ABSTRACT
BACKGROUND AND OBJECTIVES: Based on our previous single-center study on optimization of treatment of chronic otitis media with effusion (COME) and adenoid hypertrophy (AH) in children using a noninvasive system approach to lower the necessity of antibiotics, analgesic use, and surgical interventions, we proceeded to perform a multicenter investigation in an outpatient setting. The purpose of the previous prospective study in 2013-2015 was to compare outcomes in the treatment of COME and AH using the noninvasive multimodal integrative method (IM) versus conventional treatment practice (COM). MATERIALS AND METHODS: In this paper, we retrospectively analyze the data of patients treated with the integrative method between 2017 and 2020 in a multicenter setting and compared the outcomes with data from 2013-2015 in order to evaluate generalizability. In both periods, all eligible and willing participants were included and treated with the IM protocol under real-life conditions. The treatment involved pneumatization exercises, education, an antiallergic diet, nasal hygiene, useful constitutional therapy, and thermal interventions (P.E.A.N.U.T.). A total of 48 versus 28 patients, aged 1-8, were assessed, presenting with COME and AH, with moderate to severe hearing impairment at entry. RESULTS: The significant improvement found in both audiometric measures (intact hearing) and tympanometric measures (normal A-type curve) was similar in both datasets with respect to conventional treatment. The new data confirms that the P.E.A.N.U.T. method results in a significant reduction of antibiotics, analgesic use, and surgical interventions. CONCLUSION: In this multicenter trial, we confirm the effectiveness of the noninvasive system approach for the treatment of COME in lowering the need for antibiotics and analgesic use and elective surgery. This could be especially important with respect to a generally observed increase in antibiotic resistance. The method is easy to perform in different clinical settings and is effective, safe, and well-tolerated.
ABSTRACT
BACKGROUND: Chronic otitis media with effusion (COME) and adenoid hypertrophy (AH) are common entities in the pediatric population. The conventional treatment approach (conventional medicine; COM) involved mainly surgery after a period of close observation. In this study, we aimed to introduce an integrative, non-invasive approach (integrative medicine; IM) for COME, AH, and associated episodes of recurrent acute otitis media, and compared outcomes with conventional treatment. METHODS: We conducted a prospective, non-randomized study in an integrative primary care pediatric practice and a conventional pediatric otolaryngological clinic, where treatment modality was determined by patient preference. Out of a total 101 patients aged 1-8 years, integrative therapy was chosen by 46, and conventional treatment by 55. All patients had COME and AH diagnosed by an otolaryngologist and had moderate to severe hearing impairment. COM treatment was based on close observation over time, nasal decongestants and surgical intervention. In contrast, the IM involved a complex personalized approach with non-invasive interventions, non-allopathic medications, diet and patient education. RESULTS: The number of surgical interventions (adenoidectomy, pressure-equalization tube insertion, myringotomy) was significantly less in the IM cohort (1 of 28 vs. 15 of 35 in the COM group, p < 0.001). The frequency of antibiotic use was significantly less in the IM group (p < 0.001). The frequency of analgesic use was also significantly less in the IM group (p = 0.029). Improvement in tympanometric measures (normal A-type curve) was higher in IM patients compared to expected spontaneous remission during the observation period. Improvement in audiometric measures (intact hearing) of IM patients was also higher than expected compared to spontaneous remission during the observation period. CONCLUSION: Compared to conventional treatment, integrative treatment of patients with COME and AH showed significantly lower invasive surgical intervention rates and significantly decreased antibiotic and analgesic use. The integrative treatment was effective, safe and well tolerated.
