Efficacy and safety of a herbal formula that mainly consists of Cornus officinalis for erectile dysfunction: A double-blind, placebo-controlled study

Abstract

Purpose: The aim of this study was to evaluate the efficacy and safety of a herbal formula that mainly consists of Cornus officinalis for treating erectile dysfunction. Materials and methods: Eighty patients suffering with erectile dysfunction were enrolled in this randomized, double-blinded, placebo-controlled study. The average duration of erectile dysfunction of the herbal formula group (n=40) vs. the placebo group (n=40) were 19.33±18.13 months vs. 19.33±25.62 months, respectively. The safety variables we examined were the history, physical examination, vital signs, EKG, clinical laboratory tests and hormonal tests. Efficacy assessments included the International Index of Erectile Function (IIEF), the sexual encounter profile (SEP) diary and Global Assessment Questions (GAQ). Results: No significant changes in the laboratory values, hormone tests and blood pressure were observed in both groups. In comparison with the placebo group (6.57±11.72), the herbal formula group experienced a significant improvement of the IIEF (11.13±11.83) (p<0.05). When the herbal formula and placebo groups were divided by age and the IIEF score (age: 50 years and IIEF: 42) and then compared, the low IIEF group (IIEF≤ 42) and old age group (age ≥ 50) of the herbal formula group significantly improved their IIEF score (p<0.05). The herbal formula group significantly improved their GAQ score (p<0.05). The herbal formula was well tolerated. The common adverse events were headache (2.5%) and nausea (5%). Conclusions: In conclusion, the herbal formula that mainly consists Cornus officinalis was not only effective at improving erectile function, but it was also safe for the treatment of erectile dysfunction.