Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

Table 71 Descriptive characteristics of included studies focusing on the use of HBOT in bladder
cancer.*
First Author and Year
of Publication
Cade 1978 114
Kirk 1976 115
Dische 1973 116
Plenk 1972 117
NHMRC
Level
Study
Design
II RCT UK
Location
Dates of
Enrolment
May 1964 to
Dec 1971
Characteristics of Study
Population
72 Hyperbaric oxygen therapy
Size
Age (years)
Mean (SD)
236 ? † ?
II RCT UK 1966 to 1970 27 ? ?
II RCT UK from Apr 1966 67 ? ?
II RCT USA
May 1965 to
May 1970
40
I=68.8
C=68.2
Sex Ratio
(M:F)
I=19:0
C=19:2
* Abbreviations: C = comparison group, F = female, I = intervention group, M = male, RCT = randomised controlled trial, SD = standard
deviation.
† Unstated, unclear, or unknown.
The studies were published over a period of six years. All were randomised controlled
trials conducted in the USA or the UK. Patients were recruited in the mid 1960’s,
although the characteristics of some study populations were unstated. 114-116
Study quality
The adequacy of randomisation was certain only in two of the studies (Table 72). 114,116
All studies failed to adequately mention masking procedures. Except for the study by
Plenk, 117 all studies reported complete follow-up of subjects.
Table 72 Methodological quality of included studies focusing on the use of HBOT in bladder cancer.*
First Author and Year
of Publication
Study Design Randomisation Masking
Losses to Followup
Cade 1978 114 RCT Adequate Unclear No losses
Kirk 1976 115 RCT Unclear Unclear Unclear
Dische 1973 116 RCT Adequate Unclear No losses
Plenk 1972 117 RCT Unclear Unclear No losses
* Abbreviation: RCT = Randomised controlled trial
Patient criteria
Table 73 lists the inclusion and exclusion criteria used in the four studies. The three most
recent studies114-116 included patients based on very similar criteria that included the
confirmation of bladder cancer by histology, suitability to radiotherapy, and extent of
tumour spread. The study by Plenk117 used more relaxed criteria.