September 20, 2017

expert reaction to controversial treatment for CFS/ME

In a new study, and despite strong initial scepticism, researchers publishing in the Journal of Archives of Disease in Childhood report that a training course alongside specialist care has proved to be an effective treatment for children with chronic fatigue syndrome (CFS)/myalgic encdephalomyelitis (ME).

A Before the headlines analysis accompanied this roundup.

This roundup accompanied a briefing.

Prof. Alastair Sutcliffe, Professor of General Paediatrics, UCL, said:

“A recent systematic review of neurolinguistic programming (NLP) stated “There is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.” [Br J Gen Pract. 2012 Nov; 62(604): e757–e764. Published online 2012 Oct 29. doi:  10.3399/bjgp12X658287, PMCID: PMC3481516]. But now we have this interesting study by Crawley, a well-conducted single blind clinical trial that suggests NLP, in combination with other therapies and described as the ‘Lightning Process’, is effective for some children with the very hard to treat condition of chronic fatigue syndrome (CFS).

“Although in my view the effects described show some benefit and are therefore to be welcomed, this could be due to placebo which would still be GOOD news. Costs are modest and therefore this study is to be welcomed.

“These press releases are accurate, however, there is no reference to the fact that the effect may be due to placebo as this is a single-blind trial. But in a sense this is not so important as the trial shows convincing evidence of benefit and as placebo is impossible to quantify we are left with the alternative possibility that these children benefited from the package of care per se, rather than the nebulous placebo effect.

“CFS is a difficult to treat and common disorder, so overall I welcome this step in the direction of evidence-based care as, at present in the UK, there is little agreement about what is the best way to treat this illness.”

Prof. Dorothy Bishop, Professor of Developmental Neuropsychology, University of Oxford, said:

“The gains for patients in this study do seem solid, however, I am still rather uneasy because while the patient allocation and statistical analysis of the trial appear to be done to a high standard, the intervention that was assessed is commercial and associated with a number of warning signs. The Lightning Process appears based on neurolinguistic programming, which, despite its scientific-sounding name, has long been recognised as pseudoscience.

“I am sympathetic to the authors’ decision to evaluate the Lightning Process (LP), given that they had patients who had used it and reported favourably on it, and it could be argued that to fail to do so would indicate a degree of closed-mindedness. But the commercial nature of LP really creates problems. We cannot tell which aspect of LP is responsible for the gains in patients who took part.

“I noticed, for instance, that LP involves group sessions, whereas the comparison group undergoing standard medical care were treated individually. So it may be that the benefits derive from interacting with other children with chronic fatigue syndrome/ME, rather than the specific exercises and training. This is, of course, something that could be investigated in future research but meanwhile the concern is that this report will in effect act as positive publicity for a programme that is being proposed for a wide range of physical conditions (including chronic pain, low self-esteem, multiple sclerosis, and depression, to name just a few) and has to date been promoted largely through celebrity endorsements.”

Dr James Thompson, Honorary Senior Lecturer in Psychology, UCL, said:

“The treatment in this study looks like it had an effect, at least by the standard of most clinical trials. To be extra robust I would have liked to see more objective measures, but unfortunately chronic fatigue syndrome is not an objective diagnosis, it is a leftover category and fatigue is subjective.

“One limitation is that self-report scales can be subject to placebo effects, however if the patients feel better in the experimental condition in which they receive extra help, even if everyone knows it, then that is something and the pupils miss less school, which is an objective measure. In this case it may not have been the CBT element of the treatment, but it looks like it.”

Prof. Michael Sharpe, Professor of Psychological Medicine, University of Oxford, said:

“Chronic fatigue syndrome (CFS) is a name for an illness with symptoms of long lasting and disabling fatigue. It affects many young people and can interfere with their education. Whilst some people call it myalgic encephalomyelitis (ME) it is not clear if this is the same or a different condition.

“This trial tests the effectiveness of a commercially available brief intensive talking therapy for CFS called the Lightning Process. The treatment has similarities to cognitive behaviour therapy (CBT) and is given in groups. The treatment was found to be better than usual care in fatigue, physical function and school attendance, with benefit seen as long as a year later. It was also safe. The study does not tell us how it works however.

“This is a robust study because patient were allocated to one of the two treatments at random ensuring that any difference seen in outcome between these treatments, is not due to pre-existing differences in the patients. The main limitation is that, as it is not possible to hide which treatment they received from the patients, their self-ratings of fatigue and functioning could potentially be biased by their views on the treatment they received. However, differences in the school attendance a year later were also noted; it seems likely that these could be due to such a bias.

“Commercially available treatments like this one that are being used by patients should be rigorously tested. This is especially important for an illness like this one about which much misinformation is spread using social media. We need more studies and less polemic.”

* ‘Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial’ by Crawley et al. published in Journal of Archives of Disease in Childhood on Wednesday 20^th September.

Declared interests

Prof. Sutcliffe: None received

Prof. Bishop: “Member of the SMC Advisory Board”

Dr Thompson: “None”

Prof. Sharpe: “Principal investigator of the PACE trial”