OBJECTIVE: To pilot a model for determining whether homoeopathic treatment of children suffering from glue ear is more effective than standard GP care at producing a return to normal hearing (a hearing loss of less than 20 dB) within 12 months. DESIGN: Non-blind, randomized controlled trial. SETTING:General practice in two locations in southern England. SUBJECTS:Thirty-three children aged 18 months to 8 years with otitis media with effusion, hearing loss > 20 dB and an abnormal tympanogram. OUTCOME MEASURES: Hearing loss, tympanogram, referrals to specialists and number of courses of antibiotics at 12 month follow-up. RESULTS: A higher proportion of children receiving homoeopathic care had a hearing loss less then 20 dB at follow-up (64 vs 56%), though this difference did not reach statistical significance (95% confidence interval for the difference between means of -25 and 42%). More homoeopathy patients than controls had a normal tympanogram (75 vs 31%, P = 0.015). Referrals to specialists and antibiotic consumption was lower in the homoeopathy group, though differences between groups did not reach statistical significance. CONCLUSION: Further research comparing homoeopathy to standard care is warranted. Assuming recovery rates of 50 and 30% in homoeopathy and standard care groups respectively, 270 patients would be needed for a definitive trial.
RCT Entities:
OBJECTIVE: To pilot a model for determining whether homoeopathic treatment of children suffering from glue ear is more effective than standard GP care at producing a return to normal hearing (a hearing loss of less than 20 dB) within 12 months. DESIGN: Non-blind, randomized controlled trial. SETTING: General practice in two locations in southern England. SUBJECTS: Thirty-three children aged 18 months to 8 years with otitis media with effusion, hearing loss > 20 dB and an abnormal tympanogram. OUTCOME MEASURES: Hearing loss, tympanogram, referrals to specialists and number of courses of antibiotics at 12 month follow-up. RESULTS: A higher proportion of children receiving homoeopathic care had a hearing loss less then 20 dB at follow-up (64 vs 56%), though this difference did not reach statistical significance (95% confidence interval for the difference between means of -25 and 42%). More homoeopathy patients than controls had a normal tympanogram (75 vs 31%, P = 0.015). Referrals to specialists and antibiotic consumption was lower in the homoeopathy group, though differences between groups did not reach statistical significance. CONCLUSION: Further research comparing homoeopathy to standard care is warranted. Assuming recovery rates of 50 and 30% in homoeopathy and standard care groups respectively, 270 patients would be needed for a definitive trial.