-

Abstract

Objective: The aim of this study was to compare the efficacy of tamsulosin and Serenoa repens extract (SRE) in the management of patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Patients and methods: We analyzed retrospectively aged 50 and older male patient’s urological data who received LUTS medical treatment due to BPH. We divided 80 patients into 2 groups with 40 patients in each group. First group were used selective αblocker tamsulosin 0,4mg/day and second group were used 160mg/day SRE in two divided doses. We found similar prostate volumes and demographic characteristics in both groups. We compared datas including International Prostate Symptom Score (IPSS), quality of life score, maximal urinary flow rate (Qmax), average flow rate (Qmed) and urine volume of patients before and after two months of treatment. Results: At the end of 2 months, in tamsulosin and SRE receiving group average decrease for IPSS was 5,1 and 4,2 respectively. Average increase in maximum urine flow rate for two groups was 3,6 ml/sec and 2ml/sec, respectively. Improvement for IPSS and Qmax values was statistically significant intra-groups but not for in between groups (p>0.05). We also found that quality of life score in tamsulosin and SRE groups decrease from 3,7 to 2,5 and from 4 to 3,1, respectively. Conclusions: This study suggests that both tamsulosin and SRE effective in the management of LUTS associated with BPH. Both medications showed similar clinical efficacy. However, further prospective randomized trials with large number of patients are required in order to explore the clinical success of phytotherapy in BPH

Keywords

• -

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

Abstract

Amaç: 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

Keywords

• Benign Prostat Hiperplazisi, Tamsulosin, Serenoa repens Ekstresi

References

1. Berry S, Coffey D, Walsh P, Ewing L. The development of human benign prostatic hyperplasia with age. J Urol 1984;132(3):474-9.
2. Oesterling JE. Benign prostatic hyperplasia. Medical and minimally invasive treatment options. N Engl J Med. 1995;332(2): 99-109.
3. Hald T. Urodynamics in benign prostatic hyperplasia: a survey. Prostate 1989; 2(suppl): 69-77.
4. Holtgrewe HL. Current trends in management of men with lower urinary tract symptoms and benign prostatic hyperplasia. Urology 1998;51 (Suppl 4A):1-7.
5. Buck AC. Phyto theraphy for the prostate. Br J Urol 1996;78(3):325-36.
6. Wilt TJ, Ishani A, Stark G, et al. Sawpalmetto extracts for treatment of benign prostatic hyperplasia: A systematic review. JAMA 1998;280(18): 1604-9.
7. Lowe FC, Fagelman E. Phytotherapy in the treatment of benign prostatic hyperplasia: an update. Urology 1999;53(4):671-8.
8. Chacon A, Monga M. Medical management of benign prostatic hyperplasia. Geriatr Nephrol Urol 1999; 9(1): 39-48.

9. Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride. Meta-analysis of randomized clinical trials Urology 1996;48(3): 398-405.
10. DiSalle E, Briatico G, Giudici D, et al. Novel aromatase and 5 alpha-reductase inhibitors. J Steroid Biochem Mol Biol 1994; 49(4-6): 289-94.
11. DiSalle E, Briatico G, Giudici D, et al. Endocrine propertiesof thetestosterone 5 alpha-reductase inhibitorturosteride (FCE 26073). J Steroid Biochem Mol Biol 1994;48(2-3) :241-48.
12. Lepor H. Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double- blindextension of phase III trial. Tamsulosin Investigator Group. Urology 1998;51(6): 901-6.
13. Brooks SK: Effect of tamsulosin on AUA symptom score and BPH impact index as a function of symptom severity in patients with benign prostatic hyperplasia. J Urol.1999;161(suppl): 267-73.
14. Schulman CC, Cortvriend J, Jonas U, et al. Tamsulosin: 3-year long-term efficacy and safety in patients with lower urinary tract symptom suggestive of benign prostatic obstruction: Analysis of a European, multinational, multicenter, open-label study. European Tamsulosin Study Group Eur Urol 1999;36(6): 609- 20.
15. Lowe FC, Ku JC. Phytotherapy in treatment of benign prostatic hyperplasia: a critical review. Urology 1996; 48(1): 12-20.
16. Thompson IM. Alternative medicine and benign prostatic hyperplasia. AUA News1998.
17. Madersbacher S, Berger I, Ponholzer A, Marszalek M. Plantextracts: sense or nonsense? Curr Opin Urol. Review. 2008; 18(1): 16-20.
18. Descotes JL, Rambeaud JJ, Deschaseaux P, et al. Placebo- controlled evaluation of the efficacy and tolerability of Permixon in benign prostatic hyperplasia after exclusion of placebo responders. Clin Drug Invest 1995;9(5):291-97.
19. Braeckman J, Denis L, de Lavel J, et al. A double-blind, placebo-controlled study of the plantex tract Serenoa repens in the treatment of benign hyperplasia of the prostate. Eur J Clin Res 1997;9(4):247-59.
20. Carbin BE, Larsson B, Lindahl O. Treatment of benign prostatic hyperplasia with phytosterols. Br J Urol 1990; 66(6): 639-41.
21. Willetts KE, Clements MS, Champion S, et al. Serenoa repens extract for benign prostate hyperplasia: A randomized controlled trial. BJU Int 2003; 92(3):267-70.
22. Gerber GS, Kuznetsov D, Johnson BC, et al. Randomized, double-blind, placebo-controlled trial of sawpalmetto in men with lower urinary tract symptoms. Urology 2001;58(6): 960-4.
23. Bent S, Kane C, Shinohara K, et al. Saw Palmetto for benign prostatic hyperplasia. N Engl J Med 2006;354(6): 557-66.
24. Hızlı F, Uygur MC. Benign Prostat Hiperplazili hastalarda Serenoa repens (SR) ve Tamsulosin (TAM) tedavisinin etkinliğinin karşılaştırılması. Türk Üroloji Dergisi 2006; 32(4):538-42.
25. Boyle P, Robertson C, Lowe F, et al. Updated metaanalysis of clinical trials of Serenoa repens extract in thetreatment of symptomatic benign prostatic hyperplasia. BJU Int 2004;93(6):751-6.
26. Michel MC, Grubble B, Taguchi K et al. Drugs for treatment of BPH: affinity comparison at cloned α1 adrenoceptor subtypes in human prostate. J Auto Pharm. 1996;16(1):21-8.
27. Lowe F. Alfa 1-adrenoceptor blockade in the treatment of benign prostatic hyperplasia. Prostate Cancer and Prostatic Disease 1999;2(3):110-9.
28. Gonzales RR and Kaplan SA. First-line treatment for symptomatic BPH: is there a particular patient profile for a particular treatment? World J Urol 2006;24(4):360-6.
29. Schulman CC, Lock TMT and members of the European Tamsulosin Study Group. Long term use of tamsulosin to treat lower urinary tract symptoms in BPH. J Urol 2001; 166(4):1358-63.
30. Lowe F, Narayan P, Djavan B. Prospective, randomized, multicenter trial to evaluate the rapidity of onset and side effect profile of tamsulosin vs. Terazosin in men with BPH. Presented during XVII th Congress of the EAU 2002;26(I):108.
31. Debruyne F, Koch G, Boyle P, et al. For the members of the PERMAL Study Comparison of a phyto therapeutic agent (Permixon) with an α-blocker (tamsulosin) in the treatment of benign prostatic hyperplasia: A 1-year randomized international study. Eur Urol 2002;41(5): 497-507.
32. Debruyne F, Boyle P, Calais Da Silva F, et al. Evaluation of the clinical benefit of permixon and tamsulosin in severe BPH patients-PERMAL study subset analysis. Eur Urol 2004 45(6): 773-9.