Integrative Medicine: The Nuts and Bolts

On October 1, 1999, Body Positive, Inc., held the second of its annual conferences bringing together providers and consumers of HIV/AIDS-related services. Entitled "Integrating a Spectrum of HIV/AIDS Therapies: Maximizing Benefits of HAART with Complementary Care," the conference was designed to focus attention on the need for a multifaceted approach to dealing with HIV/AIDS.

The full-day conference brought the issue of integrative medicine to a diverse audience that included people living with HIV, medical practitioners, nurses, practitioners of complementary and alternative therapies, nutritionists, social service providers, and others. Our intent is to keep our lens focused on the need for increased attention to an integrative approach to HIV/AIDS, one in which complementary and alternative medicine -- CAM -- is at least as logistically accessible as a visit to a hospital emergency room -- and a lot more convenient and comfortable. Our aim is to promote practical strategies for creating and integrating quality healthcare that addresses all aspects of health and well-being, and for making it accessible to people with HIV and AIDS.

This article is the third of a three-part series presenting some of the highlights of the October 1 CAM conference. Unfortunately, space does not permit us to reproduce all of the valuable comments offered by speakers, panelists, and workshop leaders at the conference. If you would like a conference folder, or further information about any of the panel topics or workshops that you read about here, please call the Body Positive office, (212) 566-7333.

Because of the murkiness that surrounds so many of the therapies included under the banner of "CAM," last October's conference featured several afternoon workshops that provided concrete, detail-specific information about individual CAM approaches. These workshops also offered conference participants the opportunity to ask the experts questions about the use of various CAM therapies.

Workshop topics included meditation, yoga/massage, acupuncture/traditional Chinese medicine, and nutrition; and there were sessions designed to enhance the understanding of CAM research challenges and methodologies, to promote access and advocacy for CAM utilization, and to address questions about how to discuss the integration of CAM and pharmaceuticals with physicians. Several of the session leaders then came together for a final afternoon panel to highlight the most critical issues to consider as we look toward the future of healthcare integration as it relates specifically to people with HIV.

The following information was chosen for inclusion here as an introduction to some individual CAM therapies and to illuminate some of the most important challenges facing advocates for the mainstreaming of CAM into biomedical institutions within the next decade.

Where's the Evidence?

Dr. Richard Hammerschlag is a biochemist who spent 25 years in biomedical research and neurobiology before redirecting his career toward CAM research. Now, as Research Director for the Oregon College of Oriental Medicine, Hammerschlag devotes his time to refining CAM research methodologies, with a particular interest in acupuncture and traditional Chinese medicine. He led an afternoon workshop on CAM research, addressing an audience of mostly biomedically trained professionals who had some background in research techniques.

Hammerschlag highlighted the challenges that the entire spectrum of CAM therapies face as we work toward a system of truly integrative medicine. Many CAM therapies are not as yet supported by solid research in the biomedical tradition of randomized clinical trials, RCTs for short, testifying to their success and validity. RCTs create circumstances under which researchers can determine whether changes in an individual's health status can be attributed specifically to a drug, a surgical intervention, or another therapy of interest -- and not to anything else that might be going on in that individual's life. Thus RCTs are considered the gold standard for researchers, and are important prerequisites for the approval and standardization of any drug or medical procedure.

For this reason, until RCTs are designed and carried out that justify the validity of CAM therapies, a system of truly integrative medicine that includes CAM therapies will remain a distant goal. According to Hammerschlag, the real question we have to ask ourselves is, "How do we test things other than drugs and surgery [i.e., CAM therapies] using the RCT structure, and then get those more holistic methods accepted as evidence-based medicine?"

To illustrate the challenges inherent in designing RCTs that evaluate CAM therapies effectively, Hammerschlag offered the example of conducting an RCT on using acupuncture as a treatment for symptoms associated with HIV-related illnesses. In a standard RCT, the effects of an experimental therapy on one group of people are compared with the effects of an existing therapy (or, where appropriate, to a placebo therapy, sometimes called a "sugar pill") on a control group. This RCT structure allows researchers to determine whether a proposed drug is any more effective than an existing treatment.

But think about it: How do you test a therapy like acupuncture within this structure?

Hammerschlag said that some researchers have attempted to do placebo acupuncture studies -- that is, compare "true" acupuncture on one group of patients with "false" acupuncture on another group. But even within this type of trial, how can a researcher really identify what a control group would be? Or think about the difficulties that other hands-on, holistic CAM methodologies could face. What, for example, would constitute "placebo massage"?

These are difficult questions, but they are the questions that must be addressed quickly and effectively by creative CAM researchers with biomedical backgrounds if we are to speed up the nation's progress toward institutionalizing integrative healthcare. Without good CAM research in the biomedical tradition, the scientific world will not accept CAM into mainstream institutions. At the same time, Hammerschlag asserted, because of the nature of CAM therapies, research into their effectiveness requires that the structure of traditional RCTs be modified in several important ways:

• They must include the importance of social support to the success of a treatment.
• They must include the influence of a medical practitioner's prior beliefs upon his or her delivery of care.
• They must recognize the multiple steps involved in a CAM diagnosis, as compared with the more linear one-step diagnostic process in biomedicine.
• They must recognize the individual nature of treatment decisions required in CAM, as opposed to the uniformity required by the current structure of RCTs.
• They must accept the idea that how a practitioner actually provides a CAM treatment to a patient is critical to the treatment's outcome.

Acupuncture and Traditional Chinese Medicine

Dr. Joyce Anastasi, Director of the Center for AIDS Research at Columbia University's School of Nursing (photo, left), is a biomedically trained nurse, a nationally recognized researcher, and a Licensed Acupuncturist. She joined Dr. Hammerschlag in the afternoon workshop on CAM research to introduce participants to the basics of traditional Chinese medicine. She also explained how she has worked to overcome the challenges outlined by Dr. Hammerschlag to construct federally funded RCTs that demonstrate the efficacy of these therapies to treat diarrhea in people with HIV.

Anastasi explained that her interest in the use of these approaches in treating HIV-associated diarrhea arose from her exploration of literature on the subject of traditional Chinese medicine and perhaps its most well-known component, acupuncture. TCM, as it is known, is a therapeutic approach to symptom management that is holistic in nature and that has been used for more than 3,000 years to treat disorders of the gastrointestinal system. For this reason, TCM and acupuncture appeared promising complements to Western biomedical HIV treatments.

Anastasi explained that the Western biomedical approach to treatment is that if the "diarrhea is caused by a pathogen, then we often treat the diarrhea with a medication specific to that cause. If the diarrhea is a side effect of medication, then we often discontinue the medication thought to be responsible for the symptom."

But, she explained, in HIV treatment, discontinuing the medication -- for instance, stopping someone's protease inhibitor therapy -- is not always a possibility nor an appropriate solution. "We often don't want to discontinue the medication or treatment regimen," Anastasi stressed, "because of resistance issues or other reasons." In general, then, "the biomedical approach to treatment uses antidiarrheal drugs, or diet, or both to combat the diarrhea."

By contrast, she explained, TCM practitioners focus on a different set of conditions and indicators in the body that create the environment in which the diarrhea is occurring. Of principal concern to TCM practitioners is the balanced flow of qi (pronounced chee) throughout the body. Qi is the energy that exists in all living things -- animals, humans, and plants. In addition to qi, blood and other fluids are important components of overall health examined by a TCM practitioner.

When the TCM practitioner or acupuncturist makes an assessment of a patient, she or he considers eight principles to define the body's overall condition. These are actually four pairs of opposite influences: exterior/interior, hot/cold, excess/deficiency, and yang/yin. In addition, the practitioner considers something called the "five-element theory." This theory considers the relationships of TCM's five elements -- fire, earth, metal, water, and wood -- to different organs of the body. "Fire" conditions are associated with disorders of the heart and small intestine; "earth" conditions are associated with the stomach and spleen; "metal" relates to the lung and colon; "water" corresponds to the kidney and bladder; and "wood" is related to the liver and gall bladder.

Different methods of diagnosis are used to determine the condition of these elements. Practitioners conduct a tongue diagnosis, in which they examine the color, coating, appearance, and shape of the tongue. They also conduct a pulse diagnosis, in which different pulses are considered in relation to different organs to which they correspond. Unlike in Western biomedicine, the quality of the pulses -- sluggish, rolling, tight, and slippery -- is as important as their rate to diagnosis.

The practitioner also asks the patient ten classic questions of TCM during the assessment. For example, one aspect of the ten questions involves thirst. A TCM practitioner might ask a patient, "When you're thirsty, what do you crave?" By learning whether the patient prefers cold water or hot tea, the TCM practitioner establishes whether the body craves "cold" or "hot" and whether the body might be seeking to reestablish its balance through those cravings.

Like biomedicine, TCM does consider the existence and effects of pathogens in the body. The discipline divides illnesses into acute and chronic conditions, and if the condition is diagnosed as an acute one, an external pathogen may be the cause. Acute conditions are often easier to treat than chronic conditions, because they are not yet embedded in the body. According to this structure, diarrhea can be either an acute, pathogen-caused problem or a chronic condition relating to disorders of the spleen, stomach, and kidney.

Dr. Anastasi's extensive introduction to TCM formed the basis for her discussion of the difficulties of designing an RCT to explore the efficacy of acupuncture. By way of explanation, she stated, "In TCM, we need to individualize treatments, and yet, in a randomized clinical trial, or RCT, we need to develop one specific protocol that can be used on all patients."

How did Anastasi respond to this challenge? She convened a panel of expert acupuncturists to devise a single protocol that could address different causes of HIV-related chronic diarrhea. This protocol was developed by consensus and included an investigation of all the TCM diagnoses related to this pattern of diarrhea. Its development was not easy, but eventually a successful protocol was designed -- and the results of the trial were promising enough to earn Anastasi's team the respect of biomedical and CAM researchers alike.

According to Anastasi, the foundation for the group's success was that the group was comprised of experts who truly understood TCM. Had it been composed of biomedical researchers who did not possess that understanding, Anastasi is certain that success would have eluded the team. "You can't just identify some points and say, 'OK, let me select chronic diarrhea as an illness and pick ten points to treat it,'" she noted. "It doesn't work that way. You need understanding of TCM theories. It's fundamental information."

Is Good Nutrition Really an "Alternative"?

When it comes to fundamental information, few practitioners of any healing tradition -- biomedical or CAM -- would contest the idea that good nutrition is the backbone of good health. Yet today, even nutrition is considered CAM, simply because nutrition supplementation and nutrition-based therapies have become such an important complement to pharmaceutical regimens for people living with HIV.

During the conference's afternoon sessions, Dr. Lark Lands conducted a marathon question-and-answer session to address the wide variety of nutrition therapies available to people with HIV. Yet she echoed Dr. Anastasi and Dr. Hammerschlag in noting that research on these nutrition therapies is limited. The trouble with researching nutrition therapies is that the vast majority of vitamins and minerals work together, not independently. Conducting an RCT to determine the efficacy of a single vitamin, therefore, is certainly not the most sensible use of research dollars. Yet, at the same time, without the evidence that RCTs produce, the federal Food and Drug Administration simply will not approve nutrition supplements as part of an HIV treatment regimen, nor will the agency publish revised guidelines and nutrition recommendations.

[Editor's note: The federal government is finally moving to address this issue. An expert panel has been convened under the leadership of Dr. Eric Goosby, the government's Director of HIV/AIDS Policy, and charged with the task of formulating uniform HIV nutrition standards. Edwin Krales, Nutrition and Outreach Coordinator at The Momentum AIDS Project and a member of the expert panel, writes about its work in the April issue of Body Positive.]

Despite the universal recognition that generic "good nutrition" enjoys, many physicians don't stay current with the latest nutrition research. Lands therefore encouraged people with HIV to share with each other their experiences experimenting with various diets and supplements to relieve symptoms of HIV disease and side effects from HIV medications.

Over the course of the afternoon, Lands fired off a huge number of specific suggestions of therapies and regimens for participants to explore. These suggestions were made in response to questions from the audience and highlight the need for further information about issues like overall good diet and nutrition, lipodystrophy, neuropathy, diarrhea, and disrupted sleep. Here are several of her suggestions on topics of widespread concern:

Overall Good Diet and Nutrition
Starting at about the age of five, most Americans are told that a balanced diet is the key to good health. But, if you're living with HIV, what constitutes a "balanced diet"? Since HIV inhibits the absorption of some nutrients and depletes the body of others, it can be difficult to determine just what a "good" or "balanced" diet is.

One key piece of information that Lands offered the audience was an important finding from a study of nutrition in people with HIV that was conducted at the University of California at Berkeley. One of the largest and most well-respected surveys of its kind, this study looked at people with slow HIV disease progression and found that all of them were using nutrition supplements. This point is critical, according to Lands; it suggests in the strongest possible way that a person with HIV simply cannot get everything needed from a good, balanced diet.

Lands suggested checking out "Super Blend," a multivitamin produced specifically for people living with HIV by Super Nutrition, a California-based company. The multivitamin can be purchased by telephone for about $38 per month. Call (800) 262-2116 between 9:00 a.m. and 5:00 p.m. (PST). While there is no magic vitamin pill, Lands assured the audience that the combination of a good diet -- one that includes the B vitamins, vitamin C, trace minerals, carotinoids, and the various antioxidants -- and this particular multivitamin will form "an excellent base" for good health.

Lipodystrophy
Lipodystrophy is one of those HIV-related phenomena that demand more attention than a simple alteration in your diet. It is experienced by increasing numbers of people who are living with HIV and who are adhering to complex drug cocktails and refers to the abnormal accumulation of fat cells throughout the body.

Lands suggested several approaches to lipodystrophy, but focused primarily on the benefits of Serostim, a human growth hormone formulation available by prescription.

Offering a perfect example of the value of "experience-based" medicine, Lands stated that she has had excellent reports from clients that Serostim has shrunk their bellies and their buffalo humps with surprising efficacy. In some cases, Serostim has restored tissue in arms and legs, and even in the face. She noted that results seem to be very individualized, with some people getting better effects than others, but that overall the results look promising. Until more clinical evidence is available, Lands encouraged people to trust the positive experience of the community with this hormone.

The challenge to incorporating Serostim into a regimen is its price and availability. Without insurance coverage, Serostim is quite expensive, and coverage is limited to prescriptions written specifically to treat "the traditional diagnosis of wasting," which refers to a loss of at least ten percent of body weight. In order to get the Serostim paid for by Medicaid or insurance companies, therefore, patients must convince their doctors to diagnose their condition as "wasting."

Lands offered one caveat to the use of human growth hormone. The standard dose of Serostim as indicated on the bottle is 6 mg daily. This does not, however, seem to be the most appropriate dosage for people with HIV. People who have taken that amount have reported severe joint pain, including carpal tunnel and trigger finger, and they have complained that this pain is very slow to disappear.

To avoid those problems, Lands encouraged people to consider diluting the 6 mg dose to produce three doses with a concentration of 2 mg each, to be taken every other day. An added advantage is that a twelve-week prescription of Serostim at standard doses will actually last for the better part of a year, and with better effects. Refrigerate the diluted formula to preserve it safely.

Lands reminded participants that human growth hormone is not a cure. The hormone only treats lipodystrophy symptomatically, and Serostim must therefore be used on an ongoing basis to keep the syndrome at bay.

Diarrhea
Lands brought an interesting new idea about diarrhea control to the forum -- calcium. She recommends 1,000 mg per day of calcium from any source -- most basic, over-the-counter calcium supplements, or even Tums -- to help control diarrhea. A physician in San Antonio, Texas, happened upon this approach by chance and has been encouraging all of his patients to use calcium for their diarrhea. The results have been surprisingly positive.

Another new supplement that seems to be working is a Shaman Pharmaceuticals product called SB Normal Stool Formula. It works symptomatically, so it won't cure the cause of the diarrhea, but for people struggling with diarrhea associated with antiretrovirals, the Shaman product is showing excellent results without the side effects of more traditional antidiarrheals. Shaman's products can be found on the Internet at http://www.shaman.com.

Dr. Lands commented that diarrhea is a tricky condition to control, and she encouraged people to "stop everything" when they want to address the diarrhea problem. "You can't just eliminate the dairy," she said, "or any single thing. You have to do a huge assault: Cut the fat level in your diet, and take the digestive enzymes that have lipase in them, and cut out the dairy products, and go to your doctor and get a GI workup to exclude the possibility of external pathogens."

Once all of these things have been done, and assuming the diarrhea is controlled, you can start reintroducing things into your diet and see what happens. But, as Lands stressed, "You have to solve the problem first."

Looking Ahead
Participants in the final panel session of the afternoon revisited all of the issues discussed above and placed them in the context of the need for advocacy and activism around CAM and integrative medicine. While many CAM therapies simply require an individual's personal commitment to holistic health, a national system of integrative healthcare would provide the most important basis for the effective and accurate dissemination of information about CAM therapies to the general population.

The consensus of the panelists and workshop leaders in BP's October conference was clear: Join together and fight for an integrated system! Help to educate your doctor (in a nonthreatening manner) about CAM therapies.

In order to push CAM and integrative medicine into the mainstream, we must create a coalition of patients and doctors and CAM practitioners to fight for that system. All parties have a role in an integrated system, so we may as well learn to listen to each other and work with each other -- as soon as now.

Rachel Sacks, former Co-Director of Community Outreach and Education at Body Positive, Inc., organized the agency's October Complementary and Alternative Medicine Conference.

Back to the March 2000 Issue of Body Positive Magazine.