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2018-12-17T02:12:07Z

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Some evidence that HBOT improves healing of lesions associated with bisphosphonate-related osteonecrosis

**Clinical Bottom Line:'''

1.Those receiving HBOT had a higher proportion of oral lesions graded as healed or improved.

2. Lesions improved more rapidly with HBOT.

3. Pain settled more rapidly in those who received HBOT.

'''Citation/s:''' 1. Freiberger JJ, Padilla-Burgos R. Update on the Duke randomised controlled trial of hyperbaric oxygen for osteonecrosis of the jaw in patients who have taken bisphosphonates. Undersea and Hyperbaric Medicine 2007;34(4):241
2. Freiberger JJ, Padilla-Burgos R, McGraw T, Suliman HB, Kraft KH, Stolp BW, Moon RE, Piantadosi C. What is the role of hyperbaric oxygen in the management of bisphosphonate-related osteonecrosis of the jaw: a randomized controlled trial of hyperbaric oxygen as an adjunct to surgery and antibiotics. J Oral Maxillofac Surg. 2012 Jul;70(7):1573-83.

Lead author's name and fax: Jake Freiberger: john.freiberger@duke.edu

'''Three-part Clinical Question:''' For patients with bisphosphonate =related osteonecrosis of the jaw (BROJ), does the adjunctive use hyperbaric oxygen, compared to standard treatment alone, result in any improvement in healing or quality of life?

'''Search Terms:''' bisphosphonate; osteonecrosis

'''The Study:''' Non-blinded concealed randomised controlled trial without intention-to-treat.

'''The Study Patients:''' Patients with an established diagnosis of BRONJ in the absence of radiation exposure, metastatic disease or recurrent malignancy in the head and neck region.

Control group (N = 21; 21 analysed): Continued standard oral care including surgery and antibiotics as necessary. Debridement at surgeon discretion.

Experimental group (N = 25; 25 analysed): As above plus 100% oxygen breathing at 2.0 ATA for two hours twice each day for four weeks.

**The Evidence:'''

{|
| '''Outcome''' || '''Time to Outcome''' || '''Standard Group''' || '''HBOT Group''' || '''Relative risk reduction''' || '''Absolute risk reduction''' || '''NNT'''
|-
| '''Lesions healed or improved''' || Final follow-up || 0.38 || 0.68 || 78% || 0.3 || 3
|-
|^ |||||| 95% CI: || 6% to 151% || 0.02 to 0.58 || 2 to 45
|-
|}

{|
| '''Non-Event Outcomes''' || '''Time to outcome/s''' || '''Control group ''' || '''Experimental group''' || '''P-value'''
|-
| '''Mean time to lesion improvement (weeks)''' || Up to two years || 67.9 (95%CI 48.4 to 87.5) || 39.7 (95%CI 22.4 to 57.0) || 0.03
|-
| '''Mean time to gingival healing (weeks)''' || Up to two years || 70 (52.2 to 88.4) || 59 (42.8 to 75.8) || 0.32
|-
|}

**Comments:'''

1. Original study planned for 35 patients per group after power calculation. 

2. As received analysis was done in view of the number of dropouts and crossovers for various reasons.

3. The result for proportion of lesions healed/improved is for the latest follow-up across all patients analysed - however actual analysis of time points after 3 months does not show any statistically significant differences.

4. Regression also suggested a more rapid relief of pain in the HBOT group.

5. No significant differences in quality of life measures reported between groups

'''Appraised by:''' Mike Bennett: m.bennett@unsw.edul.au; Monday, 17 December 2018

'''Kill or Update By:''' December 2022

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Freiberger - Revision history

Gordoben: Imported from Wikispaces