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Arch Dis Child. 2018 Feb;103(2):155-164. doi: 10.1136/archdischild-2017-313375. Epub 2017 Sep 20.

Clinical and cost-effectiveness of the Lightning Process in addition to specialist medical care for paediatric chronic fatigue syndrome: randomised controlled trial.

Author information

1
Centre for Child and Adolescent Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol.
2
Bristol Medical School: Population Health Sciences, University of Bristol, Bristol.
3
Bristol Randomised Trials Collaboration, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol.
4
Nottingham Clinical Trials Unit, School of Medicine, Queen's Medical Centre, University of Nottingham, Nottingham, UK.

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.

KEYWORDS:

RCT; adolescent health; chronic fatigue syndrome

PMID:
28931531
PMCID:
PMC5865512
DOI:
10.1136/archdischild-2017-313375
[Indexed for MEDLINE]
Free PMC Article

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