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Clinical Trial
. 2003 Aug 2;327(7409):251-4.
doi: 10.1136/bmj.327.7409.251.

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

Michael J Radcliffe  1 , George T Lewith, Richard G Turner, Philip Prescott, Martin K Church, Stephen T Holgate
Affiliations
Clinical Trial

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

Michael J Radcliffe et al. BMJ. .

Abstract

Objective: To assess the efficacy of enzyme potentiated desensitisation in 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 a history 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, each comprising 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 fungal spores; cat and dog danders; dust and storage mites) in a total volume of 0.05 ml of buffered saline. Placebo: two injections of 0.05 ml buffered saline solution.

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

Results: The active treatment group and the placebo group did not differ in the proportion of problem-free days, quality of life scores, symptom severity scores, change in quantitative skin prick provocation threshold, or change in conjunctival provocation threshold. No clinically significant adverse reactions occurred.

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

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Figures

Fig 1
Fig 1
Flow diagram showing the numbers of participants at the different stages of the study. DNA=did not attend
Fig 2
Fig 2
Proportion of symptom-free days each week by treatment group over the 12 weeks of the study
Fig 3
Fig 3
Mean overall quality of life score by treatment group for weeks 1 to 12 of the study
Fig 4
Fig 4
Means of the average symptom scores for weeks 1 to 12 for the two treatment groups, adjusted by analysis of covariance
See this image and copyright information in PMC

Comment in

References

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