Potentially Harmful Traditional Chinese Medicinal Products

[Guest guest]

Hi Michael, & All,

 

Michael wrote:

> I think we should not be so willing to buy into government regulations

> against Chinese herbs. I know that there is a greater tendency to do

> this in the UK, perhaps in Ireland.

 

EU Regulations on what medicinals can be used in humans and animals are

becoming very stringent. If we are to stay safe from losing our licences to

practise, practitioners MUST abide by these regulations as much as

possible.

 

> I also see many of many of my American colleagues who fall into this

> tendency perhaps in an attempt to just get along. Regulatory agencies

> are notorious for having banning herbs that may have none or little

> toxicity. They make errors in their pronouncements in an antempt to err

> on the safe side which is too often against herbal medicine.

 

Agreed. It is up to clued-in practitioners to alert the Authorities if we note

an

unjustified ban.

 

> Remember, the poison is in the dose and anything at an inappropriate

> dose can prove toxic.

 

Agreed. And that applies also to the most essential ingredients for life - air

and water.

 

> Mugwort is a time-tested herb with 1000's of years of safe usage.

 

High oral doses of mugwort can input high amounts of thujone, which can be

toxic; some batches of Aiye can have high thujone levels.

 

My notes on Aiye say: TOXIC; CI: Pregnancy; Uterus~ Tonic; may cause

birth defects; AVOID in lactation; Caution in Yinxu / Xuefen Heat; overdose

is TOXIC; Risk of toxicity if 20-30g is taken orally at one time or if smaller

doses taken daily for months; it can cause dermatitis & mucosal

inflammation; Oral use can cause irritation of digestive tract; after

absorption, it can arrive at LV & can obstruct LV metabolism & cause icterus

& hepatitis; effect on CNS is prominent; TOXIC S & Ss incl hyperactive CNS

& seizures; bc of changes of nerve reflexes, it can damage vascular walls &

cause hyperemia of uterus & bleeding

 

> Asarum has very little AA's and also has a long history of safe use

> both In North America and in China -- again it is a matter of dosage.

 

Jong TT, Lee MR, Hsiao SS, Hsai JL, Wu TS, Chiang ST, Cai SQ.Analysis

of aristolochic acid in nine sources of Xixin, a traditional Chinese medicine,

by liquid chromatography/atmospheric pressure chemical ionization/tandem

mass spectrometry. J Pharm Biomed Anal. 2003 Nov 24;33(4):831-7.

Department of Chemistry, National Chung-Hsin University, Taichung,

Taiwan. ttjong Aristolochic acid I (AA-I), which is a known

nephrotoxin, is found in a commonly used Chinese medicine, Xixin, that

originates from nine Asarum species (Aristolochiaceae) found in China. A

method has been developed using reversed-phase liquid chromatography

coupled with atmospheric pressure chemical ionization (APCI) tandem mass

spectrometry under the positive ion detection mode [LC/(+)APCI/MS/MS] to

determine the amount of AA-I in Xixin. The limit of detection of AA-I,

estimated by monitoring with LC/MS/MS, was at the low microg/l level. By

applying this method to methanol extracts of nine Asarum species, the

concentrations of AA-I were found to range from 3.3 ng/mg (Asarum

sieboldii) to 3376.9 ng/mg (Asarum crispulatum). PMID: 14623612 [PubMed

- indexed for MEDLINE]

 

Some samples of Asarum have high AA levels. Other have low levels. If a

company gets it wrong (i.e. has inadequate QC checks for AA in the final

product), the consequences can be serious.

 

> I fielded this to Roy Upton who is director of the American Herbal

> Pharmacopiea and his reply was " ANy botanical with high amounts of

> sesquiterpenes has the potential for toxicity as they seem to have a

> greater degree of allergenicity than others, are photosensitizers, and

> can be hard on kidneys and liver. One point worth noting; the note

> said to use a low AA variety of Mutong. Neither Clematis nor Akebia

> contain any AA. We have conclusively shown this with extensive HPLC-MS

> work. "

 

I agree that authentic Akebia or Clematis (sold by GMP companies and

monitored by good QC) probably is safe at normal dose rates.

 

Wu KM, Farrelly JG, Upton R, Chen J. Complexities of the herbal

nomenclature system in TCM: lessons learned from the misuse of

Aristolochia-related species & the importance of the pharmaceutical name

during botanical drug product development. Phytomedicine. 2007

Apr;14(4):273-9. Epub 2006 Jul 24. Center for Drug Evaluation & Research,

FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

kueimeng.wu Herbs used in TCM have diverse cultural /

historical backgrounds & are described based on complex nomenclature

systems. Using the family Aristolochiaceae as an example, at least three

categories of nomenclature could be identified: (1) one-to-one (one plant

part from one species): GUANMUTONG = to Aristolochia manshuriensis Rx;

(2) multiple-to-one (multiple plant parts from the same species serve as

different herbs): three herbs, MADOULING, QINGMUXIANG &

TIANXIANTENG, derived from Aristolochia debilis Fr, Rx & Caulis,

respectively & (3) one-to-multiple (one herb refers to multiple species):

FANGJI = root of either Aristolochia fangchi, Stephania tetrandra or

Cocculus trilobus; in this case, the first belongs to a different family

(Aristolochiaceae) than the latter two (Menispermaceae), & only the first

contains aristolochic acid (AA), as demonstrated by independent analytical

data provided in this article. Further, MUTONG (Akebia quinata) is allowed

in TCM herbal medicine practice to be substituted with either

GUANMUTONG (Aristolochia manshuriensis) or CHUANMUTONG

(Clematis armandii); & muFANGJI (Cocculus trilobus) by GUANGFANGJ

(Aristolochia fangchi) or HANZHONGFANGJI (Aristolochia heterophylla),

thereby increasing the risk of exposing renotoxic AA-containing Aristolochia

species to patients. To avoid these & other confusions, we wish to

emphasize the importance of a pharmaceutical name, which defines the

species name, the plant part, & sometimes the special process performed

on the herb, including cultivating conditions. The pharmaceutical name as

referred to in this article is defined, & is limited to those botanicals that

are

intended to be used as drug. It is hoped that by following the pharmaceutical

name, toxic herbs can be effectively identified & substitution or adulteration

avoided. PMID: 16863692 [PubMed - indexed for MEDLINE]

 

> I don't think even in China a pharmacy like Lanzhou could stay in

> business if they were poisoning people with their many preparations. I

> think there is far too much Chinese herb bashing going on in the

> Western world. Michael Tierra

 

IMO, it is in the interest of professional herbalists to " play safe " as regards

herbs used in our practices. If there are safe substitutes for any of the herbs

listed by our Drug Regulation Authorities as dangerous or suspect, we

should use those substitutes, where possible.

 

Best regards,