title: Natural products for the management of xerostomia: a randomized, double-blinded, placebo-controlled clinical trial.
abstract: OBJECTIVE
  The aim of this study was to evaluate the clinical performance of lycopene-enriched virgin olive oil in spray form used to treat patients with drug-induced xerostomia, comparing this with a placebo spray.
  
  
  METHODS
  This double-blind, randomized clinical trial included elderly subjects with drug-induced xerostomia (n = 60). Resting salivary flow was measured using the draining technique. The Xerostomia Inventory (XI) was used to assess symptoms and the Oral Health Impact Profile 14 (OHIP-14) to assess patient quality of life. Evaluations were made before and after 12 weeks of product/placebo application.
  
  
  RESULTS
  Sixty patients took part in the study. Symptoms improved among the treatment group (n = 30) after 12 weeks in the following XI domains: 'Rate the difficulty you experience in speaking because of dryness' (P = 0.03); 'Rate how much saliva is in your mouth' (P = 0.03); and 'Rate the dryness of your lips' (P = 0.04). The placebo group (n = 30) underwent improvements in: 'Rate how much saliva is in your mouth' (P = 0.02) and 'Rate the dryness of your mouth' (P = 0.01). A significant improvement (P = 0.001) in oral-related quality of life (OHIP-14) was identified in the treatment group, while no significant differences were observed in the placebo group (P > 0.05).
  
  
  CONCLUSIONS
  The topical application of lycopene-enriched virgin olive oil and its placebo counterpart improved xerostomia-related symptoms significantly (but not salivary flow rate) in patients with drug-induced xerostomia.
authors.affiliation: Department of Oral Medicine, Ageing Research Institute, Faculty of Medicine and Dentistry, University of Murcia, Murcia, Spain.
authors.forename: Anabel
authors.initials: A
authors.lastname: Navarro Morante
authors.affiliation: Saliwell Ltd., Harutzim, Israel.
authors.forename: Andy
authors.initials: A
authors.lastname: Wolff
authors.affiliation: University of El Bosque, Bogotá, Colombia.
authors.forename: Gloria Rocio
authors.initials: GR
authors.lastname: Bautista Mendoza
authors.affiliation: Department of Oral Medicine, Faculty Medicine and odontology Biomedical Research Institute of Murcia (IMIB-Arrixaca-UMU), University Clinical Hospital 'Virgen de la Arrixaca', University of Murcia, Murcia, Spain.
authors.forename: Pia
authors.initials: P
authors.lastname: López-Jornet
mesh_terms: D000287:Administration, Topical; D000368:Aged; D001688:Biological Products / Q000627:therapeutic use*; D002338:Carotenoids / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000077276:Lycopene; D008297:Male; D008875:Middle Aged; D000069463:Olive Oil / Q000627:therapeutic use*; D011788:Quality of Life; D012463:Saliva; D011795:Surveys and Questionnaires; D064232:Visual Analog Scale; D014987:Xerostomia / Q000139:chemically induced / Q000628:therapy*
chemical_list: D001688:Biological Products; D000069463:Olive Oil; D002338:Carotenoids; D000077276:Lycopene
keywords: dry mouth; lycopene; quality of life; saliva; topical application; xerostomia