Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2%
Research output: Contribution to journal › Journal article › Research › peer-review
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
Original language | English |
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Journal | International Journal of Colorectal Disease |
Volume | 35 |
Issue number | 4 |
Pages (from-to) | 615-621 |
ISSN | 0179-1958 |
DOIs | |
Publication status | Published - 2020 |
- Anal fissure, Chronic, Randomized trial
Research areas
ID: 256161468