Efficacy and safety of high-doses sublingual immunotherapy in ultra-rush scheme in children allergic to grass pollen.

BACKGROUND: Although sublingual immunotherapy (SLIT) has been used with increasing frequency, the data on the efficacy of SLIT in pediatric asthma are limited. AIM: The aim of our study was to evaluate the efficacy and the safety of high-dose SLIT given pre-seasonally and co-seasonally in an ultra-rush scheme in children with bronchial asthma allergic to grass pollen. METHODS: Fifty children with asthma, aged 6-17, sensitive to grass pollen, participated in the 2-year prospective, randomized, double-blind, placebo-controlled trial, to investigate the efficacy and safety of SLIT (Staloral 300 IR, Stallergenes SA, 25 microg major allergens) as a standardized extract of five grass pollen with ultra-rush induction. RESULTS: SLIT significantly improved asthma symptom scores (41% vs. placebo group), reduced nasal symptoms (25% vs. placebo group) and the use of rescue medications (10% vs. placebo group), improved forced expiratory volume in 1 s, but had no effect on ocular symptoms, nasal hyper-reactivity, peak expiratory flow and forced expiratory volume between 25% and 75% of vital capacity. Serum levels of immunoglobulin E and IgG4 did not change after SLIT. After the second season of SLIT, an improvement in bronchial hyperresponsiveness was observed; however, compared with placebo, this effect was not significant. Among all subjects in SLIT group, predominantly local reactions have been recorded in 59% of subjects in the first year of treatment and in 35% in the second. CONCLUSIONS: Our study indicated that high-dose ultra-rush, co-seasonal SLIT given for 2 years, was safe and reduced a multiple symptom-medication score.

Efficacy of 12 weeks supplementation of a botanical extract-based weight loss formula on body weight, body composition and blood chemistry in healthy, overweight subjects--a randomised double-blind placebo-controlled clinical trial.

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of composite extracts in reducing weight, as the main outcome measure. Secondary measures of the study were body composition change. DESIGN: Randomised, double blind, placebo-controlled clinical trial. SETTING: Tertiary university clinic. SUBJECTS: hundred and five subjects, 5 of them withdrawn consent, 2 drop-outs not related to study preparation. INTERVENTION: two tablet per meal concept supposed to generate a "psychological" therapy-like approach during 12 weeks supported by measured physical activity. The tablets 1 (one hour before meals, comprises extracts of Asparagus, Green tea, Black tea, Guarana, Mate and Kidney beans) and 2 (taken half an hour after meals, comprises extracts of Kidney bean pods, Garcinia cambogia, and Chromium yeast) are taken twice daily with two main meals. RESULTS: A significant change of the Body Composition Improvement Index (BCI) was observed in the active extract group compared to placebo (p = 0.012). Weight, BMI, waist-to-hip ratio was not statistically different between groups. Body fat loss was greater in active group (p = 0.011) compared to placebo. A weight loss parameter corrected for exercise was introduced and found to be higher in active group (p = 0.046) than in placebo, meaning that the formula was more efficacious, due to a concurrently performed exercise program--a recommended strategy for life style modification. CONCLUSIONS: A significant change of the Body Composition Improvement Index and the decrease in body fat was statistically significant in active extract subjects compared to placebo. A change in some outcome measures like: weight, BMI failed to produce significant difference between groups.

Differential metabolism of arachidonic acid in nasal polyp epithelial cells cultured from aspirin-sensitive and aspirin-tolerant patients.

The mechanism of aspirin (acetylsalicylic acid [ASA]) sensitivity associated with severe asthma and chronic rhinosinusitis with nasal polyps ("aspirin triad") has been attributed to arachidonic metabolism alternations, although the putative biochemical defects have not been elucidated. The aim of this study was assessment of the hypothesis that local production of eicosanoids in the respiratory epithelium in patients with ASA-sensitive asthma/rhinosinusitis (ASARS) differs from that of ASA-tolerant patients with rhinosinusitis (ATRS). Nasal polyps were obtained from 10 patients with ASARS and 15 with ATRS during routine polypectomies, and epithelial cells (ECs) were cultured on bovine collagen type I matrix (Vitrogen 100), in medium supplemented with growth factors. The generation of eicosanoids in supernatants of confluent ECs (6 to 8 d of culture; purity > 98%) was quantified by immunoassays. Unstimulated ECs from ASARS patients generated significantly less prostaglandin E(2)(PGE(2)) compared with ATRS (0.8 +/- 0.3 versus 2. 4 +/- 0.5 ng/microg double-stranded deoxyribonucleic acid [dsDNA], respectively), although a similar relative increase in response to calcium ionophore and inhibition with ASA was observed in both groups. Basal levels of 15-hydroxyeicosatetraenoic acid (15-HETE) were not different between groups, and calcium ionophore enhanced its production to a similar extent. However, cells incubation with 200 microM ASA for 60 min resulted in a significant increase (mean +359%) in 15-HETE generation only in ASARS patients, whereas no effect of ASA on 15-HETE generation in ATRS patients was observed. PGF(2alpha) generation was similar in both groups, and no significant generation of PGD(2) or leukotriene C(4) (LTC(4)) was observed in epithelial cell cultures from either group. Our results indicate that nasal polyps ECs from ASA-sensitive patients have significant abnormality in basal and ASA-induced generation of eicosanoids which may be causally related to the mechanism of ASA sensitivity.

[Changes in serum calcium level in rats as the effect of administration of fenarimol]. / Zmiany poziomu wapnia w surowicy krwi szczurów jako efekt dzialania fenarimolu.

The Ca2+ concentration in rats serum after intragastrically fenarimol administration (doses 1/40, 1/20 and 1/10 LD50) during 5 days was investigated. The significant decrease of Ca2+ concentration in serum after 3 and 5 days of fenarimol administration was observed.