PC-SPES

RELATED TERMS

Baicalein, baicalin, Chrysanthemum morifolium (chrysanthemum, mum, Chu-hua), Ganoderma lucidum (Reishi mushroom, Ling Zhi), Glycyrrhiza glabra (licorice), Isatis indigotica Fortune (dyer's wood, Da Qing Ye), oridonin, Panax pseudo-ginseng (San Qi), PC-CARE, Ponicidin, Rabdosia rubescens (rubescens, Dong Ling Cao), S. baicalensis, Scutellaria baicalensis (skullcap, Huang-chin), Serenoa repens (saw palmetto).

Note: PC-SPES© should not be confused with SPES (a different product) or with other similarly named or marketed products. PC-SPES© has been recalled from the U.S. market and should not be used.

BACKGROUND

PC-SPES© is a dietary supplement that was sold for the treatment of prostate cancer. The letters "PC" stand for "prostate cancer," and spes is Latin for hope.

PC-SPES© was described as a Chinese herbal formula containing Serenoa repens (saw palmetto) and seven other herbs: Chrysanthemum morifolium (chrysanthemum, mum, Chu-hua), Ganoderma lucidum (Reishi mushroom, Ling Zhi), Glycyrrhiza glabra (licorice), Isatis indigotica Fortune (dyer's wood, Da Qing Ye), Panax pseudo-ginseng (San Qi), Rabdosia rubescens (rubescens, Dong Ling Cao), and Scutellaria baicalensis (skullcap, Huang-chin). PC-SPES© was recalled from the U.S. market in 2002, because it was found to contain the undeclared prescription drugs indomethacin (a nonsteroidal anti-inflammatory drug (NSAID)), warfarin (a blood thinner), and the female hormones diethylstilbestrol (DES) and ethinyl estradiol. Similar herbal products without these pharmaceuticals have since been reformulated and reintroduced to the market.

EVIDENCE TABLE

Conditions

TRADITION

The below uses are based on tradition, scientific theories, or limited research. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider. There may be other proposed uses that are not listed below. Antiandrogen, benign prostatic hypertrophy (BPH), breast cancer, breast enlargement, cancer, colon cancer, estrogenic effects (effects similar to females hormones), immune enhancement, lung cancer (small cell), pancreatic cancer, pain, prostate health.

DOSING

disclaimer: The below doses are based on scientific research, publications, traditional use, or expert opinion. Many herbs and supplements have not been thoroughly tested, and safety and effectiveness may not be proven. Brands may be made differently, with variable ingredients, even within the same brand. The below doses may not apply to all products. You should read product labels, and discuss doses with a qualified healthcare provider before starting therapy.

Adults (18 years and older)

PC-SPES© has been recalled from the U.S. market and should not be used.

Children (under 18 years old)

PC-SPES© has been recalled from the U.S. market and should not be used.

SAFETY

disclaimer: The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.

Allergies

PC-SPES© has been recalled from the U.S. market and should not be used. Allergy or hypersensitivity to ingredients in PC-SPES© has been reported. Throat swelling and shortness of breath have been reported.

Side Effects and Warnings

Avoid in all patients. PC-SPES© has been recalled from the U.S. market and should not be used.

Undeclared prescription drug ingredients have been found in samples of PC-SPES©. PC-SPES© may increase the risk of bleeding and may interfere with the way the body processes certain drugs, herbs, or supplements using the liver's cytochrome P450 enzyme system. Allergy or hypersensitivity to ingredients in PC-SPES© has been reported.

Possible side effects include abnormal blood clotting and bleeding, angina (chest pain), constipation, depression, diarrhea, effects on the liver, effects associated with female hormones, erectile dysfunction, estrogen-like effects, indigestion, loss of sexual desire, nausea, and vomiting.

Pregnancy and Breastfeeding

PC-SPES© has been recalled from the U.S. market and should not be used. PC-SPES© has not been studied during pregnancy or breastfeeding. Estrogen-like effects may be harmful.

INTERACTIONS

disclaimer: Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy.

Interactions with Drugs

PC-SPES© has been recalled from the U.S. market and should not be used.

PC-SPES© may increase the risk of bleeding when taken with drugs that increase the risk of bleeding. Some examples include aspirin, anticoagulants (blood thinners) such as warfarin (Coumadin©) or heparin, antiplatelet drugs such as clopidogrel (Plavix©), and nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin©, Advil©) or naproxen (Naprosyn©, Aleve©).

PC-SPES© may interfere with the way the body processes certain drugs using the liver's cytochrome P450 enzyme system. As a result, the levels of these drugs may change in the blood and may cause increased or decreased effects or potentially serious adverse reactions. Patients taking any medication should check the package insert and speak with a qualified healthcare professional, including a pharmacist, about possible interactions.

PC-SPES© may also interact with agents that affect the immune system, agents that may damage the liver, antiandrogens, anticancer agents, anti-inflammatory agents, and estrogens.

Interactions with Herbs and Dietary Supplements

PC-SPES© has been recalled from the U.S. market and should not be used.

PC-SPES© may increase the risk of bleeding when taken with herbs and supplements that are believed to increase the risk of bleeding. Multiple cases of bleeding have been reported with the use of Ginkgo biloba, and fewer cases with garlic and saw palmetto. Numerous other agents may theoretically increase the risk of bleeding, although this has not been proven in most cases.

PC-SPES© may interfere with the way the body processes certain herbs or supplements using the liver's cytochrome P450 enzyme system. As a result, the levels of other herbs or supplements may change in the blood. It may also alter the effects that other herbs or supplements potentially may have on the P450 system.

PC-SPES© may also interact with antiandrogens, anticancer herbs and supplements, anti-inflammatory herbs and supplements, herbs and supplements that affect the immune system, herbs and supplements that may damage the liver, and herbs or supplements believed to have estrogen-like properties.

ATTRIBUTION

This information is based on a systematic review of scientific literature edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

• Chaudhary UB, Rashid M, Keane TE. PC-SPES withdrawal response. Acta Oncol 2004;43(8):772-3. View abstract
• Chavez ML. PC-SPES for the treatment of prostate cancer? J Herb Pharmacother 2002;2(3):73-89. View abstract
• Das P, Kaplan I. The role of PC-SPES, selenium, and vitamin E in prostate cancer. Oncology (Williston Park) 2002;16(3):285-91; discussion 291, 295-6, 299-300. View abstract
• Du G, Zhang ZW, Zhang YK, et al. [Chinese herbal medicine PC-SPES II induces the apoptosis of androgen-independent prostate carcinoma cell line PC-3]. Zhonghua Nan Ke Xue 2007;13(6):563-7. View abstract
• Ikezoe T, Yang Y, Saitoh T, et al. PC-SPES down-regulates COX-2 via inhibition of NF-kappaB and C/EBPbeta in non-small cell lung cancer cells. Int J Oncol 2006;29(2):453-61. View abstract
• Jensen JB, Langkilde NC. [PC-SPES and ProstaSol: Chinese herbal medicine as a treatment for prostate cancer]. Ugeskr Laeger 2004;166(50):4611-2. View abstract
• Kosty MP. PC-SPES: hope or hype? J Clin Oncol 2004;22(18):3657-9. View abstract
• Lee CO. Complementary and alternative medicine patients are talking about: PC-SPES. Clin J Oncol Nurs 2005;9(1):113-4. View abstract
• Liu JJ, Huang RW, Lin DJ, et al. Ponicidin, an ent-kaurane diterpenoid derived from a constituent of the herbal supplement PC-SPES, Rabdosia rubescens, induces apoptosis by activation of caspase-3 and mitochondrial events in lung cancer cells in vitro. Cancer Invest 2006;24(2):136-48. View abstract
• Meyer JP, Gillatt DA. PC-SPES: a herbal therapy for the treatment of hormone refractory prostate cancer. Prostate Cancer Prostatic Dis 2002;5(1):13-5. View abstract
• Oh WK, Kantoff PW, Weinberg V, et al. Prospective, multicenter, randomized phase II trial of the herbal supplement, PC-SPES, and diethylstilbestrol in patients with androgen-independent prostate cancer. J Clin Oncol 2004;22(18):3705-12. View abstract
• Olsson C. PC-Spes rears its head again! Curr Urol Rep 2004;5(3):149. View abstract
• Sadava D, Winesburg J. Contaminants of PC-SPES are not responsible for cytotoxicity in human small-cell lung carcinoma cells. Cancer Lett 2005;220(2):171-5. View abstract
• Schmidt M, Polednik C, Gruensfelder P, et al. The effects of PC-Spes on chemosensitive and chemoresistant head and neck cancer cells and primary mucosal keratinocytes. Oncol Rep 2009;21(5):1297-305. View abstract
• Walsh PC. Prospective, multicenter, randomized phase II trial of the herbal supplement, PC-SPES, and diethylstilbestrol in patients with androgen-independent prostate cancer. J Urol 2005;173(6):1966-7. View abstract

disclaimer: Natural Standard Bottom Line Monograph, Copyright © 2011 (www.naturalstandard.com). Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified healthcare provider before making decisions about therapies and/or health conditions. disclaimer: While some complementary and alternative techniques have been studied scientifically, high-quality data regarding safety, effectiveness, and mechanism of action are limited or controversial for most therapies. Whenever possible, it is recommended that practitioners be licensed by a recognized professional organization that adheres to clearly published standards. In addition, before starting a new technique or engaging a practitioner, it is recommended that patients speak with their primary healthcare provider(s). Potential benefits, risks (including financial costs), and alternatives should be carefully considered. The below monograph is designed to provide historical background and an overview of clinically-oriented research, and neither advocates for or against the use of a particular therapy. disclaimer: The information in this monograph is intended for informational purposes only, and is meant to help users better understand health concerns. Information is based on review of scientific research data, historical practice patterns, and clinical experience. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions.

Copyright © 2011 Natural Standard (www.naturalstandard.com)

Copyright © 2011 Natural Standard (www.naturalstandard.com)