When the SMILE trial results were published, the ME Associated stated that we would continue to refer cases where Lightning Process practitioners are making unproven therapeutic claims to the relevant regulatory authorities.
Shortly after, Dr Shepherd referred website advertising material from Lightning Process practitioner Kathy Kent to the Advertising Standards Authority (ASA).
The ASA have now published the following adjudication:
Kathy Kent breaches UK Ad Rules with health claims about The Lightning Process on the website kathykent.co.uk
Section 12 of the CAP Code requires that advertisers must hold robust scientific evidence to support any health claims relating to their products or treatments. It also requires that advertisers must not discourage essential treatment for conditions which require medical supervision.
The website www.kathykent.co.uk contains misleading claims relating to The Lightning Process and its effectiveness in treating a number of medical conditions, including Depression and Obsessive Compulsive Disorder (OCD).
In 2012 and again in 2013 the ASA investigated health claims relating to The Lightning Process. The ASA found that there was insufficient scientific evidence to support medical claims for The Lightning Process training programme.
The CAP Compliance Team instructed Kathy Kent to remove efficacy claims for The Lightning Process and to refrain from offering advice on conditions which require medical supervision. In the absence of an appropriate response we took the decision on 14 November 2017 to place the company details on this section of the ASA website.
These details shall remain in place until such a time as Kathy Kent has removed or appropriately amended the claims on the website www.kathykent.co.uk to ensure compliance with the CAP Code.
Comment from Dr Charles Shepherd:
“I am very pleased to see that the ASA has once again taken swift and decisive action regarding a complaint from the ME Association relating to unproven therapeutic claims being made by a Lightning Process practitioner.
“However, it is very disappointing to find that the ASA Compliance Team's instruction to remove these therapeutic claims from the practitioner's website have not been complied with so far.
“We will continue to monitor what happens.
“This particular complaint is now the subject of a parliamentary question.”
ME Association statement on the SMILE trial.
ME Association critique of the SMILE trial:
“The SMILE trial is one of the worst examples of a clinical trial supposedly designed to assess the acceptability, effectiveness and safety of a treatment for ME/CFS that I have come across. In fact, in several ways it is a lesson in how not to conduct a clinical trial in people who have ME/CFS.
“There was no adequate control group, no attempt to properly measure the effectiveness of the Lightning Process® as a stand-alone intervention, and no mention of the likely placebo effect in an unblinded trial that involved comparing treatment A (i.e. specialist medical care) with treatment A + treatment B (i.e. specialist medical care plus the Lightning Process®).
“There was a serious lack of objective outcome measures (especially in relation to measuring physical activity levels), no explanation of the likely impact on self-report outcome questionnaires (where those receiving the Lightning Process® may well have been aware of the alleged benefits), and the specialist medical care ‘control’ seemed to involve a ‘pick and mix’ approach that was not at all standardised.
“It is very hard to understand why the Science Media Centre went all-out in their attempt to promote this trial. We were not therefore surprised to read of the negative scientific reaction to their coverage of it – or that one expert from their panel compared neurolinguistic programming (a key component of the Lightning Process) to ‘pseudoscience’. However, we were surprised by the way in which the British and overseas media accepted the findings without question.
“The ME Association stands by its initial statement on the SMILE trial and does not recommend the Lightning Process® for people with ME/CFS. We have referred several Lightning Process® practitioners to the Advertising Standards Authority where therapeutic claims have been made that cannot be supported. We will continue to do so, if necessary.
“We welcome sound research into treatments that could produce better outcomes for children and adolescents with ME/CFS and any applications in this area made to the MEA Ramsay Research Fund.”
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