Revised guideline for prescribing vigabatrin in children

doi:10.1136/bmj.322.7280.236

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Guideline's claim about infantile spasms is not based on appropriate evidence

Andrew L Lux (andrew.lux@ruh-bath.swest.nhs.uk), clinical research fellow,
Stuart W Edwards, UKISS research coordinator,
John P Osborne, professor of paediatrics and child health,
Eleanor Hancock, specialist registrar in paediatric neurology,
Anthony L Johnson, statistician,
Colin R Kennedy, consultant paediatric neurologist,
Finbar J K O'Callaghan, specialist registrar in paediatric neurology,
Richard W Newton, consultant paediatric neurologist,
Christopher M Verity, consultant paediatric neurologist

Bath Unit for Research in Paediatrics, Children's Centre, Royal United Hospital, Bath BA1 3NG
Royal United Hospital, Bath BA1 3NG
Chelsea and Westminster Hospital, London SW10 9NH
MRC Biostatistics Unit, Institute of Public Health, Cambridge CB2 2SR
Southampton General Hospital, Southampton SO9 4XY
Royal Manchester Children's Hospital, Manchester M27 1HA
Addenbrooke's Hospital, Cambridge CB2 2QQ
Members of the group are: Richard Appleton, consultant paediatric neurologist, Liverpool (to whom correspondence should be addressed at the Roald Dahl EEG Unit, Alder Hey Children's Hospital, Liverpool L12 2AP); Peter Baxter, consultant paediatric neurologist, Sheffield; David Calver, consultant ophthalmologist, London; Celia Cramp, consultant paediatrician, Shrewsbury; John Gibbs, consultant paediatrician, Chester; Graham Harding, consultant clinical neurophysiologist, Birmingham; John Livingston, consultant paediatric neurologist, Leeds; Richard Robinson, consultant paediatric neurologist, London; Isabelle Russell-Eggitt, consultant paediatric ophthalmologist, London; Sheila Wallace, consultant paediatric neurologist, Cardiff; and John Wild, senior lecturer in vision sciences, Birmingham.

EDITOR—The Vigabatrin Paediatric Advisory Group, which in 1998 produced a guideline to “help clinicians when prescribing vigabatrin in children,” has now revised it. 1 2 We, the steering committee of the United Kingdom infantile spasm study (UKISS), responded to the original guideline.3 Our opinion was that there is no evidence that vigabatrin is a better treatment of infantile spasms than hormonal treatments, such as prednisolone and synthetic adrenocorticotrophic hormone preparations.

When we challenged the claim that vigabatrin is the drug of choice, the advisory group offered no rebuttal. Now the claim is stated again, without any appropriate new evidence being produced. Indeed, the finding that visual field losses attributable to vigabatrin occur in children as well as adults strengthens any challenge to the guideline's claim. …