Protocol development in integrative medicine is not typically a simple process. Individuals require individualized care, and what works for one patient may not work for another.
To establish these protocols, we first developed a Rating Scale that could be used to discern the rigor of evidence supporting a specific nutrient’s therapeutic effect.
The following protocols were developed using only A through C-quality evidence.
A
Systematic review or meta-analysis of human trials
B
RDBPC human trials
2+ studies and/or 1 study with 50 + subjects
C
RDBPC human trials
1 study
As men age, concerns with fertility and sexual health arise. Erectile dysfunction (ED) is the inability to achieve or maintain an erection that is satisfactory for sexual intercourse. Prevalence of ED increases with age, with approximately 20% before age 30, 25% between age 30 to 39, 40% between age 40 to 49, 60% between age 50 to 59, 80% between age 60 to 69, and 90% above age 70. (1) ED is found as a comorbid condition to a variety of metabolic disorders and heart conditions. For example, the estimated prevalence of ED among patients with atrial fibrillation is 57%. (5) Both type 1 and type 2 diabetes mellitus also increase the likelihood of ED roughly 3.5-fold. (14)
Typical treatment of ED is varied and may consist of testosterone therapy, pharmaceutical interventions, or psychological and behavioral interventions. Many of the ingredients presented below focus on improving function and sexual satisfaction as assessed by the International Index of Erectile Function (IIEF), which is a questionnaire that assesses sexual activity, intercourse, stimulation, ejaculation, and orgasm, allowing insight into some of the possible mechanisms and areas of focus for treatment. (21)
Based on the research findings, the ingredients in the protocol below have shown efficacy in improving a variety of factors associated with improving male sexual function.
Korean ginseng (Panax ginseng)
2000 mg, total per day, minimum 8 weeks (6)(10)(13)
- International Index of Erectile Function (IIEF) score improved accounting for improvement in erectile function (ED) and overall satisfaction among patients after 8 weeks of supplementation with 1000 mg twice per day of tissue-cultured mountain ginseng extract when compared to placebo (13)
- 66.6% of patients with mild or moderate ED reported improved erection specifically rigidity, penetration, and maintenance as shown by an improvement in IIEF-5 score when given 1000 mg of Korean red ginseng 3 times per day compared to placebo (6)
- Improved IIEF scores for penetration and maintenance and improved penile tip rigidity as shown by RigiScan; 60% of patients noted that treatment helped with global efficacy (10)
- Meta-analysis of six RCTs showed benefits of Korean red ginseng for ED response rate (RR 2.40) and psychogenic ED response rate (RR 2.05) compared to placebo (11)
- Significant improvement in total and all IIEF domain scores in individuals with mild-to-moderate ED given 1400 mg ginseng berry extract daily for eight weeks (4)
750 mg, total per day, minimum 3 months (8) (12)
- Standardized active extract of Tribulus terrestris improved IIEF scores for intercourse satisfaction, orgasmic function, and sexual desire, and global efficacy (12)
- An increase in total testosterone and Arabic index of erectile function score from 2.2 at baseline to 2.7, IIEF from 10.7 at baseline to 16.1 were observed in aging males with partial androgen deficiency, ED and lower urinary tract symptoms when supplemented with Tribulus terrestris (8)
- 78% improvement in patients with Kshina Shukra (oligozoospermia) occurred when supplemented with Gokshura (Tribulus terrestris. Linn) for 60 days versus a 70% improvement for placebo (22)
Maca (Lepidium meyenii)
1500-2400 mg, total per day, minimum 8 weeks (9)(24)
- Psychological performance-related satisfaction profile (SAT-P) score increased with a particular improvement in physical and social performance aspects of the score in patients with ED supplemented with 2400 mg of dry maca extract per day for 12 weeks (24)
- Maca supplementation at both 1500 mg and 3000 mg doses improved sexual desire at week 8 and week 12 when compared to placebo (9)
- Endurance athletes improved self-rated sexual desire with maca extract supplementation compared to baseline and placebo; athletic performance in cycling time for 40 km improved as well when compared to baseline (23)
Arginine
5 g once per day for a minimum of 6 weeks (7)
- IIEF score improved accounting for increase in overall satisfaction, intercourse satisfaction, orgasmic function, and erectile function in patients with ED provided with 1500 mg to 5000 mg daily (20)
- L-arginine given as a concomitant to tadalafil improved IIEF and total testosterone compared to single-use of either in diabetic male patients (7)
- Patients with ED and a low initial urinary NOx improved subjective sexual function with high dose l-arginine of 5 g per day (3)
- Erectile function improved with 6 g of l-arginine glutamate combined with 6 mg of yohimbine supplementation taken 1-2 hours before intended sexual intercourse (15)
DHEA
50 mg of DHEA for a minimum of 6 months (18)(19)
- IIEF score increased in patients with ED when supplemented with 50 mg of DHEA for 6 months when compared to placebo (19)
- All domains of IIEF improved in elderly men with ED supplemented with 50 mg of DHEA (18)
Disclaimer
The Fullscript Integrative Medical Advisory team has developed or collected these protocols from practitioners and supplier partners to help health care practitioners make decisions when building treatment plans. By adding this protocol to your Fullscript template library, you understand and accept that the recommendations in the protocol are for initial guidance and may not be appropriate for every patient.
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- Allen, M. S., & Walter, E. E. (2019). Erectile Dysfunction: An Umbrella Review of Meta-Analyses of Risk-Factors, Treatment, and Prevalence Outcomes. The Journal of Sexual Medicine, 16(4), 531–541. https://pubmed.ncbi.nlm.nih.gov/30833150/ (F)
- Ambiye, V. R., Langade, D., Dongre, S., Aptikar, P., Kulkarni, M., & Dongre, A. (2013). Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study. Evidence-Based Complementary and Alternative Medicine: eCAM, 2013, 571420. https://pubmed.ncbi.nlm.nih.gov/24371462/ (C)
- Chen, J., Wollman, Y., Chernichovsky, T., Iaina, A., Sofer, M., & Matzkin, H. (1999). Effect of oral administration of high-dose nitric oxide donor L-arginine in men with organic erectile dysfunction: results of a double-blind, randomized, placebo-controlled study. BJU International, 83(3), 269–273. https://pubmed.ncbi.nlm.nih.gov/10233492/ (B)
- Choi, Y. D., Park, C. W., Jang, J., Kim, S. H., Jeon, H. Y., Kim, W. G., Lee, S. J., & Chung, W. S. (2013). Effects of Korean ginseng berry extract on sexual function in men with erectile dysfunction: a multicenter, placebo-controlled, double-blind clinical study. International Journal of Impotence Research, 25(2), 45–50. https://pubmed.ncbi.nlm.nih.gov/23254461/ (B)
- Chokesuwattanaskul, R., Thongprayoon, C., Pachariyanon, P., Sharma, K., Ungprasert, P., Bathini, T., & Cheungpasitporn, W. (2018). Erectile dysfunction and atrial fibrillation: A systematic review and meta-analysis. International Journal of Urology: Official Journal of the Japanese Urological Association, 25(8), 752–757. https://pubmed.ncbi.nlm.nih.gov/30014525/ (A)
- de Andrade, E., de Mesquita, A. A., Claro, J. de A., de Andrade, P. M., Ortiz, V., Paranhos, M., & Srougi, M. (2007). Study of the efficacy of Korean Red Ginseng in the treatment of erectile dysfunction. Asian Journal of Andrology, 9(2), 241–244. https://pubmed.ncbi.nlm.nih.gov/16855773/ (B)
- El Taieb, M., Hegazy, E., & Ibrahim, A. (2019). Daily Oral l-Arginine Plus Tadalafil in Diabetic Patients with Erectile Dysfunction: A Double-Blinded, Randomized, Controlled Clinical Trial. The Journal of Sexual Medicine, 16(9), 1390–1397. https://pubmed.ncbi.nlm.nih.gov/31326304/ (B)
- GamalEl Din, S. F., Abdel Salam, M. A., Mohamed, M. S., Ahmed, A. R., Motawaa, A. T., Saadeldin, O. A., & Elnabarway, R. R. (2019). Tribulus terrestris versus placebo in the treatment of erectile dysfunction and lower urinary tract symptoms in patients with late-onset hypogonadism: A placebo-controlled study. Urologia, 86(2), 74–78. https://pubmed.ncbi.nlm.nih.gov/30253697/ (C)
- Gonzales, G. F., Córdova, A., Vega, K., Chung, A., Villena, A., Góñez, C., & Castillo, S. (2002). Effect of Lepidium meyenii (MACA) on sexual desire and its absent relationship with serum testosterone levels in adult healthy men. Andrologia, 34(6), 367–372. https://pubmed.ncbi.nlm.nih.gov/12472620/ (C)
- Hong, B., Ji, Y. H., Hong, J. H., Nam, K. Y., & Ahn, T. Y. (2002). A double-blind crossover study evaluating the efficacy of korean red ginseng in patients with erectile dysfunction: a preliminary report. The Journal of Urology, 168(5), 2070–2073. https://pubmed.ncbi.nlm.nih.gov/12394711/ (C)
- Jang, D.-J., Lee, M. S., Shin, B.-C., Lee, Y.-C., & Ernst, E. (2008). Red ginseng for treating erectile dysfunction: a systematic review. British Journal of Clinical Pharmacology, 66(4), 444–450. https://pubmed.ncbi.nlm.nih.gov/18754850/ (A)
- Kamenov, Z., Fileva, S., Kalinov, K., & Jannini, E. A. (2017). Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial. Maturitas, 99, 20–26. https://pubmed.ncbi.nlm.nih.gov/28364864/ (B)
- Kim, T.-H., Jeon, S. H., Hahn, E.-J., Paek, K.-Y., Park, J. K., Youn, N. Y., & Lee, H.-L. (2009). Effects of tissue-cultured mountain ginseng (Panax ginseng CA Meyer) extract on male patients with erectile dysfunction. Asian Journal of Andrology, 11(3), 356–361. https://pubmed.ncbi.nlm.nih.gov/19234482/ (B)
- Kouidrat, Y., Pizzol, D., Cosco, T., Thompson, T., Carnaghi, M., Bertoldo, A., Solmi, M., Stubbs, B., & Veronese, N. (2017). High prevalence of erectile dysfunction in diabetes: a systematic review and meta-analysis of 145 studies. Diabetic Medicine: A Journal of the British Diabetic Association, 34(9), 1185–1192. https://pubmed.ncbi.nlm.nih.gov/28722225/ (A)
- Lebret, T., Hervé, J.-M., Gorny, P., Worcel, M., & Botto, H. (2002). Efficacy and safety of a novel combination of L-arginine glutamate and yohimbine hydrochloride: a new oral therapy for erectile dysfunction. European Urology, 41(6), 608–613; discussion 613. https://pubmed.ncbi.nlm.nih.gov/12074777/ (C)
- Lopresti, A. L., Drummond, P. D., & Smith, S. J. (2019). A Randomized, Double-Blind, Placebo-Controlled, Crossover Study Examining the Hormonal and Vitality Effects of Ashwagandha ( Withania somnifera) in Aging, Overweight Males. American Journal of Men’s Health, 13(2), 1557988319835985. https://pubmed.ncbi.nlm.nih.gov/30854916/ (B)
- Nasimi Doost Azgomi, R., Zomorrodi, A., Nazemyieh, H., Fazljou, S. M. B., Sadeghi Bazargani, H., Nejatbakhsh, F., Moini Jazani, A., & Ahmadi AsrBadr, Y. (2018). Effects of Withania somnifera on Reproductive System: A Systematic Review of the Available Evidence. BioMed Research International, 2018, 4076430. https://pubmed.ncbi.nlm.nih.gov/29670898/ (A)
- Reiter, W. J., & Pycha, A. (1999). [Placebo-controlled dihydroepiandrosterone substitution in elderly men]. Gynakologisch-geburtshilfliche Rundschau, 39(4), 208–209. https://pubmed.ncbi.nlm.nih.gov/10629385/ (C)
- Reiter, W. J., Pycha, A., Schatzl, G., Pokorny, A., Gruber, D. M., Huber, J. C., & Marberger, M. (1999). Dehydroepiandrosterone in the treatment of erectile dysfunction: a prospective, double-blind, randomized, placebo-controlled study. Urology, 53(3), 590–594; discussion 594–595. https://pubmed.ncbi.nlm.nih.gov/10096389/ (C)
- Rhim, H. C., Kim, M. S., Park, Y.-J., Choi, W. S., Park, H. K., Kim, H. G., Kim, A., & Paick, S. H. (2019). The Potential Role of Arginine Supplements on Erectile Dysfunction: A Systemic Review and Meta-Analysis. The Journal of Sexual Medicine, 16(2), 223–234. https://pubmed.ncbi.nlm.nih.gov/30770070/ (A)
- Rosen, R. C., Riley, A., Wagner, G., Osterloh, I. H., Kirkpatrick, J., & Mishra, A. (1997). The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology, 49(6), 822–830. https://pubmed.ncbi.nlm.nih.gov/9187685/ (F)
- Sellandi, T. M., Thakar, A. B., & Baghel, M. S. (2012). Clinical study of Tribulus terrestris Linn. in Oligozoospermia: A double blind study. Ayu, 33(3), 356–364. https://pubmed.ncbi.nlm.nih.gov/23723641/ (B)
- Stone, M., Ibarra, A., Roller, M., Zangara, A., & Stevenson, E. (2009). A pilot investigation into the effect of maca supplementation on physical activity and sexual desire in sportsmen. Journal of Ethnopharmacology, 126(3), 574–576. https://pubmed.ncbi.nlm.nih.gov/19781622/ (C)
- Zenico, T., Cicero, A. F. G., Valmorri, L., Mercuriali, M., & Bercovich, E. (2009). Subjective effects of Lepidium meyenii (Maca) extract on well-being and sexual performances in patients with mild erectile dysfunction: a randomised, double-blind clinical trial. Andrologia, 41(2), 95–99. https://pubmed.ncbi.nlm.nih.gov/19260845/ (B)
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