Journal of Clinical & Experimental Pharmacology

Abstract

Clinical Efficacy of a Dual Action, Topical Anti-edematous and Antiinflammatory Device for the Treatment of External Hemorrhoids

Léa Shrivastava, Gisela da Silva Borges and Ravi Shrivastava

Objective: External hemorrhoids are enlarged, bulging blood vessels in and around the anus and lower rectum. They associate several pathologies such as engorged, edematous and inflamed sinusoids, with numerous proinflammatory cytokines on their surface, requiring a multi-target therapeutic approach. In the absence of any effective treatment, we assessed a newly conceived osmotically active, hypertonic, filmogen solution (Pileseptine-e) directed at attracting hypotonic liquid and helping suppress inflammation. The clinical efficacy and safety of Pileseptine-e on external hemorrhoids was evaluated in this study.
Methods: A 2-week treatment + 1-week follow-up, comparative, randomized, double blind, clinical trial with Pileseptine-e (n=37, test product) versus saline spray (n=17, placebo) was performed in patients suffering from external hemorrhoids. Test and placebo products were applied as 3-4 sprays, 3-4 times per day, for 14 consecutive days. Parameters were evaluated employing a 0-4 or 0-10 scoring scale, before treatment (baseline, T0), 2h after 1st treatment, and on Days 2, 3, 8, and 14, with follow-up check on Day 21.
Results: The test product induced an instant and strong outward exudation of liquid from inside the edematous hemorrhoids, thereby cleaning their surface, keeping it hydrated, and reducing pain and itching. A strong reduction in the size of hemorrhoids and rectal bleeding was also observed, which improved the quality of life of the patients considerably. The placebo product also provided noticeable symptomatic relief, but without effect on the size of hemorrhoids. No adverse effects were observed in any patient.
Conclusion: Reducing edema to allow hemorrhoidal volume to regress, and to normalize the structural physiology of the anal area, is the primary prerequisite to treat external hemorrhoids. Pileseptine-e is an antiedematous, cleaning, hydrating, safe and non-irritant filmogen solution that represents great advancement in the treatment of external hemorrhoids.