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

Roncin 1996.

Methods Design: parallel (2 arms)
Country: France
Multisite: no
International: no
Treatment duration: 15 days
Follow up: 30 days
Rate of ascent (m/h): unclear
Final altitude reached: 4900 m
AMS scale: AMS‐C and AMS‐R scores from the Environmental Symptoms Questionnaire (ESQ).
Participants

  1. 44 participants in good health, with a minimum score of 2 on the acute mountain sickness questionnaire, were enrolled.

  2. Exclusion criteria: not stated

  3. Participants randomized to

    1. EGb 761 group (n = 22; 50%)

    2. Placebo group (n = 22; 50%)

  4. None of the participants dropped out of the study

  5. Main characteristics of participants

    1. Age (mean, SD): EGb 761 group = 30 (1.46); placebo group = 30.4 (1.59)

    2. Number of men, %: placebo group = 22 (100%); antacid group = 22 (100%)

    3. Body mass index (mean, SD): not reported
Interventions EGb 71 group: administration of ginkgo biloba extract (EGb 761), 2 tablets 80 mg, morning and evening
Placebo group: administration of placebo (no further details provided), 2 tablets 80 mg, morning and evening
Outcomes Primary outcomes

  1. AMS scores

  2. AMS onset


Secondary outcomes

  1. Assessment of peripheral vasomotor reactions

  2. Symptoms of acute mountain sickness
Notes

  1. Trial registration: not stated

  2. Sponsor: not stated

  3. Role of sponsor: not stated

  4. A priori sample size estimation: no

  5. Conducted: February to April 1993

  6. Declared conflicts of interest: no
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Quote: "the treatments were assigned in strictly numerical order with the assistance of a Nepalese doctor" Page 446
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 if intervention was administered before or during the ascent, or both