Clinical And Cost-Effectiveness Of The Lightning Process In Addition To Specialist Medical Care For Paediatric Chronic Fatigue Syndrome: Randomised Controlled Trial

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 pound% CI 111 pound to 2836) pound, 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.