Acute Mountain Sickness, Environmental Illness
Conditions
Keywords
acute mountain sickness, AMS, Rhodiola Crenulata, mountaineering, pulse oximetry, oxygen saturation
Brief summary
Traditional folk medicine in the Arctic and Himalayan areas used Rhodiola species to enhance physical endurance, prevent aging, resist acute mountain sickness (AMS), and to treat fatigue, depression, anemia, impotence and respiratory infections. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
Detailed description
The number of people traveling to altitude for work or for recreation is rising, and increased media attention towards these activities has also raised the profile of altitude related illness. The most effective preventive measure for acute mountain sickness (AMS)-gradual ascent-is frequently difficult or impractical for modern international travel to locations such as Lhasa in Tibet (3650 m) and La Paz in Bolivia (3740 m). In order to solve this problem, prophylactic acetazolamide was most commonly used. But prescription needed and side effects such as paresthesia and nausea are the disadvantage of using acetazolamide. Some over-the-counter herbal supplements with essentially no adverse effect were widely used, such as Rhodiola species. Rhodiola crenulata are widely used to prevent AMS in Himalayan areas and Lhasa in Tibet but none was examined by human study. The investigators conducted a randomized, double blind, placebo controlled, crossover study to investigate the efficacy of Rhodiola crenulata in preventing AMS.
Interventions
Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
DRUGplacebo
Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
Sponsors
National Science and Technology Council, Taiwan
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* age between 20 and 55 years. * able to complete the study protocol of 9-day study regimens and mountain climbing twice. * no prophylactic medication or herb one month before ascent. * maintaining the same living conditions and habits four months before the first mountain climbing and four months between two mountaineering. * living in the same altitude or within a difference of 200 meters. * no additional physical training. * no plan to gain or loss weight. * no altitude exposure above 2500m.
Exclusion criteria
* any history of chronic obstructive pulmonary disease, heart failure, cerebral neoplasm, mania, renal or hepatic insufficiency. * women in pregnancy or intending of pregnancy during the 4-month study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 3 with headache and one other symptom. | within 18 hours after ascent to altitude 3100m | The LLS rates 5 symptoms (headache, gastrointestinal symptoms such as nausea and vomiting, fatigue and/or weakness, dizziness and/or light-headedness, and difficulty sleeping), with each item graded on a scale from 0 to 3. A score of 3 points or greater constitutes AMS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood oxygen content | on arrival of altitude 3100m | Blood oxygen content was measured by pulse oximetry (NPB 40, Nellcor, Pleasanton, CA, USA) within 1-2 hours after ascent to altitude 3100m. |
| severe AMS | within 18 hours after ascent to altitude 3100m | Incidence measured by Lake Louise acute mountain sickness score (LLS) ≥ 5 with headache and one other symptom. |
| severity of headache, incidence of headache and severe headache | Within 18 hours after ascent to altitude 3100m | severe headache is determined by cut off between scores of 1 and 2 on the Lake Louise survey (ascending scale of 0-3 for severity) |
Countries
Taiwan
Outcome results
None listed