Erysimum cheiri and Rosa × damascena cerate vs. Diltiazem 2% gel in the treatment of acute anal fissure: A randomized, controlled clinical trial

Abstract

IntroductionAnal fissure which is an ischemic ulcer in the lining of the anus, is a common challenging problem in current medicine. This study was designed to evaluate the benefits of a Persian Medicine cerate containing wallflower (Erysimum cheiri) and damask rose (Rosa×damascena) oil (WDC) on anal fissure. MethodsThis randomized, controlled clinical trial was conducted on 64 acute anal fissure patients. In each group, patients were given either 0.5 g of WDC or 2.5 cm of Diltiazem 2% gel twice daily for 2 weeks. Anal pain, itching and inflammation were primary outcomes. The recurrence rate and statistical analyses were performed on a per protocol and intention-to-treat basis. ResultsFifty-three patients completed the study. The symptoms decreased significantly (p < 0.05) in all patients after 2 weeks. Comparison of responses between groups reveals no significant differences (p > 0.05) in pain, itching, and inflammation. There was no significant difference (p > 0.05) in recurrence rate of the disease, but the trend of healing in WDC group was better than Diltiazem 2% gel after six weeks. No serious adverse events were observed. ConclusionThe results suggest that topical application of the cerate containing wallflower and damask rose oil can be considered as a potential herbal medicine for the treatment of anal fissure. It exerts comparable clinical effects to current routine treatment. Further studies with long-term follow-ups and larger sample sizes are necessary to have a comprehensive overview of the safety and efficacy of this natural preparation.