Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2
| Autor: | Kirsten Lykke Wahlstrøm, Peter-Martin Krarup, K. Hagen, Helene Perregaard, Helene Tarri Hougaard, Andreas Nordholm-Carstensen |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty beta-Glucans Pain law.invention 03 medical and health sciences Diltiazem Young Adult 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Clinical endpoint Humans Chronic Adverse effect Anal fissure Wound Healing business.industry Plant Extracts Standard treatment Gastroenterology Hepatology medicine.disease Clinical trial Drug Combinations 030220 oncology & carcinogenesis Anesthesia Chronic Disease Feasibility Studies 030211 gastroenterology & hepatology Female Fissure in Ano Randomized trial business medicine.drug |
| Zdroj: | Nordholm-Carstensen, A, Perregaard, H, Wahlstrøm, K L, Hagen, K B, Hougaard, H T & Krarup, P M 2020, ' Treatment of chronic anal fissure : a feasibility study on Levorag® Emulgel versus Diltiazem gel 2% ', International Journal of Colorectal Disease, vol. 35, no. 4, pp. 615-621 . https://doi.org/10.1007/s00384-020-03515-z |
| ISSN: | 1432-1262 |
| DOI: | 10.1007/s00384-020-03515-z |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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