Chronic anal fissure: 2% topical diltiazem hydrochloride

How well does topical diltiazem hydrochloride work?

In all, 9 studies have looked at how well diltiazem cream or ointment works for treating anal fissures.

Only 1 of these studies looked at how well it worked compared with using no treatment. The anal fissure healed completely in 24 out of 30 adults who were using the diltiazem ointment compared with 10 out of 30 adults who were not using anything. The study had only a small number of people so this finding may not be accurate. Adults who were using the diltiazem ointment also had less pain than those who weren't receiving any treatment.

Out of the 9 studies, 7 compared diltiazem cream or ointment with GTN. Overall, these studies showed that the diltiazem cream or ointment worked about as well as GTN at both healing fissures and relieving pain. Other studies have found that, on average, about 49 people in every 100 who used GTN had their anal fissure healed, compared with about 36 people in every 100 who used dummy cream or ointment. One of the studies compared diltiazem cream with botulinum toxin injection. The diltiazem cream worked about as well as botulinum toxin injection at both healing fissures and relieving pain. However, the study had only a small number of people so this finding may not be accurate.

Two of the studies compared diltiazem ointment with surgery. Fewer people using diltiazem ointment had their fissures healed than people who had surgery (32 people out of 40 using diltiazem ointment compared with 38 out of 40 who had surgery in 1 study; and 63 out of 91 using diltiazem ointment compared with 93 out of 97 who had surgery in the other study). These studies had only small numbers of people so these findings may not be accurate.

Only 1 of the studies of diltiazem was in children. The average age of the children in this study was about 3 years. The study suggested that diltiazem ointment was better than GTN at healing anal fissures in children (23 out of 28 using diltiazem were healed compared with 11 out of 28 using GTN). However, the study had only a small number of children so this finding may not be accurate.

What are the possible harms or side effects?

Based on the studies, diltiazem cream or ointment does not appear to cause significant harm or side effects in adults using it in the short term. Most studies looked at use for around 3 months or less. It is not known what possible harms or side effects the treatment may cause if it is used for longer than this. However, diltiazem cream or ointment is not usually used for long periods.

A few adults in the studies had itchiness or irritation around the place where the diltiazem cream or ointment was applied. Some people had mild headaches while using it. Because of the small number of people in the studies, it is not possible to draw firm conclusions on how common these side effects are. But fewer people using diltiazem cream or ointment got headache compared with people using GTN (although some did). The 1 study in children was too small to draw conclusions about what side effects may occur when diltiazem cream or ointment is used to treat anal fissures in children, or how common they are.