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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
Author(s) -
Ledda Andrea,
Belcaro Gianni,
Cesarone Maria R.,
Dugall Mark,
Schönlau Frank
Publication year - 2010
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/j.1464-410x.2010.09213.x
Subject(s) - erectile dysfunction , double blind , placebo , medicine , urology , cardiology , pathology , alternative medicine
Study Type – Therapy (RCT)
Level of Evidence 1b 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.