Difference between revisions of "Glover"
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| − | <span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="font-family: | + | <span style="line-height:normal">'''<span style="font-size:18.0pt"><span style="font-family:"><span style="color:black">Hyperbaric oxygenation did not improve symptoms of radiation injury to the pelvis compared to a sham treatment</span></span></span>'''</span> |
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| − | <span style="font-size:large;"><span style="line-height:normal">'''<span style="font-family: | + | <span style="font-size:large;"><span style="line-height:normal">'''<span style="font-family:"><span style="color:black">1. No benefit in radiation-related problems with HBOT compared to sham treatment at one year</span></span>'''</span></span> |
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| − | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family: | + | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family:"><span style="color:black">Citation/s:</span></span>'''<span style="font-family:"><span style="color:black">1.Glover M, Smerdon GR, Andreyev HJ, Benton BE, Bothma P, Firth O, Gothard L, Harrison J, Ignatescu M, Laden G, Martin S. Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trial. The Lancet Oncology. 2016 Feb 1;17(2):224-33.<br/> '''Lead author's name and fax: '''John Yarnold John.yarnold@icr.ac.uk</span></span></span></span> |
| − | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family: | + | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family:"><span style="color:black">Three-part Clinical Question:</span></span>'''<span style="font-family:"><span style="color:black">For patients with radiation proctitis, does treatment with hyperbaric oxygen, compared to a sham treatment, result in any symptomatic improvement?<br/> '''Search Terms:''' STRI; radiation; proctitis</span></span></span></span> |
| − | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family: | + | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family:"><span style="color:black">The Study:</span></span>'''<span style="font-family:"><span style="color:black">Double-blinded concealed randomised controlled trial with intention-to-treat.<br/> '''The Study Patients:''' Adults with gastrointestinal symptoms attributed to late radiation tissue injury for at least 12 months and continuing despite three months of optimum standard treatment. (Median 42 months)<br/> '''Control group''' (N = 29; various analysed): 40 sessions at 1.3 ATA breathing air for 90 minutes once daily for five days each week.<br/> '''Experimental group''' (N = 55; various analysed): As above but breathing 100% oxygen at 2.4 ATA</span></span></span></span> |
| − | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family: | + | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family:"><span style="color:black">The Evidence:</span></span>'''<span style="font-family:"><span style="color:black">IBDQ = Inflammatory Bowel Disease Questionnaire</span></span></span></span> |
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| − | | | + | {| class="Table" style="width: 880px; background: white; border-collapse: collapse; border: 1pt solid windowtext;" width="0" |
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| − | | | + | | style="border: 1pt solid windowtext; background: white; width: 215px;" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Outcome</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 102px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="79" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Time to Outcome</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 80px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="52" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Sham group</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 81px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="53" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">HBOT group</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 117px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="95" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Relative risk reduction</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 131px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="107" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Absolute risk reduction</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 132px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="116" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">NNT</span></span></span>'''</span></p> |
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| − | | | + | | rowspan="2" style="border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; background: white; width: 215px;" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Improvement in rectal bleeding on IBDQ</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 102px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="79" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">12 months</span></span></span></span></p> |
| − | | style="width: | + | | style="width: 80px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="52" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">0.67</span></span></span></span></p> |
| − | | style="width: | + | | style="width: 81px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="53" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">0.74</span></span></span></span></p> |
| + | | style="width: 117px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="95" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">-11%</span></span></span></span></p> | ||
| + | | style="width: 131px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="107" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">-0.08</span></span></span></span></p> | ||
| + | | style="width: 132px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="116" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">13</span></span></span></span></p> | ||
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| + | | colspan="3" style="width: 269px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="184" | <p align="right" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:right; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">95% CIs:</span></span></span></span></p> | ||
| + | | style="width: 117px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="95" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">-53% to 30%</span></span></span></span></p> | ||
| + | | style="width: 131px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="107" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">-0.36 to 0.20</span></span></span></span></p> | ||
| + | | style="width: 132px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="116" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">NNT = 5 to INF; NNH = 3 to INF</span></span></span></span></p> | ||
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| − | {| class="Table" style="border: | + | {| class="Table" style="background: white; border-collapse: collapse; border: 1pt solid windowtext; width: 695px;" |
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| − | | style="width: | + | | style="width: 198px; border: 1pt solid windowtext; background: white;" width="185" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Non-Event Outcomes</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 103px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="83" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Time to outcome</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 139px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="140" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Control group</span></span></span>'''</span></p> |
| − | | style="width: | + | | style="width: 142px; border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white;" width="136" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Experimental group</span></span></span>'''</span></p> |
| − | | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding: | + | | style="border-top: 1pt solid windowtext; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-image: initial; border-left: none; background: white; width: 97px;" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">P-value</span></span></span>'''</span></p> |
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| − | | style="width: | + | | style="width: 198px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; background: white;" width="185" | |
| − | <span style=" | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Improvement in LENT SOMA scores (Median and IQR)</span></span></span>'''</span> |
| − | | style="width: | + | | style="width: 103px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="83" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">12 months</span></span></span></span></p> |
| − | | style="width: | + | | style="width: 139px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="140" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">N= 26</span></span></span></span></p> <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">1.5 (4 to 0)</span></span></span></span></p> |
| − | | style="width: | + | | style="width: 142px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="136" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">N = 46</span></span></span></span></p> <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">1 (2 to -1)</span></span></span></span></p> |
| − | | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding: | + | | style="border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white; width: 97px;" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">0.12</span></span></span></span></p> |
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| − | | style="width: | + | | style="width: 198px; border-right: 1pt solid windowtext; border-bottom: 1pt solid windowtext; border-left: 1pt solid windowtext; border-image: initial; border-top: none; background: white;" width="185" | |
| − | <span style=" | + | <span style="line-height:normal">'''<span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">Improvement in bowel function score (from IBDQ)</span></span></span>'''</span> |
| − | | style="width: | + | | style="width: 103px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="83" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">12 months</span></span></span></span></p> |
| − | | style="width: | + | | style="width: 139px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="140" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">N = 23</span></span></span></span></p> <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">4 (-6 to 9)</span></span></span></span></p> |
| − | | style="width: | + | | style="width: 142px; border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white;" width="136" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">N = 46</span></span></span></span></p> <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">3.5 (-3 to 11)</span></span></span></span></p> |
| − | | <p align="center" style="margin-bottom:.0001pt; text-align:center; padding: | + | | style="border-top: none; border-left: none; border-bottom: 1pt solid windowtext; border-right: 1pt solid windowtext; background: white; width: 97px;" | <p align="center" style="margin-top:10.8pt; margin-right:0cm; margin-bottom:.0001pt; margin-left:0cm; text-align:center; padding:0cm 0cm 0cm 0cm"><span style="line-height:normal"><span style="font-size:13.5pt"><span style="font-family:"><span style="color:#001133">0.50</span></span></span></span></p> |
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| − | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family: | + | |
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| + | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family:"><span style="color:black">Comments:</span></span>'''<br/> <span style="font-family:"><span style="color:black">1. Well-conducted RCT with reliable blinding, allocation concealment and randomisation procedures.<br/> 2. Differences in symptomatology at entry and loss/incomplete follow-up such that different individual outcomes included different numbers of patients.<br/> 3. Less improvement in LENT SOMA scores with HBO than recorded in previous studies. Patients in this study had changes of longer duration (median 42 months) than other studies and relatively mild symptomatology. Also, the assessments were subjective rather than objective.<br/> 4. Probably under-powered to find a clinically useful improvement - sample size calculated on a big difference between groups of ARR 70%. Even the staunchest proponents of hyperbaric oxygen therapy would find this an optimistic prediction.<br/> 5. The modified IBDQ was developed and validated for patients with ulcerative colitis and Crohn’s disease and maybe inappropriate to use here.</span></span></span></span> | ||
| − | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family: | + | <span style="font-size:medium;"><span style="line-height:normal">'''<span style="font-family:"><span style="color:black">Appraised by</span></span>'''<span style="font-family:"><span style="color:black">: Mike Bennett m.bennett@unsw.edu.au; Thursday, 14 May 2020<br/> <br/> '''Kill or Update By:''' May 2022</span></span></span></span> |
| + | <p style="text-align: center;">[[File:Sumhorsa.gif|center|Sumhorsa.gif]]</p> <p style="text-align: center;">'''<span style="font-size:x-large;">[[Radiation_tissue_injury|BACK]]</span>'''</p> <p style="text-align: center;">[[File:Sumhorsa.gif|center|Sumhorsa.gif]]</p> | ||
Latest revision as of 02:41, 14 May 2020
Hyperbaric oxygenation did not improve symptoms of radiation injury to the pelvis compared to a sham treatment
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1. No benefit in radiation-related problems with HBOT compared to sham treatment at one year |
Citation/s:1.Glover M, Smerdon GR, Andreyev HJ, Benton BE, Bothma P, Firth O, Gothard L, Harrison J, Ignatescu M, Laden G, Martin S. Hyperbaric oxygen for patients with chronic bowel dysfunction after pelvic radiotherapy (HOT2): a randomised, double-blind, sham-controlled phase 3 trial. The Lancet Oncology. 2016 Feb 1;17(2):224-33.
Lead author's name and fax: John Yarnold John.yarnold@icr.ac.uk
Three-part Clinical Question:For patients with radiation proctitis, does treatment with hyperbaric oxygen, compared to a sham treatment, result in any symptomatic improvement?
Search Terms: STRI; radiation; proctitis
The Study:Double-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Adults with gastrointestinal symptoms attributed to late radiation tissue injury for at least 12 months and continuing despite three months of optimum standard treatment. (Median 42 months)
Control group (N = 29; various analysed): 40 sessions at 1.3 ATA breathing air for 90 minutes once daily for five days each week.
Experimental group (N = 55; various analysed): As above but breathing 100% oxygen at 2.4 ATA
The Evidence:IBDQ = Inflammatory Bowel Disease Questionnaire
|
Outcome |
Time to Outcome |
Sham group |
HBOT group |
Relative risk reduction |
Absolute risk reduction |
NNT |
Improvement in rectal bleeding on IBDQ |
12 months |
0.67 |
0.74 |
-11% |
-0.08 |
13 |
95% CIs: |
-53% to 30% |
-0.36 to 0.20 |
NNT = 5 to INF; NNH = 3 to INF | |||
Non-Event Outcomes |
Time to outcome |
Control group |
Experimental group |
P-value |
|
Improvement in LENT SOMA scores (Median and IQR) |
12 months |
N= 26 1.5 (4 to 0) |
N = 46 1 (2 to -1) |
0.12 |
|
Improvement in bowel function score (from IBDQ) |
12 months |
N = 23 4 (-6 to 9) |
N = 46 3.5 (-3 to 11) |
0.50 |
Comments:
1. Well-conducted RCT with reliable blinding, allocation concealment and randomisation procedures.
2. Differences in symptomatology at entry and loss/incomplete follow-up such that different individual outcomes included different numbers of patients.
3. Less improvement in LENT SOMA scores with HBO than recorded in previous studies. Patients in this study had changes of longer duration (median 42 months) than other studies and relatively mild symptomatology. Also, the assessments were subjective rather than objective.
4. Probably under-powered to find a clinically useful improvement - sample size calculated on a big difference between groups of ARR 70%. Even the staunchest proponents of hyperbaric oxygen therapy would find this an optimistic prediction.
5. The modified IBDQ was developed and validated for patients with ulcerative colitis and Crohn’s disease and maybe inappropriate to use here.
Appraised by: Mike Bennett m.bennett@unsw.edu.au; Thursday, 14 May 2020
Kill or Update By: May 2022
