DOI: 10.21276/ajptr
Thu, 20 Jun 2019

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

[PDF]   Viewed: 11118   Downloaded: 637
  • Call for paper

    American Journal of PharmTech Research (AJPTR) is a peer-reviewed, bimonthly official international journal allowing access to abstracts and full-text.



  • Email & SMS Alerts

    Email/SMS alert system is one of the key features and gives update information about the submitted manuscript.


  • Article Statastics

    American Journal of PharmTech Research (AJPTR) provides unique facility for authors to know popularity of articles on basis of numbers of PDF download and views. It will display in tabulated format.

  • Online Submission

    American Journal of PharmTech Research (AJPTR) is one of the International open access journal devoted to various disciplines in science and technology.


web counter
web counter