BACKGROUND: Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
OBJECTIVES: To assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH.
SEARCH METHODS: We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 16 September 2022, with no restrictions on language or publication status.
SELECTION CRITERIA: We included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment.
DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias assessment and GRADE assessment of the certainty of the evidence. We considered review outcomes measured up to 12 months after randomization as short term, and beyond 12 months as long term. Our main outcomes included urologic symptom scores, quality of life, and adverse events.
MAIN RESULTS: For this update, we narrowed the review question to only comparisons with placebo. We included 27 studies (of which 9 were new) involving a total of 4656 participants, 19 studies comparing Serenoa repens with placebo, and 8 studies comparing Serenoa repens in combination with other phytotherapeutic agents versus placebo. Most studies included men aged > 50 (mean age range 52 to 68) with moderate urologic symptoms (International Prostate Symptom Score [IPSS] range 8 to 19). Ten studies were funded by the pharmaceutical industry; two studies were funded by government agencies; and the remaining studies did not specify funding sources. Serenoa repens versus placebo or no intervention Results for this comparison are based on predefined sensitivity analyses limited to studies at low risk of bias. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (3 to 6 months; IPSS score range 0 to 35, higher scores indicate worse symptoms; mean difference (MD) -0.90, 95% confidence interval (CI) -1.74 to -0.07; I2 = 68%; 9 studies, 1681 participants; high-certainty evidence). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (3 to 6 months; IPSS quality of life domain range 0 to 6, higher scores indicate worse quality of life; MD -0.20, 95% CI -0.40 to -0.00; I2 = 39%; 5 studies, 1001 participants; high-certainty evidence). Serenoa repens probably results in little to no difference in adverse events (1 to 17 months; risk ratio (RR) 1.01, 95% CI 0.77 to 1.31; I2 = 18%; 12 studies, 2399 participants; moderate-certainty evidence). Based on 164 cases per 1000 men in the placebo group, this corresponds to 2 more (38 fewer to 51 more) per 1000 men in the Serenoa repens group. Serenoa repens results in little to no difference in urologic symptoms at long-term follow-up (12 to 17 months, IPSS score, MD 0.07, 95% CI -0.75 to 0.88; I2 = 34%; 3 studies, 898 participants; high-certainty evidence). Serenoa repens results in little to no difference in quality of life at long-term follow-up (12 to 17 months, IPSS quality of life, MD -0.11, 95% CI -0.41 to 0.19; I2 = 65%; 3 studies, 882 participants; high-certainty evidence). There were no data on long-term adverse events for this comparison. Serenoa repens in combination with other phytotherapy versus placebo or no intervention Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (12 to 24 weeks, IPSS score, MD -2.41, 95% CI -4.54 to -0.29; I2 = 67%; 4 studies, 460 participants; low-certainty evidence). We are very uncertain about the effects of these agents on quality of life (very low-certainty evidence). These agents may result in little to no difference in the occurrence of adverse events; however, the CIs included substantial benefits and harms (12 to 48 weeks, RR 0.91, 95% CI 0.58 to 1.41; I2 = 0%; 4 studies, 481 participants; low-certainty evidence). Based on 132 cases per 1000 men in the placebo group, this corresponds to 12 fewer (55 fewer to 54 more) per 1000 men in the combined phytotherapeutic agents with Serenoa repens group.
AUTHORS' CONCLUSIONS: Serenoa repens alone provides little to no benefits for men with lower urinary tract symptoms due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.
We conducted a systematic review of literature from the years 2000 through 2017 on the prevalence and burden of lower urinary tract symptoms (LUTS) in men aged 50 and older, and medical treatments of and alternative nonmedical approaches to LUTS. EBSCOhost (Medline with Full Text) was searched for observational, experimental, and review studies in peer-reviewed journals in the English language. Our review found that LUTS were highly prevalent in the world and estimated to affect 2.3 billion people in 2018, with 44.7% being men. Men with LUTS suffer from not only burdensome symptoms such as nocturia and urgency but also adverse psychological consequences (e.g., anxiety and depression) and financial burden. Current medical treatments are clinically effective, but their efficacy is compromised by side effects and low compliance rates. Alternative nonmedical treatments for LUTS were also sought worldwide. There is evidence that lifestyle modifications such as pelvic muscle exercises and bladder training, physical activity, dietary modification, and nutritional supplements can alleviate LUTS and improve patient quality of life; however, evidence based on rigorous methodology remains minimal and cannot be generalized across populations. Evidence of effectiveness of weight loss programs to reduce LUTS is inconclusive. We conclude that although behavioral treatment is a promising approach to alleviating LUTS, especially when combined with medical treatments, well-designed randomized controlled and longitudinal clinical trials on behavioral treatments of LUTS are still needed. Minimally invasive procedures and neuromodulation therapy also show positive results of alleviating LUTS but require further research as well.
NÃO MARCADO: o que é conhecido sobre o assunto? E o que o estudo acrescentar? Durante os últimos 30 anos Serenoa repens tornou-se um fitoterapia amplamente usado nos EUA e na Europa, principalmente por causa de comparações positivas para α-bloqueadores e inibidores 5α-redutase. Durante os últimos quatro anos vimos dois ensaios de qualidade muito elevada comparando Serenoa repens ao placebo e duração de até 72 semanas '. Estes ensaios encontrado Serenoa repens não melhor do que placebo, mesmo (em um ensaio) com doses crescentes.
OBJETIVO: • Para estimar a eficácia e os efeitos nocivos de Serenoa repens monoterapia no tratamento de sintomas do trato urinário inferior (LUTS) consistentes com hiperplasia prostática benigna (BPH).
MATERIAIS E MÉTODOS: • Foram pesquisados MEDLINE, EMBASE, Cochrane Central Register de Ensaios Controlados (CENTRAL), e de outras fontes através de janeiro de 2012 para identificar ensaios clínicos randomizados. • Ensaios eram elegíveis se se randomizado homens com HBP sintomática a receber Serenoa repens extrato monoterapia durante pelo menos quatro semanas, em comparação com placebo, e avaliou os resultados clínicos e medições urodinâmica. • O nosso resultado primário foi a melhora no LUTS, com base em mudança na pontuação sintoma escala urológicas.
RESULTADOS: • Ao todo, 17 ensaios clínicos randomizados (N = 2008) avaliam monoterapia Serenoa repens (geralmente 320 mg / dia) vs placebo preencheram os critérios de inclusão controlada, embora apenas cinco relatou American Urological Association Sintoma Index (AUASI) ou internacionais (Prostate Symptom Pontuações IPSS). Comprimentos de teste variou de 4 a 72 semanas. A idade média de todos os enrolees foi 64,3 anos ea maioria dos participantes eram de raça branca. A pontuação total média da linha de base foi de 14 pontos, indicando sintomas moderadamente severas. Ao todo, 16 estudos foram duplamente cego e ocultação da alocação adequada de tratamento foi relatada em seis ensaios. • Em uma meta-análise de três estudos de longo prazo a moderada alta qualidade (n = 661), a terapia Serenoa repens não era melhor do que o placebo na redução dos sintomas miccionais baseado no AUASI / IPSS (diferença média ponderada [WMD] -0,16 pontos , 95% intervalo de confiança [IC] de -1,45 para 1,14) ou a taxa de fluxo urinário máximo (Q (max); WMD 0,40 ml / s, IC 95% -0,30 a 1,09). Com base em sua maioria estudos de curto prazo, Q (max) mensurados ao final do estudo também não foram significativamente diferentes entre os grupos de tratamento (WMD 1,15 ml / s, IC 95% -0,23 a 2,53), com evidência de heterogeneidade (I (2) 58 %). • Um estudo de escalonamento de dose de longo prazo (72 semanas) encontraram doses duplas e triplas de extrato de Serenoa repens não melhorou AUASI em comparação com placebo e as proporções de respondedores clínicos (≥ diminuição de 3 pontos no AUASI) foram quase idênticos (43% vs 44% de Serenoa repens e de placebo, respectivamente) com um rácio correspondente risco de 0,96 (IC de 95% 0,76-1,22). • A longo prazo, a terapia Serenoa repens não era melhor do que o placebo na melhoria noctúria em um estudo de alta qualidade (P = 0,19). Análise combinada de nove ensaios Permixon® de curto prazo mostraram uma redução na freqüência de noctúria (WMD -0,79 vezes / noite, 95% CI 1,28 a -0,29-), embora não houvesse evidência de heterogeneidade (I (2) de 76%) • Os eventos adversos de Serenoa repens extratos eram poucos e leves, e incidências não foram estatisticamente significativamente diferente vs placebo. Retiradas do estudo ocorreu em ≈ 10% e não diferiu entre Serenoa repens e placebo.
CONCLUSÕES: • terapia Serenoa repens não melhorar LUTS ou Q (max) em comparação com placebo em homens com HBP, mesmo em dobro e triplo da dose usual. • Os eventos adversos foram geralmente ligeiros e comparável à do placebo.
JUSTIFICATIVA: A hiperplasia prostática benigna afeta homens mais velhos. Esta revisão sistemática determinado eficácia e efeitos adversos da finasterida.
MÉTODO DE REVISÃO: PubMed, Cochrane Library, listas de referências de relatórios e comentários foram pesquisados, estudos duplo-cegos randomizados de finasterida na hiperplasia prostática benigna. Os resultados incluíram escore de sintomas, a taxa de fluxo urinário, o volume da próstata, a interrupção, e os efeitos adversos. O risco relativo e NNT ou NNH foram calculados para dados dicotômicos. As análises de sensibilidade influências estimadas de gravidade da linha de base dos sintomas, volume inicial da próstata, um ensaio dominante, e as intervenções anteriores.
RESULTADOS: Três ensaios tiveram controles ativos e 19 tiveram placebo. Em estudos controlados com placebo, 8.820 pacientes receberam finasterida 5 mg e placebo sobre 5909 3-48 meses. Mais de 48 meses finasteride produziu maiores melhorias na pontuação total de sintomas, a taxa de fluxo urinário máximo e volume da próstata. Disfunção significativamente mais sexual, impotência, distúrbios da ejaculação e diminuição da libido ocorreu com finasterida em 12 meses, o NNH para qualquer disfunção sexual em 12 meses foi de 14. Significativamente menos homens tratados com finasterida experimentado retenção aguda ou uma cirurgia em 24 ou 48 meses do que com placebo; aos 12 meses, o NNT foi de 49 (31 a 112) para evitar uma retenção urinária aguda e 31 (21 a 61), para evitar uma cirurgia . A análise de sensibilidade mostrou benefício com finasterida 5 mg a ser constante independentemente do volume inicial da próstata.
CONCLUSÕES: Informações de muitos pacientes em estudos de alta qualidade mostraram efeitos benéficos da finasterida em termos de sintomas, velocidade eo volume da próstata fluir. Mais utilidade resultaria se os resultados dos pacientes centrada foram relatados em forma dicotômica.
Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH.
OBJECTIVES:
To assess the effects of Serenoa repens in the treatment of men with LUTS consistent with BPH.
SEARCH METHODS:
We performed a comprehensive search of multiple databases (the Cochrane Library, MEDLINE, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to 16 September 2022, with no restrictions on language or publication status.
SELECTION CRITERIA:
We included randomized controlled trials of participants with BPH who were treated with Serenoa repens or placebo/no treatment.
DATA COLLECTION AND ANALYSIS:
Two review authors independently assessed studies for inclusion at each stage and undertook data extraction and risk of bias assessment and GRADE assessment of the certainty of the evidence. We considered review outcomes measured up to 12 months after randomization as short term, and beyond 12 months as long term. Our main outcomes included urologic symptom scores, quality of life, and adverse events.
MAIN RESULTS:
For this update, we narrowed the review question to only comparisons with placebo. We included 27 studies (of which 9 were new) involving a total of 4656 participants, 19 studies comparing Serenoa repens with placebo, and 8 studies comparing Serenoa repens in combination with other phytotherapeutic agents versus placebo. Most studies included men aged > 50 (mean age range 52 to 68) with moderate urologic symptoms (International Prostate Symptom Score [IPSS] range 8 to 19). Ten studies were funded by the pharmaceutical industry; two studies were funded by government agencies; and the remaining studies did not specify funding sources. Serenoa repens versus placebo or no intervention Results for this comparison are based on predefined sensitivity analyses limited to studies at low risk of bias. Serenoa repens results in little to no difference in urologic symptoms at short-term follow-up (3 to 6 months; IPSS score range 0 to 35, higher scores indicate worse symptoms; mean difference (MD) -0.90, 95% confidence interval (CI) -1.74 to -0.07; I2 = 68%; 9 studies, 1681 participants; high-certainty evidence). Serenoa repens results in little to no difference in the quality of life at short-term follow-up (3 to 6 months; IPSS quality of life domain range 0 to 6, higher scores indicate worse quality of life; MD -0.20, 95% CI -0.40 to -0.00; I2 = 39%; 5 studies, 1001 participants; high-certainty evidence). Serenoa repens probably results in little to no difference in adverse events (1 to 17 months; risk ratio (RR) 1.01, 95% CI 0.77 to 1.31; I2 = 18%; 12 studies, 2399 participants; moderate-certainty evidence). Based on 164 cases per 1000 men in the placebo group, this corresponds to 2 more (38 fewer to 51 more) per 1000 men in the Serenoa repens group. Serenoa repens results in little to no difference in urologic symptoms at long-term follow-up (12 to 17 months, IPSS score, MD 0.07, 95% CI -0.75 to 0.88; I2 = 34%; 3 studies, 898 participants; high-certainty evidence). Serenoa repens results in little to no difference in quality of life at long-term follow-up (12 to 17 months, IPSS quality of life, MD -0.11, 95% CI -0.41 to 0.19; I2 = 65%; 3 studies, 882 participants; high-certainty evidence). There were no data on long-term adverse events for this comparison. Serenoa repens in combination with other phytotherapy versus placebo or no intervention Different phytotherapeutic agents that include Serenoa repens may result in little to no difference in urologic symptoms compared to placebo at short-term follow-up (12 to 24 weeks, IPSS score, MD -2.41, 95% CI -4.54 to -0.29; I2 = 67%; 4 studies, 460 participants; low-certainty evidence). We are very uncertain about the effects of these agents on quality of life (very low-certainty evidence). These agents may result in little to no difference in the occurrence of adverse events; however, the CIs included substantial benefits and harms (12 to 48 weeks, RR 0.91, 95% CI 0.58 to 1.41; I2 = 0%; 4 studies, 481 participants; low-certainty evidence). Based on 132 cases per 1000 men in the placebo group, this corresponds to 12 fewer (55 fewer to 54 more) per 1000 men in the combined phytotherapeutic agents with Serenoa repens group.
AUTHORS' CONCLUSIONS:
Serenoa repens alone provides little to no benefits for men with lower urinary tract symptoms due to benign prostatic enlargement. There is more uncertainty about the role of Serenoa repens in combination with other phytotherapeutic agents.
