FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Volume 339:785-791 September 17, 1998 Number 12 Next

	Full Text PDF Editorial by Angell, M. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Herbal mixtures are popular alternatives to demonstrated therapies. PC-SPES, a commercially available combination of eight herbs, is used as a nonestrogenic treatment for cancer of the prostate. Since other herbal medicines have estrogenic effects in vitro, we tested the estrogenic activity of PC-SPES in yeast and mice and in men with prostate cancer.

Methods We measured the estrogenic activity of PC-SPES with transcriptional-activation assays in yeast and a biologic assay in mice. We assessed the clinical activity of PC-SPES in eight patients with hormone-sensitive prostate cancer by measuring serum prostate-specific antigen and testosterone concentrations during and after treatment.

Results In complementary yeast assays, a 1:200 dilution of an ethanol extract of PC-SPES had estrogenic activity similar to that of 1 nM estradiol, and in ovariectomized CD-1 mice, the herbal mixture increased uterine weights substantially. In six of six men with prostate cancer, PC-SPES decreased serum testosterone concentrations (P<0.05), and in eight of eight patients it decreased serum concentrations of prostate-specific antigen. All eight patients had breast tenderness and loss of libido, and one had venous thrombosis. High-performance liquid chromatography, gas chromatography, and mass spectrometry showed that PC-SPES contains estrogenic organic compounds that are distinct from diethylstilbestrol, estrone, and estradiol.

Conclusions PC-SPES has potent estrogenic activity. The use of this unregulated mixture of herbs may confound the results of standard or experimental therapies and may produce clinically significant adverse effects.

Source Information

From the Departments of Medicine (R.S.D., E.L., M.M.R., B.T.Z., H.S., S.G., W.N.H., M.A.G.), Pediatrics (H.Z., G.H.L.), and Pharmacology (W.N.H.), University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, New Brunswick; the Cancer Institute of New Jersey, New Brunswick (R.S.D., G.H.L., R.M., E.L., M.M.R., B.T.Z., H.S., S.G., W.N.H., M.A.G.); and the Environmental and Occupational Health Sciences Institute, Piscataway, N.J. (H.Z., G.H.L., R.M., B.T.Z., M.B.T., M.A.G.).

Address reprint requests to Dr. DiPaola at the Cancer Institute of New Jersey, University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, 195 Little Albany St., New Brunswick, NJ 08901.

Full Text of this Article

Related Letters:

PC-SPES in Prostate Cancer
Small E. J., Geliebter J., Tiwari R., Wu J. M., DiPaola R. S., Hait W. N., Gallo M. A.
Extract | Full Text  
N Engl J Med 1999; 340:566-568, Feb 18, 1999. Correspondence

This article has been cited by other articles:

• DiPaola, R. S., Gallo, M. A. (2008). Hearsay Medicine Is Not Evidence-Based Medicine. Clin. Cancer Res. 14: 337-338 [Full Text]  
• Goodin, S., Shen, F., Shih, W. J., Dave, N., Kane, M. P., Medina, P., Lambert, G. H., Aisner, J., Gallo, M., DiPaola, R. S. (2007). Clinical and Biological Activity of Soy Protein Powder Supplementation in Healthy Male Volunteers. Cancer Epidemiol. Biomarkers Prev. 16: 829-833 [Abstract] [Full Text]  
• Mukai, H., Watanabe, T., Ando, M., Katsumata, N. (2006). An Alternative Medicine, Agaricus blazei, May Have Induced Severe Hepatic Dysfunction in Cancer Patients. Jpn J Clin Oncol 36: 808-810 [Abstract] [Full Text]  
• DiPaola, R. S., Morton, R. A. (2006). Proven and Unproven Therapy for Benign Prostatic Hyperplasia. NEJM 354: 632-634 [Full Text]  
• Kosty, M. P. (2004). PC-SPES: Hope or Hype?. JCO 22: 3657-3659 [Full Text]  
• Oh, W. K., Kantoff, P. W., Weinberg, V., Jones, G., Rini, B. I., Derynck, M. K., Bok, R., Smith, M. R., Bubley, G. J., Rosen, R. T., DiPaola, R. S., Small, E. J. (2004). Prospective, Multicenter, Randomized Phase II Trial of the Herbal Supplement, PC-SPES, and Diethylstilbestrol in Patients With Androgen-Independent Prostate Cancer. JCO 22: 3705-3712 [Abstract] [Full Text]  
• Sparreboom, A., Cox, M. C., Acharya, M. R., Figg, W. D. (2004). Herbal Remedies in the United States: Potential Adverse Interactions With Anticancer Agents. JCO 22: 2489-2503 [Abstract] [Full Text]  
• Scher, H. I., Eisenberger, M., D'Amico, A. V., Halabi, S., Small, E. J., Morris, M., Kattan, M. W., Roach, M., Kantoff, P., Pienta, K. J., Carducci, M. A., Agus, D., Slovin, S. F., Heller, G., Kelly, W. K., Lange, P. H., Petrylak, D., Berg, W., Higano, C., Wilding, G., Moul, J. W., Partin, A. N., Logothetis, C., Soule, H. R. (2004). Eligibility and Outcomes Reporting Guidelines for Clinical Trials for Patients in the State of a Rising Prostate-Specific Antigen: Recommendations From the Prostate-Specific Antigen Working Group. JCO 22: 537-556 [Abstract] [Full Text]  
• Ikezoe, T., Yang, Y., Heber, D., Taguchi, H., Koeffler, H. P. (2003). PC-SPES: A Potent Inhibitor of Nuclear Factor-{kappa}B Rescues Mice from Lipopolysaccharide-Induced Septic Shock. Mol. Pharmacol. 64: 1521-1529 [Abstract] [Full Text]  
• Wadsworth, T., Poonyagariyagorn, H., Sullivan, E., Koop, D., Roselli, C. E. (2003). In Vivo Effect of PC-SPES on Prostate Growth and Hepatic CYP3A Expression in Rats. J. Pharmacol. Exp. Ther. 306: 187-194 [Abstract] [Full Text]  
• Piersen, C. E. (2003). Phytoestrogens in Botanical Dietary Supplements: Implications for Cancer. Integr Cancer Ther 2: 120-138 [Abstract]  
• Wilkinson, S., Chodak, G. W. (2003). Critical Review of Complementary Therapies for Prostate Cancer. JCO 21: 2199-2210 [Abstract] [Full Text]  
• Weiger, W. A., Smith, M., Boon, H., Richardson, M. A., Kaptchuk, T. J., Eisenberg, D. M. (2002). Advising Patients Who Seek Complementary and Alternative Medical Therapies for Cancer. ANN INTERN MED 137: 889-903 [Abstract] [Full Text]  
• Bonham, M. J., Galkin, A., Montgomery, B., Stahl, W. L., Agus, D., Nelson, P. S. (2002). Effects of the Herbal Extract PC-SPES on Microtubule Dynamics and Paclitaxel-Mediated Prostate Tumor Growth Inhibition. JNCI J Natl Cancer Inst 94: 1641-1647 [Abstract] [Full Text]  
• DiPaola, R. S. (2002). To Arrest or Not To G2-M Cell-Cycle Arrest : Commentary re: A. K. Tyagi et al., Silibinin Strongly Synergizes Human Prostate Carcinoma DU145 Cells to Doxorubicin-induced Growth Inhibition, G2-M Arrest, and Apoptosis. Clin. Cancer Res., 8: 3512-3519, 2002.. Clin. Cancer Res. 8: 3311-3314 [Full Text]  
• Hsieh, T.-c., Lu, X., Chea, J., Wu, J. M. (2002). Prevention and Management of Prostate Cancer Using PC-SPES: A Scientific Perspective. J. Nutr. 132: 3513S-3517 [Abstract] [Full Text]  
• Lee, M. M., Chang, J. S., Jacobs, B., Wrensch, M. R. (2002). Complementary and Alternative Medicine Use Among Men With Prostate Cancer in 4 Ethnic Populations. Am. J. Public Health 92: 1606-1609 [Full Text]  
• Huerta, S., Arteaga, J. R., Irwin, R. W., Ikezoe, T., Heber, D., Koeffler, H. P. (2002). PC-SPES Inhibits Colon Cancer Growth in Vitro and in Vivo. Cancer Res. 62: 5204-5209 [Abstract] [Full Text]  
• White, J. (2002). PC-SPES-A Lesson for Future Dietary Supplement Research. JNCI J Natl Cancer Inst 94: 1261-1262 [Full Text]  
• Sovak, M., Seligson, A. L., Konas, M., Hajduch, M., Dolezal, M., Machala, M., Nagourney, R. (2002). Herbal Composition PC-SPES for Management of Prostate Cancer: Identification of Active Principles. JNCI J Natl Cancer Inst 94: 1275-1280 [Abstract] [Full Text]  
• Bonham, M., Arnold, H., Montgomery, B., Nelson, P. S. (2002). Molecular Effects of the Herbal Compound PC-SPES: Identification of Activity Pathways in Prostate Carcinoma. Cancer Res. 62: 3920-3924 [Abstract] [Full Text]  
• Weinrobe, M. C., Montgomery, B. (2001). Acquired Bleeding Diathesis in a Patient Taking PC-SPES. NEJM 345: 1213-1214 [Full Text]  
• Teede, H. J., Dalais, F. S., Kotsopoulos, D., Liang, Y.-L., Davis, S., McGrath, B. P. (2001). Dietary Soy Has Both Beneficial and Potentially Adverse Cardiovascular Effects: A Placebo-Controlled Study in Men and Postmenopausal Women. J. Clin. Endocrinol. Metab. 86: 3053-3060 [Abstract] [Full Text]  
• Ades, T., Gansler, T., Miller, M., Rosenthal, D. S. (2001). PC-SPES: Current Evidence and Remaining Questions. CA Cancer J Clin 51: 199-204 [Full Text]  
• Greger, J. L. (2001). Dietary Supplement Use: Consumer Characteristics and Interests. J. Nutr. 131: 1339S-1343 [Abstract] [Full Text]  
• Dixon, S. C., Knopf, K. B., Figg, W. D. (2001). The Control of Prostate-Specific Antigen Expression and Gene Regulation by Pharmacological Agents. Pharmacol. Rev. 53: 73-92 [Abstract] [Full Text]  
• Geliebter, J., Mittelman, A., Tiwari, R. K. (2001). PC-SPES and Prostate Cancer. J. Nutr. 131: 164S-166 [Full Text]  
• Small, E. J., Frohlich, M. W., Bok, R., Shinohara, K., Grossfeld, G., Rozenblat, Z., Kelly, Wm. K., Corry, M., Reese, D. M. (2000). Prospective Trial of the Herbal Supplement PC-SPES in Patients With Progressive Prostate Cancer. JCO 18: 3595-3603 [Abstract] [Full Text]  
• Richardson, M. A., Sanders, T., Palmer, J. L., Greisinger, A., Singletary, S. E. (2000). Complementary/Alternative Medicine Use in a Comprehensive Cancer Center and the Implications for Oncology. JCO 18: 2505-2514 [Abstract] [Full Text]  
• Halsted, C. H (2000). Dietary supplements and The American Journal of Clinical Nutrition1. Am. J. Clin. Nutr. 71: 399-400 [Full Text]  
• Messing, E. M., Manola, J., Sarosdy, M., Wilding, G., Crawford, E. D., Trump, D. (1999). Immediate Hormonal Therapy Compared with Observation after Radical Prostatectomy and Pelvic Lymphadenectomy in Men with Node-Positive Prostate Cancer. NEJM 341: 1781-1788 [Abstract] [Full Text]  
• Richardson, M. A. (1999). Research of Complementary/Alternative Medicine Therapies in Oncology: Promising but Challenging. JCO 17: 38-43 [Full Text]  
• Cassileth, B. R. (1999). Complementary and Alternative Cancer Medicine. JCO 17: 44-52 [Full Text]  
• Orentlicher, D., Hehir, M. K. II (1999). Advertising Policies of Medical Journals: Conflicts of Interest for Journal Editors and Professional Societies. J Law Med Ethics 27: 113-121  
• Small, E. J., Geliebter, J., Tiwari, R., Wu, J. M., DiPaola, R. S., Hait, W. N., Gallo, M. A. (1999). PC-SPES in Prostate Cancer. NEJM 340: 566-568 [Full Text]  
• Angell, M., Kassirer, J. P. (1998). Alternative Medicine -- The Risks of Untested and Unregulated Remedies. NEJM 339: 839-841 [Full Text]