Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

Table 61 Descriptive characteristics of included studies focusing on the use of HBOT in head and
neck cancer.*
Characteristics of Study
Population †
First Author and
Year of Publication
Whittle 1990 99
Henk 1986 100
Sealy 1986 101
Berry 1979 102
Sause 1979 103
Chang 1973 104
Churchill-Davidson
1973 105
Shigamatsu 1973 106
Henk 1970 107
NHMRC
Level
III-2
Study
Design
Comparative
study
Location
Dates of
Enrolment
62 Hyperbaric oxygen therapy
UK
II RCT UK
II RCT
South
Africa
II RCT UK
II RCT USA
II RCT USA
III-3
III-1
III-1
Comparative
study with
historical
controls
Pseudorandomised
controlled
trial
Pseudorandomised
controlled
trial
UK
Japan
UK
1963 to
1985
1972 to
1977
Sep 1980 to
Mar 1984
Jan 1971 to
Dec 1974
Nov 1970 to
Dec 1976
Jan 1964 to
Mar 1971
1962 to
1972
1969 to
1971
Sep 1964 to
Jun 1969
Size
Age
(years)
Mean
(SD)
397 ? ‡ ?
107 ? ?
130
24
50
I=56
C=55
I=61 (6)
C=66 (9)
I=57 (38-
80) §
C=63
(36-81)
Sex Ratio
(M:F)
I=56:8
C=60:6
?
I=8:13
C=15:8
51 ? 2.5:1
171 ? ?
42
213
I=56.6
C=57.7
I=60
C=58
?
I=76:25
C=71:41
* Abbreviations: C = comparison group, F = female, I = intervention group, M = male, RCT = randomised controlled trial, SD = standard
deviation.
† Information is given for intervention and comparison groups, if available. Otherwise, total study population values are stated.
‡ Unstated, unclear, or unknown.
§ Figures in parentheses are ranges.
The studies were published from 1970 to 1990. Four studies were conducted in the UK,
three in the USA and one each in Japan and South Africa. The sample sizes ranged from
24 to 397 patients and the studies were conducted over a period ranging from two to 22
years. Five studies were described as RCTs 100-104 and a further two studies 106, 107 were
also reportedly RCTs, but examination of the descriptions of the randomisation methods
employed led to the conclusion that they are more accurately described as pseudorandomised
controlled trials.
Study quality
All five studies described as RCTs failed to provide enough detail to assess the adequacy
of randomisation (Table 62). Furthermore, as mentioned, two studies that described
themselves as RCTs were found to have used inadequate methods of randomisation,
namely birth dates (Henk et al107 ) and odd and even admission numbers (Shigamatsu et
al106 ). None of the studies reported masking procedures and as patients in the
comparison group were not subjected to a sham HBOT procedure it is reasonable to