Difference between revisions of "Pitkin"

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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 130%;">'''Hyperbaric oxygen did not reverse the changes of radiation-induced brachial plexopathy following irradiation of early breast cancer.''' </span>
 
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Clinical Bottom Line:''' </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 130%;">'''Hyperbaric oxygen did not reverse the changes of radiation-induced brachial plexopathy following irradiation of early breast cancer.'''</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. No evidence of improvement in brachial plexus function with HBOT. </span>
 
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Appraised by:''' Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Clinical Bottom Line:''' </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. No evidence of improvement in brachial plexus function with HBOT.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Sydney; Tuesday, 19 September 2000 </span>
 
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Clinical Scenario:''' A patient with pain and weakness in the arm following irradiation to the breast. </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Appraised by:''' Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Sydney; Tuesday, 19 September 2000</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Three-part Question:''' For patients with brachial plexus damage following irradiation, does the administration of hyperbaric oxygen, compared to 100% oxygen at 1ATA, result in any improvement in pain or function? </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Search Terms:''' Radiation tissue damage, breast cancer </span>
 
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study:''' </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Clinical Scenario:''' A patient with pain and weakness in the arm following irradiation to the breast. </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Three-part Question:''' For patients with brachial plexus damage following irradiation, does the administration of hyperbaric oxygen, compared to 100% oxygen at 1ATA, result in any improvement in pain or function? </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Search Terms:''' Radiation tissue damage, breast cancer</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Double-blinded concealed randomised controlled trial with intention-to-treat. </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Patients with moderate radiation- induced brachial plexopathy following irradiation for breast cancer. </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Control group''' (N = 17; 17 analysed): 41% oxygen at 2.4ATA for 90 minutes (equivalent to 100% at 1ATA) daily for 30 treatments. </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Experimental group''' (N = 18; 17 analysed): 100% oxygen at 2.4ATA on the same schedule as above. </span>
 
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Evidence:''' </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study:''' </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Double-blinded concealed randomised controlled trial with intention-to-treat. </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Patients with moderate radiation- induced brachial plexopathy following irradiation for breast cancer. </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Control group''' (N = 17; 17 analysed): 41% oxygen at 2.4ATA for 90 minutes (equivalent to 100% at 1ATA) daily for 30 treatments. </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Experimental group''' (N = 18; 17 analysed): 100% oxygen at 2.4ATA on the same schedule as above.</span>
  
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{|
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Evidence:'''</span>
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| <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">'''Outcome''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">'''Time to Outcome''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">'''Control group''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">'''HBO Group''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">'''Relative Risk Reduction''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">'''Absolute Risk Reduction''' </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">'''NNT''' </span></span>
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{|
 
|-
 
|-
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| <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 110%;">'''Warm sensory threshold normalised''' </span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">12 months </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">0 </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">0.18 </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">--- </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">0.18 </span></span> || <span style'''"display: block; text-align: center;"><span style="display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">6 </span></span>  
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| <span><span>'''Outcome'''</span></span>
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| <span><span>'''Time to Outcome'''</span></span>
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| <span><span>'''Control group'''</span></span>
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| <span><span>'''HBO Group'''</span></span>
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| <span><span>'''Relative Risk Reduction'''</span></span>
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| <span><span>'''Absolute Risk Reduction'''</span></span>
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| style="text-align: center;" | <span><span>'''NNT'''</span></span>
 
|-
 
|-
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| <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 110%;">'''95% CI''' </span> ||   ||  ||  ||  || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">-0.01 to 0.36 </span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">NNT 3 to INF </span></span><span style'''"display: block; text-align: center;"><span style="display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">NNH 199 to INF </span></span>  
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| <span>'''Warm sensory threshold normalised'''</span>
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| <span><span>12 months</span></span>
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| <span><span>0</span></span>
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| <span><span>0.18</span></span>
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| <span><span>---</span></span>
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| <span><span>0.18</span></span>
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| <span><span style="display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">6</span></span>
 
|-
 
|-
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| <span>'''95% CI'''</span>
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| &nbsp;
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| &nbsp;
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| &nbsp;
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| &nbsp;
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| <span><span>-0.01 to 0.36</span></span>
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| <span><span>NNT 3 to INF</span></span><span><span style="display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">NNH 199 to INF</span></span>
 
|}
 
|}
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 110%;">No clinically significant differences for McGill pain questionnaire or MOS SF-36 general health questionnaire. </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 110%;">No clinically significant differences for McGill pain questionnaire or MOS SF-36 general health questionnaire.</span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Comments:''' </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Comments:''' </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Cases were of relatively long-standing (median 11 yrs, range 1-29) </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">2. Very high compliance rate with follow-up. </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">3. Authors comment on two cases of marked improvement in lymphoedema </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">4. Some evidence of minor improvements on multiple comparisons with self-assessment questionnaires, but authors agree they are difficult to interpret. </span> <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">5. A follow-up at 6 to 7 years examined McGill pain and MOS SF-16 general health questionnaires and again reported no differences between the groups.</span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Cases were of relatively long-standing (median 11 yrs, range 1-29) </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">2. Very high compliance rate with follow-up. </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">3. Authors comment on two cases of marked improvement in lymphoedema </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">4. Some evidence of minor improvements on multiple comparisons with self-assessment questionnaires, but authors agree they are difficult to interpret. </span>
 
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">5. A follow-up at 6 to 7 years examined McGill pain and MOS SF-16 general health questionnaires and again reported no differences between the groups. </span>
 
  
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Expiry date:''' December 2019</span>
 
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Expiry date:''' December 2019</span>
  
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''References:''' </span>
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''References:'''</span>
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# <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Pitkin A, Pritchard J, Anand P et al. Double-blind randomised controlled trial of hyperbaric oxygen (HBO) therapy for treatment of radiation-induced brachial plexopathy (RIBP). Undersea and Hyperbaric Medicine 2000; 27(suppl):39. </span>
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# <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Pritchard J, Anand P, Broome J, Davis C, Gothard L, Hall E, Maher J, McKinna F, Millington J, Misra VP, Pitkin A, Yarnold JR. Double-blind randomized phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiother Oncol 2001 Mar;58(3):279-86. </span>
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#<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Pitkin A, Pritchard J, Anand P et al. Double-blind randomised controlled trial of hyperbaric oxygen (HBO) therapy for treatment of radiation-induced brachial plexopathy (RIBP). Undersea and Hyperbaric Medicine 2000; 27(suppl):39.</span>  
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# <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Yarnold J. Double-blind randomised phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiotherapy and Oncology 2005; 77:327.</span>
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#<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Pritchard J, Anand P, Broome J, Davis C, Gothard L, Hall E, Maher J, McKinna F, Millington J, Misra VP, Pitkin A, Yarnold JR. Double-blind randomized phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiother Oncol 2001 Mar;58(3):279-86.</span>  
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# <span style="font-family: arial,helvetica,sans-serif; font-size: 120%;">Gothard J, Haviland J, Bryson P. </span><span style="font-size: 120%;">Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer Radiotherapy and Oncology 2010; 97:101-107</span>
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#<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Yarnold J. Double-blind randomised phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiotherapy and Oncology 2005; 77:327.</span>  
 +
#<span style="font-family: arial,helvetica,sans-serif; font-size: 120%;">Gothard J, Haviland J, Bryson P. </span><span style="font-size: 120%;">Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer Radiotherapy and Oncology 2010; 97:101-107</span>  
  
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[[File:Sumhorsa.gif|center|Sumhorsa.gif]]
  
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<span style="color: #7c00ff; display: block; font-family: arial,helvetica,sans-serif; font-size: 26px; text-align: center;">'''[[Radiation tissue injury  | BACK]]'''</span>
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<span style="color: #7c00ff; display: block; font-family: arial,helvetica,sans-serif; font-size: 26px; text-align: center;">'''[[Radiation_tissue_injury|BACK]]'''</span>

Revision as of 02:11, 8 July 2019

Hyperbaric oxygen did not reverse the changes of radiation-induced brachial plexopathy following irradiation of early breast cancer.

Clinical Bottom Line: 1. No evidence of improvement in brachial plexus function with HBOT.

Appraised by: Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital Sydney; Tuesday, 19 September 2000

Clinical Scenario: A patient with pain and weakness in the arm following irradiation to the breast. Three-part Question: For patients with brachial plexus damage following irradiation, does the administration of hyperbaric oxygen, compared to 100% oxygen at 1ATA, result in any improvement in pain or function? Search Terms: Radiation tissue damage, breast cancer

The Study: Double-blinded concealed randomised controlled trial with intention-to-treat. Patients with moderate radiation- induced brachial plexopathy following irradiation for breast cancer. Control group (N = 17; 17 analysed): 41% oxygen at 2.4ATA for 90 minutes (equivalent to 100% at 1ATA) daily for 30 treatments. Experimental group (N = 18; 17 analysed): 100% oxygen at 2.4ATA on the same schedule as above.

The Evidence:

Outcome Time to Outcome Control group HBO Group Relative Risk Reduction Absolute Risk Reduction NNT
Warm sensory threshold normalised 12 months 0 0.18 --- 0.18 6
95% CI         -0.01 to 0.36 NNT 3 to INFNNH 199 to INF

No clinically significant differences for McGill pain questionnaire or MOS SF-36 general health questionnaire.

Comments: 1. Cases were of relatively long-standing (median 11 yrs, range 1-29) 2. Very high compliance rate with follow-up. 3. Authors comment on two cases of marked improvement in lymphoedema 4. Some evidence of minor improvements on multiple comparisons with self-assessment questionnaires, but authors agree they are difficult to interpret. 5. A follow-up at 6 to 7 years examined McGill pain and MOS SF-16 general health questionnaires and again reported no differences between the groups.

Expiry date: December 2019

References:

  1. Pitkin A, Pritchard J, Anand P et al. Double-blind randomised controlled trial of hyperbaric oxygen (HBO) therapy for treatment of radiation-induced brachial plexopathy (RIBP). Undersea and Hyperbaric Medicine 2000; 27(suppl):39.
  2. Pritchard J, Anand P, Broome J, Davis C, Gothard L, Hall E, Maher J, McKinna F, Millington J, Misra VP, Pitkin A, Yarnold JR. Double-blind randomized phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiother Oncol 2001 Mar;58(3):279-86.
  3. Yarnold J. Double-blind randomised phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiotherapy and Oncology 2005; 77:327.
  4. Gothard J, Haviland J, Bryson P. Randomised phase II trial of hyperbaric oxygen therapy in patients with chronic arm lymphoedema after radiotherapy for cancer Radiotherapy and Oncology 2010; 97:101-107
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