Clinical Trials

Biography

Biography: Stephen Hsu

Abstract

Previous in vitro and in vivo studies indicated that catechins from the tea plant (Camellia sinensis) possess multi-beneficial effects including a therapeutic effect for herpes simplex virus infections and restoration of salivary functions. To test the efficacy of formulations developed for treating herpes labialis and managing xerostomia, AverTeaX and MighTeaFlow, respectively, two separate double blind, placebo controlled, randomized clinical trials were design and conducted in two dental institutions located in the US and China. For the AverTeaX herpes labialis trial, the results demonstrated significant reduction of clinical episode duration (median 4.5 days, range 1-11 days vs. 9 days, p=0.003) and shortened blistering/ulceration stages within an episode from a median of 3 days to 1 day (p=0.0003). Patient’s quality of life was also improved and no adverse effect was reported. It is concluded that AverTeaX formulation containing lipophilic catechins inhibited herpes simplex labialis infection effectively with clinical significance. For the MighTeaFlow xerostomia trial, after 8 weeks of therapy of lozenges containing either MighTeaFlow formula with green tea catechins or a placebo, the catechin-containing MighTeaFlow formula resulted in a statistically significant increase in un-stimulated (3.8-fold) and stimulated (2.1-fold) saliva output verses baseline. In contrast, the xylitol-containing placebo failed to modulate saliva output. The results demonstrate that the catechin-containing MighTeaFlow formula partially restored salivary function in xerostomia patients and provided an objective improvement in saliva output. In conclusion, food additive natural compounds derived from tea plant are suitable for medicinal use to provide significantly higher efficacy than currently available medications or OTC products.