Efficacy and safety of a hexanic extract of Serenoa repens (Permixon (R)) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta-analysis of randomised controlled trials and observational studies

Objectives To comprehensively evaluate the efficacy and safety of the hexanic extract of Serenoa repens (HESr, Permixon (R); Pierre Fabre Medicament, Castres, France), at a dose of 320 mg daily, as monotherapy for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Materials and methods We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) and prospective observational studies in patients with LUTS/BPH identified through searches in Medline, Web of Knowledge (Institute for Scientific Information), Scopus, the Cochrane Library, and bibliographic references up to March 2017. Articles studying S. repens extracts other than Permixon were excluded. Data were collected on International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), nocturia, quality of life, prostate volume, sexual function, and adverse drug reactions (ADRs). Data obtained from RCTs and observational studies were analysed jointly and separately using a random effects model. A sub-group analysis was performed of studies that included patients on longer-term treatment (= 1 year). Results Data from 27 studies (15 RCTs and 12 observational studies) were included for meta-analysis (total N = 5 800). Compared with placebo, the HESr was associated with 0.64 (95% confidence interval [CI] -0.98 to -0.31) fewer voids/ night (P < 0.001) and an additional mean increase in Q(max) of 2.75 mL/s (95% CI 0.57 to 4.93; P = 0.01). When compared with a-blockers, the HESr showed similar improvements on IPSS (weighted mean difference [WMD] 0.57, 95% CI -0.27 to 1.42; P = 0.18) and a comparable increase in Q(max) to tamsulosin (WMD -0.02, 95% CI -0.71 to 0.66; P = 0.95). Efficacy assessed using the IPSS was similar after 6 months of treatment between the HESr and 5a-reductase inhibitors (5ARIs). Analysis of all available published data for the HESr showed a mean improvement in IPSS from baseline of -5.73 points (95% CI -6.91 to -4.54; P < 0.001). HESr did not negatively affect sexual function and no clinically relevant effect was observed on prostate-specific antigen. Prostate volume decreased slightly. Similar efficacy results were seen in patients treated for = 1 year (n = 447). The HESr had a favourable safety profile, with gastrointestinal disorders being the most frequent ADR (mean incidence of 3.8%). Conclusion The present meta-analysis, which includes all available RCTs and observational studies, shows that the HESr (Permixon) reduced nocturia and improved Q(max) compared with placebo and had a similar efficacy to tamsulosin and short-term 5ARI in relieving LUTS. HESr (Permixon) appears to be an efficacious and well-tolerated therapeutic option for the longterm medical treatment of LUTS/BPH

Clinical Benefit of Tamsulosin and the Hexanic Extract of Serenoa Repens, in Combination or as Monotherapy, in Patients with Moderate/Severe LUTS-BPH: A Subset Analysis of the QUALIPROST Study

To investigate whether tamsulosin (TAM) and the hexanic extract of Serenoa repens (HESr) are more effective in combination than as monotherapy in men with moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH). Subset analysis of data from a 6-month, multicenter observational study. Patients received either tamsulosin (0.4 mg/day) or HESr (320 mg/day) alone or in combination. Primary endpoints were change in symptoms and quality of life. Tolerability was also assessed. Seven hundred and nine patients were available for intention to treat (ITT) analysis, 263 treated with tamsulosin, 262 with HESr, and 184 with TAM + HESr. After 6 months, International Prostate Symptom Score (IPSS) scores improved by a mean (standard deviation) of 7.2 (5.0) points in the TAM + HESr group compared to 5.7 (4.3) points with TAM alone and 5.4 (4.6) points with HESr (p < 0.001). Quality of life showed greatest improvement with combination therapy (p < 0.02). Adverse effects were reported by 1.9% of patients receiving HESr, 13.3% receiving TAM, and 12.0% receiving TAM + HESr (p < 0.001). In men with moderate/severe LUTS/BPH, combination treatment with TAM + HESr produced more effective symptom relief and greater improvement in quality of life than with either treatment alone, with acceptable tolerability

Título en español.

A second grazing trial was conducted using the same procedure of the first except that nitrogenous fertilizer was applied to Guinea grass. This time the three roughages compared were Para grass-Kudzu, Kudzu alone and Guinea grass. The performance of Para grass-Kudzu mixture was as uniform as in the previous trial; the carrying capacity being around one head per acre. The results obtained with fertilized Guinea grass more than doubled the results in the previous trial where no fertilizer was used. Besides an increase in forage, there was also an increase in protein content. The carrying capacity increased from 0.42 to 1.12 heads per acre. Kudzu had a lower carrying capacity than the mixture with Para grass and Guinea grass. The conclusions arrived at in relation to the mixture of Para grass-Kudzu in the previous trial were verified by the results of this experiment. The uniformity in performance and high quality forage more than recommends the use of this combination for grazing, especially in the humid section of the northern part of the Island. Guinea grass is a well known forage crop, principally in the grazing area of the South. Under normal conditions, with no fertilization, it is low in protein content. Fertilization increased the protein and doubled the yield but farmers must take into consideration the cost of the fertilizer and that fertilization has only an immediate effect on the grass needing new applications at certain intervals to maintain that condition. In contrast, legumes do have a more permanent effect on the soil and the grasses growing with them. This makes them recommendable. Adapted legume grass mixtures are no more expensive to establish and are cheaper than grasses alone from all points of view. The planting of Kudzu alone is not to be recommended.Resumen en español

La severidad de la vejiga hiperactiva modifica la carga asistencial y la productividad laboral

The objective of this study is to explore the relationship between the severity of urinary urge incontinence (UUI) on healthcare resources utilization (HRU) and loss of labor productivity in subjects with overactive bladder (OAB) in the general population in Spain.1.022 JCR (2014) Q4, 60/76 Urology & nephrologyUE

Impact of daily number of urgency urinary incontinence episodes on overactive bladder patient reported outcomes

Objetivo: Explorar el impacto de la incontinencia urinaria de urgencia (IUU) en el bienestar de los pacientes no institucionalizados con vejiga hiperactiva (VH) en una muestra de la comunidad. Métodos: Se llevó a cabo un estudio transversal basado en Internet en la población general, incluyendo hombres y mujeres, >18 años de edad. Los pacientes con probable VH se identificaron utilizando un algoritmo validado junto con una puntuación ≥8 en la escala OAB-V8. La presencia de comportamiento de adaptación se consideró determinante para el diagnóstico clínico de la VH. Se determinó bienestar individual a través de una batería de mediciones de resultados comunicados por el paciente (PRO) incluida la evaluación de la calidad de vida relacionada con la salud (EQ-5D), alteraciones del sueño (sueño MOS) y satisfacción con la vida (LISAT-8). Los pacientes fueron agrupados de acuerdo con el número de episodios diarios de IUU (gravedad IUU): 0 (VH seca), 1, 2-3 o ≥4. Se realizó un análisis multivariado para evaluar los factores que afectan de forma independiente la calidad de vida. Resultados: Un total de 396 pacientes (52,5% mujeres, media de edad: 55,3 [11,1] años, OAB-V8 puntuación media: 14,5 [7,9]) de 2.035 sujetos participantes de la población general cumplieron los criterios de VH: 203 (51,3%) con 0 episodios; 119 (30,1%) con 1; 52 (13,1%) con 2 o 3 y 22 (5,6%) con >4 episodios. Se encontró una asociación ajustada lineal estadísticamente significativa entre el número de episodios de IUU y las puntuaciones de PRO. Los participantes con más episodios tenían peores perfiles de salud y calidad de autoevaluación de la vida, peor satisfacción con la vida, más trastornos del sueño y menos horas de sueño por noche. El número de episodios de incontinencia fue factor independiente para afectar a la calidad de vida utilizando los cuestionarios LISAT-8 y MOS. Conclusión: La gravedad de la IUU se asoció significativamente con peor bienestar individual en los sujetos con VH en una muestra comunitaria en España.Objective: To explore the impact of urgency urinary incontinence (UUI) on well-being in non-institutionalized patients with overactive bladder (OAB) in a community sample. Methods: A cross-sectional web-based study was conducted in the general population, including males and females, >18 years of age. Patients with probable OAB were identified using a validated algorithm together with a score ≥8 on the OAB-V8 scale. Presence of coping behavior was considered determinant for the clinical diagnosis of OAB. Individual well-being was determined through a battery of patient-reported outcomes (PRO) measurements including assessment of health-related quality of life (EQ-5D), sleep disturbances (MOS Sleep), and life satisfaction (LISAT-8). Patients were grouped according to the number of daily UUI episodes (UUI severity): 0 (dry OAB),1, 2-3, or ≥4. Multivariate analysis to evaluate factors independently affecting quality of life was undertaken. Results: A total of 396 patients (52.5% women, mean age: 55.3 [11.1] years, OAB-V8 mean score: 14.5 [7.9]) out of 2035 subjects participating from the general population met the criteria for OAB: 203 (51.3%) with 0 episodes, 119 (30.1%) with 1, 52 (13.1%) with 2 or 3, and 22 (5.6%) with ≥4 episodes. A statistically significant linear adjusted association was found between number of UUI episodes and PRO scores. Participants with more episodes had poorer health profiles and self-evaluated quality of life, worse life satisfaction, and more sleep disturbances and fewer hours of sleep per night. Number of incontinence episodes was independent factor to affect quality of life using both LISAT-8 and MOS questionnaires. Conclusion: Severity of UUI was significantly associated with poorer individual well-being in subjects with OAB in a community sample in Spain.Sin financiación1.181 JCR (2016) Q4, 60/77 Urology & NephrologyUE