Evaluation of the Efficacy and Safety of Diltiazem and Lidocaine Combination Gel in the Treatment of Anal Fissures: A Prospective, Randomized, and Comparative Study

A BSTRACT Background: Anal fissure is a common and painful anorectal condition affecting across all age groups. Pharmacological management remains the preferred first-line treatment due to its noninvasive nature and effectiveness in reducing pain, sphincter pressure, and promoting healing. This study aimed to evaluate the efficacy and safety of a combination gel containing diltiazem (DTZ) hydrochloride 2% w/w and lidocaine hydrochloride 2% w/w in compared to Lidocaine hydrochloride 2% w/w gel for the treatment of anal fissures. Materials and Methods: This was a prospective, randomized, and comparative study. Patients with anal fissures were randomized into two treatment groups: Group 1 received DTZ hydrochloride 2% w/w + lidocaine hydrochloride 2% w/w gel, while Group 2 received lidocaine hydrochloride 2% w/w gel. The endpoint was to compare efficacy on day 10 and day 21, assessed using the REALISE score, anal resting pressure, and visual analog scale (VAS) for pain. Results: A total of 50 patients were included. The mean reduction in REALISE score from baseline to day 21 was significantly higher in Group 1 (−8.2) compared to Group 2 (−7.1) ( P < 0.001). The VAS scores showed a significant reduction in Group 1 (−2.6) compared to Group 2 (−2.3) ( P < 0.001). The percentage reduction in mean resting anal pressure was around 13% in both group 1 and group 2 at day 21. Conclusion: The combination of DTZ hydrochloride 2% w/w and lidocaine hydrochloride 2% w/w gel was more effective than plain lidocaine hydrochloride 2% w/w gel in reducing pain and improving overall patient outcomes.