Some
evidence for placebo improvement in anxiety and depression scores following sham
hyperbaric therapy in patients with diabetic ulcers.
Clinical Bottom Line:
1. No evidence for improvement
from placebo treatment on general health status questionnaire SF-36.
2.Hospital anxiety and depression
scales suggest reduction in depression and anxiety following placebo
treatment.
Appraised
by:
Mike Bennett, Dept. of Diving and Hyperbaric, Prince of Wales Hospital
Sydney
; Monday, 14 January 2002. Email: m.bennett@unsw.edu.au
Three-part
Clinical Question: For patients undergoing hyperbaric therapy, is there an
identifiable placebo effect, resulting in some measure of at least subjective
improvement?
Search
Terms:
hyperbaric oxygenation, placebo effect, trial design
The
Study:
Double-blinded
randomised controlled trial intention-to-treat unknown.
The
Study Patients: Patients with
diabetic foot ulcers who were enrolled in a randomised controlled trial.
Control
group (N = 9;? analysed): Air at 2.4ATA for 90 minutes daily for a total of 30
treatments.
Experimental
group (N = 9;? analysed): 100%
oxygen at 2.4ATA on the same schedule.
The
Evidence:
Non-Event
Outcomes
Time to outcome/s
Control group
HBO group
Hospital
anxiety and
depression
scale- depression
30 days
Reduced (P=0.001)
Reduced
(P=0.001)
- anxiety
Reduced (P=0.025)
Unchanged
SF-36
- 5/8 domains
30 days
Unchanged
Unchanged
- General Health Improved
Unchanged
Improved (P=0.008)
- Health Transition
Unchanged
Improved (P=0.04)
Comments:
1.
True significance of these findings is not clear
2.
Abstract only, so little methodological or outcome detail.
3.
Probably represents the same group of patients as this author’s diabetic
patient RCTs
Kill
or Update By:
January 2004
Citation/s:
1.
Abidia A, Kuhan G, Laden G. The placebo effect of hyperbaric oxygen therapy-
fact or fiction? Undersea and Hyperbaric Medicine 2001; 28(suppl):57-58.
