ArticleCureus2026
Effectiveness and Safety of Lidocaine-Nifedipine Combination in Patients With Acute and Chronic Anal Fissure: A Retrospective, Multi-centric, Post-marketing Surveillance Study.
Article in Cureus, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background Anal fissures (AFs) are common and painful conditions that are frequently managed surgically; however, they are limited by fecal incontinence. Pharmacological management with calcium channel blockers has recently gained acceptance. This study aimed to evaluate the effectiveness and safety of twice-daily nifedipine (0.3% w/w) and lidocaine (1.5% w/w) cream in patients with acute AF (AAF) and chronic AF (CAF). Methods This retrospective, multi-centric, post-marketing surveillance study was conducted over a period of four weeks in the Department of Gastroenterology and Surgery across 46 institutes. The study included data of 431 patients with AAF (n=290) and CAF (n=141). The primary outcome measure was the percentage of patients with healed AFs, assessed at Weeks 1, 4, and 8. The secondary outcome measures were pain relief, evaluated using a 5-point VAS; percentage of patients with bleeding per anus; and adverse events (AEs), assessed at baseline and weekly follow-up intervals for eight weeks. Results At eight weeks, AF resolved significantly compared to the baseline (p<0.0001). During similar intervals, the incidence of bleeding per anus decreased significantly (p<0.0001), coupled with a significant reduction in the VAS score (p<0.0001). Though the resolution of AFs was comparable between AAF and CAF (p>0.05), the patients with AAF had a significantly greater reduction in bleeding per anus at Weeks 7 and 8 (p<0.05), with a significant decrease in the VAS score at Week 8 (p<0.05). All reported AEs were mild and self-limiting. Conclusion Topical nifedipine-lidocaine resulted in significant AF resolution, with significant pain relief and reduction in bleeding per anus, together with excellent tolerability.
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