Efficacy and Safety of a Herbal Formula that Mainly Consists of Cornus Officinalis for Erectile Dysfunction: A Double-blind, Placebo-controlled Study

Sung Chul Kam; See Min Choi; Sung Uk Jeh; Seung Hyun Lee; Jeong Seok Hwa; Ky Hyun Jung; Chang Wan Kang; Jae Seog Hyun

doi:10.4111/kju.2007.48.7.741

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Kam, Choi, Jeh, Lee, Hwa, Jung, Kang, and Hyun: Efficacy and Safety of a Herbal Formula that Mainly Consists of Cornus Officinalis for Erectile Dysfunction: A Double-blind, Placebo-controlled Study

Original Article

Korean Journal of Urology

Korean Journal of Urology 2007; 48(7): 741-747.

Published online: 31 July 2007

DOI: https://doi.org/10.4111/kju.2007.48.7.741

Efficacy and Safety of a Herbal Formula that Mainly Consists of Cornus Officinalis for Erectile Dysfunction: A Double-blind, Placebo-controlled Study

Sung Chul Kam, See Min Choi, Sung Uk Jeh, Seung Hyun Lee, Jeong Seok Hwa, Ky Hyun Jung, Chang Wan Kang¹, Jae Seog Hyun

Department of Urology, School of Medicine, Gyeongsang National University, Jinju, Korea.

¹Department of Data Information Science, School of Natural Science, Dong Eui University, Busan, Korea.

Corresponding author (hyunjs@gshp.gsnu.ac.kr)

Received 2 March 2007 Accepted 28 March 2007

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.

Keywords: Herbal formula, Erectile dysfunction, Treatment efficacy, Safety

Figures and Tables

Fig. 1

Effects on penetration success rate (SEP Q2) and intercourse success rate (SEP Q3). At the endpoint, the patients receiving herbal formula improved the penetration success rate and the intercourse success rate, but there were no significantly changes in both groups (the herbal formula groups vs. the placebo groups).

Fig. 2

Global assessment question (GAQ): satisfaction with the erection quality. At the endpoint, the patients receiving the herbal formula reported a greater percentage of successful intercourse attempts and a greater proportion of improved erections (GAQ: 95% compared to placebo: 73.5%) (p<0.05).

Table 1

Patient characteristics

^*p<0.05

Table 2

Mean change of the IIEF measures at base line and the endpoint

^*p<0.05: baseline vs. endpoint, ^†p<0.05: herbal formula vs. placebo. IIEF: International Index of Erectile Function, EF: erectile function (score range 0-35), O.F: orgasmic function (score range 0-10), SD: sexual desire (score range 0-10), IS: intercourse satisfaction (score range 0-15), OS: overall satisfaction (score range 0-10)

Table 3

Effect on quality of life (QoL) at base line and the endpoint

^*p<0.05: baseline vs. endpoint, ^†p<0.05: herbal formula vs. placebo. Life A: life as a whole, Life B: sexual life, Life C: partnership relation, IIEF: International Index of Erectile Function

Table 4

Mean change of the IIEF measures at base line and the endpoint according to age and the IIEF score

^*p<0.05: baseline vs. endpoint, ^†p<0.05: herbal formula vs. placebo. IIEF: International Index of Erectile Function

Table 5

Side effects

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