Investig Clin Urol.  2019 Jul;60(4):275-284. 10.4111/icu.2019.60.4.275.

Efficacy and safety of an herbal formula (KBMSI-2) in the treatment of erectile dysfunction: A preliminary clinical study

• Park NC
• Kim SW
• Hwang SY
• Park HJ

• KMID: 2450545
• DOI: http://doi.org/10.4111/icu.2019.60.4.275

Abstract

PURPOSE
To investigate the efficacy and safety of KBMSI-2, an herbal formula consisting of Ginseng Radix Rubra, Dioscorea tenuipes, Cornus officinalis Sieb. et Zucc., Lycium chinense Mill, and Curcuma longa Linn, for the treatment of erectile dysfunction (ED).
MATERIALS AND METHODS
Patients were instructed to take placebo or 6 g of KBMSI-2 twice per day for 8 weeks, at least 1 hour after food intake. The primary outcome was a change from baseline in erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire. Secondary outcome included changes from baseline in all domain scores of the IIEF, scores on the Aging Males' Symptoms scale, and serum total testosterone levels, as well as changes in questions 2 and 3 of the Sexual Encounter Profile, responses to the Global Assessment Question, and changes in the number of "˜yes' responses on the Androgen Deficiency in Aging Males questionnaire.
RESULTS
Patients receiving KBMSI-2 had a statistically significant improvement in baseline IIEF-EF domain scores at 8 weeks compared to the placebo group. Intercourse satisfaction domain and the total IIEF scores also increased in the KBMSI-2 group. However, we could not find any significant differences in other efficacy variables between the groups. Only one patient had an adverse event, which was mild in severity.
CONCLUSIONS
This preliminary clinical study of KBMSI-2 shows significant improvements in EF and intercourse satisfaction, as measured by the IIEF in patients with ED. Further studies using a larger number of patients in the long term should follow.

Keyword

Dioscorea; Erectile dysfunction; Ginseng; Herbal medicine; Phytotherapy

MeSH Terms

Aging
Clinical Study*
Cornus
Curcuma
Dioscorea
Eating
Erectile Dysfunction*
Herbal Medicine
Humans
Lycium
Male
Panax
Phytotherapy
Testosterone
Testosterone

Figure

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  Fig. 1 Trial schedule.

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  Fig. 2 Trial flow chart. ITT, intention to treat; PP, per-protocol.

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  Fig. 3 Effects of KBMSI-2 on International Index of Erectile Function-Erectile Function (IIEF-EF) score. *p<0.01 vs. baseline.

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  Fig. 4 Effects of KBMSI-2 on the responses to SEP 2 (A) and SEP 3 (B). SEP 2, Sexual Encounter Profile Question 2; SEP 3, Sexual Encounter Profile Question 3.

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  Fig. 5 Global Assessment Question (GAQ) after treatment.

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