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.
- chronic fatigue syndrome
- adolescent health
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Contributors EMC obtained the funding, designed and supervised the trial. DMG conducted the statistical analysis and compiled the results tables. KG conducted the health economic analyses and compiled the health economic tables. WH contributed to the study design and supervised the health economic analyses. JACS contributed to the study design and co-supervised the statistical analyses. LB contributed to the study design and running the trial. SMC managed the data and contributed to the statistical analyses. NM contributed to the study design. AAM contributed to the study design and co-supervised the statistical analyses. All authors contributed to the data interpretation and writing the paper. EMC is the guarantor.
Funding This trial was funded by the Linbury Trust (grant number LIN2038) and the Ashden Trust (grant numbers ASH1062, 1063, 1064). EMC was funded by an NIHR Clinician Scientist fellowship followed by an NIHR Senior Research Fellowship (SRF-2013-06-013) during the trial. SMC was funded by an NIHR Post Doctoral Fellowship during the analyses of the trial.
Disclaimer No member of the Linbury Trust or the Ashden Trust had any involvement in the design, analyses or in writing the paper. This report is an independent research and the views expressed in this publication of are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
Competing interests EMC runs the specialist CFS/ME service at Royal United Hospital NHS Foundation Trust.
Patient consent Obtained.
Ethics approval South West 2 Local Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The authors had access to all the data. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. Given the nature of this dataset, access is controlled. Requests are referred to the University of Bristol Data Access Committee for approval before data can be released under an appropriate data access agreement. For details on how to access data, see the repository record at http://dx.doi.org/10.5523/bris.1myzti8qnv48g2sxtx6h5nice7.
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