TY - JOUR
T1 - A phase II clinical trial of a natural formulation containing tea catechins for xerostomia
AU - De Rossi, Scott S.
AU - Thoppay, Jaisri
AU - Dickinson, Douglas P.
AU - Looney, Stephen
AU - Stuart, Mary
AU - Ogbureke, Kalu U.E.
AU - Hsu, Stephen
N1 - Funding Information:
Financial support: This study was support in part by an International Association for Dental Research /GlaxoSmithKline Innovation in Oral Care Award (2011) and by a grant from the Georgia Research Alliance .
Publisher Copyright:
© 2014 Elsevier Inc.
PY - 2014/10/1
Y1 - 2014/10/1
N2 - Objective Previous animal studies indicated catechins from the tea plant (Camellia sinensis) may modulate salivary function and possess a therapeutic effect for xerostomia. The objective of this study was to evaluate a natural formulation containing tea catechins in 60 patients with xerostomia, including patients with Sjögren syndrome. Study Design This study used a double-blind, placebo-controlled, randomized design. The functional placebo contained all natural formulation ingredients and 500 mg xylitol, but without the key plant extracts. Results After 8 weeks of therapy, the xylitol-containing placebo failed to modulate saliva output. In comparison, the catechin-containing natural formulation resulted in a statistically significant increase in unstimulated (3.8-fold) and stimulated (2.1-fold) saliva output vs baseline. The quality of life score showed a significant improvement in both groups but no significant difference between groups. Conclusions The catechin-containing natural formula partially restored salivary function in patients with xerostomia and provided an objective improvement in saliva output, which warrants large-scale clinical trials.
AB - Objective Previous animal studies indicated catechins from the tea plant (Camellia sinensis) may modulate salivary function and possess a therapeutic effect for xerostomia. The objective of this study was to evaluate a natural formulation containing tea catechins in 60 patients with xerostomia, including patients with Sjögren syndrome. Study Design This study used a double-blind, placebo-controlled, randomized design. The functional placebo contained all natural formulation ingredients and 500 mg xylitol, but without the key plant extracts. Results After 8 weeks of therapy, the xylitol-containing placebo failed to modulate saliva output. In comparison, the catechin-containing natural formulation resulted in a statistically significant increase in unstimulated (3.8-fold) and stimulated (2.1-fold) saliva output vs baseline. The quality of life score showed a significant improvement in both groups but no significant difference between groups. Conclusions The catechin-containing natural formula partially restored salivary function in patients with xerostomia and provided an objective improvement in saliva output, which warrants large-scale clinical trials.
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U2 - 10.1016/j.oooo.2014.06.015
DO - 10.1016/j.oooo.2014.06.015
M3 - Article
C2 - 25240992
AN - SCOPUS:84922851647
SN - 2212-4403
VL - 118
SP - 447-454.e3
JO - Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
JF - Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
IS - 4
ER -