Effects of Kuanxiong aerosol for preventing acute mountain sickness: an exploratory small-sample randomized,...

This study aimed to evaluate the potential efficacy and neurophysiological effects of Kuanxiong Aerosol (KXA) in preventing acute mountain sickness (AMS) during simulated high-altitude exposure.

In this randomized, double-blind, placebo-controlled trial, 20 healthy volunteers underwent a 6-hour hypobaric hypoxia session (simulated 4000 m) after receiving either KXA or placebo. Outcomes included the Lake Louise Score (LLS), AMS incidence, physiological parameters (SpO₂, heart rate), cognitive performance (PMT, Symbol-Digit Modalities Test), and cerebral blood flow (CBF) measured by MRI. An exploratory post-hoc subgroup analysis was also conducted in nine participants who voluntarily received an additional KXA session in a self-controlled manner.

In the main trial, KXA administration was associated with a non-significant reduction in total LLS and a decrease in AMS incidence from 50% (placebo) to 30% (KXA). No significant differences were observed in SpO₂, cognitive tests, or global CBF. However, the KXA group showed a smaller increase and more stable heart rate profile over time. Exploratory regional CBF analyses revealed reduced perfusion in selected subregions of the limbic and control networks in the KXA group (p < 0.05 uncorrected). In the post-hoc self-controlled subgroup (n = 9), KXA significantly reduced total LLS (p = 0.037) and decreased AMS incidence from 44% to 0%, with trends toward improved cognitive performance.

KXA shows preliminary potential for alleviating AMS symptoms under simulated high-altitude conditions, possibly through cardiac and regional cerebrovascular modulation. These findings support further investigation in larger, randomized controlled trials in real-world high-altitude settings to confirm efficacy and clarify the underlying mechanisms.

ChiCTR2500105469.