Alcohol Dependence Syndrome: One year outcome study

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1 APRIL 2007 DELHI PSYCHIATRY JOURNAL Vol. 10 No.1 Original Article Alcohol Dependence Syndrome: One year outcome study Ajeet Sidana, Sachin Rai, B.S. Chavan Department of Psychiatry, Govt. Medical College & Hospital, Sector-32, Chandigarh, India Abstract The major challenge in the treatment of patients with substance use disorders is not only to maintain the follow up but also to prevent relapse. The current study was planned to see the abstinence and relapse rate in patients with Alcohol Dependence Syndrome over a period of one year. A total of 49 patients of alcohol dependence syndrome fulfilling ICD-10 criteria were included in the study. The mean age was 43 years, majority were above 30 years, males (97.9%), employed (81.6%), and from urban (81.6%) background. the mean duration of dependence was 4.3 years, 12.2% had a family history of dependence, 20.4% had a co-morbid affective disorder and 4.0% had a co-morbid non-affective disorder. In total 71.4% received pharmacologist treatment for relapse prevention. At 6 months, abstinence rates were 100% (n = 10/ 10) for disulfiram, 60% (n=6/10) for anticraving agents (Naltrexone and Acamprosate), 30% (n=3/10) for SSRI group. At 12 months, abstinence rates were 66.67% (n=2/3) for disulfiram, 42.9% (n=3/7) for anticraving agents, 0% (n=2) for SSRI group. Keywords: Alcohol dependence, Treatment, Outcome. Introduction Alcohol is one of the commonest substances of abuse in most of the societies of the world. It is reported that nearly 30 percent of alcohol users develop temporary alcohol related problems and approximately 10 percent of men and 5 percent of women develop alcohol dependence related problems. 1 About percent of people seeking treatment from a mental health care professional have alcohol abuse or dependence. 1 Pharmacological treatment started evolving in the nineteenth century and in 1948, disulfiram became Delhi Psychiatry Journal 2007; 10:(1) Delhi Psychiatric Society the first US FDA approved drug for alcohol dependence syndrome. 2 In 1994 Naltrexone was introduced for relapse prevention. 2 Relapse prevention has been the most challenging task in alcohol dependence syndrome. One study reported an efficacy of 41% with Naltrexone and 17% with acamprosate at the end of one year. 3 In an Indian study, the reported abstinence rate was nearly 30% at the end of 2 years. 4 In another Indian Study, disulfiram was seen to be clearly superior to Naltrexone in a routine clinical practice for preventing relapse in alcohol dependent patients. 5 In a 12-week follow up study of alcohol dependent 53

2 DELHI PSYCHIATRY JOURNAL Vol. 10 No.1 APRIL 2007 patients, comparing the efficacy of naltrexone versus placebo, the authors reported that naltrexone was certainly superior in subjects who had a history of slip earlier and that at least 50% patients maintained abstinence on Naltrexone. 6 However, there are very few long-term studies for efficacy of pharmacological agents in relapse prevention of alcohol dependent patients. The current study is an attempt to assess the efficacy of pharmacotherapy in the outcome of alcohol dependence syndrome at the end of one year during routine clinical care. Aim and objectives To ascertain the follow up and outcome status of subjects with alcohol dependence syndrome undergoing treatment with various pharmacological and non-pharmacological interventions. Methodology Patients who were registered in the deaddiction clinic of the Department of Psychiatry, Government Medical College and hospital (GMCH), sector 32, Chandigarh between January 2002 to September 2002 were included in the study. A total of 49 patients of alcohol dependence syndrome fulfilling ICD-10 criteria were included in the study. Information was gathered from the Case Record Files and analyzed by a psychiatrist by using the coding plan for sociodemographic, clinical and outcome variables. Along with Pharmacological treatment, clinical psychologist imparted group education to alcohol dependent individuals. Inclusion Criteria 1. Subjects with alcohol dependence syndrome as per ICD-10 criteria. 2. Subjects who were above 18 years of age. 3. Subjects who had completed detoxification (absence of significant withdrawal symptoms) and attended weekly Group Meeting for Substance Use Disorder patients. Exclusion Criteria 1. Patients with co-morbid mental illness or substance dependence except nicotine dependence syndrome. 2. Patients with chronic medical, surgical or neurological illness. Results Table 1 shows the socio-demographic profile of the patients. The mean age was 43 years and Table 1: Sociodemographic profile Variables n = 49 Age (mean), years 43 Age Group (%) > Age of onset > Sex (%) Female 2.1 Male 97.9 Employment (%) Employed 81.6 Unemployed 12.2 Retired 4.1 Student 2.1 Education (%) Illiterate 10.2 < Matric 28.5 > = Matric 61.3 Income Rs./month (%) < > Locality (%) Rural 18.3 Urban 81.6 Religion (%) Sikh 46.9 Hindu 53.1 Others Family type (%) Joint 53.1 Nuclear 46.9 Locality (%) Rural 18.3 Urban 81.6 Religion (%) Sikh 46.9 Hindu 53.1 Others Family type (%) Joint 53.1 Nuclear Delhi Psychiatry Journal 2007; 10:(1) Delhi Psychiatric Society

3 APRIL 2007 DELHI PSYCHIATRY JOURNAL Vol. 10 No.1 majority (79.5%) were above 30 years. Majority (53.0%) of the patients had started the substance between years. Males (97.9%) grossly outnumbered females, and more patients were employed (81.6%), educated upto matric (61.3%) and with monthly income of Rs (55.1%). Also majority were from urban (81.6%), belonging to Sikh religion (46.9%) and residing in joint family system (53.1%). Table 2 shows the clinical profile of the alcohol dependence patients. The mean duration of dependence was 4.3 years. Only 12.2% had a family history of dependence. 20.4% had a comorbid affective disorder and 4.0% had a co-morbid nonaffective disorder. None of the patients had a positive family history for affective disorder however, 2.0% had a positive family history for nonaffective disorder. In total 71.4% received treatment for relapse prevention. Also, 34.7% were admitted in the ward. Table 3 shows the abstinence and relapse rates at the end of 6 months with various pharmacological agents.out of 49, 32 patients (65.3%) followed up Table-2. Clinical profile Clinical variables n = 49 Duration of dependence (mean), years 4.3 F/h/o dependence (%) 12.2 H/o other psychiatric illness (%) Affective 20.4 Non-affective 4.0 F/h/o other psychiatry illness (%) Affective Non-affective 2.0 Maintenance treatment (%) 71.4 Admission (%) in psychiatry ward Present 34.7 Absent 65.3 Table-3. Follow up and treatment Outcome at 6 months Abstinence with (%) Disulfiram (n = 10/10) 100 Nalt./acam. (n = 6/10) 60.0 SSRI (n = 3/10) 30.0 No maintenance treatment (n = 0/2) 0.0 till 6 months out of them, 2 patients were on no pharmacological agent. There were 10 patients each for disulfiram, anticraving agents (Naltrexone and acamprosate) and Serotonin specific reuptake inhibitor (SSRI). Abstinence rates were 100% (n=10/10) for disulfiram, 60% (n=6/10) for anticraving agents, 30% (n=3/10) for SSRI group. On Disulfiram, none of the patients relapsed at 6 months. However, 40% (4/10) of the patients on anticraving agent and 70% (7/10) on SSRI relapsed at 6 months. Two patients (6%) who did not take any pharmacological agent, also relapsed at 6 months. Table 4 shows the abstinence and relapse rates at 12 months with the various pharmacological agents. Only 12 out of 49 (24.5%) could be followed up at 12 months. All the 12 patients were receiving some or the other pharmacological agent. There were 3 patients on disulfiram, 7 on anticraving agents (naltrexone and acamprosate) and 2 patients on Serotonin Specific Reuptake Inhibitor (SSRI). Abstinence rates were 66.67% (n = 2/3) for disulfiram, 42.9% (n = 3/7) for anticraving agents, 0% (n = 2) for SSRI group at 1 year. Table-4. Follow up and treatment Outcome at 12 months 12 months (n = 12) Abstinence with (%) Disulfiram (n = 2/3) Nalt./acam. (n = 3/7) 42.9 SSRI (n = 0/2) 0.0 No maintenance treatment (n = 0/0) Relapse with (%) Disulfiram (n = 1/3) 33.3 Nalt./acam. (n = 4/7) 57.1 SSRI (n = 2/2) 100 No maintenance treatment (n = 0/0) Nalt.-Naltrexone, acam-acamprosate, SSRI-serotonin specific reuptake inhibitor. Discussion The mean age at presentation was 43 years with majority having their onset of alcohol intake between years. Earlier studies have also reported heavy drinking during the third and fourth decade of life. 1 The mean duration of dependence at the presentation Delhi Psychiatry Journal 2007; 10:(1) Delhi Psychiatric Society 55

4 DELHI PSYCHIATRY JOURNAL Vol. 10 No.1 APRIL 2007 for treatment was 4.3 years. This implies that people had continued alcohol for nearly 10 years before becoming dependent on it. Earlier studies have also reported duration of 8-10 years of regular alcohol use before dependence develops. 4 At 6 months follow up, all patients on disulfiram were maintaining abstinent and 60% of patients on anticraving agents (naltrexone and acamprosate) were abstinent whereas only 30% patients who were on a SSRI could remain abstinent. Similarly at 12 months, 66.67% patients on disulfiram as compared to 42.9% on anticraving agents in maintaining abstinence but the results need to be analyzed carefully. For prescribing disulfiram, a written consent was taken from the patients and patients could also opt for an anticraving agent over disulfiram. This means that the people who took disulfiram may be highly motivated to stop alcohol. Some of the earlier studies have also depicted superiority of disulfiram over anticraving agents. De Souza et al, 2004 reported an abstinent rate of 86% with disulfiram and 44% with naltrexone at one year follow up. 5 Other studies using naltrexone reported 23-62% abstinence rate after 6 week follow up. 6,7,8,9 The levels of abstincne with acamprosate in various placebo-controlled trials at 1-year follow-up ranged between 18 and 35%. 10,11,12,13 In our study, the abstinence rate with anticraving agent was 60% at 6 months and 42.9% at 12 months. These rates are similar to the rates reported in earlier studies. Thus, these agents (disulfiram or anticraving) are certainly superior to SSRIs. Certain earlier studies have reported mixed results with SSRIs as relapse prevention agents.14,15,16 Limitations and Conclusion The study was a retrospective analysis on hospitalbased population. The results need corroboration from other studies with long-term follow-ups. Sample size is small and more over due to high dropout rate, there is less number of patients in each category of treatment at 12 months period. A formal assessment of motivation and addiction severity could not be done. Such variables can affect compliance to treatment Also, along with pharmacological treatment, a psychologist imparted group education. This can also be a contributing factor for high abstinence at 6 months and 1 year. Patients who had dropped out of follow up have not been included. However, for the purpose of documenting the efficacy the status of drop out patients is also crucial. To conclude, the findings of this study suggest that pharmacological agents are useful for the relapse prevention in alcohol dependence syndrome patients. References 1. Schuckit MA. In comprehensive textbook of Psychiatry, (7th eds), Sadock BJ, Sadock VA. Alcohol related disorders. Lippincotts Williams and Wilkins: 2000; Kurtzweil P. Medications can aid recovery from alcoholism. FDA Consumer Magazine. May Rubio G, Jimenez-Arriero MA, Ponce G, Palomo T. Naltrexone versus Acamprosate: One year follow-up of Alcohol Dependence Treatment. Alcohol and Alcoholism 2001; 36 : Sarkar P, Sudarsanan S, Nath S. Outcome of Treatment of Alcohol Dependence Syndrome Patients in Military Psychiatry Set up. Medical Journal Armed Forces India 2004;60 : De Souza A, De Souza A. A one year pragmatic trial of naltrexone versus disulfiram in the treatment of alcohol dependence. Alcohol and alcoholism 2004; 39 : Volpicelli JR, Alterman AI, Hayashida M. Naltrexone in the treatment of alcohol dependence. Archives of General Psychiatry 1992; 49 : O Malley SS, Jaffe AJ, Chang G. Six month follow-up of naltrexone and psychotherapy for alcohol dependence. Archives of General Psychiatry 1996b; 53 : Anton RF, Moak DH, Waid LR. Naltrexone and cognitive behavioural therapy for the treatment of outpatient alcoholics: results of a placebocontrolled trial. Am J Psychiatry 1999; 156(11) : Chick J., Anton R., Checinski K. A multicentre, randomized, double-blind, placebo-controlled trial of naltrexone in the treatment of alcohol dependence or abuse. Alcohol and Alcoholism 2000b; 35 : Paille, FM, Guelfi JD, Perkins AC. Randomised multicentre trial of acamprosate in an 56 Delhi Psychiatry Journal 2007; 10:(1) Delhi Psychiatric Society

5 APRIL 2007 DELHI PSYCHIATRY JOURNAL Vol. 10 No.1 maintenance programme of abstinence after alcohol detoxification. Alcohol and Alcoholism 1995; 30 : Sass H, Soyka M, Mann K. Relapse prevention by acamprosate: results from a placebo controlled study on alcohol dependence Archives of General Psychiatry 1996; 53 : Whitworth AB, Fisher F, Lesch O. Comparison of acamprosate and placebo in long-term treatment of alcohol dependence. Lancet 1996; 347 : Besson J, Aeby F, Kasas A. Combined efficacy of acamprosate and disulfiram in the treatment of alcoholism: a controlled study. Alcoholism: Clinical and Experimental Research 1998; 22 : Kabel DI, Petty F. An placebo-controlled, double-blind study of fluoxetine in severe alcohol dependence: adjunctive pharmacotherapy during and after inpatient treatment. Alcohol Clin Exp Res 1996; 20 : Cornelius JR, Salloum IM, Haskett RF. Fluoxetine versus placebo in depressed alcoholics: a 1-year follow-up study. Addict Behav 2000; 25 (2) : Cornelius JR, Bukstein OG, Birmaher B. Fluoxetine in adolescents with major depression and an alcohol use disorder: an open-label trial. Addict Behav 2001; 26(5) : Delhi Psychiatry Journal 2007; 10:(1) Delhi Psychiatric Society 57

6 Statement of Ownership Printed & Published by Dr. M.S. Bhatia on behalf of Delhi Psychiatric Society and printed at AAR Computers, 290-B, D.D.A. Flats, Gazipur, Delhi and published from Department of Psychiatry, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi Dr. Manjeet Singh Bhatia Editor

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