An open observational trial of individualized homeopathic treatment in chronic suppurative otitis media and psychometric analysis of Chronic Otitis Media Outcome Test 15 (COMOT-15) Bengali questionnaire

Chronicsuppurative otitis media (CSOM) is the result of an initial episode of acute otitismedia (AOM), followed by chronic infection of middle ear and mastoid mucosa andis characterized by a persistent discharge from the middle ear through atympanic perforation. It is an important cause of preventable hearing loss,particularly in the developing world. The global burden of illness from CSOMinvolves 65-330 million individuals with draining ears, 60% of whom suffer fromsignificant hearing impairment. The majority of the homeopathyresearch studies revealed promising role of homeopathic treatment in otitis media.However, the focus was principally on acute otitis media; and CSOM remainedunder-researched. Thisstudy presents the first prospectively collected data using the BengaliCOMOT-15 and effectiveness of individualized homeopathy treatment in CSOM. Inthis project, we intend to develop translated Bengali version of COMOT-15through standardized forward-backward translation method, to validate it andtest its psychometrics on 100 CSOM patients in the ENT outpatient of MaheshBhattacharyya Homoeopathic Medical College & Hospital. Following that, weintend to use it as an outcome measure in an open observation trial testingusefulness of individualized homeopathic treatment in CSOM. The study willstart in April 2017 and is estimated to continue up to 2 years. All thepatients will be treated with individualized homoeopathic medicines in bothcentesimal and 50 millesimal potencies as per need of the case. Data will becollected at baseline, after 3 months, and after 6 months. The generated resultswill be analyzed in the end using appropriate statistical tests and the resultswill be published in scientific research journals.