Abstract
Background:
Despite the availability of several pharmacological and nonpharmacological treatments, a significant proportion of patients with alcohol dependence relapse to alcohol use after treatment. The objectives of this study were to determine the 6-month course and outcome in treatment-seeking individuals with alcohol dependence syndrome and to determine the sociodemographic and clinical correlates of the outcome in these patients.
Materials and Methods:
A longitudinal observational study was conducted in treatment-seeking male patients with alcohol dependence syndrome. Baseline sociodemographic and clinical details were gathered using a structured pro forma. The patients were followed up at 2 weeks, 1 month, 3 months, and 6 months. During the follow-up evaluation, abstinence status, number of abstinent days, and number of heavy drinking days were noted. Logistic regression was conducted to evaluate the factors associated with abstinence at 6 months.
Results:
Ninety-four patients were recruited for the study. The mean age of the participants was 43.98 years (standard deviation (SD) 10.68). Two patients were lost to follow-up. At the end of 2 weeks, 74 (80.43%) out of 92 participants remained abstinent. At the end of 1 month and 3 months, 59 (64.13%) and 38 (41.3%) participants of 92 were abstinent, respectively. At the end of 6 months, 26 (30.23%) of 86 patients were abstinent. Among those who were not abstinent at 6 months, the mean number of abstinent days was 113 (SD 51.62) days and the mean number of heavy drinking days was 56 (SD 51.62) days. Outpatients were found to have 2.91 times higher odds of remaining abstinent at 6 months when compared to inpatients.
Conclusion:
Nearly one-third of treatment-seeking patients with alcohol dependence syndrome remained abstinent at the end of 6 months. The locus of treatment was associated with abstinence at 6 months.
Keywords: Abstinence rate, alcohol dependence syndrome, outcome
INTRODUCTION
A National Mental Health Survey conducted in a nationally representative population of India found that 4.6% of the population has alcohol use disorder. The prevalence of alcohol use disorder among adult men was 9%.[1] Several community-based studies have reported a high prevalence of alcohol use, abuse, and dependence in various regions of India.[2,3,4,5] In addition to negative medical consequences, alcohol use is associated with domestic abuse, road traffic accidents, legal problems, and a negative impact on the family finances.[6]
Several effective pharmacological and nonpharmacological treatments are available for the treatment of alcohol use disorders.[7] Disulfiram, acamprosate, and naltrexone are the first-line medications used to treat these patients. Motivation enhancement therapy, cognitive behavior therapy (including relapse prevention strategies), and twelve-step facilitation therapy are evidence-based nonpharmacological interventions available for use in these patients. Despite the availability of such treatments, a significant proportion of patients relapse to alcohol use after treatment. A recent systematic review considered relapse as an “absence of abstinence” as no uniform definition was available in the literature. Various other definitions based on a return to any drinking, the proportion of heavy drinking days, and the persistence of alcohol use disorder over time were also noted.[8]
Longitudinal studies reporting the outcome of patients with alcohol use disorders from India are sparse. The relapse rates from such Indian studies varied from 9.6% to 72.6%, and only a few studies clearly defined relapse.[9] This study utilized predefined criteria to evaluate the outcomes (complete abstinence or proportion of days abstinent or proportion of heavy drinking days) of treatment-seeking patients with alcohol dependence syndrome. In addition, telephonic data collection was used to reduce the attrition rate in this study.
In this context, we conducted this study with the primary objective of determining the 6-month course and outcome in treatment-seeking individuals with alcohol dependence syndrome. The secondary objective was to determine the sociodemographic and clinical correlates of outcome in these patients.
MATERIALS AND METHODS
This was a longitudinal observational study conducted in a tertiary care teaching hospital in South India. The institute has a general hospital psychiatry unit that also provides treatment for patients with alcohol dependence syndrome on an outpatient or inpatient basis. Pharmacological and psychosocial interventions are provided to these patients after detailed medical and psychiatric evaluation by the team of postgraduates, faculty, clinical psychologist, social worker, and occupational therapist.
The study was conducted after getting approval from the Institute Ethics Committee (RC/2020/114). The participants were recruited from treatment-seeking individuals with alcohol dependence syndrome. Treatment-seeking male adult patients (age > 18 years) presenting to the psychiatry department who fulfilled International Classification of Disease (ICD-10) criteria for alcohol dependence syndrome were included in the study. Patients with comorbid serious mental illnesses or intellectual disability were excluded from the study.
Written informed consent was obtained from the participants. At baseline, sociodemographic details, including age, education, occupation, marital status, socioeconomic status, and contact details, were obtained using a structured pro forma. In addition, clinical details, such as age at onset and duration of alcohol dependence, were gathered. The severity of alcohol dependence was assessed using the Alcohol Dependence Scale.[10]
Treatment as usual (TAU) was provided on an inpatient or outpatient basis based on the severity of dependence, presence of complicated withdrawal, presence of medical comorbidities, and patient or family preference. The patients were subsequently assessed at 2 weeks, 1 month, 3 months, and 6 months. At each follow-up assessment, the following details were obtained: complete abstinence, the proportion of days abstinent, and the proportion of heavy drinking days. Complete abstinence was defined as no alcohol use between the previous evaluation and the current evaluation, and participants were categorized into complete abstinent or non-abstinent categories. The proportion of days abstinent and the proportion of heavy drinking days were calculated using the number of days between the previous evaluation and the current evaluation as the denominator. Heavy drinking was defined as consuming more than four drinks on any day as stated by the National Institute on Alcohol Abuse and Alcoholism (NIAAA).[11]
Anticipating a significant loss to follow-up, a plan for telephonic follow-up evaluations was made to minimize bias due to high attrition. If the patient did not come for assessment at the expected time, the patient and/or the family members were contacted over the phone with a request to review in the psychiatry outpatient department. If the patient and/or family members expressed an inability to visit in person, relevant details were collected over the phone. If the details given by the patient and the family members did not concur, the worse of the two was considered. The data collection was performed between January 2021 and May 2022.
Tools used
Alcohol dependence scale[10]
This scale was devised by Skinner and Allen in 1982. It provides a quantitative measure of the severity of alcohol dependence. The 25 items cover alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior. The scores are interpreted as follows:
1–13 low level of alcohol dependence
14–21 intermediate level of alcohol dependence
22–30 substantial level of alcohol dependence
31–47 severe level of alcohol dependence
Statistical analysis
The sample size for this study was calculated based on the following assumptions. The anticipated proportion of patients abstinent at six months was assumed to be 30% based on previous studies,[12,13,14] which have shown proportions ranging from 27.5% to 55%. Considering 10% as an acceptable deviation, the sample size was calculated to be 84 based on the formula 4pq/d^2. Assuming a dropout rate of 10%, we aimed to include at least 93 patients in the study.
The collected data were encoded and analyzed using IBM Statistical Package for the Social Sciences (SPSS) Statistics for Windows, Version 21.0, Armonk, NY. The categorical variables were represented as frequencies and percentages. The continuous variables were summarized as means and standard deviations (SDs). The proportion of patients abstinent at each follow-up assessment was calculated. The mean number of days abstinent and mean number of heavy drinking days were calculated for those patients who were not abstinent at six months.
Univariate logistic regression was conducted with abstinence at 6 months as the outcome variable and selected variables as independent variables. Multivariate logistic regression was conducted for those variables with P < 0.25 on univariate analysis. Odds ratio, confidence interval (CI), and P value were reported. P < 0.05 was considered statistically significant.
RESULTS
Ninety-four patients were recruited for the study. The mean age of the participants was 43.98 years (SD = 10.68). The mean family income of the participants was 18,899 (SD = 11622) rupees. More than three-fourths of the participants were Hindus, and most participants (86.17%) were married. One-third of the participants had completed high school education, and another one-third of the participants had completed either primary or middle school education. Semiskilled workers followed by unskilled workers constituted about half of the participants. Nearly three-fourths of the participants were from middle socioeconomic status [Table 1].
Table 1.
Sociodemographic or clinical characteristics of the study participants
| Sociodemographic or clinical characteristics | Frequency or mean | Percentage or standard deviation |
|---|---|---|
| Religion | ||
| Hindu | 78 | 82.67 |
| Christian | 12 | 12.76 |
| Muslim | 4 | 4.25 |
| Marital status | ||
| Unmarried | 9 | 9.57 |
| Married | 81 | 86.17 |
| Separated, widowed, or divorced | 4 | 4.25 |
| Education | ||
| Illiterate | 3 | 3.19 |
| Primary school education | 10 | 10.16 |
| Middle school education | 17 | 18.08 |
| High school certificate | 29 | 30.85 |
| Higher secondary | 12 | 12.76 |
| Graduate or postgraduate | 23 | 24.46 |
| Occupation | ||
| Unemployed | 10 | 10.63 |
| Unskilled worker | 16 | 17.02 |
| Semiskilled worker | 12 | 12.76 |
| Skilled worker | 29 | 30.85 |
| Clerical, shopkeeper, or farmer | 15 | 15.95 |
| Semiprofessional or professional | 12 | 12.76 |
| Socioeconomic status | ||
| Lower | 21 | 22.34 |
| Lower-middle | 2 | 2.12 |
| Middle | 68 | 72.34 |
| Upper-middle | 3 | 3.19 |
| Severity of alcohol dependence | ||
| Low | 41 | 43.61 |
| Intermediate | 31 | 32.97 |
| Substantial | 17 | 15.9 |
| Severe | 5 | 5.31 |
| Duration of alcohol consumption (in years) | 20.14 | 8.55 |
| Duration of alcohol dependence (in years) | 7.6 | 5.33 |
| Age at onset of alcohol dependence (in years) | 35.9 | 10.45 |
| Average alcohol consumption per day (in units) | 16.37 | 7.67 |
| Duration of hospital stay (in days) | 12.78 | 8.58 |
| Number of psychotherapy sessions attended | 3.66 | 2.06 |
| Past withdrawal seizures | 18 | 19.14 |
| Past delirium tremens | 18 | 19.14 |
| Past detoxification or deaddiction treatment | 53 | 56.38 |
| Family history of alcohol dependence | 62 | 65.95 |
| Inpatient treatment for detoxification or deaddiction | 33 | 35.1 |
| Deterrent or anti-craving medication | 14 | 14.89 |
The mean duration of alcohol consumption was 20.14 years (SD = 8.55). The mean duration of alcohol dependence was 7.60 years (SD = 5.33). The mean alcohol consumption per day was 16.37 units (SD = 7.67). About one-third of the participants underwent inpatient treatment for detoxification or deaddiction. Most patients had a low or intermediate level of alcohol dependence [Table 1].
Of the ninety-four patients who were recruited, two patients were lost to follow-up before the first evaluation after 2 weeks. The remaining 92 patients were followed up for 6 months. Six patients died between the third- and sixth-month follow-up. At the end of 2 weeks, 74 of 92 participants (80.43%) remained abstinent. At the end of 1 month and 3 months, 59 (64.13%) and 38 (41.3%) of 92 participants were abstinent, respectively. At the end of 6 months, 26 of 86 patients (30.23%) were abstinent [Figure 1a]. Among those who were not abstinent at 6 months, the mean number of abstinent days was 113 (SD 51.62). The mean number of heavy drinking days was 56 (SD 51.62) days.
Figure 1.
(a) Proportion of patients abstinent at each follow-up. (b) Common patterns of course of alcohol dependence syndrome in treatment-seeking individuals (remaining 24 patients not shown in this (figure had varying patterns of abstinence at different evaluation points)
The follow-up data collection was performed telephonically for 57 (61.96%), 62 (67.39%), 65 (70.65%), and 74 (80.43%) patients at 2 weeks, 1 month, 3 months, and 6 months, respectively. Common patterns of course of alcohol dependence that were observed are depicted in Figure 1b. The remaining 24 patients not shown in Figure 1b had varying courses (e.g. two patients were not abstinent at the 2-week evaluation and were abstinent during all the subsequent evaluations, and two other patients were abstinent at the 3-month evaluation and not abstinent at all the other evaluations).
Logistic regression was conducted to identify the factors associated with abstinence at 6 months. On univariate logistic regression, age of the patient, age at onset of alcohol dependence, and locus of treatment had P value < 0.25 and hence were included in multivariate logistic regression [Table 2]. On multivariate logistic regression, outpatients were found to have 2.91 (95% CI, 1.95–8.88) times higher odds of remaining abstinent at 6 months when compared to inpatients (P value 0.041). The other two factors in the multivariate model were not associated with abstinence at 6 months.
Table 2.
Univariate logistic regression to predict abstinence at 6 months
| Variables | Categories | Abstinence at 6 months |
Odds ratio (confidence interval) | P | |
|---|---|---|---|---|---|
| No | Yes | ||||
| Age of the patient (mean (SD)) | 42.70 (10.62) | 46.88 (11.272) | 1.04 (0.99–1.08) | 0.106 | |
| Age at onset of alcohol dependence (mean (SD)) | 34.88 (10.4) | 37.85 (11.5) | 1.02 (0.98–1.07) | 0.241 | |
| Duration of alcohol dependence (mean (SD)) | 7.27 (5.49) | 8.62 (5.25) | 1.05 (0.96–1.14) | 0.290 | |
| Locus of treatment | Inpatient | 26 (30.23) | 5 (5.81) | Ref | |
| Outpatient | 34 (39.53) | 21 (24.41) | 3.21 (1.068–9.66) | 0.038* | |
| Motivation at recruitment | Precontemplation | 39 (45.34) | 12 (13.94) | Ref | |
| Contemplation | 18 (20.93) | 8 (9.30) | 1.44 (0.5–4.14) | 0.356 | |
| Preparation | 3 (3.48) | 4 (4.65) | 4.33 (0.84–22.13) | 0.494 | |
| Action | 0 (0) | 2 (2.32) | 0 | 0.990 | |
| Past deaddiction–detoxification | No | 29 (33.72) | 10 (11.62) | Ref | |
| Yes | 31 (36.04) | 16 (18.60) | 1.49 (0.58–3.83) | 0.399 | |
| Severity of alcohol dependence | Low | 23 (26.74) | 15 (17.4) | Ref | |
| Intermediate | 20 (23.25) | 7 (8.13) | 0.54 (0.18–1.58) | 0.258 | |
| Substantial | 12 (13.95) | 4 (4.65) | 0.51 (0.13–1.88) | 0.313 | |
| Severe | 5 (5.81) | 0 (0) | 0 | 0.999 | |
| Duration of hospital stay (mean (SD)) | 13.5 (9.12) | 10.4 (6.59) | 0.937 (0.788–1.113) | 0.460 | |
*Statistically significant at 5% level of significance
DISCUSSION
In this study, nearly one-third of patients seeking treatment for alcohol dependence were abstinent at the end of 6 months. Locus of treatment was the only factor associated with abstinence at 6 months.
Similar abstinence rates were reported by three Indian studies. In a large community-based study from Goa, 21.8% of individuals with alcohol use disorders (defined based on the alcohol use disorders identification test score) at baseline were abstinent at the end of 6 years.[2] In a hospital-based follow-up study, Nandyal et al.[12] reported an abstinence of 27.5% at the end of 6 months. They used a combination of direct and telephonic follow-up interviews similar to our study. An abstinence rate of 31.35% was reported over 2 years among patients with alcohol dependence syndrome in a military setup.[13] An older naturalistic follow-up study conducted in South India reported that 32.5% of patients were abstinent or nonproblem drinkers at follow-up.[14] Recently, Sarkar et al.[9] reviewed 36 Indian studies and reported that the rates of relapse in patients with alcohol use disorder ranged from 3.4% to 90%.
The abstinence rate reported varied among other studies reported across the world. Terra et al.[15] conducted a follow-up study among 300 alcoholic Brazilian patients and found that 24.1% were abstinent at the end of 6 months. In another large study in Italy among 1040 patients at twelve residential alcohol abuse rehabilitation units, abstinence rates of 68.38% and 68.65% were reported at 6 months and 1 year, respectively.[16] A 20-year longitudinal prospective study from Spain reported that 32.6% were abstinent, 3.4% were controlled drinkers, and 10.2% were heavy drinkers.[17] The different abstinence rates reported could be attributed to the variations in the study population (age and gender), presence of comorbid substance use disorders, nature of treatment provided, and duration of follow-up.
In the present study, patients who underwent outpatient treatment had a greater likelihood of remaining abstinent than those who underwent inpatient treatment. This was an unexpected finding as inpatients are likely to undergo more intense pharmacological and nonpharmacological management. One possible reason could be that only patients with severe alcohol dependence got admitted, whereas less severe patients were treated on an outpatient basis. However, no association was found between the severity of alcohol dependence and abstinence at 6 months in our study. This counterintuitive finding could be because of the possibility of various other differences in the participants who underwent outpatient versus inpatient treatment. Patients who were given inpatient treatment probably had a greater number or severity of medical and nonmedical complications of alcohol dependence, greater psychiatric comorbidities, and previous failed outpatient treatments. An early study from National Institute of Mental Health and Neurosciences observed that less severely dependent patients who opted for outpatient treatment had a favorable outcome.[18] A recent systematic review has identified various other biological factors and psychological, social, and spiritual factors associated with relapse in patients with alcohol dependence syndrome.[8] Notably, the severity of alcohol use disorder, motivation, and past treatment history were significantly associated with relapse in most of the studies examined. These factors were not found to be associated with 6-month abstinence in the present study probably because it was underpowered to detect these associations (sample size was calculated based on the first objective).
The longitudinal and prospective nature of the study, minimal loss to follow–up, and use of predefined outcome criteria are the major strengths of the study. Generalizability to other settings has to be performed with caution depending on the nature of services provided and the sociodemographic details of the patients. The findings have to be interpreted with the following limitations in mind: Only treatment-seeking male patients were included; the outcome data were collected telephonically for a significant proportion of the participants; and the study was not adequately powered to detect the factors associated with abstinence. In addition, the treatment details of the study participants were not systematically collected.
In the future, multicentric studies with a longer follow-up period can be conducted and the results will be periodically published. Studies with a larger sample size can help researchers and clinicians draw firm conclusions regarding the factors associated with abstinence.
CONCLUSION
Nearly one-third of treatment-seeking patients with alcohol dependence syndrome remained abstinent at the end of 6 months. The locus of treatment was associated with abstinence at 6 months.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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