Difference between revisions of "Stavitsky"

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'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Hyperbaric oxygen reduced time to pain relief in patients following acute myocardial infarction.</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:x-large;">'''<span style="font-family: " times="" new="" roman",="" serif;"="">Hyperbaric oxygen reduced time to pain relief in patients following acute myocardial infarction.</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. The time to pain relief following myocardial infarction was reduced following the addition of hyperbaric oxygen to the treatment protocol.
 
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2. There was no significant improvement in other measures of outcome, although there was a trend to lower CPK levels, LVEF and mortality. </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, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Sydney; Friday, 4 June 1999</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 acute myocardial infarction. </span>
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<span style="border-color: windowtext; border-style: solid; border-width: 1.5pt; display: block; padding: 1pt 4pt;"><span style="padding-bottom: 0cm; padding-left: 0cm; padding-right: 0cm; padding-top: 0cm;"><span style="font-size:large;">'''<span style="font-family: " times="" new="" roman",="" serif;"="">Clinical Bottom Line:</span>'''</span></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;">In patients with acute myocardial infarction, does the early administration of hyperbaric oxygen, in addition to a standard care protocol including thrombolysis, result in any demonstrable improvement in outcome? </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;"> myocardial infarction, thrombolysis</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="border-color: windowtext; border-style: solid; border-width: 1.5pt; display: block; padding: 1pt 4pt;"><span style="padding-bottom: 0cm; padding-left: 0cm; padding-right: 0cm; padding-top: 0cm;"><span style="font-family: 'Times New Roman','serif'; font-size: 16px;">1. The time to pain relief following myocardial infarction was reduced following the addition of hyperbaric oxygen to the treatment protocol.</span></span></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 without intention-to-treat.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Patients with AMI diagnosed by ECG changes and clinical features and who were eligible for thrombolysis.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Control group (N = 69;63 analysed (41 all data)): Standard care including thrombolytics and aspirin. No sham treatment.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Experimental group (N = 69;59 analysed (40 all data)): As above, but immediately following diagnosis, patients were given hyperbaric oxygen at 2ATA on 100% for a total chamber time of 2 hours. </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="border-color: windowtext; border-style: solid; border-width: 1.5pt; display: block; padding: 1pt 4pt;"><span style="padding-bottom: 0cm; padding-left: 0cm; padding-right: 0cm; padding-top: 0cm;"><span style="font-family: 'Times New Roman','serif'; font-size: 16px;">2. There was no significant improvement in other measures of outcome, although there was a trend to lower CPK levels, LVEF and mortality.</span></span></span>
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{|
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">Outcome</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">Time to Outcome</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">Control group</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">HBO group</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">Relative risk reduction</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">Absolute risk reduction</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">NNT</span>'''</span></span>  
+
*
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Appraised by:</span>'''<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital</span>'''  
 +
 
 +
<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Sydney; Friday, 4 June 1999</span>
 +
 
 +
*
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Clinical Scenario:</span>'''<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">A patient with acute myocardial infarction.</span>'''  
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Three-part Question: </span>'''<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">In patients with acute myocardial infarction, does the early administration of hyperbaric oxygen, in addition to a standard care protocol including thrombolysis, result in any demonstrable improvement in outcome?</span>'''  
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Search Terms:</span>'''<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">myocardial infarction, thrombolysis</span>'''  
 +
 
 +
*
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">The Study:</span> 
 +
 
 +
<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Non-blinded randomised controlled trial without intention-to-treat.</span> <span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Patients with AMI diagnosed by ECG changes and clinical features and who were eligible for thrombolysis.</span> <span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Control group (N = 69;63 analysed (41 all data)): Standard care including thrombolytics and aspirin. No sham treatment.</span> <span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Experimental group (N = 69;59 analysed (40 all data)): As above, but immediately following diagnosis, patients were given hyperbaric oxygen at 2ATA on 100% for a total chamber time of 2 hours.</span>
 +
 
 +
*
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">The Evidence:</span>  
 +
 
 +
{|
 
|-
 
|-
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">Death</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">Discharge</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">0.032</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">0.017</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">47%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">0.015</span></span> || <span style'''"display: block; text-align: center;"><span style="display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">67</span></span>  
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| <span><span>'''<span>Outcome</span>'''</span></span>
 +
| <span><span>'''<span>Time to Outcome</span>'''</span></span>
 +
| <span><span>'''<span>Control group</span>'''</span></span>
 +
| <span><span>'''<span>HBO group</span>'''</span></span>
 +
| <span><span>'''<span>Relative risk reduction</span>'''</span></span>
 +
| <span><span>'''<span>Absolute risk reduction</span>'''</span></span>
 +
| <span><span>'''<span style="font-family: 'Times New Roman','serif';">NNT</span>'''</span></span>
 
|-
 
|-
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; text-align: center;">'''<span style'''"font-family: &#39;Times New Roman&#39;,&#39;serif&#39;;">95%CI:</span>'''</span></span> ||   ||  ||  || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">-100% to 100%</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">-0.04 to 0.07</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; text-align: center;">NNT'''14 to INF NNH=25 to INF</span></span>  
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| <span><span>'''<span>Death</span>'''</span></span>
 +
| <span><span>Discharge</span></span>
 +
| <span><span>0.032</span></span>
 +
| <span><span>0.017</span></span>
 +
| <span><span>47%</span></span>
 +
| <span><span>0.015</span></span>
 +
| <span><span style="display: block; font-family: 'Times New Roman','serif'; text-align: center;">67</span></span>
 
|-
 
|-
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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><span>'''<span>95%CI:</span>'''</span></span>
 +
| &nbsp;
 +
| &nbsp;
 +
| &nbsp;
 +
| <span><span>-100% to 100%</span></span>
 +
| <span><span>-0.04 to 0.07</span></span>
 +
| <span><span>NNT'''14 to INF NNH=25 to INF'''</span></span>
 
|-
 
|-
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| <span style'''"line-height: normal; margin-bottom: 0pt;">'''Time to pain relief'''</span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">Variable</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">614</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">261</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style="display: block; text-align: center;"><0.001</span></span>  
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| <span>'''Non-event outcomes'''</span>
 +
| <span><span>'''Time to outcome'''</span></span>
 +
| <span><span>'''Control group'''</span></span>
 +
| <span><span>'''HBO group'''</span></span>
 +
| <span><span style="display: block; text-align: center;">'''P-value'''</span></span>
 
|-
 
|-
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| <span style'''"line-height: normal; margin-bottom: 0pt;">'''CPK (activity)'''</span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">12 hours</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">1,828</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style'''"display: block; text-align: center;">1,690</span></span> || <span style'''"display: block; line-height: normal; margin-bottom: 0pt; text-align: center;"><span style="display: block; text-align: center;">>0.05</span></span>  
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| <span>'''Time to pain relief'''</span>
 +
| <span><span>Variable</span></span>
 +
| <span><span>614</span></span>
 +
| <span><span>261</span></span>
 +
| <span><span style="display: block; text-align: center;"><0.001</span></span>
 
|-
 
|-
 +
| <span>'''CPK (activity)'''</span>
 +
| <span><span>12 hours</span></span>
 +
| <span><span>1,828</span></span>
 +
| <span><span>1,690</span></span>
 +
| <span><span style="display: block; text-align: center;">>0.05</span></span>
 
|}
 
|}
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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. Multicentre study with considerable loss of data, no intention to treat analysis and no blinding. There is some danger of bias.</span>
 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">2. All outcomes except time to pain relief show a non-significant trend in favour of the HBO group. A larger study may confirm a treatment effect.</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 2021</span>
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*
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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: 'Times New Roman','serif'; font-size: 16px;">Comments:</span> 
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<span style="font-family: &#39;Times New Roman&#39;,&#39;serif&#39;; font-size: 16px;">Stavitsky Y, Shandling AH, Ellestad MH, Hart GB, Van Natta B, Messenger JC, Strauss M, Dekleva MN, Alexander JM, Mattice M, Clarke D. Hyperbaric oxygen and thrombolysis in myocardial infarction: the 'HOT MI' randomised multicenter study. Cardiology 1998; 90:131-136.</span>
+
 
 +
<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">1. Multicentre study with considerable loss of data, no intention to treat analysis and no blinding. There is some danger of bias.</span> <span style="font-family: 'Times New Roman','serif'; font-size: 16px;">2. All outcomes except time to pain relief show a non-significant trend in favour of the HBO group. A larger study may confirm a treatment effect.</span>
 +
 
 +
*
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Expiry date:</span>'''<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">June 2021</span>'''
 +
**<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">References:</span>  
 +
 
 +
<span style="font-family: 'Times New Roman','serif'; font-size: 16px;">Stavitsky Y, Shandling AH, Ellestad MH, Hart GB, Van Natta B, Messenger JC, Strauss M, Dekleva MN, Alexander JM, Mattice M, Clarke D. Hyperbaric oxygen and thrombolysis in myocardial infarction: the 'HOT MI' randomised multicenter study. Cardiology 1998; 90:131-136.</span>
  
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<span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">'''[[Acute ischaemia | BACK]]'''</span></span>
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<span style="color: #7c00ff; display: block; font-size: 26px; text-align: center;">'''[[Acute_ischaemia|BACK]]'''</span>

Revision as of 03:20, 8 September 2021

Hyperbaric oxygen reduced time to pain relief in patients following acute myocardial infarction.

Clinical Bottom Line:

1. The time to pain relief following myocardial infarction was reduced following the addition of hyperbaric oxygen to the treatment protocol.

2. There was no significant improvement in other measures of outcome, although there was a trend to lower CPK levels, LVEF and mortality.

    • Appraised by:Mike Bennett, Dept. of Diving and Hyperbaric Medicine, Prince of Wales Hospital

Sydney; Friday, 4 June 1999

    • Clinical Scenario:A patient with acute myocardial infarction.
    • Three-part Question: In patients with acute myocardial infarction, does the early administration of hyperbaric oxygen, in addition to a standard care protocol including thrombolysis, result in any demonstrable improvement in outcome?
    • Search Terms:myocardial infarction, thrombolysis
    • The Study:

Non-blinded randomised controlled trial without intention-to-treat. Patients with AMI diagnosed by ECG changes and clinical features and who were eligible for thrombolysis. Control group (N = 69;63 analysed (41 all data)): Standard care including thrombolytics and aspirin. No sham treatment. Experimental group (N = 69;59 analysed (40 all data)): As above, but immediately following diagnosis, patients were given hyperbaric oxygen at 2ATA on 100% for a total chamber time of 2 hours.

    • The Evidence:
Outcome Time to Outcome Control group HBO group Relative risk reduction Absolute risk reduction NNT
Death Discharge 0.032 0.017 47% 0.015 67
95%CI:       -100% to 100% -0.04 to 0.07 NNT14 to INF NNH=25 to INF
Non-event outcomes Time to outcome Control group HBO group P-value
Time to pain relief Variable 614 261 <0.001
CPK (activity) 12 hours 1,828 1,690 >0.05
    • Comments:

1. Multicentre study with considerable loss of data, no intention to treat analysis and no blinding. There is some danger of bias. 2. All outcomes except time to pain relief show a non-significant trend in favour of the HBO group. A larger study may confirm a treatment effect.

    • Expiry date:June 2021
    • References:

Stavitsky Y, Shandling AH, Ellestad MH, Hart GB, Van Natta B, Messenger JC, Strauss M, Dekleva MN, Alexander JM, Mattice M, Clarke D. Hyperbaric oxygen and thrombolysis in myocardial infarction: the 'HOT MI' randomised multicenter study. Cardiology 1998; 90:131-136.

 

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