Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2

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

8 Citationer (Scopus)

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.

OriginalsprogEngelsk
TidsskriftInternational Journal of Colorectal Disease
Vol/bind35
Udgave nummer4
Sider (fra-til)615-621
Antal sider7
ISSN0179-1958
DOI
StatusUdgivet - apr. 2020

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