Difference between revisions of "Pitkin"
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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> | <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> | ||
| − | <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 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%;">'''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%;">'''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> | ||
| + | |||
| + | <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 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: 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%;">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%;">'''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%;">'''Expiry date:''' December 2019</span> | <span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Expiry date:''' December 2019</span> | ||
Revision as of 23:19, 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