A phase II clinical trial of a natural formulation containing tea catechins for xerostomia

Scott S. De Rossi, Jaisri Thoppay, Douglas P. Dickinson, Stephen Looney, Mary Stuart, Kalu U.E. Ogbureke, Stephen Hsu

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)447-454.e3
JournalOral Surgery, Oral Medicine, Oral Pathology and Oral Radiology
Volume118
Issue number4
DOIs
StatePublished - Oct 1 2014

ASJC Scopus subject areas

  • Surgery
  • Oral Surgery
  • Pathology and Forensic Medicine
  • Dentistry (miscellaneous)
  • Radiology Nuclear Medicine and imaging

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