In July 2019 corrections and clarifications to this article were published by the researchers in the BMJ, though all critics’ questions about the validity of the results have not been answered. They point out that this is an unblinded trial with subjective outcome measures and no long term follow up (LTFU) data, with unanswered questions about the data and changes in protocol.
Notice of correction and clarification: Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial
Prof David Tuller has been one of many people asking for clarification re the trial. Read his letters and blog posts.
The publication of the results of the controversial SMILE trial has caused a flurry of concerned responses in the media, which we will report on later.
Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial by Esther M Crawley et al in Archives of disease in childhood Sep 2017
What is already known on this topic?
- Paediatric chronic fatigue syndrome (CFS)/myalgic encephalitis (ME) is relatively common with a negative impact on school, mood and quality of life.
- Even with effective treatment, a significant number of children have not recovered at 6 months.
- The Lightning Process (LP) is used by children with CFS/ME in the UK but with no evidence of effectiveness.
What this study adds?
- At 6 months, children who received LP in addition to SMC had better physical function, fatigue and less anxiety.
- At 12 months, children who received LP in addition to SMC had better fatigue, anxiety, depression and school attendance.
- Adding LP is probably cost-effective but not all children wish to take part.
Objective Investigate the effectiveness and cost-effectiveness of the Lightning Process (LP) in addition to specialist medical care (SMC) compared with SMC alone, for children with chronic fatigue syndrome (CFS)/myalgic encephalitis (ME).
Design Pragmatic randomised controlled open trial. Participants were randomly assigned to SMC or SMC+LP. Randomisation was minimised by age and gender.
Setting Specialist paediatric CFS/ME service.
Patients 12–18 year olds with mild/moderate CFS/ME.
Main outcome measures The primary outcome was the the 36-Item Short-Form Health Survey Physical Function Subscale (SF-36-PFS) at 6 months. Secondary outcomes included pain, anxiety, depression, school attendance and cost-effectiveness from a health service perspective at 3, 6 and 12 months.
Results We recruited 100 participants, of whom 51 were randomised to SMC+LP. Data from 81 participants were analysed at 6 months. Physical function (SF-36-PFS) was better in those allocated SMC+LP (adjusted difference in means 12.5(95% CI 4.5 to 20.5), p=0.003) and this improved further at 12 months (15.1 (5.8 to 24.4), p=0.002). At 6 months, fatigue and anxiety were reduced, and at 12 months, fatigue, anxiety, depression and school attendance had improved in the SMC+LP arm. Results were similar following multiple imputation. SMC+LP was probably more cost-effective in the multiple imputation dataset (difference in means in net monetary benefit at 12 months £1474(95% CI £111 to £2836), p=0.034) but not for complete cases.
Conclusion The LP is effective and is probably cost-effective when provided in addition to SMC for mild/moderately affected adolescents with CFS/ME.
Trial registration number ISRCTN81456207,
University of Bristol news announcement, 21 Sep 2017: Study investigating effectiveness of The Lightning Process® programme to treat children with mild or moderate CFS or ME finds symptoms improve
“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.”