Wu
The addition of hyperbaric oxygen treatment did not enhance improvements in diabetic control in patients receiving bone marrow mononuclear cell infusions to the pancreas.
Clinical Bottom Line:
1. The improvement in diabetic control with bone marrow mononuclear cells was not enhanced by the co-administration of hyperbaric oxygen
Citation/s:1.Wu Z, Cai J, Chen J, Huang L, Wu W, Luo F, Wu C, Liao L, Tan J. Autologous bone marrow mononuclear cell infusion and hyperbaric oxygen therapy in type 2 diabetes mellitus: an open-label, randomized controlled clinical trial. Cytotherapy. 2014 Feb 1;16(2):258-65.
Lead author's name and fax:Jianming Tan doctorjm@yahoo.com
Three-part Clinical Question:Does the addition of HBO exposure to the administration of bone marrow mononuclear cells improve blood sugar control in patients with Diabetes mellitus?
Search Terms: diabetes mellitus, stem cell therapy, C-peptide
The Study:Non-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Adult patients with type II diabetes mellitus following a four month period of standard diabetes management with insulin and metformin to achieve HbAic > 7% and < 9% . Bone marrow Mononuclear Cell (BM-MNC) (N = 20; 20 analysed): Pancreatic arterial infusion of BM-MNC. Experimental group (N = 21; 20 analysed): As above but in addition 20 sessions of oxygen breathing at 2 ATA for sixty minutes daily before and after MB-MNC infusion.
The Evidence:
Outcome |
Time to Outcome |
BM-MNC |
HBO and BM-MNC |
Relative risk reduction |
Absolute risk reduction |
NNT |
No longer requiring insulin |
12 months |
0.10 |
0.05 |
52% |
0.05 |
19 |
95% CIs: |
-108% to 100% |
-0.11 to 0.21 |
NNT = 5 to INF; NNH = 9 to INF | |||
Measure |
BM-MNCGroup |
HBO and BM-MNC Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
|
Area under the curve of C-peptide during GTT (higher is better) |
469 |
102.5 |
455.4 |
122.1 |
13.6 |
-8119.7 to 8146.9 |
|
HbA1c at 12 months |
7.4 |
0.9 |
7.4 |
0.8 |
0.000 |
-0.46 to 0.46 |
|
QoL score at 12 months |
77.1 |
13.2 |
78.3 |
11.8 |
-1.2 |
-101.5 to 99.1 |
Comments:
1. Well conducted study.
2. There were no changes in outcome in two other groups also randomised in this study - control of no treatment and HBO alone.
Appraised by: Mike Bennett m.bennett@unsw.edu.au; Saturday, 16 May 2020
Kill or Update By: May 2022
