Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...
Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...
Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...
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Table 57 Descriptive characteristics of included studies focusing on the use of HBOT in sudden<br />
deafness and acoustic trauma.*<br />
First Author and<br />
Year of Publication<br />
Cavallazi 1996 95<br />
Vavrina 1995 96<br />
Hoffmann 1993 97<br />
(acute)<br />
Hoffmann 1993 98<br />
(chronic)<br />
NHMRC<br />
Level<br />
III-2<br />
III-2<br />
Study<br />
Design<br />
Comparative<br />
study<br />
Comparative<br />
study<br />
Location<br />
Dates of<br />
Enrolment<br />
Characteristics of Study<br />
Population†<br />
58 <strong>Hyperbaric</strong> oxygen therapy<br />
Size<br />
Italy ? ‡ 62<br />
Switzerland ? 78<br />
Age<br />
(years)<br />
Mean (SD)<br />
48.2 (29-<br />
70) §<br />
I=24.9<br />
(6.3)<br />
C=22.7<br />
(7.6)<br />
II RCT Germany ? 20 ? ?<br />
II RCT Germany ? 44 ? ?<br />
Sex Ratio<br />
(M:F)<br />
* Abbreviations: C = comparison group, F = female, I = intervention group, M = male, RCT = randomised controlled trial, SD = standard<br />
deviation.<br />
† <strong>Information</strong> is given for intervention and comparison groups, if available. Otherwise, total study population values are stated.<br />
‡ Unstated, unclear, or unknown.<br />
§ Figures in parentheses are ranges.<br />
The studies were published over a period of three years. All were conducted in Europe.<br />
The sample sizes varied from 20 to 78 subjects. Only the study by Vavrina et al 96 was not<br />
an RCT. None of the studies indicated the dates during which subjects were recruited.<br />
The two smallest studies (both conducted by Hoffmann et al) 97,98 failed to provide ages<br />
and sexes of participants, while the study of Vavrina et al 96 did not indicate the<br />
distribution of sexes.<br />
Study quality<br />
All the RCTs failed to provide enough detail to assess the adequacy of randomisation<br />
(Table 58). Except for one of the studies by Hoffmann et al98 none of the studies<br />
provided enough details to assess masking. All of the studies reported complete followup<br />
of participants.<br />
Table 58 Methodological quality of included studies focusing on the use of HBOT in sudden deafness<br />
and acoustic trauma.*<br />
First Author and<br />
Year of Publication<br />
32:30<br />
Study Design Randomisation Masking Losses to Follow-up<br />
Cavallazi 1996 95 Comparative study None Unclear No losses<br />
Vavrina 1995 96 Comparative study None Unclear No losses<br />
Hoffmann 1993 97<br />
(acute)<br />
Hoffmann 1993 98<br />
(chronic)<br />
RCT<br />
RCT<br />
* Abbreviation: RCT = Randomised controlled trial<br />
Unclear Unclear No losses<br />
Unclear Double-masked 1<br />
Patient criteria<br />
None of the studies provided objective criteria on which the diagnoses of sudden<br />
deafness and acoustic trauma were based. Two of the studies explicitly recruited patients<br />
?