Dear the Editor
We have read with great interest a review article entitled ‘Trends in treatment of hemorrhoids, fistula, and anal fissure: Go along the current trends’ by Hwang[1]. This comprehensive review highlighted recent advances in hemorrhoidal treatment and novel sphincter-preserving procedures for anal fistulas. However, as noted in the article, there was no innovative pharmacological approach to chronic anal fissure and its management remained unchanged for years despite the modest efficacy of these medical therapies. Although topical nitrates or calcium channel blockers could reduce pain and promote fissure healing compared to placebo, their efficacy had low certainty of evidence according to a recent systematic review and meta-analysis of 37 randomized controlled trials[2]. In fact, these chemical sphincterotomies including botulinum toxin injection were associated with approximately 50% fissure healing and half of them will experience a recurrent disease[1].
In our view, apart from anal sphincter hypertonicity which might improve with chemical sphincterotomy[2], poor tissue healing per se is another underlying pathophysiology of anal fissures[3]. Therefore, a promotion of epithelial healing using a topical agent would be of great interest for treating anal fissures. Being introduced in Japan as a selective mucosal protecting agent in 1960s and now available worldwide, oral and topical sucralfate is known to promote epithelial healing by forming a polyanion gel as a protective layer over the wound, increasing mucus production leading to further mucosal protection, and facilitating tissue repair by enhancing the action of tissue growth factors and epidermal growth factors[4].
Based on the healing properties of this drug, we investigated the effects of 3% sucralfate ointment in 17 adult patients with chronic anal fissure (Thai Clinical Trial Registration number: TCTR20221013003). Anal fissures persisting longer than six weeks together with the exposed internal anal sphincter were defined as chronic. The ointment was applied twice daily onto the fissure for 2 weeks and could extend to 4 weeks if a fissure remained unhealed. Osmotic laxatives were also prescribed as our standard of care if patients had hard stool or constipation.
The studied patients had average age of 45 years and average symptom duration of 3 months. Fourteen patients (82%) had healed fissure after 2-week treatment and all except one (94%) had healed fissure at 4 weeks. Two patients (12%) reported anal itching during the application of drug. Compared with their baselines, patients' quality of life evaluated by HEMO-FISS-QoL[5] (scale from 0 to 100; 0 indicating best and 100 indicating worst health status) significant improved at 2 weeks after treatment (30.4 [IQR 17.4-39.1] vs 14.1 [IQR 1.1-19.6], p<0.001). During 3-month follow-up, one patient (6%) had recurrent fissure which was well responsive to the re-application of topical sucralfate.
Although this small cohort had no control group, its encouraging results of topical sucralfate for treating chronic anal fissure are worth exploring in large randomized control trials especially in the light of low efficacy of currently available chemical sphincterotomy and a relatively small number of researches examining novel treatment of anal fissures[1].
Conflicts of Interest
There are no conflicts of interest.
Author Contributions
VL outlined the content, reviewed literature and wrote the manuscript. VL and AM collected and analyzed data. AM critically reviewed the manuscript. All authors read and approved the final manuscript.
Approval by Institutional Review Board (IRB)
This study was approved by the Institutional Review Board (Si 681/2022).
Consent to Participate
Informed consent was obtained from each patient.
Consent for Publication
Informed consent was obtained from each patient.
Availability of Data and Material
According to the institution's policy, the research data are confidential.
Code Availability
Not applicable
References
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