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  1. Article ; Online: Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2.

    Nordholm-Carstensen, Andreas / Perregaard, Helene / Wahlstrøm, Kirsten Lykke / Hagen, Kikke Bartholin / Hougaard, Helene Tarri / Krarup, Peter-Martin

    International journal of colorectal disease

    2020  Volume 35, Issue 4, Page(s) 615–621

    Abstract: Purpose: To compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures.: Methods: This was a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal ... ...

    Abstract Purpose: To compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures.
    Methods: This was a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal fissure were randomised to treatment with diltiazem or Levorag® Emulgel twice daily for 8 weeks. Primary endpoint was complete healing of the anal fissure after 12 weeks. Secondary endpoints included incidence of adverse events and efficacy on pain relief.
    Results: In total, 55 patients were included. Inclusion was terminated prematurely due to a slow inclusion rate. Complete fissure healing at 12 weeks follow-up was overall achieved in 31 of 55 (56%) patients, 18 of 29 (62%) in the diltiazem group compared with 13 of 26 (50%) in the Levorag® Emulgel group (P = 0.424). Pain relief was significantly better at day seven in patients treated with diltiazem (P = 0.040) compared with Levorag® Emulgel, whereas there were no differences in early (3 days) or late (12 weeks) pain relief. Three patients (10.3%) developed severe perianal exanthema during diltiazem treatment, whereas no side effects were observed in the Levorag® Emulgel group.
    Conclusion: The study demonstrated statistical non-inferiority of Levorag® Emulgel compared with diltiazem in the treatment of chronic anal fissure. Diltiazem resulted in a more prompt pain relief and also in a substantial number of local allergic reactions. Levorag® Emulgel may therefore be an alternative in these patients.
    Trial registration: Clinicaltrials.gov no. NCT02158013.
    MeSH term(s) Adult ; Chronic Disease ; Diltiazem/adverse effects ; Diltiazem/therapeutic use ; Drug Combinations ; Feasibility Studies ; Female ; Fissure in Ano/complications ; Fissure in Ano/drug therapy ; Humans ; Male ; Pain/drug therapy ; Pain/etiology ; Plant Extracts/adverse effects ; Plant Extracts/therapeutic use ; Wound Healing ; Young Adult ; beta-Glucans/adverse effects ; beta-Glucans/therapeutic use
    Chemical Substances Drug Combinations ; Levorag ; Plant Extracts ; beta-Glucans ; Diltiazem (EE92BBP03H)
    Language English
    Publishing date 2020-01-24
    Publishing country Germany
    Document type Comparative Study ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 84975-3
    ISSN 1432-1262 ; 0179-1958
    ISSN (online) 1432-1262
    ISSN 0179-1958
    DOI 10.1007/s00384-020-03515-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Serotonin, calcitonin and calcitonin gene-related peptide in acute pancreatitis.

    Wahlstrøm, Kirsten Lykke / Novovic, Srdan / Ersbøll, Annette Kjær / Hasbak, Philip / Jørgensen, Lars Nannestad / Berner Hansen, Mark

    Scandinavian journal of gastroenterology

    2017  Volume 52, Issue 10, Page(s) 1140–1147

    Abstract: Objective: The aim of this study was to investigate plasma levels of serotonin, calcitonin and calcitonin gene-related peptide (CGRP) in the course of acute pancreatitis (AP) taking organ failure, etiology and severity into consideration.: Material ... ...

    Abstract Objective: The aim of this study was to investigate plasma levels of serotonin, calcitonin and calcitonin gene-related peptide (CGRP) in the course of acute pancreatitis (AP) taking organ failure, etiology and severity into consideration.
    Material and methods: Sixty consecutive patients with alcohol- or gallstone-induced AP were included over a 15-month period. Patients were treated according to a standardized algorithm and monitored for organ specific morbidity and mortality. Organ functions and blood samples were assessed on days 0, 1, 2 and 14 after hospital admission. Twenty healthy volunteers, matched for age and gender, comprised the reference group.
    Results: Lower levels of serotonin were observed in patients at admission compared to healthy volunteers (p = .021). Serotonin levels increased from day 2 to 14 (p < .001), but with no relation to severity, etiology or organ failure. No difference in calcitonin levels was found in patients at admission compared to healthy volunteers. However, calcitonin levels decreased over time (p < .001) and higher levels were found in patients with respiratory failure (p = .039). No difference was observed in relation to severity or etiology. CGRP levels in patients at admission did not differ from healthy volunteers, nor did CGRP change over time or show any relationship to severity, etiology or organ failure.
    Conclusion: Our data suggest serotonin and calcitonin levels to be associated to time-course of AP, and calcitonin levels to organ dysfunction. We hypothesize that serotonin plays a pathogenic role in the compromised pancreatic microcirculation, and calcitonin a role as a biomarker of severity in AP.
    MeSH term(s) Acute Disease ; Adult ; Aged ; Aged, 80 and over ; Alcoholism/complications ; Biomarkers/blood ; Calcitonin/blood ; Calcitonin Gene-Related Peptide/blood ; Case-Control Studies ; Female ; Gallstones/complications ; Humans ; Male ; Middle Aged ; Pancreas/physiopathology ; Pancreatitis/blood ; Pancreatitis/etiology ; Pancreatitis/physiopathology ; Prospective Studies ; Serotonin/blood ; Severity of Illness Index ; Time Factors ; Young Adult
    Chemical Substances Biomarkers ; Serotonin (333DO1RDJY) ; Calcitonin Gene-Related Peptide (83652-28-2) ; Calcitonin (9007-12-9)
    Language English
    Publishing date 2017-10
    Publishing country England
    Document type Journal Article
    ZDB-ID 82042-8
    ISSN 1502-7708 ; 0036-5521
    ISSN (online) 1502-7708
    ISSN 0036-5521
    DOI 10.1080/00365521.2017.1346703
    Database MEDical Literature Analysis and Retrieval System OnLINE

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