Gamma-hydroxybutyric acid (GHB) in the treatment of alcohol withdrawal syndrome: a randomized comparative study versus benzodiazepine.
BACKGROUND
Benzodiazepine has been shown to be one of the most effective class of drugs in the management of alcohol withdrawal syndrome (AWS). Gamma-hydroxybutyric acid (GHB) has recently been introduced in the treatment of alcohol problems, including AWS. At present there are no comparative studies between benzodiazepines and GHB in AWS treatment. The aim of the present randomized, controlled, single-blind study was to evaluate the efficacy and safety of GHB compared with diazepam in the treatment of AWS.


METHODS
Sixty alcoholics affected by AWS were enrolled in the study. Diazepam (0.5-0.75 mg/kg body weight for 6 days, tapering the dose 25% daily until day 10) was administered orally to 30 patients (25 males, 5 females; mean age 44.3 +/- 10.9 years); GHB (50 mg/kg body weight for 10 days) was administered orally to 30 patients (26 males,4 females; mean age 41.7 +/- 10.4 years). The Clinical Institute Withdrawal Assessment for Alcohol-revised scale (CIWA-Ar) was used to evaluate the AWS physical symptoms. The State Anxiety Inventory test for current anxiety assessment and the Zung self-rating Depression Scale for current depression assessment were performed.


RESULTS
Eight patients (26.6%) in the diazepam group and 4 patients (13.3%) in the GHB group dropped out. Both treatments were effective in reducing AWS. No significant difference was found between the groups in CIWA-Ar total score at baseline and at the different times of observation. Considering the CIWA-Ar subscore and Zung scale, a significant reduction of anxiety on day 4 (p < 0.02), agitation on day 5 (p < 0.02) and time of recovery of depression on day 5 (p < 0.02) was observed in the GHB group with respect to the diazepam group. Drowsiness and vertigo developed after initial drug administration in the GHB (19.2%) and diazepam (36.4%) groups and quickly resolved in both groups.


CONCLUSIONS
GHB is as effective in the management of AWS as benzodiazepine and it seems to be quicker in reducing anxiety, agitation, and depression. Both drugs are safe and well-tolerated in AWS management.
Addolorato
G
G
Institute of Internal Medicine, Universita' Cattolica del Sacro Cuore, Rome, Italy. ecapristo@pelagus.it
Balducci
G
G
Capristo
E
E
Attilia
M L
ML
Taggi
F
F
Gasbarrini
G
G
Ceccanti
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy; D001569:Benzodiazepines / Q000627:therapeutic use*; D002492:Central Nervous System Depressants / Q000009:adverse effects*; D003863:Depression / Q000188:drug therapy; D000431:Ethanol / Q000009:adverse effects* / Q000097:blood; D005260:Female; D006801:Humans; D006885:Hydroxybutyrates / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D013375:Substance Withdrawal Syndrome / Q000097:blood / Q000188:drug therapy*; D011795:Surveys and Questionnaires
D014151:Anti-Anxiety Agents; D002492:Central Nervous System Depressants; D006885:Hydroxybutyrates; D001569:Benzodiazepines; C111420:4-hydroxybutyric acid; D000431:Ethanol