Traditional Chinese medicine (TCM) has been used for thousands of years for the prevention and treatment of illness. Infections for which TCM has been used include:

• Hepatitis
• Herpes
• Tuberculosis

Currently licensed pharmaceutical therapies do not cure HIV infection and are associated with side effects. As a result, some people with HIV/AIDS and their care providers are turning to traditional medical systems for help in the following areas:

• Relieving their symptoms.
• Maintaining or improving their quality of life.
• Improving their lab test results.

Lab experiments have shown that several herbs used in TCM have anti-HIV activity, including:

• Andrographis paniculata
• Viola yedonensis
• Prunella vulgaris

Some people assume that taking a large enough quantity of these herbs may result in anti-HIV activity in the body. There may be many reasons why this belief might not be true. One thing to bear in mind is that TCM herbs also have complex effects on the immune system, including an anti-inflammatory activity. This effect can have subtle and important implications. Some symptoms of HIV/AIDS can be relieved with the use of anti-inflammatory drugs. However, these drugs may also impair the immune system's ability to fight AIDS-related infections. By extension, therefore, some TCM herbs may also weaken the ability of the immune system to fight certain infections.

Doctors in Switzerland conducted a six-month, placebo-controlled study of a standardized preparation of more than 30 TCM herbs. We now report their results.

Study details

Doctors recruited 68 HIV-positive people:

• 21 per cent female
• 79 per cent male
• 22 per cent had AIDS

The research staff randomly assigned subjects to receive pills containing a mixture of TCM herbs or fake TCM herbs (placebo) for six months. Key lab values for subjects assigned to TCM herbs were as follows:

• CD4+: half had a count of three to 198 cells; the other half had between 198 and 700 cells.
• Viral load: half the subjects had 171 to 36,000 copies; the other half had between 36,000 and 500,000 copies.

Among subjects assigned to receive placebo, the lab values were as follows:

• CD4+: half had a count of zero to 245 cells; the other half had between 245 and 900 cells.
• Viral load: half the subjects had 146 to 52,000 copies; the other half had between 52,000 and two million copies.

For six months, subjects took seven pills four times daily for a total of 28 pills per day. During the study, some subjects also took anti-HIV drugs, usually AZT, ddI or ddC. Statistical analysis suggested that any differences between the two study groups with respect to the following characteristics were not significant:

• Age
• Gender
• Stage of HIV disease
• CD4+ cell count
• Viral load

Results - who completed the study

Although 68 subjects entered the study, only 24 of 34 in the group (or arm) that received herbs completed the study. The equivalent figure for the placebo arm was 29 of 34.

Results - CD4+ and CD8+ cell counts

The authors reported no significant changes in CD4+ cell counts between the two groups. Regardless of which arm of the study they were in, subjects' CD4+ counts fell by about 50 cells if they were not on antiviral therapy.

According to the researchers, levels of CD8+ cells remained stable during the study.

Results - viral load

By the end of the study, changes in viral load within or between the study groups were not statistically significant.

Results - side effects

The number of reported side effects was twice as high for those receiving TCM herbs as it was for subjects on placebo. This difference was statistically significant: not likely due to chance alone. Subjects receiving TCM herbs were more likely to report the following side effects:

• Increased number of bowel movements per day
• Abdominal pain
• Nausea

Technicians did not detect any bone marrow, kidney or liver toxicity resulting from exposure to TCM herbs.

Results - symptoms of HIV/AIDS

One subject in each group developed a new AIDS-related condition during the study. Several surveys designed to assess mental and physical well-being revealed no changes during the study in either group.

Questions about the herbal mix

According to the researchers, the herbs used in this study were chosen because of their traditional usefulness in reducing the following symptoms:

• Tiredness
• Fever
• Weight loss
• Night sweats
• Diarrhea
• Arthritis
• Swollen lymph nodes

Points to consider:

1. 1. In HIV-positive people, symptoms such as tiredness, fever, night sweats, diarrhea and swollen lymph nodes may signal the beginning of a life-threatening complication. Suppressing these symptoms may provide temporary relief but could allow the developing infection or cancer to spread. A thorough physical exam combined with extensive laboratory tests might be more useful in the long term because they may allow doctors to diagnose the cause of symptoms.
2. 2. Drugs such as corticosteroids may suppress inflammation, fatigue and fever in the short term, but long-term use may weaken the immune system's ability to fight HIV and other microbes. It is possible that some of the herbs used in the Swiss study, with their history of use in inflammatory disorders, may have weakened the type of immunity needed to fight HIV. Indeed, the general increase in viral load seen among subjects who received TCM herbs is troubling and suggests this possibility.
3. 3. TCM is a complex medical system in which treatment is tailored to the needs of each patient. Patients are monitored and assessed on a regular basis by TCM practitioners, and the mix of herbs prescribed may change from month to month. In this study, the authors used a standardized mixture of herb, which they formulated by considering general symptoms of HIV-disease. They did not, therefore, vary the herbal mix for individual needs.
4. 4. According to the physicians involved, the results of the Swiss study show that this standardized Chinese herb preparation isnot effective for treating HIV-infected people.
5. 5. This clinical trial highlights some of the difficulties related to the use of conventional current methodologies to study the effects of TCM. Perhaps new and different types of statistics should be explored to evaluate something as complex as TCM.

REFERENCES

1. Weber R, Christen L, Loy M, et al. Randomized, placebo-controlled trial of Chinese herb therapy for HIV-1-infected individuals. Journal of Acquired Immune Deficiency Syndromes 1999;22(1):56-64.

2. Basak A, Cooper S, Roberge AG, et al. Inhibition of proprotein convertases-1, -7 and furin by diterpines of Andrographis paniculata and their succinoyl esters. Biochemical Journal 1999;338(part 1):107-113.

3. Ngan F, Chang RS, Tabba HD and Smith KM. Isolation, purification and partial characterization of an active anti-HIV compound from the Chinese medicinal herb Viola yedonensis. Antiviral Research 1988;10(1-3):107-116

4.Yao XJ, Wainberg MA and Parniak MA. Mechanism of inhibition of HIV-1 infection in vitro by purified extract of Prunella vulgaris. Virology 1992;187(1):56-62.

5. DeKruyff RH, Fang Y and Umetsu DT. Cortiocosteroids enhance the capacity of macrophages to induce Th2 cytokine synthesis in CD4+ lymphocytes by inhibiting IL-12 production. Journal of Immunology 1998;160(5):2231-2237.

6. Imami N, Antonopoulos C, Hardy GAD,e t al. Assessment of Type 1 and Type 2 cytokines in HIV Type-1-infected individuals: impact of Highly Active Antiretroviral Therapy. AIDS Research and Human Retroviruses 1999;15(17):1499-1508.

7. Malakoff D.Bayes offers a 'new' way to make sense of numbers. Science 1999;286:1460-1464.

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