Cheng-Rong Zheng1, Guo-Zhu Chen2, Jie Yu2, Jun Qin2, Pan Song1, Shi-Zhu Bian2, Bai-Da Xu1, Xu-Gang Tang1, Yong-Tao Huang1, Xiao Liang1, Jie Yang1, Lan Huang3. 1. Institute of Cardiovascular Science, Xinqiao Hospital, Third Military Medical University, Chongqing, China. 2. Institute of Cardiovascular Science, Xinqiao Hospital, Third Military Medical University, Chongqing, China; PLA Institute of Cardiovascular Disease, Chongqing, China. 3. Institute of Cardiovascular Science, Xinqiao Hospital, Third Military Medical University, Chongqing, China; PLA Institute of Cardiovascular Disease, Chongqing, China. Electronic address: huanglan260@126.com.
Abstract
BACKGROUND: This double-blind, randomized controlled trial aimed to investigate inhaled budesonide and oral dexamethasone compared with placebo for their prophylactic efficacy against acute mountain sickness after acute high-altitude exposure. METHODS: There were 138 healthy young male lowland residents recruited and randomly assigned to receive inhaled budesonide (200 μg, twice a day [bid]), oral dexamethasone (4 mg, bid), or placebo (46 in each group). They traveled to 3900 m altitude from 400 m by car. Medication started 1 day before high-altitude exposure and continued until the third day of exposure. Primary outcome measure was the incidence of acute mountain sickness after exposure. RESULTS:One hundred twenty-four subjects completed the study (42, 39, and 43 in thebudesonide, dexamethasone, and placebo groups, respectively). Demographic characteristics were comparable among the 3 groups. After high-altitude exposure, significantly fewer participants in the budesonide (23.81%) and dexamethasone (30.77%) groups developed acute mountain sickness compared with participants receiving placebo (60.46%) (P = .0006 and P = .0071, respectively). Both the budesonide and dexamethasone groups had lower heart rate and higher pulse oxygen saturation (SpO2) than the placebo group at altitude. Only the budesonide group demonstrated less deterioration in forced vital capacity and sleep quality than the placebo group. Four subjects in the dexamethasone group reported adverse reactions. CONCLUSIONS: Both inhaled budesonide (200 μg, bid) and oral dexamethasone (4 mg, bid) were effective for the prevention of acute mountain sickness, especially its severe form, compared with placebo. Budesonide caused fewer adverse reactions than dexamethasone.
RCT Entities:
BACKGROUND: This double-blind, randomized controlled trial aimed to investigate inhaled budesonide and oral dexamethasone compared with placebo for their prophylactic efficacy against acute mountain sickness after acute high-altitude exposure. METHODS: There were 138 healthy young male lowland residents recruited and randomly assigned to receive inhaled budesonide (200 μg, twice a day [bid]), oral dexamethasone (4 mg, bid), or placebo (46 in each group). They traveled to 3900 m altitude from 400 m by car. Medication started 1 day before high-altitude exposure and continued until the third day of exposure. Primary outcome measure was the incidence of acute mountain sickness after exposure. RESULTS: One hundred twenty-four subjects completed the study (42, 39, and 43 in the budesonide, dexamethasone, and placebo groups, respectively). Demographic characteristics were comparable among the 3 groups. After high-altitude exposure, significantly fewer participants in the budesonide (23.81%) and dexamethasone (30.77%) groups developed acute mountain sickness compared with participants receiving placebo (60.46%) (P = .0006 and P = .0071, respectively). Both the budesonide and dexamethasone groups had lower heart rate and higher pulse oxygen saturation (SpO2) than the placebo group at altitude. Only the budesonide group demonstrated less deterioration in forced vital capacity and sleep quality than the placebo group. Four subjects in the dexamethasone group reported adverse reactions. CONCLUSIONS: Both inhaled budesonide (200 μg, bid) and oral dexamethasone (4 mg, bid) were effective for the prevention of acute mountain sickness, especially its severe form, compared with placebo. Budesonide caused fewer adverse reactions than dexamethasone.
Authors: Víctor H Nieto Estrada; Daniel Molano Franco; Roger David Medina; Alejandro G Gonzalez Garay; Arturo J Martí-Carvajal; Ingrid Arevalo-Rodriguez Journal: Cochrane Database Syst Rev Date: 2017-06-27
Authors: Tineke Vanderhaeghen; Steven Timmermans; Deepika Watts; Ville Paakinaho; Melanie Eggermont; Jolien Vandewalle; Charlotte Wallaeys; Lise Van Wyngene; Kelly Van Looveren; Louise Nuyttens; Sylviane Dewaele; Joke Vanden Berghe; Kelly Lemeire; Joey De Backer; Laura Dirkx; Wim Vanden Berghe; Guy Caljon; Bart Ghesquière; Karolien De Bosscher; Ben Wielockx; Jorma J Palvimo; Rudi Beyaert; Claude Libert Journal: EMBO Rep Date: 2021-10-26 Impact factor: 8.807
Authors: Lara Muralt; Michael Furian; Mona Lichtblau; Sayaka S Aeschbacher; Ross A Clark; Bermet Estebesova; Ulan Sheraliev; Nuriddin Marazhapov; Batyr Osmonov; Maya Bisang; Stefanie Ulrich; Tsogyal D Latshang; Silvia Ulrich; Talant M Sooronbaev; Konrad E Bloch Journal: Front Physiol Date: 2018-06-22 Impact factor: 4.566