Efficacy and Safety Evaluation of Ruscus Aculeatus L in Patients With Hemorrhoids

Summary

Hemorrhoidal disease is characterized by distal displacement and deterioration of structural integrity of vascular cushions in the anal canal, which physiologically help defecation and continence. Unlike advanced stage (stage IV) hemorrhoids, which require surgical intervention, various topical agents (gels, ointments, creams), oral venoactive drugs, homeopathic and phytotherapeutic products and nutritional supplements are widely used in stage II and III hemorrhoidal disease. The genus Ruscus (family Asparagaceae) is a group of plants native to the Mediterranean basin, Southern and Western Europe, and Iran, represented by perennial, rhizome-based, and evergreen shrubs. Among the species belonging to this genus, Ruscus aculeatus L. has the widest distribution area. The subsoil parts of the Ruscus plant are rich in steroidal saponins and show vasoconstrictor, diuretic, anti-inflammatory and venotonic effects, especially with ruscogenin and neoruscogenin compounds. Due to these properties, R. aculeatus stands out as a traditional phytotherapy agent that has been used for a long time in chronic venous insufficiency. However, there are no controlled clinical studies in the literature evaluating the efficacy and safety of Ruscus aculeatus L. in hemorrhoidal disease. Therefore, this study was aimed to systematically evaluate the contribution of a phytotherapeutic product containing R. aculeatus to the treatment of stage II-III hemorrhoidal patients and to provide scientific evidence of a new and potentially safe herbal treatment option that can be used in the treatment of hemorrhoids.

Timeline

Start

2025-08-01

Primary completion

2026-08-01

Completion

2026-11-02

Publications

• Background Bouskela E, Cyrino FZ, Marcelon G. Effects of Ruscus extract on the internal diameter of arterioles and venules of the hamster cheek pouch microcirculation. J Cardiovasc Pharmacol. 1993 Aug;22(2):221-4. doi: 10.1097/00005344-199308000-00008.
• Background Masullo M, Pizza C, Piacente S. Ruscus Genus: A Rich Source of Bioactive Steroidal Saponins. Planta Med. 2016 Dec;82(18):1513-1524. doi: 10.1055/s-0042-119728. Epub 2016 Nov 8.
• Background Boyle P, Diehm C, Robertson C. Meta-analysis of clinical trials of Cyclo 3 Fort in the treatment of chronic venous insufficiency. Int Angiol. 2003 Sep;22(3):250-62.
• Background Pompilio G, Nicolaides A, Kakkos SK, Integlia D. Systematic literature review and network Meta-analysis of sulodexide and other drugs in chronic venous disease. Phlebology. 2021 Oct;36(9):695-709. doi: 10.1177/02683555211015020. Epub 2021 May 13.

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