Abstract | OBJECTIVE: 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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Authors | Michael J Radcliffe, George T Lewith, Richard G Turner, Philip Prescott, Martin K Church, Stephen T Holgate |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 327
Issue 7409
Pg. 251-4
(Aug 02 2003)
ISSN: 1756-1833 [Electronic] England |
PMID | 12896934
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Allergens
- Cyclohexanols
- Protamines
- cyclohexane-1,3-diol
- Glucuronidase
|
Topics |
- Adult
- Allergens
(administration & dosage, immunology)
- Cyclohexanols
(administration & dosage)
- Desensitization, Immunologic
(methods)
- Double-Blind Method
- Female
- Glucuronidase
(administration & dosage)
- Humans
- Injections, Intradermal
- Male
- Poaceae
(immunology)
- Pollen
(immunology)
- Protamines
(administration & dosage)
- Quality of Life
- Rhinitis, Allergic, Seasonal
(therapy)
- Skin Tests
- Treatment Outcome
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