[A prospective, randomized double-blind study on the treatment of anal fissures with Nitroglycerin ointment].

BACKGROUND

Anal fissure is a common disease. Treatment includes conservative measures or surgery. One of the treatment options is topical Nitroglycerin ointment.

MATERIALS AND

METHODS

We present a prospective, randomized, double-blind study, encompassing 48 patients suffering from chronic anal fissure. The subjects were divided into three groups according to the dose of Nitroglycerin ointment received--group I--0% (placebo), group II--0.2% (0.75 mg) and group III--0.4% (1.5 mg). Demographic data, medical history and physical findings were recorded. Healing, pain relief and adverse events were evaluated during and after the treatment period.

RESULTS

No significant difference (p<0.05) was found between the groups with respect to patient age, gender, past history, physical examination, amount of ointment used and adverse events. Thirty three of the 48 (69%) patients completed the study. No significant differences were found between the groups with respect to the reasons and rates of leaving the study (p=0.494). Fifteen patients failed to complete the study; eight patients (17%) due to headaches, one patient was operated upon and six patients left the study because of cooperation problems. No significant difference was found between the groups regarding healing (p=0.952) or pain relief (p=0.458-0.8 according to the type of pain checked).

CONCLUSIONS

According to our study, there was no benefit regarding healing or pain relief, in treating patients suffering from an anal fissure with Nitroglycerin ointment in combination with stool softeners and sitz baths, compared to the same treatment without Nitroglycerin ointment.