madman
Super Moderator
ABSTRACT
We evaluated the efficacy of Tribulus Terrestris in two different dosage regimes for the treatment of sexual dysfunction in pre and postmenopausal women and its effect on the vascular resistance of the clitoral artery using Power Doppler. A total of 104 women were randomly assigned to receive 94mg, three times/day (TT3) or 280mg once/day for 90 days (TT1). The evaluation was performed using FSFI and QS-F questionnaires, serum levels of prolactin, TSH, total testosterone, and SHBG, and clitoral artery assessment with Power Doppler ultrasound. FSFI results demonstrated an improvement in all domains in both groups (P<0.05) except for the “Satisfaction” in the TT3 premenopausal group. QS-F results showed a significant improvement in the mean total score in women of both reproductive phases, for both groups. Postmenopausal patients improved in all sexual domains, except for “orgasm” in the TT1 group. PI of the clitoral artery showed no difference in both reproductive phases, in both groups. We conclude that TTerrestris can be a safe alternative for the treatment of sexual dysfunction in pre and postmenopausal women as it is effective in reducing the symptoms with no side effects. Moreover, its use increased total, free and bioavailable testosterone.
Introduction
Female sexual dysfunction (FSD) refers to a change in the sexual response associated with personal suffering. Includes lack of sexual desire, difficulty or lack of arousal/lubrication, difficulty or inability to reach orgasm and/or pain during sexual activity (American Psychiatric Association, 2013). It is caused by an imbalance of a complex interaction of anatomical, endocrine, neuronal, vascular, psychological, and social factors (Clayton & Groth, 2013). Sexual complaints are reported by approximately 40% of women worldwide, and approximately one in eight women at some point in life experience some sexual dysfunction (Fugl-Meyer et al., 2004; Laumann et al., 2005; Nappi et al., 2016; Shifren, Monz, Russo, Segreti, & Johannes, 2008; Wolpe, Zomkowski, Silva, Queiroz, & Sperandio, 2017; Zhang et al., 2017).
FSD is classified as sexual desire dysfunction, arousal dysfunction, orgasm dysfunction, and sexual pain dysfunction (American Psychiatric Association, 2013). This classification is based on a better understanding of the sexual response and the recognition of the cyclical model proposed by Basson, Wierman, van Lankveld, and Brotto (2010). Recently the American Psychiatric Association (APA) guidelines require that, in order to be considered a sexual dysfunction, the sexual complaint must be recurrent or persistent, cause personal suffering or interpersonal difficulty, and the problem must be present for at least six months1. A careful approach and the use of available therapies can improve the sexual function of many women. The use of herbal medicines, especially Tribulus Terrestris (TTerrestris), has been proposed to improve sexual response and may be an alternative for the treatment of FSD (Akhtari et al., 2014; De Sousa & Lima, 2017; De Souza, Vale, & Geber, 2016; Gama et al., 2014; Mazaro-Costa, Andersen, Hachul, & Tufik, 2010; Postigo et al., 2016; Vale, Zanolla Dias de Souza, Rezende, & Geber, 2018).
Tribulus Terrestris is a medicinal herb in the family Zygophyllaceae. Protodioscin is the dominant component of the herb, considered the main pharmacologically active steroid saponin (Dinchev et al., 2008). Some studies suggested that protodioscin regulates the hormonal balance without interfering with the physiological mechanisms of hormonal regulation and stimulates the enzyme 5-a-reductase, which converts testosterone into dihydrotestosterone, increasing endogenous levels of biologically active testosterone (Antonio, Uelmen, Rodriguez, & Earnest, 2000; Qureshi, Naughton, & Petroczi, 2014; Semerdjieva & Zheljazkov, 2019). Testosterone is the primary hormone that modulates the sex drive response in the brain, triggering sexual desire. It is also essential in modulating the physiology of the clitoris and vagina to facilitate engorgement, genital arousal, and lubrication (Nappi et al., 2003). Previous animal and human studies also suggested that protodioscin stimulates the release of nitric oxide into the endothelium of genital vessels, increasing vascularity and promoting genital engorgement (Adaikan, Gauthaman, Prasad, & Ng, 2000; Sahin et al., 2016; Semerdjieva & Zheljazkov, 2019). The use of the Doppler technique allowed the study of the clitoral artery to assess its vasculature and clitoral function, however, this method has not been used to evaluate the effects of Tribulus Terrestris (Khalifé, Binik, Cohen, & Amsel, 2000; Souto, Palma, & Riccetto, 2010).
There are several herbal supplements and pharmaceutical preparations available using the TTerrestris have been used to try to improve libido in women. However, data in the literature are still scarce with regard to its effectiveness for the treatment of female sexual dysfunction (Ștefănescu, Tero-Vescan, Negroiu, Aurică, & Vari, 2020). Most studies generally use teas or plant extracts that have a possible action on female sexual response, with few studies using the formulation in accordance with the worldwide standardization criteria for the treatment of female sexual dysfunction (De Souza et al., 2016; Neychev & Mitev, 2016; Postigo et al., 2016; Vale et al., 2018; Zhu, Du, Meng, Dong, & Li, 2017).
*Based on this knowledge of the protodioscin mechanism of action on the sexual response, we performed this study to evaluate the effect of Tribulus Terrestris, in two different dosage regimes, on the treatment of women with FSD using the FSFI and Q-SF questionnaire, hormonal evaluation, and on the vascular analysis of the clitoral artery using ultrasound with power Doppler.
Conclusion
In conclusion, our study suggests that Tribulus Terrestris is an effective alternative for the treatment of pre and postmenopausal women with FSD, probably through a mechanism leading to an increase in the serum levels of testosterone. For postmenopausal women, it may also improve clitoral artery blood flow. Moreover, the use of 280 mg, once a day seems to have a better effect than the fractional dose administered 3 times a day.
We evaluated the efficacy of Tribulus Terrestris in two different dosage regimes for the treatment of sexual dysfunction in pre and postmenopausal women and its effect on the vascular resistance of the clitoral artery using Power Doppler. A total of 104 women were randomly assigned to receive 94mg, three times/day (TT3) or 280mg once/day for 90 days (TT1). The evaluation was performed using FSFI and QS-F questionnaires, serum levels of prolactin, TSH, total testosterone, and SHBG, and clitoral artery assessment with Power Doppler ultrasound. FSFI results demonstrated an improvement in all domains in both groups (P<0.05) except for the “Satisfaction” in the TT3 premenopausal group. QS-F results showed a significant improvement in the mean total score in women of both reproductive phases, for both groups. Postmenopausal patients improved in all sexual domains, except for “orgasm” in the TT1 group. PI of the clitoral artery showed no difference in both reproductive phases, in both groups. We conclude that TTerrestris can be a safe alternative for the treatment of sexual dysfunction in pre and postmenopausal women as it is effective in reducing the symptoms with no side effects. Moreover, its use increased total, free and bioavailable testosterone.
Introduction
Female sexual dysfunction (FSD) refers to a change in the sexual response associated with personal suffering. Includes lack of sexual desire, difficulty or lack of arousal/lubrication, difficulty or inability to reach orgasm and/or pain during sexual activity (American Psychiatric Association, 2013). It is caused by an imbalance of a complex interaction of anatomical, endocrine, neuronal, vascular, psychological, and social factors (Clayton & Groth, 2013). Sexual complaints are reported by approximately 40% of women worldwide, and approximately one in eight women at some point in life experience some sexual dysfunction (Fugl-Meyer et al., 2004; Laumann et al., 2005; Nappi et al., 2016; Shifren, Monz, Russo, Segreti, & Johannes, 2008; Wolpe, Zomkowski, Silva, Queiroz, & Sperandio, 2017; Zhang et al., 2017).
FSD is classified as sexual desire dysfunction, arousal dysfunction, orgasm dysfunction, and sexual pain dysfunction (American Psychiatric Association, 2013). This classification is based on a better understanding of the sexual response and the recognition of the cyclical model proposed by Basson, Wierman, van Lankveld, and Brotto (2010). Recently the American Psychiatric Association (APA) guidelines require that, in order to be considered a sexual dysfunction, the sexual complaint must be recurrent or persistent, cause personal suffering or interpersonal difficulty, and the problem must be present for at least six months1. A careful approach and the use of available therapies can improve the sexual function of many women. The use of herbal medicines, especially Tribulus Terrestris (TTerrestris), has been proposed to improve sexual response and may be an alternative for the treatment of FSD (Akhtari et al., 2014; De Sousa & Lima, 2017; De Souza, Vale, & Geber, 2016; Gama et al., 2014; Mazaro-Costa, Andersen, Hachul, & Tufik, 2010; Postigo et al., 2016; Vale, Zanolla Dias de Souza, Rezende, & Geber, 2018).
Tribulus Terrestris is a medicinal herb in the family Zygophyllaceae. Protodioscin is the dominant component of the herb, considered the main pharmacologically active steroid saponin (Dinchev et al., 2008). Some studies suggested that protodioscin regulates the hormonal balance without interfering with the physiological mechanisms of hormonal regulation and stimulates the enzyme 5-a-reductase, which converts testosterone into dihydrotestosterone, increasing endogenous levels of biologically active testosterone (Antonio, Uelmen, Rodriguez, & Earnest, 2000; Qureshi, Naughton, & Petroczi, 2014; Semerdjieva & Zheljazkov, 2019). Testosterone is the primary hormone that modulates the sex drive response in the brain, triggering sexual desire. It is also essential in modulating the physiology of the clitoris and vagina to facilitate engorgement, genital arousal, and lubrication (Nappi et al., 2003). Previous animal and human studies also suggested that protodioscin stimulates the release of nitric oxide into the endothelium of genital vessels, increasing vascularity and promoting genital engorgement (Adaikan, Gauthaman, Prasad, & Ng, 2000; Sahin et al., 2016; Semerdjieva & Zheljazkov, 2019). The use of the Doppler technique allowed the study of the clitoral artery to assess its vasculature and clitoral function, however, this method has not been used to evaluate the effects of Tribulus Terrestris (Khalifé, Binik, Cohen, & Amsel, 2000; Souto, Palma, & Riccetto, 2010).
There are several herbal supplements and pharmaceutical preparations available using the TTerrestris have been used to try to improve libido in women. However, data in the literature are still scarce with regard to its effectiveness for the treatment of female sexual dysfunction (Ștefănescu, Tero-Vescan, Negroiu, Aurică, & Vari, 2020). Most studies generally use teas or plant extracts that have a possible action on female sexual response, with few studies using the formulation in accordance with the worldwide standardization criteria for the treatment of female sexual dysfunction (De Souza et al., 2016; Neychev & Mitev, 2016; Postigo et al., 2016; Vale et al., 2018; Zhu, Du, Meng, Dong, & Li, 2017).
*Based on this knowledge of the protodioscin mechanism of action on the sexual response, we performed this study to evaluate the effect of Tribulus Terrestris, in two different dosage regimes, on the treatment of women with FSD using the FSFI and Q-SF questionnaire, hormonal evaluation, and on the vascular analysis of the clitoral artery using ultrasound with power Doppler.
Conclusion
In conclusion, our study suggests that Tribulus Terrestris is an effective alternative for the treatment of pre and postmenopausal women with FSD, probably through a mechanism leading to an increase in the serum levels of testosterone. For postmenopausal women, it may also improve clitoral artery blood flow. Moreover, the use of 280 mg, once a day seems to have a better effect than the fractional dose administered 3 times a day.
