Pregabalin, tiapride and lorazepam in alcohol withdrawal syndrome: a multi-centre, randomized, single-blind comparison trial.
BACKGROUND
The aim of this trial was to compare lorazepam with non-benzodiazepine medications such as pregabalin and tiapride in the treatment of alcohol withdrawal syndrome (AWS). These drugs were chosen for their inhibitorial effects on the hypersecretion of neurotransmitters usually observed in AWS. Craving reduction and improvement of psychiatric symptoms were the secondary end-points.


METHODS
One hundred and ninety subjects affected by current alcohol dependence were considered consecutively: 111 were enrolled and divided into three groups of 37 subjects each. Within a treatment duration of 14 days, medication was given up to the following maximum doses (pregabalin 450 mg/day; tiapride 800 mg/day; lorazepam 10 mg/day). Withdrawal (CIWA-Ar), craving [visual analogue scale (VAS); Obsessive and Compulsive Drinking Scale (OCDS)], psychiatric symptoms [Symptom Check List 90 Revised (SCL-90-R)] and quality of life (QL-index) rating scales were applied.


RESULTS
On the CIWA-Ar score, all the groups showed a significant reduction between times (P < 0.001) with a higher reduction for the pregabalin group (P < 0.01) on items regarding headache and orientation. Retention in treatment was lower in the tiapride group (P < 0.05), while the number of subjects remaining alcohol free was higher in the pregabalin group (P < 0.05). Significant reduction between baseline and the end of the treatment was found in all the groups at the OCDS and the VAS for craving, at the SCL-90-R and QL-index (P < 0.001).


CONCLUSIONS
All the medications in the trial showed evidence of safety and efficacy in the treatment of uncomplicated forms of AWS, with some particular differences. The efficacy of pregabalin was superior to that of tiapride, used largely in research trials and, for some measures, to that of the 'gold standard', lorazepam. Accordingly, pregabalin may be considered as a potentially useful new drug for treatment of AWS, deserving further investigation.
Martinotti
Giovanni
G
Clinica Villa Maria Pia, Via del Forte Trionfale 36, Rome 00135 Italy. giovanni.martinotti@libero.it
di Nicola
Marco
M
Frustaci
Alessandra
A
Romanelli
Roberto
R
Tedeschi
Daniela
D
Guglielmo
Riccardo
R
Guerriero
Luigi
L
Bruschi
Angelo
A
De Filippis
Rocco
R
Pozzi
Gino
G
Di Giannantonio
Massimo
M
Bria
Pietro
P
Janiri
Luigi
L
D000293:Adolescent; D000328:Adult; D000368:Aged; D000437:Alcoholism / Q000188:drug therapy* / Q000523:psychology / Q000534:rehabilitation; D000700:Analgesics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008140:Lorazepam / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000069583:Pregabalin; D016037:Single-Blind Method; D013375:Substance Withdrawal Syndrome / Q000188:drug therapy* / Q000523:psychology; D013976:Tiapamil Hydrochloride / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D008140:Lorazepam; D013976:Tiapamil Hydrochloride