A study protocol on comparative randomised controlled trial of Homoeopathy -vs- allopathy in acute otitis media and its recurrence in Children

Abstract

Background: Acute otitis media (AOM) is one of the most common acute infections in children, and injudicious prescription of antibiotics may lead to increase of antibiotic resistant cases. Homoeopathic treatment may provide a safer and more effective treatment. Objective: Earlier, a pilot study conducted by the Central Council for Research in Homoeopathy (CCRH) on eighty patients at a single centre showed non inferiority results. This study shall be undertaken to substantiate the earlier findings. Methods: This will be an open label, non inferiority, randomised controlled (parallel arm) trial to be conducted on children in the age group of 2–12 years, suffering from AOM. The trial will include 240 children; each participant shall be randomly selected to receive either individualised homoeopathic medicine or symptomatic allopathic medicine. In case a child does not have ≥50% improvement with assigned treatment on day 3, he/she shall be given antibiotics. Children shall be treated/followed up for a period of 1 year to check recurrence, if any, in both the groups. The primary outcomes are changes in the Tympanic Membrane Examination Scale and Acute Otitis Media Severity of Symptoms scale, time to improvement in pain through the Facial Pain Scale Revised between the groups and recurrence (number of episodes, intensity and duration) of AOM between the groups at 1 year. Discussion: The study will consolidate the findings observed during a pilot study conducted by the CCRH at Jaipur, India. It is proposed to compare the role of individualised homoeopathy over allopathy in the treatment of AOM and to assess its role in controlling the recurrence.