In this trial, the effectiveness of The Lightning Process® (LP) in addition to specialist medical care was compared to specialist medical care alone in children with mild or moderate chronic fatigue syndrome (also known as myalgic encephalomyelitis (CFS/ME)).

CFS or ME affects at least one per cent of secondary school children in the UK and is very disabling. Despite the number of young people affected by this debilitating condition there is limited evidence for how we should treat this condition in children. The National Institute for Health and Care Excellence (NICE) recommends three treatment approaches: cognitive behavioural therapy (CBT), graded exercise therapy (GET) or activity management, however, even with treatment, only about two thirds of children can be expected to recover at six months.

Around 250 children with CFS/ME use LP each year. The programme, developed from osteopathy, life coaching and neuro-linguistic programming, teaches techniques for using the brain to make changes to the body's level of health and cost £620 when the study was carried out. However, there have been no reported studies investigating its effectiveness, cost-effectiveness or possible side effects.

The randomized controlled SMILE (Specialist Medical Intervention and Lightning Evaluation) trial, led by researchers at the Bristol Medical School – Population Health Sciences, is the first study to investigate the effectiveness and cost-effectiveness of LP in addition to specialist medical care compared with specialist medical care alone.

The trial recruited 100 eligible participants aged 12-to 18-years with a diagnosis of mild or moderate CFS/ME. Patients were allocated at random to either specialist medical care, or specialist medical care plus LP and were asked to read information about LP, attend three group sessions and receive follow-up phone calls with an LP practitioner. All participants were asked to complete questionnaires at regular intervals on levels of physical function, fatigue, pain, anxiety and school attendance.

After carrying out statistical and cost analyses, the team report that participants in the group allocated with LP in addition to specialist medical care had improved physical function at six months which improved further at 12 months. Fatigue and anxiety were reduced at six and 12 months when depression was also reduced. School attendance had also improved at 12 months.

The study's findings indicate that LP offered in addition to specialist medical care is effective and probably cost effective for children and young people who have been diagnosed with mild/moderate CFS/ME.

Professor Esther Crawley, Professor of Child Health in the University's Centre for Child and Adolescent Health and Consultant Paediatrician at the Royal United Hospital, said: "I was surprised that the LP provided additional benefit to specialist medical care. This is an important study as it provides another treatment approach that some children may find helpful. Ultimately, our aim is to find the most effective treatments that can help improve the debilitating symptoms of CFS or ME in children.

"However, while these results are promising, further research is needed to establish which aspects of the LP are helpful and whether it is an effective treatment on its own and whether it could be used to help more severely affected patients. Many children and families in our service did not want to have LP and therefore, this approach is not for everybody so we must continue to investigate other treatment approaches."

The paper titled, "Clinical and cost-effectiveness of the Lightning Process in addition to Specialist Medical Care for pediatric Chronic Fatigue Syndrome: randomized controlled trial," was published in the journal Archives of Disease in Childhood.