1.11.11 - 1.11.16 (3 of 4)
Physical maintenance
p.26 line 16: We think the subsection, 'Physical maintenance' is a helpful, practical subsection that can make a difference to the well-being of people with ME/CFS and their carers.
————————
1.11.11:
p.26 lines 17-22: Include dental health in 1.11.11. Dental consultations present problems of travel, being upright for wait time and coping with examination for people with ME/CFS.
p.26 lines 17-18: After the first sentence, we suggest adding:
‘Any proposal for physical maintenance needs to be based on a realistic assessment of the person's ability to sustain the action. The possibility of causing PEM, consequent reduction in function and lowered PEM threshold, alongside displacement of essential activities should be weighed carefully against likely benefits of any physical maintenance.'
p.26 lines 17-22: We suggest inclusion of sensible examples of appropriate physical maintenance. Eg., ‘
Muscle flexibility e.g. gentle stretches in bed.’
——————————-
1.11.12
——————————-
1.11.13
—————————
1.11.14
===============
Physical activity
p.27 line 20:
Comment on the subsection 'Physical activity':
We are pleased the committee recognises the high risk of bias presented by open label trials with subjective outcome measures, the impact of this on interpreting evidence, and that there is no good quality evidence that exercise or activity programmes are effective treatments or cures for ME/CFS (Evidence Review G, pp. 137-165, 334-335; Draft guideline: Rationale and impact, p.63 lines 7-8).
However, on the same basis, there should be no recommendation to offer physical activity programmes in this guideline. Therefore, the content of the subsection on physical activity should be deleted and replaced with a clear statement outlining types of activity and exercise programmes that should
not be offered to people with ME/CFS.
Rationale:
There is no reliable evidence that physical activity programmes are effective in treating or managing ME/CFS, or increasing function or tolerance to activity in people with ME/CFS (which may be viewed as treating). Evidence quality for all GET and other exercise intervention studies was judged to be low or very low, with inconsistency of findings across outcome measures (Evidence Review G pp.137-165, 334-335).
The recommendations on considering physical activity programmes for people with ME/CFS (1.11.17 - 1.11.20) therefore introduce confusion to the guideline as to which types of activity programme are acceptable and which are not. The recommendation not to offer any therapy based on physical activity or exercise as a treatment or cure for ME/CFS is thus weakened.
Existing GET programmes that are nominally compliant (e.g. by allowing increase by flexible increments) will remain in place under the new guise of 'optional physical activity programmes', and continue to do harm to people with ME/CFS. It has been suggested by GET proponents that the poor objective outcomes and high drop out rates reported for ME/CFS specialist clinics, and the lack of support for GET from people with ME/CFS is due to an implementation problem. However, even under clinical trial conditions with delivery by well trained experts, there has been no objective evidence of benefit from any exercise or activity program.
We are pleased to see the guidance not to offer any therapy based on physical activity or exercise as a treatment or cure for ME/CFS (p.28 lines 1-2) and some of the specific guidance not to offer certain types of physical activity or exercise programmes and therapies in 1.11.16. However, the section on 'Physical activity' does not go far enough to protect people with ME/CFS from harmful programmes.
There is no justification for offering any sort of activity programme to people able to mobilise without aids. 'Programmes', however slow and gentle, are by their nature timetabled and structured, and often done in a group setting, which can encourage people to push through to keep up with the group.
It is inappropriate to offer activity programmes to people if they 'would like' them as this offers a false version of patient choice, implying by the existence of such a programme that it will improve the person's health, or the NHS would not be offering it. People with ME/CFS long to be able to do more, and find it difficult to manage cutting back their activities sufficiently to avoid PEM. Any suggestion that an activity programme might be helpful if they 'would like' it, is not supported by evidence.
We propose the content of the 'Physical activity' section be deleted and replaced with the following:
1. People with ME/CFS need advice and support to rest and avoid over-exerting to minimise PEM. If a person feels they are able to increase activity, they should be advised to proceed cautiously, particularly on good days when they may think they can do more without resulting PEM. If requested, referral to a specialist physiotherapist with up-to-date training in ME/CFS consistent with this guideline should be provided to those with problems mobilising without aids who need specialist advice.
2. If able to increase, people with ME/CFS, particularly if already ambulant, will generally do this naturally without input from a HCP.
3. ‘Activity’ and ‘physical activity’ are defined in the guideline and HCPs should recognise that an increase of any type of activity, however seemingly trivial, may cause worsening for people with severe or very severe ME/CFS.
4. Do not advise people with ME/CFS to undertake general exercise, such as going to the gym or exercising more, because this may worsen their symptoms.
5. Therapy based on physical activity or exercise is not a treatment or cure for ME/CFS and should not be offered as such.
6. There is no reliable evidence that physical activity programmes are effective in managing ME/CFS or its symptoms, or increasing function or tolerance to activity. They should not be offered as such.
7. Offering activity programmes with the objective of managing ME/CFS or its symptoms, or increasing function or tolerance to activity, can be regarded as offering them to treat ME/CFS. Any therapy based on physical activity or exercise as a treatment or cure for ME/CFS should not be offered (Rationale and impact, p.63 lines 7-8).
8. Do not offer the following to people with ME/CFS:
a. generalised physical activity or exercise programmes. This includes programmes developed for healthy people or people with other illnesses;
b. any programme that has increasing activity or exercise as its objective, regardless of whether this is by fixed or flexible increments, for example graded exercise therapy;
c. any activity or exercise programme based on a hypothesis of the cause of ME/CFS, as this is not yet known. This includes activity or exercise programmes based on deconditioning, central sensitisation, or fear avoidance, and ones that aim to desensitise people with ME/CFS to exertion or triggers (eg., light, sound) through exposure.
d. therapies derived from osteopathy, life coaching and neurolinguistic programming (for example the Lightning Process).
We are pleased that some of the above is addressed at 1.11.15 and 1.11.16. However, we do not feel the guideline adequately protects patients from harm in its current form.
——————————————
p.27 line 20: We provide comments on each recommendation in support of our suggestion to replace the current ‘Physical activity’ section as outlined above. These comments should also be considered as stand alone feedback.
————————
1.11.15:
p.27 lines 21-23: This clause needs clarifying. It is not clear if supervised unstructured or unsupervised structured exercise is acceptable and these terms are not defined. Suggested edit: ‘
Do not advise people with ME/CFS to undertake general exercise, such as telling them to go to the gym or to exercise more, as this may worsen their symptoms.’
—————————
1.11.16:
p.28 lines 1-2: Suggest replace with ‘
Any therapy based on physical activity or exercise as it is not a treatment or cure for ME/CFS and should not be offered as such.’ (Rationale and impact, p.63 lines 7-8)
.
p.28 lines 3-5: Good. Should be retained.
p.28 lines 6-7: Suggest replace with: ‘
any programme that has increasing activity or exercise as its objective, regardless of whether this is by fixed or flexible increments, for example graded exercise therapy.’
By specifying that programmes based on fixed incremental increases should not be offered, any programme based on flexible increases would remain acceptable under the guideline. E.g. Programmes with scheduled increases except when PEM is present may be viewed as incorporating flexible increments and therefore guideline compliant, yet may do significant harm.
There is no standard definition of GET (Evidence Review G, p.335 lines 8-10), and therefore no requirement that increases in GET programmes must be by fixed increments. It can be seen from Evidence Review H that, in fact, studies of GET included in the evidence review did include flexible increments. It is therefore clear that the portrayal of programmes involving fixed increments as poorly evidenced and potentially harmful and programmes involving flexible increments as of potential benefit is a false distinction; studies of GET programmes have been assessed as low or very low quality evidence regardless of whether they involve fixed or flexible increments, with inconsistency of findings across outcome measures (Evidence Review G pp.137-165, 334-335).
We provide excerpts from study summaries in Evidence Review H, illustrating increasing by non-fixed increments:
Broadbent (2016), pp.34-35:
‘Exercise sessions were progressed by increasing the duration of the session only as tolerated for each participant. The workload was not increased until participants had achieved three consecutive exercise sessions of 30 min in total with no increase in symptoms, and the increase was 10% of the current workload. If participants reported any increase in fatigue or other symptoms during post-exercise, the exercise intensity was reduced until participants felt able to manage progression.’
Clark (2017), pp.92-93:
‘If symptoms increased after an incremental change in activity, participants were advised to maintain activity at the same level until symptoms had settled, before considering another incremental increase.’
Wallman (2004), pp.230-231:
‘Subjects were instructed to exercise every second day unless they had a relapse. If this occurred or if symptoms became worse, the next exercise session was shortened or cancelled and subsequent sessions were reduced to a length that subjects felt was manageable (pacing)’
Descriptions of other GET study interventions included in the evidence review also indicated that increasing was not by fixed increment (Fulcher, 1997; Wearden, 1998; White, 2011). Further, Evidence Review G acknowledges the heterogeneity of interventions described in GET studies (p.335, lines 9-10). Therefore, it is not sufficient to recommend that 'any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy' should not be offered to people with ME/CFS. To accurately reflect the evidence and adequately protect people with ME/CFS from harms, lines 6-7 should recommend that all programmes that have increasing activity or exercise as their objective, regardless of whether this is by fixed or flexible increments, should not be offered to people with ME/CFS. This includes but is not limited to GET.
p.28 lines 8-9: Delete ‘structured’. Suggested edit: ‘a
ny activity or exercise programme based on a hypothesis of the cause of ME/CFS, as this is not yet known. This includes activity or exercise programmes based on deconditioning, central sensitisation, or fear avoidance, and ones that aim to desensitise people with ME/CFS to exertion or triggers (eg., light, sound) through exposure.’
p.28 line 10-11: Good. Should be retained.
p.28 lines 1-11: Include an additional recommendation after 1.11.16: ‘
There is no reliable evidence that activity programmes are effective in managing ME/CFS or its symptoms or increasing function or tolerance to activity. Therefore they should not be offered as such.’
=============