Comparison of Efficacy and Safety Of 2% Nigella Sativa Ointment with 2% Diltiazem Ointment in the Management of Chronic Anal Fissure

Abstract

Objective: To compare the efficacy and safety of 2% diltiazem ointment with 2% nigella sativa ointment in the healing of chronic anal fissure (AF).

Methodology: This comparative experimental study was done at the Department of Pharmacology and Department of Surgery LUMHS, Jamshoro from October 2023 to March 2024. Diagnosed cases of chronic anal fissure of both genders and aged > 12 years were included and divided into two groups.  Patients of group A underwent topical application of 2% Diltiazem (DTZ) ointment over the anal verge twice daily for a period of 6 weeks along with sitz bath. Patients of group B underwent topical application of 2% Nigella sativa ointment (NSO) ointment over the anal verge twice daily for a period of 6 weeks with sitz bath. Patients were evaluated on the basis of severity of pain and overall effect on the quality of life QOL at 1st visit and after 6th week of treatment. After completion of 6 weeks of treatment plan both groups were assessed for healing of fissure and possible side effects during treatment. All the information was collected via study proforma.

Results: Median duration of complaints in groups A and B was 8 and 10 months respectively. Males were in majority in both groups. Patients’ VAS score decreased from 5.8±8.2 to 3.5±6.3 in DTZ group whereas in NSO group it decreased from 7.8±0.96 to 1.47±0.8 after 6th week. WHOQOL-BREF score in DTZ group did not show notable improvement in all four domains whereas patients in NSO group showed significantly elevated WHOQOL-BREF scores after 6th week of treatment. Overall fissure healing rate was significantly higher in NSO group (80.3%) compared to the DTZ group (p<0.05).

Conclusion: As per study conclusion, treatment with NSO was observed to be safer and more effective in comparison to DTZ.