An anal fissure is a linear ulcer in the lower half of the anal canal, which follows a tearing in the epithelial layer covering the anal canal under the dentate line area. Fissures are most often located in the middle posterior section of the anal area. Constipation is one of the predisposing factors for anal fissure. The characteristic symptoms of anal fissure include: presence of pain at the time of defecation and hemorrhage from the anal area manifested by observation of light and fresh blood in the stool or on the cleaning tissue. Aim of the treatment in anal fissure is alleviation of pain, spasm and ischemia which has resulted in the ulcer.
The extract of chamomile has anti-inflammatory and antispasmodic properties and improves wound healing. Commission E of Germany has approved the local use of chamomile for treatment of inflammations of the skin and mucus, wounds and burns, bacterial infections of the skin and anogenital inflammations. In a comparative study, in 161 patients with eczema, the efficacy of a chamomile cream called Kamillosan has been reported as equal to hydrocortisone 0.25% and more than the efficacy of bufexamac 5% (a non-steroidal anti-inflammatory agent) and flucortin 0.75% (a glucocorticoid). The British Herbal Pharmacopeia recommends the local use of chamomile for treatment of hemorrhoid, mastitis and leg ulcers.
Aleppo oak gall contains 60-70% tannin which accounts for its astringent properties. Also, dry extract of Aleppo oak gall has analgesic properties. Local indication of Aleppo oak gall include treatment of skin inflammations and adjuvant treatment of skin infections.
In a randomized, double-blind clinical trial, 58 patients with anal fissure were administered for 8 weeks, twice a day, either Anti-fissure Topical Cream or lidocaine H ointment. The patients were examined every 2 weeks and the course of treatment was followed up.
Analysis of the data gathered in this study showed that the general symptoms of anal fissure decreased 95% in the group taking lidocaine H ointment, and 100% in the group taking Anti-fissure Topical Cream, but no statistically significant difference existed between the two groups (p>0.3). The effect of both drugs on hemorrhage, pain at the time of defecation, burning of the anus, tenesmus and constant pain was statistically significant. In the lidocaine H ointment group and in the Anti-fissure Topical Cream group, the improvement in the amount of hemorrhage was 36% and 76.7%, respectively (p=0.07); improvement in pain at the time of defecation was 4.5% and 14%, respectively (p=0.4); improvement in tenesmus was 23.1% and 44%, respectively (p=N.S) and improvement in constant pain was observed as 38.2% and 56.5%, respectively (p=0.07); and the efficacy of Anti-fissure Topical Cream in comparison with lidocaine H ointment was significant in the case of constant pain (p=0.009). Regarding adverse reactions, no statistically significant difference existed between the two groups (p>0.2).
The researchers came to the conclusion that generally no statistically significant difference exists between lidocaine H ointment and Anti-fissure Topical Cream with regard to efficacy and adverse effects in treatment of anal fissure. However, due to the fact that the ingredients in Anti-fissure Topical Cream are natural and can be produced inside the country, special attention needs to be paid to this product.