Traditional Medicine: Handle with Care

(Beijing) -- Dating back to antiquity, herbal preparations made under Traditional Chinese Medicine (TCM) practices remain a popular form of medical treatment. But there are both hidden benefits and hidden harms to methods often used with little detailed knowledge on toxicity. A growing number of health incidents related to TCM have rekindled controversy on how Chinese medical literature confirms the safety of traditional medications.

Western medical practices require side effects of medicinal substances to be clearly identified, said Wei Lixin, a member of the Professional Commission of Ethnic Medicines and Traditional Chinese Medicines Standard Substances under the Chinese Pharmacopoeia Commission. Wei said most medicinal substances in TCM practices do not have elaborate guidelines on toxicity.

Given that the side effects of Chinese medicine drugs are not well-documented, information on toxicity is hard to come by. As a result, domestic and foreign commercial health care companies have often touted the herbal preparations to be free of any harm in promotional materials.

However, the adverse effects of some TCM remedies have long been documented in thousands of years of Chinese medical literature. Every element has its benefit and its harm, according to TCM theory. Ancient literature has sought to document the potency, toxicity and severity of side effects associated with various medicinal preparations. However, modern TCM practices have yet to move much further from initial developments, and use the same dosage suggestions.

The State Council issued a guideline in 1998 which detailed provisions for production, management and use of medicines. It defines toxic drugs as "substances with severe toxicity," for which "improper use may cause human poisoning or death." The law classified 28 herbs and medicinal materials used in Chinese medicines as poisonous.

The list has since expanded, and in 2010, a total of 81 types of toxic substances were listed in the

Chinese Pharmacopoeia. But the China Food and Drug Administration stated in February of this year, "The fact that some Chinese medicines contain toxic substances cannot be automatically interpreted as displaying toxic side effects in their clinical application."

Wei said the toxicity of Chinese medicines must undergo a chemical compound analysis for dosage guidelines. Wei used the example of cinnabar, which can be toxic in high doses. "It's an incomplete statement to say cinnabar is poisonous. In fact, it will only become harmful to humans in high and extended usage."

Dangerous Effects

With poor labeling on side effects, many TCM preparations have been known to cause adverse reactions. In April 2013, the Medicine and Healthcare Products Regulatory Authority (MHRA) in Britain issued a warning to ban the use of a TCM headache remedy containing aconitine, which may cause heart and nerve system failure.

Early in 2006, the MHRA had received five incidents of complaints of the side effects of Chinese medicines, which resulted in the complete importing ban of several Chinese medicine products in the country.

Public data shows, from 1994 to 1996, 88 patients with chronic hepatitis in Japan contracted interstitial pneumonia as a result of taking an herbal supplement called radix bupleuri. Ten people died as a result of the herbal remedy. Another highly publicized scandal came in the late 1980s and early 1990s when a popular TCM weight loss remedy was exported from Hong Kong to western Europe and over 100 young women developed kidney disease. The onset of uremia was linked to the drug's excessive levels of aristolochic acid.

The harmful effects associated with some TCM remedies have dimmed enthusiasm abroad for the natural remedies. Yu Zhibin, deputy director of the Chinese Medicine Department of the China Chamber of Commerce for Import and Export of Medicines and Health Products, said that in many countries and regions, including the United States and European Union, Chinese herbs and drugs have been imported as a health food, which undergoes stricter inspection for toxicity than drugs.

Yu said some TCM supplement manufacturers have adjusted the chemical makeup of some products to meet foreign import standards. For example, Yunnan Baiyao, a traditional Chinese medicine famous for its properties linked to stoppage of bleeding, adjusted its formula to omit aconitine-containing ingredients for export.

Pinpointing Harms

China's drug regulatory authorities have been under increasing pressure by the public to document the health hazards of TCM substances. Within the TCM community, however, the stricter regulation of herbal remedies has been met with deep reservations.

Some experienced Chinese medicine doctors believe that ancient prescriptions are the best treatment for some ailments, despite harmful side effects. TCM theory adheres to a view that toxicity can be mitigated and controlled.

For decades, the Chinese medical community has been trying to use modern Western medicine methodologies to measure toxicity in herbal remedies. Chen Keji, president of the Chinese Association of Integrative Medicine and member of the Chinese Academy of Sciences, said that in the current pharmacopoeia, 18.3 percent of Chinese medicines do not have instructions for dosage or toxicity analysis.

Many Chinese medicine practitioners believe, given the present situation, it will be a long time before authorities can provide a systematic analysis for all substances used in Chinese medicine.

But the effort goes on, and at the national level three Chinese medicine safety evaluation centers and four TCM standardization clinical trial centers have been established in recent years. Newly created TCM drugs are required to satisfy the standards of a safety evaluation system before receiving regulatory approval and safety guidelines are developed.

Wei said, "I hope that the central government can launch a comprehensive toxicity study for all TCM medicines as soon as possible, but the reality is that we do not have the time and energy to conduct scientific safety evaluation on all of them. A toxicity problem is often not addressed until a poisoning incident is reported."

Meanwhile, the Chinese medicine community has not yet reached a consensus on whether Western toxicological analysis should be applied in the studies of Chinese herbs and TCM drugs.

Yu added that another issue surrounding harmful effects of TCM methods is the need for better medical education among both doctors and patients. Citing an old saying that prevails in the Chinese medicine community Yu said, "The scourge of bad medicines lies with the doctors instead of the medicines."