The Department of Health today (June 8) reiterated that the importation and sale of the Chinese herb, Aristolochia Linn, and its products were prohibited with effect from June 1, 2004 due to its harmful effects.
Speaking at a press conference, the Deputy Director of Health, Dr TH Leung said Chinese medicine traders must recall Aristolochia Linn herbs as well as proprietary Chinese medicines that contain Aristolochia Linn herbs or Aristolochic Acid (AA).
Regarding the herb, Asarum Linn, Dr Leung said only the root of Herba Asari could be used.
"However, it should be used under the advice of Chinese medicine practitioners. For those proprietary Chinese medicines that consist of Herba Asari, proof must be submitted that they do not contain AA before the proprietary Chinese medicine can be accepted for registration," Dr Leung said.
According to medical documents, prolonged and excessive use of herbs containing AA is associated with kidney failure and cancer of the urinary tract.
Dr Leung said that the Department of Health announced on April 24 that the importation and sale of the specified Chinese herb, Aristolochia Linn, and proprietary Chinese medicines containing AA had been prohibited, while the importation and sale of the specified Chinese herb, Asarum Linn, would be suspended with effect from June 1, 2004.
The department, in collaboration with the Hong Kong Government Laboratory and Hong Kong Baptist University, conducted chemical analysis using AA as the test marker on some herbs and proprietary Chinese medicines.
According to the study results, Caulis Aristolochiae Manshuriensis contained the highest amount of AA, followed by Radix Aristolochiae, Fructus Aristolochiae, Herba Aristolochiae Mollissimae, and Radix Aristolochiae Fangchi. Herba Asari had the least AA.
Regarding the amount of AA in Herba Asari, the parts above ground contained a much higher content than the root. Also, the amount of AA obtained through water extraction was lower than that obtained through organic solvent extraction. The AA level became undetectable after decoction of Herba Asari root in combination with other herbs in the formulation.
Based on these study results, the Chinese Medicines Board of the Hong Kong Chinese Medicine Council has reassessed the related regulatory measures and decided to maintain that importation and sale of the Chinese herb, Aristolochia Linn, were to be prohibited with effect from June 1. As for Herba Asari, it can be used under appropriate circumstances, as follows:
* Herba Asari should be used under the prescription and advice of Chinese medicine practitioners.
* The species of Herba Asari used must be specified in the Chinese Medicine Ordinance.
* The medicinal part of Herba Asari is restricted to the root only.
* The dosage should not exceed the limit of 1-3 grams as specified in the Chinese Pharmacopoeia (2000 edition).
* The time of decoction should not be less than 60 minutes.
* The medicines traders should only import roots of Herba Asari belonging to the species as specified in Chinese Medicine Ordinance from herb processing factories.
* Herba Asari should only be taken in decoction form. It should not be grinded into a powder to be taken orally.
The Chinese Medicines Board also decided to prohibit the use of Aristolochia Linn in the manufacture of proprietary Chinese medicines. Regarding proprietary Chinese medicines containing Asarum Linn. Herb ingredients, the quality requirement is that AA must not be detected.
Also, the temporary suspension of the use of Herba Solani Lyrati since March 13 this year will be lifted.
"The department considered that the confusion in the market has been rectified, so decided to reinstate the supply of Herba Solani with effect from June 14, 2004," Dr Leung said.
He said that the Chinese Medicine Practitioners' Board of the Hong Kong Chinese Medicine Council would issue the leaflet, "Guideline on Safe Use of Herba Asari", to all Chinese medicine practitioners.
The Chinese Medicines Board will also issue a leaflet, "Guideline on Handling Herbs and their Products Containing Aristolochic Acid" to all Chinese medicine traders in Hong Kong.
Chinese medicine traders must recall all proprietary Chinese medicines that contain AA or Aristolochia Linn herbs, as well as Herba Asari (except the roots) and the herbs of Aristolochia Linn.
"The Department of Health will organise briefing sessions to introduce the content of the above guidelines to the traders and practitioners in due course," Dr Leung said.
He stressed that members of the public should consult Chinese medicine practitioners and follow their advice before taking Chinese medicines.
Enquiries related to the recall of proprietary Chinese medicines and herbs can be made to 2209 9409 or 2209 9405 during office hours.
Ends/Tuesday, June 8, 2004