title: Metadoxine in acute alcohol intoxication: a double-blind, randomized, placebo-controlled study.
abstract: BACKGROUND
  At present there are only intriguing and preliminary clinical results regarding the efficacy of metadoxine (pyridoxol L-2-pyrrolidone-5-carboxylate) in acute alcohol intoxication. The present study was planned with the aim of investigating the effectiveness of metadoxine in the management of patients affected by acute ethanol intoxication.
  
  
  METHODS
  A double-blind, randomized, multicenter, placebo-controlled trial was carried out on 58 patients of both sexes with acute ethanol intoxication. Patients were treated with a single dose of 900-mg intravenous metadoxine (n = 29) or with placebo (n = 29). Patients were clinically and biochemically evaluated at 0.5, 1, 2, 3, 6, 9, and 12 hr after treatment.
  
  
  RESULTS
  Treatment with metadoxine significantly decreased the half-life of ethanol in blood (from 6.70 +/- 1.84 to 5.41 +/- 1.99 hr; p < 0.013) and showed a faster rate of ethanol elimination. The effects on ethanol half-life in blood were accompanied by a faster onset of recovery from intoxication, defined as the time of the transition of blood ethanol levels to the immediately lower range defined by intoxication categories (in g/liter: 0 to 0.5, absent; 0.51 to 1.0, mild; 1.1 to 2.5, moderate; >2.5, severe). Thus the median time to onset of recovery was 0.95 hr with metadoxine and 2.34 hr with placebo (p = 0.013). The effects of treatment on blood alcohol levels were paralleled by a significant decrease in the rating of the toxic clinical symptomatology. At 2 hr the improvement of toxic symptoms (in percent of maximum possible) was 68 +/- 28 vs. 44 +/- 27% in controls (p < 0.002).
  
  
  CONCLUSIONS
  In patients with acute ethanol intoxication metadoxine accelerated the elimination of ethanol from blood, which led to faster recovery from intoxication, and improved the behavioral toxic symptomatology. Metadoxine could be helpful in the management of acute ethanol intoxication.
authors.affiliation: Narcological County Dispensary, Vasyleostrovsky District 4.th, Line V. 0.2 3-2 5, St. Petersburg, Russia.
authors.forename: Leonid S
authors.initials: LS
authors.lastname: Shpilenya
authors.forename: Alexander P
authors.initials: AP
authors.lastname: Muzychenko
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gasbarrini
authors.forename: Giovanni
authors.initials: G
authors.lastname: Addolorato
mesh_terms: D000328:Adult; D000427:Alcohol Deterrents / Q000009:adverse effects / Q000627:therapeutic use*; D000435:Alcoholic Intoxication / Q000097:blood / Q000188:drug therapy*; D000704:Analysis of Variance; D016009:Chi-Square Distribution; D004311:Double-Blind Method; D004338:Drug Combinations; D000431:Ethanol / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011736:Pyridoxine / Q000009:adverse effects / Q000627:therapeutic use*; D011761:Pyrrolidonecarboxylic Acid / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000427:Alcohol Deterrents; D004338:Drug Combinations; D000431:Ethanol; C037845:metadoxine; D011736:Pyridoxine; D011761:Pyrrolidonecarboxylic Acid