BACKGROUND Although medical requirements are urgent, no effective intervention has been proven for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). To facilitate the development of new therapeutics, we systematically reviewed the randomized controlled trials (RCTs) for CFS/ME to date. METHODS RCTs targeting CFS/ME were surveyed using two electronic databases, PubMed and the Cochrane library, through April 2019. We included only RCTs that targeted fatigue-related symptoms, and we analyzed the data in terms of the characteristics of the participants, case definitions, primary measurements, and interventions with overall outcomes. RESULTS Among 513 potentially relevant articles, 55 RCTs met our inclusion criteria; these included 25 RCTs of 22 different pharmacological interventions, 28 RCTs of 18 non-pharmacological interventions and 2 RCTs of combined interventions. These studies accounted for a total of 6316 participants (1568 males and 4748 females, 5859 adults and 457 adolescents). CDC 1994 (Fukuda) criteria were mostly used for case definitions (42 RCTs, 76.4%), and the primary measurement tools included the Checklist Individual Strength (CIS, 36.4%) and the 36-item Short Form health survey (SF-36, 30.9%). Eight interventions showed statistical significance: 3 pharmacological (Staphypan Berna, Poly(I):poly(C12U) and CoQ10 + NADH) and 5 non-pharmacological therapies (cognitive-behavior-therapy-related treatments, graded-exercise-related therapies, rehabilitation, acupuncture and abdominal tuina). However, there was no definitely effective intervention with coherence and reproducibility. CONCLUSIONS This systematic review integrates the comprehensive features of previous RCTs for CFS/ME and reflects on their limitations and perspectives in the process of developing new interventions.

中文翻译：

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慢性疲劳综合征/肌痛性脑脊髓炎（CFS/ME）随机对照试验的系统评价。

背景虽然医疗需求迫切，但对于慢性疲劳综合征/肌痛性脑脊髓炎（CFS/ME）尚无有效的干预措施。为了促进新疗法的开发，我们系统地回顾了迄今为止针对 CFS/ME 的随机对照试验 (RCT)。方法 截至 2019 年 4 月，使用 PubMed 和 Cochrane 图书馆这两个电子数据库对针对 CFS/ME 的随机对照试验进行了调查。我们仅纳入针对疲劳相关症状的随机对照试验，并根据参与者特征、病例定义对数据进行了分析、主要测量结果以及对总体结果的干预措施。结果 在 513 篇潜在相关文章中，55 篇随机对照试验符合我们的纳入标准；其中包括 22 种不同药物干预措施的 25 项随机对照试验、18 项非药物干预措施的 28 项随机对照试验和 2 项联合干预措施的随机对照试验。这些研究共有 6316 名参与者（1568 名男性和 4748 名女性、5859 名成人和 457 名青少年）。CDC 1994（福田）标准主要用于病例定义（42 个随机对照试验，76.4%），主要测量工具包括个体强度检查表（CIS，36.4%）和 36 项简短健康调查（SF-36， 30.9%）。八项干预措施显示出统计学显着性：3 项药物治疗（Staphypan Berna、Poly(I):poly(C12U) 和 CoQ10 + NADH）和 5 项非药物治疗（认知行为治疗相关治疗、分级运动相关治疗、康复） 、针灸和腹部推拿）。然而，没有具有一致性和可重复性的绝对有效的干预措施。结论 本系统评价整合了以往 CFS/ME 随机对照试验的综合特征，并反思了它们在制定新干预措施过程中的局限性和观点。