Important note: Information in this article was accurate in 2002. The state of the art may have changed since the publication date. 
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Wall Street Journal - July 25, 2002
Leslie Chang, Staff Reporter of The Wall Street Journal
The compound, qiankunning, is a mixture of extracts from 14 herbs that have been used for centuries to fight infection and strengthen the immune system.
But the company's study, which is continuing, is so flawed that it is scientifically worthless.
There was no control group -- a set of patients who get a placebo treatment for comparison purposes -- on the grounds that the practice is immoral because it tricks patients into thinking they are getting treatment. Of the 31 patients who completed the study, all farmers from surrounding Sichuan province who were infected through selling blood, as many as eight started and stopped taking the medicine at will. The duration of treatment ranged between nine months and four years but test results don't distinguish between these widely varying dosages.
None of this seems to bother Xue Yongxin, chairman and chief executive of the Enwei Group, which owns the institute. "People in the studies can drop out whenever they want," says Mr. Xue, a cheerful 50-year-old entrepreneur, whose medical knowledge has come, he says, from studying Buddhist and Taoist texts for more than a decade. "We want to see the long-term effects of the medicine."
As alternative medicine gains credence in the West, Chinese researchers are exploring traditional herbal treatments for AIDS, sifting through a vast catalogue of herbs prescribed by doctors for centuries. But a dearth of regulations and persistently sloppy research are undermining the effort. In fact, the most active work in the field is being done in the U.S., raising the prospect that Chinese researchers are being beaten at their own game.
Sorely Needed Progress
Progress is sorely needed. While the standard "cocktail" of AIDS drugs has helped patients in developed nations, its expense coupled with the complexity of treatment and distribution have kept it out of reach of most of the developing world. Herbal medicines, which tend to be cheaper than conventional medicines, could hold promise as an alternative.
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Traditional Chinese medicine is a promising area for Chinese drug makers and researchers are studying herbal treatments for various cancers and diseases such as diabetes and hepatitis. Beijing has been promoting the field as one where the domestic industry, based mostly on copycat drugs, can shine.
But traditional Chinese researchers are turning out studies that often lack scientific merit and fail to meet international standards, outside AIDS researchers say. China's State Drug Administration hasn't issued standards on clinical trials for herbal AIDS medications. In their absence, researchers pursue studies independently and often with lax standards and little oversight.
China's long history of herbal medicine actually could prove a handicap.
While Chinese researchers in conventional medicine are approaching world-class standards, outside doctors say traditional practitioners have stuck to their old ways as they seek to test drugs. They tailor treatments to individual patients, a cardinal principle of traditional medicine but one that contravenes the drug trial's purpose of testing a single formulation.
Many also reject as unethical the use of placebos. Their research reports lean heavily on anecdotal evidence or cite average rates of change among a large pool of patients, rather than a detailed listing and analysis of individual results typical in Western drug trials.
Traditional practitioners "think they are No. 1 in Chinese medicine, so they don't want to listen to anyone else's opinion," says Yuan Chun-su, director of the Center for Alternative Medical Therapies at the University of Chicago's Pritzker School of Medicine.
Far more than their Western counterparts, Chinese researchers still seem wedded to the hope of a miracle cure for AIDS. Since the advent of the cocktail therapy in the U.S., most traditional Chinese medicine research has focused on remedies to build up the immune system or treat AIDS-related symptoms.
In China, much of the research focuses on the far more complicated effort of attacking the virus itself. "I wish there was more coming out of China, but when I see the claims being made, it doesn't make sense to me from a virological point of view," says Misha Cohen, a leading Chinese-medicine practitioner for AIDS in the U.S.
The Enwei Institute is a prime example. Founded in 1986, the private company has thrived on sales of a cleansing lotion that claims to treat skin conditions and venereal disease. The institute's labs are filled with gleaming machines from the U.S. and imported white mice. The company has spent $4 million, which is high by domestic standards, to develop qiankunning.
Sweeping Conclusions
But the research has many flaws. In a study launched last year to test the effect of qiankunning on 61 HIV patients, researchers did divide patients into treated and placebo groups. But 20 patients were given the wrong medicine. While Enwei dropped the results of those 20 after a researcher was fired for allegedly testing his own medicine and intentionally doctoring results, the company still is using most of the results of his work. Enwei says the researcher was employed for less than two months and hadn't corrupted the rest of the study.
Enwei's reports frequently cite results for only a portion of test subjects, casting doubt on any conclusions. The company also points to the fact that people who dropped out of its study died at far higher rates than people who stayed without addressing whether the dropouts might have been worse off to begin with or otherwise affected by not taking part.
The Enwei researchers, like many traditional practitioners, show a propensity to draw sweeping conclusions. Its study, begun in 1997, showed only mixed results regarding the drug's ability to lower viral levels in the blood or to raise the count of a type of white blood cell that fights the virus. But the report's conclusion reads: "For HIV patients who took qiankunning, it was effective toward stabilizing or even during a certain time of raising [white blood cell] levels and inhibiting [HIV]."
Enwei executives concede many of their studies don't adhere to international standards for clinical trials, but blame the State Drug Administration for not issuing rules that would allow companies to test and market their products. In the meantime, Enwei sells its herbal compound, at about $60 for a month's supply, in Africa and Southeast Asia but not in China. State Drug Administration officials didn't respond to requests for comment.
Quality issues aren't confined to the private sector. As early as 1987, the government-run China Academy of Traditional Chinese Medicine launched experimental herbal treatments in Tanzania, whose government had requested help from Beijing. The academy has supplied more than 40 researchers to Tanzania. It also has drafted standards to evaluate traditional medicines for AIDS that it has presented to the government back home.
Yet the academy's own research lags behind international norms. Citing studies of between 300 and 400 patients who were given different herbal prescriptions for three to six months, the academy says its treatments showed an effectiveness rate of 76% in improving symptoms and a 50% effectiveness rate in strengthening the immune system.
Such a broad statistic is frequently used in Chinese medicine journals but is deemed faulty by most outside researchers because such averages can be skewed by one exceptional result. The fact that patients were given different prescriptions also clouds the question of which, if any, worked.
Wei Jianan, director of the academy's AIDS research department, declines to reveal more detailed results of the study. As to why it didn't adhere to international standards for clinical trials, he says, "This is a scientific exploration. It is not a clinical trial."
Write to Leslie Chang at leslie.chang@wsj.com
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