Day Julia, Yust-Katz Shlomit, Cachia David, Wefel Jeffrey, Katz Lior H, Tremont Ivo, Bulbeck Helen, Armstrong Terri, Rooney Alasdair G
Edinburgh Centre for Neuro-Oncology (ECNO), Western General Hospital, Crewe Road South, Edinburgh, Scotland, UK, EH4 2XU.
Cochrane Database Syst Rev. 2016 Apr 13;4(4):CD011376. doi: 10.1002/14651858.CD011376.pub2.
Fatigue is a common and disabling symptom in people with a primary brain tumour (PBT). The effectiveness of interventions for treating clinically significant levels of fatigue in this population is unclear.
To assess the effectiveness and safety of pharmacological and non-pharmacological interventions for adults with PBT and high levels of fatigue.
In March 2016, we searched the Cochrane Register of Controlled Trials (CENTRAL), MEDLINE, PsycINFO and CINAHL and checked the reference lists of included studies. We also searched relevant conference proceedings, searched for ongoing trials via ClinicalTrials.gov and contacted major co-operative groups with trials in this area.
We included randomised controlled trials (RCTs) that investigated any pharmacological or non-pharmacological intervention in adults with PBT and fatigue, where fatigue was the primary outcome measure. We restricted inclusion specifically to studies that enrolled only participants with clinically significant levels of fatigue.
Three review authors (JD, SYK, DC) independently evaluated search results, extracted data from selected studies and carried out a bias risk assessment. We extracted data on fatigue, cognition, mood, quality of life and adverse events outcomes.
We identified nine studies. We excluded eight of these as they did not restrict participation to people with high fatigue. The single eligible trial investigated the use of modafinil compared to placebo. Although this study found a significant improvement over time in the primary outcome of fatigue, the improvement occurred after both modafinil and placebo with no significant difference in response between the two groups. The included trial did not reach its planned recruitment target and therefore may not, in practice, have been adequately powered to detect a difference. The trial was at a low risk of bias across most areas. There was an unclear risk of bias related to the use of mean imputation because the investigators did not analyse the impact of imputation on the results.
AUTHORS' CONCLUSIONS: There was insufficient evidence to draw reliable and generalisable conclusions regarding potential effectiveness or harm of any pharmacological or non-pharmacological treatments for fatigue in people with PBT. More research is needed on how best to treat people with brain tumours with high fatigue.
疲劳是原发性脑肿瘤（PBT）患者常见且致残的症状。目前尚不清楚针对该人群临床显著程度疲劳的干预措施的有效性。
评估药物和非药物干预对患有PBT且疲劳程度较高的成年人的有效性和安全性。
2016年3月，我们检索了Cochrane对照试验注册库（CENTRAL）、MEDLINE、PsycINFO和CINAHL，并检查了纳入研究的参考文献列表。我们还检索了相关会议论文集，通过ClinicalTrials.gov搜索正在进行的试验，并联系了该领域进行试验的主要合作组。
我们纳入了随机对照试验（RCT），这些试验研究了对患有PBT和疲劳的成年人进行的任何药物或非药物干预，其中疲劳是主要结局指标。我们特别将纳入范围限制在仅招募具有临床显著疲劳水平参与者的研究。
三位综述作者（JD、SYK、DC）独立评估检索结果，从选定研究中提取数据并进行偏倚风险评估。我们提取了关于疲劳、认知、情绪、生活质量和不良事件结局的数据。
我们识别出9项研究。我们排除了其中8项，因为它们没有将参与限制在高疲劳人群。唯一符合条件的试验比较了莫达非尼与安慰剂的使用。尽管该研究发现随着时间推移疲劳的主要结局有显著改善，但莫达非尼组和安慰剂组均出现了改善，两组之间的反应无显著差异。纳入的试验未达到其计划的招募目标，因此在实际中可能没有足够的效力来检测差异。该试验在大多数领域的偏倚风险较低。由于研究人员未分析插补对结果的影响，因此与均值插补使用相关的偏倚风险不明确。
没有足够的证据就任何药物或非药物治疗对PBT患者疲劳的潜在有效性或危害得出可靠且可推广的结论。需要更多关于如何最佳治疗高疲劳脑肿瘤患者的研究。
