PC-SPES

PC-SPES

Background

PC-SPES® is an herbal combination product that was produced and marketed until early 2002 by BotanicLab, Inc. for the treatment of prostate cancer. The initials "PC" stand for "prostate cancer," and " spes " is Latin for hope.

Based on a Chinese herbal formula, the ingredients of PC-SPES® were officially listed as including 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 Fort (Da Qing Ye, dyer's wood); Panax pseudo-ginseng (San Qi); Rabdosia rubescens (rubescens, Dong Ling Cao); and Scutellaria baicalensis (skullcap, Huang-chin).

In low quality studies, PC-SPES® was observed to reduce serum prostate specific antigen (PSA) levels, reduce evidence of metastatic disease, diminish pain, and improve quality of life in patients with prostate cancer. This evidence was viewed as promising by major U.S. cancer centers.

However, in early 2002, the FDA Safety Information and Adverse Event Reporting Program issued a warning to consumers to avoid using PC-SPES® based on findings that the product contained the anticoagulant ("blood thinner") warfarin. Bleeding disorders had previously been reported with PC-SPES®. The manufacturer voluntarily recalled the product. Samples of PC-SPES® were later found to contain variable amounts of the non-steroidal anti-inflammatory drug indomethacin, the synthetic estrogen diethystilbesterol (DES), and the estrogen ethinyl estradiol.

A study published in the September 2002 issue of the Journal of the National Cancer Institute analyzed lots of PC-SPES® manufactured between 1996 and 2001 (Sovak, 2002). This evaluation found variable ingredients in PC-SPES® between lots, with higher levels of indomethacin and DES after 1999. These post-1999 samples were found to have much greater estrogenic properties compared to earlier samples, and to possess a higher level of activity against prostate cell lines in laboratory tests. After 2001, greater amounts of the natural constituents licochalcone A and baicalin, as well as warfarin, were found in samples. These results suggest that PC-SPES® produced at different times may not be equivalent or comparable, and that the "anti-cancer" effects of PC-SPES® may have been due to undeclared prescription drug ingredients.

Several other BotanicLab products have also been found to contain undeclared prescription drugs. It is not clear if these adulterants were present in raw materials obtained by BotanicLab from other sources, or were added later in the manufacturing process.

Since BotanicLab closed its doors, several products with similar names have been introduced on the market, but none has been evaluated scientifically to the same extent as PC-SPES®. The National Center for Complementary and Alternative Medicine (NCCAM) has expressed willingness to support future research on formulations that are true to the claimed ingredients and proven not to be contaminated.

Synonyms

Chrysanthemum morifolium (chrysanthemum, mum, Chu-hua) ; Ganoderma lucidum (reishi mushroom, Ling Zhi); Glycyrrhiza glabra (licorice); Isatis indigotica Fort (Da Qing Ye, dyer's wood); Panax pseudo-ginseng (San Qi); Rabdosia rubescens (rubescens, Dong Ling Cao); Scutellaria baicalensis (skullcap, Huang-chin); Serenoa repens (saw palmetto).

Not to be confused with SPES (a different product), or with copycat products marketed with similar names.

Evidence

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare provider.

Uses based on scientific evidenceGrade*Prostate cancer
Uncontrolled human studies of PC-SPES® have reported improvements in patients with both androgen-dependent and androgen-independent prostate cancer (de la Taille, 2000; DiPaola, 1998; Oh, 2001; Pfeifer, 2000; Small, 2000). Overall, these studies found prostate-specific antigen (PSA) levels to fall by greater than 50% in most patients, improvements in bone scans and x-rays, reductions in pain scores, and improvements in quality of life. In a 2002 preliminary report (conference abstract) of a comparison between PC-SPES® and diethylstilbestrol (DES) in patients with androgen-independent metastatic prostate cancer, patients treated with PC-SPES® had a greater reduction in PSA levels (Small, 2002). However, the later finding that undeclared amounts of DES are present in some PC-SPES® samples clouds these results. Various explanations for the effectiveness of PC-SPES® were initially proposed. Estrogen-like effects were reported prior to 1998. These may be due to herbs with estrogen-like effects, or to undeclared estrogenic drugs. The constituent baicalin, a flavone found in Scutellaria baicalensis , was found in laboratory experiments to inhibit the enzymes 12-lipoxygenase, 5-alpha-reductase, and aromatase. In addition, PC-SPES® extracts were reported to cause cell death (apoptosis) or to slow the growth of cancer cell lines. The recent finding that different lots of PC-SPES® produced between 1996 and 2001 contained different ingredients from each other has raised questions about whether studies of PC-SPES® can be compared with each other. The discovery of undeclared prescription drug ingredients including the non-steroidal anti-inflammatory drug indomethacin, the synthetic estrogen diethystilbesterol (DES), the estrogen ethinyl estradiol, and the anticoagulant warfarin, make it unclear if these constituents may have caused the observed clinical effects. Because of these complicated circumstances, and the fact that PC-SPES® has never been compared to placebo or standard cancer treatments in a well-reported study, the question of effectiveness remains unclear. Due to known and theoretical safety concerns, samples of PC-SPES® that may be in the possession of patients should not be used.

C

* Key to grades
A: Strong scientific evidence for this use;
B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use (it may not work);
F: Strong scientific evidence against this use (it likely does not work).

Uses based on tradition or theory
The below uses are based on tradition or scientific theories. 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.

Benign prostatic hypertrophy, breast cancer, breast enlargement, cancer prevention, leukemia, lymphoma, melanoma, "prostate health."

Dosing

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.

Adult dosing (18 years and older):

Based on known safety concerns associated with PC-SPES®, no dosing regimen is recommended. Samples of PC-SPES® that may be in the possession of patients should not be used.

Safety

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

In one human study, allergic reactions were reported in 2% of patients, and treatment was stopped in one case due to throat swelling and shortness of breath. It is not clear which ingredient in PC-SPES® might have been responsible. Products containing herbs similar to PC-SPES® should be avoided by people with allergies to any of the included herbs.

Side Effects and Warnings

PC-SPES® has been recalled and should not be used. Undeclared prescription drug ingredients have been found in samples of PC-SPES®, including indomethacin, diethystilbesterol (DES), ethinyl estradiol, and warfarin.

PC-SPES® may increase the risk of blood clots. Several cases of blood clots, including life-threatening clots to the lungs, have been reported with PC-SPES® use. In contrast, cases of bleeding have also been reported. These are theorized to be due to undeclared amounts of the prescription drug warfarin in some samples of PC-SPES®, or to the presence of the PC-SPES® ingredient saw palmetto which is associated with one report of bleeding. This would add to the risk of bleeding in patients with bleeding disorders or taking drugs that may increase the risk of bleeding. The bleeding disorder disseminated intravascular coagulation (DIC), that can include clotting, bleeding, or both, has also been reported.

PC-SPES® has also been associated with erectile dysfunction, loss of libido, hot flashes, breast/nipple tenderness, breast enlargement, water retention (edema), and leg cramps.

Adverse effects associated with undeclared prescription drug ingredients in PC-SPES® are possible, such as gastrointestinal distress from indomethacin.

Pregnancy and Breastfeeding

PC-SPES® has not been evaluated during pregnancy or breastfeeding and should be avoided. Estrogenic-effects may be harmful. The undeclared prescription drug DES, discovered in some samples of PC-SPES®, may increase the risk of reproductive tract abnormalities in daughters born to women taking this drug.

References

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January 01, 2004