Antidepressants and inflammatory bowel disease: a systematic review Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey Genomic and Clinical Effects Associated with a Relaxation Response Mind-Body Intervention in Patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease Reduction of chronic abdominal pain in patients with inflammatory bowel disease through transcranial direct current stimulation: a randomized controlled trial Efficacy, Safety and Immunogenicity of Biosimilars in Inflammatory Bowel Diseases: A Systematic Review. Presenting features of inflammatory bowel disease in Great Britain and Ireland
Background A number of studies have suggested a link between the patient 's psyche and the course of inflammatory bowel disease ( IBD ) . Although pharmacotherapy with antidepressants has not been widely explored , some investigators have proposed that treating psychological co-morbidities with antidepressants may help to control disease activity . To date a systematic analysis of the available studies assessing the efficacy of antidepressants for the control of somatic symptoms in IBD patients has not been performed . Methods We search ed electronic data bases , without any language restriction . All relevant papers issued after 1990 were examined . Results 12 relevant publications were identified . All of them referred to non-r and omised studies . Antidepressants reported in these publications included paroxetine , bupropion , amitriptyline , phenelzine , and mirtazapine . In 10 articles , paroxetine , bupropion , and phenelzine were suggested to be effective for treating both psychological and somatic symptoms in patients suffering from IBD . Amitriptyline was found ineffective for treating somatic symptoms of IBD . Mirtazapine was not recommended for IBD patients . Conclusion Although most of review ed papers suggest a beneficial effect of treatment with antidepressants in patients with IBD , due to the lack of reliable data , it is impossible to judge the efficacy of antidepressants in IBD . Properly design ed trials are justified and needed based upon the available uncontrolled data Introduction Crohn ’s disease ( CD ) and ulcerative colitis ( UC ) , the main forms of inflammatory bowel disease ( IBD ) , are chronic , progressive and disabling disorders of the gastrointestinal tract . Although data from r and omised controlled trials ( RCTs ) provide the foundation of evidence that vali date s medical therapy for IBD , considerable heterogeneity exists in the measured outcomes used in these studies . Furthermore , in recent years , there has been a paradigm shift in IBD treatment targets , moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance , inflammatory biomarkers and histological and radiographic end points . The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development . Accordingly , there exists a need to harmonise measures used in clinical trials through the development of a core outcome set ( COS ) . Methods and analysis The development of an IBD-specific COS includes four steps . First , a systematic literature review is performed to identify outcomes previously used in IBD RCTs . Second , semistructured qualitative interviews are conducted with key stakeholders , including patients , clinicians , research ers , pharmaceutical industry representatives , healthcare payers and regulators to identify additional outcomes of importance . Using the outcomes generated from literature review and stakeholder interviews , an international two-round Delphi survey is conducted to prioritise outcomes for inclusion in the COS . Finally , a consensus meeting is held to ratify the COS and disseminate findings for application in future IBD trials . Ethics and dissemination Given that over 30 novel therapeutic compounds are in development for IBD treatment , the design of robust clinical trials measuring relevant and st and ardised outcomes is crucial . St and ardising outcomes through a COS will reduce heterogeneity in trial reporting , facilitate valid comparisons of new therapies and improve clinical trial quality Introduction Irritable Bowel Syndrome ( IBS ) and Inflammatory Bowel Disease ( IBD ) can profoundly affect quality of life and are influenced by stress and resiliency . The impact of mind-body interventions ( MBIs ) on IBS and IBD patients has not previously been examined . Methods Nineteen IBS and 29 IBD patients were enrolled in a 9-week relaxation response based mind-body group intervention ( RR-MBI ) , focusing on elicitation of the RR and cognitive skill building . Symptom question naires and inflammatory markers were assessed pre- and post-intervention , and at short-term follow-up . Peripheral blood transcriptome analysis was performed to identify genomic correlates of the RR-MBI . Results Pain Catastrophizing Scale scores improved significantly post-intervention for IBD and at short-term follow-up for IBS and IBD . Trait Anxiety scores , IBS Quality of Life , IBS Symptom Severity Index , and IBD Question naire scores improved significantly post-intervention and at short-term follow-up for IBS and IBD , respectively . RR-MBI altered expression of more genes in IBD ( 1059 genes ) than in IBS ( 119 genes ) . In IBD , reduced expression of RR-MBI response genes was most significantly linked to inflammatory response , cell growth , proliferation , and oxidative stress-related pathways . In IBS , cell cycle regulation and DNA damage related gene sets were significantly upregulated after RR-MBI . Interactive network analysis of RR-affected pathways identified TNF , AKT and NF-κB as top focus molecules in IBS , while in IBD kinases ( e.g. MAPK , P38 MAPK ) , inflammation ( e.g. VEGF-C , NF-κB ) and cell cycle and proliferation ( e.g. UBC , APP ) related genes emerged as top focus molecules . Conclusions In this uncontrolled pilot study , participation in an RR-MBI was associated with improvements in disease-specific measures , trait anxiety , and pain catastrophizing in IBS and IBD patients . Moreover , observed gene expression changes suggest that NF-κB is a target focus molecule in both IBS and IBD— and that its regulation may contribute to counteracting the harmful effects of stress in both diseases . Larger , controlled studies are needed to confirm this preliminary finding . Trial Registration Clinical Trials . Gov Abstract Inflammatory bowel disease ( IBD ) is frequently associated with chronic abdominal pain ( CAP ) . Transcranial direct current stimulation ( tDCS ) has been proven to reduce chronic pain . This study aim ed to investigate the effects of tDCS in patients with CAP due to IBD . This r and omized , sham-controlled , double blind , parallel- design ed study included 20 patients with either Crohn disease or ulcerative colitis with CAP ( ≥3/10 on the visual analog scale ( VAS ) in 3/6 months ) . Anodal or sham tDCS was applied over the primary motor cortex for 5 consecutive days ( 2 mA , 20 minutes ) . Assessment s included VAS , pressure pain threshold , inflammatory markers , and question naires on quality of life , functional and disease specific symptoms ( Irritable Bowel Syndrome – Severity Scoring System [ IBS – SSS ] ) , disease activity , and pain catastrophizing . Follow-up data were collected 1 week after the end of the stimulation . Statistical analyses were performed using analysis of variance and t tests . There was a significant reduction of abdominal pain in the anodal tDCS group compared with sham tDCS . This effect was evident in changes in VAS and pressure pain threshold on the left and right sides of the abdomen . In addition , 1 week after stimulation , pain reduction remained significantly decreased in the right side of the abdomen . There was also a significant reduction in scores on pain catastrophizing and on IBS – SSS when comparing both groups . Inflammatory markers and disease activity did not differ significantly between groups throughout the experiment . Transcranial direct current stimulation proved to be an effective and clinical ly relevant therapeutic strategy for CAP in IBD . The analgesic effects observed are unrelated to inflammation and disease activity , which emphasizes central pain mechanisms in CAP BACKGROUND Anti-tumor necrosis factor ( anti-TNF ) monoclonal antibodies have revolutionized the treatment of inflammatory bowel diseases ( IBD ) . However , because of their complexity , their production is expensive contributing to their high price . As the patent protection of these therapies has expired in several countries , biosimilars have been developed to reduce the healthcare costs . The aim of this article is to review the literature on the safety , efficacy and immunogenicity of biosimilars in IBD . METHODS A PubMed literature search was performed using the following terms until May 2016 :  ' biosimilars ' , ' CT-P13 ' , ' infliximab ' , ' Crohn 's disease ' , ' ulcerative colitis ' , ' inflammatory bowel diseases ' , ' efficacy ' , ' safety ' , ' immunogenicity ' . Additionally , abstract s from international meetings were also review ed . RESULTS A total of eleven studies in IBD patients provided real-world evidence on the efficacy , safety and immunogenicity profile of biosimilars in IBD patients . Based on the available evidence , CT-P13 is efficacious and well tolerated in IBD patients in a real-life setting . The vast majority of studies only included IBD patients who had never received biological therapies . Information regarding the interchangeability between CT-P13 and its originator is currently being investigated in the NOR-SWITCH trial . Otherwise , the immunogenicity profile of CT-P13 seems to be similar to the originator . CONCLUSION The infliximab biosimilar seems to be efficacious , safe and with a similar immunogenicity profile as the originator in IBD . Large prospect i ve post-marketing studies are needed to assess the long-term safety profile of CT-P13 . The use of infliximab biosimilars may lead to major healthcare cost savings Background : Reports from individual referral centres suggest that a significant proportion of children with inflammatory bowel disease ( IBD ) present after prolonged delays and with impaired growth . Aims : To prospect ively document the presenting features , delay in presentation , disease localisation , and growth in newly diagnosed cases of IBD . Methods : For 13 months , between June 1998 and June 1999 , 3247 paediatricians , adult gastroenterologists , and surgeons across the UK and Irel and were prospect ively surveyed each month and asked to report every newly diagnosed case of childhood IBD . Results : A total of 739 new IBD cases aged less than 16 years were identified . Only one quarter of Crohn ’s disease ( CD ) cases presented with the “ classic triad ” of diarrhoea , weight loss , and abdominal pain ; nearly half did not report diarrhoea . The median delay from onset of symptoms to diagnosis was 5 months ( mean 11 months ) , with one fifth having symptoms of more than one year . Delays were most common in CD and in younger children .  Short stature was noted only in those with CD and not with ulcerative colitis . One fifth of CD cases had disease activity in the jejunum and this group had significantly reduced stature . Ileo-colonic involvement was documented in most CD cases , with only a small minority having isolated ileal or isolated colonic disease . Pan-colitis was reported in most UC cases , with very few having only an isolated proctitis . Conclusions : Many children are diagnosed after prolonged delays and have growth failure . Improved knowledge of the presenting features of IBD , and earlier investigation of suspected cases , may help reduce the delays noted
Psychosocial factors associated with pain-related interference included depression , catastrophising , fear avoidance , lower self-efficacy and worse mental well-being .
Conclusions Pain in IBD is significantly associated with cognitive and behavioural factors as well as low mood .
Objective Pain is frequently reported by patients with inflammatory bowel disease ( IBD ) .
Pain in IBD is not fully explained by disease activity or other clinical findings , and a recent systematic review suggested that psychosocial factors have an important role in IBD-pain .
The aim of this study was to investigate psychosocial factors associated with pain in IBD .