Retrospective analysis on the efficacy of botulinum toxin alone versus combined botulinum toxin and topical diltiazem

This study aims to compare the short- and long-term outcomes of botulinum toxin (BT) alone versus BT combined with topical diltiazem (TD) in the treatment of chronic anal fissures (CAF).

The study is designed as a retrospective analysis, reviewing data from 1296 patients diagnosed with anal fissures who presented to our clinic between 2017 and 2022.

Single center (University hospital).

A total of 217 patients who met the inclusion criteria were analyzed, with 143 receiving BT alone and 74 receiving the combination of BT + TD.

BT was administered as 100 IU injected into four quadrants. TD was applied twice daily for 10 days immediately following the BT injection.

Primary outcome measures were fissure healing at 2 months and days to pain-free defecation. Secondary outcome measures were complete healing and recurrence rates at 24 months.

There were no significant differences in demographic characteristics and symptom duration between the BT and BT + TD groups. The median time to pain-free defecation was 7 days across the entire series, with no statistical difference between groups. At 2 months, complete healing was observed in 74.4% of patients, with no significant difference between groups: 74.8% for BT and 74.3% for BT + TD. During a median follow-up of 53 (22-101) months, a recurrence rate of 26.3% was observed, and TD showed no effect on complete healing and recurrence rates.

The most significant limitation of our study is its retrospective design and the absence of a placebo control for TD.

The study demonstrates that BT is an effective and safe treatment for CAF, with or without the addition of TD. The combination therapy did not show superior outcomes.