Zhang
Weak evidence that the addition of hyperbaric oxygen may improve the effectiveness of radio-iodine stent placement for the treatment of advanced oesophageal cancer.
Clinical bottom line:
1. There was no statistically significant improvement in tumour response to radio-iodine with the addition of hyperbaric oxygen. |
Citation/s:1. Zhang QZ, Li GL, Shang JB, Ren YM, Xie JL. Clinical study of a 125I particle-integrated esophageal covered stent and hyperbaric oxygen in the treatment of advanced esophageal cancer. Rev Esp Enferm Dig. 2021 Aug;113(8):576-579. doi: 10.17235/reed.2020.7377/2020. PMID: 33261505.
Lead author's name and fax: Qizhou Zhang: zh_qizhou854694@126.com
Three-part Clinical Question:For patients with oesophageal cancer, does the addition of hyperbaric oxygen to the implantation of an oesophageal stent with radio-iodine result in any improved outcome?
Search Terms: Radioactive iodine seeds, Coated stent, Oesophageal cancer
The Study:Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Adult patients with advanced oesophageal cancer and no radiotherapy or chemotherapy in the past 3 months.
Control group (N = 19; 19 analysed): Placement of a radio-iodine implanted stent under local anaesthesia.
Experimental group (N = 26; 26 analysed): As above plus 100% oxygen breathing at 2 ATA for 60 minutes daily to a total of 30 sessions. Very slow compression and decompression periods.
The Evidence:
Outcome |
Time to Outcome |
Control group |
HBO group |
Relative risk reduction |
Absolute risk reduction |
NNT |
Proportion with complete or partial response |
2 weeks |
0.6 |
0.8 |
28% |
0.2 |
6 |
95% CIs: |
-70% to 14% |
-0.1 to 0.4 |
NNT = 2 to INF NNH = 11 to INF | |||
Proportion with complete tumour response |
2 weeks |
0.1 |
0.2 |
83% |
0.1 |
11 |
95% CIs: |
-100 to 278% |
-0.1 to 0.3 |
NNT = 3 to INF NNH = 3 to INF |
Measure |
Control Group |
HBO Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
Functional score (Karnofsky performance score, 0 worst to 100 best) at 2 weeks |
89.7 |
9.3 |
91.6 |
8.2 |
2.0 |
-43.8 to 47.7 |
Comments:
1. Stents relieve dysphagia and have been palliative in the past. Stents implanted with radio-iodine may effectively treat the oesophageal cancer but have not been fully evaluated.
2. No description of randomisation process or explanation of difference in the numbers allocated to the two groups.
3. The authors report a statistically significant benefit in response rate of tumours with the addition of HBOT. Our statistics do not confirm this finding.
4. Our results suggest a non-significant benefit from HBO that would be clinically important if confirmed.
5. Dysphagia relieved and minor discomfort only reported in both groups.
6. Authors hypothesise the intermittent reversal of hypoxic areas of tumour improves the effect of radiotherapy here.
Appraised by:Mike Bennett m.bennett@unsw.edu.au ; Saturday, 9 April 2022
Kill or Update By: April 2024