Enzyme potentiated desensitisation in treatment of seasonal allergic rhinitis: double blind randomised controlled study

doi:10.1136/bmj.327.7409.251

BMJ 2003;327:251-254 (2 August), doi:10.1136/bmj.327.7409.251

Paper

Enzyme potentiated desensitisation in treatment of seasonal allergic rhinitis: double blind randomised controlled study

Michael J Radcliffe, visiting clinical research fellow¹, George T Lewith, senior clinical research fellow², Richard G Turner, associate specialist in allergy³, Philip Prescott, professor of statistics⁴, Martin K Church, professor of immunopharmacology¹, Stephen T Holgate, MRC clinical professor of immunopharmacology¹

¹ School of Medicine, Infection Inflammation and Repair Research Division, University of Southampton, Southampton General Hospital, Southampton SO16 6YD, ² School of Medicine, Community Clinical Sciences Research Division, University of Southampton, Royal South Hants Hospital, Southampton SO14 0YG, ³ North Hampshire Hospital, Basingstoke RG24 9NA, ⁴ Faculty of Mathematical Studies, University of Southampton, Southampton SO17 1BJ

Correspondence to: M J Radcliffe michael{at}radcliffe.net

Objective To assess the efficacy of enzyme potentiated desensitisationin the treatment of severe summer hay fever poorly controlled by pharmacotherapy.

Design Double blind randomised placebo controlled parallel group study.

Setting Hospital in Hampshire.

Participants 183 participants aged between 18 and 64 with ahistory of severe summer hay fever for at least two years;all were skin prick test positive to timothy grass pollen.90 randomised to active treatment; 93 randomised to placebo.

Interventions Active treatment: two injections of enzyme potentiated desensitisation, given between eight and 11 weeks apart, eachcomprising 200 Fishman units of ${beta}$ glucuronidase, 50 pg 1,3-cyclohexanediol,50 ng protamine sulphate, and a mixed inhaled allergen extract(pollen mixes for trees, grasses, and weeds; allergenic fungalspores; cat and dog danders; dust and storage mites) in a totalvolume of 0.05 ml of buffered saline. Placebo: two injectionsof 0.05 ml buffered saline solution.

Main outcome measures Proportion of problem-free days; global rhinoconjunctivitis quality of life scores assessed weeklyduring pollen season.

Results The active treatment group and the placebo group didnot differ in the proportion of problem-free days, qualityof life scores, symptom severity scores, change in quantitativeskin prick provocation threshold, or change in conjunctivalprovocation threshold. No clinically significant adverse reactionsoccurred.

Conclusions Enzyme potentiated desensitisation showed no treatment effect in this study.

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Rapid Responses:

Read all Rapid Responses

Why a mixture of allergens ?: Eduardo Costa Silva
bmj.com, 2 Aug 2003 [Full text]
What conclusion can be drawn ?: J P Dias
bmj.com, 3 Aug 2003 [Full text]
Desensitisation for Hayfever: Stephen R Durham
bmj.com, 4 Aug 2003 [Full text]
AS expected...: Hugo P. VAN BEVER
bmj.com, 4 Aug 2003 [Full text]
Misleading heading: Joao A Fonseca
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Useless vs Helpful allergy therapy: michael l loren
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Enzyme potentiated desensitisation: Failure of intervention or inappropriate outcome measures?: Michal R Pijak, et al.
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Enzyme potentiated desensitisation: Failure of intervention or inappropriate outcome measures?: Michal R Pijak, et al.
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Erratum: George T Lewith
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Immunotherapy is effective: Anthony J Frew
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