title: Hospital clinical trial: Homeopathy (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum 9CH) as adjuvant, in children with otitis media with effusion.
abstract: BACKGROUND
  Otitis media with effusion (OME) is the most common cause of paediatric hearing loss. No single treatment has proved its effectiveness. There is a lack of evidence-based medicine studies in the area of homeopathy.
  
  
  METHODS
  A prospective randomized, double blinded interventional placebo control study was conducted. Patients, from 2 months to 12 years, with OME diagnosed by pneumatic otoscopy (PNO) and tympanometry, were randomized into two groups. Both groups received aerosol therapy (mucolytics and corticosteroids). In addition, the experimental group (EG) received homeopathy (Agraphis nutans 5CH, Thuya Occidentalis 5CH, Kalium muriaticum 9CH and Arsenicum iodatum), and the placebo group (PG) placebo, both of them for 3 months. Patients were evaluated by PNO examination and tympanometry at baseline, at 45 and 90 days.
  
  
  RESULTS
  97 patients were enrolled. In the EG, 61.9% of individuals were cured (PNO went from negative in the 1st visit to positive in the 3rd visit) compared with 56.8% of patients treated with placebo. 4.8% of patients in the EG suffered a recurrence (positive PNO in the 2nd visit changed to negative in the 3rd visit) while 11.4% did in the PG. No significant difference was found. Adverse events were distributed similarly, except in the case of upper respiratory tract infections, which were less frequent in EG (3 vs. 13, p: 0.009).
  
  
  CONCLUSIONS
  The homeopathic scheme used as adjuvant treatment cannot be claimed to be an effective treatment in children with OME.
  
  
  BACKGROUND
  EUDRACT number: 2011-006086-17, PROTOCOL code: 55005646.
authors: Department of Pediatiric Otolaryngology, IdiPAZ, Health Research Institute, La Paz University Hospital, Spain. Electronic address: mf.pedrero@gmail.com.
authors: M F
authors: MF
authors: Pedrero-Escalas
authors: Department of Otolaryngology, Toledo Hospital Complex, Spain.
authors: J
authors: J
authors: Jimenez-Antolin
authors: Department of Otolaryngology, IdiPAZ, Health Research Institute, La Paz University Hospital, Spain.
authors: L
authors: L
authors: Lassaletta
authors: Boiron SIH, Spain.
authors: G
authors: G
authors: Diaz-Saez
authors: Department of Otolaryngology, IdiPAZ, Health Research Institute, La Paz University Hospital, Spain.
authors: J
authors: J
authors: Gavilán
mesh_terms: D000158:Acoustic Impedance Tests; D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006705:Homeopathy; D006801:Humans; D008297:Male; D010034:Otitis Media with Effusion / Q000175:diagnosis / Q000628:therapy*; D008517:Phytotherapy; D011446:Prospective Studies; D012008:Recurrence; D029783:Thuja; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000305:Adrenal Cortex Hormones
keywords: Homeopathy; Otitis media with effusion; Pneumatic otoscopy