More on AA from John Chen

June 14, 2000

There has been a lot of negative publicity about

Chinese herbs that we need

to address now. The purposes of this e-mail is to address the

issue of

nephropathy caused by incorrect substation of two Chinese herbs.

1. Nephropathy: There have been several cases of nephropathy related

to the

use of herbs over the past few years in Belgium, England, and other

countries. Though nephropathy has been documented,

these incidences

occurred because the herbs were inappropriately-used and

incorrectly-substituted. On May 16, 2000, FDA released a formal

letter

warning the general public that the use of herbs that contain aristolochic

acid may cause kidney damage. On June 8, 2000, New England Journal

of

Medicine published an article that continuously use and address the

term

"Chinese-herb nephropathy."

We firmly believe that a vast majority of articles published thus far

unfairly and unjustly evaluated the entire situation. This incidence

is not

"Chinese-herb nephropathy," but "inappropriate-use and incorrect substation

of herb" that cause nephropathy. In Belgium, instead of using

the correct

herb Stephania tetrandra (han fang ji), the incorrect herb Aristolochia

westlandi (guan fang ji) was used. In England, instead of using

the correct

herb Clematis armandii (chuan mu tong), the incorrect herb Aristolochia

manshuriensis was used. The other issue is inappropriate use.

Why did the

doctors in Belgium use herbs in combination with drugs for weight loss?

The

two Chinese herbs, Stephania tetrandra (fang ji) and Magnolia officinalis

(hou po), were never intended for weight-loss. Furthermore, why

were they

allowed to be combined with drugs, and prescribed and dispensed by

someone

without adequate training? Instead of blaming the incidence as

"Chinese-herb

nephropathy," we should examine the incidence by looking for solutions

on how

herbs can be used more responsibly and only by someone who is properly

trained and educated. We should all take this opportunity to

educate the

general publish that herbs is not just an dietary supplement, but a

form of

medicine that require professional training for safe and effective

use.

For more information, please refer to the articles published by Dr.

John Chen

in CJOM, Winter 2000, page 46; HerbalGram #48, 2000, page 44; and the

article

listed below.

We believe incidences like this will make us stronger, not weaker.

We wanted

to make sure practitioners of TCM are informed of all the facts.

More

importantly, we wanted to make sure patients who use herbs are assured

of

safety. Such incidences will not occur if herbs are manufactured

properly.

Sincerely,

John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac.

President, Lotus Herbs.

Nephropathy associated with the use of Aristolochia westlandi (guan

fang ji)

and Aristolochia manshuriensis (guan mu tong)

by John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac.

ABSTRACT

As the use of herbal medicine becomes more prevalent in the United States,

it

is becoming increasingly important that the practitioners understand

the

botany and toxicology of herbs. With adequate training, the vast

majority of

Chinese herbal medicine can be used safely and effectively. However,

there

are some herbs which have demonstrated significant toxicology profile

and

should not be used unless the benefit outweighs the risks. This

article

addresses the issue of nephropathy associated with the use of Aristolochia

westlandi (guan fang ji) and Aristolochia manshuriensis (guan mu tong).

It

will discuss such issues as botanical identification, documentation

of

toxicology, clinical application, and selection of herbs from manufacturers.

Most importantly, one must recognize that it is not Chinese herbs that

are

toxic, but the incorrect use and substitution of Aristolochia westlandi

(guan

fang ji) and Aristolochia manshuriensis (guan mu tong) that cause nephropathy.

KEY WORDS

Nephropathy, Aristolochia westlandi (guan fang ji), Aristolochia

manshuriensis (guan mu tong), Stephania tetrandra (han fang ji), Clematis

armandii (chuan mu tong), Clematis montana (chuan mu tong), Chinese

herbal

medicine

ARTICLE

The issue of nephropathy associated with the use of Chinese herbal remedies

was first reported in Belgium in the early 1990's in a group of women

taking

a slimming preparation which contained fenfluramine, diethylpropion,

cascara

powder, belladonna extract, acetazolamide, Stephania tetrandra (han

fang ji)

and Magnolia officinalis (hou po). Of all who ingested this preparation,

33

cases of nephropathy were reported initially. To date,

more than 100 cases

of nephropathy have been reported. The cause of nephropathy was

attributed

to the substitution of Aristolochia westlandi (guan fang ji) for Stephania

tetrandra (han fang ji). Aristolochia westlandi (guan fang ji) contains

a

substance called aristolochic acid, which is a known nephrotoxin .

All cases

of nephropathy can be traced to the ingestion of the herbal preparation

prepared by the same clinic containing the incorrect herbal ingredient

of

Aristolochia westlandi (guan fang ji).

This unfortunate incidence of nephropathy occurred because there was

a poor

handling of Chinese herbs. In this case, the prescribed herb was Stephania

tetrandra (han fang ji), but was incorrectly substituted with Aristolochia

westlandi (guan fang ji). These are two different herbs with

distinct

physical appearances and laboratory presentations. Aristolochia westlandi

(guan fang ji) root is round, 8-15 cm in length, and 1.5-4.5 cm in

diameter.

The root has a thick and rough outer layer that is grayish-brown in

color. In

contrast, Stephania tetrandra (han fang ji) root is round or cylindrical,

3-5

cm in length, and 3.5-5 cm in diameter. The outer layer of the

root is

dirt-brown in color with numerous pores.

In August 7, 1999, The Lancet reported two additional cases of end-stage

renal failure associated with the use of Chinese herbal remedies.

Case one

was a 49 year-old white female who took a Chinese herbal remedy for

her

eczema for 2 years. After complaining of headache and hypertension,

she was

screened for renal function and was found to have acute renal failure.

She

began dialysis immediately and subsequently received a cadaveric renal

transplant. Case two was a 57-year-old white woman who took a

Chinese herbal

remedy for her eczema for 6 years. After a 6-month history of

anorexia,

lethargy, nausea, and weight loss, she was admitted to the hospital

with

end-stage renal failure. She began dialysis immediately and is

currently on

the waiting list for renal transplant. In both cases, Aristolochia

manshuriensis (guan mu tong) was the common ingredient in the herbal

remedies. The Lancet reported that the investigation for other

causes of

renal failure were negative.

In this case, nephropathy occurred because there was a lack of verification

resulting in the inadvertent use of Aristolochia manshuriensis (guan

mu

tong). According to the Pharmacopoeia of the People's Republic

of China, the

herb mu tong may be derived from the following species of plants: Clematis

armandii (chuan mu tong), Clematis montana (chuan mu tong), or Aristolochia

manshuriensis (guan mu tong). , Due to the toxicity associated

with

aristolochic acid in Aristolochia manshuriensis (guan mu tong),

Clematis

armandii (chuan mu tong) or Clematis montana (chuan mu tong) are now

used as

the preferred sources of mu tong. In regards to visual inspection,

Aristolochia manshuriensis (guan mu tong) is long and round, approximately

1

m in length and 1.5-3 cm in diameter. The outer layer is grayish-yellow

or

light brown in color. It has enlarged joints in between parts

of the plant

and a distinct camphor-like odor. In contrast, Clematis armandii

(chuan mu

tong) or Clematis montana (chuan mu tong) long and round, 50-100 cm

in

length, and 2-3.5 cm in diameter. The outer layer is light to

dark

yellow/brown in color. It has no joints and no odor.

Nephropathy associated with the use of Aristolochia westlandi (guan

fang ji)

and Aristolochia manshuriensis (guan mu tong) is not an isolated incidence.

It has been documented in China, Belgium and England. Proper

cautions must

be taken to avoid such adverse reactions. Correct identification

of the herb

is imperative toward safe and effective use of the herbs. Physical

inspection is the most commonly used method of identification.

It, however,

is not 100% accurate or reliable. In the Belgium incidence, an

incorrect

substitution was used. In the England incidence, there was a

lack of

verification for the safest herb used. Therefore, it can be concluded

that

visual inspection is not sufficient for correct identification of the

herbs

as physical appearance of the herbs are often indistinguishable.

Laboratory

techniques such as High Performance Liquid Chromatography (HPLC), Thin-Layer

Chromatography (TLC), and Liquid-Column Chromatography (LCC) must be

used to

confirm qualitative and quantitative analyses. Furthermore, such

examinations must be performed on each and every batch of the herbs

as random

examinations will not ensure the safety of the herbs. It is the

duty of the

herbal manufacturer to instill the most stringent quality control measures

to

ensure the safety of the herbs, and it is the duty of the practitioners

to

purchase and dispense herbs from manufacturers who meet such criteria.

ABOUT THE AUTHOR

Dr. John Chen is the president and founder of Lotus Herbs, Inc.

He is a

recognized authority on western pharmacology and Chinese herbal medicine.

He

graduated from the University of Southern California (USC) School of

Pharmacy

and South Baylo University of Oriental Medicine. He also received

extensive

post-graduate training in China specializing in herbology and internal

medicine. He currently teaches herbal medicine and pharmacology

at USC

School of Pharmacy, South Baylo University, Yo San University and Emperor's

College. He is a member of the Herbal Medicine Committee for

the American

Association of Oriental Medicine (AAOM) and a consultant for the California

Association of Acupuncture and Oriental Medicine (CAAOM). Dr.

Chen

co-authored "Sixty-Five Herbal Formulas for the Stateboard Exam," and

published many articles, and given numerous seminars at universities,

state

and national organizations. In 1998, he was invited as a guest

speaker by

USC to present the continuing education seminar "Where Do Herbal Remedies

Fit? Counseling the Patients on the Use of Herbal Remedies" at the

Bergen

Brunswig annual convention where more than 400 pharmacists and medical

doctors attended. Lastly, Dr. Chen was the featured speaker of

herbal

medicine at the First Annual Festival of Health in Los Angeles, an

event

hosted by the Los Angeles Times and University of Southern California.

Dr.

John Chen is the president and founder of Lotus Herbs, and is available

for

medical consultations through the Lotus Herbal Consultation Line at

telephone: (626) 916-1070 and fax: (626) 917-7763.

REFERENCE

Depierreux M, Van-Damme B, Vanden-Houte K, Vanherweghem JL.

Pathological

aspects of a newly described nephropathy related to the prolonged use

of

Chinese herbs. American Journal of Kidney Diseases, (1994 Aug) vol.

24(2):172-80.

Vanherweghem JL, Depierreux M, Tielemans C, et al. Rapidly Progressive

interstitial fibrosis in young women: association with slimming regimen

including Chinese herbs. Lancet 1993; 341:387-91.

Vanherweghem JL. Misuse of herbal remedies: the case of an outbreak

of

terminal renal failure in Belgium (Chinese herbs nephropathy). J Altern

Complement Med 1998; 4:9-13

Chinese Herbal Botany, December 1974

Lord GM, Tagore R, Cook T, Gower P, Pusey CD. Nephropathy caused

by Chinese

herbs in the UK. The Lancet August 7, 1999; 354:481-482,494

Goshi T, ed. Pharmacopoeia of the People's Republic of China

1992; 16-17

and 304-05.

Zheng HZ, Dong ZH et al. Modern Study of . October

1997.

Vol 1. 936:954

Zhejiang Journal of , 1965;12:32

Zheng HZ, Dong ZH et al. Modern Study of . October

1997.

Vol 1. 936:954

Zheng HZ, Dong ZH et al. Modern Study of . October

1997.

Vol 1. 936:954

>>

June 14, 2000

Todd are you saying here that (a) medical doctor prescribed the wrong herbs. If that is so

* For any medical doctors to prescribe herbs with drugs would be outside their scope of practice. - if not they are at the minimum negligent in their duty and (in the US) are criminally liable.

The solution may be to send over to Belgium a team of our very qualified U.S. malpractice attorneys as well as any number of our national political Spin Masters to handle the PR.

Ed Kasper L.Ac., Santa Cruz, California

[herb-t]Wednesday, June 14, 2000 11:52 AMcha More on AA from John Chen

There has been a lot of negative publicity about Chinese herbs that we need to address now. The purposes of this e-mail is to address the issue of nephropathy caused by incorrect substation of two Chinese herbs. 1. Nephropathy: There have been several cases of nephropathy related to the use of herbs over the past few years in Belgium, England, and other countries. Though nephropathy has been documented, these incidences occurred because the herbs were inappropriately-used and incorrectly-substituted. On May 16, 2000, FDA released a formal letter warning the general public that the use of herbs that contain aristolochic acid may cause kidney damage. On June 8, 2000, New England Journal of Medicine published an article that continuously use and address the term "Chinese-herb nephropathy." We firmly believe that a vast majority of articles published thus far unfairly and unjustly evaluated the entire situation. This incidence is not "Chinese-herb nephropathy," but "inappropriate-use and incorrect substation of herb" that cause nephropathy. In Belgium, instead of using the correct herb Stephania tetrandra (han fang ji), the incorrect herb Aristolochia westlandi (guan fang ji) was used. In England, instead of using the correct herb Clematis armandii (chuan mu tong), the incorrect herb Aristolochia manshuriensis was used. The other issue is inappropriate use. Why did the doctors in Belgium use herbs in combination with drugs for weight loss? The two Chinese herbs, Stephania tetrandra (fang ji) and Magnolia officinalis (hou po), were never intended for weight-loss. Furthermore, why were they allowed to be combined with drugs, and prescribed and dispensed by someone without adequate training? Instead of blaming the incidence as "Chinese-herb nephropathy," we should examine the incidence by looking for solutions on how herbs can be used more responsibly and only by someone who is properly trained and educated. We should all take this opportunity to educate the general publish that herbs is not just an dietary supplement, but a form of medicine that require professional training for safe and effective use. For more information, please refer to the articles published by Dr. John Chen in CJOM, Winter 2000, page 46; HerbalGram #48, 2000, page 44; and the article listed below. We believe incidences like this will make us stronger, not weaker. We wanted to make sure practitioners of TCM are informed of all the facts. More importantly, we wanted to make sure patients who use herbs are assured of safety. Such incidences will not occur if herbs are manufactured properly. Sincerely, John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. President, Lotus Herbs. Nephropathy associated with the use of Aristolochia westlandi (guan fang ji) and Aristolochia manshuriensis (guan mu tong) by John K. Chen, Ph.D., Pharm.D., O.M.D., L.Ac. ABSTRACT As the use of herbal medicine becomes more prevalent in the United States, it is becoming increasingly important that the practitioners understand the botany and toxicology of herbs. With adequate training, the vast majority of Chinese herbal medicine can be used safely and effectively. However, there are some herbs which have demonstrated significant toxicology profile and should not be used unless the benefit outweighs the risks. This article addresses the issue of nephropathy associated with the use of Aristolochia westlandi (guan fang ji) and Aristolochia manshuriensis (guan mu tong). It will discuss such issues as botanical identification, documentation of toxicology, clinical application, and selection of herbs from manufacturers. Most importantly, one must recognize that it is not Chinese herbs that are toxic, but the incorrect use and substitution of Aristolochia westlandi (guan fang ji) and Aristolochia manshuriensis (guan mu tong) that cause nephropathy. KEY WORDS Nephropathy, Aristolochia westlandi (guan fang ji), Aristolochia manshuriensis (guan mu tong), Stephania tetrandra (han fang ji), Clematis armandii (chuan mu tong), Clematis montana (chuan mu tong), Chinese herbal medicine ARTICLE The issue of nephropathy associated with the use of Chinese herbal remedies was first reported in Belgium in the early 1990's in a group of women taking a slimming preparation which contained fenfluramine, diethylpropion, cascara powder, belladonna extract, acetazolamide, Stephania tetrandra (han fang ji) and Magnolia officinalis (hou po). Of all who ingested this preparation, 33 cases of nephropathy were reported initially. To date, more than 100 cases of nephropathy have been reported. The cause of nephropathy was attributed to the substitution of Aristolochia westlandi (guan fang ji) for Stephania tetrandra (han fang ji). Aristolochia westlandi (guan fang ji) contains a substance called aristolochic acid, which is a known nephrotoxin . All cases of nephropathy can be traced to the ingestion of the herbal preparation prepared by the same clinic containing the incorrect herbal ingredient of Aristolochia westlandi (guan fang ji). This unfortunate incidence of nephropathy occurred because there was a poor handling of Chinese herbs. In this case, the prescribed herb was Stephania tetrandra (han fang ji), but was incorrectly substituted with Aristolochia westlandi (guan fang ji). These are two different herbs with distinct physical appearances and laboratory presentations. Aristolochia westlandi (guan fang ji) root is round, 8-15 cm in length, and 1.5-4.5 cm in diameter. The root has a thick and rough outer layer that is grayish-brown in color. In contrast, Stephania tetrandra (han fang ji) root is round or cylindrical, 3-5 cm in length, and 3.5-5 cm in diameter. The outer layer of the root is dirt-brown in color with numerous pores. In August 7, 1999, The Lancet reported two additional cases of end-stage renal failure associated with the use of Chinese herbal remedies. Case one was a 49 year-old white female who took a Chinese herbal remedy for her eczema for 2 years. After complaining of headache and hypertension, she was screened for renal function and was found to have acute renal failure. She began dialysis immediately and subsequently received a cadaveric renal transplant. Case two was a 57-year-old white woman who took a Chinese herbal remedy for her eczema for 6 years. After a 6-month history of anorexia, lethargy, nausea, and weight loss, she was admitted to the hospital with end-stage renal failure. She began dialysis immediately and is currently on the waiting list for renal transplant. In both cases, Aristolochia manshuriensis (guan mu tong) was the common ingredient in the herbal remedies. The Lancet reported that the investigation for other causes of renal failure were negative. In this case, nephropathy occurred because there was a lack of verification resulting in the inadvertent use of Aristolochia manshuriensis (guan mu tong). According to the Pharmacopoeia of the People's Republic of China, the herb mu tong may be derived from the following species of plants: Clematis armandii (chuan mu tong), Clematis montana (chuan mu tong), or Aristolochia manshuriensis (guan mu tong). , Due to the toxicity associated with aristolochic acid in Aristolochia manshuriensis (guan mu tong), Clematis armandii (chuan mu tong) or Clematis montana (chuan mu tong) are now used as the preferred sources of mu tong. In regards to visual inspection, Aristolochia manshuriensis (guan mu tong) is long and round, approximately 1 m in length and 1.5-3 cm in diameter. The outer layer is grayish-yellow or light brown in color. It has enlarged joints in between parts of the plant and a distinct camphor-like odor. In contrast, Clematis armandii (chuan mu tong) or Clematis montana (chuan mu tong) long and round, 50-100 cm in length, and 2-3.5 cm in diameter. The outer layer is light to dark yellow/brown in color. It has no joints and no odor. Nephropathy associated with the use of Aristolochia westlandi (guan fang ji) and Aristolochia manshuriensis (guan mu tong) is not an isolated incidence. It has been documented in China, Belgium and England. Proper cautions must be taken to avoid such adverse reactions. Correct identification of the herb is imperative toward safe and effective use of the herbs. Physical inspection is the most commonly used method of identification. It, however, is not 100% accurate or reliable. In the Belgium incidence, an incorrect substitution was used. In the England incidence, there was a lack of verification for the safest herb used. Therefore, it can be concluded that visual inspection is not sufficient for correct identification of the herbs as physical appearance of the herbs are often indistinguishable. Laboratory techniques such as High Performance Liquid Chromatography (HPLC), Thin-Layer Chromatography (TLC), and Liquid-Column Chromatography (LCC) must be used to confirm qualitative and quantitative analyses. Furthermore, such examinations must be performed on each and every batch of the herbs as random examinations will not ensure the safety of the herbs. It is the duty of the herbal manufacturer to instill the most stringent quality control measures to ensure the safety of the herbs, and it is the duty of the practitioners to purchase and dispense herbs from manufacturers who meet such criteria. ABOUT THE AUTHOR Dr. John Chen is the president and founder of Lotus Herbs, Inc. He is a recognized authority on western pharmacology and Chinese herbal medicine. He graduated from the University of Southern California (USC) School of Pharmacy and South Baylo University of Oriental Medicine. He also received extensive post-graduate training in China specializing in herbology and internal medicine. He currently teaches herbal medicine and pharmacology at USC School of Pharmacy, South Baylo University, Yo San University and Emperor's College. He is a member of the Herbal Medicine Committee for the American Association of Oriental Medicine (AAOM) and a consultant for the California Association of Acupuncture and Oriental Medicine (CAAOM). Dr. Chen co-authored "Sixty-Five Herbal Formulas for the Stateboard Exam," and published many articles, and given numerous seminars at universities, state and national organizations. In 1998, he was invited as a guest speaker by USC to present the continuing education seminar "Where Do Herbal Remedies Fit? Counseling the Patients on the Use of Herbal Remedies" at the Bergen Brunswig annual convention where more than 400 pharmacists and medical doctors attended. Lastly, Dr. Chen was the featured speaker of herbal medicine at the First Annual Festival of Health in Los Angeles, an event hosted by the Los Angeles Times and University of Southern California. Dr. John Chen is the president and founder of Lotus Herbs, and is available for medical consultations through the Lotus Herbal Consultation Line at telephone: (626) 916-1070 and fax: (626) 917-7763. REFERENCE Depierreux M, Van-Damme B, Vanden-Houte K, Vanherweghem JL. Pathological aspects of a newly described nephropathy related to the prolonged use of Chinese herbs. American Journal of Kidney Diseases, (1994 Aug) vol. 24(2):172-80. Vanherweghem JL, Depierreux M, Tielemans C, et al. Rapidly Progressive interstitial fibrosis in young women: association with slimming regimen including Chinese herbs. Lancet 1993; 341:387-91. Vanherweghem JL. Misuse of herbal remedies: the case of an outbreak of terminal renal failure in Belgium (Chinese herbs nephropathy). J Altern Complement Med 1998; 4:9-13 Chinese Herbal Botany, December 1974 Lord GM, Tagore R, Cook T, Gower P, Pusey CD. Nephropathy caused by Chinese herbs in the UK. The Lancet August 7, 1999; 354:481-482,494 Goshi T, ed. Pharmacopoeia of the People's Republic of China 1992; 16-17 and 304-05. Zheng HZ, Dong ZH et al. Modern Study of . October 1997. Vol 1. 936:954 Zhejiang Journal of , 1965;12:32 Zheng HZ, Dong ZH et al. Modern Study of . October 1997. Vol 1. 936:954 Zheng HZ, Dong ZH et al. Modern Study of . October 1997. Vol 1. 936:954 >>

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