Unethical Bristol/Bath Lightning Process ME/CFS children pilot study

eBMJ: Unethical Bristol/Bath Lightning Process –  ME/CFS children pilot study

Shortlink: http://wp.me/p5foE-2XC

The following response was submitted to eBMJ Rapid Responses on 15 July, and is currently unpublished.  A copy also appears on the ONE CLICK website.

Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine

Suzy Chapman,
Carer
Dorset

15 July 2010

Send response to journal:
Re: Re: Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine

In his response “Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine”, Dr Munglani, Consultant in Pain Medicine, West Suffolk Hospital, recommends the Lightning Process [1].

The Lightning Process is a three-day course said to be based on neuro-linguistic programming (NLP) and life coaching. It is marketed not as a therapy or a treatment but as a “training program”. It is unregulated and its practitioners are trained and “licensed” by the Phil Parker organisation. Many of those who train to become Lightning Process instructors are former “trainees”, themselves.

I note that Dr Munglani has a provided a number of personal testimonials for the pages of the website of a Suffolk Lightning Process centre [2].

The website states that there are now NHS and private consultants, GPs and occupational therapists referring patients to the centre, and that NHS clinicians have attended as observers of the work carried out there. Visitors to the site are encouraged to contact an OT at the James Paget University Hospital pain clinic or OTs at the Norfolk and Suffolk ME/CFS service, for which contact details are given.

On one of its web pages is the following:

What does the Lightning Process work for?

People using the Lightning Process™  have recovered from, or experienced significant improvement with the following issues and conditions

“ME, chronic fatigue syndrome, PVFS, adrenal fatigue, acute and chronic pain, back pain, fibromyalgia, rheumatoid arthritis, migraine, injury, PMT, perimenopausal symptoms and menopause, clinical depression, bipolar disorder, anxiety and panic attacks, OCD and PTSD, low self- esteem, confidence issues, hay fever, asthma and allergies, candida, interstitial cystitis, urinary infections, bladder and bowel problems, IBS, coeliac disease, crohns disease, food intolerances and allergies, blood pressure, cardiac arrhythmia, type 2 diabetes, restless leg syndrome, hyper/hypo thyroidism, insomnia and sleep disorders, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, weight and food issues, anorexia and eating disorders, multiple sclerosis, cerebral palsy, parkinsonian tremor, motor neurone disease”

On 16 June, the Advertising Standards Authority (ASA) published an adjudication against a Bournemouth company following its upholding of a complaint about a Lightning Process advertisement [3].

The ASA records their concerns that “the company did not hold robust evidence to support their claims that the lightning process was an effective treatment for CFS or ME. We therefore reminded them of their obligations under the CAP Code to hold appropriate evidence to substantiate claims prior to publication. Because we had not seen any evidence to demonstrate the efficacy of the lightning process for treating the advertised conditions, we concluded that the claims had not been proven and were therefore misleading.”

The company was advised to ensure “they held substantiation before making similar efficacy claims for the lightning process”.

The Advertising Standards Authority’s remit does not extend to website content. But I hope that Dr Munglani, who provides personal testimonials for the Suffolk centre, has satisfied himself that this centre is able to provide robust evidence to substantiate its claims that people using the Lightning Process, said to be based on neuro-linguistic programming (NLP) and life coaching, have “recovered from, or experienced significant improvement” from diseases and conditions which, in addition to ME and chronic fatigue syndrome, include urinary infections, coeliac disease, crohns disease, blood pressure, cardiac arrhythmia, type 2 diabetes, hyper/hypo thyroidism, autistic spectrum disorder, dyspraxia, ADHD, lymes disease, glandular fever, epstein barr virus, multiple sclerosis, cerebral palsy, parkinsonian tremor and motor neurone disease.

This is a very topical issue because in March, the Royal National Hospital for Rheumatic Diseases NHS Foundation Trust, also known as the Min, and the University of Bristol announced a pilot study looking into interventions and treatment options for Chronic Fatigue Syndrome [4].

Funding of £164,000 from the Linbury Trust and the Ashden Trust has been awarded to a research team led by Dr Esther Crawley, Consultant Paediatrician, Royal National Hospital for Rheumatic Diseases, Bath, CFS Clinical Lead for Bath NHS FT and a Senior Lecturer, University of Bristol.

The pilot study, scheduled to start in September, will look at the feasibility of recruiting children aged 8 to 18 with CFS and ME into a randomised controlled trial (RCT) comparing the Lightning Process and specialist medical care. The study has the involvement of Phil Parker and colleagues.

“The study will involve in depth interviews with the patients and their parents, and the primary outcome measure will be school attendance after six-months. It is hoped that over 90 children aged between eight and 18 and their families will be involved in the study. They will be recruited after assessment by the specialist team at the Min.”

The Medical Research Council (MRC) produces specific guidelines for research involving vulnerable patient groups. The document “MRC Medical Research Involving Children” is clear:

4.1 Does the research need to be carried out with children? Research involving children should only be carried out if it cannot feasibly be carried out on adults.” [5]

No rigorous RCTs into the application of the Lightning Process in adults with CFS and ME have been undertaken.

Data from two large patient surveys carried out by Action for M.E./AYME (published 2008) and by the ME Association (published May 2010) show similar levels of worsening of symptoms in CFS and ME patients following the three day “training program”, or of no improvement at all (AfME/AYME: Worse: 16%, No change: 31%; MEA: Slightly worse 7.9%; Much worse 12.9%; No change 34.7%) [6].

With no robust data from the application of Lightning Process in adults, how can the research team determine that overall the likely benefits of the research outweigh any risks to child participants and that undergoing the training program would not be detrimental to a child’s current health status and psychological well-being, as a patient diagnosed with CFS or ME?

There are considerable concerns that an NHS paediatric CFS unit should be planning a study involving children as young as eight when no rigorous trials have first been undertaken into the safety, acceptability, long and short-term effects of the application of this controversial and unregulated “process”.

Not only is it feasible to carry out research into the application of the Lightning Process using adults with ME and CFS, many feel it unethical not to do so first.

References

[1] Failure to appreciate pain is a symptom not a diagnosis is what leads to bad medicine: Rajesh Munglani, 8 March 2010:
http://www.bmj.com/cgi/eletters/340/jan06_2/b5683#232414

[2] The Rowan Centre, Suffolk:
http://www.simpsonandfawdry.com/about-simpson-and-fawdry.htm

[3] Advertising Standards Authority Adjudication, 16 June 2010:
http://www.asa.org.uk/Complaints-and-ASA-action/Adjudications/2010/6/Withinspiration/TF_ADJ_48612.aspx

[4] Media Release, University of Bristol, 2 March 2010:
http://www.bristol.ac.uk/news/2010/6866.html

[5] MRC Medical Research Involving Children (Nov 2004, revised Aug 2007):
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430

[6] Patient Survey 2008, Action for M.E. and AYME:
http://www.afme.org.uk/res/img/resources/Survey%20Summary%20Report%202008.pdf

Patient Survey May 2010, ME Association:
http://www.meassociation.org.uk/images/stories/2010_survey_report_lo-res.pdf

Competing interests: None declared

Related material:

Press Release issued 2 March 2010: Research study to investigate a chronic childhood condition
 

For background to this issue see ME agenda 5 July report:

Advertising Standards Authority (ASA) Adjudication: Withinspiration (Lightning Process)

Poll: Do you think it is ethical to undertake a pilot study looking at the feasibility of recruiting children aged 8 to 18 with CFS and ME into a randomised controlled trial (RCT) comparing Lightning Process and specialist medical care when no rigorous RCTs into the application of LP in adults have been undertaken? 

Register your opinion here: http://tinyurl.com/LightningProcessPilotStudyPoll 

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