Correspondence Indian Pediatrics 2008; 45:513 |
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Hypertonic Saline Treatment in Cerebral Edema –Is the Evidence Sufficient? |
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First, outcome variable of "duration of comatose state" included all patients irrespective of their survival status. Failure to censor this time-to-event ‘duration of coma’ variable by mortality in this study is a major methodological flaw in evaluating treatment efficacy. Indeed, more aptly definable endpoint would be the "duration of resolution of abnormal mental status (or length of time to recovery from coma)". Second, a P-value 0.003 in Table II while comparing the outcome of mortality (proportion) appears erroneous(1)? Using factual data about mortality and survival given by authors in their study, the calculated P value is 0.07. To substantiate this point further, we conducted a simple logistic regression with mortality as dependent binary variable and type of hyperosmolar therapy (categorical variable with 3 levels of treatment) as predictor using data provided by authors in the study. Only mixed treatment group was a significant prognostic predictor for survival of children with cerebral edema (OR: 4; 95% CI; 1.0 to 15.8; P= 0.049). Similarly, though odds of survival were three times higher with hypertonic saline treatment as compared to mannitol (Odds ratio 3.16), yet it failed to produce any significant 95% CI (0.91 to 10.9, P= 0.07). To conclude, this study simply offers evidence that hypertonic saline is about as effective as mannitol (certainly not more) and is safe and effective alternative to mannitol. Bhavneet Bharti,
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