Efficacy of individualized homoeopathic treatment of chronic suppurative otitis media: double-blind, randomized, placebo-controlled trial

Chronic suppurative otitis media (CSOM) is theresult of an initial episode of acute otitis media (AOM), followed by chronicinfection of middle ear and mastoid mucosa and is characterized by a persistentdischarge from the middle ear through a tympanic perforation.It is an important cause of preventable hearing loss, particularly in thedeveloping world. Although there is no consensus on the duration of symptoms,generally long lasting infection and irreversible mucosal damage over 3 monthsis accepted as CSOM in clinical practice. The global burdenof illness from CSOM involves 65-330 million individuals with draining ears,60% of whom suffer from significant hearing impairment. CSOM accounts for 28,000deaths and a disease burden of over 2 million DALYs. We tested whether individualized homoeopathic (IH) medicines can produce any significantly different effect in comparison to placebo intreatment of chronic suppurative otitis media (CSOM) in a double-blind, randomized, placebo controlled,two parallel arms, clinical trial involving 142 patients (verum: 71; placebo: 71). The outcome measure is the Bengali version of the COMOT-15 questionnaire, to be assessed at baseline, after 3 months, andafter 6 months. Comparative analyses will be run to detect group differences if any. Results will be published in scientific journals