title: Efficacy and safety of a new oral saliva equivalent in the management of xerostomia: a national, multicenter, randomized study.
abstract: OBJECTIVE
  The clinical efficacy, safety, and acceptability of a new oral saliva equivalent (Novasial) administered four times daily in the treatment of xerostomia in various medical conditions was compared with that of oxygenated glycerol triester oral spray (Aequasyal) and a moisturizing spray (Biotene) in a 2-week, multicenter, randomized, crossover study. Assessment included patient-based evaluation of mouth dryness score (primary endpoint) with a visual analog scale (VAS), blinded assessment of the oral tissue condition by a four-point ordinal scale, and patient-based assessment of tolerability and acceptability.
  
  
  RESULTS
  At day 14, Novasial decreased oral mouth dryness by 19.5%, (12.5 ± 22.6 mm, P < .0001 versus baseline), versus 10% (6.6 ± 17.9 mm with Aequasyal, P < .0001 versus Baseline; and P < .0156 versus Novasial) and 13% (8.6 ± 18.9 mm) with Biotene (P < .0001 versus baseline). The 50% decrease in the primary endpoint was not achieved, and the overall efficacy of Novasial and Aequasyal were similar with respect to xerostomia. Novasial was preferred to Aequasyal and Biotene in alleviating taste alteration and chewing difficulty. Treatment compliance was higher with Novasial (P = .0014 versus Aequasyal). The treatments improved the oral condition with equal efficacy and were safe and well tolerated (VAS 72-77 mm).
  
  
  CONCLUSIONS
  Novasial was a safe, well-tolerated, and acceptable treatment in patients with xerostomia induced by various treatments or pathologic conditions.
authors.affiliation: Hôpital Privé Léopold Bellan, Magnaville, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Salom
authors.affiliation: Department of Internal Medicine, hôpital Claude Huriez, University Nord-de-France, Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: Assistance Publique-Hopitaux de Paris (AP-HP), University of Paris VI, Department of Dental & Head Surgery, hôpital de la Pitié-Salpétrière, France.
authors.forename: Chloé
authors.initials: C
authors.lastname: Bertolus
authors.affiliation: CHU Clermont-Ferrand, Department of Oral Surgery & INSERM U1107, Clermont-Ferrand, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Deschaumes
authors.affiliation: AP-HP, University of Paris-Diderot, Unit of Therapeutic Research, Department of Internal Medicine, hôpital Lariboisière, Paris, France.
authors.forename: Guy
authors.initials: G
authors.lastname: Simoneau
authors.affiliation: AP-HP, University of Paris-Diderot, Unit of Therapeutic Research, Department of Internal Medicine, hôpital Lariboisière, Paris, France. Electronic address: Stephane.mouly@lrb.aphp.fr.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Mouly
mesh_terms: D000284:Administration, Oral; D000368:Aged; D018592:Cross-Over Studies; D004338:Drug Combinations; D004529:Egg White; D005260:Female; D005949:Glucose Oxidase / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007784:Lactoperoxidase / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D009113:Muramidase / Q000008:administration & dosage / Q000627:therapeutic use*; D012464:Saliva, Artificial / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014280:Triglycerides / Q000008:administration & dosage / Q000627:therapeutic use; D014987:Xerostomia / Q000188:drug therapy*
chemical_list: C111669:Biotene; D004338:Drug Combinations; D012464:Saliva, Artificial; D014280:Triglycerides; D005949:Glucose Oxidase; D007784:Lactoperoxidase; D009113:Muramidase