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Investigation of a complex plant extract for mild to moderate erectile dysfunction in a randomized, double-blind, placebo-controlled, parallel-arm study.

Abstract

OBJECTIVE

To assess the effects of a complex plant extract (Prelox®, a formulation of pine bark extract and l-arginine aspartate; Horphag Research UK Ltd, London, UK) on erectile dysfunction (ED) in men, as sexual desire typically persists in ageing men, while their erectile and endothelial function gradually declines.

PATIENTS AND METHODS

In this double-blind, placebo-controlled study we assessed the effects of Prelox in 124 patients (aged 30-50 years) with moderate ED over an investigational period of 6 months. The International Index Of Erectile Function (IIEF) was used to quantify changes in sexual function.

RESULTS

The erectile domain of the IIEF (questions 1-5 plus 15) improved with Prelox from a baseline mean (sd) score of 15.2 (6.6) to 25.2 (2.1) after 3 months and 27.1 (2.1) after 6 months of treatment. In the placebo group there was an increase from a baseline score of 15.1 (7.0) to 19.1 (3.0) and 19.0 (3.1) after 3 and 6 months, respectively. The effects with Prelox were statistically significant compared with placebo (P < 0.05). Mean (SD) total plasma testosterone levels increased significantly from 15.9 (2.3) to 18.9 (2.6) nmol/L (P < 0.05) after 6 months with Prelox, compared to an increase from 16.9 (2.4) to 17.3 (2.3) nmol/L in the placebo group.

CONCLUSION

This study shows that Prelox is effective for improving erectile function, and that this effect persists on continuous therapy for up to 6 months. Moreover, there is some evidence that erectile function continues to improve the longer the therapy is used.

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  • Authors+Show Affiliations

    ,

    Irvine Vascular Laboratories and Physiology, Department of Biomedical Sciences, Gabriele D'Annunzio University, Chieti-Pescara, Italy.

    , , ,

    Source

    BJU international 106:7 2010 Oct pg 1030-3

    MeSH

    Adult
    Arginine
    Aspartic Acid
    Drug Combinations
    Drug Therapy, Combination
    Epidemiologic Methods
    Flavonoids
    Humans
    Impotence, Vasculogenic
    Male
    Middle Aged
    Phytotherapy
    Pinus
    Plant Extracts
    Treatment Outcome
    Vasodilator Agents

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    20184576

    Citation

    Ledda, Andrea, et al. "Investigation of a Complex Plant Extract for Mild to Moderate Erectile Dysfunction in a Randomized, Double-blind, Placebo-controlled, Parallel-arm Study." BJU International, vol. 106, no. 7, 2010, pp. 1030-3.
    Ledda A, Belcaro G, Cesarone MR, et al. Investigation of a complex plant extract for mild to moderate erectile dysfunction in a randomized, double-blind, placebo-controlled, parallel-arm study. BJU Int. 2010;106(7):1030-3.
    Ledda, A., Belcaro, G., Cesarone, M. R., Dugall, M., & Schönlau, F. (2010). Investigation of a complex plant extract for mild to moderate erectile dysfunction in a randomized, double-blind, placebo-controlled, parallel-arm study. BJU International, 106(7), pp. 1030-3. doi:10.1111/j.1464-410X.2010.09213.x.
    Ledda A, et al. Investigation of a Complex Plant Extract for Mild to Moderate Erectile Dysfunction in a Randomized, Double-blind, Placebo-controlled, Parallel-arm Study. BJU Int. 2010;106(7):1030-3. PubMed PMID: 20184576.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Investigation of a complex plant extract for mild to moderate erectile dysfunction in a randomized, double-blind, placebo-controlled, parallel-arm study. AU - Ledda,Andrea, AU - Belcaro,Gianni, AU - Cesarone,Maria R, AU - Dugall,Mark, AU - Schönlau,Frank, Y1 - 2010/02/22/ PY - 2010/2/27/entrez PY - 2010/2/27/pubmed PY - 2010/11/4/medline SP - 1030 EP - 3 JF - BJU international JO - BJU Int. VL - 106 IS - 7 N2 - OBJECTIVE: To assess the effects of a complex plant extract (Prelox®, a formulation of pine bark extract and l-arginine aspartate; Horphag Research UK Ltd, London, UK) on erectile dysfunction (ED) in men, as sexual desire typically persists in ageing men, while their erectile and endothelial function gradually declines. PATIENTS AND METHODS: In this double-blind, placebo-controlled study we assessed the effects of Prelox in 124 patients (aged 30-50 years) with moderate ED over an investigational period of 6 months. The International Index Of Erectile Function (IIEF) was used to quantify changes in sexual function. RESULTS: The erectile domain of the IIEF (questions 1-5 plus 15) improved with Prelox from a baseline mean (sd) score of 15.2 (6.6) to 25.2 (2.1) after 3 months and 27.1 (2.1) after 6 months of treatment. In the placebo group there was an increase from a baseline score of 15.1 (7.0) to 19.1 (3.0) and 19.0 (3.1) after 3 and 6 months, respectively. The effects with Prelox were statistically significant compared with placebo (P < 0.05). Mean (SD) total plasma testosterone levels increased significantly from 15.9 (2.3) to 18.9 (2.6) nmol/L (P < 0.05) after 6 months with Prelox, compared to an increase from 16.9 (2.4) to 17.3 (2.3) nmol/L in the placebo group. CONCLUSION: This study shows that Prelox is effective for improving erectile function, and that this effect persists on continuous therapy for up to 6 months. Moreover, there is some evidence that erectile function continues to improve the longer the therapy is used. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/20184576/full_citation L2 - https://doi.org/10.1111/j.1464-410X.2010.09213.x DB - PRIME DP - Unbound Medicine ER -