Treatment and management of CFS/ME: all roads lead to Rome

AndyPR

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Guiding the lifeboats to safer waters.
Abstract - available here http://onlinelibrary.wiley.com/doi/10.1111/bph.13702/full
This comprehensive review explores the current evidence on benefits and harms of therapeutic interventions in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) and makes recommendations.

CFS/ME is a complex, multi-system, chronic medical condition whose pathophysiology remains unknown. No established diagnostic tests exist; nor are any FDA-approved drugs available for treatment. Because of the range of symptoms of CFS/ME, treatment approaches vary widely. Studies undertaken have heterogeneous designs and are limited by sample size, length of follow-up, applicability and methodological quality. The use of rintatolimod and rituximab as well as counselling, behavioural and rehabilitation therapy programs may be of benefit for CFS/ME, but the evidence of their effectiveness is still limited. Similarly, adaptive pacing appears to offer some benefits, but the results are debatable: so is the use of nutritional supplements, which may be of value to CFS/ME patients with lab-proven deficiencies.

To summarize, then, the recommended treatment strategies should include proper administration of nutritional supplements in CFS/ME patients with demonstrated deficiencies and personalized pacing programs to relieve symptoms and improve performance of daily activities, but a larger RCT evaluation is required to confirm these preliminary observations.

At present no firm conclusions can be drawn because the few RCTs undertaken to date have been small-scale, with a high risk of bias, and have used different case definitions. Further RCTs are now urgently needed with rigorous experimental designs and appropriate data analysis, focusing particularly on the comparison of outcomes measures according to clinical presentation, patient characteristics, case criteria and degree of disability (i.e., severely ill ME cases or bedridden).
Full paper here - http://sci-hub.cc/10.1111/bph.13702

ETA all below.
Part of the full papers comments on PACE
However, looking at the original data of the follow-up study and other PACE trials (McCrone
et al. , 2012; Twisk et al., 2009), we believe that neither CBT nor GET qualify as rehabilitative therapies for all CFS or ME patients.

First, the PACE trial investigated the effects of CBT and GET in chronic fatigue, as defined by the 1991 Oxford criteria – not in CFS/ME as defined by the other case criteria, let alone ME cases.

The study used such a broad definition of the disease that it is likely to have included many patients who did not truly have CFS at all (Smith et al., 2015). Second, the positive effect of CBT and GET on subjective measures, fatigue and physical functioning cannot be qualified as sufficient. Third, the PACE trial follow-up study (Sharpe et al., 2015) concluded that outcomes with SMC alone or APT were similar to those achieved with CBT and GET at follow-up. This finding suggests that the vast majority of patients improved subjectively to the same level with
SMC and APT as with CBT and GET, without the need for additional therapies (including CBT and GET).

In brief, CBT and GET are moderately effective in subjective terms in chronic fatigue. However
looking at the patients studied and the (subjective and objective) outcomes of the PACE trial, CBT and GET do not meet the requirements for rehabilitative or effective therapies for CFS, let alone for ME sufferers. The PACE trial design changed so significantly that many experts were left wondering whether there is any value in the study itself.

Firstly, the physical functioning threshold in SF-36 was lowered because of poor recruitment; this increased the likelihood that many participants did not have ME/CFS at all. Secondly, rhe authors claimed to have performed an intention-to-treat analysis, but in fact they excluded any subjects fpr whom there were no primary outcome data, and so it was not an intention-to-treat
analysis at all.

It seems that the most we can glean from PACE is that study design is essential to good science, and the flaws in this design were enough to doom its results from the start.
Spelling mistakes are from the paper, other than that seems quite an accurate summarisation of PACE.
 
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NexusOwl

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Seems like Spain is not entirely submitted to the psychobabblers' nonsense. Do you know the people involved in this study @NexusOwl ?
Interesting!

I only know José Alegre there, it's a "expert" from Catalonia that has used almost every approach and has launched a lot of private clinics for CFS/ME and FM.
He is like the maximum authority in Spain for CFS/ME. I'm happy to see they have decided to be rigurously updated in these topics. Will add this to the spanish situation thread and I'll try to contact them to congratulate and thank them for this well done job.

Also I'll try to help spread this conclusion through my country. Thanks for tagging me, @Cheshire
 

CFS_for_19_years

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Hmmm, they missed the Addendum from the AHRQ that the value of GET and CBT have been downgraded, due to studies relying on Oxford criteria, and not using patients who have ME based on CCC or Fukuda.

Page 32:
An AHRQ report concluded that only counseling therapies and GET help improve fatigue and physical function in some (though not all) subsets of adults CFS/ME patients (https://www.ncbi.nlm.nih.gov/books/NBK293931).
 

CFS_for_19_years

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