Editor’s Comment: Numerous critiques of the Lightning Process have been made by physicians, medical practitioners, and patient organizations. There are cases in which LP has resulted in long-lasting physical harm. (You can read about these cases here and here.) Dr. Charles Shepherd, an ME/CFS specialist, does not recommend LP for any ME/CFS patients.
Abstract:
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.
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Source: Crawley EM, Gaunt DM, Garfield K, Hollingworth W, Sterne JAC, Beasant L, Collin SM, Mills N, Montgomery AA. Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial. Arch Dis Child. 2017 Sep 20. pii: archdischild-2017-313375. doi: 10.1136/archdischild-2017-313375. [Epub ahead of print] https://www.ncbi.nlm.nih.gov/pubmed/28931531