Abstract
Abstract
Background:
We investigated the therapeutic efficacy of a new composite natural drug based on Tribulus terrestris, BIOVIS® and the alga Ecklonia bicyclis in order to improve male sexual function, selecting patients using the International Index of Erectile Function (IIEF), Nocturnal Penile Tumescence and Rigidity Testing (NPTR) using the RigiScan® device and hormonal levels.
Materials and methods:
A total of 164 patients with erectile dysfunction (ED) were enrolled between September 2009 and January 2010. Patients were classified as having mild (n = 64), moderate (n = 62) or severe (I = 38) ED. Mean age was 53.1 years. A new compound (150 mg of the alga Ecklonia bicyclis, 396 mg of Tribulus terrestris and 144 mg of BIOVIS®) was administered to all patients twice a day for 60 days. The IIEF questionnaire was administered and NPTR testing was carried out using the Rigiscan® device both pre and post-treatment with all patients.
Results:
150 patients were evaluable, and their IIEF scores were all significantly improved, with an increase of 78% in the mild ED group, an 80% improvement in the moderate ED group, and an improvement of 108% in the severe ED group compared with the baseline. The mean IIEF scores for all the patients showed significant improvement after 8 weeks of treatment with this new composite drug (baseline 14.3 ± 1.5 to 26.2 ± 3.2; P = 0.01). Among other parameters penile rigidity and tumescence, as tested using the RigiScan® showed significant improvement for treated patients. Furthermore, no significant side effects were claimed.
Conclusion:
The active components of these three natural compounds (namely protodioscin, a steroidal saponin, contained in Tribulus terrestris; the polyphenols, dieckol, florofucofuroeckol and bieckol, contained in the alga Ecklonia bicyclis; and the polymers of d-glucosamine and n-acetyl-d-glucosamine contained in BIOVIS®) when combined, seem to work in synergy not only improving erectile function but also stimulating testosterone-dependent sexual desire. Protodioscin is able to stimulate testosterone production and it also has an androgen-mimetic action, binding and activating the testosterone receptors. Polyphenols play an anti-nflammatory role, modulating the cytokines (lipopolisaccarids, TNF-alpha, IFN-gamma) with a potent antioxidant and antifibrotic effect. BIOVIS® acts on both the non-adrenergic and non-cholinergic system (NANC) and on the endothelial cell system as a strong nitric oxide synthetase (NOS) stimulator. Our study demonstrated that this new composite drug was effective in the oral treatment of ED.
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