Difference between revisions of "Cekin"
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| − | + | <span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="font-family:" times="" new="" roman",serif"="">No evidence of benefit with hyperbaric oxygen therapy for sudden hearing loss.</span></span>'''</span> | |
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| − | + | <span style="line-height:normal">'''<span style="font-size:14.0pt"><span style="font-family:" times="" new="" roman",serif"="">Clinical Bottom Line:</span></span>'''</span> | |
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| − | + | #<span style="line-height:normal"><span style="tab-stops:list 36.0pt"><span style="font-size:14.0pt"><span style="font-family:" times="" new="" roman",serif"="">Statistically non-significant small benefit for those treated with HBOT.</span></span></span></span> | |
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| − | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Citations:</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">1.'''Çekin E, Cincik H, Ulubil SA, Gungor A. Effectiveness of hyperbaric oxygen therapy in management of sudden hearing loss. The journal of laryngology and otology 2009; 123: 609-12.</span></span></span> | |
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| − | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Three-part clinical question:</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">For patients with sudden hearing loss within 3 days of onset, does the application of hyperbaric oxygen combined with systemic corticosteroid therapy, compared to corticosteroid therapy alone, improve hearing recovery.</span></span></span> | |
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| − | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Search Terms:</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Sudden Hearing Loss, Inner Ear</span></span></span> | |
| − | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">The study:</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Non-blinded randomised controlled trial. Intention to treat not stated.</span></span></span> | |
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| + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">The study patients:</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Males and females aged 18-82 with sudden onset hearing loss either or both ears, within 3 days. Hearing loss defined as loss of at least 30dB in three frequencies within three days of enrolment.</span></span></span> | ||
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| + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Control Group (n=21):</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Prednisolone 1mg/kg starting dose reducing over three weeks plus famotidine 40mg daily.</span></span></span> | ||
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| + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">HBO Group (n=36):</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">As above plus 100% oxygen at 2.5 ATA for 90 minutes, 10 daily sessions over 10 days.</span></span></span> | ||
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| + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">The evidence:</span></span>'''</span> | ||
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| + | {| class="Table" style="border: 1pt solid windowtext; width: 741px;" | ||
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| − | | '''<span style | + | | style="width: 151px; border: 1pt solid windowtext;" width="120" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Outcome</span></span>'''</span></p> |
| + | | style="width: 83px; border: 1pt solid windowtext;" width="68" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Time to Outcome</span></span>'''</span></p> | ||
| + | | style="width: 57px; border: 1pt solid windowtext;" width="68" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Control Group</span></span>'''</span></p> | ||
| + | | style="width: 74px; border: 1pt solid windowtext;" width="66" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">HBOT Group</span></span>'''</span></p> | ||
| + | | style="width: 106px; border: 1pt solid windowtext;" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Relative Risk Reduction</span></span>'''</span></p> | ||
| + | | style="width: 112px; border: 1pt solid windowtext;" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Absolute Risk Reduction</span></span>'''</span></p> | ||
| + | | style="width: 104px; border: 1pt solid windowtext;" width="72" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">NNT</span></span>'''</span></p> | ||
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| − | | | + | | rowspan="2" style="width: 151px; border: 1pt solid windowtext;" width="120" | |
| + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Complete or moderate improvement with treatment</span></span>'''</span> | ||
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| + | | style="width: 83px; border: 1pt solid windowtext;" width="68" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">10 days</span></span></span></p> | ||
| + | | style="width: 57px; border: 1pt solid windowtext;" width="68" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.71</span></span></span></p> | ||
| + | | style="width: 74px; border: 1pt solid windowtext;" width="66" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.83</span></span></span></p> | ||
| + | | style="width: 106px; border: 1pt solid windowtext;" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">14%</span></span></span></p> | ||
| + | | style="width: 112px; border: 1pt solid windowtext;" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">0.12</span></span></span></p> | ||
| + | | style="width: 104px; border: 1pt solid windowtext;" width="72" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">8</span></span></span></p> | ||
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| + | | colspan="3" style="width: 228px; border: 1pt solid windowtext;" width="201" | <p align="right" style="margin-bottom:.0001pt; text-align:right; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">95% CIs:</span></span></span></p> | ||
| + | | style="width: 106px; border: 1pt solid windowtext;" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">-13% to 42%</span></span></span></p> | ||
| + | | style="width: 112px; border: 1pt solid windowtext;" width="104" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">-0.11 to 0.35</span></span></span></p> | ||
| + | | style="width: 104px; border: 1pt solid windowtext;" width="72" | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding:.75pt .75pt .75pt .75pt"><span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">NNT 3 to INF; NNH 9 to INF</span></span></span></p> | ||
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| − | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Comments:</span></span>'''</span> | |
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| − | + | <span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">1. Large difference in patient numbers between treatment and control arms is not explained.</span></span></span> | |
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| − | + | <span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">2, Time period of outcome assessment not defined (possibly at 10 days).</span></span></span> | |
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| − | + | <span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">3. Reducing dose of prednisolone regimen not stated.</span></span></span> | |
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| + | <span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">4. Average mean audiometry quoted in dB, but how many frequencies affected not described.</span></span></span> | ||
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| + | <span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">5. Power calculation is inadequately described – no suggestion what effect they were aiming to confirm.</span></span></span> | ||
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| + | <span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">6. 12 years to collect data at a single centre and two patients recruited outside the protocol period</span></span></span> | ||
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| + | <span style="line-height:normal"><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">7. Some discrepancy between text and Table II results.</span></span></span> | ||
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| − | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Appraised by:</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">D. Smart, Monday 1st August 2016</span></span><span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">[mailto:dsmart@iinet.net.au| <span style="color:blue">dsmart@iinet.net.au</span>]</span></span></span> | |
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| − | + | <span style="line-height:normal">'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">Kill or Update by:</span></span>'''<span style="font-size:12.0pt"><span style="font-family:" times="" new="" roman",serif"="">June 2022</span></span></span> | |
| − | [[File: | + | [[File:Sumhorsa.gif|center|Sumhorsa.gif]] |
| − | <span style="display: block; text-align: center;">[[Audiovestibular | BACK]]</span> | + | <span style="display: block; text-align: center;"><span style="font-size:xx-large;">[[Audiovestibular|BACK]]</span></span> <span style="display: block; text-align: center;"></span> |
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Latest revision as of 01:45, 30 September 2021
No evidence of benefit with hyperbaric oxygen therapy for sudden hearing loss.
Clinical Bottom Line:
- Statistically non-significant small benefit for those treated with HBOT.
Citations:1.Çekin E, Cincik H, Ulubil SA, Gungor A. Effectiveness of hyperbaric oxygen therapy in management of sudden hearing loss. The journal of laryngology and otology 2009; 123: 609-12.
Three-part clinical question:For patients with sudden hearing loss within 3 days of onset, does the application of hyperbaric oxygen combined with systemic corticosteroid therapy, compared to corticosteroid therapy alone, improve hearing recovery.
Search Terms:Sudden Hearing Loss, Inner Ear
The study:Non-blinded randomised controlled trial. Intention to treat not stated.
The study patients:Males and females aged 18-82 with sudden onset hearing loss either or both ears, within 3 days. Hearing loss defined as loss of at least 30dB in three frequencies within three days of enrolment.
Control Group (n=21):Prednisolone 1mg/kg starting dose reducing over three weeks plus famotidine 40mg daily.
HBO Group (n=36):As above plus 100% oxygen at 2.5 ATA for 90 minutes, 10 daily sessions over 10 days.
The evidence:
Outcome |
Time to Outcome |
Control Group |
HBOT Group |
Relative Risk Reduction |
Absolute Risk Reduction |
NNT |
|
Complete or moderate improvement with treatment |
10 days |
0.71 |
0.83 |
14% |
0.12 |
8 |
95% CIs: |
-13% to 42% |
-0.11 to 0.35 |
NNT 3 to INF; NNH 9 to INF | |||
Comments:
1. Large difference in patient numbers between treatment and control arms is not explained.
2, Time period of outcome assessment not defined (possibly at 10 days).
3. Reducing dose of prednisolone regimen not stated.
4. Average mean audiometry quoted in dB, but how many frequencies affected not described.
5. Power calculation is inadequately described – no suggestion what effect they were aiming to confirm.
6. 12 years to collect data at a single centre and two patients recruited outside the protocol period
7. Some discrepancy between text and Table II results.
Appraised by:D. Smart, Monday 1st August 2016dsmart@iinet.net.au
Kill or Update by:June 2022