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

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Clinical Protocols
  • Combined Modality Therapy
  • Cost-Benefit Analysis
  • Fatigue Syndrome, Chronic / economics
  • Fatigue Syndrome, Chronic / psychology
  • Fatigue Syndrome, Chronic / rehabilitation
  • Fatigue Syndrome, Chronic / therapy*
  • Female
  • Humans
  • Male
  • Psychotherapy, Group* / economics
  • Treatment Outcome