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Topical Diltiazem Cream Versus Botulinum Toxin A for the Treatment of Chronic Anal Fissure: A Double-Blind Randomized Clinical Trial

Samim, Morsal BSc*; Twigt, Bas MD*; Stoker, Lennart PharmD; Pronk, Apollo MD, PhD*

doi: 10.1097/SLA.0b013e318225178a
Randomized Clinical Trials

Objective: A double-blind randomized clinical trial to compare topical diltiazem with botulinum toxin A (BTA) in the treatment of chronic anal fissure.

Background: Chronic anal fissures remain a challenging condition. Topical diltiazem and BTA are promising agents in the treatment of anal fissure. As to date diltiazem and BTA were never compared in a solid randomized trial, which is the purpose of this study.

Methods: One hundred thirty-four patients were randomized to receive either diltiazem cream and placebo injection or BTA injection and placebo cream. The primary end point was fissure healing after 3 months.

Results: After 3 months healing of the fissure was noted in 32 of 74 (43%) patients in the diltiazem group and 26 of 60 (43%) patients in the BTA group. Reduction >50% in mean pain score was noted in 58 of 74 (78%) patients in the diltiazem group and 49 of 60 (82%) patients in the BTA group. Perianal itching was the only side effect reported and was noted in 15% of patients in the diltiazem group, and this difference was statistically significant (P = 0.012).

Conclusions: BTA yields higher healing rates in the short term, though after 3 months diltiazem and BTA resulted in equal healing rates. Also no significant difference in pain reduction was observed for both treatments. This study shows no significant advantage of one treatment compared to the other. This randomized clinical trial is registered by the Dutch Trial Register as NTR1012.

A prospective randomized controlled trial in the treatment of anal fissures comparing botulinum toxin A versus topical diltiazem.

*Department of Surgery

Department of Hospital Pharmacy, Diakonessenhuis Hospital, The Netherlands.

Reprints: Apollo Pronk, MD, PhD, Department of Surgery, Diakonessenhuis Hospital, PO box 80250 3508 TG Utrecht, The Netherlands. E-mail:

Disclosure: Supported by the Foundation of Science in surgery, Diakonessenhuis hospital. Diltiazem cream and Botox were supplied for free by: S.L.A. Pharma (United Kingdom), and Allergan (The Netherlands). The sponsor of the study had no role in the protocol design, study conduct or data analysis.

© 2012 Lippincott Williams & Wilkins, Inc.