Insufficient evidence for treatments of myalgic encephalomyelitis/chronic fatigue syndrome

1. From a systematic review of myalgic encephalomyelitis/chronic fatigue syndrome (ME-CFS) symptom relief, most treatments showed inconclusive or no statistically significant benefits.

2. In mostly fair-quality trials, rintatolimod, valganciclovir, and CBT were linked to mild improvements in ME-CFS symptoms.

Evidence Rating Level: 2 (Good)

Study Rundown: Myalgic encephalomyelitis/chronic fatigue syndrome (ME-CFS), defined by post-exertional malaise and changes in memory or concentration, is a poorly understood debilitating condition of unknown cause. This systematic review evaluated ME-CFS treatment trials of at least 12 weeks duration. Most treatments, including galantamine, hydrocortisone, IgG, isoprinosine, fluoxetine, diets, phototherapy, supplements, qigong exercise, graded exercise therapy (GET) and distant healing (prayer), showed inconclusive or no statistically significant benefit when compared to usual care or placebo. Valganciclovir, counseling, and behavioral therapy were potentially associated with mild improvements in fatigue symptoms. Rintatolimod improved activities of daily living and exercise performance and duration, but was associated with flu-like symptoms. A variety of counseling and behavioral therapies showed improved fatigue, physical function, quality of life and work impairment, but were too different to allow for comparison across therapies. Cognitive behavioral therapy (CBT) was linked to significant improvements in physical function, but one meta-analysis on CBT showed no significant benefit in physical function. Harms were poorly reported across all studies. This study was limited by the lack of high-quality trials using comparable outcomes, methods and baseline groups. Overall, it is clear that better evidence is needed to assess effective treatments for ME-CFS.

Click to read the study, published today in the Annals of Internal Medicine

Relevant Reading: Treatment Outcome and Metacognitive Change in CBT and GET for Chronic Fatigue Syndrome

In-Depth [systematic-review]: This systematic review of the treatment for ME-CFS included 9 medication trials, 7 complementary and alternative medicine trials, 14 counseling and behavioral therapy trials and 4 mixed trials. The trials were mostly fair- (24 trials) and poor-quality (5 trials), with many being underpowered (n <20), dissimilar baseline groups, high loss to follow-up, poor randomization or inadequate blinding. There are currently no FDA approved therapies for ME-CFS. Of the off-label medications used to treat ME-CFS, only rintatolimod and valganciclovir showed benefit. Rintatolimod improved exercise tolerance (36.5% v. 15.2%, p=0.047) and improved exercise work (11.8% v. 5.8%, p=0.01). Seven trials (quality: 1 good, 5 fair, 1 poor) of alternative/complementary medicines and dietary supplements showed no benefit when compared to usual care. CBT was linked to improved physical function (mean weighted difference 10.46, CI -7.47 to 27.77, P=0.002). Graded exercise therapy showed no statistically significant improvements in physical function and clinical global impression of change score.

Image: PD

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