United Kingdom: 2007 NICE CFS/ME GUIDELINE

this is the 2007 updated report:
https://www.york.ac.uk/media/crd/crdreport35.pdf


"DISCUSSION

Methodological quality of included studies
There are now a considerable number of studies evaluating interventions for the treatment and
management of CFS/ME and many of them have used robust research methods; the majority of the
included studies were RCTs and many of these were of high methodological quality (Table 8).
However, RCTs generally scored poorly for concealment of treatment allocation and many failed to
use an intention-to-treat analysis. These issues should be addressed in designing future clinical trials of interventions for CFS/ME."

"Interventions
Although we have discussed all the studies evaluating a particular intervention together, the treatment offered to patients receiving a particular type of therapy in practice may vary considerably, particularly for behavioural interventions. For example, in the CBT study by Stulemeijer et al.93, participants in the intervention group received ten individual therapy sessions over 5 months in a hospital child psychology department, whereas in the study by Whitehead et al.95 the intervention was a form of ‘brief CBT’ delivered by general practitioners. Further standardisation of methods for delivering behavioural interventions in research and practice would be desirable."

"
Participants in included studies and diagnostic criteria
The studies included in our review also show a lack of uniformity in terms of case definitions for
CFS/ME, study inclusion and exclusion criteria and the basic information provided about the
participants. For example, baseline functional status and duration of illness are not always reported.
This makes it difficult to assess the generalisability of the findings of many of these studies."

Withdrawals and drop-outs
Some studies of behavioural interventions have reported significant rates of withdrawal from
treatment or loss to follow-up, as high as 20–40% in some studies9596. This update did not find any
new evidence of adverse effects (sufficient to cause withdrawal from treatment) associated with GET
or CBT. However, reasons for withdrawals were often poorly reported and should be investigated in
more detail in future studies. The new studies included in the update confirmed previous reports of
withdrawals because of adverse events associated with immunological/antiviral and pharmacological
interventions.

Patients with severe CFS/ME
There remains a lack of studies evaluating the effectiveness of interventions for patients severely
affected by CFS/ME. The protocols for many clinical studies require patients to attend a clinic for
treatment and/or assessment. These conditions may exclude people severely affected with CFS/ME
from taking part. The balance between effectiveness and adverse effects of interventions may be
different in more severely affected compared with less severely affected patients and methods of
delivery/doses may need to be different. Research to evaluate the effectiveness of interventions for
severely affected patients should be considered a priority."

CONCLUSIONS

A total of 70 trials investigated the effectiveness of seven different categories of intervention:
behavioural, immunological, antiviral, pharmacological, supplements, complementary/
alternative and other.

• Overall the interventions demonstrated mixed results in terms of effectiveness. All
conclusions about effectiveness should be considered together with the methodological
inadequacies in some of the studies.

• Interventions which have shown evidence of effectiveness include CBT and GET.
• There is insufficient evidence about how sub-groups of patients may respond differently to
treatments and further studies investigating additional subgroups are needed.
• In some of the included studies bed or wheelchair restricted patients and children have been
excluded, which raises questions about the applicability of findings to all people with CFS/ME.
• CBT and immunoglobulin G are the only interventions which have been investigated in young
people.
• There is insufficient evidence for additive or combined effects of interventions where more
than one therapy is used.
• Future research could usefully compare CBT and GET and there is a need to evaluate the
effectiveness of pacing, ideally in comparison to CBT and GET."

Don't know how this conclusion came about!!!!

"
• Future research needs to combine scientific rigour with patient acceptability.
• The large number of outcome measures used makes standardisation of outcomes a priority
for future research."

Having read their 'analyses' of the studies they selected for inclusion how they came up with their conclusions is baffling, but then I'm no 'expert'.

eta:
find this very confusing:
"
The remaining three RCTs reported a beneficial effect of CBT when compared to controls.22, 25, 26
All three RCTs found a significant short term improvement in physical functioning, fatigue, and global improvement, but neither of the two studies that assessed depression found any differences between groups.22, 25

One of these RCTs also followed patients for five years after the intervention.
At the five year follow-up assessment global improvement was greater in the intervention group, as was the proportion of participants who completely recovered,23

however, no differences were reported between the groups in terms of physical functioning, fatigue, general health, symptoms, relapses or
the proportion of participants that no longer met the UK criteria for CFS."

What does this mean?

eta2: this is also an interesting document as it shows how they assessed/scored the research papers that were under consideration. Although, how the GDG finally came to the conclusion it did based on this evidence is another question.

 

It sounds like classic BPS doublespeak. People said they felt better, and were even recovered according to our measure, but actually the objective evidence said otherwise.

 

I really hope we have some good people on the GDG, or they'll pull the same nonsense evident in these minutes. In essence, evidence matters, except when they say it doesn't. And they use bureaucracy and 'methodology' to discount anything they don't like. The whole process, like the PACE minutes, reveals a complete mess designed to wear patient reps down and continue the status quo.

What's most annoying is how truly ignorant most of them come across in these minutes, too. They witter on in zigzags of ideas, and they seem to have no self-awareness of their own limitations. Ego over education. There's not a truly critical thought among them.

 

review of his book on Amazon
"
1.0 out of 5 stars Horrendous endorsement of the biggest unknown medical scandal of the 21st Century

Reviewed in the United Kingdom on 24 July 2021

The NICE draft guidelines (November 2020) state: “If anyone deserves an apology it is the people with ME/CFS, many of whom have experienced years of being told that their symptoms are “all in the mind” and given no meaningful medical management – mainly as a result /of the dominance of the psychosocial model of causation. As a result, progress involving biomedical research into the underlying cause of ME/CFS has been severely hampered.”

The ME Association further clarifies, “The reason why people with ME/CFS feel angry and let down by the medical establishment stems from the fact that almost all biomedical research until recently has been funded by donations to the charity sector. Almost all government funding has gone into research based on a flawed psychosocial model of causation.”.

These methods and paradigms of the Wessely School , PACE trial and the Brain Retraining Methods have prevented serious biochemical medical research into post-viral illness. We need immunologists not psychiatrists. 40 years of institutional abuse have occurred in this field. The underlying disease mechanism is not understood in ME because for decades the Behavioural Psychiatrists and Psychologists have fought for ME to be only located in their field, which has dominated funding, research, clinical guidelines and medical insurance.

The PACE trial is one of the medical scandals equivalent to Andrew Wakefield, MMR and Autism. Patients campaigned for 5 years for the full data to be released and it was found to be substandard with the researchers making up data to fulfil their hypothesis.

Bruce Levin, Biostatistician of Columbia calls this "the height of clinical trial amateurism,"
Ronald Davis of Stanford says, "I’m shocked that the Lancet published it…The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review";
Prof Jonathon Edwards of UCL says it "is an unblinded trial with subjective outcome measures. That makes it a non-starter in the eyes of any physician or clinical pharmacologist familiar with problems of systematic bias in trial execution."

“The history of ME remains one of the worst examples of unacknowledged institutional abuse in modern times.” ~ Valerie Eliot Smith 2019

It is vital to not repeat the mistakes that were made with treating and diagnosing ME in Long Covid. It was through the faulty belief established through Behavioural Cognitive Psychology (Wessely School ) that ME was caused by deconditioning and patients had too much fear to be active therefore keeping themselves in a vicious circle, and that ME was a disease of psychiatric origin with the cause also being seen as mass hysteria.

This is also known as the biopsychosocial model (BPS). Therefore GET (Graded Exercise Therapy) was prescribed to condition them and make them overcome their fear and psychological therapies were given such as CBT to help them change their negative thought and emotional processes about exercise. While on this programme, physical and diagnostic tests are also to be actively avoided. Receiving benefits or sick pay is also discouraged as this is seen as an obstacle to recovery."

 

Does anyone have a link to the archived 2007 guideline or saved a copy?

In this thread I could only find the minutes of the 2007 gl committee and this document on "Occupational Aspects of the Management of CFS -- A National Guideline" which is still online.

I thought it could be helpful to have the old guideline to check what was actually said on nutritional support there.

I vaguely remember there was a comment from some BPS people on malnutrition in ME/CFS either in the making of the 2007 guideline or in the stakeholders comments on the 2020 (?) draft, but rather on not including malnutrition in the diagnosis so that additional consulting/ diagnosis would be necessary if malnutrition occurred in pwME/CFS?

Sorry for not being able to continue searching and also for complicated wording, just think that bit was missing from the discussion on the inquest on Maeve's death: What was actually being recommended in the old NICE guidance that was still in place when Maeve needed treatment?

Now oo late for the inquest, but maybe still relevant for the comments on/ responses to the coroners report?

Also what did the draft say on issues with nutrition that if I remember correctly was also accessible then?

A first search only brought me to what seems to be a recent (non-NICE) guideline for ME/CFS in children -- but have no access (paywalled) :

(Thank you @Kitty for posting.)

 

2007 guideline could previously be found at https://www.nice.org.uk/guidance/cg53 - there are no details there and it just points to the 2021 guideline.

Archives of the 2007 webpage can be found at https://web.archive.org/web/20240000000000*/https://www.nice.org.uk/guidance/cg53. To see the actual guideline you would need to look at an archived version before Oct 2021, such as this from Feb 2020, https://web.archive.org/web/20200207202031/https://www.nice.org.uk/guidance/cg53

The bits that seemed relevant to me are

Diet

and

Care of people with severe "CFS/ME".

 

I think the answer is that nothing in the 2007 guideline impacted negatively on the general nutrition support guideline of 2017. As far back as 1977 I remember giving parenteral nutrition to a young man losing weight for whom we had no clear diagnosis. Feeding comes before diagnosis and continues to be imperative whatever the diagnosis.