Rhodiola crenulata extract for prevention of acute mountain sickness: a randomized, double-blind, placebo-controlled, crossover trial

Te-Fa Chiu, Lisa Li-Chuan Chen, Deng-Huang Su, Hsiang-Yun Lo, Chung-Hsien Chen, Shih-Hao Wang, Wei-Lung Chen, Te-Fa Chiu, Lisa Li-Chuan Chen, Deng-Huang Su, Hsiang-Yun Lo, Chung-Hsien Chen, Shih-Hao Wang, Wei-Lung Chen

Abstract

Background: Rhodiola crenulata (R. crenulata) is widely used to prevent acute mountain sickness in the Himalayan areas and in Tibet, but no scientific studies have previously examined its effectiveness. We conducted a randomized, double-blind, placebo-controlled crossover study to investigate its efficacy in acute mountain sickness prevention.

Methods: Healthy adult volunteers were randomized to 2 treatment sequences, receiving either 800 mg R. crenulata extract or placebo daily for 7 days before ascent and 2 days during mountaineering, before crossing over to the alternate treatment after a 3-month wash-out period. Participants ascended rapidly from 250 m to 3421 m on two separate occasions: December 2010 and April 2011. The primary outcome measure was the incidence of acute mountain sickness, as defined by a Lake Louise score ≥ 3, with headache and at least one of the symptoms of nausea or vomiting, fatigue, dizziness, or difficulty sleeping.

Results: One hundred and two participants completed the trial. There were no demographic differences between individuals taking Rhodiola-placebo and those taking placebo-Rhodiola. No significant differences in the incidence of acute mountain sickness were found between R. crenulata extract and placebo groups (all 60.8%; adjusted odds ratio (AOR) = 1.02, 95% confidence interval (CI) = 0.69-1.52). The incidence of severe acute mountain sickness in Rhodiola extract vs. placebo groups was 35.3% vs. 29.4% (AOR = 1.42, 95% CI = 0.90-2.25).

Conclusions: R. crenulata extract was not effective in reducing the incidence or severity of acute mountain sickness as compared to placebo.

Trial registration: ClinicalTrials.gov NCT01536288.

Figures

Figure 1
Figure 1
Mountaineering schedule. Total of 10 checkpoints (CPs): CP 1, Linkou (250 m); 2, Cingjing Farm (1743 m); 3, Yuanfeng parking lot (2756 m); 4, training camp (3100 m) at noon; 5, East Peak (3421 m) of Hehuan Mountain; 6, training camp (evening); 7, training camp (next morning); 8, Main Peak (3416 m) of Hehuan Mountain; 9, Cingjing Farm and 10, Linkou. Solid line indicates that participants were transported by bus.
Figure 2
Figure 2
Participant flow diagram.
Figure 3
Figure 3
AMS occurrence in 2 periods. The incidence of AMS was 65.7% (67/102) in period 1 and 55.9% (57/102) in period 2 (OR: 0.66, 95% CI: 0.45 - 0.98). There were no between-group differences in either period.
Figure 4
Figure 4
Sensitivity analysis. Data was presented as adjusted odds ratio (AOR) and 95% confidence interval (CI). Comparison between Rhodiola arm and placebo arm was analyzed by generalized linear models with generalized estimating equations. Regardless of any extreme scenarios, Rhodiola was not effective in preventing AMS. *: significant difference statistically.

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