Journal List > Korean J Urol > v.50(2) > 1005276

Ham, Kim, Lee, Ju, Kang, Oh, Her, Chung, Park, and Choi: Efficacy and Safety of Red Ginseng Extract Powder in Patients with Erectile Dysfunction: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Abstract

Purpose

To evaluate the safety and efficacy of red ginseng extract powder (OKBT) for treating erectile dysfunction.

Materials and Methods

Sixty-nine adult patients with mild to moderate erectile dysfunction of various etiologies were randomized to receive placebo or red ginseng extract powder. The red ginseng extract powder used in the present study was named OKBT. The primary efficacy parameter was response to the International Index of Erectile Function (IIEF) erectile function domain at baseline and week 8. Other IIEF domain scores were evaluated as secondary parameters. For safety evaluation, we performed history taking, physical examination, clinical laboratory tests, and hormonal tests at baseline and week 8.

Results

There were no significant differences in the patients' characteristics between the 2 groups. After 8 weeks of administration, primary efficacy (erectile function domain) and all secondary efficacy domains were significantly improved in the OKBT group compared with the placebo group (p<0.05). Notably, even the domain related to sexual desire, frequency and degree of sexual desire, was also improved in the OKBT group (p<0.001). There were no significant adverse reactions with OKBT administration, and there were also no significant differences in the results of laboratory tests between the 2 groups after administration.

Conclusions

Our data show that red ginseng extract powder can be used as an alternative remedy for Korean men suffering from mild to moderate erectile dysfunction.

Figures and Tables

Table 1
Characteristics of patients
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OKBT: red ginseng extract powder, PSA: prostate-specific antigen, a: mean±SD, b: Student's t-test, c: Fisher's exact test

Table 2
Change from baseline in IIEF erectile score
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IIEF: International Index of Erectile Function, OKBT: red ginseng extract powder, a: Linear by linear association test

Table 3
Results for primary efficacy (erectile function domain)
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IIEF: International Index of Erectile Function, Last observ.: last observation after 8 weeks, OKBT: red ginseng extract powder, a: mean±SD, b: analysis of covariance (ANCOVA) test

Table 4
Results of the secondary efficacy (IIEF domain except erectile function) analysis
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IIEF: International Index of Erectile Function, Last observ: last observation after 8 weeks, OKBT: red ginseng extract powder, a: mean±SD, b: analysis of covariance (ANCOVA) test

Table 5
Results for adverse events in overall cases
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OKBT: red ginseng extract powder

Notes

This study was supported by BT gin, Inc. (4-2004-0018) and a grant of the Korea Healthcare technology R&D Project, Ministry for Health, Welfare & Family Affairs, Republic of Korea (A084120).

References

1. McKinlay JB. The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res. 2000. 12:Suppl 4. S6–S11.
2. Kim TH, Chung TG, Ahn TY. Relation between lower urinary tract symptoms and erectile dysfunction: epidemiologic study in Jeong-Eup, Korea. Korean J Androl. 1998. 16:87–91.
3. Ryu SB, Min KD, Park KS, Park YI, Rhee JA, Kweon SS. Epidemiologic study of the male erectile dysfunction with risk factors in rural area. Korean J Androl. 2001. 19:125–131.
4. Chun DC, Choi YD, Choi HK. The clinical characteristics of male patients complaining sexual dysfunction. Korean J Urol. 1998. 39:391–395.
5. Zheng BL, He K, Kim CH, Rogers L, Shao Y, Huang ZY, et al. Effect of a lipidic extract from lepidium meyenii on sexual behavior in mice and rats. Urology. 2000. 55:598–602.
6. Hadidi KA, Aburjai T, Battah AK. A comparative study of Ferula hermonis root extracts and sildenafil on copulatory behaviour of male rats. Fitoterapia. 2003. 74:242–246.
7. Kim DW, Kim DH, Choi DH, Kim DH, Jung GW. Effects of Ginseng alkaloid on the tension of rabbit corpus cavernosum. Korean J Androl. 2002. 20:16–22.
8. Kim SW, Paick SC. Clinical efficacy of Korean Ginseng on vasculogenic impotent patients. Korean J Androl. 1999. 17:23–28.
9. Juilfs DM, Soderling S, Burns F, Beavo JA. Cyclic GMP as substrate and regulator of cyclic nucleotide phosphodiesterases (PDEs). Rev Physiol Biochem Pharmacol. 1999. 135:67–104.
10. Hayreh SS. Erectile dysfunction drugs and non-arteritic anterior ischemic optic neuropathy: Is there a cause and effect relationship? J Neuroophthalmol. 2005. 25:295–298.
11. Danesh-Meyer HV, Levin LA. Erectile dysfunction drugs and risk of anterior ischaemic optic neuropathy: casual or causal association? Br J Ophthalmol. 2007. 91:1551–1555.
12. Kekilli M, Beyazit Y, Purnak T, Dogan S, Atalar E. Acute myocardial infarction after sildenafil citrate ingestion. Ann Pharmacother. 2005. 39:1362–1364.
13. Hayat S, Al-Mutairy M, Zubaid M, Suresh C. Acute myocardial infarction following sildenafil intake in a nitrate-free patient without previous history of coronary artery disease. Med Princ Pract. 2007. 16:234–236.
14. Lee U, Lee M, Kim SY, Ji YH, Hong JH, Ahn TY. Clinical efficacy and safety of sildenafil in the men with erectile dysfunction in Korea. Korean J Urol. 2001. 42:435–440.
15. Yoo C, Park J, Kim W, Hong B, Hong J, Ahn TY. Comparison of the efficacy, safety and patient preference of the phosphodiesterase type 5 inhibitors for the patients with erectile dysfunction. Korean J Urol. 2007. 48:219–225.
16. Kam SC, Choi SM, Jeh SU, Lee SH, Hwa JS, Jung KH, et al. Efficacy and safety of a herbal formula that mainly consist of cornus officinalis for erectile dysfunction: a double-blind, placebo-controlled study. Korean J Urol. 2007. 48:741–747.
17. Hah JS, Kang BS, Kang DH. Effect of Panax ginseng alcohol extract on cardiovascular system. Yonsei Med J. 1978. 19:11–18.
18. Kim ND, Kang SY, Schini VB. Ginsenosides evoke endothelium-dependent vascular relaxation in rat aorta. Gen Pharmacol. 1994. 25:1071–1077.
19. Choi YD, Park JA, Choi HK, Nam KY. Effects of composition of saponin fraction from Korean Red Ginseng in the relaxation of rabbit and rat corpus cavernosum. J Ginseng Res. 1999. 23:13–20.
20. Choi YD, Xin ZC, Choi HK. Effect of Korean Ginseng on the isolated rabbit corpus cavernosal smooth muscle. J Ginseng Res. 1996. 20:133–139.
21. Nam KY, Ko SR, Choi KJ. Relationship of saponin and non-saponin for the quality of Ginseng. J Ginseng Res. 1998. 22:274–283.
22. Adimoelja A. Phytochemicals and the breakthrough of traditional herbs in the management of sexual dysfunctions. Int J Androl. 2000. 23:Suppl 2. 82–84.
23. Ito TY, Polan ML, Whipple B, Trant AS. The enhancement of female sexual function with ArginMax, a nutritional supplement, among women differing in menopausal status. J Sex Marital Ther. 2006. 32:369–378.
24. Ito TY, Trant AS, Polan ML. A double-blind placebo-controlled study of ArginMax, a nutritional supplement for enhancement of female sexual function. J Sex Marital Ther. 2001. 27:541–549.
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Kwangsung Park
https://orcid.org/http://orcid.org/0000-0001-8827-162X

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