|
1. Some indication of benefit from HBOT with
cerebral palsy in respect to gross motor function measures. |
Citation/s:
1. Mathai SS, Bansali P, Singh Gill B, Nagpal S, John MJ, Aggarwal H, Bhatt V.
Effects of hyperbaric oxygen therapy in children with cerebral palsy.
Proceedings of the International Conference on Diving and Hyperbaric Medicine,
Three-part Clinical Question: In children with cerebral palsy, does
hyperbaric oxygen improve function?
Search Terms: Cerebral palsy
The Study:
Double-blinded randomised controlled trial with intention-to-treat.
The Study Patients: Children with cerebral palsy aged 1 to 10 years and
able to attend chamber over several months.
Control group (N = 9; 9 analysed): Compression to 1.5 ATA breathing air
for one hour daily for 5 weeks (30 treatments). Repeated 3 times with one month
interval (total 90 treatments).
Experimental group (N = 11; 11 analysed): As above, but breathing 100%
oxygen.
The Evidence:
|
Outcome |
Time
to Outcome |
Sham
rate |
HBOT
rate |
Relative
risk reduction |
Absolute
Risk Reduction |
NNT |
|
Improvement
in upper limb spasticity score |
One month
|
0.333 |
0.364 |
9% |
0.03 |
32 |
|
95% Confidence Intervals: |
135% to -100% |
0.45 to -0.39 |
NNT = 2 to INF; NNH = 3 to INF |
|||
|
Improvement
in lower limb spasticity score |
One month |
0.222 |
0.455 |
105% |
-0.23 |
4 |
|
95% Confidence Intervals: |
285% to -75% |
0.63 to -0.17 |
NNT = 2 to INF; NNH = 6 to INF |
|||
|
Improved
SPECT scan |
One month |
0.222 |
0.545 |
145% |
0.32 |
3 |
|
95% Confidence Intervals: |
326% to -35% |
0.72 to -0.08 |
NNT = 1 to INF; NNH = 13 to INF |
|||
|
Measure |
Sham
Group |
HBOT
Group |
Difference |
95% CI |
||
|
Mean |
SD |
Mean |
SD |
|||
|
Mean change in gross motor function measure |
5.8 |
2.9 |
14.6 |
4.2 |
8.8 |
12.3 to 5.3 |
|
Non-Event
Outcomes |
Time to
outcome/s |
Control
group |
Experimental
group |
P-value |
|
Change in speech score |
One month |
pre: 2.0 +/- 0.7 post: 2.4 +/- 0.8 |
pre: 2.2 +/- 0.5 post: 3.1 +/- 0.5 |
>0.05 <0.05 |
Comments:
1. No sample size calculation and this study has very low power to detect even
quite large differences between groups.
2. Given the method of randomisation by sealed envelopes, it is not clear why
the groups are not equal in numbers.
3. Long course of HBOT is unusual - 90 treatments over six months.
4. No plausible mechanism of action and the authors imply that most cases of CP
are due to hypoxia in the perinatal or early postnatal period, rather than
developmental in aetiology.
5. Many potentially important confounders have not been considered (e.g. Apgar
scores, prematurity) and there is a strong possibility of bias given the small
numbers.
6. Clinical significance of the improvement in GMFM requires expert interpretation.
Appraised by: Sean Hopson, Mike Bennett, POWH Sydney ; Friday, 11 August 2006
Email: m.bennett@unsw.edu.au
Kill or Update By: August 2007