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

Abstract

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.

Polyherbal formulation Anoac‑H suppresses the expression of RANTES and VEGF for the management of bleeding hemorrhoids and fistula

“…Anoac-H suppresses the cell migratory potential. Several cell types infiltrate the site of hemorrhoids and fistula to induce an inflammatory reaction (8,15,(20)(21)(22). Several cell types, including macrophages and fibroblasts, migrate to the site of inflammation and have a critical role in the inflammatory reaction (20)(21)(22).…”

“…Hemorrhoids and fistulas are associated with inflammation. Different types of cells, such as macrophages, neutrophils, and fibroblasts, are present in the inflammatory environment of hemorrhoids and fistulas (8,15,(20)(21)(22). Natural remedies for hemorrhoids and fistula, including laxatives, analgesics and anti-inflammatory agents, have drawn much attention recently due to their relatively higher effectiveness, low cost and lower invasiveness (23,24).…”

“…Previous studies indicated that severe inflammatory reaction takes place in the vascular wall and the surrounding connective tissue of the hemorrhoids and it gradually leads to mucosal ulceration, ischemia and thrombosis ( 7 ). In this area, tissue damage induces an inflammatory response, which manifests as infiltration of T-lymphocytes, macrophages, neutrophils, monocytes, mast cells and dendritic cells ( 8 ). These cells secrete both anti- and proinflammatory cytokines.…”

“…These cells secrete both anti- and proinflammatory cytokines. However, due to excessive production of proinflammatory cytokines, the proinflammatory response gradually overtakes the anti-inflammatory response ( 8 , 9 ). IL-1β, IL-6, regulated upon activation, normal T cell expressed and presumably secreted (RANTES), VEGF and TNF-α are considered proinflammatory cytokines which have a critical role in human health and disease ( 10 , 11 ).…”

The efficacy of alum sitz baths followed by topical gall ointment in hemorrhoids—a single-arm clinical trial

“…Hemorrhoidal disease is classified as internal, external, and interno-external hemorrhoids based on their location (Shrivastava et al 2018 ). External hemorrhoids are located below the dentate line in the distal one-third of the anal canal and are covered by anoderm (skin), while internal hemorrhoids commence beyond the dentate line covered with a mucus membrane.…”