**13. Our experience: Nifedipine gel 0.2% with lidocaine**

### **13.1 Subjects**

Seventy children suffering from acute and chronic anal fissures treated by us between 2004 and 2010 comprised the study population. They were all treated topically with nifedipine gel 0.2% with lidocaine for 4 weeks and followed up for as long as possible in our outpatient clinic (a maximum of 5 years).

#### **13.2 Methods**

Because anal fissure has such a distinctive appearance, its healing is the most objective measure of treatment efficacy available that can be standardized. Combining all analyses in which a placebo was used as the comparison group, the healing rate in the placebo group is 35.5 percent, a level of response that is fairly uniform across studies (standard deviation, 11.8 percent). For these reasons we did not find necessary to use a control group in the present pilot study.

#### **13.3 Results**

There were 28 males and 42 females. Their clinical presentation consisted of constipation, rectal bleeding, anal and abdominal pain, perianal itching and rectal prolapse (58, 50, 33, 6, 4, and 1 cases, respectively). Posterior, anterior, multiple, both posterior and anterior, and both posterior and lateral fissures were the main physical findings (44, 16, 5, 4, and 1 cases, respectively). Fifty eight patients completed the 4-week treatment course, with another 7 patients requiring a second 4-week treatment course in order to achieve complete remission, indicated by resolution of symptoms and complete healing of the fissure (65 patients altogether). The remaining 5 patients had recurrence of symptoms in 2, 4, 11, 18 and 19 months, respectively, treated successfully by an additional 4-week course of nifedipine. The recurrence rate observed was very low (7.14%). All the 70 patients had a mean follow-up of 1.88 years, ranging from 6 months to 5.2 years. Problems with compliance were not observed, one of the main reasons for treatment failure in adults. No side effects of nifedipine were observed.

Fig. 4. Clinical presentation (percentage)
