A Clinical Trial of Proton Pump Inhibitors to Treat Children with Chronic Otitis Media with Effusion
Abstract
OBJECTIVE
Gastroesophageal reflux (GER) is considered a cause of otitis media with effusion (OME). This study aimed to investigate whether OME can be effectively treated with a proton pump inhibitor (PPI), therefore implicating GER as a causative factor of OME.
MATERIALS AND METHODS
A PPI or placebo was randomly administered to enrolled subjects for 4-8 weeks. To monitor effusion status, subjects underwent monthly pneumatic otoscopy and acoustic reflectometry. At enrollment and at completion of treatment, subjects underwent an audiogram and tympanogram for assessing changes in hearing due to altered fluid levels in the middle ear. After the treatment period, tympanostomy tube placement was recommended for subjects with unresolved effusion.
RESULTS
This study enrolled 16 patients with an average age of 5.17 years. Between the treatment and placebo groups, there was no significant difference in the need for tympanostomy tubes. At completion of this study, patients receiving Lansoprazole demonstrated a significant improvement in pure tone average (p<0.01) and speech recognition thresholds (p=0.04). Four patients (25%) from the cohort dropped out of the study. Eight patients (50%) from the cohort required tympanostomy tube placement.
CONCLUSION
Owing to difficulties with recruitment and small sample size, this study was unable to demonstrate the use of PPI in treating OME. A larger study is needed for further evaluation of this process.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 16 participants or records.
Read the paper
Related studies
- The Prediction of the In Vitro Release Curves for PLGA-Based Drug Delivery Systems with Neural Networks
- Promising Ursolic Acid as a Novel Antituberculosis Agent: Current Progress and Challenges
- Proof of principle concept for the analysis and functional prediction of rare genetic variants in the CYP2C19 and CYP2D6 genes
- Fabrication, characterization, and docking studies of furosemide-loaded nanosponges using the emulsion solvent diffusion method
- The Effect of Concomitant Administration of Proton Pump Inhibitors on the Pharmacokinetics of CDK4/6 Inhibitors in Rats: Implications for the Evaluation of Hepatic and Transporter-Mediated Drug–Drug Interactions
- Mining the Metabolic Capacity of Clostridium sporogenes Aided by Machine Learning
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.