editorial comment

Available at: web.health.gov/dietsupp. Accessed July 2001 33. Mueller, C.: The regulatory status of medical foods and dietary supplements in the United States. Nutrition, 15: 249, 1999 34. US Food and Drug Administration: Center for Food Safety and Applied Nutrition. Dietary Supplement Strategy: ten year plan. January 2000. Available from: http://vm.cfsan.fda.gov/ dms/ds/strat.html. Accessed August 18, 2001 35. Betz, J. M.: Plant toxins. J AOAC Int, 82: 781, 1999 36. Goepel, M., Hecker, U., Krege, S., Rubben, H. and Michel, M. C.: Saw palmetto extracts potently and noncompetitively inhibit human alpha1-adrenoceptors in vitro. Prostate, 38: 208, 1999 37. Strauch, G., Perles, P., Vergult, G., Gabriel, M., Gibelin, B., Cummings, S. et al: Comparison of finasteride (Proscar) and Serenoa repens (Permixon) in the inhibition of 5-alpha reduc- tase in healthy male volunteers. Eur Urol, 26: 247, 1994 EDITORIAL COMMENT This study, indicating marked variability in dosage (and presum- ably in bioavailability) between manufacturers and between lots from the same manufacturers of nutritional supplements commonly used for prostate related disease, should give pause to their users and advocates. These findings should be discussed with patients, and should give potential participants and practitioners impetus to study in controlled fashion whether these agents are beneficial for their advertised purpose, be it maintenance of “prostate health,” symp- toms ascribed to prostatic enlargement, prostatitis, prevention of prostate cancer or adjuncts to other therapy for established cancers. Only controlled clinical trials in which the entry criteria are uniform and well-defined, the chemical composition of the supplements have minimal batch-to-batch variability, and the end points are prespeci- fied and rigorously analyzed can accurately gauge whether and in what circumstances these agents might be beneficial. Eric A. Klein Section of Urologic Oncology Cleveland Clinic Cleveland, Ohio REPLY BY AUTHORS We agree that clinical trials remain the only way to demonstrate the use of these agents. However many patients still choose herbal and vitamin products to complement medical care or as alternatives. Practicing clinicians are warranted in demanding knowledge about the composition of the products they recommend. A way to meet this demand is by FDA or voluntary regulation, via a certificate or seal of approval from health advocacy groups, such as the American Uro- logical Association to ensure that the appropriate quality standards our patients deserve are met. COMMONLY USED NUTRITIONAL SUPPLEMENTS IN PROSTATE DISEASE 154

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Available at: web.health.gov/dietsupp. Accessed July 200133. Mueller, C.: The regulatory status of medical foods and dietary

supplements in the United States. Nutrition, 15: 249, 199934. US Food and Drug Administration: Center for Food Safety and

Applied Nutrition. Dietary Supplement Strategy: ten yearplan. January 2000. Available from: http://vm.cfsan.fda.gov/�dms/ds/strat.html. Accessed August 18, 2001

35. Betz, J. M.: Plant toxins. J AOAC Int, 82: 781, 199936. Goepel, M., Hecker, U., Krege, S., Rubben, H. and Michel, M. C.:

Saw palmetto extracts potently and noncompetitively inhibithuman alpha1-adrenoceptors in vitro. Prostate, 38: 208, 1999

37. Strauch, G., Perles, P., Vergult, G., Gabriel, M., Gibelin, B.,Cummings, S. et al: Comparison of finasteride (Proscar) andSerenoa repens (Permixon) in the inhibition of 5-alpha reduc-tase in healthy male volunteers. Eur Urol, 26: 247, 1994

EDITORIAL COMMENT

This study, indicating marked variability in dosage (and presum-ably in bioavailability) between manufacturers and between lotsfrom the same manufacturers of nutritional supplements commonlyused for prostate related disease, should give pause to their usersand advocates. These findings should be discussed with patients, andshould give potential participants and practitioners impetus to studyin controlled fashion whether these agents are beneficial for their

advertised purpose, be it maintenance of “prostate health,” symp-toms ascribed to prostatic enlargement, prostatitis, prevention ofprostate cancer or adjuncts to other therapy for established cancers.Only controlled clinical trials in which the entry criteria are uniformand well-defined, the chemical composition of the supplements haveminimal batch-to-batch variability, and the end points are prespeci-fied and rigorously analyzed can accurately gauge whether and inwhat circumstances these agents might be beneficial.

Eric A. KleinSection of Urologic OncologyCleveland ClinicCleveland, Ohio

REPLY BY AUTHORS

We agree that clinical trials remain the only way to demonstratethe use of these agents. However many patients still choose herbaland vitamin products to complement medical care or as alternatives.Practicing clinicians are warranted in demanding knowledge aboutthe composition of the products they recommend. A way to meet thisdemand is by FDA or voluntary regulation, via a certificate or seal ofapproval from health advocacy groups, such as the American Uro-logical Association to ensure that the appropriate quality standardsour patients deserve are met.

COMMONLY USED NUTRITIONAL SUPPLEMENTS IN PROSTATE DISEASE154

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