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Background and aims This study examined differences in personality, psychological distress, and stress coping in inflammatory bowel disease (IBD) depending on type of disease and disease activity. We compared patients suffering from Crohn’s disease (CD) and ulcerative colitis (UC) with controls. While the literature is replete with distinctive features of the pathogenesis of IBD, the specific differences in psychological impairments are not well studied. Methods In this German national multicenter study, participants were recruited from 32 centers. Two hundred ninety-seven questionnaires were included, delivering vast information on disease status and psychological well-being based on validated instruments with a total of 285 variables. Results CD patients were more affected by psychological impairments than patients suffering from UC or controls. Importantly, patients with active CD scored higher in neuroticism (p Conclusions We identified specific aspects of psychological impairment in IBD depending on disease and disease activity. Our results underscore the need for psychological support and treatment particularly in active CD.

Zusammenfassung Einleitung Der Einfluss einer SARS-CoV-2-Infektion auf chronisch entzündliche Darmerkrankungen (CED) ist bislang nicht gut charakterisiert, und es ist unklar, ob diese eine Anpassung der immunsuppressiven Therapie erfordert. Methodik Für die retrospektive Dokumentation klinischer Parameter und Veränderungen einer immunsuppressiven Therapie von mit SARS-CoV-2 infizierten CED-Patienten wurde ein nationales Melderegister etabliert. Ergebnisse Insgesamt wurden nur 3 von 185 CED-Patienten (1,6 %) wegen abdomineller Symptome auf eine SARS-CoV-2-Infektion getestet. Im COVID-19-Krankheitsverlauf entwickelten 43,5 % Durchfall, abdominelle Schmerzen oder Hämatochezie (Hospitalisierungsrisiko mit vs. ohne abdominelle Symptome: 20,0 % vs. 10,6 %, p Diskussion Bei mit SARS-CoV-2 infizierten CED-Patienten traten häufig neue abdominelle Symptome bei Infektion auf. Diese führten aber nur selten zur SARS-CoV-2-Testung. Eine hohe CED-Aktivität zum Zeitpunkt des SARS-CoV-2-Nachweises war mit einem erhöhten Hospitalisierungsrisiko assoziiert.

This study examined differences in personality, psychological distress, and stress coping in inflammatory bowel disease (IBD) depending on type of disease and disease activity. We compared patients suffering from Crohn's disease (CD) and ulcerative colitis (UC) with controls. While the literature is replete with distinctive features of the pathogenesis of IBD, the specific differences in psychological impairments are not well studied. In this German national multicenter study, participants were recruited from 32 centers. Two hundred ninety-seven questionnaires were included, delivering vast information on disease status and psychological well-being based on validated instruments with a total of 285 variables. CD patients were more affected by psychological impairments than patients suffering from UC or controls. Importantly, patients with active CD scored higher in neuroticism (p 0.01), psychological distress (p 0.001) and maladaptive stress coping (escape, p = 0.03; rumination, p 0.03), but less need for social support (p = 0.001) than controls. In contrast, patients suffering from active UC showed psychological distress (p 0.04) and maladaptive coping (avoidance, p 0.03; escape, p = 0.01). Patients in remission seemed to be less affected. In particular, patients with UC in remission were not inflicted by psychological impairments. The group of CD patients in remission however, showed insecurity (p 0.01) and paranoid ideation (p = 0.04). We identified specific aspects of psychological impairment in IBD depending on disease and disease activity. Our results underscore the need for psychological support and treatment particularly in active CD. Diese Studie untersuchte Unterschiede in der Persönlichkeit, psychische Belastung und Stressbewältigung bei chronisch-entzündlichen Darmerkrankungen (CED) in Abhängigkeit von der Art der Erkrankung und der Krankheitsaktivität. Wir verglichen Patienten mit Morbus Crohn (CD) und Colitis ulcerosa (UC) mit Kontrollgruppen. Während die Literatur zu charakteristischen Merkmalen der Pathogenese von IBD zahlreich ist, sind die spezifischen Unterschiede in den psychischen Beeinträchtigungen nicht ausreichend untersucht. In dieser deutschen nationalen Multicenterstudie wurden Teilnehmer aus 32 Zentren rekrutiert. Es wurden 297 Fragebögen mit umfassenden Informationen über den Krankheitsstatus und das psychische Wohlbefinden auf der Grundlage validierter psychosozialer Instrumente mit insgesamt 285 Items evaluiert. CD-Patienten waren stärker von psychischen Beeinträchtigungen betroffen als Patienten mit UC oder Kontrollen. Wichtig ist, dass Patienten mit aktiver CD in den Bereichen Neurotizismus (p 0,01), psychische Belastung (p 0,001) und maladaptive Stressbewältigung (p 0,03) höhere Werte, aber weniger Bedarf für soziale Unterstützung (p = 0,001) als Kontrollen aufwiesen. Im Gegensatz dazu zeigten Patienten, die an aktiver UC litten, psychische Belastung (p 0,04) und maladaptive Coping (Vermeidung, p 0,03; Flucht, p = 0,01). Patienten in Remission schienen weniger betroffen zu sein. Die Gruppe der CD-Patienten in Remission zeigte jedoch Unsicherheit (p 0,01). Wir identifizierten spezifische Aspekte der psychischen Beeinträchtigung bei IBD abhängig von Krankheit und Krankheitsaktivität. Unsere Ergebnisse untermauern den Bedarf an psychologischer Unterstützung und Behandlung, insbesondere bei aktiver CD.

Primary biliary cirrhosis (PBC) is a chronic cholestatic, progressive inflammatory liver disease with a suspected autoimmunological pathogenesis. The disease is typically diagnosed in women at an age between 30 and 65 years and has a prevalence of up to 1 in 1000 women over the age of 40. The only approved medical therapy for PBC is ursodeoxycholic acid (UDCA) in a recommended dose of 13–15mg/kg/day. UDCA is a hydrophilic dihydroxy bile acid (3a,7bdihydroxy-5b-cholanoic acid). In humans, UDCA accounts for up to 4% of the bile acid pool. Following oral administration, approximately 30–60% of UDCA is absorbed in the gut. After intestinal absorption, UDCA enters the portal circulation and is then taken up by the hepatocytes via specific bile acid transporters. Within the hepatocyte, UDCA is conjugated to glycine or taurine and is subsequently transported into the bile ducts by the bile salt export pump (BSEP). In bile, UDCA concentration peaks 1 3 h following oral administration. In humans, the biological half-life of UDCA is 3.5–5.8 days and the predominant route of elimination is by feces. UDCA exerts its beneficial effects at the level of hepatocytes and cholangiocytes. It stimulates hepatocyte secretion by mostly post-transcriptional mechanisms, including insertion of transporters like BSEP and the anion exchanger AE2. In addition, UDCA exerts antiapoptotic effects in hepatocytes and protects cholangiocytes against endogenous toxic bile acids by modifying micelle formation. UDCA consistently improves the biochemical parameters of cholestasis, delays the histological progression and the time to liver transplantation in patients suffering from PBC. Both, UDCA 250mg capsules and UDCA 500mg tablets (“Ursofalk1”), are registered in Germany and other European countries for the treatment of PBC. UDCA 500mg tablets were developed to facilitate medication intake compared to the standard UDCA 250mg capsule preparations. Tablets are considerably smaller, but contain twice as much active pharmaceutical ingredient compared to the capsule preparation, which might improve the compliance of patients and thereby increase its therapeutic efficacy. Ursofalk tablets were registered in Germany on the basis of bioequivalence studies comparing tmax, Cmax, and AUC values of UDCA between capsules and tablets. Cmax values of UDCA in plasma are probably of only limited clinical relevance for the efficacy and safety of UDCA. Aim of this trial was to assess if the therapeutic efficacy of UDCA 500mg tablets is equivalent to that of UDCA 250mg capsules (both at 14 2mg/kg BW/day once daily) in patients with PBC. Therapeutic efficacy was measured by comparing the liver enzyme parameters alkaline phosphatase (AP), g-glutamyl transferase (gGT), and alanine aminotransferase (ALT) under both treatments. The secondary objectives were to assess the safety Clinical Pharmacology in Drug Development XX(XX) 1–6 © The Author(s) 2013 DOI: 10.1002/cpdd.24