Collatz Ansel, Johnston Samantha C, Staines Donald R, Marshall-Gradisnik Sonya M
National Centre for Neuroimmunology and Emerging Diseases, Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia; School of Medical Sciences, Griffith University, Gold Coast, QLD, Australia.
National Centre for Neuroimmunology and Emerging Diseases, Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia; School of Medical Sciences, Griffith University, Gold Coast, QLD, Australia.
Clin Ther. 2016 Jun;38(6):1263-1271.e9. doi: 10.1016/j.clinthera.2016.04.038. Epub 2016 May 24.
The pathogenesis of chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is complex and remains poorly understood. Evidence regarding the use of drug therapies in CFS/ME is currently limited and conflicting. The aim of this systematic review was to examine the existing evidence on the efficacy of drug therapies and determine whether any can be recommended for patients with CFS/ME.
MEDLINE, EMBASE, and PubMed databases were searched from the start of their records to March 2016 to identify relevant studies. Randomized controlled trials focusing solely on drug therapy to alleviate and/or eliminate chronic fatigue symptoms were included in the review. Any trials that considered graded exercise therapy, cognitive behavior therapy, adaptive pacing, or any other nonpharmaceutical treatment plans were excluded. The inclusion criteria were examined to ensure that study participants met specific CFS/ME diagnostic criteria. Study size, intervention, and end point outcome domains were summarized.
A total of 1039 studies were identified with the search terms; 26 studies met all the criteria and were considered suitable for review. Three different diagnostic criteria were identified: the Holmes criteria, International Consensus Criteria, and the Fukuda criteria. Primary outcomes were identified as fatigue, pain, mood, neurocognitive dysfunction and sleep quality, symptom severity, functional status, and well-being or overall health status. Twenty pharmaceutical classes were trialed. Ten medications were shown to be slightly to moderately effective in their respective study groups (P < 0.05).
These findings indicate that no universal pharmaceutical treatment can be recommended. The unknown etiology of CFS/ME, and complications arising from its heterogeneous nature, contributes to the lack of clear evidence for pharmaceutical interventions. However, patients report using a large number and variety of medications. This finding highlights the need for trials with clearly defined CFS/ME cohorts. Trials based on more specific criteria such as the International Consensus Criteria are recommended to identify specific subgroups of patients in whom treatments may be beneficial.
慢性疲劳综合征或肌痛性脑脊髓炎（CFS/ME）的发病机制复杂，目前仍知之甚少。关于CFS/ME药物治疗的证据目前有限且相互矛盾。本系统评价的目的是审查现有药物治疗疗效的证据，并确定是否有任何药物可推荐给CFS/ME患者。
检索MEDLINE、EMBASE和PubMed数据库自创建记录起至2016年3月的文献，以识别相关研究。纳入本评价的是仅专注于药物治疗以减轻和/或消除慢性疲劳症状的随机对照试验。任何考虑分级运动疗法、认知行为疗法、适应性节奏或任何其他非药物治疗方案的试验均被排除。检查纳入标准以确保研究参与者符合特定的CFS/ME诊断标准。总结研究规模、干预措施和终点结局领域。
通过检索词共识别出1039项研究；26项研究符合所有标准，被认为适合进行评价。确定了三种不同的诊断标准：霍姆斯标准、国际共识标准和福田标准。主要结局确定为疲劳、疼痛、情绪、神经认知功能障碍和睡眠质量、症状严重程度、功能状态以及幸福感或总体健康状况。试验了二十类药物。十种药物在各自的研究组中显示出轻微至中度疗效（P < 0.05）。
这些发现表明无法推荐通用的药物治疗方法。CFS/ME病因不明，且因其异质性产生的并发症导致缺乏药物干预的明确证据。然而，患者报告使用了大量且种类繁多的药物。这一发现凸显了针对明确界定的CFS/ME队列进行试验的必要性。建议基于更具体的标准（如国际共识标准）进行试验，以识别可能从治疗中获益的特定患者亚组。
