Abstract

BACKGROUND: Inhaled budesonide has been suggested as a novel prevention for acute mountain sickness. However, efficacy has not been compared with the standard acute mountain sickness prevention medication acetazolamide.METHODS: This double-blind, randomized, placebo-controlled trial compared inhaled budesonide versus oral acetazolamide versus placebo, starting the morning of ascent from 1240m (4100 ft) to 3810m (12,570 ft) over 4 hours. The primary outcome was acute mountain sickness incidence (headache and Lake Louise Questionnaire=3 and another symptom).RESULTS: A total of 103 participants were enrolled and completed the study; 33 (32%) received budesonide, 35 (34%) acetazolamide, and 35 (34%) placebo. Demographics were not different between the groups (P>.09). Acute mountain sickness prevalence was 73%, with severe acute mountain sickness of 47%. Fewer participants in the acetazolamide group (n=15, 43%) developed acute mountain sickness compared with both budesonide (n=24, 73%) (odds ratio [OR]3.5, 95% confidence interval [CI] 1.3-10.1) and placebo (n=22, 63%) (OR0.5, 95% CI 0.2-1.2). Severe acute mountain sickness was reduced with acetazolamide (n=11, 31%) compared with both budesonide (n=18, 55%) (OR2.6, 95% CI 1-7.2) and placebo (n=19, 54%) (OR0.4, 95% CI 0.1-1), with a number needed to treat of 4.CONCLUSION: Budesonide was ineffective for the prevention of acute mountain sickness, and acetazolamide was preventive of severe acute mountain sickness taken just before rapid ascent.

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