This review includes twenty-three randomised controlled trials involving 1614 patients with traumatic head injury. In each trial, the patients were randomly divided into two groups: one group remained at normal body temperature, and the other group was cooled to a maximum of 35 degrees Celsius (or 95 degrees Fahrenheit) for at least 12 consecutive hours. Cooling could be of the whole body (e.g. with a blanket with circulating cold water), or just the head (e.g. with a helmet with circulating cold water). Information on death, disability, and pneumonia were evaluated for each trial.
The review authors found that fewer people died or became severely disabled if they were treated with hypothermia, but this finding may be due to chance. It was also found that patients given hypothermia were more likely to develop pneumonia, and some patients died from pneumonia, but the increased risk of pneumonia could also be due to chance.
Some of the trials included in the review were of low methodological quality. Low quality trials have a tendency to overestimate the effect of a treatment. In this review, the lower quality trials showed hypothermia treatment to be somewhat effective in reducing death and disability among patients with head injury. However, the good quality trials showed no decrease in the likelihood of death with hypothermia treatment and a reduced likelihood of pneumonia. Some of the findings in this review are therefore contradictory, and this is probably due to the inclusion of data from low quality trials.
The review authors conclude that there is no evidence that hypothermia is beneficial in the treatment of head injury. Most of the positive and negative effects found may be due to chance. Hypothermia should not be used except in the context of a randomised controlled trial with good allocation concealment.
There is no evidence that hypothermia is beneficial in the treatment of head injury. Hypothermia may be effective in reducing death and unfavourable outcomes for traumatic head injured patients, but significant benefit was only found in low quality trials. Low quality trials have a tendency to overestimate the treatment effect. The high quality trials found no decrease in the likelihood of death with hypothermia, but this finding was not statistically significant and could be due to the play of chance. Hypothermia should not be used except in the context of a high quality randomised controlled trial with good allocation concealment.
Hypothermia has been used in the treatment of head injury for many years. Encouraging results from small trials and laboratory studies led to renewed interest in the area and some larger trials.
To estimate the effect of mild hypothermia for traumatic head injury on mortality and long-term functional outcome complications.
We searched the Cochrane Injuries Group Specialised Register, Current Controlled Trials MetaRegister of trials, Zetoc, ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S), CENTRAL (The Cochrane Library), MEDLINE and EMBASE. We handsearched conference proceedings and checked reference lists of all relevant articles. The search was last updated in April 2009.
Randomised controlled trials of hypothermia to a maximum of 35ºC for at least 12 consecutive hours versus control in patients with any closed traumatic head injury requiring hospitalisation. Two authors independently assessed all trials.
Data on death, Glasgow Outcome Scale and pneumonia were sought and extracted, either from published material or by contacting the investigators. Odds ratios (ORs) and 95% confidence intervals (CIs) were calculated for each trial on an intention-to-treat basis.
We found 23 trials with a total of 1614 randomised patients. Twenty-one trials involving 1587 patients reported data on deaths. There were fewer deaths in patients treated with hypothermia than in the control group (OR 0.85, 95% CI 0.68 to 1.06). Nine trials with good allocation concealment showed no decrease in the likelihood of death with hypothermia compared with the control group (OR 1.11, 95% CI 0.82 to 1.51). In both cases the result was not statistically significant. Twenty-one trials involving 1587 patients reported data on unfavourable outcomes (death, vegetative state or severe disability). Patients treated with hypothermia were less likely to have an unfavourable outcome than those in the control group (OR 0.77, 95% CI 0.62 to 0.94). Nine trials with good allocation concealment showed patients treated with hypothermia were less likely to have an unfavourable outcome than those in the control group, but the reduction was small and non-significant (OR 0.93, 95% CI 0.70 to 1.23). Hypothermia treatment was associated with a slight increase in the odds of pneumonia (OR 1.35, 95% CI 0.95 to 1.91) but there was a reduction in pneumonia for trials with good allocation concealment (four trials analysed separately, 306 patients, OR 0.84, 95% CI 0.52 to 1.35) although in both cases the results are not statistically significant.