Choosing the Best Models for Integrative Research
Studies structured to meet the expectations of conventional medicine, while conforming to the basic tenets of an individual modality, will encourage a better understanding and wider acceptance of integrative medicine.
CONVENTIONAL MEDICINE focuses on separating out the individual actions of substances that have an effect on systems or diseases defined by conventional research. For example, the action of milk thistle on the liver is mostly defined in research as the action of silymarin (silybin) upon physiologic processes in the liver. Silymarin was chosen as the single most active chemical in milk thistle. With the exception of death from liver failure, most physiologic processes in silymarin studies are measured by laboratory tests used to measure liver function.
Actions of natural substances, as with the actions of drugs, are measured by their ability to decrease or increase an abnormal value back to normal. These actions are by and large viewed as one-way. For example, Western drugs for hypertension decrease blood pressure. One side effect of such drugs is to reduce blood pressure below normal.
INCORPORATING INTEGRATIVE RESEARCH INTO A CONVENTIONAL MODEL
Any integrative research has to recognize this world view and incorporate it, if possible, into the research model. However, to properly study traditional medicine, you must also include the basic precepts of whatever modality you are studying. If this is not done, you run the risk of improper setup of the research protocol, and/or improper interpretation of test results. Investigators on both sides of the question run the risk of such impropriety.
For example, some herbal formulas for blood pressure can both increase or decrease blood pressure, depending on whatever is needed to return blood pressure to normal values. This also implies fewer side effects related to blood pressure itself, or effects that are more likely to be related to nausea and diarrhea with an overdose, rather than abnormally low blood pressure.
Another example is the idea of “normalizing” a body’s immune reaction. In conventional medicine, tests are done on substances to see if they will increase or decrease the activity or numbers of various white blood cells (WBCs). Such action is looked upon as one-way; if a substance increases numbers/ actions of WBCs in one set of circumstances, and decreases them in a different set of circumstances, this is usually interpreted as “conflicting” evidence.
INTEGRATIVE MEDICINE LOOKS AT CASES INDIVIDUALLY
When traditional medicine looks on diseases and physiology as circular, as seen in the Five Element cycle of Traditional Chinese Medicine (TCM), different practitioners may decide to attack the same disease process at different parts of that cycle. The treatments may be seen as different by conventional medicine, but can be consistent within the confines of TCM. When looking at case studies or case series involving such circular views, therefore, final conclusions should be based on two criteria: were the cases treated successfully, and were all cases within the series consistent based on the traditional, not the conventional, view?
With situations that are even more individualized, such as in the TCM diagnosis of a case, there may be agreement on the basic diagnosis (such as inflammatory bowel disease) but various cases may have TCM differences within that basic diagnosis (such as Heat or Cold signs). In studies of human acupuncture, researchers are starting to look at basic points that everyone would use, plus two or three optional points that will differ depending on the specific TCM diagnosis. When designing a study for integrative medicine, this approach can help satisfy both the conventional method of choosing treatments, and traditional methods that ensure better outcomes.
AN AGREEMENT OF STUDY STANDARDS IS NEEDED
Often, herbal research looks at isolated herbs within a successful formula to determine what each one does, and which are most likely to be effective for specific conditions. If a formula has withstood the test of time and has been used for decades or even hundreds or thousands of years, it is most likely that there’s a reason for using a specific combination of herbs, as opposed to a single herb, for the disease in question.
The isolation of individual compounds in one herb, or of a single herb in a formula, can help us understand part of the contribution the compound or herb makes to the whole. But such research should not be used to champion single herbs or compounds, separate from the traditional formula, when the sum of the parts is most likely to have the best results.
When looking for a treatment for a specific disease or syndrome, a standardized (as much as possible) formula should be consistently used in all research involving the same formula and disease. Otherwise, research reviews of integrative medicine will continue to conclude that a formula has little to recommend it because individual components have weak actions against the problem. There is some precedent for this in cancer therapy, where combinations of chemotherapy (either together or sequentially) have been found to be more effective than a single method.
Herbs can vary greatly in their activity, depending on how and where they are grown and harvested and which parts of the plant are used. Even with the help of older texts, the exact combinations and quantities of herbs in a formula, and the exact doses of that formula, may vary from author to author. The situation is less extreme for Traditional Chinese herbal formulas, but there is still variation between brands.
Before herbal medicine can be taken seriously, there must be some agreement of standards. If researchers can agree on the formulas most in need of study (to become more widely accepted), and on one specific formula and dose, integrative herbal medicine could find wider acceptance. A standardized formulation and dose meets the conventional need for studies of a standard disease with a standard treatment. Once acceptance occurs, individual variations can be introduced.
Finally, in the case of modalities such as homeopathy, where every case of a conventional disease is looked at even more individually than in TCM, the research may need to be structured a little differently. In order for acceptance to occur, initial research may need to be more standardized. While palliation is not the desired endpoint, the fact that a remedy fairly consistently “improves” (to the conventional eye) the symptoms of a specific “disease” (as defined by conventional medicine) may open the door to acceptance of homeopathy as a valid part of integrative medicine.
Conflicting or supporting evidence?
Echinacea (most commonly Echinacea purpurea) has usually been studied with the expectation that it will increase immune reactions in some way. However, it may have more of an immune-modulating effect, as evidenced by at least one trial showing a decrease in WBC activity. Instead of viewing this as conflicting evidence, it would be better to examine herbal tradition, including the translation of original documents, to see whether this herb has been used as an immune “normalizer”. If so, the conflicting evidence is actually supporting evidence for the original premise.
While each modality has unique research challenges, scientific methods can be adapted to produce credible results. If research is structured in such a way that conventional expectations can be met, while conforming to the basic tenets of the individual modality, the needs of both sides can be satisfied. In addition, an explanation of an expected holistic effect before demonstrating it (such as bringing a reaction back to the norm, whether or not it is above or below the baseline measurement), can go far to allaying misinterpretations of what are seen as “inconsistent” results.