Complementary Medicine and HIV: The Research Dilemma

A 1990s Success Story

Twenty years ago, complementary medicine was an obscure term and the practices associated with it were unknown to the majority of Americans. In the 1990s, however, professional interest in complementary therapies increased markedly with the 1993 publication by David Eisenberg and colleagues of the report "Unconventional Medicine in the United States."

The report became a landmark in terms of validating complementary medicine's relevance within the Western medical establishment, and prompted a 1998 follow-up. Based on the extrapolation of data from the 1998 study, Americans visiting providers of complementary medicine rose from 427 million in 1990 to 629 million in 1997. That same follow-up study also revealed that 42% of adults surveyed reported using complementary medicine, spending approximately $21.2 billion annually -- with more than $12.2 billion coming out of their own pockets.

Additional evidence of the ever-growing interest in complementary therapies lies in the increased status and authority given by the U.S. Congress to the National Center for Complementary and Alternative Medicine (formerly the Office of Alternative Medicine) at the National Institutes of Health (NIH), which in 1998 awarded the agency a budget increase from $20 million to $50 million. From 1997 to 1999, the Center has received a 400% increase in funding -- a clear reflection of the interest in complementary medicine by conventional researchers, academia, Western-trained medical practitioners, and consumers. In fact, a recent issue of the Journal of the American Medical Association (JAMA) (vol. 280, no. 18, 1998) was devoted entirely to complementary medicine.

What is Complementary Medicine?

One definition that appears to offer the best description of the field, and will not likely be dated by current practices in health care, was recently proposed by Daniel P. Eskinazi, DDS, PhD, L.Ac: "a broad set of health care practices (i.e., already available to the public) that are not readily integrated into the dominant health care model because they pose challenges to diverse societal beliefs and practices (cultural, economic, scientific, medical, and educational)."

For the duration of this article, the terms complementary medicine and complementary therapies will be utilized, with complementary therapies being the treatment modalities (i.e., acupuncture, acupressure, qi gong) under complementary medicine. Readers should understand that this is a brief overview of complementary medicine and not a comprehensive text.

Researching Complementary Medicine in HIV: Limited Studies

Although one set of surveys in the mid-1990s revealed that the prevalence of using complementary therapies among people with HIV/AIDS ranged from 36% to 56%, research attempting to assess the effectiveness of specific complementary therapies in the treatment of HIV-related conditions remains -- for reasons to be discussed shortly -- a rarity in scientific literature. A review of scientific literature reveals that the majority of the studies involving complementary medicine have been surveys, case studies, anecdotal reports and/or studies reporting small sample sizes.

A few studies involving complementary medicine approaches are summarized here:

• One 1996 study by Dr. Gail Ironson and colleagues involved 20 HIV-positive men and found that daily massage for one month showed significant improvement in natural killer cells and CD8 counts as well as reported reductions in HIV-related symptoms. However, meaningful changes in CD4 counts were not noted, something which may be explained by the short duration of the study.

• In 1998, Dr. Judith C. Shlay and colleagues conducted a randomized, placebo-controlled clinical trial in 10 cities across the United States to evaluate the efficacy of a standardized acupuncture regimen and amitriptyline on HIV-related peripheral neuropathy. The study assigned 239 patients to the acupuncture versus control group, and 136 were enrolled into either the active or placebo amitriptyline group. Results showed that patients in all four groups had a reduction in mean pain scores at six and 14 weeks compared to baseline values. Thus, the study did not show that acupuncture or amitriptyline could relieve pain associated with peripheral neuropathy better than their placebos. However, it must be noted that sham acupuncture points used as controls may still have analgesic effects by releasing endogenous opioids when manipulated, thus possibly explaining the lack of convincing results.

• Sometimes research with non-HIV patients can help us speculate on the benefit of certain complementary therapies for conditions caused by HIV. For example, a 1996 article described a clinical trial involving qi gong (a Chinese movement and breathing practice) on patients diagnosed with malignant cancer. All patients received chemotherapeutic regimes. Ninety-seven patients practiced qi gong two hours a day for three to six months and 30 patients were in the control group. Patients in the qi gong group showed more improvement in strength, appetite, diarrhea reduction and weight gain compared to the control group. Thus, one can speculate on the potential benefit of qi gong that could be applied to people with HIV/AIDS dealing with some of the same conditions.

Roadblocks to Herbal Studies

Several factors contribute to the paucity of formal research investigating complementary medicine's efficacy in HIV. One of them relates to the pharmaceutical industry's lack of incentive to conduct such research. Even though several herbal formulations have undergone in vitro testing which has shown evidence of their having antiretroviral activity, few drug companies have conducted preclinical or clinical investigations to provide further evidence of their efficacy or safety. Perhaps that is because -- unlike with pharmaceutical agents, for which drug companies must comply with strict Food and Drug Administration (FDA) guidelines prior to taking them to market -- drug companies aren't allowed to patent herbal formulations and consequently seize exclusive rights to them. Thus, the financial incentives for drug companies to conduct research on herbal formulations is probably not very large.

Dilemmas in Complementary Medicine Research

Dilemmas are often encountered by researchers of complementary medicine when they try to apply to their research the standards and techniques of conventional medicine -- which they must adhere to in order to gain the Western medical establishment's credibility and acceptance. These dilemmas include problems with creating a placebo, individualization of treatment, and outcome measures.

In standard medical research, placebo techniques are incorporated into study designs to control for the natural progression of a disease and to assess the effectiveness of a treatment. However, some complementary therapies -- such as massage -- have no comparable placebo. Controls would have to be designed to test the efficacy of the massage treatment.

Individualization of treatment is another dilemma. In conventional medical research, assessing and evaluating the effectiveness of treatments (i.e. drug trials) generally involves utilizing the same treatment protocol for enrolled study subjects. However, each treatment in complementary medicine is specifically tailored to each individual. For example, several patients visiting an acupuncturist for the same condition may each be managed differently depending on their unique constitution, lifestyle and emotional state. In contrast, patients with the same condition visiting conventional medical doctors are generally prescribed identical treatments.

Another problematic issue has to do with the lack of congruent terminology and explanations between Western conventional medical conditions and treatments and their non-Western counterparts (see table).

The final dilemma involves outcome measures, which in most complementary therapies have not been validated, as have those for conventional medical theory and practice. Western practice relies upon such physiologic measures as lab tests and x-rays to assess a patient's baseline status, post-treatment status and follow-up reports. A more specific example, for instance, is in the case of rheumatoid arthritis (RA), whereas in conventional medicine an elevated erythrocyte sedimentation rate (ESR) serves as a laboratory marker (measure) for RA. However, in Chinese Medicine, a self-report of symptoms, and an evaluation of tongue and pulse have been the traditional diagnostic tools.

The extent to which the conventional medical establishment will become more open to alternative outcome measures for complementary medicine research, or to which it will accommodate the ever-increasing role of complementary therapies, should make for interesting observation among both patients and health care workers in the years ahead.

Joyce K. Anastasi, PhD, RN, FAAN, L.Ac, associate professor and director of the Center for AIDS Research at Columbia University School of Nursing, is a nationally recognized nurse clinician, researcher and acupuncturist in HIV/AIDS.