIMS.: To evaluate the role of infliximab looking at the predictors of response in a large series of patients with Crohn's disease., Patients and Methods: Five hundred and seventy-three patients with luminal refractory Crohn's disease (Crohn's Disease Activity Index (CDAI)>220-400) (312 patients) or with fistulising disease (190 patients) or both of them (71 patients) were treated with a dose of 5 mg/kg in 12 Italian referral centres. The primary endpoints of the study were clinical response and clinical remission for luminal refractory and fistulising disease. We evaluated at univariable and multivariable analysis the following variables: number of infusions, sex, age at diagnosis, smoking habit, site of disease, previous surgery, extraintestinal manifestations and concomitant therapies, and type of fistulas., Results: Patients with luminal refractory disease: 322 patients (84.1%) had a clinical response and 228 (59.5%) reached clinical remission. Patients with fistulising disease: 187 patients (72%) had a reduction of 50% of the number of fistulas and in 107 (41%) a total closure of fistulas was observed. For luminal disease, single infusion (OR 0.49, 95% CI 0.28-0.86) and previous surgery (OR 0.53, 95% CI 0.30-0.93) predicted a worse response for fistulising disease. Other fistulas responded worse than perianal fistulas (OR 0.57, 95% CI 0.303-1.097)., Conclusion: In Crohn's disease infliximab is effective in luminal refractory and in fistulising disease. A single infusion and previous surgery predicted a worse response in luminal disease whereas perianal fistulas predicted a better response than other type of fistulas.