Topical Diltiazem Alone Versus Diltiazem With Lidocaine for the Treatment of Chronic Anal Fissure: A Prospective, Randomized Controlled Clinical Trial
Kushal Mital1, Sanjay Kumar Maroo2*, Ketan Patel2, Rakesh Ojha2
1.Department of general surgery, Medicare Hospital, Mumbai, India
2.Medical Services Department, Troikaa Pharmaceuticals Limited, Commerce House 1, Bodakdev, Ahmedabad Gujarat
Increase in anal resting pressure (ARP) is considered as the primary cause of chronic anal fissure (CAF). Reduction in ARP is the primary objective in treatment of CAF. Topical diltiazem is considered as first-line treatment option in CAF as surgical treatment may be associated with several post operative complications including permanent incontinence in some cases. Few studies have reported that lidocaine alone is inferior to anal dilators for pain relief in CAF which suggest that relief of internal anal sphincter is required for effective symptomatic management. The aim of this study was to evaluate whether combined treatment with diltiazem and lidocaine has any significant advantage over diltiazem monotherapy in patients with CAF. To evaluate this, 150 patients were enrolled and randomized to either treatment group. ARP, pain intensity and adverse events were recorded at various time points over 20 days study period. Fall in the mean ARP from baseline was comparable in both the study groups. However, significantly greater fall in pain intensity from baseline was observed with combined treatment with diltiazem and lidocaine, which can be attributed to the additional local anesthetic effects of lidocaine with combination treatment. No patient had any systemic or local adverse effects. Global assessment by patients and investigator was also favourable for combination treatment. We conclude that combined treatment with topical diltiazem and lidocaine is safe and effective option for pharmacological treatment of CAF, and addition of lidocaine to diltiazem significantly increases the pain relief achieved with diltiazem alone.
Keywords: Chronic anal fissure, diltiazem, lidocaine, anal resting pressure
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