title: Efficacy and safety of rebamipide for the treatment of dry mouth symptoms in patients with Sjögren's syndrome: a double-blind placebo-controlled multicenter trial.
abstract: The effects of rebamipide on dry mouth and salivary secretion in Sjögren's syndrome patients were investigated in a double-blind placebo-controlled study. Rebamipide (100 mg TID) or placebo was administered for eight weeks and patient-assessed improvement of dry mouth and increase in salivary secretion measured by the Saxon test were evaluated. At two, four, and eight weeks, dry mouth improvement rates were, respectively, 26.0, 44.0, and 46.9% for rebamipide and 20.0, 27.1, and 39.1% for placebo, and mean increases in salivary secretion were, respectively, 0.14, 0.24, and 0.35 g for rebamipide and 0.03, 0.09, and 0.17 g for placebo, indicating higher values in the rebamipide group for both parameters at all timepoints but no significant differences between the two groups. Analysis by baseline characteristics suggested a statistically significant salivary secretion increasing effect of rebamipide in cases of primary Sjögren's syndrome. No difference in the incidence of adverse events was seen between the two groups, confirming the safety of rebamipide. As a salivary secretion increasing effect was strongly suggested in cases of primary Sjögren's syndrome, further study on the administration of rebamipide for the treatment of dry mouth in patients with Sjögren's syndrome is required.
authors.affiliation: Kanazawa Medical University, Ishikawa, Japan. sussugai@helen.ocn.ne.jp
authors.forename: Susumu
authors.initials: S
authors.lastname: Sugai
authors.forename: Hiroki
authors.initials: H
authors.lastname: Takahashi
authors.forename: Shuji
authors.initials: S
authors.lastname: Ohta
authors.forename: Makoto
authors.initials: M
authors.lastname: Nishinarita
authors.forename: Masami
authors.initials: M
authors.lastname: Takei
authors.forename: Shigemasa
authors.initials: S
authors.lastname: Sawada
authors.forename: Ken
authors.initials: K
authors.lastname: Yamaji
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Oka
authors.forename: Hisanori
authors.initials: H
authors.lastname: Umehara
authors.forename: Ichiro
authors.initials: I
authors.lastname: Koni
authors.forename: Eiji
authors.initials: E
authors.lastname: Sugiyama
authors.forename: Susumu
authors.initials: S
authors.lastname: Nishiyama
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kawakami
mesh_terms: D000368:Aged; D000409:Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009055:Mouth / Q000187:drug effects; D011453:Prostaglandins / Q000096:biosynthesis; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012463:Saliva / Q000187:drug effects / Q000378:metabolism; D012859:Sjogren's Syndrome / Q000188:drug therapy*; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome; D014987:Xerostomia / Q000188:drug therapy*
chemical_list: D000893:Anti-Inflammatory Agents; D011453:Prostaglandins; D015363:Quinolones; C052785:rebamipide; D000409:Alanine