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Oral Testofen, L-Citrulline, Resveratrol, and Caffeine Supplement Drink Improves Sexual Function in Men with Phosphodiesterase 5 Inhibitors: Randomized, Double-Blind, Placebo-Controlled Crossover Pilot Study
Masato Shirai, Yuto Miyoshi, Taiki Ogasa, Miho Miyoshi, Keisuke Ishikawa, Ippei Hiramatsu, Yuka Uesaka, Taiji Nozaki, Taro Koyama, Akira Tsujimura
Purpose: Sexuality is very important for men’s health. Currently, phosphodiesterase type 5 inhibitors (PDE5i) remain the first-line therapy for erectile dysfunction, and no other oral drugs or drinks are approved and used clinically to treat male libido or orgasm dysfunction. In reference to a pharmaceutical dosage document, growing health consciousness is said to have boosted yearly sales of supplement drinks to more than 170 billion yen (1.58 billion US dollars) in Japan. We have created a supplement drink comprised of testofen, L-citrulline, resveratrol, and caffeine. We hypothesized that our supplement drink would be effective for men with sexual dysfunction, and especially libido dysfunction.
Materials and Methods: In this study, men with sexual dysfunction received a placebo drink for 14 days or our supplement drink (testofen, 600 mg/d; L-citrulline, 800 mg/d; resveratrol, 300 mg/d; and caffeine, 40 mg/d) for another 14 days separated by a 7-day washout period. Patients continued on-demand use of PDE5i. The International Index of Erectile Function (IIEF) score and adverse events were assessed.
Results: Twenty patients aged 30–47 years old were enrolled in and concluded the study with no adverse events experienced. The IIEF domains of desire frequency, erection frequency, erection firmness, erection confidence, intercourse satisfaction, ejaculation frequency, orgasm frequency, and overall satisfaction were significantly improved with our supplement drink.
Conclusions: This is the first study to show that our supplement drink may not only be effective for erection but also for libido, orgasm, and ejaculation.
INTRODUCTION
Sexuality is very important for men’s health [1]. Men with erectile dysfunction (ED) report low rates of quality of life [1]. Thus, treatment for ED is very important for an improved quality of life. Libido dysfunction and orgasmic dysfunction are also important aspects of men’s quality of life. In general, treatment for male libido dysfunction or orgasmic dysfunction is challenging. In the treatment of female libido dysfunction, flibanserin is the only approved oral drug [2]. Testosterone replacement therapy (TRT) is the only approved medical treatment that improves libido in hypogonadal men with sexual dysfunction [3]. However, men with sexual dysfunction and normal testosterone levels should not be offered TRT [4]. Additionally, in the treatment of male libido or orgasm dysfunction, no oral drugs or drinks are approved and used clinically. Currently, vacuum erection devices, intracavernous injections, and surgical penile prosthesis implantation are appropriate treatments for ED [5] if phosphodiesterase type 5 inhibitors (PDE5i) are not effective. However, as very few Japanese patients choose these therapies [6], it is extremely important that sexual function be improved by oral administration of effective agents.
Testofen is a specialized extract from Trigonella foenum-graecum seeds that reduces age-related symptoms in healthy aging males [7]. Significant androgenic activity in men is achieved with Testofen supplementation [8] through its increase of testosterone and free testosterone levels [9].
Caffeine is an alkaloid present in the everyday diet, such as coffee and tea. It is a nonselective phosphodiesterase inhibitor that raises the levels of intracellular cyclic guanosine monophosphate (cGMP) and cyclic adenosine monophosphate [10]. Caffeine improved sexual function in animal studies [11], but few such studies have been fully performed on humans with sexual dysfunction.
We showed that combination therapy with an L-citrulline and resveratrol capsule with on-demand use of PDE5i is effective in ED patients [12]. In reference to a pharmaceutical dosage document, growing health consciousness is said to have boosted yearly sales of supplement drinks to more than 170 billion yen (1.58 billion US dollars) in Japan [13]. We have created a supplement drink containing testofen, L-citrulline, resveratrol, and caffeine. We hypothesized that our supplement drink would be effective for patients with sexual dysfunction and especially libido dysfunction. Therefore, we investigated the efficacy of our supplement drink in improving male sexual function.
*Despite being a prospective, placebo-controlled study, the present study has some limitations. First, this two institution study with a small sample size was short, lasting only 5 weeks. We will be planning a longer-duration study that includes more institutions. Second, this study excluded ED patients taking tadalafil once daily for LUTS, which is an effective and well-tolerated medical treatment for patients with these conditions [30]. Daily use of PDE5i may be more effective in treating ED treatment combined with testofen, L-citrullines, resveratrol, and caffeine. Third, information on patient comorbidities that might affect sexual function, such as diabetes and neurologic disease was lacking. Fourth, we did not have data on the use of our supplement drink alone, not in combination with PDE5i. Fifth, we did not measure hormonal levels before and after treatment. We will be planning a study that includes such data. Sixth, the participants of the present study were young men. We could not recruit a different participant cohort, which might have been able to minimize the placebo effect.
CONCLUSIONS
This is the first study to show that our supplement drink may not only be effective for erection treatment in men with ED along with the added on-demand use of PDE5i but also effective in improving libido, orgasm, and ejaculation. The present results showed that our supplement drink may be a possible treatment option for these patients.
Masato Shirai, Yuto Miyoshi, Taiki Ogasa, Miho Miyoshi, Keisuke Ishikawa, Ippei Hiramatsu, Yuka Uesaka, Taiji Nozaki, Taro Koyama, Akira Tsujimura
Purpose: Sexuality is very important for men’s health. Currently, phosphodiesterase type 5 inhibitors (PDE5i) remain the first-line therapy for erectile dysfunction, and no other oral drugs or drinks are approved and used clinically to treat male libido or orgasm dysfunction. In reference to a pharmaceutical dosage document, growing health consciousness is said to have boosted yearly sales of supplement drinks to more than 170 billion yen (1.58 billion US dollars) in Japan. We have created a supplement drink comprised of testofen, L-citrulline, resveratrol, and caffeine. We hypothesized that our supplement drink would be effective for men with sexual dysfunction, and especially libido dysfunction.
Materials and Methods: In this study, men with sexual dysfunction received a placebo drink for 14 days or our supplement drink (testofen, 600 mg/d; L-citrulline, 800 mg/d; resveratrol, 300 mg/d; and caffeine, 40 mg/d) for another 14 days separated by a 7-day washout period. Patients continued on-demand use of PDE5i. The International Index of Erectile Function (IIEF) score and adverse events were assessed.
Results: Twenty patients aged 30–47 years old were enrolled in and concluded the study with no adverse events experienced. The IIEF domains of desire frequency, erection frequency, erection firmness, erection confidence, intercourse satisfaction, ejaculation frequency, orgasm frequency, and overall satisfaction were significantly improved with our supplement drink.
Conclusions: This is the first study to show that our supplement drink may not only be effective for erection but also for libido, orgasm, and ejaculation.
INTRODUCTION
Sexuality is very important for men’s health [1]. Men with erectile dysfunction (ED) report low rates of quality of life [1]. Thus, treatment for ED is very important for an improved quality of life. Libido dysfunction and orgasmic dysfunction are also important aspects of men’s quality of life. In general, treatment for male libido dysfunction or orgasmic dysfunction is challenging. In the treatment of female libido dysfunction, flibanserin is the only approved oral drug [2]. Testosterone replacement therapy (TRT) is the only approved medical treatment that improves libido in hypogonadal men with sexual dysfunction [3]. However, men with sexual dysfunction and normal testosterone levels should not be offered TRT [4]. Additionally, in the treatment of male libido or orgasm dysfunction, no oral drugs or drinks are approved and used clinically. Currently, vacuum erection devices, intracavernous injections, and surgical penile prosthesis implantation are appropriate treatments for ED [5] if phosphodiesterase type 5 inhibitors (PDE5i) are not effective. However, as very few Japanese patients choose these therapies [6], it is extremely important that sexual function be improved by oral administration of effective agents.
Testofen is a specialized extract from Trigonella foenum-graecum seeds that reduces age-related symptoms in healthy aging males [7]. Significant androgenic activity in men is achieved with Testofen supplementation [8] through its increase of testosterone and free testosterone levels [9].
Caffeine is an alkaloid present in the everyday diet, such as coffee and tea. It is a nonselective phosphodiesterase inhibitor that raises the levels of intracellular cyclic guanosine monophosphate (cGMP) and cyclic adenosine monophosphate [10]. Caffeine improved sexual function in animal studies [11], but few such studies have been fully performed on humans with sexual dysfunction.
We showed that combination therapy with an L-citrulline and resveratrol capsule with on-demand use of PDE5i is effective in ED patients [12]. In reference to a pharmaceutical dosage document, growing health consciousness is said to have boosted yearly sales of supplement drinks to more than 170 billion yen (1.58 billion US dollars) in Japan [13]. We have created a supplement drink containing testofen, L-citrulline, resveratrol, and caffeine. We hypothesized that our supplement drink would be effective for patients with sexual dysfunction and especially libido dysfunction. Therefore, we investigated the efficacy of our supplement drink in improving male sexual function.
*Despite being a prospective, placebo-controlled study, the present study has some limitations. First, this two institution study with a small sample size was short, lasting only 5 weeks. We will be planning a longer-duration study that includes more institutions. Second, this study excluded ED patients taking tadalafil once daily for LUTS, which is an effective and well-tolerated medical treatment for patients with these conditions [30]. Daily use of PDE5i may be more effective in treating ED treatment combined with testofen, L-citrullines, resveratrol, and caffeine. Third, information on patient comorbidities that might affect sexual function, such as diabetes and neurologic disease was lacking. Fourth, we did not have data on the use of our supplement drink alone, not in combination with PDE5i. Fifth, we did not measure hormonal levels before and after treatment. We will be planning a study that includes such data. Sixth, the participants of the present study were young men. We could not recruit a different participant cohort, which might have been able to minimize the placebo effect.
CONCLUSIONS
This is the first study to show that our supplement drink may not only be effective for erection treatment in men with ED along with the added on-demand use of PDE5i but also effective in improving libido, orgasm, and ejaculation. The present results showed that our supplement drink may be a possible treatment option for these patients.
