Difference between revisions of "Schwab"

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'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">No evidence of improvement in hearing loss or tinnitus with hyperbaric oxygen compared to a regime of hydroxyethyl starch and pentoxifylline.</span>'''
 
  
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<span style="border-color: windowtext; border-style: solid; border-width: 1.5pt; display: block; padding: 1pt 4pt;">
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'''<span style="font-size:18.0pt"><span style="line-height:107%">No evidence of improvement in hearing loss or tinnitus with hyperbaric oxygen compared to a regimen of hydroxyethyl starch and pentoxifylline.</span></span>'''
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<span style="padding-bottom: 0cm; padding-left: 0cm; padding-right: 0cm; padding-top: 0cm;">'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Clinical Bottom Line:</span>'''
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">1. No statistically significant improvement in hearing loss or tinnitus was demonstrated in this trial.
 
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2. There was a trend to more improvement in hearing loss in the hyperbaric group </span></span>
 
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</span>
 
  
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Appraised by:</span>'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;"> Mike Bennett, Department of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney Thursday, 11 November 1999</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-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Clinical Scenario:</span>'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;"> A patient with sudden loss of hearing and tinnitus of unknown cause presented for treatment. </span>
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<span style="font-size:14.0pt"><span style="line-height:107%">1. No statistically significant improvement in hearing loss or tinnitus was demonstrated in this trial.</span></span>
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Three-part Question:</span>'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;"> For patients presenting for treatment of acute hearing loss and or tinnitus, does administration of hyperbaric oxygen, compared to pentoxifylline and hydroxyethyl starch, result in any improvement in either complaint?</span>
 
  
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Search Terms:</span>'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;"> Hyperbaric oxygenation, sudden hearing loss, tinnitus</span>
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<span style="font-size:14.0pt"><span style="line-height:107%">2. There was a trend to more improvement in hearing loss in the hyperbaric group</span></span>
  
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">The Study:</span>'''
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Non-blinded randomised controlled trial with intention-to-treat.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Sudden hearing loss with at least 20dB loss in one or more frequencies and /or tinnitus, seen within 2 weeks and without any prior therapy.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Control group (N = 38; 31 analysed): Intravenous hydroxyethyl starch 6% 250mls and pentoxyphylline 300mg daily for ten days.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Experimental group (N = 37; 24 analysed): 100% oxygen at 2.5ATA for 75 minutes daily for 10 days. </span>
 
  
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">The Evidence:</span>'''
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'''<span style="font-size:12.0pt"><span style="line-height:107%">References:</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">1. Schwab B, Flunkert C, Heermann R, Lenarz T. HBO in the therapy of cochlear dysfunctions - first results of a randomized study. Collected manuscripts of XXIV Annual Scientific Meeting of the European Underwater and Baromedical Society, M Gennser, ed. Stockholm 1998; 40-42.</span></span>
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{|
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| <span style'''"line-height: normal; margin-bottom: 0pt;">'''Non-event outcomes'''</span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">'''Time to outcome'''</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">'''Control group'''</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">'''HBO group'''</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style="display: block; text-align: center;">'''P-value'''</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 loss of hearing and tinnitus of unknown cause presented for treatment.</span></span>
 +
 
 +
'''<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%">For patients presenting for treatment of acute hearing loss and or tinnitus, does administration of hyperbaric oxygen, compared to pentoxifylline and hydroxyethyl starch, result in any improvement in either complaint?</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, sudden hearing loss, tinnitus</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. Sudden hearing loss with at least 20dB loss in one or more frequencies and /or tinnitus, seen within 2 weeks and without any prior therapy.</span></span>
 +
 
 +
'''<span style="font-size:12.0pt"><span style="line-height:107%">Control group (N = 38; 31 analysed):</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">Intravenous hydroxyethyl starch 6% 250mls and pentoxyphylline 300mg daily for ten days.</span></span>
 +
 
 +
'''<span style="font-size:12.0pt"><span style="line-height:107%">Experimental group (N = 37; 24 analysed):</span></span>'''<span style="font-size:12.0pt"><span style="line-height:107%">100% oxygen at 2.5ATA for 75 minutes daily for 10 days.</span></span>
 +
 
 +
'''<span style="font-size:12.0pt"><span style="line-height:107%">The Evidence:</span></span>'''
 +
 
 +
{| class="Table" style="background:white; border-collapse:collapse; border:solid windowtext 1.0pt"
 
|-
 
|-
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| <span style'''"line-height: normal; margin-bottom: 0pt;">'''Mean hearing change (dB)'''</span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">?4 weeks</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">10.7</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">15.6</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style="display: block; text-align: center;">NS</span></span>  
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| style="width:148.6pt; border:solid windowtext 1.0pt; background:white" width="198" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm">'''<span style="font-size:12.0pt"><span style="line-height:107%">Non-event outcomes</span></span>'''</p>
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| style="width:92.15pt; border:solid windowtext 1.0pt; border-left:none; background:white" width="123" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm">'''<span style="font-size:12.0pt"><span style="line-height:107%">Time to outcome</span></span>'''</p>
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| style="width:77.95pt; border:solid windowtext 1.0pt; border-left:none; background:white" width="104" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm">'''<span style="font-size:12.0pt"><span style="line-height:107%">Control group</span></span>'''</p>
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| style="width:70.9pt; border:solid windowtext 1.0pt; border-left:none; background:white" width="95" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm">'''<span style="font-size:12.0pt"><span style="line-height:107%">HBO group</span></span>'''</p>
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| style="width:49.6pt; border:solid windowtext 1.0pt; border-left:none; background:white" width="66" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm">'''<span style="font-size:12.0pt"><span style="line-height:107%">P-value</span></span>'''</p>  
 
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|-
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| <span style'''"line-height: normal; margin-bottom: 0pt;">'''Tinnitus rating (0 to 10 scale)'''</span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">?4 weeks</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">4.0</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">3.6</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style="display: block; text-align: center;">NS</span></span>  
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| style="width:148.6pt; border:solid windowtext 1.0pt; border-top:none; background:white" width="198" |
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'''<span style="font-size:12.0pt"><span style="line-height:107%">Mean hearing change (dB)</span></span>'''
 +
 
 +
| style="width:92.15pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="123" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">?4 weeks</span></span></p>
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| style="width:77.95pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="104" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">10.7</span></span></p>
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| style="width:70.9pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="95" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">15.6</span></span></p>
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| style="width:49.6pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="66" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">NS</span></span></p>  
 
|-
 
|-
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| style="width:148.6pt; border:solid windowtext 1.0pt; border-top:none; background:white" width="198" |
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'''<span style="font-size:12.0pt"><span style="line-height:107%">Tinnitus rating (0 to 10 scale)</span></span>'''
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 +
| style="width:92.15pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="123" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">?4 weeks</span></span></p>
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| style="width:77.95pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="104" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">4.0</span></span></p>
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| style="width:70.9pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="95" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">3.6</span></span></p>
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| style="width:49.6pt; border-top:none; border-left:none; border-bottom:solid windowtext 1.0pt; border-right:solid windowtext 1.0pt; background:white" width="66" | <p align="center" style="text-align:center; padding:0cm 0cm 0cm 0cm"><span style="font-size:12.0pt"><span style="line-height:107%">NS</span></span></p>
 
|}
 
|}
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Comments:</span>'''
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">1. There may be a significant clinical benefit in hearing recovery with hyperbaric oxygen, however, this trial is of insufficient power to confirm this.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">2. The numbers reaching follow-up are unclear.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">3. There is no placebo control to establish the rate of spontaneous improvement.</span>
 
  
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Expiry date:</span>'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;"> June 2020</span>
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&nbsp;
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**<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">References: </span>'''
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">1. Schwab B, Flunkert C, Heermann R, Lenarz T. HBO in the therapy of cochlear dysfunctions - first results of a randomized study. Collected manuscripts of XXIV Annual Scientific Meeting of the European Underwater and Baromedical Society, M Gennser, ed. Stockholm 1998; 40-42.</span>
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'''<span style="font-size:12.0pt"><span style="line-height:107%">Comments:</span></span>'''
 +
 
 +
<span style="font-size:12.0pt"><span style="line-height:107%">1. There may be a significant clinical benefit in hearing recovery with hyperbaric oxygen, however, this trial is of insufficient power to confirm this.</span></span>
 +
 
 +
<span style="font-size:12.0pt"><span style="line-height:107%">2. The numbers reaching follow-up are unclear.</span></span>
 +
 
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<span style="font-size:12.0pt"><span style="line-height:107%">3. There is no placebo control to establish the rate of spontaneous improvement.</span></span>
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 +
&nbsp;
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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, Department of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney Thursday, 11 November 1999</span></span>
  
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[[File:sumhorsa.gif|center]]
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'''<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 2020</span></span>
  
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[[File:Sumhorsa.gif|center|Sumhorsa.gif]]
  
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<span style="display: block; text-align: center;"><span style="font-size: 29.9px;">[[Audiovestibular | BACK]]</span></span>
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<span style="display: block; text-align: center;"><span style="font-size: 29.9px;">[[Audiovestibular|BACK]]</span></span>

Latest revision as of 03:58, 28 September 2021

No evidence of improvement in hearing loss or tinnitus with hyperbaric oxygen compared to a regimen of hydroxyethyl starch and pentoxifylline.

Clinical Bottom Line:

1. No statistically significant improvement in hearing loss or tinnitus was demonstrated in this trial.

2. There was a trend to more improvement in hearing loss in the hyperbaric group

References:1. Schwab B, Flunkert C, Heermann R, Lenarz T. HBO in the therapy of cochlear dysfunctions - first results of a randomized study. Collected manuscripts of XXIV Annual Scientific Meeting of the European Underwater and Baromedical Society, M Gennser, ed. Stockholm 1998; 40-42.

Clinical Scenario:A patient with sudden loss of hearing and tinnitus of unknown cause presented for treatment.

Three-part Question:For patients presenting for treatment of acute hearing loss and or tinnitus, does administration of hyperbaric oxygen, compared to pentoxifylline and hydroxyethyl starch, result in any improvement in either complaint?

Search Terms:Hyperbaric oxygenation, sudden hearing loss, tinnitus

The Study:Non-blinded randomised controlled trial with intention-to-treat. Sudden hearing loss with at least 20dB loss in one or more frequencies and /or tinnitus, seen within 2 weeks and without any prior therapy.

Control group (N = 38; 31 analysed):Intravenous hydroxyethyl starch 6% 250mls and pentoxyphylline 300mg daily for ten days.

Experimental group (N = 37; 24 analysed):100% oxygen at 2.5ATA for 75 minutes daily for 10 days.

The Evidence:

Non-event outcomes

Time to outcome

Control group

HBO group

P-value

Mean hearing change (dB)

?4 weeks

10.7

15.6

NS

Tinnitus rating (0 to 10 scale)

?4 weeks

4.0

3.6

NS

 

Comments:

1. There may be a significant clinical benefit in hearing recovery with hyperbaric oxygen, however, this trial is of insufficient power to confirm this.

2. The numbers reaching follow-up are unclear.

3. There is no placebo control to establish the rate of spontaneous improvement.

 

Appraised by:Mike Bennett, Department of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney Thursday, 11 November 1999

Expiry date:June 2020

Sumhorsa.gif

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