Chinese Herbs Hold Little Benefit for Hepatitis C

[Guest guest]

I wonder what herbs did they use in that study.

 

This is the public article:

http://www.nlm.nih.gov/medlineplus/news/fullstory_18759.html

 

this is the real abstract:

http://archinte.ama-assn.org/cgi/content/abstract/164/12/1341

 

Dan.L

[Guest guest]

, " Danny Levin "

<dan_lv@h...> wrote:

> I wonder what herbs did they use in that study.

>

 

It also appears they used a prepared medicine. This would be

typical. use research based upon high dose decotion and then study

low dose patents, perhaps even with the expert advice of one of

our " peers " .

 

[Guest guest]

I just received an email from the author that explains that the herbs used

were a 5:1 concentrated extract (I'll also include a list of the herbs

cited in the journal article). At 10g/d this represents a pretty standard

low-end dose. This makes it harder to write off this study as irrelevant

to current clinical practice, never mind the larger impact of having a

negative result like this in the Archives of Internal Medicine.

 

........

 

Dear Mr. Short,

The product used is made by KPC at a 5/1 ratio of

concentrated powder.The powder was then made into

tablets and given to tablets.

Sincerely, Uli Beyendorff, Lic. AC., Dipl.

C.H.(NCCAOM)

 

.......

 

Arch Intern Med. 2004;164:1341-1346

 

TREATMENT REGIMEN

 

Before initiating the study, participants stopped using all other

herbs and dietary supplements for 3 weeks. Participants randomized

to active treatment received a fixed combination of 10

traditional Chinese medicinal herbs, 10 g/d, that contained the

following components: Radix astragali (6%), Radix acanthopanax

(8%), Radix bupleuir (8%), Radix et tuber curcumae (10%),

Rhizoma polygonum (10%), Radix glycyrrhiza (4%), Radix isatis

(14%), Radix paeoniae rubra (14%), Radix salviae (14%), and Herba

taraxaci (12%). Participants in the control arm consumed an

equivalent amount of a similar-appearing and similar-tasting placebo.

The treatment and placebo remedies were administered

orally in the form of 7 tablets 2 times a day for 12 weeks. Kaiser

Pharmaceuticals Company Products, Inc, Tainan, Taiwan, performed

high-performance liquid chromatography of each component

and the final mixture to ensure appropriate levels of constituent

ingredients. Formulation Technology, Oakdale, Calif,

a Food and Drug Administration–approved facility, made the

herbal compound and the placebo into a tablet. All study personnel

were blinded with regard to treatment assignment. The

study nurse (S.M.C.) distributed bottles of medication prelabeled

with participant identification numbers by the study coordinator

(T.A.B.); the study coordinator was also responsible

for randomization and had no patient contact.

or quality of life. This instrument has been used by several

groups12,13,18 to evaluate quality of life in patients with HCV.

The HQLQ was administered at weeks 0, 4, 8, and 12 and at 8

weeks posttreatment.

 

 

>

>

>

> Dear Mr. Beyendorff,

>

> Could you please tell me if the formula in this

> study used a 10g/day

> regimen of concentrated extract, or of raw herbs

> compounded into tablets?

> If the herbs were a " dried decoction " , what was the

> extraction ratio (e.g.

> 5:1 bulk-dispensed herbs to extract)?

 

> , " Danny Levin "

> <dan_lv@h...> wrote:

>> I wonder what herbs did they use in that study.

>>

>

> It also appears they used a prepared medicine. This would be

> typical. use research based upon high dose decotion and then study

> low dose patents, perhaps even with the expert advice of one of

> our " peers " .

>

 

>

>

>

>

> Chinese Herbal Medicine offers various professional services, including

> board approved continuing education classes, an annual conference and a

> free discussion forum in Chinese Herbal Medicine.

>

>

>

>

[Guest guest]

The problem with this study may be two fold:

1) The form of herbal administration.

What process did they use to make the tablets from the granules?

I do not see how 14 tablets per day could equal 50g raw since they

started with a 5:1 ratio and then must have added more binders to

make the tablets. How much did each tablet weigh? more than 1 gram?

Also the tablet making process might have affected the herbs as well.

 

2) Pattern differentiation

As usual there was no pattern differentiation in this study so it

does not replicate the use of herbs within TCM.

 

I do not see how the large body of literature both from China and

especially Japan could be all wrong. There probably is another

answer. Who paid for this research by the way?

 

Rich Blitstein L.Ac.

PCOM Chicago

 

 

 

 

 

 

 

 

 

 

 

, mshort@z... wrote:

> I just received an email from the author that explains that the

herbs used

> were a 5:1 concentrated extract (I'll also include a list of the

herbs

> cited in the journal article). At 10g/d this represents a pretty

standard

> low-end dose. This makes it harder to write off this study as

irrelevant

> to current clinical practice, never mind the larger impact of

having a

> negative result like this in the Archives of Internal Medicine.

>

> .......

>

> Dear Mr. Short,

> The product used is made by KPC at a 5/1 ratio of

> concentrated powder.The powder was then made into

> tablets and given to tablets.

> Sincerely, Uli Beyendorff, Lic. AC., Dipl.

> C.H.(NCCAOM)

>

> ......

>

> Arch Intern Med. 2004;164:1341-1346

>

> TREATMENT REGIMEN

>

> Before initiating the study, participants stopped using all other

> herbs and dietary supplements for 3 weeks. Participants randomized

> to active treatment received a fixed combination of 10

> traditional Chinese medicinal herbs, 10 g/d, that contained the

> following components: Radix astragali (6%), Radix acanthopanax

> (8%), Radix bupleuir (8%), Radix et tuber curcumae (10%),

> Rhizoma polygonum (10%), Radix glycyrrhiza (4%), Radix isatis

> (14%), Radix paeoniae rubra (14%), Radix salviae (14%), and Herba

> taraxaci (12%). Participants in the control arm consumed an

> equivalent amount of a similar-appearing and similar-tasting

placebo.

> The treatment and placebo remedies were administered

> orally in the form of 7 tablets 2 times a day for 12 weeks. Kaiser

> Pharmaceuticals Company Products, Inc, Tainan, Taiwan, performed

> high-performance liquid chromatography of each component

> and the final mixture to ensure appropriate levels of constituent

> ingredients. Formulation Technology, Oakdale, Calif,

> a Food and Drug Administration–approved facility, made the

> herbal compound and the placebo into a tablet. All study personnel

> were blinded with regard to treatment assignment. The

> study nurse (S.M.C.) distributed bottles of medication prelabeled

> with participant identification numbers by the study coordinator

> (T.A.B.); the study coordinator was also responsible

> for randomization and had no patient contact.

> or quality of life. This instrument has been used by several

> groups12,13,18 to evaluate quality of life in patients with HCV.

> The HQLQ was administered at weeks 0, 4, 8, and 12 and at 8

> weeks posttreatment.

>

>

> >

> >

> >

> > Dear Mr. Beyendorff,

> >

> > Could you please tell me if the formula in this

> > study used a 10g/day

> > regimen of concentrated extract, or of raw herbs

> > compounded into tablets?

> > If the herbs were a " dried decoction " , what was the

> > extraction ratio (e.g.

> > 5:1 bulk-dispensed herbs to extract)?

>

> > , " Danny Levin "

> > <dan_lv@h...> wrote:

> >> I wonder what herbs did they use in that study.

> >>

> >

> > It also appears they used a prepared medicine. This would be

> > typical. use research based upon high dose decotion and then

study

> > low dose patents, perhaps even with the expert advice of one of

> > our " peers " .

> >

>

> >

> >

> >

> >

> > Chinese Herbal Medicine offers various professional services,

including

> > board approved continuing education classes, an annual conference

and a

> > free discussion forum in Chinese Herbal Medicine.

> >

> >

> >

> >

[Guest guest]

, mshort@z... wrote:

> I just received an email from the author that explains that the herbs used

> were a 5:1 concentrated extract (I'll also include a list of the herbs

> cited in the journal article). At 10g/d this represents a pretty standard

> low-end dose. This makes it harder to write off this study as irrelevant

> to current clinical practice, never mind the larger impact of having a

> negative result like this in the Archives of Internal Medicine.

 

 

the formula looks reasonable. was one formula used for all? However I would

dispute

your position that the dosage was adequate. while adequate by japanese

standards, it is

about 3 times lower than amounts typically used in PRC hep studies (50g

equivalent

versus 150-180g). While I agree that this dose is the low end of normal, it is

not fair to

generalize the results to those who use large dose decoction. The researchers

were either

influenced by the company's literature or practitioners who advised this. If

one was

familiar with the disparity between this dose and that used in PRC studies, the

only

reasonable thing to do is to have multiple goups taking increasing dosages.

This will be

one of many unfortunate results that has nothing to do with TCM not being

amenable to

study and everything to do with careless research and ignorant advisors. While

we can

criticize chinese research as being shoddy, we should at least be cognizant of

the

unanimity of chinese researchers on the dosage issue. And yet american

researchers

underdose their subjects time and time again. Until we study what is actually

being done

in china, the research being done proves nothing.

 

[Guest guest]

Hi Folks:

I just read the HCV study from the Archives late June issue. Uli can tell u=

s, but I

believe this study took place several years ago at Hennepin County.

I had many methodological problems with it when I was told about it origina=

lly 3 or 4

years ago and unfortunately all the problems rear their heads in this unfor=

tunate

paper in a major medical journal. Now I know why doctors are telling my cli=

ents in the

last few weeks that " herbs don't work in HCV " . It is also all over the " CV =

Internet "

The main issues:

1. Herbs chosen inadequately (mostly herbs used for HBV in China not HCV, =

not from

long-term clinical experience other than generalized Japanese style Sho-Sai=

ko-To

which is usally not given by diagnosis by Chinese medicine practitioners bu=

t by MDs

and in very large doses). This is also not a formula that was widely used c=

linically

prior to studying the formula (see my talk at CHA Conference for more infor=

mation on

how to design herbal studies with this as a strong component).

The main herbs used in HCV are not in the formula--it is a very general. Th=

e rationale

for herbs chosen is very weak.

2. Full herbal formulas as we use in clinic with enough dosing were not us=

ed as far as

I can tell. Only 10 grams of herbs per day--we use at least 21 grams of ext=

ract and

concetnrated herbs with many highly extracted herbs such as Schizandra with=

 

extracted schizandrins etc. It is also hard to tell how much people actuall=

y took per

day on average--there are just percentages in the study iof " adherence " but=

nono of

individual adherence. Full adherence would be critical with such low doses

3. Twelve weeks is just enough to see if people can tolerate herbs much le=

ss be a full

study of herb effect. Any HCV study of herbs needs to be at least a year. A=

nd eight

weeks is REALLY short for a QOL study in an HCV group--especially with only=

45

people in the group. QOL changes over a long time and with a complete progr=

am of

Chinese and natural therpeutics. One primary symptom looked at was fatigue-=

-the

herbs are inadequate in this study to address fatigue much less than in 8-1=

2 weeks.

4. Some wrong parameters chosen as primary outcome--viral load for one. Th=

is is a

set-up as VL is never cleared with Chinese herbs. It is fine as a secondary=

or tertiary

measure.

5. No Chinese medicine diagnosis done--we couldn't know if any group did b=

etter

than another.

6. Study group was too small for the effect size. We have been talking abo=

ut this

exact problem for two years in an HCV integrated medicine research group I =

am

involved with in designing an herbal study for HCV. Effect size must be det=

ermined

accurately. Without prior extensive clinical experience it is almost imposs=

ible to

determine an effect size.

7. We can't compare herbs to interferon, especially ones not normally used=

in HCV!!

Herbs should be used as adjunctive therapies in general, not alone (with ac=

upuncture,

supplements, Western meds, whatever). As an alternative therapy, they need =

to be

much more focused and are NOT as an alternative to interferon therapy. The =

 

conclusion of the study will always be negative in this case.

This study is hauntingly similar to the SFGH Enhance study we did in HIV in=

1991-92

(reported in JAIDS 1996) from which we learned not to do it that way (even =

though the

outcome was positive in that study in terms of QOL and digestive symptoms)

Anyone interested in writing a letter to Archives from CHA about study flaw=

s and

indicate that this is not truly a study that would be able to show effect o=

r not of herbs

in HCV.

, mshort@z... wrote:

 

> I just received an email from the author that explains that the herbs use=

d

> were a 5:1 concentrated extract (I'll also include a list of the herbs

> cited in the journal article). At 10g/d this represents a pretty standard=

 

> low-end dose. This makes it harder to write off this study as irrelevant

> to current clinical practice, never mind the larger impact of having a

> negative result like this in the Archives of Internal Medicine.

>

> .......

>

> Dear Mr. Short,

> The product used is made by KPC at a 5/1 ratio of

> concentrated powder.The powder was then made into

> tablets and given to tablets.

> Sincerely, Uli Beyendorff, Lic. AC., Dipl.

> C.H.(NCCAOM)

>

> ......

>

> Arch Intern Med. 2004;164:1341-1346

>

> TREATMENT REGIMEN

>

> Before initiating the study, participants stopped using all other

> herbs and dietary supplements for 3 weeks. Participants randomized

> to active treatment received a fixed combination of 10

> traditional Chinese medicinal herbs, 10 g/d, that contained the

> following components: Radix astragali (6%), Radix acanthopanax

> (8%), Radix bupleuir (8%), Radix et tuber curcumae (10%),

> Rhizoma polygonum (10%), Radix glycyrrhiza (4%), Radix isatis

> (14%), Radix paeoniae rubra (14%), Radix salviae (14%), and Herba

> taraxaci (12%). Participants in the control arm consumed an

> equivalent amount of a similar-appearing and similar-tasting placebo.

> The treatment and placebo remedies were administered

> orally in the form of 7 tablets 2 times a day for 12 weeks. Kaiser

> Pharmaceuticals Company Products, Inc, Tainan, Taiwan, performed

> high-performance liquid chromatography of each component

> and the final mixture to ensure appropriate levels of constituent

> ingredients. Formulation Technology, Oakdale, Calif,

> a Food and Drug Administration–approved facility, made the

> herbal compound and the placebo into a tablet. All study personnel

> were blinded with regard to treatment assignment. The

> study nurse (S.M.C.) distributed bottles of medication prelabeled

> with participant identification numbers by the study coordinator

> (T.A.B.); the study coordinator was also responsible

> for randomization and had no patient contact.

> or quality of life. This instrument has been used by several

> groups12,13,18 to evaluate quality of life in patients with HCV.

> The HQLQ was administered at weeks 0, 4, 8, and 12 and at 8

> weeks posttreatment.

>

>

> >

> >

> >

> > Dear Mr. Beyendorff,

> >

> > Could you please tell me if the formula in this

> > study used a 10g/day

> > regimen of concentrated extract, or of raw herbs

> > compounded into tablets?

> > If the herbs were a " dried decoction " , what was the

> > extraction ratio (e.g.

> > 5:1 bulk-dispensed herbs to extract)?

>

> > , " Danny Levin "

> > <dan_lv@h...> wrote:

> >> I wonder what herbs did they use in that study.

> >>

> >

> > It also appears they used a prepared medicine. This would be

> > typical. use research based upon high dose decotion and then study

> > low dose patents, perhaps even with the expert advice of one of

> > our " peers " .

> >

>

> >

> >

> >

> >

> > Chinese Herbal Medicine offers various professional services, includin=

g

> > board approved continuing education classes, an annual conference and a=

 

> > free discussion forum in Chinese Herbal Medicine.

> >

> >

> >

> >

[Guest guest]

Some wrong parameters chosen as primary outcome--viral load for one. Th=

is is a

set-up as VL is never cleared with Chinese herbs

>>>>Misha what does this tell you, especially with Hep-C since VL is what is

related to eventual liver failure?

Alon

 

 

[Guest guest]

, " Alon Marcus " <alonmarcus@w...>

wrote:

> Some wrong parameters chosen as primary outcome--viral load for one. Th=

> is is a

> set-up as VL is never cleared with Chinese herbs

> >>>>Misha what does this tell you, especially with Hep-C since VL is what is

related to eventual liver failure?

> Alon

Alon:

That is actually not the case in HCV--in HCV there is no direct relationship of

high

viral load to the development of more serious liver disease such as in hepatitis

B.

These are two very different viruses in every way including that HCV is a

systemic

disease with many autoimmune complications and other issues connected to the

virus

directly even if the stage of liver fibrosis is zero or one and a person will

never

develop cirrhosis (80% of all people with chronic HCV never develop serious

liver

disease but many of those have serious complications of the virus itself such as

cryoglobulinemia). On the other hand, HBV affects the liver as the main and

often only

issue until cirrhosis and ESLD or liver cancer develops--the higher the viral

load in

HBV the more serious the liver disease.

What is really the question that you want to ask regarding Chinese herbal

medicine

and HCV?

Misha

[Guest guest]

What is really the question that you want to ask regarding Chinese herbal

medicine

and HCV?

>>>I guess I was not up on HCV since i always thought there was a relationship

between viral load and cirrhosis

Alon