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

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.