Evaluation of the Clinical Benefit of Permixon and Tamsulosin in Severe BPH Patients—PERMAL Study Subset Analysis

Debruyne, F.M.J.; Boyle, Peter; Silva, Fernando Calais da; Gillenwater, J.G.; Hamdy, Freddie C.; Perrin, Paul B.; Teillac, P.; Vela-Navarrete, R.; Raynaud, Jean‐Pierre; Schulman, Claude

doi:10.1016/j.eururo.2004.01.015

Cited by 71 publications

(69 citation statements)

References 24 publications

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“…These could not find any difference in the treatment of BPH with serenoa repens to placebo. Studies comparing SR with 5-alpha-reductase inhibitors or alpha-blockers have been previously reported [14,15,16,17], but a limited number of studies comparing TAM with SR + TAM were found during our literature review [18,19]. Debruyne et al [15] previously reported that Permixon, a phytotherapeutic agent showed the equivalent efficacy as tamsulosin, a selective alpha-blocker, commonly used for the treatment of LUTS related to BPH.…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study

et al. 2015

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Introduction: In Korea, increasing attention has recently been given to the use of phytotherapeutic agents to alleviate the symptoms of BPH. Serenoa repens has been shown to have an equivalent efficacy to Finasteride or Tamsulosin in the treatment of BPH in previous studies. The present study was designed to compare the efficacy and safety of Serenoa repens plus tamsulosin with tamsulosin only over 12 months in men with LUTS secondary to BPH. Materials and Methods: One hundred forty men with symptomatic BPH (IPSS ≥10) were recruited in our hospital for a 12-month, open-label, randomized trial. Patients were randomly assigned to either tamsulosin 0.2 mg/day plus Serenoa repens 320 mg/day (n = 60) or tamsulosin 0.2 mg/day only (n = 60). Prostate volume and PSA were measured at baseline and at end-point, whereas total IPSS, and its storage and voiding subscores, LUTS-related QoL, Qmax, and PVR were evaluated at baseline and later every 6 months. Results: Total 103 patients were finally available: 50 in the TAM + SR group and 53 in the TAM group. At 12 months, total IPSS decreased by 5.8 with TAM + SR and 5.5 with TAM (p = 0.693); the storage symptoms improved significantly more with TAM + SR (-1.7 vs. -0.8 with TAM, p = 0.024). This benefit with regard to storage symptom in the TAM + SR group lasts at 12 months (-1.9 vs. -0.9, p = 0.024). The changes of voiding subscore, LUTS-related QoL, Qmax, PVR, PSA, and prostate volume showed no significant differences between the TAM + SR and TAM groups. During the treatment period, 8 patients (16.9%) with TAM and 10 (20%) with TAM + SR had drug-related adverse reactions, which included ejaculatory disorders, postural hypotension, dizziness, headache, gastro-intestinal disorders, rhinitis, fatigue and asthenia. Conclusions: The combination treatment of Serenoa repens and tamsulosin was shown to be more effective than tamsulosin monotherapy in reducing storage symptoms in BPH patients after 6 months and up to 12 months of treatment.

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Section: Discussionmentioning

confidence: 99%

“…Debruyne et al [16] conducted a subset analysis of the trial mentioned above. One hundred twenty-four patients with severe LUTS (IPSS >19, mean IPSS = 22.7) were stratified: 59 and 65 patients were randomized to the tamsulosin and SPE groups, respectively.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study

et al. 2015

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“…Interest in phytotherapeutic agents is growing in both Europe and North America, especially as a consequence of patients' dissatisfaction due to the adverse effects of other medical alternatives [2,3]. The most frequently prescribed and studied such agent is Serenoa repens extract, derived from the berry of the dwarf palm tree.…”

Section: Introductionmentioning

confidence: 99%

Long-Term Efficacy of <i>Serenoa repens</i> Treatment in Patients with Mild and Moderate Symptomatic Benign Prostatic Hyperplasia

et al. 2011

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Introduction: The study aimed to evaluate the long-term efficacy of treatment with extract of Serenoa repens (Prostamol Uno) in patients with lower urinary tract symptoms (LUTS) induced by benign prostatic hyperplasia (BPH). Patients and Methods: We studied 120 patients with mild or moderate LUTS induced by BPH, maximal urinary flow (Q_max) <15 ml with a voided volume ≧150 ml, prostate-specific antigen <4 ng/ml, and residual urinary volume <150 ml, treated daily for 24 months with one capsule of 320 mg ethanolic extract of Serenoa repens. Results: Statistically significant improvements in the International Prostate Symptom Score (5.5 points), quality of life (QoL; 1.8 points), Q_max (5.6 ml/s), International Index of Erectile Function (IIEF; 6.4 points) and reduction in residual urinary volume were observed during the study period. The mean prostate volume at 24 months was 36 ml, compared to 39.8 ml at baseline. Conclusions: Long-term treatment with 320 mg ethanolic extract of Serenoa repens proved to be efficient in reducing urinary obstruction, improving symptomatology and QoL of BPH patients. It also had a positive effect on sexual function, demonstrated by the statistically significant increase in the IIEF.

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“…Tamsulosin ile SRE'in AÜS yakınmalarını azaltmadaki etkinliği araştırılmış ve birçok çalışmada eşit etkinliğe sahip olduğu gösterilmiştir (31,32). Yurt dışında tamsulosin ile SRE'in karşılaştırdığı bir çalışmada Qmax değerlerinde tamsulosin grubunda 1,7 ml/sn, SRE grubunda 1,2 ml/sn artışın gruplar arasında fark göstermediği bulunurken, IPSS'deki azalmanın SRE grubunda daha anlamlı olduğu vurgulanmıştır (32). Bizim çalışmamızda ise SRE ve tamsulosin grubunda IPSS, Qmax değerlerindeki iyileşmeler arasında istatistiksel olarak anlamlı farklılık yokken; yaşam kalitesi skorundaki düzelmenin tamsulosin lehine daha anlamlı olduğu görülmüştür.…”

Section: Discussionunclassified

Benign Prostat Hiperplazisine Bağlı Alt Üriner Sistem Yakınmalarının Tedavisinde Tamsulosin ve Serenoa repens Ekstresi'nin (Prostagood) Etkinliklerinin Karşılaştırılması

Çoban¹

2014

Konuralp Tıp Dergisi

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Bu çalışmanın amacı benign prostat hiperplazisi (BPH)'ne bağlı alt üriner sistem yakınmaları (AÜSY) olan hastaların tedavisinde kullanılan tamsulosin ve Serenoa repens ekstresi (SRE)'nin etkinliklerini karşılaştırmaktır. Gereç ve Yöntem: BPH'ne bağlı AÜSY medikal tedavi almış olan 50 yaş ve üzeri erkek hastaların ürolojik verileri retrospektif olarak incelendi. Selektif α-bloker olan tamsulosin 0,4 mg/gün 1x1 kullanmış olan 40 hasta 1. grupta ve SRE 160 mg/gün iki eşit dozda alan 40 hasta 2. grupta yer aldı. Her iki gruptaki hastaların prostat volümleri ve demografik özellikleri benzer bulundu. Tüm hastaların tedavi öncesi ve iki aylık tedavi sonrasındaki Uluslararası Prostat Semptom Skoru (IPSS), yaşam kalitesi skoru, maksimal idrar akım hızı (Qmax), ortalama akım hızı (Qort) ve idrar volümü ölçümleri retrospektif olarak karşılaştırıldı. Bulgular: Tamsulosin alan grupta ikinci ay sonunda IPSS'deki ortalama düşüş 5,1 iken SRE grubunda 4,2 idi. Maksimal idrar akım hızındaki ortalama artış ise her iki grup için sırasıyla 3,6 ve 2 ml/sn idi. IPSS ve Qmax değerlerindeki iyileşme her iki grupta kendi içinde anlamlı iken, gruplar arasında istatistiksel olarak anlamlı farklılık saptanmadı (p>0.05). Bununla birlikte yaşam kalitesi skoru tamsulosin grubunda 3,7'den 2,5'e düşerken, SR alan grupta 4'den 3,1'e düşmüştü (p<0.05). Sonuç: BPH ilişkili AÜSY'nın tedavisinde hem tamsulosin, hem de SRE'nin anlamlı derecede etkin olduğu, ancak her iki ilacın birbirine üstünlüğü olmadığı görülmüştür. Bununla birlikte fitoterapötik ajanların etkinliğini daha net olarak ortaya koymak için uzun süreli, yüksek hasta sayılarına sahip, randomize prospektif çalışmalara ihtiyaç vardır.

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Evaluation of the Clinical Benefit of Permixon and Tamsulosin in Severe BPH Patients—PERMAL Study Subset Analysis

Cited by 71 publications

References 24 publications

Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study

Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study

Long-Term Efficacy of <i>Serenoa repens</i> Treatment in Patients with Mild and Moderate Symptomatic Benign Prostatic Hyperplasia

Benign Prostat Hiperplazisine Bağlı Alt Üriner Sistem Yakınmalarının Tedavisinde Tamsulosin ve Serenoa repens Ekstresi'nin (Prostagood) Etkinliklerinin Karşılaştırılması

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