Percutaneous Posterior Tibial Nerve Stimulation vs Perianal Application of Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: A Randomized Clinical Trial.

BACKGROUND

Current therapeutic guidelines for the treatment of chronic anal fissure establish a medical approach as the first step. Glyceryl trinitrate ointment is the most popular of the available topical treatments in Spain but it is associated with the appearance of headache.

OBJECTIVE

The purpose of this study was to compare the compliance rate among patients receiving glyceryl trinitrate treatment for chronic anal fissure with that among patients receiving percutaneous posterior tibial nerve stimulation.

DESIGN

This was a prospective randomized study.

SETTINGS

The study was conducted at Garcilaso Clinic (Madrid, Spain).

PATIENTS

Subjects with persistent anal fissure despite hygiene and dietary measures applied over at least a 6-week period were included.

INTERVENTIONS

Study interventions were perianal application of glyceryl trinitrate ointment (twice daily for 8 weeks) and percutaneous posterior tibial nerve stimulation (30-minute session 2 days per week for 8 weeks).

MAIN OUTCOME MEASURES

Compliance with the treatment and healing rate of chronic anal fissure in patients receiving glyceryl trinitrate ointment or undergoing percutaneous posterior tibial nerve stimulation were evaluated.

RESULTS

Forty patients were included in each group. In the glyceryl trinitrate ointment group, 15% of the patients discontinued treatment because of disabling headaches. There were no adverse effects or treatment withdrawals in the percutaneous posterior tibial nerve stimulation group (p = 0.033). After 8 weeks of treatment, the healing rate in the percutaneous posterior tibial nerve stimulation group was 87.5% vs 65.0% in the glyceryl trinitrate ointment group (p = 0.018).

LIMITATIONS

Because the patients were not blinded to the treatment, we cannot rule out a placebo effect derived from the needle insertion in the percutaneous posterior tibial nerve stimulation group.

CONCLUSIONS

Percutaneous posterior tibial nerve stimulation is a safe and effective alternative that is in some ways superior to glyceryl trinitrate ointment for the treatment of chronic anal fissure.