Benin prostat hiperplazili hastalarda serenoa repens (SR) ve tamsulosin (TAM) tedavisinin etkinliğinin karşılaştırılması

Comparison of the efficacy of serenoa repens (SR) and tamsulosin (TAM) treatment for patients with benign prostate hyperplasia

Özet

Alt üriner sistem (AÜS) belirtileri sıklıkla benin prostat hiperplazisi (BPH) ile ilişkilidir ve tedavisinde fitoteropatik ajanlar üzerine olan ilgi son yıllarda artmıştır. Bu ajanlardan en çok üzerinde çalışılan ve en iyi tanımlanmış olan Seronea-Repens (SR) lipido-sterolik ekstresi, Türkiye’deki ismiyle Prostagood®’dur. Bu çalışma, BPH’ye bağlı AÜS belirti tedavisinde SR ve α-blokör olan Tamsulosin (TAM) etkinlik ve güvenilirliğini karşılaştırmak amacı ile yapılmıştır. BPH’ye bağlı AÜS belirtileri nedeni ile başvuran toplam 40 hasta verilen tedavi şekline göre 2 gruba ayrıldı. 1. gruptaki 20 hastaya SR (320 mg/gün), 2. gruptaki 20 hastaya TAM (0.4 mg/gün) tedavisi verildi. Uluslararası prostat semptom skoru (IPSS)≥10, maksimum üriner akım hızı (Qmax)=5-15 ml/s arasında olan hastalar çalışmaya alındı. 2., 4. ve 6. aylardaki IPSS, Qmax ve yaşam kalite skoru (QL) değerleri kaydedildi. Hastaların ortalama yaşı 57.8±6.8 (43-72) yıldı. Başlangıç ve 6. ayın sonundaki IPSS, Qmax ve QL değerleri her iki grupta da istatistiksel olarak farklı idi. Tedaviden 6 ay sonar gruplar arasında, IPSS ve QL’deki ortalama düşüş ve Qmax’daki ortalama artış yönünden anlamlı fark saptanmadı (p>0.05). BPH’ye bağlı AÜS belirti tedavisinde SR ve TAM’nin eşit etkinliğe sahip olduğu ancak, SR’in daha az yan etkiye yol açması nedeni ile daha iyi tolere edildiği sonucuna varılmıştır.

Abstract

Introduction: Lower urinary tract symptoms (LUTS) are frequently associated with benign prostatic hyperplasia (BPH), a non-malignant enlargement of the prostate. Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of BPH in recent times. The most described and studied phytotherapeutic agent for the medical treatment of symptomatic BPH is the lipido-sterolic extract of Serenoa repens, Permixon® which is known as Prostagood® in Turkey. This prospective study was designed to evaluate and compare the efficacy and safety of Serenoa Repens (SR) and Tamsulosin (TAM) in men with LUTS secondary to BPH during a 6-month period. Materials and Methods: This prospective study was designed to have 2 arms including SR 320 mg per day (N=20) and Tamsulosin (TAM) 0.4 mg per day (N=20) to reveal the superiority or equivalence between these treatment regimens in BPH. Patients with International Prostate Symptom Score (I-PSS) ≥10, a maximal urinary flow rate (Qmax) of 5-15 ml/s were included in the study. The I-PSS- and LUTS-related quality of life scores (QL) and uroflowmetry test results were recorded. Statistical Package for Social Sciences (SPSS v10.0) software was used for statistical analyses. A p value <0.05 was considered statistically significant. Results: Mean age of patients was 57.8±6.8 (range 43-72) years. After 6 months, mean decrease in I-PSS was 6.1 and 4.6 in the SR and TAM group, respectively. Mean increase in Qmax was similar in both the SR and TAM groups (3.2 ml/s for SR, 3.7 for TAM). The difference between IPSS and Qmax values at baseline and 6 months were significant in each group. However, the groups were not statistically different with regard to increase in Qmax and decrease in I-PSS and QL scores (p>0.05). During the 6-month treatment period, 12 (40%) patients treated with TAM had drug-related adverse reactions while no adverse effect was detected in SR group. Conclusion: LUTS associated with BPH are very common in men over the age of 60 years worldwide. Currently, there is no consensus for the management of LUTS due to BPH. An alternative treatment of BPH with phytotherapeutic agents seems to be increasing in some European countries. In most placebo-controlled studies, the efficacy of SR is shown to be greater than placebo. Previous studies have compared TAM to SR and most have found equivalent efficiency in resolving LUTS due to BPH. In vitro studies have shown that SR is a non-competitive inhibitor of type I 5-alpha-reductase and non-competitively inhibits the type II isozyme. Another most widely accepted mechanism of action by which SR has been suggested to improve voiding symptoms in men with BPH is through inhibition of dihydrotestosterone binding to the cytosolic androgen receptor in prostatic cells. Anti-proliferative and anti-inflammatory mechanisms have been also described, while the major mechanism still remains undetermined. In summary, we found that treatment of BPH by both SR and TAM seems to be effective alone. None of them had superiority to another and additionally, SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH.