The mountain cedar model in clinical trials of seasonal allergic rhinoconjunctivitis.

BACKGROUND: Clinical trials of seasonal allergic rhinoconjunctivitis use the mountain cedar (Juniperus ashei) season as the predominate model. OBJECTIVE: To evaluate clinical trials of rhinoconjunctivitis using mountain cedar, to present analysis of pollen counts during 18 seasons, and to discuss the model. METHODS: The medical literature was searched for clinical trials performed using mountain cedar either in or out of season. Pollen counts were recorded and analyzed for the duration of 18 seasons. RESULTS: Thirty-eight trials were identified. Of these, 1 evaluated onset of allergy, 8 were immunotherapy trials, 28 were pharmaceutical clinical trials, and 1 studied symptoms elicited in a pollen challenge chamber trial. Many generic equivalency trials are unreported. In the 18 years of counts in the Texas Hill Country, a dependable and intense pollen density was present in every season. The combination of dependable seasons without confounding pollens, the large number of allergic patients, and the ability to concentrate resources in one geographic area has made mountain cedar allergy a mainstay for therapeutic trials for allergic rhinoconjunctivitis. CONCLUSION: Mountain cedar allergy presents a dependable and durable model of allergic rhinoconjunctivitis.

Early neutral prebiotic oligosaccharide supplementation reduces the incidence of some allergic manifestations in the first 5 years of life.

BACKGROUND: A mixture of neutral prebiotic oligosaccharides has been shown to reduce the incidence of atopic dermatitis (AD) and allergy associated symptoms during the first 2 years of life. OBJECTIVE: To evaluate if this protective effect against allergy lasted beyond the intervention period until 5 y of age. METHODS: In a prospective, double blind, placebo-controlled fashion, healthy term infants at risk of atopy were fed either a prebiotic-supplemented (0.8 g/100 ml scGOS/lcFOS) or placebo-supplemented (0.8 g/100 ml maltodextrin) hypoallergenic formula during the first 6 mo of life. Following this intervention period, follow-up continued until 5 y of life. The present study evaluated (i) the cumulative incidence of allergic manifestations during 5 y, and (ii) the prevalence of allergic and persistent allergic manifestations at 5 y. Monitored allergic manifestations were AD, recurrent wheezing, allergic rhinoconjunctivitis and urticaria. RESULTS: Ninety-two children (50 in placebo group, 42 in intervention group) completed the 5-y follow-up. The 5-y cumulative incidences of any allergic manifestation and atopic dermatitis were significantly lower in the scGOS/lcFOS group (30.9, 19.1 %, respectively) compared to placebo group (66, 38 %, respectively) (p< 0.01 and< 0.05). Children in the scGOS/lcFOS group tended to have a lower incidence of allergic rhinoconjunctivitis, and allergic urticaria (4.8 vs 16% for both manifestations, p=0.08). There was no difference in the cumulative incidence of recurrent wheezing. With regard to the prevalences at 5 y, intervention group had significantly lower prevalence of any persistent allergic manifestation and rhinoconjunctivitis (4.8, 2.4 %, respectively) compared to placebo (26, 14 %, respectively) (p < 0.01 and =0.05). Prevalence of persistent AD tended to be lower in the intervention group (2.4 vs 12%, p= 0.09). Although intervention group had 75% reduction in the prevalence of persistent wheezing (4.8 vs 14 %), no significance was shown. CONCLUSION: Oligosaccharide prebiotics (scGOS/lcFOS), when started early in life have a protective effect against allergic manifestations in high risk infants. The protection lasts beyond infancy until 5 y of life, for AD and allergic rhinoconjunctivitis. Long-term follow-up studies in larger populations are warranted to evaluate the potential preventive effect of this mixture on asthma.