The practice of Traditional Chinese Herbal Medicine (TCHM) may appear archaic to those who misunderstand the theories and principals that guide it. In fact, TCHM continues to evolve and new systems are consistently being discovered and applied within the tradition. Modern scientific analyses have also been utilized to look at herbs from a chemical perspective. It is here where in many cases, we may applaud the sages for their categorization of the herbs and the specific rules for the selection, combination, harmonization and processing methods that keep TCHM from being harmful.
The wisdom of TCHM doesn't end with safety. There are numerous TCHM effectiveness studies throughout the world, with heavy concentrations of research located in China, Taiwan and Japan. Detractors point to the poor quality of TCHM research and that products are not required to pass randomized, double-blinded, placebo-controlled studies (RDBPC).
Western medicine pharmaceuticals are expected to prove safety and effectiveness above placebo with RDBPC, prior to a product being release to the market. Pharmaceutical medicines must prove they are doing more good than harm, because in some cases pharmaceutical drugs can cause serious adverse events (SAE), meaning they require a patient to be hospitalized, or worse. TCHM practiced by a licensed practitioner has been under the radar for good reason, the occurrence of adverse events are rare and SAEs extremely rare.
The RDBPC study design may not be appropriate for TCM in many cases, since TCM practitioners do not sort patients by disease, but rather assign individual patient patterns or syndrome identifications that may result in a customized formula versus a one-size-fits all approach.
Patient case studies, outcomes, and evaluations of TCHM effectiveness are possible and are being conducted throughout the world, illustrating trends of effectiveness within TCHM.
Today, I sit with Galina Roofener of Cleveland Clinic to learn how her team conducts outcome studies of their work.
Shellie: Galina, as TCHM attempts to find acceptance in Western medical health care, what issues do you see in regards to research?
Galina: Iman Majd, a Western MD and acupuncture practitioner from Seattle, says it best, "The medical field has many questions in regards to the safety of TCHM. This safety issue, which covers a wide range, including safety of quality of products, efficacy, and interaction with other medications, has created a burden to further include TCHM in mainstream medical services. Medical services provided in conventional medical systems, are accepted based on their safety and efficacy according to a model that is designed for standardized research in Western research."
Shellie: As a medical practitioner at the Cleveland Clinic, what do you consider high-quality research? What are some of the major problems with existing research that deems it inappropriate for your team?
Galina: The biggest issues I see with many articles of current research are as follows:
Shellie: To improve research quality with TCHM, it is important to begin with the quality of herbs administered in research. The FDA, under Title 21 CFR 111, regulates TCHM products, which is the portion of the law that refers to Good Manufacturing Practices GMPs.
Industry research partners that provide products need to be capable of providing the following:
They do so by generating testing reports of:
So, my question to you, Galina, is, how does Cleveland Clinic look at these factors?
Galina: These quality issues impede the implementation of TCHM research into mainstream clinical practice. Requirements for the standardization of TCHM research, as well as for clinical practice are necessary, if TCHM is to advance as a medical option for more people. TCM trained researchers are desperately needed. TCM colleges need to begin offering not only DAOM programs, but also PhD studies, with a focus in TCM research.
We have taken on the challenge of research at Cleveland Clinic. In fact, I wrote a paper, which will be published this year, "Prescribed Custom Traditional Chinese Herbal Medicine Clinic Practice Safety Within Cleveland Clinic Integrative and Lifestyle Medicine Department; Outpatient Retrospective Observational Trial." This has been approved by our Institutional Review Board (IRB) and may be a big step leading the way for schools to begin conducting similar research trials.
Shellie: High-quality evaluation tools and research to measure the effectiveness of TCHM in the U.S. are necessary to tell the story of how TCHM performs in patient populations. Continued meta-analyses need to be performed with current research, as well as with practitioner clinic evaluation tools, to determine where TCHM strengths occur. This may make a case for funding for high-quality RDBPC TCHM research.
In the absence of RDBPC or, a comparable scientific account, TCHM may remain prone to skepticism and not fully accepted by the integrative health care model.
Galina: This is an area that we are working diligently to overcome at Cleveland Clinic. We want to conduct our work at the highest available standards, to bring quality care to our patients and better visibility for TCHM. I would like to see more herbal research that is based on TCM pattern differentiation and is clinically relevant available for TCM practitioners in the future.
Structured water (H3O2) can be considered a fourth state of water between liquid and solid. It has the hexagonal structure of ice; however, missing a critical bond, it behaves more like a gel than a solid, but retains some of its crystalline structure.
In the past five years of my clinical practice, I have seen an astonishing upsurge in the chronic use of proton-pump inhibitor (PPI) medications for the gastrointestinal issue diagnosed by allopathic medicine as GERD. It is not uncommon to encounter patients taking these prescriptions for five-plus years.
Working with chronically ill patients entails acknowledging the reality that not all patients will survive their diagnosis. Chinese medicine and acupuncture play a crucial role in palliative and end-of-life care, addressing medication and disease side effects, alleviating pain associated with death, reducing anxiety and stress, and helping patients find peace during the dying process.
