When Lai Zuqin, a traditional Chinese medicine (TCM) doctor in southwest China's Yunnan Province, tried in the late 1980s to develop a treatment for a strange syndrome which had a combination of symptoms - coughing, headaches, nausea, diarrhoea and hair-loss - he did not expect to become the inventor of China's first authorized anti-AIDS TCM: the Tang Herbal Tablet.

In the early 1990s, he knew the disease was called AIDS and that AIDS was fatal for all.

But to his astonishment, some of his AIDS patients were able to check the development of their illnesses after taking his medicine.

The discovery led Lai to give up all of his clinical work and focus on researching a new medicine based on his prescription.

He was joined by Qi Jieyuan, a Beijing-based pharmaceutical firm, in the medicine's research and development.

It took Lai and the company 10 years to obtain final approval from the State Food and Drug Administration in April 2004.

Like Lai, when TCM doctor teams of the Chinese Academy of TCM were sent to Tanzania to help treat local diseases in the early 1990s, they also thought of TCM.

The only difference is that Lai and the company developed the TCM into a tablet, while doctors from the Academy insisted on using various prescriptions of herbs.

More choices

"Chinese doctors, with little knowledge about AIDS at that time, found many of its symptoms could be treated with TCM. Later, they developed some effective prescriptions against AIDS," said Wei Jian'an, deputy director of the Center of HIV/AIDS Treatment under the Academy.

Wei joined a Chinese TCM doctor team in Tanzania between 1999 and 2000, and chaired the research into using TCM when he returned to Beijing.

On October 30, a TCM prescription - CATCM-II - developed by Wei and his colleagues and based on their experience in Tanzania, was ranked as a major scientific innovation by the Ministry of Science and Technology.

Yet CATCM-II and the Tang Herbal Tablet are only a small part of nationwide efforts to treat HIV/AIDS with TCM.

In March, SH - another TCM theories-based herbal medicine invented by Chinese researchers in Kunming, Yunnan Province - was approved by Thai drug authorities as a new drug.

She Jing, vice-minister of health and the director of the State Administration of TCM, said at a news conference last month that another two were undergoing clinical trials.

They are TCM, called Ke'aite, literally "the drug that overcomes AIDS," and Qiankunning, produced by the Chengdu-based Enwei Pharmaceutical Co Ltd.

On October 31, Ke'aite reportedly passed the first stage of the trials and was approved by the Drug Administration to launch clinical trial II.

Director of the research center at Enwei said Qiankunning was in the third phase of a clinical trial and may get the approval from drug authorities within one or two years.

Major advantages

"All the development illustrates that TCM has great potential to deal with HIV/AIDS," Wei said.

The disease is a new one to human beings as far as studies go, but its symptoms are not.

TCM theories are based on the analysis of the whole human body at the onset of the virus or bacteria attacks from the symptoms. The prescriptions are then developed to improve bodily functions to fight attacks and relieve symptoms.

Jin Lu, executive director of the Hong Kong-listed Golden Meditech Co Ltd, said that 200 AIDS patients were treated with TCM during the three clinical trial stages of the TCM, alongside another 200 in five hospitals in Beijing and Kunming.

Golden Meditech acquired Qi Jieyuan in June this year after the latter obtained new drug license for its Tang Herbal Tablet.

All of the 200 AIDS patients taking the tablet during this trial are still alive, and most of their clinical symptoms have been reduced or even disappeared.

Ninety percent of them improved their CD4 - a major index used to evaluate immunology against HIV/AIDS - with 51 percent of them increasing their CD4 by more than 30 percent.

Wei says one major advantage of using TCM to treat AIDS is its fewer side-effects, early treatment and lower cost.

The commonly used cocktail therapy - using a combination of different AIDS drugs and antibiotics - can control HIV and prolong life for AIDS sufferers.

But doctors say the therapy also has strong side-effects such as anorexia, insomnia and hair-loss.

"In certain cases, some AIDS patients give up the treatments because of these strong side-effects," Jin said.

The cocktail therapy has very strict standards on when to start treatment. If it is too early, the virus might develop strong drug-resistance.

It is often difficult for AIDS patients to know when they contracted the disease, so many of them lose the best chance to receive treatment at the right time. But TCM prescriptions can be used at any time during the disease's development, Jin told China Daily.

TCM researchers say the cost of using CATCM-II and the Tang Herbal Tablet is no more than 3,000 yuan (US$362.32) a year, and it could be lowered further when production costs are cut.

In contrast, using generic chemical medicines - such as Zidovudine, Stavudine, Didanosine and Zalcitabine - produced by Chinese drug makers for cocktail therapy - costs about 10,000 yuan per year (US$1,210), including the drugs and necessary medical checks.

For some poor countries which do not have the capability of producing generic chemical medicine against AIDS at a low cost, the expenditure is much higher.

Thailand's drug authorities are fully supportive of the development of SH in a bid to meet the urgency for inexpensive AIDS drugs, according to Luo Shide, the inventor of SH and a professor at the Kunming Institute of Botany under the Chinese Academy of Sciences.

Developing SH

Luo has been researching AIDS medicine based on the combination of TCM theories and modern chemical techniques since the late 1980s, after he returned to China from Germany.

His method is to first determine and purify the vital elements of herbal plants recorded by classic TCM books that treat poisons, and then to combine them into dozens of TCM prescriptions. In the end, some of these prescriptions proved effective in significantly reducing HIV levels.

Luo said his research has not been done at the molecular level, however. It is still difficult to make sure exactly what a single herbal plant's chemical content is, let alone a compound consisting of 20 plants.

He did not receive any government or company's financial support on his work for the first eight years.

"At that time, it was widely considered that HIV/AIDS was not a big problem for China. And anyway, no one believed TCM could be really used to treat HIV/AIDS," Luo said.

In 1998, Luo's research made some major progress and the achievement was posted in his institute's newspaper.

"A visiting Thai public health official found the report and immediately contacted me," Luo said.

The Thailand Government decided to finance Luo's research and offer the necessary equipment for clinical trials to take place.

In China, encouraged by TCM's potential to treat AIDS, China's health authorities have launched a program to offer free TCM-based treatments to AIDS sufferers.

So far, the program, chaired by Wei, covers 2,300 patients across five Chinese provinces. The number may double over next year.

The Ministry of Health estimates there were 840,000 HIV/AIDS patients in China in 2003. Experts warn that without effective control measures, the number of HIV carriers may exceed 10 million by 2010.

Challenges remain

Despite the promises, David Ho at New York-based Rockefeller University and the inventor of cocktail therapy, said there was no compelling evidence published in internationally recognized journals that TCM actually enhances immunity.

"I see no reason why TCM would not have some benefits for the immune system or for stopping the spread of HIV. But these claims must be supported by scientific studies. Too few of them have been done properly," Ho says.

Wei and Jin say they have not published their clinical reports in international journals, partly because it is difficult to explain TCM in Western scientific jargon.

They also say their medicines are so far better at improving immunity than directly stopping disease progression.

Luo said TCM may not be powerful enough to kill the virus because many vital elements may be lost during the traditional processing methods.

Luo said some purification work has been done in the United States to insure better purification of active ingredients of TCM. Jin said her company has been negotiating with the World Health Organization and another South Asian country to perform wider clinical research there.

"Based on our current very limited knowledge of TCM at the molecular level, it is impossible for TCM to pass the evaluation process of the US Food and Drug Administration and the European Union's drug authorities," Jin said.

There are still few regulations on using traditional Chinese medicine to treat HIV/AIDS. Any search on the Internet for TCM and AIDS will come up with dozens of websites claiming effective treatments. Even Ke'aite is sold online, yet this is still undergoing clinical trials.

Wei admitted there was little national standardization in using TCM to treat AIDS. "To solve the problem, there should be some official indices to evaluate the true effects of TCM," Wei says.

(China Daily November 23, 2004)