Liability Regarding Complementary and Alternative Medicine (Part IX)
By Dr. Gary L. Deel, Ph.D., J.D.
Faculty Director, School of Business, American Public University
This is the ninth article in a 10-part series discussing the duties of American medical professionals to disclose complementary and alternative medical treatments to patients.
In the previous part, we discussed the important role of clinical trials in parsing the efficacy and legitimacy of different complementary and alternative (CAM) treatments. In this part, we will look at several examples of traditional Chinese medicine (TCM) and the current clinical trials being undertaken to investigate them.
The Different Forms of Traditional Chinese Medicine
Yoga, tai chi, and Chinese martial arts are all forms of physical exercise developed by the ancient Chinese to help maintain the balance of qi in one’s life and to promote a healthy body and mind. The distinction between these forms of TCM and some others under review (e.g. acupuncture and herbology, for example) is that practicing these types of treatment typically requires neither an MD nor an ND (Naturopathic physician).
Most often, industry credentials and certifications are required in order to practice with the endorsement of respected governing bodies. But this system is regulated by the industry itself, not the law.
Chinese martial arts (e.g. kung fu) and yoga have become very popular physical activities — also known as behavioral treatments — for remedial and preventative purposes. They have been investigated for treating insomnia, cancer, multiple sclerosis and other age-related disorders. Some of these trials have begun recently, and others have been underway for as many as 10 years. So far, research has shown mostly positive results.
Tai chi is another very popular behavioral treatment that has seen a huge spike in demand among the elderly. By contrast to yoga and martial arts, tai chi is a much less physically demanding form of therapeutic physical exercises, consisting of slower movements and more fluid and graceful transitions. However, despite its less rigorous physical regiment, it has consistently exhibited positive effects in treating such ailments as fibromyalgia, cardiovascular disease, arthritis, and balance and motor control-related issues.
Other Forms of Traditional Chinese Medicine Require More Stringent Clinical Review
Other forms of traditional Chinese medicine such as cupping therapy, acupuncture, and herbology are more invasive in nature and thus require more stringent clinical review. However, initial testing has at least established a foundation of knowledge from which to pursue further understanding.
Acupuncture is an ancient Chinese medicinal procedure involving the use of needles placed into the skin at certain points believed to be most sensitive to stress levels and the intricate balance of yin and yang (discussed in Part II). Clinical trials have shown that acupuncture “may help ease types of pain that are often chronic such as low-back pain, neck pain, and osteoarthritis/knee pain. It also may help reduce the frequency of tension headaches and prevent migraine headaches.”
Cupping (also known as moxa therapy), although related to acupuncture in the type of ailments it has been posited to remedy, is much different in application. Cupping is a type of reverse-massage therapy that utilizes glass or ceramic cups which are first superheated from the inside.
The openings of the cups are then placed against the skin; once the air in the cups cools, it creates suction against the skin that is believed by practitioners to be of therapeutic benefit for muscle injuries and similar ailments. So far, formal research into cupping therapy has shown that there may be some benefits in treating pain and herpes zoster (also known as shingles).
Lastly, herbology is debatably one of the oldest segments of TCM. Originating over 3,000 years ago, herbology involves the use of natural herbs and plant extracts to treat ailments and illnesses. There are currently over 10,000 known formulas in the science of Chinese herbology. Obviously, with this many different purported treatments, there haven’t been clinical trials to explore them all.
However, those treatments that have seen testing have produced generally optimistic results thus far. For example, Jing Fang Bai Du San and Ying Qiao, two complex formulas of dried plants native to Asia, completed clinical trials in 2012 for their efficacy in treating upper respiratory tract infections. Evidence suggested no significant benefit to these particular herbs in this specific application.
In another example, the prototypical formula Food Allergy Herbal Formula 2 (FAHF-2) completed Phase I trials and showed general safety and preliminary efficacy in suppressing peanut-induced anaphylaxis.
In a third example, a blend of herbal Chinese medicines and Western therapies underwent clinical trials for their efficacy in treating influenza caused by the H1N1 virus. Results suggest that some herbs have a positive effect against the virus, but more testing is needed.
Great Forethought Should Go into the Development of Disclosure Standards
Given the wide variety in the degree of testing conducted thus far and the conclusiveness (or lack thereof) of results among just these few forms of TCM in a much larger world of CAM options, it is clear that great forethought and care should go into establishing a standard of relevance/significance that would simultaneously ensure 1) that all pertinent information would be shared with patients, and 2) that information on potentially ineffective and/or dangerous methods would not be forced on patients by misguided law.
With these objectives in mind, it would be prudent for courts to implement a threshold standard of clinical trials whereby a certain quantity and quality of favorable results should suffice for the legal requirement of disclosure. For example, if the threshold were established at a requirement of at least one year in Phase II trials with an 80% success rate among test subjects and minimal adverse side effects, such a standard would require disclosure of certain, more credible types of CAM.
Using our earlier analysis of TCM treatments, this standard would include more tried-and-true treatments such as yoga, martial arts, and tai chi. However, other less reputable treatments such as acupuncture and cupping would be excluded from required disclosure.
If a particular type of CAM treatment satisfied the proposed standard, it would be concluded that it was sufficiently relevant or recognized in the medical community. Thus, doctors would be legally required to disclose it as applicable in informed consent discussions.
In the final part of this series, we’ll assess the benefits to such an approach, were it to be adopted by U.S. courts.
About the Author
Dr. Gary Deel is a Faculty Director with the School of Business at American Public University. He holds a J.D. in Law and a Ph.D. in Hospitality/Business Management. Gary teaches human resources and employment law classes for American Public University, the University of Central Florida, Colorado State University and others.