SAW PALMETTO FOR BENIGN PROSTATIC HYPERPLASIA to 95 percent and sterol levels of more than 0.2 percent.The saw palmetto extract in our study ed by(D.e)from the Dr.K having re had the same range of values for these ingredi Me d In d ha ents and is the ore similar to the majority o daily for one year does not improve lower urinary nd Evel and Arle tract symptoms caused by benign prostatic hy- mm REEERINGES ta (Per- g ac di s osi prostatica.Uro 57.68 Medical Cer 99 d trial of an extr of th rstein JD. 25.5y with l s MS,Cha As 20039226757 26.Lepor n AW.p aL smith H.Memo atic b atic N EnglI Med 19%6335533-9 020 27. ruske 25 M.e The effe 40 6.Carbin BE.Larsson B.Lindahl O. nt am 17. BanerHwasaosuCCosdMn ized con ollege Departm ikam 200 62 02.346-5列 dmiedmeicd L De vl lege Sta Serenoa rep ex.:Stat 20L0 Gould AL,Roehrborn CG. ische ing im ent of benign of ra Dru3laet1995 I RL. a in fficacy of the e n guide sdi on the 1.Emili E,Lo Cig M.Petrone U.R. OM,e ati clinici su un n dinical progre of be N ENGLJ MED 354:6 WWW.NEJM.ORG 565 Journal of Medici Downloaded from nejm 18201F saw palmetto for benign prostatic hyperplasia n engl j med 354;6 www.nejm.org february 9, 2006 565 to 95 percent and sterol levels of more than 0.2 percent.39 The saw palmetto extract in our study had the same range of values for these ingredi￾ents and is therefore similar to the majority of currently available products. In summary, we found that 160 mg of saw palmetto given twice daily for one year does not improve lower urinary tract symptoms caused by benign prostatic hy￾perplasia. Supported by a grant (1 RO1 DK56199-01, to Dr. Avins) from the National Institute of Diabetes and Digestive and Kidney Dis￾eases and by a grant (1 K08 ATO1338-01, to Dr. Bent) from the National Center for Complementary and Alternative Med icine. Dr. Kane reports having received consulting fees from both American Medical Systems and Intuitive Surgical, and having re￾ceived lecture fees from Merck and TAP. Dr. Shinohara reports having received lecture fees from GlaxoSmithKline and Pfizer. Dr. Avins reports receiving grant support from Merck. No other poten￾tial conflict of interest relevant to this article was reported. We are indebted to the study team — Drs. Suzanne Staccone and Evelyn Badua, Amy Padula, Bertina Lee, and Arleen Saka￾moto — as well as to Drs. Henry Leung (research pharmacy) and Howard Leong (laboratory sciences) for providing outstanding clinical care; and to Dr. Joseph Presti for his help in the initial planning of the study. References Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alter￾native medicine use among adults: United States, 2002. Adv Data 2004;343:1-19. Lowe FC, Ku JC. Phytotherapy in treat￾ment of benign prostatic hyperplasia: a critical review. Urology 1996;48:12-20. Champault G, Patel JC, Bonnard AM. A double-blind trial of an extract of the plant Serenoa repens in benign prostatic hyperplasia. Br J Clin Pharmacol 1984;18: 461-2. Tasca A, Barulli M, Cavazzana A, Zat￾toni F, Artibani W, Pagano F. Treatment of obstructive symptomatology caused by prostatic adenoma with an extract of Serenoa repens: double-blind study vs. placebo. Minerva Urol Nefrol 1985;37:87- 91. (In Italian.) Reece Smith H, Memon A, Smart CJ, Dewbury K. The value of permixon in be￾nign prostatic hypertrophy. Br J Urol 1986; 58:36-40. Carbin BE, Larsson B, Lindahl O. Treatment of benign prostatic hyperplasia with phytosterols. Br J Urol 1990;66:639- 41. Bauer HW, Casarosa C, Cosci M, Fratta M, Blessmann G. Saw palmetto fruit ex￾tract for treatment of benign prostatic hyperplasia: results of a placebo-controlled double-blind study. MMW Fortschr Med 1999;141:62. (In German.) Metzker H, Kieser M, Holscher U. Wirksamkeit eines Sabal-Urtica-kombina￾tionspraparates bei der behandlung der benignen prostatahyperplasie (BPH). Uro￾loge [B] 1996;36:292-300. Descotes JL, Rambeaud JJ, Deschas￾eaux P, Faure G. Placebo-controlled eval￾uation of the efficacy and tolerability of Permixon in benign prostatic hyperplasia after the exclusion of placebo responders. Clin Drug Invest 1995;9:291-7. Mandressi A, Tarallo U, Maggioni A, Tombolini P, Rocco F, Quadraccia S. Med￾ical treatment of benign prostatic hyper￾plasia: efficacy of the extract of Serenoa repens (Permixon) compared to that of the extract of Pygeum africanum and a placebo. Urologia 1983;50:752-8. Emili E, Lo Cigno M, Petrone U. Ri￾sultati clinici su un nuovo farmaco nella 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. terapia dell’ipertofia della prostata (Per￾mixon). Urologia 1983;50:1042-8. Boccafoschi C, Annoscia S. Confronto fra estratto di serenoa repens e placebo mediante prova clinica controllata in pazienti con adenomatosi prostatica. Uro￾logia 1983;50:1257-68. Gerber GS, Kuznetsov D, Johnson BC, Burstein JD. Randomized, double-blind, placebo-controlled trial of saw palmetto in men with lower urinary tract symptoms. Urology 2001;58:960-4. Willetts KE, Clements MS, Champion S, Ehsman S, Eden JA. Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial. BJU Int 2003;92:267-70. Marks LS, Partin AW, Epstein JI, et al. Effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia. J Urol 2000;163:1451-6. Cukier J, Ducassou J, Le Guillou M, et al. Permixon versus placebo: results of a multicenter study. C R Ther Pharmacol Clin 1985;4:15-21. Gabric V, Miskic H. Behandlung des benignen Prostata-adenoms und der chro￾nischen prostatitis. Therapiewoche 1987; 37:1775-88. Mattei FM, Capone M, Acconcia A. Medikamentose therapie der benignen prostatahyperplasie mit einem extrakt der sagepalme. T W Urologie Nephrologie 1990;2:346-50. Braeckman J, Denis L, De Leval J, et al. A double-blind placebo-controlled study of the plant extract Serenoa repens in the treatment of benign hyperplasia of the prostate. Eur J Clin Res 1997;9:247-59. Lobelenz J. Extractum Sabal fructus bei benigner prostatahyperplasie (BPH). Klinische prufung im stadium I und II. Therapeutikon 1992;6:34-7. Wilt T, Ishani A, Mac Donald R. Sere￾noa repens for benign prostatic hyperpla￾sia. Cochrane Database Syst Rev 2002;3: CD001423. American Urological Association guide￾line on the management of benign pros￾tatic hyperplasia. Linthicum, Md.: Ameri￾can Urological Association Education and Research, 2003. Fowler FJ Jr, Barry MJ. Quality of life 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. assessment for evaluating benign pros￾tatic hyperplasia treatments: an example of using a condition-specific index. Eur Urol 1993;24:Suppl 1:24-7. Ware JE, Snow KK, Kosinski M, Gan￾dek B. SF-36 health survey manual and interpretation guide. Boston: New England Medical Center Health Institute, 1993. Barry MJ, Williford WO, Chang Y, et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Uro￾logical Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients? J Urol 1995;154:1770-4. Lepor H, Williford WO, Barry MJ, et al. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. N Engl J Med 1996;335:533-9. McConnell JD, Bruskewitz R, Walsh P, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. N Engl J Med 1998;338:557-63. Ryan P. RALLOC: Stata module to de￾sign randomized controlled trials: Sta￾tistical Software Components s319901. Boston: Boston College Department of Economics, 2000. McCulloch CE, Searle SR. General￾ized, linear, and mixed models. New York: John Wiley, 2001. Stata statistical software. College Sta￾tion, Tex.: Stata Corporation, 2003. Rothman KJ. No adjustments are need￾ed for multiple comparisons. Epidemiol￾ogy 1990;1:43-6. Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treat￾ment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology 1996;48:398-405. Roehrborn CG, Siegel RL. Safety and efficacy of doxazosin in benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. Urology 1996;48:406-15. McConnell JD, Roehrborn CG, Bau￾tista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of be- 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. The New England Journal of Medicine Downloaded from nejm.org on October 18, 2011. For personal use only. No other uses without permission. Copyright © 2006 Massachusetts Medical Society. All rights reserved