Tribulus terrestris versus placebo en el tratamiento de la disfunción eréctil: un estudio aleatorizado, prospectivo y doble ciego / Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study

Objetivos: Evaluar los posibles efectos de la fitoterapia con tribulus terrestris en el tratamiento de la disfunción eréctil y cuantificar su impacto potencial en los niveles de testosterona sérica. Diseño y métodos: Estudio prospectivo, aleatorizado, doble ciego y controlado con placebo incluyendo 30 hombres sanos seleccionados entre 100 pacientes que se presentaron espontáneamente con disfunción eréctil, ≥ 40 años de edad, no fumadores, no sometidos a tratamiento para el cáncer de próstata o disfunción eréctil, sin dislipidemia, sin uso de inhibidores de la fosfodiesterasa, sin manipulación hormonal y si presentaban hipertensión y/o diabetes mellitus debían ser controlados. El índice internacional de función eréctil (IIFE-5) y la testosterona sérica se obtuvieron antes de la aleatorización y después de 30 días de estudio. Los pacientes fueron divididos aleatoriamente en 2 grupos de 15 sujetos cada uno. El grupo de estudio recibió 800 mg de Tribulus terrestris, divididos en 2 dosis al día durante 30 días y el grupo control recibió placebo administrado de la misma manera. Resultados: Los grupos fueron estadísticamente equivalentes en todos los aspectos evaluados. La media de edad (DE) fue de 60 (9,4) y 62,9 (7,9) —p = 0,36— para la intervención y los grupos de placebo, respectivamente. Antes del tratamiento el grupo de intervención mostró una media de IIFE-5 de 13,2 (5-21) y la media de testosterona total de 417,1 ng/dl (270,7-548,4 ng/dl); el grupo de placebo mostró una media de IIFE-5 de 11,6 (6-21) y una media de testosterona total de 442,7 ng/dl (301-609,1 ng/dl). Después del tratamiento el grupo de intervención mostró una media de IIFE-5 de 15,3 (5-21) y una media de testosterona total de 409,3 ng/dl (216,9-760,8 ng/dl); el grupo placebo mostró una media de IIFE-5 de 13,7 (6-21) y una media de testosterona total de 466,3 ng/dl (264,3-934,3 ng/dl). El factor tiempo causó cambios estadísticamente significativos en ambos grupos solo para IIFE-5 (p = 0,0004), sin embargo no hubo ninguna diferencia entre los 2 grupos (p = 0,7914). Conclusiones: A la dosis y el intervalo estudiado Tribulus terrestris no fue más eficaz que el placebo en la mejora de los síntomas de la disfunción eréctil o la testosterona sérica total

Objectives: To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Design and methods: Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. Results: The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = 0.36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = 0.0004), however, there was no difference between the two groups (P = 0.7914). Conclusions: At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone

Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

OBJECTIVES: To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. DESIGN AND METHODS: Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. RESULTS: The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). CONCLUSIONS: At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total testosterone.

[Strategies for transfusion-free radical retropubic prostatectomy in Jehovah's witnesses]. / Estrategias para la prostatectomía retropúbica radical sin transfusión en testigos de Jehová

OBJECTIVES: While radical retropubic prostatectomy carries significant potential for blood loss requiring transfusion, Jehovah's Witnesses do not permit the use of allogeneic blood products. This study presents strategies for transfusion-free radical retropubic prostatectomy for prostate cancer treatment in Jehovah's Witnesses patients. METHODS: From March 1998 to May 2009, 25 Jehovah's Witnesses patients diagnosed with prostate cancer underwent radical prostatectomy and bilateral iliac and obturatory lymphadenectomy. Preoperative hemoglobin boost utilizing erythropoietin aiming hemoglobin over 14 g/dL, normovolemic hemodilution and availability of cell salvage machine were provided for blood loss management. RESULTS: The mean age was 62 (43 to 70) years and the mean hospitalization time was 3.5 (3 to 7) days. Mean intra-operative bleeding was 430 (+/-120) ml and the mean pre- and post-operative hemoglobin (measured before discharge) was 15.1 (+/-0.8) and 11.7 (+/-2.3) g/dL, respectively. There was no need for cell salvage machine or transfusion. The lowest hemoglobin was 5.7 g/dL due to post-operative bladder neck bleeding, which responded to twenty days of office based erythropoietin subcutaneously on alternate days reaching 12 g/dL hemoglobin. There was no complication related to non-transfusion. CONCLUSIONS: The proposed techniques were essential for maximum reduction of the need for transfusions without increasing complications. Further studies are needed to introduce these methods in all cases of radical retropubic prostatectomy regarding the benefits in lowering costs and risks related to transfusion.

Estrategias para la prostatectomía retropúbica radical sin transfusión en testigos de Jehová / Strategies for transfusion-free radical retropubic prostatectomy in Jehovah's witnesses

Objetivos: Aunque en la prostatectomía retropúbica radical (PRR) existe una gran posibilidad de pérdidas de sangre que exijan una transfusión, los testigos de Jehová no permiten el uso de hemoderivados alogeneicos. En este estudio se presentan estrategias para la PRR sin transfusión en el tratamiento del cáncer de próstata en pacientes que son testigos de Jehová. Métodos: Desde marzo de 1998 a mayo de 2009 se sometió a prostatectomía radical y a linfadenectomía ilíaca y obturatriz bilateral a 25 testigos de Jehová, a quienes se había diagnosticado cáncer de próstata. Para controlar la pérdida de sangre se administró eritropoyetina antes de la cirugía para aumentar la hemoglobina (Hb) por encima de 14g/dl, se practicó hemodilución normovolémica y se dispuso de una máquina de rescate de células. Resultados: La edad media de los pacientes fue de 62 años (43–70) y el tiempo medio de hospitalización fue de 3,5 días (3–7). La pérdida media de sangre intraoperatoria fue de 430 ml (±120) y la Hb preoperatoria y postoperatoria media (medida antes del alta) fue de 15,1 (±0,8) y de 11,7g/dl (±2,3), respectivamente. No hubo necesidad de la máquina de rescate de células ni de transfusiones. El valor más bajo de Hb fue de 5,7g/dl, debida a hemorragia postoperatoria del cuello vesical, que respondió a 20 días de administración subcutánea de eritropoyetina en consulta en días alternos con una elevación a 12g/dl de Hb. No hubo complicaciones relacionadas con la ausencia de transfusión. Conclusiones: Las técnicas propuestas fueron esenciales para una reducción mínima de la necesidad de transfusiones sin aumentar las complicaciones. Se necesitan más estudios sobre las ventajas de estos métodos para reducir los costes y los riesgos relacionados con la transfusión antes de introducirlos en todos los casos de PRR (AU)

Results: The mean age was 62 (43 to 70) years and the mean hospitalization time was 3.5 (3 to 7) days. Mean intra-operative bleeding was 430 (±120) ml and the mean pre- and post-operative hemoglobin (measured before discharge) was 15.1 (±0.8) and 11.7 (±2.3)g/dL, respectively. There was no need for cell salvage machine or transfusion. The lowest hemoglobin was 5.7g/dL due to post-operative bladder neck bleeding, which responded to twenty days of office based erythropoietin subcutaneously on alternate days reaching 12g/dL hemoglobin. There was no complication related to non-transfusion. Conclusions: The proposed techniques were essential for maximum reduction of the need for transfusions without increasing complications. Further studies are needed to introduce these methods in all cases of radical retropubic prostatectomy regarding the benefits in lowering costs and risks related to transfusion (AU)

Erectile dysfunction and hormonal imbalance in morbidly obese male is reversed after gastric bypass surgery: a prospective randomized controlled trial.

The effects of weight loss on erectile function and hormones have not been well studied. The aim of this study was to measure the degree to which sexual function and in particular erectile function and hormonal environment change after substantial weight loss, surgically and non-surgically induced in the morbidly obese male in a prospective randomized long-term controlled trial. Furthermore, how surgery makes a difference when treating morbidly obese men was envisaged in this context. We prospectively studied 20 morbidly obese men for 24 months, divided into two groups: group A included 10 patients who underwent life style modifications (exercise and diet) for 4 months and subsequently gastric bypass, and another 10 patients in group B were kept on weekly follow-up. None of the men were taking phosphodiesterase type-5 inhibitors. All patients underwent International Index of Erectile Function (IIEF)-5 questionnaire, serum oestradiol, prolactin (PRL), luteinizing (LH) and follicle-stimulating (FSH) hormones, free and total testosterone (FT and TT) at baseline (time 0), surgery - 4 months latter baseline (time 1) and final evaluation - 24 months (time 2). From times 0 to 1, group A presented a mean body mass index (BMI) reduction of 12.6 (p < 0.0001), whereas group B, 2.1 (p > 0.05). The BMI reductions between times 0 and 2 were 24.7 (p < 0.0001) and 0.7 (p > 0.05) for groups A and B respectively. BMI average between the two groups was similar at time 0 (p = 0.2142), and different at times 1 (p = 0.0033) and 2 (p < 0.0006). Increase in IIEF-5 score (p = 0.0469), TT (p = 0.0349) and FSH levels (p = 0.0025), and reduction in PRL level (p < 0.0001) were observed in group A from times 0 to 2 and 1 to 2. There were no changes from times 0 to 1. Comparing groups A and B at time 2, IIEF-5, TT and FT increased significantly in group A (p = 0.0224, 0.0043 and 0.0149 respectively). Surgery-induced weight loss increased erectile function quality measured by IIEF-5 questionnaire, increased TT, FT and FSH and reduced PRL levels. The hormonal impact verified could justify the improvement in erectile function. Lifestyle modifications impacted BMI without hormonal or sexual impact in morbidly obese. New studies are warranted in the field to support our data.

Efficacy and safety of flexible-dose oral sildenafil citrate (Viagra) in the treatment of erectile dysfunction in Brazilian and Mexican men.

A 12-week, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of flexible-dose sildenafil citrate (Viagra) treatment (25, 50 or 100 mg) in Brazilian and Mexican men with erectile dysfunction (ED) of broad-spectrum etiology. Efficacy was assessed on the basis of responses to the 15-item International Index of Erectile Function (IIEF) questionnaire, completed at baseline and after 12 weeks of treatment. At end point, mean scores for all IIEF domains of sexual function (erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall satisfaction) were significantly (P<0.0001) higher in the sildenafil group (n=109) than in the placebo group (n=105). These findings confirm the significant increases in frequency of penetration and frequency of maintained erections reported previously. Sildenafil treatment was well tolerated. The most common adverse events were headache and flushing. In conclusion, sildenafil is a well-tolerated and effective treatment for ED of broad-spectrum etiology in Latin American men.

Nonadrenergic, noncholinergic relaxation of human isolated corpus cavernosum induced by scorpion venom.

OBJECTIVES: To examine the effects of Tityus serrulatus scorpion venom (TSV) on human corpus cavernosum (HCC) using a bioassay cascade. Priapism is occasionally observed in scorpion envenomation, mostly in children. METHODS: HCC strips were suspended in a cascade system and superfused with aerated and warmed Krebs' solution at 5 mL/min. Noradrenaline (3 micromol/L) was infused to induce a submaximal contraction of the HCC strips. The release of cyclooxygenase products was prevented by infusing indomethacin (6 micromol/L). RESULTS: N(omega)-nitro-L-arginine methyl ester (10 micromol/L; n = 10) increased the tone of the preparations and significantly reduced (P <0.01) the acetylcholine (ACh) and TSV-induced relaxations. Subsequent infusion of L-arginine (300 micromol/L) partially reversed the increased tone and significantly restored the relaxations induced by TSV and ACh (P <0.01). The soluble guanylyl cyclase inhibitor ODQ (10 micromol/L; n = 8) markedly reduced (P <0.01) the relaxations induced by TSV, ACh, glyceryl trinitrate, and bradykinin. 7-Nitroindazole (10 micromol/L; n = 8) inhibited the relaxations induced by TSV by 84% (P <0.01) and also caused small, but significant, reductions in the ACh and bradykinin-induced HCC relaxations (P <0.05). Atropine (1 micromol/L; n = 6) abolished the relaxations evoked by ACh (P <0.01), but had no effect on those elicited by TSV. Tetrodotoxin (1 micromol/L; n = 6) abolished the relaxations induced by TSV (P <0.01) and also reversed the established TSV-induced relaxation (n = 4). CONCLUSIONS: Our results indicate that TSV relaxes HCC through the release of nitric oxide from nonadrenergic, noncholinergic (NANC) nerves. The elucidation of the mechanism responsible for the TSV-induced relaxations might be useful for a better understanding of the development of priapism in cases of scorpion envenomation.

Continuous fermentation of sugar cane syrup using immobilized yeast cells.

Several strains of Saccharomyces sp. and commercial Baker's yeast were immobilized by adhesion onto chrysotile, a fibrous magnesium silicate (Mg6Si4O10 (OH)8). The activity of the cells is higher when immobilized, mainly for fermentation of 30 to 50% w/v glucose solutions. In the medium containing 30% w/v glucose, the initial fermentation rate increased 1.2-2.5 times. Yields were in the range of 80.4 to 97.3% for the immobilized cells and 72.7 to 84.5% for the free cells. A packed bed reactor for continuous fermentation was set up using one of the tested strains immobilized onto chrysotile. An average productivity of 20 to 25 g.l(-1).h(-1) was obtained in the first 20 d, and an average of 16 g.l(-1).h(-1) was obtained after 50 d of operation.

Pharmacological characterization of kinin-induced relaxation of human corpus cavernosum.

OBJECTIVE: To characterize the kinin receptor subtype involved in the relaxation of human isolated corpus cavernosum (HCC) induced by bradykinin (BK), Lys-bradykinin (Lys-BK), Met-Lys-bradykinin (Met-Lys-BK) and des-Arg9-bradykinin, and to investigate whether the kinin-induced relaxation of HCC results from the stimulation of nonadrenergic, noncholinergic (NANC) neurons supplying the cavernosal tissue. MATERIALS AND METHODS: Excised HCC tissues were immediately placed in Krebs solution and kept at 4 degrees C until use (never > 24 h after removal). HCC was cut in strips of approximately 2 cm, suspended in a cascade system and superfused with oxygenated and warmed Krebs solution at 5 mL/min. After equilibration for approximately 90 min, noradrenaline (3 micromol/L) was infused to induce a submaximal contraction of the HCC strips. The release of cyclo-oxygenase products was prevented by infusing indomethacin (6 micromol/L). HCC strips were calibrated by injecting a single bolus of the nitrovasodilator glyceryl trinitrate (GTN) and the sensitivity of the tissues adjusted electronically to be similar. The agonists (kinins, histamine and acetylcholine) were injected as a single bolus (up to 100 microL) and the relaxation of HCC expressed as a percentage of the submaximal relaxation induced by GTN. RESULTS: Bradykinin, Lys-BK and Met-Lys-BK significantly relaxed the HCC tissues; on a molar basis, there was no statistical difference among the degrees of relaxation induced by these peptides. The B1 kinin receptor agonist des-Arg9-bradykinin had no effect on the HCC. The infusion of the B2 kinin receptor antagonist Hoe 140 (50 nmol/L) virtually abolished the relaxation induced by BK, Lys-BK and Met-Lys-BK without affecting those induced by acetylcholine and histamine. The infusion of the nitric oxide synthase inhibitor N(omega)-nitro-L-arginine methyl ester increased the tone of the HCC tissues and significantly reduced (P < 0.01) the relaxation induced by BK (74%), Lys-BK (90%), Met-Lys-BK (87%) and acetylcholine (89%) without affecting those induced by GTN. The subsequent infusion of L-arginine (300 micromol/L) partially reversed the increased tone and significantly (P < 0.01) restored the relaxation induced by BK, Lys-BK and Met-Lys-BK. The results were similar with the novel guanylate cyclase inhibitor 1H-[1,2,4] oxadiazolo[4,3,-alquinoxalin-1-one] which reduced by > 95% (P < 0.01) the relaxation induced by BK, Lys-BK, Met-Lys-BK, acetylcholine and GTN. The infusion of the sodium-channel blocker tetrodotoxin had no significant effect on the BK-, GTN- and acetylcholine-induced relaxation of HCC. CONCLUSION: This study clearly showed the existence of functional B2 kinin receptors in human erectile tissues that when activated lead to the release of NO and hence relaxation of the HCC tissues. As tetrodotoxin failed to affect the kinin-induced relaxation of HCC strips, it is likely that these peptides release NO from the endothelium of sinusoidal capillaries rather than from neuronal sources supplying the cavernosal tissue. Although tissue kallikreins and their components have been found in the male reproductive system, the physiopathological importance of these findings has yet to be elucidated.