Difference between revisions of "Pitkin"
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| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: | + | <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%;">''' | + | <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> |
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;"> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">''' | + | <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%;"> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">''' | + | <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%;">''' | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">''' | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The | + | <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> |
| − | + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Evidence:'''</span> | |
| − | + | ||
| + | {| | ||
|- | |- | ||
| − | | <span | + | | <span><span>'''Outcome'''</span></span> |
| + | | <span><span>'''Time to Outcome'''</span></span> | ||
| + | | <span><span>'''Control group'''</span></span> | ||
| + | | <span><span>'''HBO Group'''</span></span> | ||
| + | | <span><span>'''Relative Risk Reduction'''</span></span> | ||
| + | | <span><span>'''Absolute Risk Reduction'''</span></span> | ||
| + | | style="text-align: center;" | <span><span>'''NNT'''</span></span> | ||
|- | |- | ||
| − | | <span | + | | <span>'''Warm sensory threshold normalised'''</span> |
| + | | <span><span>12 months</span></span> | ||
| + | | <span><span>0</span></span> | ||
| + | | <span><span>0.18</span></span> | ||
| + | | <span><span>---</span></span> | ||
| + | | <span><span>0.18</span></span> | ||
| + | | <span><span style="display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">6</span></span> | ||
|- | |- | ||
| + | | <span>'''95% CI'''</span> | ||
| + | | | ||
| + | | | ||
| + | | | ||
| + | | | ||
| + | | <span><span>-0.01 to 0.36</span></span> | ||
| + | | <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> | ||
|} | |} | ||
| − | <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> | + | <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> |
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Comments:''' </span> | + | <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> |
| − | <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> | ||
<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> | ||
| − | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''References:''' </span> | + | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''References:'''</span> |
| − | # <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> | + | |
| − | # <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> | + | #<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> |
| − | # <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%;">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> |
| − | # <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> | + | #<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> | ||
| − | [[File: | + | [[File:Sumhorsa.gif|center|Sumhorsa.gif]] |
| − | <span style="color: #7c00ff; display: block; font-family: arial,helvetica,sans-serif; font-size: 26px; text-align: center;">'''[[ | + | <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:
- 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.
- 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.
- Yarnold J. Double-blind randomised phase II study of hyperbaric oxygen in patients with radiation-induced brachial plexopathy. Radiotherapy and Oncology 2005; 77:327.
- 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