title: Effects of omeprazole on sleep disturbance: randomized multicenter double-blind placebo-controlled trial.
abstract: OBJECTIVE
  Gastroesophageal reflux is considered to cause sleep disturbance, whereas proton pump inhibitor (PPI) administration is reported to improve insomnia associated with gastroesophageal reflux disease (GERD). The majority of patients with gastroesophageal reflux are asymptomatic and a significant number with erosive esophagitis are also reported to be asymptomatic. We examined whether PPI administration has a therapeutic effect for improving insomnia in patients without reflux symptoms in the same manner as patients with reflux symptoms.
  
  
  METHODS
  We performed a randomized multicenter double-blind placebo-controlled trial using 176 patients with insomnia regardless of the presence of reflux symptoms. The patients were divided into those administered omeprazole (20 mg) or a placebo for 14 days. Four self-reporting questionnaires, QOLRAD-J (Japanese translation of Quality of Life in Reflux and Dyspepsia), Pittsburg Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and a sleep diary, were used for evaluating GERD-related quality of life (QOL) and sleep disturbance.
  
  
  RESULTS
  We evaluated 171 patients with insomnia, of whom 69 had typical reflux symptoms. Omeprazole statistically significantly improved GERD-related QOL from 30.8±0.7 to 33.0±0.5 (P<0.01) (QOLRAD-J, total) and from 6.0±0.2 to 6.6±0.1 (P<0.01) (QOLRAD-J, sleep-related) when administrated to patients with reflux symptoms. Omeprazole also improved insomnia significantly better than the placebo in patients with reflux symptoms; PSQI, from 9.3±0.5 to 7.9±0.5 (P<0.01) and sleep diary, from 2.1±0.1 to 1.8±0.1 (P<0.01). On the other hand, the therapeutic effects of omeprazole and the placebo were not different in patients without reflux symptoms.
  
  
  CONCLUSIONS
  Our results showed that PPI administration is effective only for insomnia in patients with reflux symptoms.
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University, Izumo, Japan.
authors.forename: Masahito
authors.initials: M
authors.lastname: Aimi
authors.affiliation: Department of Medicine, Izumo City Medical Center, Izumo, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Komazawa
authors.affiliation: Hamamoto Medical Clinic, Izumo, Japan.
authors.forename: Naoharu
authors.initials: N
authors.lastname: Hamamoto
authors.affiliation: Department of Medicine, Yamane Hospital, Hamada, Japan.
authors.forename: Yuko
authors.initials: Y
authors.lastname: Yamane
authors.affiliation: Department of Medicine, Masuda Medical Association Hospital, Masuda, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Furuta
authors.affiliation: Department of Gastroenterology, Matsue Red Cross Hospital, Matsue, Japan.
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Uchida
authors.affiliation: Department of Endocrinology and Metabolism, Shimane University, Izumo, Japan.
authors.forename: Shozo
authors.initials: S
authors.lastname: Yano
authors.affiliation: Department of Endocrinology and Metabolism, Shimane University, Izumo, Japan.
authors.forename: Miwa
authors.initials: M
authors.lastname: Morita
authors.affiliation: Department of Neurology, Shimane University, Izumo, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Oguro
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University, Izumo, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Miyake
authors.affiliation: Department of Endocrinology and Metabolism, Shimane University, Izumo, Japan.
authors.forename: Toshitsugu
authors.initials: T
authors.lastname: Sugimoto
authors.affiliation: Department of Pharmacy, Shimane University Hospital, Izumo, Japan.
authors.forename: Seiichi
authors.initials: S
authors.lastname: Nagi
authors.affiliation: Department of Pharmacy, Shimane University Hospital, Izumo, Japan.
authors.forename: Kohji
authors.initials: K
authors.lastname: Naora
authors.affiliation: Goubaru Medical Clinic, Oda, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Goubaru
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University, Izumo, Japan.
authors.forename: Shunji
authors.initials: S
authors.lastname: Ishihara
authors.affiliation: Department of Gastroenterology and Hepatology, Shimane University, Izumo, Japan.
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Kinoshita