Quality of life as an outcome measure in the treatment of alcohol dependence.

BACKGROUND: Quality of life has emerged as an important treatment outcome measure for alcohol dependence whose natural course comprises of remission and relapse.
MATERIALS AND METHODS: The purpose of this study was to examine the prospective change in Quality of life (QoL) in 56 patients aged 18-45 years of alcohol dependence over a three months' period and compare it with QoL of 150 age- and gender- matched healthy controls using WHOQoL-BREF. Severity of alcohol dependence and drinking parameters were assessed.
RESULTS: Significant improvement in QoL of patients of alcohol dependence over three months' abstinence. The physical, psychological, social, and environment domains of QoL in alcohol dependence subjects were significantly lower before treatment initiation than the healthy controls. Alcoholic liver disease emerged as a predictor of improvement in psychological and social domains of QoL.
CONCLUSION: The study confirms poor quality of life in patients of alcohol dependence before intervention. The regular follow-up with the family members in out-patient setting enables the patients achieve complete abstinence, thereby improving their quality of life.

Alcohol dependence, a common psychiatric disorder in the general population, has a significant impact on health. In recent years, alcohol dependence has become a major social and personal menace in most societies. According to Global Status Report on Alcohol,[1] alcohol use disorders accounted for 1.4% of the global disease burden. Alcohol consumption causes 3.2% of deaths (1.8 million) and 4.0% of the disability-adjusted life years lost (58.3 million).

In northern India including Delhi, the 1-year prevalence of alcohol use has been estimated as 25 to 40% in the general population, whereas in southern India, this rate has been estimated as 30 to 50%. In southern India, the prevalence of alcohol use is higher among people of lower socio-economic status and those with lower levels of education.[2] A large-scale survey over 32,000 people performed in 2001 in India found alcohol use rates of 20 to 38% in males and 10% among females.[3] Some people are more likely to experience the consequences of alcohol use. These tend to be male[45] having high perceived stress and anxiety with dissatisfaction and poor quality of life, lack of social support, economic strains, and chronic stress.[6] Das, Balakrishnan, and Vasudevan reported that in a developing country like India, over 20% of all disability-adjusted life years are lost chiefly because of poor health status of the people, marked nutritional deficiencies, and widely prevalent alcohol addiction.[7]

QoL is an important parameter that provides an insight into how a disorder impacts life of those affected. World Health Organization[8] defined quality of life as “an individual's perception of their position in life, and in the context of culture and value systems in which they live, and also in relation to their goals, expectations, standards, and concerns.” Among various psychiatric disorders, alcohol-related disorders significantly affect QoL, but this area has not been extensively studied.

The alcohol use disorder, which is usually chronic, requires patients to muster all their capacities for reconstruction and adaptation. QoL, which is a concept situated between social and clinical sciences, is a pertinent indicator to evaluate the subjective experience of the patient and to quantify the psychosocial burden of alcoholism.[910] Patient-reported outcome measures such as QoL may be useful in orientating choice between different therapeutic options since effective treatment should not only improve the clinical state and prognosis of the patient but also their QoL. In current practice, the QoL of alcohol-dependent patients is not measured systematically, even though this is relevant to the psychosocial context of interventions.[1112] Studies on alcohol-dependent patients have found QoL as considerably decreased, but little information is available on how QoL changes following a therapeutic intervention.[11121314] Some studies had reported a poor QoL in alcohol-dependent patients at the beginning of treatment, but the factors responsible for it have not been investigated in a systematic way.[1516] Foster et al.[17] reviewed ‘QoL in alcohol-dependent subjects and noted 24 publications on the topic from 1982 to 1997. A Medline BIDS database record search from 1998 to 2004 with the same key words identifies only three additional studies. QoL of alcohol-dependent subjects was reduced compared with that of a normative healthy population.[141819] Foster et al.[20] reported poorer quality of life for women in comparison to men who were alcohol-dependent.

There is paucity of published literature on QoL in alcohol dependence subjects treated in an outpatient clinic. To the best of our knowledge, this is the first study from a developing country, which incorporated laboratory parameters, psychosocial consequences, drinking parameters associated with changes in QoL of alcohol dependence subjects after intervention in an outpatient setting. The present study was, therefore, undertaken with objectives (1) to determine the change in QoL in patients of alcohol dependence subjects prospectively over three months’ follow up; (2) compare QoL among patients with alcohol dependence and healthy controls and assess the relationship between disease severity and QoL; and (3) study the factors associated with the outcome of QoL.

MATERIALS AND METHODS

The sample consisted of consecutive male patients aged 18 to 45 years suffering from alcohol dependence according to DSM-IV TR criteria.[21] The present study was conducted in the De-addiction Outpatient Clinic of University College of Medical Sciences and Guru Teg Bahadur Hospital, a tertiary care hospital in Delhi, from November 2007 to June 2008.

All the consecutive men suffering from alcohol dependence, who were not in intoxicated state, were requested to participate in the study. Approval for the study was obtained from the Ethics Committee of Institution as well as from Council of Scientific and Industrial Research, Delhi. All patients who agreed to participate in the study signed the written informed consent form. The participants were explained that the study aimed at assessing drinking parameters, psychological and physical health domains, and the severity of alcohol dependence. The assessments would include answering questionnaires, undergoing laboratory investigations, attending group sessions, receiving medication, and involvement of family members/caregivers in the treatment plan.

One hundred and fifty healthy controls who were age- and gender- matched with the study subjects and had no relevant findings on physical examination and investigations were taken. Exclusion criteria consisted of patients with a history of bipolar disorder, schizophrenia or any psychotic disorder, epilepsy or present condition or history of organic mental disorder or any non-stable physical disease, multiple drug abuse. Each patient was administered Mini Mental State Examination (MMSE). Those patients with cognitive deficits (as defined by a score <24 on MMSE) were excluded.

The participants were recruited according to the above-mentioned inclusion criteria by a qualified psychiatrist after obtaining an informed consent. World Health Organization Quality of Life instrument (WHOQoL BREF version), 26-item questionnaire was administered at baseline and at 3 months follow-up who was unaware of the intervention allocation of the subjects.

Alcoholic liver disease is defined as damage to the liver and its function due to alcohol abuse. Alcoholic liver disease (ALD) covers a spectrum of injury ranging from fatty liver to alcoholic hepatitis to frank cirrhosis. In a study by Levitsky and Mailliard,[22] the diagnosis of alcoholic liver disease was based on a history of significant alcohol intake, clinical evidence of liver disease, and supporting laboratory abnormalities.

Routine laboratory investigations including liver function tests and ultrasound abdomen were carried out for all the participants. The subjects with deranged liver function tests and evidence of liver disease on ultrasound abdomen were included for alcoholic liver disease.

Identifiable psychiatric disorders including psychoactive substance-related disorders (other than alcohol) as per the DSM-IV TR criteria[21] were included under the category of psychiatric co-morbidity.

The subjects were detoxified using benzodiazepines, vitamin tablets, pharmacological treatment for medical or psychiatric co-morbidities, psycho-education and counseling sessions for study subjects and family members. Psychosocial intervention included motivational interviewing for the study participants. Psycho-educative group sessions for the study subjects comprised of harmful effects of alcohol, medical complications, craving and relapse prevention and were held once in a week.

Apart from the pharmacological interventions, the study subjects and caregivers were educated about different non-pharmacological options like Yoga[23] and Alcoholic Anonymous.[24] It was emphasized in the psycho-educative group sessions that addicts need to be involved in alternate coping strategies and healthy lifestyle.

The caregiver, usually a family member who visited the outpatient clinic most of the times with the patient, had been a reliable informant. Caregivers were involved in the treatment process from the beginning of history-taking, examinations, and investigations. The caregivers were psycho-educated about various issues in group sessions once in a week like, for example, alcohol and its ill effects on physical and mental health (first session), alcohol dependence is a disorder which requires specialized treatment and care (second session), family support plays a pivotal role in achieving complete abstinence, especially in managing exposure to cues and peer pressures (third session), treatment adherence was duly emphasized in all the follow-up visits to the caregivers (all sessions), medical complications (fourth session), social, family, and legal complications were duly explained and their queries were addressed (fifth session). Caregivers were in constant contact with the treating team by means of follow-up visits, scheduled psycho-educative group sessions for the caregivers once in two weeks. Telephonic contact with the caregivers was ensured. Caregivers were explained the differences between a lapse and a relapse.

The study was carried out in a tertiary care teaching government hospital on an outpatient basis, which has free supply of essential drugs, no consultation fees, free or nominal laboratory/ultrasound charges, and free group sessions making the services available to poor people.

Socio-demographic data which included age, gender, marital status, occupation, education level, monthly income of the patient and family, religion were noted from each participant. The details about alcohol use included severity of dependence, duration of use, quantity, type and frequency of alcohol used per day in the month prior to admission. The data also included the relevant treatment history, previous attempts at abstinence, past, family history, personal history, and findings of general physical and psychiatric examination were collected.

Physical consequences of alcohol consumption were obtained through a self-report questionnaire for history-taking, physical examination findings, and relevant investigation.

Social consequences of drinking were assessed using Quantitative Inventory of Alcohol disorders (QIHD).[25] Participants were then administered Severity of Alcohol Dependence Questionnaire (SADQ),[26] which consisted of five sections - physical withdrawal, affective withdrawal, withdrawal relief, typical daily consumption, and the morning after two days heavy drinking following at least four weeks of abstinence. Items in the first four sections used a 4-point scale (almost never, sometimes, often, or nearly always). The last section employed a severity scale. The instrument had good reliability and validity.

WHO Quality of Life (WHOQOL) - BREF is a 26-item multiple-choice questionnaire. It assesses a quality of life profile consisting of four domains i.e. physical, psychological, social, and environmental. There are also two items that are examined separately: Question 1 asks about an individual's overall perception of quality of life, and question 2 asks about an individual's overall perception of their health. A pilot study by Da Salva Lima et al.[27] demonstrated that WHO QoL (BREF version) is a valid instrument for the assessment of quality of life in patients with alcohol dependence.

Statistical analyses

Statistical analysis was done using Statistical Package for Social Sciences (SPSS) version 17.0 (SPSS Inc., Chicago, IL). Comparison between the baseline and three months’ QoL domain scores of study subjects was carried out using paired t-test. Comparison was also made between baseline QoL domain scores of alcohol dependence subjects and healthy controls by using unpaired t-test. Pearson correlation coefficients were used to examine the relationship between disease severity and QoL domain scores of the study subjects. Logistic regressions were performed to obtain the relationship by considering difference of three months and baseline domain scores of QoL as dependent factors. Baseline socio-demographic variables, duration of alcohol use, liver disease, severity of quantity consumed per day, and psychosocial consequences were entered as independent variables one by one.

RESULTS

Characteristics of the study population

A total of 65 patients were recruited for the study. Five patients dropped out of the study after their first visit. Three of these patients cited reason that they were traveling long distance, and the other two refused to undergo any investigations done. Four patients were excluded from the study because they had alcohol withdrawal delirium, alcohol-induced psychosis, or alcohol withdrawal seizures. Mean age of the sample was 35.94 (±7.32) years. Mean year of education was 8.17 (±5.13). Majority were married (89.8%). The regular duration of treatment was 12.85 years (±8.13). The average daily consumption of alcohol was 169 gm (±160 gm), and psychosocial index was 7.0. 52.5% had alcoholic liver disease. Majority of patients had monthly income of 5,000 or below (41%), followed by those between 5000 to 10,000 (28.6%) and above 10.000 (30.4%).

QoL in alcohol dependence subjects

The mean scores on WHO QoL- BREF were statistically significant when compared at the baseline and three months’ follow up [Table 1]. The baseline mean scores of each domain of the WHO QoL- BREF were also compared with age- and sex- matched healthy controls [Table 2]. The physical, psychological, social, and environment domains of Qol in alcohol-dependent subjects were significantly lower before treatment initiation than the healthy controls. The results indicated no correlations between the severity of alcohol dependence scores and domain scores of WHOQoL– BREF (Physical domain: r = −0.17, P = 0.2; psychological domain: r = −0.19, P = 0.14; social domain: r = 0.04, P = 0.75; environment domain: r = 0.4, P = 0.77).

Table 1

Baseline domain scores of the WHO QoL BREF (n=56) compared with 3 months domain scores (n=56) after treatment intervention using paired t-test

Table 2

Domain scores of the WHOQoL BREF (n=56) alcohol dependence patients compared with healthy controls (n=150) using independent sample t-test

Predictive factors for improvement in QoL

In patients with alcohol dependence, there was no significant association in the physical domain of QoL with regards to severity of alcohol dependence, alcohol liver disease, psychosocial consequences, and socio-demographic variables.

The difference between scores on psychological domain at baseline and three months was calculated. Using the median value of psychological domain score (d2 = 3) as cut-off, study subjects were divided into two groups consisting of 36 and 20 subjects. Alcoholic liver disease emerged as significant predictor of improvement in psychological and social domains scores of QoL [Table 3]. Neither severity of disease, psychosocial consequences, duration of regular drinking nor the psychiatric co-morbidity appeared to be significant predictors of improvement in QoL for psychological and social domains. The patients’ monthly income was significantly associated with improvement in environmental domain of quality of life [Table 4].

Table 3

Variables associated with improvement in psychological and social domains of WHOQoL - BREF at baseline and three months’ follow up using logistic regression analysis, (n=56) Variable tested, yes vs. no (OR=1), odd ratio (95% C1)

Table 4

Variables associated with improvement in environment domain baseline and three months’ follow-up using logistic regression analysis, 56 study subjects. Variable tested, yes vs. no (OR=1) odd ratio (95% C1)

DISCUSSION

Consistent with previous reports that employed a variety of instruments to measure QoL, clinical characteristics and drinking parameters, the present study demonstrated substantial impairment in QoL in all the domain scores before treatment initiation.[1128] The domain scores on QoL were significantly lower in patients with alcohol dependence when compared with healthy controls. This has also been observed by another Indian study by Pal et al.[29]

We did not find any significant correlation between domain scores of WHOQoL-BREF and scores of Severity of Alcohol Dependence Questionnaire (SADQ). Lahmek et al.[30] also reported no significant association of improvement in physical and mental component scores of QoL with severity of alcohol dependence. The improvements in different domains of QoL were associated with several factors like alcoholic liver disease, average daily alcohol consumption, level of education, and monthly income of the patients.[31]

QoL improved significantly in all the domains when the subjects were abstinent for 3 months. This has also been reported by few previous studies.[2028323334]

Several factors could explain the improvement in QoL: i.e. complete abstinence, effective control of withdrawal symptoms, feedback about deranged liver function tests and other medical complications, use of patient-friendly therapeutic facilities, regular presence of a close family member during the follow-up visits, free medications and investigations, and outpatients consultations services, and effective management of psychiatric co-morbidity and medical complications using Liaison services in a tertiary care hospital.

This study demonstrates that it is possible to improve quality of life in patients of alcohol dependence with minimum financial resources in a developing country and achieve complete abstinence. The involvement of caregivers in the treatment plan encourages patients to adhere to treatment plan and continue to work. Furthermore, the study used standardized instruments and relevant investigations.

Limitations

Few limitations in the study exist. The study included small sample size and short duration of follow-up of 3 months. Longer duration of follow-up could have predicted the impact of certain treatment-related variables on QoL in these patients.

CONCLUSION AND FUTURE DIRECTIONS

To conclude, the present study found poor quality of life in alcohol-dependent Indian patients before treatment initiation. The regular follow-up in an out-patient setting along with the caregivers improve the compliance and enables the patients to pursue their work and take up other responsibilities. This enhances the self-esteem and achieves complete abstinence, thereby improving their quality of life.

Findings stress the need of public health officials to incorporate quality of life as an important measure to evaluate treatment outcome in alcohol dependence whose natural course consists of relapses. Treatment of alcohol dependence with a favorable outcome is possible with minimal financial resources, regular follow up, and the involvement of caregivers. There is a need to create general awareness in public that alcohol dependence is a disorder that requires immediate attention.