Article ; Online: Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2.
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 |
Full text online
More links
Kategorien
In stock of ZB MED Cologne/Königswinter
Zs.A 2121: Show issues | Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG) |
Order via subito
This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.