Dr.Junqiang Tian
Shanghai Medical University at Shanghai, China.
Title: Introducing Western-Medicine-Derived Therapies to Traditional Chinese Medicine Through Stringent Clinical Trials
Biography
Biography: Dr.Junqiang Tian
Abstract
Traditional Chinese Medicine (TCM) therapeutics stem from a unique, complex system of pathophysiological
principles and historically has not utilized Western Medicine (WM) methods of clinical research to statistically
demonstrate the efficacy of its therapies. In this series of clinical studies, we developed a novel, evidence-based
approach to test the hypothesis that ß-glucan (a WM-derived immune modulator) enhances Protective Qi (PQi), an
important TCM concept which stipulates that a protective force circulates throughout the body surface and works as
the first line of defense of against “external pernicious influences (外邪)”.
To test our hypothesis, we first conducted an uncontrolled (before-after), small-scale (n = 37) trial to seek the proofof-
principle and investigate the feasibility of a definitive trial1. Part of the enrollees who were PQi Deficient (PQD,
n =21) were treated with Proglucamune®, a commercially available ß-glucan containing product, at a daily dose of
~200mg ß-glucan for 8 weeks. Through this preliminary trial, we observed that: 1) an effective multifactorial PQD
risk score can be obtained through statistical modeling of a group of standardized predictors; 2) a clinical trial of β-
glucan can be effectively conducted in PQD participants in terms of recruitment, retention, and compliance; 3) β-
glucan-treated participants demonstrated improvement of PQD that warrants future randomized trials.
Next, we recruited 151 individuals with or without PQD in a continued effort to construct a standardized PQD
diagnostic risk score through logistic modeling. Each individual was evaluated using the conventional method of
PQD diagnosis (dependent variable) and a standardized protocol that scored 12 candidate PQD-predicting
parameters (independent variable). Using this training dataset, we obtained an algorithm that is comprised of 7
parameters and is able to predict PQD risk with an accuracy >90% and a reliability (inter-rater consistency) > 99%2.
Subsequently, this algorithm was reexamined using a validation dataset obtained from a separate group of enrollees
(n = 56), and a similar degree of accuracy and reliability was achieved.
Finally, we conducted a randomized, placebo-controlled, and triple-blinded clinical trial with ß-glucan. The trial
consisted of 138 participants who had suboptimal PQD status, and lasted 12 weeks with a daily dose of 200mg ßglucan.
While the β-glucan and placebo group had similar PQi status at baseline, significant improvement of PQi
indices was observed in the β-glucan (vs placebo) group after 4 weeks of treatment and lasted until the end of the
trial. Additionally, β-glucan had a positive impact on immune and general health status.
This study provides evidence that ß-glucan ameliorates PQi in PQD individuals. More importantly, it demonstrated
that: 1) clinical trials utilizing WM guidelines, including statistical analysis, can effectively evaluate an intervention
based upon TCM outcomes; and 2) WM-derived remedies, such as ß-glucan, can be employed to advance TCM
therapeutics.