Randomized, double-blinded, placebo-controlled trial or “RCT” is a powerful tool for evaluating the efficacy of a pharmaceutical medicine to treat a specific symptom or condition, but it is a poor tool for evaluating the effectiveness of a complex botanical medicine, a botanical formula, or a multi-layered/multi-disciplinary approach. In this webinar, we explore a new model for evaluating the effectiveness of botanical medicines and the use of traditional medical diagnostic and therapeutic methods.
The biomedical community has often overlooked the relevance and importance of the contributions of traditional medical systems to the practice of medicine in general. The principles upon which these systems have been founded are derived, in large part, from what is called empirical data, that is, knowledge that has been recorded based on observations over time. In traditional Chinese, Ayurvedic, and other traditional medical systems, there is a foundation of thousands of years of data that has been gathered, recorded, evaluated, and used extensively in the clinical setting. The primary reason for this unfortunate oversight is the heavy reliance of medical science on the randomized, double-blinded, placebo-controlled trial or “RCT”.
Although not yet considered a part of the gold standard of medical science, effectiveness research provides a potential avenue for expanding our evidence base for making clinical decisions. Effectiveness research differs from efficacy research and provides an opportunity to evaluate therapeutic methods and complex approaches to medical conditions.
Comparative Effectiveness Study Example
A group of patients that have been diagnosed with ulcerative colitis (UC) is divided into two groups. One group receives the biomedical standard of care treatment for UC, which includes the 5-aminosalicylic acid medications, corticosteroids, immunomodulating agents, and biologics, such as Remicade and Humira. The other group is assigned to the care of a Mederi Medicine or other holistic practitioner, who applies their diagnostic and therapeutic methods to treat the patients. Over the course of the study, both groups are evaluated by laboratory tests and symptom assessment tools. The results are then presented in a scientific research paper, and the two methods of treatment are compared for their effectiveness to treat the condition.
Randomized clinical trial (RCT) data has become the primary arbiter for clinical decision-making in modern medical practice, and it is often heralded as the basis for “Evidence-Based Medicine” (“EBM”). However, when it comes to botanical medicine, evidence in the form of RCT data is underrepresented.
There are several reasons for the lack of RCT data in botanical medicine, with the primary reasons being:
- Botanical medicine is founded on the application of complex mixtures of naturally-occurring chemical compounds that do not fit neatly into the single-molecule, single-target framework of modern pharmaceutical medicine.
- Because botanical medicines are not patentable, studying botanical medicine does not provide a lucrative return on investment for those funding the research.
By expanding the definition of “EBM” to include “best available evidence”, we are able to bridge the gap between RCT data and the medically relevant information embedded in the world’s well-established traditional medical systems. Such a reframing of the “evidence” we use to guide our medical decision-making could provide us with an opportunity to significantly enhance our clinical outcomes in the management of chronic disease.
For many of us who practice herbal medicine, our evidence base includes:
- Knowledge passed on to us by teachers
- Historical writings
- Modern text books written by experts in the field (Text books often cite historical writings and bring traditional medical systems into the context of modern medicine)
- Available scientific research
- Clinical experience
When considering the relevance of RCT data to clinical decision-making, I often use the analogy that when I look at the night sky, the vast majority of what I see is blackness, with points of light scattered throughout. In this analogy, the blackness of the night sky represents the potential circumstances that a clinician faces, and the stars represent clinical situations that are informed by relevant RCT data.
The point of this exercise is to recognize that the vast majority of case-related circumstances and clinical decisions are not informed by RCTs. Simply put, there just aren’t nearly enough RCTs to provide guidance for each medical circumstance that the clinician encounters.
Three Primary Forms of Evidence:
- Traditional Usage
- Does this medicine have a long history of safe and effective use in a traditional medical system such as TCM or Ayurveda?
- Scientific Research
- Human trials
- Animal Trials
- In vitro experiments
- Basic Sciences research
- Clinical Experience
- Based on study and experience, the clinician applies her knowledge and skills to create a therapeutic solution for the patient.
Making well-informed clinical decisions in our field of medicine puts greater demands on the clinician to put together different forms of evidence.
Note: This webinar is intended for healthcare practitioners.