Clinical bottom line:
| 1.
Significant improvement in hearing in 4 of 5 frequencies 2. Some evidence that HBOT is more effective with mild initial loss and in people under 50 years. |
Citation/s:
Topuz E., Yigit O, Cinar U, Seven H. Should hyperbaric oxygen be added to
treatment in idiopathic sudden sensorineural hearing loss. Eur Arch
Otorhinolaryngol 2004, 261: 393-396
Lead author's name and fax: O Yigit Fax: +90-212-2341121
Three-part Clinical Question: Does the addition of a hyperbaric oxygen
regimen to a standard medical treatment improve the hearing in people with acute
idiopathic sudden sensorineural hearing loss (ISSHL).
Search Terms: hyperbaric oxygenation, idiopathic sudden sensorineural
hearing loss, ISSHL, hearing loss
The Study:
Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Sudden hearing loss of >30dB in at least 3
continguous pure tone frequencies. Less than 2 weeks since onset of symptoms.
All were admitted to hospital.
Control group (N = 21; 21 analysed): Prednisone 1mg/kg/day for 2 weeks,
rheomacrodex 500mL/day for 5 days, diazepam 5mg twice a day (? duration),
pentoxiphyllin 200mg iv twice a day (? duration).
Experimental group (N = 30; 30 analysed): As above + hyperbaric oxygen
2.5ATA for 90 minutes twice a day over 5 days then 2.5ATA daily for 15 days.
The Evidence:
|
Non-Event
Outcomes |
Time to
outcome |
Control
group (?sd) |
HBOT
group (?sd) |
P-value |
|
Mean hearing gain all patients (dB) |
4 weeks |
17.4dB |
33.3dB |
? |
|
Mean hearing gain by initial hearing levels (dB) <=60 61-80 >=80 |
4 weeks |
22.33 +/-9.311 6.18 +/-9.00 13.00 +/-6.58 |
22.53+/-12.68 35.45+/-22.09 50.70+/-21.54 |
0.758 0.014 0.005 |
Comments:
1. There is no "functional" improvement assessment performed.
2. Intervals given above are not defined (probably standard deviations).
3.
Results given for ‘34 ISSHL out of 30 patients’ in the HBOT group. Meaning
not clear.
4. Only age and sex were considered as possible confounders, no other
patient data.
5. No indication of loss to recruitment or attempt to recruit consecutive
patients.
Difficult to assess numbers in this study because there was
Appraised by: Dr Glen Hawkins, Department of Diving and Hyperbaric Medicine,
Prince of Wales Hospital, NSW, AUSTRALIA; Thursday, 10 March 2005
Email: hawkeye@swiftdsl.com.au
Kill or Update By: 15 March 2006