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 Table of Contents  
RESEARCH PROTOCOL
Year : 2014  |  Volume : 8  |  Issue : 4  |  Page : 187-193

A randomized controlled trial in the management of alcohol dependence: Homoeopathic vs. standard Allopathic treatment


, India

Date of Submission21-Oct-2014
Date of Acceptance03-Dec-2014
Date of Web Publication18-Dec-2014

Correspondence Address:
Central Council for Research in Homoeopathy
Director General, Central Council for Research in Homoeopathy, New Delhi-110 058
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7168.147308

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  Abstract 

Background and Objective: Alcoholism (alcohol dependence) is a chronic illness marked by dependence on alcohol consumption. It interferes with health, social as well as family life and job responsibilities. Based on the experience of an observational single-arm study with positive outcomes, this protocol is being implemented to compare the effectiveness of homoeopathic intervention with standard allopathic treatment.
Materials and Methods: This will be a randomized controlled open-label comparative trial. Patients will be randomized to receive either Homoeopathy or Allopathy group of intervention using computerized randomization chart. The period of treatment cum follow up shall be for 1 year. Supportive counseling shall be given to both the groups. Primary outcome will be more than 50% reduction in 'Severity of Alcohol Dependence (SADQ)' rating scale in comparison to baseline at the exit of treatment of 1 year and secondary outcomes will comprise of changes in World Health Organisation quality of life -BREF(WHOQOL-BREF) at baseline and at end of the study, management of detoxification shall be done using Clinical Institute Withdrawal Assessment for Alcohol Scale, Revised (CIWA-Ar). Further changes in alcohol consumption pattern in terms of quantity and frequency shall be assessed.
Discussion: The study shall help in designing further rigorous randomized controlled trial (RCT)/pragmatic study with homoeopathic intervention.

Keywords: Allopathy, Alcohol dependence, Alcohol withdrawal, Comparative trial, Homoeopathy, Psychiatric illness


How to cite this article:
Central Council for Research in Homoeopathy. A randomized controlled trial in the management of alcohol dependence: Homoeopathic vs. standard Allopathic treatment. Indian J Res Homoeopathy 2014;8:187-93

How to cite this URL:
Central Council for Research in Homoeopathy. A randomized controlled trial in the management of alcohol dependence: Homoeopathic vs. standard Allopathic treatment. Indian J Res Homoeopathy [serial online] 2014 [cited 2019 Nov 18];8:187-93. Available from: http://www.ijrh.org/text.asp?2014/8/4/187/147308


  Introduction Top


Background and rationale

Alcohol is a psychoactive substance with dependence-producing properties that has been widely used in many cultures for centuries. [1] The harmful use of alcohol causes health problems as well as social and economic burden in societies. Its consumption is one of the leading causes of death and disability globally. About two billion people worldwide consume alcoholic beverages and one-third is likely to have one or more diagnosable alcohol use disorders. [2] About 16.0% of drinkers aged 15 years or older engage in heavy episodic drinking. In 2012, about 3.3 million deaths, or 5.9% of all global deaths, 139 million disability-adjusted life years (DALYs), or 5.1% of the global burden of disease and injury, were attributable to alcohol consumption. [1]

Prevalence of alcohol use in India is reported to be 21.4% and there is increasing alcohol intake among the young people. Moreover, 4.5% males and 0.6% females in age-group of 15 years and above are suffering from alcohol use disorders and 3.8% of males and 0.4% of females are suffering from alcohol dependence. Total per capita consumption in Indian adults (15 + years) is 28 litres of pure alcohol. Deaths attributed to alcohol consumption in males and females are 62.9% and 33.2%, respectively of total deaths in the country. [3] The role of alcohol in domestic violence is substantial as most of the violence takes place during intoxication. [4] The alcohol-related problems account for more than a fifth of hospital admissions; 18% of psychiatric emergencies; more than 20% of all brain injuries and 60% of all injuries reporting to India's emergency rooms. [4] Commonly used medications for alcohol abuse and dependence are Disulfiram, Naltrexone, Acamprosate and Topiramate. [5] The review of existing allopathic treatment concludes that there can be certain side effects and a major problem of non-compliance. [6],[7]

A double-blind placebo-controlled trial [8] applying Homoeopathy to chemical dependency showed decreased relapse rate of recovering alcoholics and drug addicts undergoing Homoeopathic treatment. Observational studies of Homoeopathy for alcohol dependence conclude that homoeopathy can be valid and effective therapy to help patients to break the cycle of dependence as well as to improve alcohol-related problems like sleep disturbances. [9],[10]

One of the studies carried out by Central Council for Research in Homoeopathy (CCRH) at its Clinical Research Unit, Varanasi, India in which out of 261 drug-dependent patients referred from a drug de-addiction, 209 patients showed improvement in withdrawal symptoms, whereas 32 patients did not improve. The outcome of the study shows that homoeopathic medicines are useful in the management of withdrawal symptoms of drug dependents and can check the menace of the chemical dependency. [11] A pilot study by Gopinadhan [12] on the effect of Arsenic album in alcohol dependents reflected the development of aversion to alcoholic drinks.

One barrier to developing a national alcohol policy for India is lack of data and research on this burning problem. Keeping in view the limitations of established effective intervention, i.e., allopathy, other intervention like Homoeopathy can be tested for its effectiveness. [13] Reviews of the evidence of the safety indicate that Homoeopathy medicinal products may cause mild transient side effects, but not strong or persisting side effects. [14]

Based on positive findings of previous studies, a randomized controlled trial on patients with alcohol dependence shall be conducted to assess the effects of individualized homoeopathic treatment in the management of alcohol dependence in comparison with the standard allopathy treatment.


  Materials and Methods Top


This study will be a randomized controlled comparative, open-label trial to be conducted at Central Research Institute, Kottayam, Kerala, India. Homoeopathy treatment will be given by trained homoeopath and allopathy treatment by the psychiatrist involved in the study. Rescue allopathy medication in severe withdrawal symptoms, if required will be prescribed by psychiatrist in both groups. Supportive assistance in maintaining follow-ups shall be provided by psychiatric social worker.

The study protocol is in accordance with the latest revision of the Helsinki declaration [15] on human experimentation and Good Clinical Practices of India. [16] Although medicines proposed to be used during the study are known homoeopathic pharmacopoeia preparations, yet necessary clearance of the Ethical Committee and Scientific Advisory Committee has been obtained before undertaking the study. Trial is registered with Clinical Trial Registry of India (CTRI/2011/12/002213).

Recruitment process and inclusion criteria

Patients shall be screened from outpatient department of the institute as per verbal screening form-Cutting down, Annoyance by criticism, Guilty feeling, and Eye-openers scale(CAGE(scale) [17] -and those satisfying the CAGE scale shall further be screened for inclusion and exclusion criteria by the investigator who is experience and trained in treating patients of alcohol dependence. Patients meeting the inclusion/eligibility criteria shall be given detailed explanation of the project requirements and shall be invited to participate in the trial. Informed consent will be obtained from all participants following which they shall be randomly divided to receive either homoeopathic/allopathic as per the randomization chart informing the same through patient information sheet. All patients in the study shall be advised to be abstinent from alcohol, under the guidance of investigator/psychiatrist. Flow diagram of study is given in [Figure 1].
Figure 1: Flow chart of the study

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Patients are eligible if they are: In age-group of 15 to 60 years, male and female; diagnosed as per International Classification of Diseases, 10 th Revision (ICD-10) criteria [Table 1] for alcohol dependence; willing to quit alcohol and to take Homoeopathy/allopathy treatment; normal findings in ultrasound of upper abdomen, liver function test. Patients with any chronic systemic illness or with life-threatening disease, cirrhosis of liver, diagnosed psychological disorder associated with alcohol dependence and cases with other substance abuse/addiction shall be excluded from the study. Pregnant and lactating women, patients those are not willing to sign the consent form shall also be excluded from trial.
Table 1: International Classification of Diseases, 10th Reviswion (ICD-10) criteria for alcohol dependence

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Randomization and group allocation

A random allocation sequence using statistical software has been generated by a statistician independent of the project prior to the commencement of recruitment. Participant allocation to group (1:1 ratio) has done immediately after baseline case recording.

Intervention

Homoeopathy


Investigator shall make an in-depth interview with the patient and his guardian, after thorough case taking in the Case Recording format (CRF), shall form totality of symptoms and repertorized the symptoms using appropriate repertory. Selection of medicine will be made out of the medicines that fetch the highest value on repertorisation. Selection of potency and repetition of medicine will be as per discretion of investigator and as per patient's condition. The CRF will include the analysis, evaluation and totality of symptoms, repertorial analysis chart.

Allopathy

Patients in this group will also have an in-depth interview with investigator. The psychiatrist involved in the study will administer the allopathic medicine. Common allopathic drugs used for alcohol dependence shall be used as per discretion of psychiatrist.

Apart from the above intervention the following procedure shall be carried out.

Withdrawal Phase (Detoxification)

Patients with withdrawal symptoms will be admitted in the Inpatient Department (IPD) of the institute till improvement noticed or for 2 weeks whichever earlier. However, the mild cases will be studied in OPD. In mild to moderate withdrawal symptoms, patients will receive assigned group of intervention but psychiatrist will manage severe withdrawal symptoms with a rescue allopathic medicines in IPD. Rescue medicines will be provided to the patients of both the groups. Data of such cases will be maintained separately. After detoxification is complete, the patient will receive his/her assigned group intervention.

Supportive counseling

Counseling shall be given to patients of both the groups by psychiatrist involved in study. Psychiatric Social Worker (PSW) will be helping the investigators in motivating patients during treatment and maintaining follow-up by home visit or personal interaction with families.

Outcome measures

Primary outcome will be more than 50% reduction in symptom score in comparison to baseline as per rating scale SADQ at the exit of treatment of 1 year.

Secondary outcome measures will comprises of changes in quality of life, management of detoxification and changes in alcohol consumption pattern in terms of quantity and frequency.

Criteria for baseline and follow up assessment

Assessment of study participants for alcohol dependence will be done using Severity of Alcohol Dependence (SADQ) every month [18] . For assessment of alcohol withdrawal symptoms, Clinical Institute Withdrawal Assessment, Revised (CIWA-Ar) [19] for alcohol scale will be used every day at the time of admission in IPD; each time when patient comes with withdrawal symptoms and admitted in IPD in 1 year period of follow up. Total episodes of detoxification for each patient will also be considered for assessment at the end of the study.

Laboratory investigations shall be conducted at 3, 6, 9 and 12 months of follow up. World Health Organisation quality of life Bref (WHOQOL-BREF) shall be filled at baseline and at end of study for assessing and comparing quality of life. Details of study timeline are given in [Table 2].
Table 2: Timeline of the study

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Data collection

Standard CRF, pre designed spread sheet shall be used for data capturing. Data recording shall be done through validated questionnaires/tools for outcome measures, i.e. SADQ, CIWA-Ar, WHO WHOQOL-BREF. Apart from these physical, psychological, clinical and demographic information of the patient shall also be noted,

Sample size

Assuming the recovery of 90% with allopathic treatment and 50% with homoeopathic treatment, (on the basis of previous pilot study by using arsenic album which was effective in 7 out of 10 cases, at Kottayam) with α =0.05, power (1-β) =0.85. The required sample sizes will be 22 sample/group for assessment. By considering the drop out of 20%, the total sample size will be 60 (30/group).

Statistical analysis

Data obtained during the study would be verified and analyzed using Statistical Package for Social Sciences (SPSS) version 20. For the primary outcome and each of the secondary outcomes, both per protocol and modified Intention To Treat (mITT) analysis will be done. Descriptive statistics shall include demographic profile. Quantitative continuous measures will be compared between the groups using t tests for normally distributed continuous variables. Chi-square tests of association or other nonparametric tests shall be used for dichotomous data or non normal data wherever appropriate. Percentage reduction of the SADQ scores shall be calculated and compared between the groups. Missing values will be filled with last observation carry forward method or as appropriate.


  Discussion Top


There is little or no evidence of the comparative effectiveness of treatments for many conditions, since most studies compare a given treatment to a placebo rather than head-to-head with competing treatments. [20] Therefore, this study protocol is designed as randomized controlled trial with allopathic treatment as a comparative arm, which will help in generating evidence to support a intervention, i.e., Homoeopathy for alcohol dependence, further leading to improvement in the delivery of patient care. Comparative effectiveness studies add to the public knowledge base about what works in health care and what does not, and may lead to cost savings. Moreover, research should provide evidence facilitating decision-making in health care. [20]

The spectrum of alcohol withdrawal symptoms ranges from minor symptoms as insomnia and tremulousness to severe complications such as withdrawal seizure and delirium tremens. [21] Keeping in view the ethical issues and safety, rescue allopathic medication shall be available for both groups of patients to manage severe complications. Such patients will be analyzed separately as subgroup. After rescue medication patient will receive the initial assigned group of intervention.

Studies have shown better QOL with homoeopathic intervention irrespective of disease condition. [22] The alcohol dependent patients have poor quality of life and interventional studies need to consider QOL as one of the parameters for judging its effectiveness. Therefore this present protocol also aims to assess and compare quality of life of patient's on alcohol dependence.

The protocol shall generate data that can be reported as per CONSORT guidelines for reporting randomized trials with parallel groups [23] and the Reporting data on Homoeopathic Treatments (RedHot) supplement to CONSORT. [24] It is in accordance with the SPIRIT 2013. [25] Further this study involves administration of individualized homoeopathic medicine with the involvement of homoeopathic experienced doctors in treating alcohol dependents, using validated assessment scale, which will be amenable to profession at large thus covering all the domains of Model Validity of Homoeopathic Trials (MVHT). [26]

Trial status

The data analysis is in progress and the result will be published soon.


  Competing Interests Top


The authors declare that they have no competing interests.

Contributors

Study concept and design: V.A. Siddiqui 1 , Rupali Bhalerao2
Drafting of manuscript: Rupali Bhalerao 2 , Varanasi Roja 3
Critical review of manuscript: Raj K. Manchanda, Praveen Oberai 4
Statistical planning Critical review of manuscript: Maya Padmanabhan5, Abha Agarwal6
Funding/Support: Central Council for Research in Homoeopathy

Contributor's information

1 Assistant Director (H)/Scientist-4, Central Research Institute (Homoeopathy), Noida
2 Senior Research Fellow, Central Council for Research in Homoeopathy
3 Research Officer(H)/Scientist-1, Central Council for Research in Homoeopathy
Director General, Central Council for Research in Homoeopathy
4 Research Officer(H)/Scientist-4, Central Council for Research in Homoeopathy
5 Statistical Assistant, Central Council for Research in Homoeopathy
6 Scientist F, National Institute of Medical Statistics, ICMR

 
  References Top

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Girish N, Kavita R, Gururaj G, Benegal V. Alcohol use and implications for public health: Patterns of use in four communities. Indian J Community Med 2010;35:238-44.  Back to cited text no. 2
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World Health Organization. Country Profile India. 2014; 252. Available from: http://www.who.int/substance_abuse/publications/global_alcohol_report/msb_gsr_2014_2.pdf?ua=1. [Last cited on 2014 Sep 18].  Back to cited text no. 3
    
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Alcoholism treatment. (WebMD) Substance abuse and addiction medications. Available from: http://www.webmd.com/mental-health/addiction/alcohol-abuse-and-dependence-medications. [Last cited on 2014 Oct 4].  Back to cited text no. 5
    
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Sinclair JD. Evidence about the use of naltrexone and for different ways of using it in the treatment of alcoholism. Alcohol Alcohol 2001;36:2-10.  Back to cited text no. 6
    
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Bouza C, Magro A, Muñoz A, Amate JM. Efficacy and safety of naltrexone and acamprosate in the treatment of alcohol dependence: A systematic review. Addiction 2004;99:811-28.  Back to cited text no. 7
    
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Garcia-Swain S. A double-blind, placebo- controlled trial applying homeopathy to chemical dependency. hahnemann college of homeopathy, Albany, California. Available from: http://www.the-alcoholism-guide.org/homeopathic-remedies-for-alcohol-withdrawal.html [Last cited on 2014 Oct 9].  Back to cited text no. 8
    
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Gopinadhan S, Balachandran VA. A pilot study on the effect of Arsenicum Album in Alcohol dependents. CCRH Qly Bull 1994;16:10-5.  Back to cited text no. 12
    
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Bornhöft G, Wolf U, von Ammon K, Righetti M, Maxion-Bergemann S, Baumgartner S, et al. Effectiveness, safety and cost-effectiveness of homeopathy in general practice-summarized health technology assessment. Forsch Komplementmed 2006;13:19-29.  Back to cited text no. 13
    
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National Institute on Alcohol Abuse and Alcoholism. Assessing Alcohol Problems: A Guide for Clinicians and Researchers. 2 nd ed. NIH Pub. No. 03-3745. Washington: U.S. Dept. of Health and Human Services, Public Health Service. Revised 2003 Available from: http://pubs.niaaa.nih.gov/publications/AssessingAlcohol/index.pdf. [Last cited on 2014 Oct 4].  Back to cited text no. 17
    
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Dean ME, Coulter MK, Fisher P, Jobst KA, Walach H. Reporting data on homoeopathic treatments (Red Hot): A supplement to CONSORT. J Altern Complement Med 2007;13:19-23.  Back to cited text no. 24
    
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Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: Guidance for protocols of clinical trials. BMJ 2013;346:e7586.  Back to cited text no. 25
    
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