[Results of a comparative multi-center randomized clinical study of efficacy and safety of EFFEX Tribulus and Tribestan in patients with erectile dysfunction].

RELEVANCE: Erectile dysfunction (ED) is a common condition. Pharmacological management of ED involves medications produced by chemical synthesis. Despite high efficiency, their use is often accompanied by some side effects. Considering this, herbal preparations with sufficient efficacy and greater safety have received much attention. AIM: To compare the efficacy and safety of two herbal preparations (EFFEX Tribulus and Tribestan) based on Tribulus Terrestris herb dry extract in patients with ED. MATERIALS AND METHODS: A total of 173 patients were enrolled in the study, of whom 87 (group I) and 86 (group II) received EFFEX Tribulus and Tribestan, respectively. The mean age of patients was 42.2+/-11.5 years in group I and 42.8+/-11.2 years in group II. One hundred fifty two patients completed the study. The follow-up was 13 weeks (the herbal preparation dose was titrated at week five after the treatment initiation). The effectiveness of treatment was assessed on five follow-up visits using the IIEF, AMS, MSF, GAQ questionnaires, and a complex of diagnostic and laboratory studies. RESULTS: At visit five compared to visit 1, the mean IIEF erectile function domain score increased by 5.7+/-4.6 and 5.2+/-4.3 points in group I and II, respectively. In both groups, all other IIEF domain scores demonstrated a statistically significant increase. The AMS scores decreased from 32.93+/-10.04 to 25.02+/-7.62 points in group I and 31.78+/-10.37 to 24.55+/-7.31 points in group II. The SMF scores increased from 22.36+/-4.85 to 27.16+/-4.80 points in group I and from 22.13+/-3.69 to 26.10+/-5.69 points in group II. Besides, the use of the herbal preparations was associated with a decrease in the serum cholesterol level, more pronounced with increasing patient age (correlation coefficient -0.06, p=0.41). CONCLUSION: The herbal preparations EFFEX Tribulus and Tribestan have a similar efficacy and safety profiles.

[The results of the 10-year study of efficacy and safety of Serenoa repens extract in patients at risk of progression of benign prostatic hyperplasia].

The article presents the results of an open, noncomparative, observational study of the efficacy and safety of continued use of the Serenoa repens (prostamol uno) plant extract at a dose of 320 mg 1 time a day for 10 years in 38 patients with early manifestations of BPH and the risk of its progression. The results of study showed the absence of progression, both on subjective criteria (IPSS, and QoL scores), and objective criteria (prostate volume, the rate of urination, residual urine volume). Furthermore, patients had no undesirable effects directly related to the use of this drug.

[Treatment of chronic prostatitis in prophylaxis of prostatic adenoma].

The results of a retrospective study of efficacy of prostamol uno in a standard single dose of 320 mg/day in prevention of chronic prostatitis recurrences and prostatic adenoma used for 5 years as an adjuvant to standard therapy of chronic prostatitis exacerbations were compared with those of standard course antibacterial and anti-inflammatory treatment alone. The analysis demonstrated that prostamol uno (Serenoa repens extract) in a dose 320 mg/day improves both subjective symptoms (data of IPSS, QoL scale) and objective ones (the absence of the disease progression and adverse effects, enhancement of the erectile function). Prostamol uno is effective for prevention of both recurrences of chronic prostatitis exacerbations and development of prostatic adenoma.

[A comparative clinical randomized trial of cernilton efficacy and safety in patients with chronic abacterial prostatitis].

The trial of efficacy and safety of two doses of the drug cernilton in patients with chronic abacterial prostatitis made in the Research Institute of Urology and I.M. Sechenov Medical Academy in 2008 gave evidence for subjective (NIH-CPSI, Sex-4, IPSS and other scales, QOL) and objective (leucocyte count in prostatic secretion) pronounced anti-inflammatory effects of the drug which persist for at least 6 months. Comparison of the two doses of cernilton showed significant differences in subjective response of the patients (NIH-CPSI and Symptom Frequency Scale). Cernilton is recommended as a medication of choice for treatment of patients with chronic abacterial prostatitis.

[Results of three-year clinical study of prostamol uno efficacy and safety in patients with initial symptoms of prostatic adenoma and risk of its progression].

Prostamol Uno (PU) efficacy and safety were studied in a multicenter, open-population, randomized and comparative trial. PU was given in a single daily dose 320 mg for 36 months to 50 patients with initial symptoms of prostatic adenoma (PA) in comparison with 50 matched controls. The trial evaluated PU action on the symptoms progression and quality of life with application of questionnaires IPSS and QoL (BS). It was found that PU treatment relieved PA symptoms by IPSS, while these symptoms progressed in the controls. QoL improved in the study group and deteriorated in the control one. Administration of PU significantly increased urinary flow rate though in the controls urinary flow rate decreased, size of the prostate diminished and increased, respectively. Changes in the PSA were not seen and were insignificant, respectively. The results of the study say that prostamol Uno in a dose 320 mg/day can prevent PA progression without side effects.

[Efficacy and safety of prostamol-UNO in the treatment of patients with initial symptoms of prostatic adenoma and risk of progression: 2 years of investigations].

The article presents 2-year pilot results of a multicenter, randomized, controlled trial of prostamol-UNO effects on symptoms progression, quality of life, tolerance and safety in patients with early prostatic adenoma. The drug was used in a single dose 320 mg/day for 36 months. Prostamol-UNO efficacy in arrest of the symptoms progression and quality of life was assessed with the use of IPSS and QoL (BS) questionnaires. Measurements were also made of changes in Qmax, urine volume, residual urine, size of the prostate.

[Cernilton in the treatment of prostatic adenoma and chronic prostatitis].

The efficacy of the drug cernilton was studied in patients with prostatic adenoma (PA) and chronic bacterial prostatitis (CBP). One group and two subgroups of patients were studied: 31 men with PA received cernilton for 3 months (group 1); 32 patients with CBP received antibacterial treatment (for 8 months) and cernilton for 3 months (group IIa); 30 CBP patients received standard antibiotic treatment for 2 months maximally (group IIb). All the patients were examined before the treatment and 3 months later. According to IPSS, patients of group 1 showed a significant (p < 0.001) regress of low urinary tract symptoms and improvement of quality of life. PSA in the serum lowered by 21.2%. Qmax significantly increased (p < 0.001), Vprost and Vres diminished. According to the scale NIH-CPSI, relief of pain, dysuria was greater, quality of life improved more in patients of group IIa than in group IIb (p < 0.05). The same trend was in the values Qmax, Vres and Vprost. Thus, it is evident that cernilton is effective in monotherapy of PA and combined treatment of CBP.

[Results of a multicenter trial of serenoa repens extract (permixon) in patients with chronic abacterial prostatitis].

Chronic prostatitis (CP) morbidity now makes up 8 to 35% in males aged 20-40 years (N.A. Lopatkin et al., 1998; O.L. Tiktinsky, 1999). In general population CP incidence rate is 5 to 8% (J.C. Nickel, 1999). Phytotherapy is now widely practiced in CP. A multicenter trial conducted by the authors demonstrates high efficacy ofpermixon in the treatment of chronic prostatitis/chronic pelvic pain syndrome. The results of 6-month follow-up are presented.

[Efficiency and safety of prostamol-Uno in patients with chronic abacterial prostatitis].

In this open label prospective study in patients with category III prostatitis we assessed efficacy and safety of Sabal serrulata plant extract (prostamol Uno 320 mg) (group I, n=30) as compared to watchful waiting (group II, n=24). Efficacy was evaluated by means of NIH-CPSI, IPSS-QoL questionnaires, patients' general subjective assessment of treatment outcome, uroflowmetry and transrectal Doppler mapping (colour doppler and spectral doppler) of the prostate. Patients receiving prostamol Uno in comparison with watchful waiting group had significant improvement of mean NIH-CPSI (from 17.8 to 11.4 vs 17.1 to 16.5) and IPSS (from 13.0 to 6.3 vs 13.2 to 11.6) scores, Qmax values (from 12.9 ml/s to 17.8 ml/s vs 13.3 ml/s to 14.4 ml/s) and Doppler parameters of vascular resistance in the prostate. According to the patients' subjective assessment, moderate and significant improvement was reported by 76.7% patients in prostamol Uno group vs 23.3% in the watchful waiting group. There were no severe side effects. In prostamol Uno group one patient (3.3%) had moderate dyspepsia that resolved without termination of the drug administration. Prostamol Uno showed good efficacy and safety profile in patients with category III prostatitis.

[Causes of erectile dysfunction after transurethral resection of hyperplastic prostate and its prophylaxis].

The study was made of 60 sexually active patients with prostatic hyperplasia after monopolar transurethral operations (mean age 61.3 years). 30 patients entered a control group, 30 ones--the study group. The latter received 10 mg vardenafil each other day for 7 weeks after the intervention. The patients filled in questionnaire, underwent dopplerography and electromyography of the penis. Questionnaire said that erection was worse after operation in 6 (20%) patients (p < 0.01) of the control group and none of the study group. The latter also showed better circulation. All the men with postoperative erectile dysfunction (ED) had electromyographic signs of impaired autonomic innervation of the penis. Thus, ED after transurethral operations for prostatic hyperplasia is primarily neurogenic and is seen in 20% operated patients. Early vardenafil therapy is effective in prevention of postoperative ED.

[The results of long-term permixon treatment in patients with symptoms of lower urinary tracts dysfunction due to benign prostatic hyperplasia]. / Rezul'taty dolgosrochnogo primeneniia permiksona u bol'nykh s simptomami narusheniia funktsii nizhnikh mochevykh putei, obuslovlennymi dobrokachestvennoi giperplaziei predstatel'noi zhelezy.

The trial enrolled 155 patients (mean age 65 years) with documented benign prostatic hyperplasia and lower urinary tracts symptoms (LUTS) (IPSS > 6). All the patients received permixon in a dose 160 mg twice a day for 2 years. The data on 130 patients eligible for assessment were processed statistically by dynamics of IPSS, quality of life (QOL), index of sexual function (MSF-4), size of the prostate, urodynamic and biological parameters which were estimated in 6 (V6), 12 (V12), 18 (V18) and 24 months (V24). Clinical examination with registration of all side effects was made each 3 months. Permixon was found to noticeably reduce IPSS and QOL and increase maximal urine flow speed. The size of the prostate diminished insignificantly. Sexual function remained unchanged for 1 year and improved markedly within the second year (p = 0.001). Permixon had no effect on the level of prostate-specific antigen. Plasma hormones (testosterone, DHT, estradiol, LH, androstendion) did not change. Nine patients developed 10 side effects but they were unrelated to the treatment.

[Five-year experience in treating patients with prostatic hyperplasia patients with permixone (Serenoa repens "Pierre Fabre Medicament)]. / Piatiletnii opyt lecheniia permiksonom (Seronoa repens "Pierre Fabre Medicament") bol'nykh s giperplaziei predstatel'noi zhelezy.

Specialists of the urologic clinic of the I.M. Sechenov Moscow Medical Academy studied effectiveness of lipidosterol extract Serenoa repens (permixon) in 26 patients with prostatic hyperplasia (total prostate-specific antigen was under 4 ng/ml). The trial has been performed from November 1995 up to now. The drug was taken before meal with a small quantity of water in a total daily dose 320 mg twice a day. Initial IPSS values ranged from 8 to 18 scores (mean 11.65 +/- 0.59). Life quality index was 1 to 4 scores (mean 2.46 +/- 0.15). Initial size of the prostate varied from 26 to 63 cm3 (mean 36.23 +/- 1.57 cm3). Maximal urinary flow rate (Qmax) made up 8.7 to 14.6 ml/s (mean 11.83 +/- 0.31 ml/s). Residual urine was initially 0-60 ml (mean 10.58 +/- 2.91 ml). Permixon significantly reduced the disease symptoms and improved quality of life. 5 years of treatment decreased mean IPSS by 8.8 +/- 0.18 (75.5%). QOL--by 1.31 +/- 0.08 (53.3%), size of the prostate--by 10.81 +/- 0.55 cm3 (29.8%). Neither the symptoms nor quality of life became worse for these five years. The size of the prostate reduced in 16, unchanged in 9 and increased only in 1 patient. Qmax was initially under 15 ml/s and rose after the treatment by 4.13 +/- 0.51 ml/s (35%), on the average. Qmax rose above 15 ml/s in 16 patients. Residual urine increased during the treatment in one patient only. Permixon intolerance was not observed. Thus, continuous 5-year therapy with lipidosterol extract Serenoa repens (permixon) proved highly effective and safe in 26 patients with initial or moderate symptoms of prostatic hyperplasia.

[Transurethral electrosurgery in the treatment of benign prostatic hyperplasia]. / Transuretral'naia élektrokhirurgiia v lechenii dobrokachestvennoi giperplazii predstatel'noi zhelezy.

The article is devoted to topical problem of modern urology, one of the lines of surgical treatment of benign prostatic hyperplasia (BPH)--transurethral electrosurgery. Physical principles which are the basis of transurethral electrosurgical interventions and influence of transurethral electrosurgery on prostatic tissue are described. Methods of necessary preoperative examination of patients with BPH are presented. The most often used transurethral electrosurgical technique for destruction of hyperplastic prostatic tissue is described. The results of 5-year use of combination of transurethral electroresection and electrovaporisation in the treatment of BPH and its complications are presented. Ways of prophylaxis of possible complications are proposed.

[Effect of prazosin on human prostatic adenoma tissue]. / Vliianie prazozina na tkan' adenomy predstatel'noi zhelezy cheloveka.

The effect of prazosin on epinephrine-induced contractions of human benign prostatic hyperplasia strips was studied. It was shown that prazosin has a pronounced adrenoblocking activity (EC50 = 5.10(-9) g/ml) but fails to affect strip contractions induced by KCL. It is suggested that prazosin can be used in the treatment of patients suffering from benign prostatic hyperplasia.