Study: Oral Prednisone vs. Methylprednisolone Injections for SSNHL

Here are the study results:

https://clinicaltrials.gov/ct2/show/results/NCT00097448

Study details:

Brief Summary:
This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).

Detailed Description:
Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous improvement is seen in approximately 20% of subjects. Improvement is seen in approximately 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and uncontrolled case series have suggested the intratympanic corticosteroids may work as well or better than oral treatment. The risks of oral prednisone are well-known. In theory, intratympanic treatment should achieve a higher drug concentration at the target (inner ear) with less risk of systemic side effects. This study is a head-to-head comparison of oral prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden deafness. The study is designed as a non-inferiority trial testing that hypothesis that intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day) followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include word recognition hearing levels and safety issues of local vs. systemic steroid side-effects and pain.

 

I'm an idiot but I can't understand the outcome data.

 

I don't think the data analysis on the clinical trials website is very detailed. My understanding is they took every participant and measured their change in dB threshold at 500, 1000, 2000, and 4000 Hz. They then treated every data point the same, creating a one dimensional data set. They can computed basic descriptive statistics like mean and standard deviation.

Of course, I'm sure there is a ton more data behind the scenes. It looks as though IT steroids are quite good, and largely are "systemic side-effect" sparing.

If you look at the side effects, it seems like IT steroids cause more ear pain, vertigo, infection, and tympanic membrane perforation. Then all of the truly nasty systemic stuff is worse for oral steroids.

I read this as a positive finding, overall.

 

My understanding is they measured the hearing threshold (what participants in the study could not hear) after administering oral steroids to one group and injecting steroids to the other, and the results were pretty much the same, around 28 dB for one group and 30 dB for the other.

This is consistent with the opinions I have been hearing from ENTs for many years.

So basically oral or injected corticosteroids have similar impact, there are no great differences at the end of the day.