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The use of Tribestan in the treatment of andrological diseases

The World Health Organization defines “reproductive health” as the absence of reproductive dysfunction in both men and women, implying the physical, mental and social well-being of both partners [3]. Male reproductive health is the subject of andrology, a broad and rapidly developing area of medical science. The central problems of andrology are male infertility and erectile dysfunction. About 15% of sexually active couples do not achieve pregnancy within 1 year of unprotected sex. Ultimately, 5% of couples remain childless despite treatment attempts. In approximately 50% of childless couples, infertility is associated with the “male factor” - deviations in the parameters of the ejaculate [4]. The causes of male infertility can be varicocele, urogenital infections, cryptorchidism, ejaculation and erection disorders, endocrine and genetic disorders, as well as immunological factors [1,2,4,6]. It should be noted that in 30–40% the etiological factor of male infertility is not identified. For the treatment of male infertility, both complex conservative therapy using various drugs - antimicrobial, anti-inflammatory, hormonal - and surgical intervention or a combination thereof is used. The increasing incidence of diseases of the male reproductive system, as well as neuroendocrine diseases, determines the relevance of the use of drugs to restore male fertility. For a number of years, various herbal preparations have been successfully used in the complex treatment of fertility disorders - they are quite effective and safe for long-term use. Currently, determining the place and significance of such drugs in the complex treatment of fertility disorders is relevant and can help optimize the treatment of such a complex category of patients. According to the clinical guidelines of the European Association of Urology (2010), erectile dysfunction is defined as the persistent inability to achieve and maintain an erection sufficient for successful sexual intercourse [4]. Erectile dysfunction occurs in 7–10% of men [2]. There are organic, psychogenic and mixed forms of erectile dysfunction. Psychogenic factors, such as visual or auditory images, are powerful inducers of erection. At the same time, emotions such as fear or memories of a previous bad experience can interfere with erectile function. The causes of primary disorders depend on the social sphere and upbringing. Secondary disorders usually occur acutely and are situation- or partner-specific. The prognosis and treatment of erectile dysfunction largely depend on identifying the relationship with weakened sexual desire or fear of failure [3]. First-line drugs for the treatment of erectile dysfunction are phosphodiesterase type 5 inhibitors [1,2,4,6]. It should be noted that these medications do not initiate an erection, but require sexual stimulation for an erectile response to occur. For a long period of time, herbal preparations have been used in the complex treatment of functional sexual disorders. When sexual function is impaired due to neurohumoral disorders, there is a significant decrease in libido with preserved erection and normal ejaculation in some patients and inadequate sexual desire in others. A significant group of sexual disorders is based on mental disorders, often associated with interpersonal relationships between partners and manifested primarily by erectile dysfunction [5]. According to Miroshnikov V.M. (2005), in the treatment of these conditions it is necessary to prescribe herbal preparations to suppress anxiety, fear and tension, relieve neurotic reactions and relax the spinal and extraspinal centers of erection and ejaculation. Prescribing these drugs may be useful for increasing the body's defenses, its immune responses, as well as for eliminating the inflammatory process of the prostate gland and stimulating all components of the copulative cycle: neurohumoral (libido), mental, erectile, ejaculatory (orgasmic) [5]. It can be assumed that the use of herbal preparations will find a special place in the complex therapy of primarily functional sexual disorders, including psychogenic erectile dysfunction. The many existing herbal preparations for the treatment of sexual disorders indicate the absence of absolutely effective remedies. Until the results of large-scale clinical studies of the effectiveness of such drugs (with evidence-based data) are available, treatment remains mostly empirical. The importance of Tribestan in the treatment of andrological diseases For 30 years, Tribestan, a non-hormonal drug, has been successfully used in clinical practice for the treatment of certain forms of impaired fertility in men, erectile dysfunction, neurovegetative and neuropsychic manifestations of menopausal and post-castration syndromes, as well as hypercholesterolemia. The active substance of the drug, containing steroidal saponins of the furastanol type, is obtained from the aerial part of the perennial plant Tribulus terrestris L. (tribulus creeping), which is widespread everywhere. According to their structure, saponins are divided into triterenoid and steroid. Steroidal saponins are a widespread group in plants and are chemically related to cardiac glycosides and steroidal glycoalkaloids. Steroidal saponins are used as raw materials for the production of steroid hormones. Both of the predominant furastanol bigcosides in Tribulus terrestris L., protodioscin and protogracilin, have been tested as biologically pure substances. It is believed that protodioscin is metabolized in the body to dehydroepiandrosterone, which has beneficial effects on erectile function, immunity, cell membrane integrity and cholesterol metabolism. Other saponins, which are part of the Tribulus terrestris L. extract, presumably modulate the effect of protodioscin [7,8]. Pharmacokinetic studies of Tribestan have demonstrated that protodioscin is rapidly eliminated from blood plasma and after three hours its concentration becomes negligible. After oral administration of the drug within 24 hours, 2–4% of protodioscin is excreted in the bile, and its concentration in the urine cannot be measured. The experimental data obtained demonstrate that Tribestan is excreted primarily through bile. The low percentage of excretion of unchanged protodioscin compared to the dose taken confirms the assumption of its intensive biotransformation in the body [8]. The therapeutic effects of the drug include increased libido, improved quality of erections, increased sperm count and motility, increased serum levels of certain hormones, and decreased blood cholesterol levels. In order to determine the effect of Tribestan on the physiological mechanisms of hormonal regulation, as well as to assess the effect of the drug on the serum concentration of certain hormones, the NIRR and the Chemical and Pharmaceutical Research Institute in Bulgaria conducted a study of healthy men and women aged 28–45 years. In the study participants, the initial levels of pituitary (ACTH, STH, LH, FSH), sex (testosterone and estradiol) and adrenal (aldosterone and cortisol) hormones were determined. It should be noted that the study was performed twice (at 8 and 12 o'clock) in 1 day. before starting to take the drug. The next day, study participants began taking Tribestan 250 mg 3 times a day. within 5 days. After finishing taking the drug (on the 6th day), the level of hormones in the blood was checked again, twice (at 8 and 12 hours). The results obtained were processed using the method of variation analysis using the Student's t test. When analyzing the results of the study, it turned out that in men the LH level increased with a high degree of reliability to the same extent in both samples (at 8 and 12 hours). In addition, taking Tribestan significantly increased the concentration of testosterone - by 3 times - and estradiol - by about 1.5 times. The use of the drug also led to an increase in aldosterone levels. At the same time, the concentrations of other hormones - FSH, ACTH, cortisol - did not change [1,8]. It should also be noted that an important advantage of the drug is its safety - no serious side effects have been reported with the use of Tribestan over the past years. In clinical studies, the effectiveness of Tribestan in the treatment of oligoasthenozoospermia was studied. A study conducted by Protich M. et al. at the Scientific Institute of Obstetrics and Gynecology in Bulgaria involved 71 patients aged 20 to 41 years (average age 32 years) who had been infertile for more than 2 years [7]. All patients with oligoasthenozoospermia were divided into 4 groups. In 38 patients of the 1st group, idiopathic oligoasthenozoospermia was determined, 16 men of the 2nd group had previously undergone surgery for varicocele and had no improvement in sperm parameters within a year after surgical treatment. The third group consisted of 12 men with chronic prostatitis, and the 4th group consisted of 5 patients with chronic epididymitis. Before treatment with Tribestan, a clinical examination of patients was carried out (history collection, andrological examination), and a semen analysis (spermogram) was performed twice (with an interval of 2 weeks). Patients took Tribestan 1 tablet 3 times a day. within 2 months. No other medications were prescribed during therapy with this drug. The main parameters of sperm were assessed over time: ejaculate volume, sperm concentration, percentage of motile sperm, their average speed and percentage of pathological forms. The results of Tribestan treatment for all patients with oligoasthenozoospermia are presented in Table 1. The ejaculate volume in all patients before treatment was within normal limits. After treatment with Tribestan, he did not change. After a course of therapy with this drug, an increase in the number of sperm in 1 ml of semen was noted (statistically unreliable), as well as sperm motility (statistically significant). In patients who underwent surgery for varicocele, treatment with Tribestan led to an increase in sperm motility, and other sperm parameters improved insignificantly. In the third and fourth groups (in patients with chronic prostatitis and chronic epididymitis), researchers did not observe a statistically significant improvement in sperm parameters during Tribestan therapy [7]. In another study, when treating 7 patients with idiopathic oligoasthenozoospermia with Tribestan for more than 90 days at a daily dose of 1.5 g, a statistically significant increase in sperm concentration and motility was recorded. At the same time, an increase in libido was recorded in all patients. Moeloek et al. in 1994 presented the results of a multicenter, double-blind, placebo-controlled study of the effectiveness of Tribestan in patients with oligoasthenoteratozoospermia. 30 men took this drug, 1 tablet 3 times a day. for 12 weeks, and 9 received placebo. After this course of treatment, 22% of the patients' spouses became pregnant [8]. Nikolov V. and Stanislov R. in 1999, at the Congress on Immunology and Reproduction in Italy, demonstrated the results of a five-year open randomized study of the effectiveness of Tribestan in infertility. 100 men took this drug, 1 tablet 3 times a day. within 2 months. As a result of the therapy, sperm motility and their ability to penetrate the cervical mucus increased in 30% of patients, and an increase in libido was also observed. In 44% of sexual partners of patients who took part in the study, within 12 months. after therapy pregnancy occurred. A number of domestic publications are also devoted to studies of the effectiveness of Tribestan in patients with various fertility disorders. In the urological clinic MMA named after. THEM. Sechenov studied the effectiveness of this drug in 15 patients with oligoasthenozoospermia and 5 patients with aspermia. Patients with a body weight of less than 80 kg Tribestan were prescribed 1 tablet 3 times a day, more than 80 kg - 2 tablets 3 times a day. within 2 months. When analyzing the results of the study, it turned out that in patients with oligoasthenozoospermia there was an increase in the volume of ejaculate, the number of sperm in the ejaculate and the percentage of motile forms of sperm, along with an increase in libido. For aspermia, drug therapy was ineffective [8]. Sepp O.N. has experience in the clinical use of Tribestan in 27 men aged 24 to 52 years with infertility in marriage for more than 1 year. 11 patients suffered from chronic prostatitis, 6 from chronic prostatovesiculitis, 3 from chronic epididymitis, 5 from varicocele, 2 from cryptorchidism. All patients had pathospermia: asthenozoospermia, asthenozoospermia in combination with oligo- and teratozoospermia, azoospermia. Half of the patients suffering from chronic inflammatory disease had complaints of decreased libido, shortened sexual intercourse, and decreased severity of orgasm. Tribestan was used 1 tablet 3 times a day. for 2 months, 15 days – 1 tablet 2 times a day. and 15 days – 1 tablet 1 time/day. Patients with azoospermia received Tribestan 2 tablets 3 times a day. – 1 month, then 1 tablet 3 times a day. – 1 month and then 1 tablet 2 times a day. 15 days and 1 tablet 1 time/day. - 15 days. Patients suffering from chronic inflammation were prescribed antimicrobial, anti-inflammatory drugs and physiotherapeutic procedures. During the rehabilitation period, these patients took Tribestan in monotherapy or in combination with other drugs that improve sperm quality. All patients, regardless of the identified diseases, against the background of complex therapy, including Tribestan, noted an improvement in general well-being, an increase in performance and a decrease in fatigue, along with an increase in libido, increased orgasmic sensations and prolongation of sexual intercourse. In all patients studied, both with normozoospermia and oligospermia, the number of sperm in the ejaculate increased. After using Tribestan, a complete restoration of sperm motility was noted in 80% of patients with asthenozoospermia, in the remaining 20% the motility was at least 40–45%. The ratio of low- and fast-motile forms of sperm changed towards an increase in the percentage of the latter, and in patients with combined pathospermia and motility A + B from 7 to 15%, an increase in motility was observed at least 2–3 times. In the patients studied, there was no noticeable increase in sperm volume. Of particular relevance are the results of a study of Tribestan in patients with testicular hypotrophy. In 1 of 4 patients in this group, unilateral testicular hypotrophy was detected in 2, bilateral in 2, and severe bilateral testicular hypotrophy in 1. After treatment with Tribestan, all patients noted an increase in the volume of ejaculate and an improvement in sperm parameters: an increase in the concentration of sperm and an increase in their motility [1,8]. For a long time, Tribestan has also been used to treat sexual dysfunction. Of particular interest are the results of a study of the effectiveness of Tribestan in patients with erectile dysfunction and decreased libido [8]. In a study conducted by Nasution in 1993, patients with decreased or absent libido and erectile dysfunction were prescribed the drug 1 tablet 3 times a day. within 2 weeks. In 50% of these patients, as a result of using Tribestan, sexual desire appeared or increased, and in 57.1% the frequency and duration of erection increased. Another clinical study [Adimoelja, Adaikan, 1997] involved 45 patients with erectile dysfunction and decreased libido, including 15 with concomitant diabetes mellitus. Patients took the drug 1 tablet 3 times a day. within 3 weeks. As a result of this therapy, an increase in libido was registered in 8 (53%) men with diabetes mellitus and in 20 (67%) patients with normoglycemia. 28 (62%) men who took part in the study noted an increase in sexual desire and an increase in the frequency of sexual intercourse with good erections. Moreover, increased libido was observed in some patients already on the tenth day of treatment. Victorov I. et al. prescribed Tribestan 1–2 tablets 3 times a day. within 1–3 months. 107 patients aged 16–60 years with: varicocele and changes in spermogram (33 patients), decreased libido (14 patients), prostatitis (36 patients), early menopause (13 patients), testicular hypotrophy (4 patients), idiopathic azoospermia ( 7 patients). At the same time, patients with oligo- and azoospermia had unsuccessfully taken masterolone before participating in the study. It should be added that patients with prostatitis were additionally prescribed antimicrobial drugs taking into account the sensitivity of the microflora. 14 patients with decreased libido were treated with Tribestan at a daily dose of 1.5 g. As a result of treatment, 12 of them showed an increase in libido 30 days from the start of therapy. In 1 patient, an increase in libido was noted after 60 days and in 1 more patient the effect of the use of tribestan was not observed. After the treatment of the tribestan of patients with chronic prostatitis and a decrease in libido, it turned out that 15 (42%) men noted a significant increase in sexual desire. 12 (33%) patients reported a relatively good increase in libido and only in 9 (25%) men with a duration of the disease for more than five years did not reveal a clinically significant improvement. In the Andrological Clinic of the Clinical Center for Urology and the Immunonerandocrinological Section of the Biology and Immunology of Reproduction in Bulgaria, a study of the effectiveness of tribestan in 37 patients with primary idiopathic hypogonadism with severe disorders of erection aged from 22 to 50 years (on average - 34 years) [8]. In all patients, insufficient sex drive and erection were noted. The tribestan was assigned 2 tablets 3 times/day. Within 60 days, then 2 tablets 2 times/day. Within 15 days and further 1 tablet 1 time/day. Within 15 days. The total duration of the course of therapy was 90 days. According to Opch M., Tsvetkova D. and others (1983), the dose of the drug should be reduced gradually and smoothly, while 90 -day treatment has a favorable effect on the male reproductive system [7]. In this study, 14 patients with the help of a radiimmune method studied the plasma level of testosterone before and after tribestan therapy. The obtained testosterone levels in patients with hypogonadism were compared with the results of the control group of healthy men of middle age (21.15 ± 3.75 years) and subjected to statistical analysis. When evaluating the results of the study, it turned out that 30 (81.1%) patients noted an increase in sex drive without a significant improvement in erection. In 7 (18.9 %) patients after the treatment of the tribestan there were no positive changes. An analysis of this subgroup of patients showed that 3 of them suffered from diabetes mellitus, and 4 - severe hypogonadism and androgenic failure. The concentration of testosterone levels in blood plasma with primary idiopathic hypogonadism and erectile dysfunction before and after tribestan therapy demonstrates table 2. As can be seen from table 2, after the treatment of tribestan, patients were noted a statistically reliable increase in the level of testosterone in the blood. In the treatment of this drug, there were no side effects. The conclusion is currently a relevant drug for the treatment of some violations of fertility and sexual dysfunction in men. The most noticeable effect of the tribestan has on the quality of sperm, reliably increasing sperm mobility, to a lesser extent their amount and volume of ejaculation. The appointment of the drug leads to an improvement in the quality of an erection and an increase in libido. The tribestan does not violate the physiological mechanisms of hormonal regulation. Many years of experience and the results of clinical studies of the drug indicate the absence of an increase in the concentration of hormones in the blood above physiological norms. The tribestan has no contraindications and is a sufficiently safe drug - during its appointment, there were no serious undesirable phenomena. The undoubted above advantages of the drug determine the possibility of its further successful use both independently and as part of complex therapy. Thus, the tribestan continues to successfully occupy a special niche among numerous plant drugs that are successfully used in the treatment of andrological diseases.

Literature 1. Alyaev Yu.G., Grigoryan V.A., Chaly M.E. Disorders of sexual and reproductive functions in men. - M.: Litterra, 2006. - 188 p. 2. Andrology. Clinical recommendations. / Ed. P.A. Shchepleva, O.I. Apolikhina. - M.: MEDPRACTIKA-M, 2007. - 164 p. 3. Andrology. Men's health and reproductive system dysfunction. / Ed. E. Nishlaga, G.M. Bere, trans. edited by I.I. Dedova - M.: MIA, 2005. - 554 p. 4. Clinical recommendations of the European Association of Urology. - M.: ABV-press, 2010. 5. Miroshnikov V.M. Medicinal plants and herbal preparations in urology. - M.: MEDpress-inform, 2005. - 240 p. 6. Male diseases. / Ed. A.A. Kamalova, N.A. Lopatkina. - M.: MIA, 2008. - 320 p. 7. Protich M., Tsvetkov D. et al. Clinical trial of the drug Tribestan on infertile men. // Obstetrics and gynecology. - 1983. - T.12, No. 4. - P. 326–329, (Bulgarian) 8. Tribestan is a phytoregulator of the body’s endocrine system. Application experience. / Ed. M.E. Chaly, O.N. Sepp, S.V. Larina, I.V. Khaikova. - M.: 2006. - 50 p.