Isosorbide dinitrate ointment vs botulinum toxin A (Dysport) as the primary
treatment for chronic anal fissure: a randomized multicentre study.
Author(s): Berkel AE(1), Rosman C, Koop R, van Duijvendijk P, van der Palen J, Klaase JM.
Affiliation(s): Author information:
(1)Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands.
Publication date & source: 2014, Colorectal Dis. , 16(10):O360-6
AIM: Nitric oxide donors, such as isosorbide dinitrate ointment (ISDN), are
considered as first-choice agents in the treatment of chronic anal fissure.
Injection with botulinum toxin A in the internal anal sphincter is often used as
a second-line therapy, although it may give better results and fewer side effects
than nitric oxide donors. The aim of this randomized clinical trial was to
investigate whether botulinum toxin A (Dysport) is more effective than ISDN in
the primary treatment of chronic anal fissure.
METHOD: From April 2005 until October 2009, 60 patients (32 men) with a median
age of 42 (25-82) years were randomized to receive either ISDN 10 mg/ml (1%) (n =
33) or injection with 60 units of Dysport (n = 27). The primary end-point was the
percentage of complete fissure healing after 8 weeks.
RESULTS: After a median of 9 weeks complete fissure healing was noted in 18 of 27
patients in the Dysport group and in 11 of 33 patients in the ISDN group (P =
0.010). Absolute improvement of pain scores after 9 weeks was similar in both
groups (P = 0.733). Patients treated with Dysport had fewer side effects than
patients treated with ISDN (P = 0.028). Of the patients with a healed fissure,
28% of the Dysport group and 50% of the ISDN group had a recurrence within 1 year
(P = 0.286; hazard ratio 2.08; 95% CI = 0.54-7.97).
CONCLUSION: Dysport is more effective than ISDN ointment and has fewer side
effects in the primary treatment of chronic anal fissure. The recurrence rate
within 1 year in both treatment groups is high.
|