Table 3.
Outcomes
| Outcome |
Rhodiola
|
Placebo |
Odds ratio/difference |
Adjusted |
|---|---|---|---|---|
| (N=102) | (N=102) | (95% CI) | P value | |
|
Primary endpoint | ||||
| AMSa |
62 (60.8) |
62 (60.8) |
1.02 (0.69, 1.52) †† |
0.90 |
|
Secondary endpoint | ||||
| Severe AMSb |
36 (35.3) |
30 (29.4) |
1.42 (0.90, 2.25) †† |
0.13 |
| Headache |
81 (79.4) |
78 (77.5) |
1.17 (0.75, 1.83) †† |
0.48 |
| Severe headachec |
33 (32.4) |
30 (29.4) |
1.16 (0.71, 1.89) †† |
0.55 |
| SpO2, %d |
88.6 ± 3.9 |
88.6 ± 4.3 |
–0.13 (–0.93, 0.66) ‡‡ |
0.74 |
| ∆SpO2, % |
9.6 ± 3.8 |
9.5 ± 4.2 |
0.16 (–0.65, 0.97) ‡‡ |
0.70 |
| Pulse rate, /mine |
99.2 ± 14.6 |
99.8 ± 14.2 |
–0.30 (–2.61, 2.02) ‡‡ |
0.80 |
|
Other clinical measures | ||||
| AMS symptoms scoref | ||||
| Headache |
1.17 ± 0.81 |
1.13 ± 0.83 |
0.05 (-0.10, 0.20) ‡‡ |
0.50 |
| Dizziness |
0.87 ± 0.82 |
0.79 ± 0.79 |
0.09 (-0.06, 0.25) ‡‡ |
0.29 |
| Weakness |
0.94 ± 0.81 |
0.99 ± 0.84 |
–0.02 (–0.17, 0.13) ‡‡ |
0.81 |
| Vomiting |
0.52 ± 0.70 |
0.41 ± 0.62 |
0.12 (–0.01, 0.25) ‡‡ |
0.08 |
| Sleep |
1.45 ± 0.99 |
1.55 ± 0.96 |
–0.07 (–0.29, 0.14) ‡‡ |
0.49 |
| LLS score | 3.84 ± 2.49 | 3.77 ± 2.54 | 0.19 (-0.27, 0.55) ‡‡ | 0.51 |
For each outcome, data were grouped into two datasets (one for Rhodiola and one for placebo) to create a data summary. Categorical outcomes are presented as count (percentage), and continuous outcomes as mean ± standard deviation. The treatment effect is presented in the column "Odds ratio/difference (95% CI)". Odds ratio is used for categorical outcomes and defined as Rhodiola versus placebo, while difference is used for continuous outcomes and defined as Rhodiola minus placebo. The generalized linear models with generalized estimating equations method, assuming logit/ identity link as appropriate and unstructured correlation, was used to obtain the results after adjustment of period effects.
a Lake Louise score (LLS score) ≥3 with headache and at least one other symptom was defined as AMS. At each period, occurrence of AMS during checkpoints 3 to 8 was defined as AMS.
b AMS and LLS score ≥5.
c Defined as headache score of >1 on the headache item of LLS (ascending scale of 0–3 for severity).
d SpO2, oxygen saturation by pulse oximetry (SpO2) at checkpoint 4 (3100 m).
∆SpO2, the difference between checkpoints 1 and 4 (SpO2 at checkpoint 1 – SpO2 at checkpoint 4).
e Pulse rate was measured at checkpoint 4 (3100 m).
f All symptoms in AMS are defined as the worst score in the interval between checkpoints 3 and 8.
†† odds ratio.
‡‡ difference.