by A recent study conducted by the University Medicine Halle in Germany has revealed that high-dose therapy does not lead to better outcomes than the standard treatment for sudden hearing loss. The large-scale randomized controlled trial, which involved over 300 patients, also discovered that high-dose therapy was associated with a higher risk of side effects. The results, published in NEJM Evidence, have raised doubts about the efficacy of the standard treatment itself.
Sudden hearing loss affects several hundred thousand people worldwide each year, making it a significant health concern. Currently, anti-inflammatory drugs known as glucocorticoids, which are similar to cortisone, are commonly used to treat this condition.
Previous assumptions suggested that administering a high systemic dose of glucocorticoids over a short period of time would have a superior effect compared to the standard treatment. To investigate this further, the researchers conducted the largest clinical trial with systemic glucocorticoids to date.
The trial involved 325 patients from 39 sites across Germany who were randomly assigned to three treatment groups. One group received the standard treatment, while the other two groups received a significantly higher dose of either the same drug or a similar substance. The researchers then evaluated the extent of hearing improvement after 30 days and recorded any side effects that occurred.
The study found that a higher dose of glucocorticoids did not result in better outcomes compared to the standard therapy. However, adverse events were more frequent in the high-dose therapy groups. These side effects included elevated blood sugar levels or a rise in blood pressure in patients with pre-existing hypertension.
Interestingly, despite immediate treatment with glucocorticoids, symptoms persisted in the majority of patients in all groups. Even in the group receiving the standard therapy, which had the best results after 30 days, 60 percent of the patients had not fully recovered.
These findings cast doubt on the value of glucocorticoids as the standard treatment for sudden hearing loss. The study highlights the need for further investigation to determine whether glucocorticoid treatment is more effective than a placebo or if alternative treatment options should be explored.
Professor Stefan Plontke, the coordinating investigator of the trial and director of the Department of Otorhinolaryngology, Head and Neck Surgery at University Medicine Halle, emphasizes the importance of new drug treatment options for sudden hearing loss. Despite glucocorticoids being the worldwide standard of care for 50 years, their effectiveness in treating idiopathic sudden sensorineural hearing loss is still unclear. Therefore, further research is needed to establish the most effective course of treatment for this condition.
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1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
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