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.

Pytel YA, Vinarov A, Lopatkin N, Sivkov A, Gorilovsky L, Raynaud JP: Long-term clinical and biologic effects of the lipidosterolic extract of Serenoa repens in patients with symptomatic benign prostatic hyperplasia. Adv Ther 2002;19:297-306.
Sinescu I, Geavlete P, Multescu R, et al: Long-term efficacy of Serenoa repens treatment in patients with mild and moderate symptomatic benign prostatic hyperplasia. Urol Int 2011;86:284-289.
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;58:960-964.
Bent S, Kane C, Shinohara K, et al: Saw palmetto for benign prostatic hyperplasia. N Engl J Med 2006;354:557-566.
Barry MJ, Meleth S, Lee JY, et al: Effect of increasing doses of Saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA 2011;306:1344-1351.
Terris MK, Stamey TA: Determination of prostate volume by transrectal ultrasound. J Urol 1991;145:984-987.
Willetts KE, Clements MS, Champion S, Ehsman S, Eden JA: Serenoa repens extract for benign prostate hyperplasia: a randomized controlled trial. BJU Int 2003;92:267-270.
Lepor H, Williford WO, Barry MJ, et al: The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. N Engl J Med 1996;335:533-539.
Ernst E: The risk-benefit profile of commonly used herbal therapies: Ginkgo, St. John's Wort, Ginseng, Echinacea, Saw Palmetto, and Kava. Ann Intern Med 2002;136:42-53.
Wilt TJ, Ishani A, Rutks I, et al: Phytotherapy for benign prostatic hyperplasia. Public Health Nutr 2000;3:459-472.
Avins AL, Bent S, Staccone S, et al: A detailed safety assessment of a saw palmetto extract. Complement Ther Med 2008;16:147-154.
Tacklind J, MacDonald R, Rutks I, Stanke JU, Wilt TJ: Serenoa repens for benign prostatic hyperplasia. Cochrane Database Syst Rev 2009;15:CD001423.
MacDonald R, Tacklind JW, Rutks I, Wilt TJ: Serenoa repens monotherapy for benign prostatic hyperplasia (BPH): an updated Cochrane systematic review. BJU Int 2012;109:1756-1761.
Carraro JC, Raynaud JP, Koch G, et al: Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients. Prostate 1996;29:231-240.
Debruyne F, Koch G, Boyle P, et al: Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study. Eur Urol 2002;41:497-506.
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;45:773-779.
Wilt TJ, Ishani A, Stark G, et al: Saw palmetto extracts for treatment of benign prostatic hyperplasia: a systematic review. JAMA 1998;280:1604-1609.
Glemain P, Coulange C, Billebaud T, et al; Groupe de l'essai OCOS: [Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial]. Prog Urol 2002;12:395-403.
Zlotta AR, Teillac P, Raynaud JP, et al: Evaluation of male sexual function in patients with Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) treated with a phytotherapeutic agent (Permixon), Tamsulosin or Finasteride. Eur Urol 2005;48:269-276.
Hizli F, Uygur MC: A prospective study of the efficacy of Serenoa repens, tamsulosin, and Serenoa repens plus tamsulosin treatment for patients with benign prostate hyperplasia. Int Urol Nephrol 2007;39:879-886.
Gerber GS: Saw palmetto for the treatment of men with lower urinary tract symptoms. J Urol 2000;163:1408-1412.
Veltri RW, Marks LS, Miller MC, et al: Saw palmetto alters nuclear measurements reflecting DNA content in men with symptomatic BPH: evidence for a possible molecular mechanism. Urology 2002;60:617-622.
Glemain P, Coulange C, Billebaud T, et al: Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial. Prog Urol 2002;12:395-403.
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.