title: Efficacy of disulfiram for the treatment of alcohol dependence assessed with a multicenter randomized controlled trial.
abstract: BACKGROUND
  The efficacy of disulfiram in preventing an alcoholic relapse has been controversial. The aim of our study was to assess the efficacy of supervised disulfiram for the treatment of alcohol dependence with a multi-institutional study in Japan.
  
  
  METHODS
  In a single-blinded, randomized placebo-controlled study, we recruited 109 patients diagnosed with alcohol dependence under ICD-10 criteria. The patients were randomly allocated to 4 treatment groups, depending on whether they took disulfiram (200 mg daily) or a placebo or whether they received adjunctive therapy consisting of mailed letters which delineated and emphasized the harmful effect of alcohol and the management of alcohol craving. The proportion of abstinence among the 4 groups at 26 weeks after discharge was the primary outcome measure. The proportion of abstinence was compared with the severity of alcohol dependence and craving. Furthermore, we examined the proportion of abstinence in patients with inactive aldehyde dehydrogenase-2 (ALDH2).
  
  
  RESULTS
  There were no significant differences among the 4 groups in terms of abstinent patients or study dropouts. The ratio of abstinence was not related to the severity of alcohol dependence or the degree of alcohol craving. Patients with inactive ALDH2 significantly sustained abstinence with the use of disulfiram (p = 0.044).
  
  
  CONCLUSIONS
  Supervised oral disulfiram use followed by intervention via letters seems to be ineffective for increasing abstinence. Further studies are necessary to prove the efficacy of disulfiram for the pharmacological treatment of alcohol dependence. We indicated the effectiveness of disulfiram for the maintenance of abstinence in patients with inactive ALDH2.
authors.affiliation: National Hospital Organization, Kurihama Medical and Addiction Center, Yokosuka, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Yoshimura
authors.forename: Mitsuru
authors.initials: M
authors.lastname: Kimura
authors.forename: Hisakazu
authors.initials: H
authors.lastname: Nakayama
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Matsui
authors.forename: Fukiko
authors.initials: F
authors.lastname: Okudaira
authors.forename: Shigeru
authors.initials: S
authors.lastname: Akazawa
authors.forename: Masao
authors.initials: M
authors.lastname: Ohkawara
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Cho
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Kono
authors.forename: Koji
authors.initials: K
authors.lastname: Hashimoto
authors.forename: Masayuki
authors.initials: M
authors.lastname: Kumagai
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Sahashi
authors.forename: Sungwon
authors.initials: S
authors.lastname: Roh
authors.forename: Susumu
authors.initials: S
authors.lastname: Higuchi
mesh_terms: D000328:Adult; D017668:Age of Onset; D000368:Aged; D000427:Alcohol Deterrents / Q000627:therapeutic use*; D000437:Alcoholism / Q000150:complications / Q000188:drug therapy*; D000444:Aldehyde Dehydrogenase / Q000235:genetics; D004221:Disulfiram / Q000627:therapeutic use*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D038801:International Classification of Diseases; D007564:Japan; D053208:Kaplan-Meier Estimate; D008111:Liver Function Tests; D008297:Male; D001523:Mental Disorders / Q000453:epidemiology / Q000209:etiology; D008875:Middle Aged; D016037:Single-Blind Method; D012959:Socioeconomic Factors; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000427:Alcohol Deterrents; D000444:Aldehyde Dehydrogenase; D004221:Disulfiram
keywords: ALDH2; Alcohol Dependence; Disulfiram; Efficacy; Randomized Controlled Trial