Get Well Clinic And Nursing Home, 33rd Road, Off Linking Road, Bandra, Mumbai 400050, Maharashtra State, India
* Author to whom correspondence should be addressed: Tel.: +91 22 26460785; E-mail: avinashdes999{at}yahoo.co.uk
(Received 11 March 2005; first review notified 6 June 2005; in final revised form 21 June 2005; accepted 2 July 2005)
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ABSTRACT |
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INTRODUCTION |
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Pooled analysis of ACP trials confirms its efficacy in the maintenance of abstinence in alcohol dependence (Lesch et al., 2001; Slattery et al., 2003
; Mann et al., 2004
; Verheul et al., 2004
) (www.docs.scottishmedicines.org/docs/pdf/Alcohol%20Report.pdf). However, this efficacy is relatively modest with an average effect size of only 0.26 (Berglund et al., 2003
) and some subsequent studies have not shown efficacy (e.g. Namkoong et al., 2003
). ACP reduces the severity of relapse in alcoholics undergoing abstinence-oriented treatment (Chick et al., 2003
), and may even be effective in the management of alcohol-dependent adolescents (Niederhofer and Staffen, 2003
). It is the only anti-craving agent so far with good cost effectiveness ratings in the management of alcoholism (Schadlich and Brecht, 1998
; Foster and McClellan, 1999
).
DSF is an alcohol deterrent that inhibits acetaldehyde dehydrogenase. The resulting increase in acetaldehyde levels in the body leads to the characteristic DSFethanol reaction that includes a sense of uneasiness, flushing, nausea, and vomiting (Savas and Gullu, 1997). Several reviews support the efficacy of DSF, if supervised, in the treatment of alcohol dependence (Brewer, 1992
; 1995
; Berglund et al., 2003
; Slattery et al., 2003
).
We reported a comparison of DSF and NTX and found DSF considerably more effective in reducing the frequency and severity of relapse (De Sousa and De Sousa, 2004). However, there have been no studies so far comparing DSF and ACP, though Besson et al. (1998)
found that, in a study where there was random allocation to placebo or ACP, patients who had chosen to take DSF did particularly well compared to patients who had not chosen DSF whether on placebo or ACP. The aim of this study was to compare DSF and ACP in patients with pure alcohol dependence. As with our comparison of DSF and NTX, an open trial design was chosen, partly because it would have been difficult to maintain compliance and blinding in a long trial and partly because the patients' awareness that they are taking DSF is an important factor in DSF's effectiveness.
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SUBJECTS and METHODS |
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Inclusion criteria
Exclusion criteria
Assessment procedure
After signing the informed consent declaration, subjects completed:
They were given a calendar to record any alcohol consumption during the follow-up. Baseline aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transferase (GGT), and serum bilirubin were done.
Following randomisation, patients received either 250 mg of DSF or 1998 mg of ACP per day. DSF was given as a single daily dose after breakfast while ACP was given as 666 mg thrice daily after meals. The importance of family members observing patients when they took medication to enhance compliance was emphasised. Only the non-dispersible form of DSF is available in India.
Patients were followed up weekly for the first 3 months and then fortnightly until the end of the trial. At each follow-up, they were assessed for craving and adverse effects along with compliance and alcohol consumption. Self-reports were checked against reports of family members. All patients were offered weekly supportive group psychotherapy during the trial. It was probably less structured than in classical treatment programmes. Abstinence was positively reinforced. Patients also received symptomatic treatment for depression (escitalopram 10 mg/day) or insomnia (zolpidem 510 mg at night), when required. Benzodiazepines were not prescribed.
Outcome measures
The following outcome measures were assessed:
Statistical analysis
Chi square test and Student's t-test were used in the statistical analysis. All outcome analyses were conducted on an intention to treat principle. Drop-outs were considered as relapses. The number of drinks consumed per week, number of drinks consumed at a time, and the serum GGT were analysed using the analysis of covariance (ANCOVA).
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RESULTS |
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Table 1 shows that there were no significant differences between the treatment groups in terms of baseline socio-demographic or clinical variables.
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DISCUSSION |
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LIMITATIONS |
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ACKNOWLEDGEMENTS |
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REFERENCES |
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