title: Irsogladine maleate and rabeprazole in non-erosive reflux disease: A double-blind, placebo-controlled study.
abstract: OBJECTIVE
  To evaluate the efficacy of adding irsogladine maleate (IM) to proton-pump inhibitor (PPI) therapy in non-erosive reflux disease (NERD) treatment.
  
  
  METHODS
  One hundred patients with NERD were recruited and randomized to receive rabeprazole plus IM (group I) or rabeprazole plus placebo (group P). The efficacy of the treatment was assessed using the Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease (FSSG) and the short form (SF)-36 quality of life questionnaires after four weeks of treatment. We also assessed whether patients with NERD with minimal changes (grade M) had different responses to the therapies compared with patients who did not have minimal changes (grade N).
  
  
  RESULTS
  Group I and group P showed significant improvements in their FSSG scores after the treatment (from 17.9 ± 7.9 to 9.0 ± 7.6, and from 17.7 ± 7.3 to 11.2 ± 7.9, respectively, P = 0.0001), but there was no statistically significant difference between the FSSG scores in group I and those in group P. Subgroup analysis showed that significant improvements in the FSSG scores occurred in the patients in group I who had NERD grade N (modified Los Angeles classification) (7.8 ± 7.4 vs 12.5 ± 9.8, P = 0.041). The SF-36 scores for patients with NERD grade N who had received IM and rabeprazole were significantly improved in relation to their vitality and mental health scores.
  
  
  CONCLUSIONS
  The addition of IM to rabeprazole significantly improves gastroesophageal reflux disease symptoms and the quality of the lives of patients with NERD grade N.
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Takayoshi
authors.initials: T
authors.lastname: Suzuki
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Matsushima
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Aya
authors.initials: A
authors.lastname: Masui
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Tsuda
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Jin
authors.initials: J
authors.lastname: Imai
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Nakamura
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Tsukune
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Tetsufumi
authors.initials: T
authors.lastname: Uchida
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yuhara
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Muneki
authors.initials: M
authors.lastname: Igarashi
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Koike
authors.affiliation: Takayoshi Suzuki, Masashi Matsushima, Aya Masui, Shingo Tsuda, Jin Imai, Jun Nakamura, Yoko Tsukune, Tetsufumi Uchida, Hiroki Yuhara, Muneki Igarashi, Jun Koike, Tetsuya Mine, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 259-1193, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mine
mesh_terms: D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D064750:Rabeprazole / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D014227:Triazines; D064750:Rabeprazole; C041836:irsogladine
keywords: Frequency scale for the symptoms of gastroesophageal reflux disease; Irsogladine maleate; Non-erosive reflux disease; Quality of life; Rabeprazole; Randomized controlled trial