title: A phase II clinical trial of a natural formulation containing tea catechins for xerostomia.
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.
  
  
  METHODS
  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.
authors.affiliation: Georgia Regents University, Augusta, GA, USA.
authors.forename: Scott S
authors.initials: SS
authors.lastname: De Rossi
authors.affiliation: University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Jaisri
authors.initials: J
authors.lastname: Thoppay
authors.affiliation: DENTAC, US Army, Fort Gordon, GA, USA.
authors.forename: Douglas P
authors.initials: DP
authors.lastname: Dickinson
authors.affiliation: Georgia Regents University, Augusta, GA, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Looney
authors.affiliation: Tingay Dental Clinic, Fort Gordon, GA, USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Stuart
authors.affiliation: The University of Texas Health Science Center at Houston, School of Dentistry, Houston, TX, USA.
authors.forename: Kalu U E
authors.initials: KU
authors.lastname: Ogbureke
authors.affiliation: Georgia Regents University, Augusta, GA, USA. Electronic address: shsu@gru.edu.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hsu
mesh_terms: D000328:Adult; D000368:Aged; D002392:Catechin / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013662:Tea; D016896:Treatment Outcome; D014987:Xerostomia / Q000188:drug therapy*; D014993:Xylitol
chemical_list: D010936:Plant Extracts; D013662:Tea; D002392:Catechin; D014993:Xylitol