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Alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide improve erectile function, sexual quality of life, and ejaculation function in patients with moderate mild-moderate erectile dysfunction: a prospective, randomized, placebo-controlled, single-blinded study.

Sansalone S, Leonardi R, Antonini G, Vitarelli A, Vespasiani G, Basic D, Morgia G, Cimino S, Russo GI - Biomed Res Int (2014)

Bottom Line: We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up.Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A.Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.

View Article: PubMed Central - PubMed

Affiliation: Department of Experimental Medicine and Surgery, Tor Vergata University of Rome, Rome, Italy.

ABSTRACT
We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90). Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD), and sexual quality of life (SQoL-M) were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B (P < 0.05). PSV (P < 0.05), IIEF-intercourse satisfaction (P < 0.05), IIEF-orgasmic function (mean P < 0.05), IIEF-sexual desire (P < 0.05), IIEF-overall satisfaction (P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05) were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.

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Mean changes from baseline to 3 months for International Index of Erectile Function domain (aP < 0.05, versus baseline; bP < 0.05, versus Group B).
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fig2: Mean changes from baseline to 3 months for International Index of Erectile Function domain (aP < 0.05, versus baseline; bP < 0.05, versus Group B).

Mentions: Table 2 lists the mean change differences from baseline to 3 months relative to main outcome measures. When concerning the primary endpoint of this study, we observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B at the intergroup analysis (mean difference: 10.22; P < 0.05). In Group A, significant differences from baseline to last follow-up were observed relative to PSV (mean difference: 1.36 cm/s; P < 0.05), IIEF-IS (mean difference: 1.72; P < 0.05), IIEF-OF (mean difference: 2.2; P < 0.05), IIEF-SD (mean difference: 1.03; P < 0.05), IIEF-OS (mean difference: 2.51; P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05). In Group A, patients with moderate arterial dysfunction showed significant increase of IIEF-EF (mean difference: 1.82; P < 0.05), PSV (mean difference: 1.56; P < 0.05), MSHQ-EjD (mean difference: 1.23; P < 0.05), and SQoL-M (mean difference: 11.65; P < 0.05) from baseline to 3 months. Significant differences were found at the intergroup analysis when considering previous outcome measures (Table 2) and (Figure 2). Patients with normal arterial function and with severe arterial dysfunction of Group A did not report improvement of penile CDU measures after treatment. When considering serum TT and EDV, both groups did not show any difference after 3 months. All subjects included in the study protocol tolerated treatments, and none reported adverse events.


Alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide improve erectile function, sexual quality of life, and ejaculation function in patients with moderate mild-moderate erectile dysfunction: a prospective, randomized, placebo-controlled, single-blinded study.

Sansalone S, Leonardi R, Antonini G, Vitarelli A, Vespasiani G, Basic D, Morgia G, Cimino S, Russo GI - Biomed Res Int (2014)

Mean changes from baseline to 3 months for International Index of Erectile Function domain (aP < 0.05, versus baseline; bP < 0.05, versus Group B).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4127274&req=5

fig2: Mean changes from baseline to 3 months for International Index of Erectile Function domain (aP < 0.05, versus baseline; bP < 0.05, versus Group B).
Mentions: Table 2 lists the mean change differences from baseline to 3 months relative to main outcome measures. When concerning the primary endpoint of this study, we observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B at the intergroup analysis (mean difference: 10.22; P < 0.05). In Group A, significant differences from baseline to last follow-up were observed relative to PSV (mean difference: 1.36 cm/s; P < 0.05), IIEF-IS (mean difference: 1.72; P < 0.05), IIEF-OF (mean difference: 2.2; P < 0.05), IIEF-SD (mean difference: 1.03; P < 0.05), IIEF-OS (mean difference: 2.51; P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05). In Group A, patients with moderate arterial dysfunction showed significant increase of IIEF-EF (mean difference: 1.82; P < 0.05), PSV (mean difference: 1.56; P < 0.05), MSHQ-EjD (mean difference: 1.23; P < 0.05), and SQoL-M (mean difference: 11.65; P < 0.05) from baseline to 3 months. Significant differences were found at the intergroup analysis when considering previous outcome measures (Table 2) and (Figure 2). Patients with normal arterial function and with severe arterial dysfunction of Group A did not report improvement of penile CDU measures after treatment. When considering serum TT and EDV, both groups did not show any difference after 3 months. All subjects included in the study protocol tolerated treatments, and none reported adverse events.

Bottom Line: We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up.Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A.Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.

View Article: PubMed Central - PubMed

Affiliation: Department of Experimental Medicine and Surgery, Tor Vergata University of Rome, Rome, Italy.

ABSTRACT
We aimed to evaluate the efficacy of oral therapy with alga Ecklonia bicyclis, Tribulus terrestris, and glucosamine oligosaccharide (Tradamix TX1000) in patients with erectile dysfunction (ED) at 3 months of follow-up. From January 2013 to September 2013, 177 patients diagnosed with mild-moderate ED (IIEF-EF < 26) were enrolled in this multicenter, single-blinded, placebo-controlled study and randomized in Group A (Tradamix, n = 87) and Group B (placebo, n = 90). Penile color Doppler ultrasound measures, IIEF-15 questionnaire, male sexual health questionnaire-ejaculation disorder (MSHQ-EjD), and sexual quality of life (SQoL-M) were collected. We observed significant changes of the IIEF-15 in Group A (mean difference: 11.54; P < 0.05) at 3 months versus Group B (P < 0.05). PSV (P < 0.05), IIEF-intercourse satisfaction (P < 0.05), IIEF-orgasmic function (mean P < 0.05), IIEF-sexual desire (P < 0.05), IIEF-overall satisfaction (P < 0.05), MSHQ-EjD (mean difference: 1.21; P < 0.05), and SQoL-M (mean difference: 10.2; P < 0.05) were significantly changed in Group A versus baseline and Group B. Patients with moderate arterial dysfunction showed significant increase of PSV (P < 0.05), IIEF-EF (P < 0.05), MSHQ-EjD (P < 0.05), and SQoL-M (P < 0.05) in Group A. Therapy with Tradamix improves erectile and ejaculation function and sexual quality of life in patients with mild-moderate ED and in particular for those with moderate arterial dysfunction.

Show MeSH
Related in: MedlinePlus