A Double-Blind Randomised Controlled Trial Comparing the Efficacy of Nifedipine and Diltiazem Ointments in the Treatment of Anal Fissure.

Abstract

Anal fissure, a common anorectal disorder, usually presents with pain, bleeding, and itching during or after defecation. These fissures can be classified as acute, chronic, or acute on chronic, depending on the duration of symptoms (6 weeks or less for acute and more than 6 weeks for chronic). Traditional treatment involves medical interventions to reduce sphincter tone and improve blood flow. Topical calcium channel blockers (CCBs) have shown promising results in conservative management. This study aimed to compare the efficacy and safety of Nifedipine versus Diltiazem ointments in treating anal fissures through a double-blind, randomized controlled trial conducted at a tertiary care centre. From August 2022 to November 2023, 110 patients with acute, chronic, or acute-on-chronic anal fissures were randomized into two groups, receiving 1 g of either 0.3% Nifedipine and 2% lidocaine or 2% Diltiazem and 2% lidocaine ointments twice daily for 6 weeks. The primary outcome was assessed using the REALISE score, which measures pain, bleeding, and overall quality of life. Secondary outcomes included perianal irritation and adverse events. Both treatments significantly improved the REALISE scores, with reductions from baseline to 6 weeks indicating effective symptom relief. Nifedipine reduced the score from 17.7 ± 3.9 to 5.3 ± 1.8 (p = 0.0001), while Diltiazem reduced it from 16.3 ± 3.9 to 5.8 ± 2.3 (p = 0.0001). Healing rates were comparable between groups (70.9% for Nifedipine and 67.3% for Diltiazem), and both treatments were well-tolerated with minimal side effects. This study confirms that both Nifedipine and Diltiazem are effective first-line treatments for anal fissures, offering viable short-term non-surgical options. Further research with longer follow-up and multicentric studies is needed to evaluate long-term outcomes and treatment combinations. This study was registered in the Indian Clinical Trials Registry under the code: CTRI/2022/04/042081. Registered on April 22, 2022 (URL: https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=66601&EncHid=71722.40664&modid=1&compid=19).