Objectives

Graded exercise therapy (GET) is an effective treatment for chronic fatigue syndrome (CFS), but concerns have been raised about its safety. Two randomised controlled trials have not supported these concerns. We further assessed safety outcomes in all ten published trials of GET for CFS.

Methods

We undertook meta-analyses of three outcomes: Self-ratings of Clinical Global Impression (CGI) change scores of 6 or 7 (“much worse” or “very much worse”), numbers of participants withdrawing from treatments, and numbers of participants dropping out of trial follow up. We provide risk ratios (95% confidence intervals (CI)), comparing GET with control interventions.

Results

The 10 trials involved 1279 participants. CGI scores of 6 or 7 were reported by 14/333 (4%) participants after GET and 26/334 (8%) participants after control interventions (RR (CI): 0.62 (0.32, 1.17)). Withdrawals from treatment occurred in 64/535 (12%) participants after GET and 53/534 (10%) participants after control interventions (RR (CI):1.21 (0.86, 1.69)). Drop-outs from trial follow up occurred in 74/679 (11%) participants after GET and 41/600 (7%) participants after control interventions (RR (CI): 1.51 (1.03, 2.22)). The certainty of this evidence was rated low by GRADE, due to imprecision.

Conclusions

There was no evidence of excess harm with graded exercise therapy by either self-rated deterioration or by withdrawing from GET, in comparison to control interventions. More GET participants dropped out of trial follow up in comparison to control interventions. Future research should ascertain the most effective and safest form of graded exercise therapy.

中文翻译：

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成人慢性疲劳综合征患者分级运动疗法试验的不良结果

目标

分级运动疗法 (GET) 是慢性疲劳综合征 (CFS) 的有效治疗方法，但人们对其安全性提出了担忧。两项随机对照试验不支持这些担忧。我们进一步评估了 GET 用于 CFS 的所有 10 项已发表试验的安全性结果。

方法

我们对三个结果进行了荟萃分析：临床总体印象 (CGI) 的自我评分变化为 6 或 7 分（“更糟糕”或“非常糟糕”）、退出治疗的参与者数量和下降的参与者数量审外跟进。我们提供风险比（95% 置信区间 (CI)），将 GET 与对照干预进行比较。

结果

这 10 项试验涉及 1279 名参与者。GET 后 14/333 (4%) 的参与者和对照干预后的 26/334 (8%) 参与者报告了 6 或 7 的 CGI 分数（RR (CI): 0.62 (0.32, 1.17)）。GET 后 64/535 (12%) 名参与者和对照干预后 53/534 (10%) 名参与者退出治疗 (RR (CI):1.21 (0.86, 1.69))。GET 后 74/679 (11%) 名参与者和对照干预后 41/600 (7%) 名参与者退出试验随访 (RR (CI): 1.51 (1.03, 2.22))。由于不精确，该证据的确定性被 GRADE 评为低。

结论

与对照干预相比，没有证据表明分级运动疗法会因自评恶化或退出 GET 造成过度伤害。与对照干预相比，更多的 GET 参与者退出试验随访。未来的研究应该确定最有效和最安全的分级运动疗法。