herbal supplement PC-SPES?

What IS this PC-SPES please?
It sounds interesting.

http://www.ncbi.nlm.nih.gov/entrez/q...=pubmed_docsum

Dear Hugh,

On Jan 27, 6:13?am, "Hugh Kearnley" <hughkearn...@btinternet.com>
wrote:
> What IS this PC-SPES please?
> It sounds interesting.
>
> http://www.ncbi.nlm.nih.gov/entrez/q...&cmd=Retrieve&...

I found this site which has a good general overview.

QUESTIONABLE CANCER THERAPIES I:
PC-SPES

[itmonline.org]

essay by Subhuti Dharmananda, Ph.D., Director, Institute for
Traditional Medicine, Portland, Oregon

What I have read about PC-SPES is that it was supposed to be a
combination of herbs, but it turned out that it contained several
potent drugs, including DES, Xanax and more. Therefore, it was
withdrawn from the US market.

However, I think it is intriguing because it seemed to be (very)
effective. However, they weren't sure what agent was causing the
benfit -- herbs or drugs?

It would be nice if they followed up on that.

Good luck,

Leah

Dear Hugh,

On Jan 27, 6:13?am, "Hugh Kearnley" <hughkearn...@btinternet.com>
wrote:
> What IS this PC-SPES please?
> It sounds interesting.
>
> http://www.ncbi.nlm.nih.gov/entrez/q...&cmd=Retrieve&...

I just came across this on one of my mailing lists
(prostatepointers,org, P2P. I think you will find it interesting.

(From advice to a patient.) You know, Dr. Strum may not be
mainstream, but it could be he's taking risks in the right direction.
>From what I've read, it does sound like they threw out the baby with
the bathwater in this case.

Stephen B. Strum, MD>

Once a neoplasm--a cancer-- has developed, the most common effect that
a
dietary & supplement change can evoke has been to stabilize the
process. I
have not seen any prostate cancers disappear from the use of
nutritional or
life style changes. So, your story above is what I would have
expected. If
we find a nutritional approach that eradicates PC, then we will have
something very exciting to talk about. The closest agent that I have
seen
in that category has been PC SPES. The controversy over what accounts
for
the anti-PC effect of PC SPES is still not resolved & many believe
that it
was due to the DES (Diethylstilbestrol) that was found in many lots of
the
product. However, in the randomized study done by Small et al, the PC
SPES
arm containing tiny amounts of DES was found to be superior to the DES
arm
of the study.

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
22:3705-3712, 2004.

PURPOSE: To evaluate the herbal combination, PC-SPES, and
diethylstilbestrol
(DES) in patients with androgen independent prostate cancer (AIPC).
PATIENTS AND METHODS: A randomized phase II study was conducted with
cross-over design. Patients were randomly assigned to receive either
three
PC-SPES capsules orally three times a day or DES 3 mg orally once a
day.
Prophylactic warfarin was administered. At clinical or prostate-
specific
antigen progression, patients received the other therapy. The study
closed
prematurely after PC-SPES was withdrawn from the market. Chemical
analyses
were performed on multiple lots of PC-SPES. RESULTS: Ninety patients
were
enrolled, of whom 85 were assessable for response. Prostate-specific
antigen
declines > or = 50% were noted in 40% (95% CI, 25% to 56%) with PC-
SPES, and
24% (95% CI, 12% to 39%) with DES. Median response duration was not
reached
with PC-SPES, and was 3.8 months with DES. Median time to progression
for
randomly assigned patients was 5.5 months for PC-SPES and 2.9 months
for
DES. Common toxicities included mild fatigue, gynecomastia, and
mastodynia.
Five thromboembolic events occurred (one PC-SPES, four DES). Responses
in
the cross-over phase were inconclusive. Four lots of PC-SPES had
measurable
quantities of DES, ranging from 0.01% to 3.1% of the dose used in the
DES
arm. Ethinyl estradiol was also detected in PC-SPES lots. CONCLUSION:
PC-SPES and DES demonstrate activity in AIPC and are well tolerated.
However, the synthetic estrogens, DES and ethinyl estradiol, were
detected
in various lots of PC-SPES, including those used in this trial.
Clinical
trials that utilize herbal therapies must account for issues of purity
and
consistency.

SS: 0.01% x 3mg = .0003mg; 3.1% = 0.093mg; These are extremely tiny
doses of
DES and most clinicians would likely say that the anti-PC effect of
this
product cannot be explained by such amounts of DES. Thus, the only
product
that we had available in the category of an herbal blend has been
banned by
the FDA. We threw out the baby with the bathwater in this case, in my
opinion.

Imagine me quoting Dr. Strum. Well, I am becoming Empowered, maybe.
Got the Primer yesterday. Strum, here I come!

Isn't it too bad that you only hear about Dr. Strum when it's too
late? That is, if he has anything to say. It depressed me to read
the whole alphabet soup of tests that he recommends that were not
done. But he's just one person.

Also, Dr. Strum seems to be getting more "transparent". Here's what
was appended to this post:

"The pathologist that does the most complete job as well as does the
entire work himself (not referred to a junior associate) is Helmut
Bonkhoff
in Berlin, Germany.

II have no affiliation relating to financial or any
other benefits with Dr. Bonkhoff. I just think he is the top
pathologist in
the Western Hemisphere doing work on PC pathology. In fact, none of
the
names every noted on P2P in my posts relate to ANYONE that I have a
financial or otherwise beneficial relationship with.

[LEF? - he's on the Board]

And there's more:

One other issue to mention. Many of you think that I am an owner or
affiliated with P2P. I am not; I am purely a volunteer MD answering
your
emails. I was instrumental in the concept involved in developing
P2P--that's it.

Also, my work here is not associated in any way with the PCRI & I am
not an
employee of the PCRI.

I hope so.

Good luck, Hugh.

Leah

Hugh Kearnley wrote:

> What IS this PC-SPES please?
> It sounds interesting.
>
> http://www.ncbi.nlm.nih.gov/entrez/q...=pubmed_docsum

Uses based on scientific 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.

Grade* C

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, Pfeiffer, 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.

*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).

On January 27, Hugh Kearnley wrote:

> What IS this PC-SPES please? It sounds interesting.

(snip)

The item Hugh cites is six years old, and the data is likely older than
that.

PC-SPES was found to be contaminated with certain prescription drugs,
Warfarin (blood thinner) for one. It is no longer legally available. It
has been replaced on the market by certain very similar concoctions.

Here is a not entirely adverse 2005 article from the ACS on the matter:

http://www.cancer.org/docroot/eto/co...p?sitearea=eto

Note that, toward the end, the following appears: "PC-SPES was not
recommended for cancers that were still responding to conventional
hormonal treatments, or for men with localized prostate cancer that
could be treated with surgery or radiation therapy."

And that certain SEs are mentioned, among them the risk of developing
blood clots.

I expect that I will now be attacked for mentioning this.

Regards,

Steve J

"Digressions, objections, delight in mockery, carefree mistrust are
signs of health; everything unconditional belongs in pathology."
--Friedrich Nietzsche

"Hugh Kearnley" <hughkearnley@btinternet.com> wrote in message
news:IqydnX4uM61yribYnZ2dnUVZ8siknZ2d@bt.com...
> What IS this PC-SPES please?
> It sounds interesting.
>
> http://www.ncbi.nlm.nih.gov/entrez/q...=pubmed_docsum

Hugh,

As others have pointed out, PC-SPES contained varying amounts
of prescription hormone and hormone therapy drugs, and anti-
inflammatories. No doubt there were many men who took these
drugs, saw their PSA drop, and assumed that it was curing them.
In fact, what these men were getting was probably a poorly
controlled and less effective form of hormone therapy that they
could have gotten from a doctor. In many cases the drop in
PSA masked the fact that their disease was continuing to
progress so that they wound up with untreatable disease.

Clearly, the makers of PC-SPES were unethical in the labelling
of their product and in using drugs that were not approved
for non-prescription use. They were making apparently
random changes in the formula - perhaps based on whatever
ingredients happened to be around at the time.

In some ways, I'd rather give my money to an honest mugger
than to the makers of PC-SPES. At least the mugger wouldn't
make false promises about what he was doing.

Alan

hi hugh - here's something from my file who did check out PC-SPES.
although it is somewhat dated, i thought you might find it
interesting.......

~ curtis

=============



Subject:PC-SPEC -- a clinical study

From: ** JohnMarkCarter@CompuServe.com Subject: ** PC-SPEC -- a
clinical study Date: ** Mon, Jun 1, 1998, 3:53pm (CST+6) Group:
** alt.support.cancer.prostate

Last Friday (29MAY98) I attended the 1998 annual retreat of cancer
research in New Jersey. One abstract that was very interesting to me is
worth sharing with the group. It presented results from a small clinical
study of PC-SPES. The study was somewhat poorly designed and performed,
but some of the results are nonetheless conclusive. Below I present the
abstract exactly as it was published in the proceedings. Then I offer a
translation into lay language. Then my notes from the lecture that the
primary author delivered.

And finally a professional critique of the study. (Although the latter
is offered IMHO, I am a PhD biochemist with 10 years experience in
research including a few recent years studying breast and prostate
cancer.)

ABSTRACT:
Clinical and Biological activity of an Herbal Combination (PC-SPES) in
the Treatment of Prostate Cancer.
Robert S. DiPaola, Huayan Zhang, George Lambert, Robert Mecker, Edward
Licitra, Heidi Spaulding, Susan Goodie, Michel B. Toledano, William
Hait, Michael Gallo.

The Cancer Institute of New Jersey, Robert Wood Johnson Medical School,
New Brunswick, NJ and EOHSI.
Background. Herbal medicines have gained popular appeal as alternatives
to proven therapies. PC-SPES, a commercially available herbal
combination, is touted as a non-estrogenic treatment for cancer of the
prostate, although other herbal medicines have been known to have in
vitro estrogenic effects. Therefore we tested the clinical and
biological activity of PC-SPES in men with cancer of the prostate.
Methods. Estrogenic activity of PC-SPES was measured by transcriptional
activation assays in yeast and in a biological assay in rodents. The
clinical activity of

PC-SPES was determined in patients with hormone-sensitive cancer of the
prostate by measuring PSA and serum testosterone concentrations during
and after treatment. Results. In complimentary yeast assays, a 1:200
dilution of an ethanol extract of PC-SPES (320 mg per capsule) contained
estrogenic activity similar to 1 nM estradiol. In ovarectomized CD-1
mice, PC-SPES
increased uterine weights compared to vehicle controls (p=0.004). In 6/6
patients, PC-SPES suppressed the concentration of serum testosterone by
71% +/- 8.0 (p=0.025), and in 8/8 patients decreased PSA by 64% +/- 11
(p=0.005). Patients consuming PC-SPES experienced estrogenic side
effects including breast tenderness (8/8), loss of libido (8/8), and
venous thrombosis (1/8).

Conclusions.

PC-SPES has potent estrogenic activity, as demonstrated in yeast,
rodents, and man. PC-SPES is capable of androgen ablation, reducing PSA,
and producing estrogenic side effects in men with cancer of the
prostate. The use of this agent may confound results of standard or
experimental therapies, and may produce significant toxicity. These data
highlight the potent beneficial and adverse biological activities that
can be associated with unrestricted nutritional food supplements.


LAY TRANSLATION:

PC-SPES works on CaP the same way that androgen ablation therapy works.

That is, it acts like estrogen and inhibits the production of
testosterone which is needed by hormone sensitive CaP for its survival
and growth. It works, but it has side effects, as do most drugs. If you
decide to use PC-SPES tell your physician, since it's a very potent
drug.


MY NOTES:

1. PC-SPES contains the following herbs: chrysanthemum, isatis,
licorice, Lucid gamoderma, pseudoginseng, rubescens, saw palmetto, and
scute.
2. PSA levels typically began to increase within three weeks of
withdrawal from PC-SPES.
3. 2 of 6 patients experienced testosterone depression to <25 ng/dl.
This is castrate level. All 6 of 6 patients experienced significant
reduction of serum testosterone.
4. HPLC analysis of the clinically active ethanol extract administered
in the study indicated many compounds, but no estrogen. (This rules out
the possibility that the distributor simply added cheap estrogen to an
inert herbal compound.)


CRITIQUE:

1. This is a shaky little preliminary trial.

You can't believe everything that it purports. However, it looks really
very interesting. It looks interesting enough that I'm going to write a
grant proposal based on isolation of the active principle(s) from the
mixture. This principle well be a good lead towards a new therapeutic.
Some people will always prefer to take "natural" remedies. But chemists
like me can often improve on the activity and side effect profiles of
naturally occurring remedies. As a matter of fact, that's where a lot of
new drugs come from.
2. It's not really fair of the authors to make an issue of the one
incidence of venous thrombosis they observed, especially since
thrombosis was not pre-decided to be one of the clinical parameters they
would study. However, it's worth watching. One of the reasons CaP
patients don't just take cheap estrogen is because estrogen causes so
many undesirable side effects, including a risk of potentially
life-threatening blood clots.
3. Chalk one up for the alternative medicine folks! I'd like to see a
thorough comparison of PC-SPES versus traditional medicine, with costs
and risks compared to health benefits. Right now most CaP patients will
have to take synthetic pharmaceuticals, since that's what their docs
will prescribe, and it's all their health insurance plans will pay for.
Pretty cool, huh? In closing I reiterate: if you take PC-SPES (or any
other remedy) tell your doc and your pharmacist.
Mark


DISCLAIMER:
This is not a professional evaluation. I did not examine any patient
prior to making these comments, and I have neither charged nor received
any fee. Discuss these comments with your personal physician, and act
upon his/her advice. By participating in an Internet discussion, I am
not creating a physician-patient relationship, nor may I be held
responsible for any potential breach of confidentiality.

knowledge is power - growing old is mandatory - growing wise is optional
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc

It really doesn't offer anything remarkably different from Androgen Blockade
Drugs do - I think the only "thing" about them is that PC-SNES is meant for
those folk who don't want to take the drug road - by that I mean those who
are LOOKING for a 'natural' way of doing the deed.
That apart, the drug IS being marketed in Europe but the original formula
has been changed - to what - it doesn't say. It's also quite expensive.
I think I'll stick with my FREE NHS-Provided drugs.
Thanks to everyone for all the help though.
Cheers.
Hughie.

"c palmer" <PALMER_ENT@webtv.net> wrote in message
news:11147-45BC768F-787@storefull-3216.bay.webtv.net...
hi hugh - here's something from my file who did check out PC-SPES.
although it is somewhat dated, i thought you might find it
interesting.......

~ curtis

=============



Subject:PC-SPEC -- a clinical study

From: JohnMarkCarter@CompuServe.com Subject: PC-SPEC -- a
clinical study Date: Mon, Jun 1, 1998, 3:53pm (CST+6) Group:
alt.support.cancer.prostate

Last Friday (29MAY98) I attended the 1998 annual retreat of cancer
research in New Jersey. One abstract that was very interesting to me is
worth sharing with the group. It presented results from a small clinical
study of PC-SPES. The study was somewhat poorly designed and performed,
but some of the results are nonetheless conclusive. Below I present the
abstract exactly as it was published in the proceedings. Then I offer a
translation into lay language. Then my notes from the lecture that the
primary author delivered.

And finally a professional critique of the study. (Although the latter
is offered IMHO, I am a PhD biochemist with 10 years experience in
research including a few recent years studying breast and prostate
cancer.)

ABSTRACT:
Clinical and Biological activity of an Herbal Combination (PC-SPES) in
the Treatment of Prostate Cancer.
Robert S. DiPaola, Huayan Zhang, George Lambert, Robert Mecker, Edward
Licitra, Heidi Spaulding, Susan Goodie, Michel B. Toledano, William
Hait, Michael Gallo.

The Cancer Institute of New Jersey, Robert Wood Johnson Medical School,
New Brunswick, NJ and EOHSI.
Background. Herbal medicines have gained popular appeal as alternatives
to proven therapies. PC-SPES, a commercially available herbal
combination, is touted as a non-estrogenic treatment for cancer of the
prostate, although other herbal medicines have been known to have in
vitro estrogenic effects. Therefore we tested the clinical and
biological activity of PC-SPES in men with cancer of the prostate.
Methods. Estrogenic activity of PC-SPES was measured by transcriptional
activation assays in yeast and in a biological assay in rodents. The
clinical activity of

PC-SPES was determined in patients with hormone-sensitive cancer of the
prostate by measuring PSA and serum testosterone concentrations during
and after treatment. Results. In complimentary yeast assays, a 1:200
dilution of an ethanol extract of PC-SPES (320 mg per capsule) contained
estrogenic activity similar to 1 nM estradiol. In ovarectomized CD-1
mice, PC-SPES
increased uterine weights compared to vehicle controls (p=0.004). In 6/6
patients, PC-SPES suppressed the concentration of serum testosterone by
71% +/- 8.0 (p=0.025), and in 8/8 patients decreased PSA by 64% +/- 11
(p=0.005). Patients consuming PC-SPES experienced estrogenic side
effects including breast tenderness (8/8), loss of libido (8/8), and
venous thrombosis (1/8).

Conclusions.

PC-SPES has potent estrogenic activity, as demonstrated in yeast,
rodents, and man. PC-SPES is capable of androgen ablation, reducing PSA,
and producing estrogenic side effects in men with cancer of the
prostate. The use of this agent may confound results of standard or
experimental therapies, and may produce significant toxicity. These data
highlight the potent beneficial and adverse biological activities that
can be associated with unrestricted nutritional food supplements.


LAY TRANSLATION:

PC-SPES works on CaP the same way that androgen ablation therapy works.

That is, it acts like estrogen and inhibits the production of
testosterone which is needed by hormone sensitive CaP for its survival
and growth. It works, but it has side effects, as do most drugs. If you
decide to use PC-SPES tell your physician, since it's a very potent
drug.


MY NOTES:

1. PC-SPES contains the following herbs: chrysanthemum, isatis,
licorice, Lucid gamoderma, pseudoginseng, rubescens, saw palmetto, and
scute.
2. PSA levels typically began to increase within three weeks of
withdrawal from PC-SPES.
3. 2 of 6 patients experienced testosterone depression to <25 ng/dl.
This is castrate level. All 6 of 6 patients experienced significant
reduction of serum testosterone.
4. HPLC analysis of the clinically active ethanol extract administered
in the study indicated many compounds, but no estrogen. (This rules out
the possibility that the distributor simply added cheap estrogen to an
inert herbal compound.)


CRITIQUE:

1. This is a shaky little preliminary trial.

You can't believe everything that it purports. However, it looks really
very interesting. It looks interesting enough that I'm going to write a
grant proposal based on isolation of the active principle(s) from the
mixture. This principle well be a good lead towards a new therapeutic.
Some people will always prefer to take "natural" remedies. But chemists
like me can often improve on the activity and side effect profiles of
naturally occurring remedies. As a matter of fact, that's where a lot of
new drugs come from.
2. It's not really fair of the authors to make an issue of the one
incidence of venous thrombosis they observed, especially since
thrombosis was not pre-decided to be one of the clinical parameters they
would study. However, it's worth watching. One of the reasons CaP
patients don't just take cheap estrogen is because estrogen causes so
many undesirable side effects, including a risk of potentially
life-threatening blood clots.
3. Chalk one up for the alternative medicine folks! I'd like to see a
thorough comparison of PC-SPES versus traditional medicine, with costs
and risks compared to health benefits. Right now most CaP patients will
have to take synthetic pharmaceuticals, since that's what their docs
will prescribe, and it's all their health insurance plans will pay for.
Pretty cool, huh? In closing I reiterate: if you take PC-SPES (or any
other remedy) tell your doc and your pharmacist.
Mark


DISCLAIMER:
This is not a professional evaluation. I did not examine any patient
prior to making these comments, and I have neither charged nor received
any fee. Discuss these comments with your personal physician, and act
upon his/her advice. By participating in an Internet discussion, I am
not creating a physician-patient relationship, nor may I be held
responsible for any potential breach of confidentiality.

knowledge is power - growing old is mandatory - growing wise is optional
"Many more men die with prostate cancer than of it. Growing old is
invariably fatal. Prostate cancer is only sometimes so."
http://community.webtv.net/PALMER_ENT/doc