Tsai Tou-Yuan, Wang Shih-Hao, Lee Yi-Kung, Su Yung-Cheng
School of Medicine, Tzu Chi University, Hualien, Taiwan.
Emergency Department, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
BMJ Open. 2018 Aug 17;8(8):e022005. doi: 10.1136/bmjopen-2018-022005.
Trials of ginkgo biloba extract (GBE) for the prevention of acute mountain sickness (AMS) have been published since 1996. Because of their conflicting results, the efficacy of GBE remains unclear. We performed a systematic review and meta-analysis to assess whether GBE prevents AMS.
The Cochrane Library, EMBASE, Google Scholar and PubMed databases were searched for articles published up to 20 May 2017. Only randomised controlled trials were included. AMS was defined as an Environmental Symptom Questionnaire Acute Mountain Sickness-Cerebral score ≥0.7 or Lake Louise Score ≥3 with headache. The main outcome measure was the relative risk (RR) of AMS in participants receiving GBE for prophylaxis. Meta-analyses were conducted using random-effects models. Sensitivity analyses, subgroup analyses and tests for publication bias were conducted.
Seven study groups in six published articles met all eligibility criteria, including the article published by Leadbetter , where two randomised controlled trials were conducted. Overall, 451 participants were enrolled. In the primary meta-analysis of all seven study groups, GBE showed trend of AMS prophylaxis, but it is not statistically significant (RR=0.68; 95% CI 0.45 to 1.04; p=0.08). The I statistic was 58.7% (p=0.02), indicating substantial heterogeneity. The pooled risk difference (RD) revealed a significant risk reduction in participants who use GBE (RD=-25%; 95% CI, from a reduction of 45% to 6%; p=0.011) The results of subgroup analyses of studies with low risk of bias, low starting altitude (<2500 m), number of treatment days before ascending and dosage of GBE are not statistically significant.
The currently available data suggest that although GBE may tend towards AMS prophylaxis, there are not enough data to show the statistically significant effect of GBE on preventing AMS. Further large randomised controlled studies are warranted.
自1996年以来,已有关于银杏叶提取物(GBE)预防急性高原病(AMS)的试验发表。由于结果相互矛盾,GBE的疗效仍不明确。我们进行了一项系统评价和荟萃分析,以评估GBE是否能预防AMS。
检索Cochrane图书馆、EMBASE、谷歌学术和PubMed数据库中截至2017年5月20日发表的文章。仅纳入随机对照试验。AMS被定义为环境症状问卷急性高原病-脑型评分≥0.7或路易斯湖评分≥3且伴有头痛。主要结局指标是接受GBE预防的参与者发生AMS的相对风险(RR)。使用随机效应模型进行荟萃分析。进行了敏感性分析、亚组分析和发表偏倚检验。
六篇已发表文章中的七个研究组符合所有纳入标准,包括Leadbetter发表的文章,该文章进行了两项随机对照试验。总体而言,共纳入451名参与者。在对所有七个研究组的主要荟萃分析中,GBE显示出预防AMS的趋势,但无统计学意义(RR = 0.68;95%CI 0.45至1.04;p = 0.08)。I统计量为58.7%(p = 0.02),表明存在显著异质性。合并风险差(RD)显示使用GBE的参与者风险显著降低(RD = -25%;95%CI,从降低45%至降低6%;p = 0.011)。偏倚风险低、起始海拔低(<2500米)、上升前治疗天数和GBE剂量的研究亚组分析结果无统计学意义。
现有数据表明,尽管GBE可能倾向于预防AMS,但尚无足够数据显示GBE预防AMS的统计学显著效果。有必要进行进一步的大型随机对照研究。