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Hyperbaric Oxygen Therapy - Hyperbaric Chamber Information ...

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HBOT used in conjunction with thrombolytic therapy may be beneficial in pain relief<br />

although more studies are needed to arrive at a firm and generalisable conclusion.<br />

Cerebrovascular disease<br />

Two studies of carotid artery stroke were retrieved and assessed (Table 41). Both studies<br />

were randomised controlled trials and were published four years apart. The study<br />

populations were similar in size, enrolling about 35 to 40 people. One group of<br />

participants was older by a mean difference of about 10 years.<br />

Table 41 Descriptive characteristics of included studies focusing on the use of HBOT in<br />

cerebrovascular disease.*<br />

First Author and Year<br />

of Publication<br />

NHMRC<br />

Level<br />

Study<br />

Design<br />

Location<br />

Nighoghossian 1995 79 II RCT France<br />

Dates of<br />

Enrolment Size<br />

Dec 1988 to<br />

Mar 1992<br />

Anderson 1991 80 II RCT USA ?‡ 39<br />

Characteristics of Study Population †<br />

Age<br />

Mean (SD)<br />

Sex Ratio<br />

(M:F)<br />

46 <strong>Hyperbaric</strong> oxygen therapy<br />

34<br />

I=53 (3)<br />

C=54 (3)<br />

I=63.7<br />

C=69.1<br />

I=9:8<br />

C=12:5<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 total study population values, and treatment and control groups.<br />

‡ Unstated, unclear, or unknown.<br />

Study quality<br />

The randomisation procedures used by both studies are uncertain; no information was<br />

provided to properly assess the methods used (Table 42). Anderson et al80 report the use<br />

of double-masked procedures, while Nighoghossian et al79 is unclear. There were a total<br />

of 12 losses to follow-up in the study by Anderson et al80 In the comparison group, the<br />

five losses were distributed as follows: deaths (n = 2), migration (n = 2), and refusals (n<br />

= 1); in the intervention group, there were two deaths, one migration, three refusals, and<br />

one stroke. No comparisons of baseline characteristics between those lost to follow-up<br />

and those remaining in the study were made.<br />

Table 42 Methodological quality of included studies focusing on the use of HBOT in cerebrovascular<br />

disease.*<br />

First Author and Year<br />

of Publication<br />

Study Design Randomisation Masking Losses to Follow-up<br />

Nighoghossian 1995 79 RCT Unclear Unclear 1<br />

Anderson 1991 80 RCT Unclear Double masked T=7, C=5<br />

* Abbreviations: C = control or comparison group, RCT = randomised controlled trial, T = treatment group<br />

Patient criteria<br />

The two studies used similar patient inclusion criteria (Table 43). Nighoghossian et al79 enrolled patients between 20 and 75 years of age with neurological deficit highly<br />

suggestive of middle cerebral artery occlusion while excluding patients with a history of<br />

stroke; those who exhibited substantial improvement or resolution of the deficit within 1<br />

hour; were pregnant; experienced seizures at stroke onset; had metabolic encephalopathy,<br />

significant pulmonary disease, congestive heart failure, or uncontrolled hypertension.<br />

?

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