PC-SPES Contains Estrogen, Lowers Testosterone and PSA

BY JACQUELINE STRAX

November 26, 1998, PSA Rising. Two sets of results from a New Jersey study of the herbal mixture PC-SPES show it is strongly positive for estrogen. Dr. Robert DiPaolo and Huayan Zhang of the Cancer Institute of New Jersey say that in patients with prostate cancer, PC-SPES decreases testosterone as well as PSA.

In Dr. DiPaolo's study, testosterone (the male hormone and primary fuel for prostate cancer) rose sharply after PC-SPES was discontinued.

Initial findings came from laboratory assays, mouse studies, and tests run first on three and eventually on eight patients who took PC-SPES while not treated with any "known androgen ablation therapy."

All the patients experienced breast tenderness and loss of libido, typical side-effects of estrogen and of testosterone-blocking therapies standard today. One out of the eight men developed thrombosis, a known hazard of estrogen therapy for men with prostate cancer.

Found "potent" levels of plant estrogen
The researchers say they assessed "the clinical activity of PC-SPES" in eight patients with hormone-sensitive prostate cancer by measuring PSA and testosterone concentrations during and after treatment. "In six of six men with prostate cancer," they write "PC-SPES decreased serum testosterone concentrations (P

REACTION

The New England Journal of Medicine published DiPaolo and Zhang's report on September 17, 1998. The Journal added an editorial attacking the concept of alternative medicine while conceding that if alternative treatments pass scientific tests they will be accepted. The editors raise a valid alarm -- prior to these New Jersey studies, PC-SPES was sold to prostate cancer patients as an immune system booster, leaving patients blind as to what specifically the drug might do to their hormonal status and thereby to their hormonally dependent or hormonally refractory cancer.

Proper testing must be done, but it seems ungenerous of this leading medical journal not to grant how orthodox medicine has put barriers in the way of studies such as this.

Although tiny, the PC-SPES study among others shows how non-Western medicines may work far more specifically than expected. And Western medicine still has far to go toward

• overcoming modern cultural prejudices, which have often treated non-Western medicine as not even worth scientific testing
• becoming more evidence-based, reevaluating dogmatic Western practices in light of scientific research
• becoming more patient-centered and responsive to patients as people with an active role in health and healing.

DiPaolo and Zhang   "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. In six of six men with prostate cancer, PC-SPES decreased serum testosterone concentrations (P

New England Journal of Medicine Said: "Herbal remedies may ... be sold without any knowledge of their mechanism of action. DiPaola and his colleagues report that the herbal mixture called PC-SPES ... has substantial estrogenic activity. Yet this substance is promoted as bolstering the immune system in patients with prostate cancer that is refractory to treatment with estrogen. Many men taking PC-SPES have thus received varying amounts of hormonal treatment without knowing it, some in addition to the estrogen treatments given to them by their conventional physicians." "It is time for the scientific community to stop giving alternative medicine a free ride. There cannot be two kinds of medicine -- conventional and alternative. There is only medicine that has been adequately tested and medicine that has not, medicine that works and medicine that may or may not work. Once a treatment has been tested rigorously, it no longer matters whether it was considered alternative at the outset. If it is found to be reasonably safe and effective, it will be accepted.... Alternative treatments should be subjected to scientific testing no less rigorous than that required for conventional treatments." [The editors fail to note that since the development of Lupron, Zoladex etc., estrogen for prostate cancer is seldom used; and that it was a cause of death in some prostate cancer patients when it was used]. See links below

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PC-SPES is labeled as a mixture of eight herbs used in Chinese and Western medicine: Chrysanthemum, Isatis, Licorice, Lucid ganoderma , Pseudoginseng, Rabdosia Rubescens, Saw Palmetto and Scute (Scutellaria baicalensis (huang­qin), or Skullcap). PC-SPES is sold in the USA as a nutritional supplement. The name PC-SPES comes from PC for prostate cancer and SPES, Latin for "hope."

Phytoestrogens in Plants
Innumerable plants and herbs contain phytoestrogens (phyto = plant). Plant estrogens are akin to the female hormone estrogen in animals including humans. Consumed by men or women as part of a daily diet high in vegetables and vegetable products like soy tofu -- and especially if taken as concentrated supplements -- plant estrogens can "plug into" hormone receptors. So they can take the place of human sex hormones, either estrogen or testosterone.

The plant versions are classified as "weak" estrogens but they can have potent effects -- even drastically lowering testosterone levels in a man.

DiPaolo and Zhang, using yeast tests or assays, found that PC-SPES contains estrogen. Before testing PC SPES on the human patients, they fed it to female mice whose ovaries had been surgically removed. Although these mice could no longer make estrogen in their own bodies, changes just like changes that estrogen causes occurred in their wombs. Estrogen, Dr. DiPaolo says, could only have come from the herbs.

With this preclinical evidence, the researchers began their study of men with prostate cancer. When the men took PC-SPES, their testosterone dropped dramatically. "In the first 3 patients," Di Paolo's team reported , "the serum PSA decreased by 93% while on PC-SPES." As soon as they come off the pills, this went into reverse. "Testosterone level increased 11 fold in 3 patients after PC-SPES was discontinued." DiPaolo and Zhang decided that with this big an impact, PC-SPES required more study of its "efficacy and safety."

 Although this was the first study to start out by looking for estrogen content, in 1997 a small study of PC-SPES for patients with metastatic prostate cancer ran for a brief time in California. The investigators, Israel Barken M.D., Stephen Strum, M.D. and Abraham Mttelman, M.D. halted it after two patients developed blood clots. The California trial was sponsored by Botaniclab (Brea, CA), which makes and distributes the product.

Memorial Sloan-Kettering Cancer Center (MSKCC) in New York said last spring that they will hold a clinical trial of PC-SPES. Details have not yet been announced.

See Update on early results of UCSF clinical trial

Links and sources

A Phase II Pilot Study of a Dietary Supplement, PC SPES® in Patients with Prostate Cancer (98554) University of California San Francisco Investigator: Eric Small, MD Phone contact: Paige Fratesi, 415/885-7329
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Clinical and Biologic Activity of an Estrogenic Herbal Combination (PC-SPES) in Prostate Cancer Robert S. DiPaola, Huayan Zhang, George H. Lambert, Robert Meeker, Edward Licitra, Mohamed M. Rafi, Bao Ting Zhu, Heidi Spaulding, Susan Goodin, Michel B. Toledano, William N. Hait, Michael A. Gallo The New England Journal of Medicine September 17, 1998 -- Volume 339, Number 12 (abstract)

Alternative Medicine -- The Risks of Untested and Unregulated Remedies The New England Journal of Medicine -- September 17, 1998 -- Volume 339, Number 12

See follow up: Letters to the New England Journal of Medicine on "PC-Spes in Prostate Cancer" and Response from DiPaolo free online registration

PC-SPES in the Study of Prostate cancer Protocol for a California study (now discontinued) with notes on the herbal ingredients

The Southwest School of Botanical Medicine Home Page

Research abstracts for herbal medicinal plants includes two herbs in PC-SPES, Glycyrrhiza (licorice) and Scutellaria (Skullcap)

Flora of China

w3Tropicos plant name data base searcher at Missouri Botanical Gardens

Plant Compounds and Chemotherapy At Indiana University's BioTech Project