Difference between revisions of "Cavalazzi"
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| − | + | '''<span style="font-size:18.0pt"><span style="line-height:107%">No significant improvement in hearing with the addition of hyperbaric oxygen to a pharmacological regimen for the treatment of sudden idiopathic sensorineural hearing loss.</span></span>''' | |
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| − | + | '''<span style="font-size:14.0pt"><span style="line-height:107%">Clinical Bottom Line:</span></span>''' | |
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| − | + | <span style="font-size:14.0pt"><span style="line-height:107%">1. No significant improvement in the proportion of patients gaining over 50% hearing return was demonstrated.</span></span> | |
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| − | + | <span style="font-size:14.0pt"><span style="line-height:107%">2. Similarly, there was no significant proportion of patients obtaining 25% improvement or better.</span></span> | |
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| + | <span style="font-size:12.0pt"><span style="line-height:107%">'''Citations: '''1. Cavallazzi G, Pignataro L, Capaccio P. Italian experience in hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss. In Proceedings of the International Joint Meeting on Hyperbaric and Underwater Medicine. Marroni A, Oriani G, Wattel F, eds. Grafica Victoria, Bologna 1996:647-649.</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Clinical Scenario:</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">A patient with sudden onset of sensorineural hearing loss of unknown origin.</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Three-part Question:</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">In adult patients with sudden idiopathic sensorineural hearing loss, does the addition of hyperbaric oxygen therapy to a standard treatment regime result in any additional benefit?</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Search Terms:</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">Hyperbaric oxygenation, deafness, hearing loss, noise induced</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">The Study:</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">Non-blinded randomised controlled trial with intention-to-treat. Adults with sudden sensorineural hearing loss where no cause was known.</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Control group (N = 30; 30 analysed):</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">Multiple drug therapy consisting of heparin, betamethasone, nicotinic acid, flunarizine, citidinephosphocoline, dextran, vitamins, neurotropic and antiviral drugs- doses not given.</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Experimental group (N = 34; 34 analysed):</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">Pharmacotherapy as for control group plus oxygen at 2.5ATA for 60 minutes daily for 15 sessions over 3 weeks.</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">The Evidence:</span></span>''' | ||
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| + | {| class="Table" style="border:solid windowtext 1.0pt" | ||
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| − | | | + | | style="width:82.5pt; border:solid windowtext 1.0pt" width="113" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:12.0pt"><span style="line-height:107%">Outcome</span></span>'''</p> |
| + | | style="width:48.5pt; border:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:12.0pt"><span style="line-height:107%">Time to Outcome</span></span>'''</p> | ||
| + | | style="width:40.7pt; border:solid windowtext 1.0pt" width="57" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:12.0pt"><span style="line-height:107%">Control</span></span>'''</p> | ||
| + | | style="width:26.85pt; border:solid windowtext 1.0pt" width="38" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:12.0pt"><span style="line-height:107%">HBO</span></span>'''</p> | ||
| + | | style="width:83.75pt; border:solid windowtext 1.0pt" width="114" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:12.0pt"><span style="line-height:107%">Relative benefit increase</span></span>'''</p> | ||
| + | | style="width:83.45pt; border:solid windowtext 1.0pt" width="113" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt">'''<span style="font-size:12.0pt"><span style="line-height:107%">Absolute benefit increase</span></span>'''</p> | ||
| + | | style="width:73.05pt; border:solid windowtext 1.0pt" width="100" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">NNT</span></span></p> | ||
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| − | | | + | | rowspan="2" style="width:82.5pt; border:solid windowtext 1.0pt" width="113" | |
| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Return of hearing greater than 50%</span></span>''' | ||
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| + | | style="width:48.5pt; border:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">3 weeks</span></span></p> | ||
| + | | style="width:40.7pt; border:solid windowtext 1.0pt" width="57" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">0.43</span></span></p> | ||
| + | | style="width:26.85pt; border:solid windowtext 1.0pt" width="38" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">0.53</span></span></p> | ||
| + | | style="width:83.75pt; border:solid windowtext 1.0pt" width="114" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">22%</span></span></p> | ||
| + | | style="width:83.45pt; border:solid windowtext 1.0pt" width="113" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">0.096</span></span></p> | ||
| + | | style="width:73.05pt; border:solid windowtext 1.0pt" width="100" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">10</span></span></p> | ||
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| − | | | + | | colspan="3" style="width:119.05pt; border:solid windowtext 1.0pt" width="163" | <p align="right" style="text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">95% CI</span></span></p> |
| + | | style="width:83.75pt; border:solid windowtext 1.0pt" width="114" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">-34% to 79%</span></span></p> | ||
| + | | style="width:83.45pt; border:solid windowtext 1.0pt" width="113" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">-0.15 to 0.34</span></span></p> | ||
| + | | style="width:73.05pt; border:solid windowtext 1.0pt" width="100" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">NNT7 to INF NNH3 to INF</span></span></p> | ||
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| − | | | + | | rowspan="2" style="width:82.5pt; border:solid windowtext 1.0pt" width="113" | |
| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Return of hearing greater than 25%</span></span>''' | ||
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| + | | style="width:48.5pt; border:solid windowtext 1.0pt" width="68" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">3 weeks</span></span></p> | ||
| + | | style="width:40.7pt; border:solid windowtext 1.0pt" width="57" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">0.57</span></span></p> | ||
| + | | style="width:26.85pt; border:solid windowtext 1.0pt" width="38" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">0.74</span></span></p> | ||
| + | | style="width:83.75pt; border:solid windowtext 1.0pt" width="114" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">30%</span></span></p> | ||
| + | | style="width:83.45pt; border:solid windowtext 1.0pt" width="113" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">0.168</span></span></p> | ||
| + | | style="width:73.05pt; border:solid windowtext 1.0pt" width="100" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">6</span></span></p> | ||
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| + | | colspan="3" style="width:119.05pt; border:solid windowtext 1.0pt" width="163" | <p align="right" style="text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">95% CI</span></span></p> | ||
| + | | style="width:83.75pt; border:solid windowtext 1.0pt" width="114" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">-11% to 70%</span></span></p> | ||
| + | | style="width:83.45pt; border:solid windowtext 1.0pt" width="113" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">-0.06 to 0.40</span></span></p> | ||
| + | | style="width:73.05pt; border:solid windowtext 1.0pt" width="100" | <p align="center" style="text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="font-size:12.0pt"><span style="line-height:107%">NNT16 to NF<br/> NNH=3 to INF</span></span></p> | ||
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| − | <span style="font- | + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Comments:</span></span>''' |
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| − | <span style="font- | + | <span style="font-size:12.0pt"><span style="line-height:107%">1. No details given on randomisation, blinding or exclusions from analysis.</span></span> |
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| + | <span style="font-size:12.0pt"><span style="line-height:107%">2. Small study with no power, significance levels or confidence intervals given.</span></span> | ||
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| + | <span style="font-size:12.0pt"><span style="line-height:107%">3. Trends apparent for some improvement with the addition of hyperbaric oxygen, but do not reach statistical significance.</span></span> | ||
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| + | <span style="font-size:12.0pt"><span style="line-height:107%">4. No details given on outcome measures.</span></span> | ||
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| + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Appraised by:</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney, Monday, 23 November, 1998</span></span> | ||
| − | + | '''<span style="font-size:12.0pt"><span style="line-height:107%">Expiry date:</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">June 2022</span></span> | |
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| − | [[File: | + | [[File:Sumhorsa.gif|center|Sumhorsa.gif]] |
| − | <span style="display: block; text-align: center;"><span style="font-size: 29.9px;">[[Audiovestibular | + | <span style="display: block; text-align: center;"><span style="font-size: 29.9px;">[[Audiovestibular|BACK]]</span></span> |
Latest revision as of 03:49, 28 September 2021
No significant improvement in hearing with the addition of hyperbaric oxygen to a pharmacological regimen for the treatment of sudden idiopathic sensorineural hearing loss.
Clinical Bottom Line:
1. No significant improvement in the proportion of patients gaining over 50% hearing return was demonstrated.
2. Similarly, there was no significant proportion of patients obtaining 25% improvement or better.
Citations: 1. Cavallazzi G, Pignataro L, Capaccio P. Italian experience in hyperbaric oxygen therapy for idiopathic sudden sensorineural hearing loss. In Proceedings of the International Joint Meeting on Hyperbaric and Underwater Medicine. Marroni A, Oriani G, Wattel F, eds. Grafica Victoria, Bologna 1996:647-649.
Clinical Scenario:A patient with sudden onset of sensorineural hearing loss of unknown origin.
Three-part Question:In adult patients with sudden idiopathic sensorineural hearing loss, does the addition of hyperbaric oxygen therapy to a standard treatment regime result in any additional benefit?
Search Terms:Hyperbaric oxygenation, deafness, hearing loss, noise induced
The Study:Non-blinded randomised controlled trial with intention-to-treat. Adults with sudden sensorineural hearing loss where no cause was known.
Control group (N = 30; 30 analysed):Multiple drug therapy consisting of heparin, betamethasone, nicotinic acid, flunarizine, citidinephosphocoline, dextran, vitamins, neurotropic and antiviral drugs- doses not given.
Experimental group (N = 34; 34 analysed):Pharmacotherapy as for control group plus oxygen at 2.5ATA for 60 minutes daily for 15 sessions over 3 weeks.
The Evidence:
Outcome |
Time to Outcome |
Control |
HBO |
Relative benefit increase |
Absolute benefit increase |
NNT |
|
Return of hearing greater than 50% |
3 weeks |
0.43 |
0.53 |
22% |
0.096 |
10 |
95% CI |
-34% to 79% |
-0.15 to 0.34 |
NNT7 to INF NNH3 to INF | |||
|
Return of hearing greater than 25% |
3 weeks |
0.57 |
0.74 |
30% |
0.168 |
6 |
95% CI |
-11% to 70% |
-0.06 to 0.40 |
NNT16 to NF | |||
Comments:
1. No details given on randomisation, blinding or exclusions from analysis.
2. Small study with no power, significance levels or confidence intervals given.
3. Trends apparent for some improvement with the addition of hyperbaric oxygen, but do not reach statistical significance.
4. No details given on outcome measures.
Appraised by:Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney, Monday, 23 November, 1998
Expiry date:June 2022