A Double-Blind Randomized Trial Comparing the Effectiveness and Safety of Nifedipine and Isosorbide Dinitrate in Chronic Anal Fissure|
Khaledifar, Borzoo; Mahmoudi, Mehran Yousefi Ahmad & Mobasheri, Mahmoud
Chronic anal fissure is a common disease that is accompanied with pain and
bleeding during defecation. Various surgical and non-surgical methods have been offered for the
treatment of this condition.
The aim of this randomised clinical study was to compare the effectiveness and
safety of nifedipine and isosorbide dinitrate (ISDN) in the treatment of chronic anal fissure.
This double-blind clinical trial study was performed on patients aged 20 to 60
years old in 2012 to 2013. The samples with a primary diagnosis of chronic anal fissure were enrolled
from the patients admitted to public treatment at the educational Imam Ali Clinic, Shahrekord, Iran
by researchers and general surgery specialists. The patients were randomised into two groups:
nifedipine 0.3% (n = 35) or ISDN 0.2% (n = 35) applied three times a day for three weeks. The patients
were examined on the 7th, 14th, and 21st days of treatment, and the symptoms including bleeding,
pain, and healing status, as well as the side effects of the drugs, were assessed. Pain was evaluated
using a visual analogue scale (VAS).
After 21 days of follow-up, complete healing was achieved in 77.1% (n = 27) of
patients in the nifedipine group and 51.4% (n = 18) in the ISDN group (P = 0.05). The mean VAS of
the pain on day 21 was 0.91 (SD 0.01) in the ISDN group and 0.45±0.78 in the nifedipine group, with
a statistically significant difference (P = 0.038). The bleeding was similar in the two groups (P =
In view of the findings on healing status and pain in the patients, nifedipine may
be significantly more effective in the treatment of chronic anal fissure than ISDN.
chronic; anal fissure; nifedipine; isosorbide dinitrate