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 - 2020/4
Y1 - 2020/4
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 - Adult
KW - Chronic Disease
KW - Diltiazem/adverse effects
KW - Drug Combinations
KW - Feasibility Studies
KW - Female
KW - Fissure in Ano/complications
KW - Humans
KW - Male
KW - Pain/drug therapy
KW - Plant Extracts/adverse effects
KW - Wound Healing
KW - Young Adult
KW - beta-Glucans/adverse effects
U2 - 10.1007/s00384-020-03515-z
DO - 10.1007/s00384-020-03515-z
M3 - Journal article
C2 - 31980871
SN - 0179-1958
VL - 35
SP - 615
EP - 621
JO - International Journal of Colorectal Disease
JF - International Journal of Colorectal Disease
IS - 4
ER -