TY - JOUR

T1 - Treatment of chronic anal fissure

T2 - a feasibility study on Levorag® Emulgel versus Diltiazem gel 2%

AU - Nordholm-Carstensen, Andreas

AU - Perregaard, Helene

AU - Wahlstrøm, Kirsten Lykke

AU - Hagen, Kikke Bartholin

AU - Hougaard, Helene Tarri

AU - Krarup, Peter Martin

PY - 2020

Y1 - 2020

N2 - 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

AB - 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

KW - Anal fissure

KW - Chronic

KW - Randomized trial

U2 - 10.1007/s00384-020-03515-z

DO - 10.1007/s00384-020-03515-z

M3 - Journal article

C2 - 31980871

AN - SCOPUS:85078323293

VL - 35

SP - 615

EP - 621

JO - International Journal of Colorectal Disease

JF - International Journal of Colorectal Disease

SN - 0179-1958

IS - 4

ER -