[The role of antioxidants in the therapy of metabolic syndrome in men].

INTRODUCTION: Metabolic syndrome (MetS) is a combination of hormonal, metabolic and clinical disorders. Currently, MetS in men is considered as one of the main risk factors for the development of cardiovascular diseases, insulin resistance, and pathology of the reproductive system. AIM: To study the effect of a complex of folic acid, L-carnitine, vitamin E, zinc and selenium, which are part of the biologically active food supplement "Speroton", on the parameters of carbohydrate and lipid metabolism in men with MetS, especially in the early stages of its development, as well as on erectile function and quality of life of patients. MATERIALS AND METHODS: A total of 64 patients aged 30 to 51 years with MetS of varying severity were included in the study. The main group consisted of 34 patients aged 32 to 51 years (mean age 46.2+/-2.1 years), while in the control group, there were 30 patients aged 30 to 49 years (mean age 45.4+/-3.4 years). The standard therapy in the main group was supplemented by taking the dietary supplement "Speroton" for 3 months. In the control group, patients received only standard therapy for MetS. The results were evaluated after 3 and 6 months from the start of treatment. All patients underwent laboratory evaluation of sex hormones, carbohydrate metabolism and lipid profile. In addition, the concentration of zinc in the spermatozoa was measured, as well as the level of total antioxidant capacity of the sperm. The uroflowmetry, ultrasound of the bladder with the measurement of the postvoid residual, and transrectal ultrasound of the prostate were also performed. RESULTS: An addition of the antioxidant complex "Speroton" to the combination treatment of MetS in the main group allowed to decrease the parameters of oxidative stress by almost two times. By the 6th month of follow-up, the level of insulin improved, which was accompanied by a decrease in the level of HbA1c by 16.3%, suggesting the stabilization of carbohydrate metabolism. A decrease in body mass index by almost 14% (p<0.05) in the main group was found, as well as normalization of the lipid profile. According to the analysis of the erectile function in patients of the main group after 6 months from the beginning of therapy, there was a decrease in the total score to a moderate erectile dysfunction (12.5+/-2.1 points). There was a decrease in storage symptoms and, in part, voiding symptoms in patients in the main group, who received antioxidant therapy. In addition, a positive correlation between the concentration of zinc and the level of total antioxidant capacity in the ejaculate was seen. CONCLUSIONS: Our results suggest the high therapeutic efficiency of dietary supplement "Speroton" as an antioxidant complex for the treatment of patients with MetS of varying severity. The addition of antioxidants "Speroton" to the standard therapy of MetS contributes to the improvement of the sensitivity of insulin receptors, the normalization of carbohydrate and lipid metabolism, endothelial function and blood pressure, which is accompanied by a significant decrease in LUTS severity, as well as an improvement in the erectile function of patients.

Mechanisms Suggesting a Relationship between Vitamin D and Erectile Dysfunction: An Overview.

Vitamin D deficiency (VDD) and erectile dysfunction (ED) heavily burden the male population. The higher prevalence of both conditions in the elderly suggests a possible relationship between the two conditions. In addition, in vitro, animal, and human studies have revealed several mechanisms that may relate VDD to ED. The main mechanism by which vitamin D might exert its action on sexual function appears to be through the regulation of endothelial function. Indeed, VDD correlates with several markers of endothelial function. The action of vitamin D on the endothelium would be exercised both indirectly through its intervention in inflammatory processes and through the production of oxygen free radicals, and directly through the regulation of vascular stiffness, the production of nitric oxide, and the regulation of vessel permeability. Furthermore, the ubiquitous distribution of the vitamin D receptor in the human body means that this hormone can also exert a beneficial effect on erectile function by interfering with those comorbidities significantly associated with ED, such as hypertension, diabetes mellitus, hypercholesterolemia, chronic kidney disease, and hypogonadism. In this review, we thoroughly and carefully presented the evidence and mechanisms that would appear to relate vitamin D levels to erectile function. Furthermore, we have summarized the meta-analytic evidence for and against this association to provide a true representation of this topic. Data published to date suggest that low levels of vitamin D could contribute to worsening erectile function through several mechanisms. Therefore, vitamin D levels should be measured in patients with ED and maintained at adequate levels by specific supplementation in case of deficiency. However, the low quality and heterogeneity of clinical trials evaluating the effects of vitamin D administration on erectile function and ED-associated comorbidities do not allow for a univocal conclusion, and indicate the need for further studies to analyze these aspects.

Leech-Centipede Granules Suppress EndMT to Improve Erectile Dysfunction in Rats with Diabetes Mellitus via TGF-ß/Smad Pathway.

OBJECTIVE: To investigate whether Leech-Centipede (LC) Granules can improve erectile function in rats with diabetes mellitus-associated erectile dysfunction (DMED) through endothelial-to-mesenchymal transition (EndMT) inhibition. METHODS: Components of LC Granules were identified via ultra-high-performance liquid chromatography. Thirty male Sprague Dawley rats were injected with streptozotocin and fed continuously for 8 weeks to establish the DMED rat model. Rats with erectile dysfunction symptoms diagnosed using apomorphine were divided into DMED and low-, medium-, and high-doses LC groups (n=6 in each). The negative control (NC, n=6) and DMED groups were given 5 mL of deionized water via intragastric gavage, and the low-, medium- and the high-doses LC groups were administered LC at 1.6, 3.2, and 6.4 g/kg, respectively, via intragastric gavage for 4 weeks. The intracavernous pressure (ICP), mean arterial pressure (MAP), and nitric oxide (NO) levels in cavernous tissue were measured for each group. Quantitative reverse transcription-polymerase chain reaction and Western blot were used to detect mRNA and protein expressions of endothelial and mesenchymal markers. Immunofluorescence staining was used to observe α-SMA, and Masson's trichrome staining was performed to determine the myofiber/collagen ratio. RESULTS: A total of 474 active components were identified. After treatment, the ICP/MAP value and NO level were significantly higher in the medium- and high-dose LC groups than in the DMED group (P<0.05). Compared with the DMED groups, the medium- and high-dose groups LC significantly increased and decreased endothelial and mesenchymal markers expression, respectively (P<0.05). Tumor growth factor (TGF)ß R II, p-Smad2, and p-Smad3 levels were considerably higher following diabetes onset but reduced following LC intervention (P<0.05), except for TGF ß 1 (P>0.05). α-SMA expression was significantly higher in the DMED group and was reduced in all LC intervention groups (P>0.05). The myofiber/collagen ratio in the LC groups was higher than that in the DMED group but lower than that in the NC group (all P<0.05). CONCLUSIONS: LC Granules may improve the erectile function of DMED rats by suppressing TGF-ß/Smad pathway to reverse EndMT.

Nutraceutical potential of almond fruits in managing diabetes-related erectile dysfunction: Effect on Nrf-2 level and smooth muscle/collagen ratio.

Oxidative stress is one of the major crosstalk between diabetes and erectile dysfunction. Tropical almond is a natural antioxidant that works in a way to neutralize the effect of reactive oxygen species in disease management. This study therefore aimed to evaluate the effects of tropical almond on the nuclear factor erythroid-2-related factor-2 (nrf-2) level and smooth muscle/collagen ratio, as well as other biochemical indices in the penile tissue of diabetic rats. Six non-diabetic male rats (control) and 36 diabetic male rats were divided into six groups (n = 6). The diabetic male rats were placed on almond-supplemented diets except for the diabetic control group. Thereafter, the rats were sacrificed penile tissues were excised for nrf-2, smooth muscle/collagen ratio, and other biochemical analyses. The results revealed a significant (p < 0.05) decrease in nrf-2 level, smooth muscle/collagen ratio, and total thiol level, with a concomitant increase in acetylcholinesterase activity in comparison to the control group. Interestingly, therapy with diets high in almond fruits significantly enhances the nrf-2 level, smooth muscle/collagen ratio, and total thiol level in comparison with the untreated diabetic group. In addition, dietary inclusion of almond fruits significantly reduced acetylcholinesterase activity in diabetic male rats. Therefore, the preventive management with almond fruits could be beneficial in combating erectile dysfunction associated with diabetes. The activities of almond fruits reported in this study could be due to their antioxidant property and the inherent phytoconstituents (amino acids, phenolic compounds, and flavonoids).

N-acetylcysteine improves diabetic associated erectile dysfunction in streptozotocin-induced diabetic mice by inhibiting oxidative stress.

Oxidative stress appears to play a role in the pathogenesis of diabetes mellitus erectile dysfunction (DMED). This study aimed to investigate the effect of N-acetylcysteine (NAC) on DMED in streptozotocin-induced diabetic mice and to explore potential mechanisms. In the present study, we show that an erectile dysfunction is present in the streptozotocin-induced mouse model of diabetes as indicated by decreases in intracavernous pressure responses to electro-stimulation as well as from results of the apomorphine test of erectile function. After treatment of NAC, the intracavernous pressure was increased. In these DMED mice, oxidative stress and inflammatory responses were significantly reduced within the cavernous microenvironment, while activity of antioxidant enzymes in this cavernous tissue was enhanced after NAC treatment. These changes protected mitochondrial stress damage and a significant decreased in apoptosis within the cavernous tissue of DMED mice. This appears to involve activation of the nuclear factor erythroid 2-like-2 (Nrf2) signalling pathway, as well as suppression of the mitogen-activated protein kinase (MAPK) p38/ NF-κB pathway within cavernous tissue. In conclusion, NAC can improve erectile function through inhibiting oxidative stress via activating Nrf2 pathways and reducing apoptosis in streptozotocin-induced diabetic mice. NAC might provide a promising therapeutic strategy for individuals with DMED.

Neuroprotective effect of Hongjing I granules on erectile dysfunction in a rat model of bilateral cavernous nerve injury.

Neurogenic erectile dysfunction (NED) is an inevitable postoperative disease of cavernous nerve injury which will lead to various pathophysiological changes in the corpus cavernosum and dorsal penile nerve caused by radical prostatectomy (RP). Although serval years of clinical application of HJIG I granules (HJIG), an innovative formulation, has demonstrated its reliable clinical efficacy against NED, the mechanism of HJIG remains unclear. This study aimed to assess the neuroprotective effect of HJIG, to repair damaged nerves in a rat model of bilateral cavernous nerve injury (BCNI) in vivo and their effects on neurites of major pelvic ganglia (MPG) regeneration and Schwann cells (SCs) proliferation in vitro. Rats were divided into five groups randomly: normal control (NC), BCNI-induced ED model (M), M + low-dose HJIG (HL), M + medium-dose HJIG (HM), and M + high-dose HJIG (HH). All groups were treated with normal saline or the relevant drug for 28 consecutive days after a standard NED animal model. Our data revealed that administration of HJIG improved NED that was detected by intracavernous pressure (ICP) in a dose-dependent manner. The haematoxylin-eosin (HE) and Immunofluorescence (IF) staining demonstrated that HJIG ameliorate the shape of penis and induced the protein synthesis of GAP43, NF200, S100, and nNOS. NF200 and S100 level were also detected by western blotting. Moreover, HJIG (0.78 mg/mL) markedly increased SCs viability and promoted neurites regeneration of MPG. These findings provide new insights into the NED therapy by HJIG.

Comparative Study of the Effectiveness and Safety of Transurethral Bipolar Plasmakinetic Enucleation of the Prostate and Transurethral Bipolar Plasmakinetic Resection of the Prostate for Massive Benign Prostate Hyperplasia (>80 ml).

BACKGROUND The aim of this study was to compare the clinical safety and effectiveness of transurethral bipolar plasmakinetic enucleation of the prostate (PKEP) vs. transurethral bipolar plasmakinetic resection of the prostate (PKRP) in the treatment of benign prostate hyperplasia (BPH) more than 80 ml. MATERIAL AND METHODS From June 2015 to February 2019, 179 BPH patients with prostate volume greater than 80 ml were enrolled and separated into a PKEP (n=81) group and a PKRP group (n=98). The patients in the 2 groups were followed up for 6 months. We collected and analyzed data from the international Prostate Symptom Score (IPSS), residual urine volume (RUV), quality of life (QOL), maximum urine flow rate (Qmax), and international erectile function index (ILEF-5). The clinical data collected during and after the operation and surgical complications were compared between the 2 groups. RESULTS The PKEP group had significantly shorter operation time, bladder flushing time, indwelling catheter time, and hospitalization time, and has less intraoperative blood loss, intraoperative blood transfusion, postoperative secondary hemorrhage, bladder neck contracture, capsule perforation, and retrograde ejaculation (P<0.05). Compared with the PKRP group, the postoperative IPSS and QOL scores were significantly lower in the PKEP group (P<0.05), while the excision glandular tissue weight and Qmax were significantly improved (P<0.05). There were no significant differences in ILEF-5 scores, RUV, urethral stricture, urinary incontinence, or erectile dysfunction between the 2 groups (p>0.05). CONCLUSIONS PKEP treatment of BPH with a large volume (>80 ml) has the advantages of complete gland resection, good surgical effect, improved surgical safety, and reduced intraoperative and postoperative complications.

Traditional Chinese medicine on treating diabetic mellitus erectile dysfunction: Protocol for a systematic review and meta-analysis.

BACKGROUND: Diabetic mellitus erectile dysfunction (DMED) refers to erectile dysfunction (ED) secondary to diabetes. As people's lifestyle changes and the population ages, the incidence of DMED continues to increase. Many clinical trials have proven that Chinese medicine has a significant effect in the treatment of DMED. In this systematic review, we aim to evaluate the effectiveness and safety of traditional Chinese medicine (TCM) for DMED. METHODS: We will search PubMed, Cochrane Library, AMED, EMbase, WorldSciNet; Nature, Science online and China Journal Full-text Database, China Biomedical Literature CD-ROM Database, and related randomized controlled trials included in the China Resources Database. The time is limited from the construction of the library to February, 2019.We will use the criteria provided by Cochrane 5.1.0 for quality assessment and risk assessment of the included studies, and use the Revman 5.3 and Stata13.0 software for meta-analysis of the effectiveness, recurrence rate, and symptom scores of DMED. ETHICS AND DISSEMINATION: This systematic review will evaluate the efficacy and safety of TCM for treating Diabetic mellitus erectile dysfunction. Because all of the data used in this systematic review and meta-analysis has been published, this review does not require ethical approval. Furthermore, all data will be analyzed anonymously during the review process trial.

A comparison of time taken to return to baseline erectile function following focal and whole gland ablative therapies for localized prostate cancer: A systematic review.

OBJECTIVES: To systematically review erectile function (EF) outcomes following primary whole gland (WG) and focal ablative therapies for localized prostate cancer to ascertain whether the treatment modality or intended treatment volume affects the time taken to recover baseline EF. METHOD AND MATERIALS: A systematic review was performed according to the preferred reporting items for systematic review and meta-analysis statement. Inclusion criteria were men with localized prostate cancer treated with primary, ablative therapy. Primary outcome was the return to baseline EF measured with objective, validated symptoms scores. Secondary outcome was use of phosphodiesterase inhibitors or erectile aids. Meta-analysis was not performed owing to heterogenous outcome measures. RESULTS: Of 222 articles identified in February 2017, 55 studies which reported EF after ablative therapy were identified but only 17 used validated outcome measures and met inclusion criteria. WG cryotherapy was used in 2 studies, WG high-intensity focused ultrasound (HIFU) in 5, focal cryotherapy in 2, focal HIFU in 3, focal phototherapy or laser therapy in 4, vascular-targeted photodynamic therapy in 3, and irreversible electroporation in 2. WG cryotherapy was associated with a significant decline in EF at 6 months with minimal improvement at 36 months. Baseline IIEF-15 of patients undergoing focal HIFU fell 30 points at 1 month but returned to baseline by 6 months. The remaining focal therapies demonstrated minimal or no effect on EF, but the men in these studies had small foci of disease. The review is limited by lack of randomized studies and heterogenous outcome measures. CONCLUSIONS: Most studies assessing the outcomes of focal therapy on sexual function were not of high quality, used heterogenous outcomes, and had relatively short follow up, highlighting the need for more robustly designed studies using validated patient reported outcome measures  for comparison. However, FT in general resulted in less effect on EF than WG ablation.

Associação entre Disfunção Erétil e Piora na Qualidade de Vida de Pacientes com Doença Arterial Coronariana / Association between Erectile Dysfunction and Quality of Life in Patients with Coronary Artery Disease

Fundamentos: A disfunção erétil (DE) e a doença arterial coronariana (DAC) compartilham os mesmos fatores de risco e as associações entre DE, qualidade de vida (QV) e DAC têm sido motivo de estudos recentes. Objetivo: Avaliar se a DE está associada a piora da QV em pacientes com DAC. Métodos: Estudo transversal, multicêntrico, prospectivo e analítico, realizado de dezembro de 2014 a abril de 2016, que recrutou 304 homens (idade média: 57 ± 9,9 anos) com diagnóstico clínico de DAC. A QV foi avaliada através do Short Form-36 e a DE pelo Índice Internacional de Função Erétil. Foram realizadas análises estatísticas descritiva e analítica, sendo que o teste não paramétrico Kruskal-Wallis foi usado para analisar se existem diferenças significativas em cada domínio de qualidade de vida quando se comparam os diferentes tipos de DE. Para todos os testes, valor de p ≤ 0,05 foi considerado significante. Resultados: A prevalência de DE foi de 76,3%. As medianas e percentis 25 e 75 de cada domínio de qualidade de vida de acordo com a ausência de DE, DE leve, leve a moderada, moderada e grave, respectivamente, foram: Capacidade funcional: 85 (63-100), 75 (50-95), 60 (32-85), 55 (35-75), 50 (30-70), p < 0,001; Aspectos físicos: 87 (0-100), 40 (0-100), 0 (0-100), 0 (0-31), 0 (0-12), p < 0,001; Dor: 72 (51-100), 66 (51-100), 74 (51-100), 62 (51-100), 51 (31-62), p = 0,001; Estado geral de saúde: 77 (62-87), 72 (57-77), 67 (55-82), 67 (59-75), 52 (37-68), p < 0,001; Vitalidade: 75 (60-85), 65 (50-75), 65 (55-75), 60 (43-75), 50 (32-65), p < 0,001; Aspectos sociais: 87 (62-100), 87 (62-100), 87 (68-100), 75 (62-100), 75 (50-93), p = 0,139; Aspectos emocionais: 100 (58-100), 100 (33-100), 100 (33-100), 100 (0-100), 0 (0-100), p = 0,001; Saúde mental: 80 (67-89), 72 (60-84), 72 (66-80), 68 (58-80), 56 (50-74), p < 0,001. Conclusões: A prevalência de disfunção erétil foi elevada. A DE esteve associada a piora da QV em pacientes com DAC

Background: Erectile dysfunction (ED) and coronary artery disease (CAD) share the same risk factors and the associations between ED, quality of life (QoL) and CAD have been the subject of recent studies. Objective: To evaluate whether ED is associated with worsening QoL in patients with CAD. Methods:A cross-sectional, multicenter, prospective and analytic study was carried out from EDcember 2014 to April 2016, which recruited 304 men (mean age: 57 ± 9.9 years) with clinical diagnosis of CAD. QoL was assessed using Short Form-36 and ED by the International Erectile Function InEDx. EDscriptive and analytical statistical analyzes were performed, and the Kruskal-Wallis non-parametric test was used to test whether there are significant differences in each quality of life domain when comparing different types of ED. For all tests, p ≤ 0.05 was consiEDred significant. Results: The prevalence of ED was 76.3%. The median and percentiles 25 and 75 of each life quality domain according to the absence of ED; mild ED, mild to moderate, moderate and severe ED and severe ED, respectively, were: Functional capacity: 85 (63-100), 75 (50 -95), 60 (32-85), 55 (35-75), 50 (30-70), p < 0.001; Physical aspects: 87 (0-100), 40 (0-100), 0 (0-100), 0 (0-31), 0 (0-12), p < 0.001; Pain: 72 (51-100), 66 (51-100), 74 (51-100), 62 (51-100), 51 (31-62), p = 0.001; General state of health: 77 (62-87), 72 (57-77), 67 (55-82), 67(59-75), 52 (37-68), p < 0.001; Vitality: 75 (60-85), 65 (50-75), 65 (55-75), 60 (43-75), 50 (32-65), p < 0.001; Social Aspects: 87 (62-100), 87 (62-100), 87 (68-100), 75 (62-100), 75 (50-93), p = 0.139; Emotional Aspects: 100 (58-100), 100 (33-100), 100 (33-100), 100 (0-100), 0 (0-100), p = 0.001; Mental health: 80 (67-89), 72 (60-84), 72 (66-80), 68 (58-80), 56 (50-74), p < 0.001. Conclusions: The prevalence of erectile dysfunction was high. ED was associated with worsening of QoL in patients with CAD

Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. PARTICIPANTS AND DESIGN: Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan®, Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. RESULTS: 86 patients in each group completed the study. The IIEF score improved significantly in the TT group compared with the placebo group (Р<0.0001). For intention-to-treat (ITT) there was a statistically significant difference in change from baseline of IIEF scores. The difference between TT and placebo was 2.70 (95% CI 1.40, 4.01) for the ITT population. A statistically significant difference between TT and placebo was found for Intercourse Satisfaction (p=0.0005), Orgasmic Function (p=0.0325), Sexual Desire (p=0.0038), Overall Satisfaction (p=0.0028) as well as in GEQ responses (p<0.0001), in favour of TT. There were no differences in the incidence of adverse events (AEs) between the two groups and the therapy was well tolerated. There were no drug-related serious AEs. Following the 12-week treatment period, significant improvement in sexual function was observed with TT compared with placebo in men with mild to moderate ED. TT was generally well tolerated for the treatment of ED.

Combination of mesenchymal stem cell injection with icariin for the treatment of diabetes-associated erectile dysfunction.

The present study was aimed to examine whether icariin, a traditional Chinese medicine, could improve therapeutic effects of adipose derived mesenchymal stem cells (ADSCs) for diabetes-associated erectile dysfunction (DMED). DMED were induced in rats by intraperitoneal injection of streptozotocin and confirmed by erectile function measurement. Then, rats of diabetic ED were randomly divided to receive the treatment of saline, ADSCs, icariin or ADSCs combined with icariin respectively. Compared with the treatment by ADSCs or icariin alone, intracavernosum injection of ADSCs combined with the following daily gastric gavage of icariin significantly augmented the value of ICP and ICP/MAP (p<0.01). Meanwhile, the survival of transplanted ADSCs was much improved due to the application of icariin. Similarly, immunofluorescent staining analysis demonstrated that the improved erectile tissue structure by combination of ADSCs and icariin was significantly associated with the increased expression of endothelial markers (vWF) (p<0.01) and smooth muscle markers (α-SMA) (p<0.01). Furthermore, the structure changes in corpus cavernosum were further confirmed by the Masson's trichrome staining. To explore the possible mechanism underlying icariin-enhanced therapeutic efficacy of MSCs, we employed an in vitro testing system by introducing H2O2 to imitate oxidative stress condition considering the oxidative environment faced by engrafted ADSCs and anti-oxidative capacity of icariin. In vitro, we found that the addition of icariin considerably reduced the apoptosis of ADSCs, and attenuated the intracellular reactive oxygen species (ROS), the superoxidase dismutase (SOD) activity and the lactate dehydrogenase (LDH). Subsequently, we examined the expression of apoptosis-related proteins and explored the potential signaling pathway through which icariin promoted the survival of ADSCs against oxidative stress. It was demonstrated that icariin significantly inhibited the upregulation of apoptosis-related proteins under oxidative condition, including Bax and cleaved caspase-3, while promoted the expression of anti-apoptotic factor BCL2. These effects were accompanied with the activation of signal molecules, PI3K/Akt and STAT3. The further signal protein inhibition assays exhibited that the suppression of STAT3 abrogated the icariin-mediated anti-apoptotic effects observed above, while did not influence the expression of PI3K/Akt. However, PI3K inhibition could abrogate icariin-mediated STAT3 activation and achieved a similar effect as STAT3 inhibition. Our results suggested that icariin was an effective adjuvant for enhancing ADSC-based therapy of DMEM, which may be ascribed to their protection of ADSCs against oxidative stress via the regulation of PI3K/Akt-STAT3 signal pathway.

Turn back crime: medicamentos ilegales y papel del farmacéutico comunitario / Turn back crime: illicit products and the role of the community pharmacist

El objetivo del presente trabajo fue describir y analizar la situación en España de los productos de venta ilícita, tanto medicamentos como complementos alimenticios, poniendo en conocimiento las principales acciones realizadas en los últimos meses y su contextualización a nivel mundial. Asimismo, servir de alerta sobre la magnitud del problema y la importancia del papel del farmacéutico comunitario. Se realizó una búsqueda de información tanto a nivel nacional como internacional y se realizó un análisis descriptivo de las Notas Informativas de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (medicamentos ilegales, uso humano, 2015). Los productos de venta ilícita representan un problema grave para la salud pública que no ha parado de aumentar. En España, en 2015 se publicaron 20 notas donde se prohibió y retiró un total de 35 productos. Dichos productos estaban comercializados como complemento alimenticio y presentaban un principio activo en cantidad suficiente para conferirle legalmente la condición de medicamento. El 86% se dirigía a la disfunción eréctil. Para minimizar este problema, es imprescindible la colaboración internacional, siendo la última y más importante operación PANGEA VIII, en junio del 2015, implicando a 115 países. En enero del 2016 entró en vigor la Convención Medicrime, tratado internacional sobre la falsificación de productos médicos y delitos similares. Por otro lado, también es necesario concienciar a la ciudadanía y dotarla de mecanismos para identificar el riesgo potencial. Los productos adquiridos fuera de los canales legales de distribución no aseguran el cumplimiento de las normas de correcta fabricación, distribución, ni posterior conservación y carecen de la información adecuada (AU)

The objective of this article was to describe and analyze the situation of illicit products in Spain, both medicines and dietary supplements, notifying main actions taken in recent months and their worldwide contextualization. Also serve as a warning about the magnitude of the problem and the importance of the role of the community pharmacist. Searches of information were looked at a national and international level. A descriptive analysis of the Information Notes published by the Spanish Agency of Medicines and Medical Devices (AEMPS, Illegal Drugs, Human Use, 2015) was also conducted. Illicit sale products constitute a major problem for public health that has not stopped increasing. Specifically, in Spain, 20 Notes were published in 2015. These included the prohibition and withdrawal of a total of 35 products. Marketed as dietary supplement, they contained an active ingredient enough to be legally considered as a medicine. 86% were aimed at treating erectile dysfunction. It is essential international collaboration to minimize this issue. The last and most important operation was PANGEA VIII in June 2015, which involved 115 countries. In January 2016, the «Medicrime Convention» entered into force, an international agreement on counterfeiting of medical products and similar crimes. In addition, it is necessary to raise awareness and provide the citizens with mechanisms to identify potential risks inherent to the illicit sale products. Products purchased outside the permitted distribution channels do not ensure compliance with good manufacturing practice, distribution or subsequent storage, and they lack of adequate information (AU)

[New data on the effectiveness of Tadalafil alone and in combination with NeyroDoz in treating erectile dysfunction associated with secondary premature ejaculation].

AIM: To compare the effectiveness of the phosphodiesterase type 5 inhibitor (PDE-5i) tadalafil alone and in combination with a biologically active dietary supplement (BADS) NeyroDoz, containing the precursors of serotonin in patients with erectile dysfunction (ED) associated with secondary premature ejaculation (SPE). MATERIAL AND METHODS: 105 patients (mean age 36.2+/-9.1 years) with concomitant ED and SPE were included in a prospective study and divided into 2 groups. The patients of group 1 (n=47) received PDE-5i 5 mg daily for 1 month. In patients of group 2 (n=58) PDE-5i was co-administered with BADS 2 capsules twice daily. Treatment efficacy was evaluated using "Criteria for premature ejaculation" (CriPE) and IIEF-5 questionnaires at baseline and on completion of the treatment course. Besides, a polymorphism in the serotonin transporter gene (5-HTTLPR) was tested. RESULTS: The treatment was effective in 35 (74.5%) and 48 (82.7%) patients of group 1 and 2, respectively (p<0.0001) with similar statistically significant (p<0.001) improvement in erectile function. According to CriPE scores, 6.4, 8.5, 23.4, 10.6 and 12.8% patients of group 1 and 10.3, 1.7, 40.0, 25.9, 10.3 and 31.0% patients of group 2 with LaLa, LaLg, LgLg, Sla, SLg, SS genotypes were rendered free of SPE, respectively. CONCLUSION: Treating ED-associated SPE with the combination of serotonin precursors and tadalafil can better improve ejaculatory function recovery compared with PDE-5i monotherapy.

[Clinical efficacy of Shuganyiyang capsule combined with Western medicine for the treatment of type III prostatitis complicated by erectile dysfunction].

OBJECTIVE: To investigate the clinical efficacy of Shuganyiyang Capsule combined with conventional Western medicine (tamsulosin hydrochloride sustained release tablets + prostat tablets) for the treatment of type III prostatitis complicated by erectile dysfunction (ED). METHODS: Eighty patients with type III prostatitis complicated by ED were equally randomized to an experimental and a control group, the former treated with Shuganyiyang Capsule combined with tamsulosin hydrochloride sustained release tablets and prostat tablets, while the latter with tamsulosin hydrochloride and prostat only, both for 8 weeks. Then the prostatitis symptoms, erectile function and psychological conditions of the patients were evaluated using NIH-CPSI, IIEF-5, and hospital anxiety and depression scale (HADA and HADD) respectively. The rates of recovery, excellence, effectiveness and ineffectiveness were calculated. RESULTS: The scores on NIH-CPSI, IIEF-5, HADA and HADD obtained at 4 and 8 weeks after treatment showed statistically significant differences between the two time points as well as from the baseline (P < 0.01). At 8 weeks, the scores on NIH-CPSI, IIEF-5, HADA and HADD were 6.83 +/- 4.96, 21.03 +/- 2.54, 6.05 +/- 1.62, and 5.35 +/- 3.30 in the experimental group, as compared with 7.55 +/- 4.89, 17.68 +/- 4.15, 6.88 +/- 2.45, and 7.85 +/- 3.77 in the control (P < 0.05). The rate of effectiveness was significantly higher in the experimental than in the control group (90% [36/40] vs 70% [28/40], P < 0.05). CONCLUSION: Shuganyiyang Capsule combined with conventional Western medicine, such as alpha blockers and galenica, produces definite effect on chronic prostatitis complicated by ED, improves the psychological conditions of the patient, and enhances the therapeutic efficiency of chronic prostatits.

Patients' perceptions of depression and coronary heart disease: a qualitative UPBEAT-UK study.

BACKGROUND: The prevalence of depression in people with coronary heart disease (CHD) is high but little is known about patients' own perceptions and experiences of this. This study aimed to explore (i) primary care (PC) patients' perceptions of links between their physical condition and mental health, (ii) their experiences of living with depression and CHD and (iii) their own self-help strategies and attitudes to current PC interventions for depression. METHOD: Qualitative study using consecutive sampling, in-depth interviews and thematic analysis using a process of constant comparison. 30 participants from the UPBEAT-UK cohort study, with CHD and symptoms of depression. All participants were registered on the General Practitioner (GP) primary care, coronary register. RESULTS: A personal and social story of loss underpinned participants' accounts of their lives, both before and after their experience of having CHD. This theme included two interrelated domains: interpersonal loss and loss centred upon health/control issues. Strong links were made between CHD and depression by men who felt emasculated by CHD. Weaker links were made by participants who had experienced distressing life events such as divorce and bereavement or were living with additional chronic health conditions (i.e. multimorbidity). Participants also felt 'depressed' by the 'medicalisation' of their lives, loneliness and the experience of ageing and ill health. Just under half the sample had consulted their GP about their low mood and participants were somewhat ambivalent about accessing primary care interventions for depression believing the GP would not be able to help them with complex health and social issues. Talking therapies and interventions providing the opportunity for social interaction, support and exercise, such as Cardiac Rehabilitation, were thought to be helpful whereas anti-depressants were not favoured. CONCLUSIONS: The experiences and needs of patients with CHD and depression are diverse and include psycho-social issues involving interpersonal and health/control losses. In view of the varying social and health needs of patients with CHD and depression the adoption of a holistic, case management approach to care is recommended together with personalised support providing the opportunity for patients to develop and achieve life and health goals, where appropriate.

An improvement in sexual function is related to better quality of life, regardless of urinary function improvement: results from the IDIProst® Gold Study.

OBJECTIVE: The relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has recently received increased attention. The aim of this study was to evaluate the efficacy of the Alfa-5® association of Serenoa repens, Pinus massoniana Bark Extract (PMBE) and Crocus sativus (IDIProst® Gold) in improvement of patient's quality of life, when compared with Serenoa repens alone. MATERIALS AND METHODS: All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia (BPH) and ED, attending 5 Italians Urological Institutions from May to December 2012 were enrolled in this prospective, multicentre, phase 3 study. Participants were assigned to receive oral capsules of IDIProst® Gold (one capsule q24 h) or Serenoa repens 320 mg (one capsule q24h) for 3 months. Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy. IPSS, IIEF-5 and SF-36 questionnaires have been used. The main outcome measure was the improvement of quality of life at the end of the whole study period. RESULTS: 129 (mean age 45-71 ± 4.36) men were randomly allocated to IDIProst® Gold (n = 83) or Serenoa repens (n = 46). The baseline questionnaire mean scores were 17.1 ± 6.4, 14.9 ± 3.7, 96.3 ± 1.2 for IPSS, IIEF-5 and SF-36, respectively. At the follow-up examination, statistically significant differences have been reported in terms of IPSS (11.9 vs 13.8; p < 0.001), IIEF-5 and SF-36 mean scores (19.3 vs 16.1; 99.7 vs 96.3; p < 0.003; p < 0.001). Moreover, statistically significant differences were then reported between the two visits, in terms of IPSS, IIEF-5 and SF-36 scores (p < 0.003; p < 0.001; p < 0.001), only in the IDIProst® Gold group. CONCLUSIONS: In conclusions, we found that IDIProst® Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED, specifically in terms of sexual function, highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function.

El fruto de sabal mejora los síntomas de la hiperplasia benigna de próstata y la disfunción sexual. Resultados de un estudio piloto / Saw palmetto Berry improves BHP symptoms and sexual dysfunctions. Results from a pilot trial

La hyperplasia prostática benigna (HPB) es un importante factor de riesgo para la disfunción sexual. Además, el tratamiento estándar, los bloqueadores alpha-adrenérgicos y los inhibidores de la 5alpha-reductasa pueden causar a su vez disfunción sexual. Los preparados del fruto de sabal (Serenoa repens (W. Bartram) Samall son un tratamiento eficaz y bien tolerado para la HPB leve o moderada y se han utilizado tradicionalmente para tratar disfunciones sexuales. Se ha llevado a cabo un estudio clínico piloto, abierto, multicéntrico para investigar si el preparado de fruto de sabal Prostasan (comercializado en España como Sabalsan) influye en los síntomas de la HPB y las disfunciones sexuales. Ochenta y dos pacientes participaron en el estudio, de 8 semanas de duración, tomando una cápsula diaria (320mg) de un extracto lipofílico de fruto de sabal. Al final del tratamiento, la puntuación en la escala internacional de síntomas prostáticos (IPSS) se redujo de 14,4 a 6,9 (p<0,0001); las disfunciones sexuales, medidas con el inventario breve de la función sexual mejoraron de 22,4 a 31,4 (p<0,0001); la puntuación del componente de la vida sexual del cuestionario de calidad de vida para la HPB (Urolife BHP QoL-9 sex), mejoró de 137,3 a 195 (p<0,0001). Las evaluaciones de los investigadores y pacientes confirmaron la eficacia, tolerabilidad y aceptación por los pacientes. Los análisis de correlación confirmaron la vinculación entre la mejoría de los síntomas de la HPB y la reducción de la disfunción sexual. Este es el primer estudio que demuestra una mejoría simultánea en los síntomas de la HPB y las disfunciones sexuales con extracto de fruto de sabal (AU)

The benign prostate hiperplasia (BPH) is a major risk factor for sexual dysfunctions. Additionally, the standard treatments for BPH symptoms, alpha-blockers and 5alpha-reductase inhibitors, cause sexual dysfunction themselves. Preparations from saw palmetto (Serenoa repens (W. Bartram) Small) fruit have shown efficacy and good tolerability been used to treat sexual dysfunctions. We conducted an open, multicentric, clinical pilot trial to investigate wheter Prostasan (marketed in Spian as Sabalsan), a preparation of saw palmetto fruit, influenced BPH symptoms and sexual dysfunctions. Eighty two patients participated in a 8-week trial, taking one capsule (320mg) of the saw palmetto lipophilic extract daily. At the end of the treatment, the International Prostate Symptom Score (IPSS) was reduced from 14.4 to 6.9 (p<0.0001). Sexual dysfunctions measured with the brief Sexual Function Inventory improved from 22.4 to 31.4 (p<0.0001), and the score of the component regarding sexual life of the life quality questionnaire for benign prostatic syperplasia (Urolife BPH QoL-9 sex) improved from 13.7 to 195 (p<0.0001). Investigators, and patients' assessments confirmed the efficacy, tolerability and acceptance by the patients. Correlation analyses confirmed the relationship between improved BPH symptoms and reduced sexual dysfunction. This is the first trial with Sabal serrulata showing improvement in BPH symptoms and in sexual dysfunction as well (AU)

[Efficacy of compound xuanju capsule on type-III prostatitis-related sexual dysfunction].

OBJECTIVE: To investigate the value of Compound Xuanju Capsule in the treatment of type-III prostatitis-related sexual dysfunction. METHODS: We randomly divided 90 type-III prostatitis patients with sexual dysfunction diagnosed by NIH clinical criteria into an experiment group and a control group to be treated with Compound Xuanju Capsule and antibiotics, respectively. We analyzed the therapeutic results based on the scores on chronic prostatitis symptom index (CPSI), prostatitis-related sexual function index (PSFI ) and self-rating anxiety scale (SAS), and compared them between the two groups and with the baseline data. RESULTS: The degree of prostatitis-related sexual dysfunction was not correlated with that of prostatitis symptoms. Prostatitis symptoms and sexual function were significantly improved in the experiment group than in the control (P < 0.05), and the SAS score was markedly lower in the former than in the latter (P < 0.05). CONCLUSION: Compound Xuanju Capsule can not only alleviate the symptoms of type-III prostatitis, but also improve its related sexual dysfunction and anxiety.

[Cytoflavin in the treatment of patients with chronic abacterial prostatitis and erectile dysfunction].

The problem of chronic prostatitis (CP) and erectile dysfunction (ED) involves not only their high prevalence, but also the insufficient effectiveness of their treatments. In this regard, there is need for administration the pathogenetic drugs with antihypoxic, antioxidant and neuroprotective effects and improving blood flow to the genitals. The study included 60 men with CP associated with ED, aged 22 to 60 years. Patients were randomized into 2 groups of 30 people. Patients of comparison group received baseline therapy (alpha1-adrenoblockers, non-specific anti-inflammatory drugs, digital prostate massage and vacuum phallostimulation). Antibiotics were applied on the basis of their potential effectiveness in chronic abacterial prostatitis. In addition to the above treatment, patients of main group received step-down therapy with cytoflavin (in infusion, then oral administration). Positive dynamics was noted in both groups of patients; however, according to the indicators of the severity of pain and dysuria, as well as quality of life, positive dynamics in the main group of patients was more significant. Similarly, the dynamics of objective criteria for inflammation in the prostate gland was more pronounced when using cytoflavin. After treatment, the rigid phase of erection during vacuum fallotest occurred within 2-3 min from the beginning of the procedure in 16 (53.3%) patients of main group and only in 9 (30%) patients of comparison group. During follow-up examination at 6 months after treatment, stable remission was found in 75% of patients of main group. Thus, the inclusion of cytoflavin in the scheme of complex treatment of patients with abacterial CP associated with ED is pathogenetically justified, makes it more efficient and provides good DFS.