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. 2019 Apr 23;2019(4):CD013315. doi: 10.1002/14651858.CD013315

Moraga 2007.

Methods Design: parallel design (3 arms)
Country: Chile
Multisite: no
International: yes
Treatment duration: 4 days
Follow up: 4 days
Rate of ascent (m/h): began 830 hours from Antofagasta (sea level) via highway. Arrival to Calama (2400 m) at 1230 hours was followed by a 1‐hour stop, and arrival at Ollagüe was 1700 hours. Travel time was approximately 8.5 hours
Final altitude reached: 3696 meters
AMS scale: The Lake Louise Questionnaire
Participants
  1. 50 participants enrolled (students from the Medical College at the University of Antofagasta voluntarily consented to participate in the present study). 13 students were excluded for having previous experience with high altitude (1500 + m). 2 were evaluated by physicians and were excluded for having incidents of seizure and recent pneumonia.

  2. 36 participants were randomized to

    1. Ginkgo biloba (12, 33%)

    2. Acetazolamide (12, 33%)

    3. Placebo (12, 33%)

  3. No participants were lost at follow‐up

  4. Main characteristics of participants

    1. Age (mean ± SD): ginkgo biloba group = 22.1 ± 2.9; acetazolamide group: 23.3 ± 1.2; placebo group: 22.1 ± 1.1

    2. Number of women/men: 36 men (100%)

    3. History of AMS: not stated

Interventions Ginkgo biloba group (Intervention A): ginkgo biloba extract (Egb761) 80 mg/12 hours, by 24 hours before ascending and continued for 3 days
Acetazolamide group (Intervention B): acetazolamide 250 mg/12 hours, by 24 hours before ascending and continued for 3 days
Placebo group (control): unclear
Outcomes Primary outcomes
  1. Incidence of AMS

  2. Lake Louise Questionnaire measurement

Notes
  1. Trial registration: not stated

  2. Sponsor: University of Antofagasta, Chile

  3. Role of sponsor: not stated

  4. A priori sample size estimation: no

  5. Conducted: not stated

  6. Declared conflicts of interest: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote "randomization was computer generated" Page 252
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to score this item as low or high risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No patients were lost at follow‐up
Selective reporting (reporting bias) High risk Patient‐important outcomes, such as adverse events, were not reported
Other bias Unclear risk Unclear impact of administration of intervention during the ascent (additional to prophylaxis)
Quote: "each group was evaluated under 2 conditions (...) 2) at high altitude, where the same participants received placebo, acetazolamide, or G biloba 24 hours before ascending and continued for 3 days" Page 252