Allergy, Sinustitis and Hayfever

Those suffering with allergic conditions exhibit a predominantly TH2 profile which implies more inflammatory IL-4 secretion and hence greater release of IgE. In testing this hypothesis, 24 individuals with allergic rhinitis/sinusitis were given the sterol/sterolin mixture over a 12- week period and found to have significant reductions in their objective- (e.g. reduced rhinorrea, post-nasal drip, nasal turbinate hypertrophy, IgE levels) and subjective clinical symptoms. Moducare has also been tested on allergic symproms in children where peak nasal flow rate was measured to show how Moducare affected allergy induced rhinitis, rhino-sinusitis and sinusitis. In just six months of Moducare use improvements were seen.

Scientific Abstract on Moducare use in Allergies

Reference: Myers, L and Bouic, PJD. Flow cytometric analysis of the TH1-TH2 shift in allergic individuals using Moducare® (sterols/sterolins). Proc. 26th Annu Cong Physiol Soc S. Afr. 1998; Abstract 178.

Study: A placebo-controlled blinded pilot study was performed on 24 atopic individuals (mainly pollen sensitivity) over a 12- week period. To determine whether the balance between TH1 and TH2 CD4 cells differs between allergic and non-allergic individuals, several laboratory and clinical markers of activity were measured. Four groups were followed: allergic persons were given either placebo or active Moducare® capsules and the lymphokine profile was determined at baseline and again 4 weeks later. A group of non-allergic persons serving as controls was similarly formed. Blood lymphocytes were analysed using flow cytometry.

Results: It was shown that allergic persons exhibited significantly raised IL4 containing CD4+ cells at the start of the study when compared to the non-allergic control group. The intake of Moducare® induced a significant decrease in IL4 in both allergic as well as in the control groups. It was interesting to note that, unlike the allergic persons, the non-allergic controls receiving the sterols/sterolins capsules increased their IFN-y CD4+ cells after 4 weeks of therapy. Statistically significant changes occurred with the allergic iindividuals in the following: less rhinorea, less turbinate hypertrophy, less post nasal drip symptoms, lower IgE plasma levels and higher TH1 producing cells. Subjective improvements were reported by the patients themselves when use of an international questionnaire was made to record patient symptoms.

Clinical Summary: The TH1-TH2 response in allergic individuals appears perturbed then compared to that of healthy, non-allergic controls. Moducare® appears to decrease the synthesis of IL4 in allergic persons as well as in healthy controls.

Scientific Abstract on Moducare use in Allergies in Children

Reference: Aivazis, V et al Aristotle University of Thessaloniki, Greece Clinical and laboratory changes at children with allergic rhinitis after 6 months treatment with combination of beta-sitosterol and beta-sitosterol glucoside EAACI 2008 barcelona June 11th 2008 Poster Session - Treatment Options in Rhinitis/Rhinosinusitis (913)

Study: This study took place between May and December 2007. The aim was to investigate the affect of the combination of beta-sitosterol (BSS*) and beta-sitosterol glucoside (BSSG*) at children who suffered from allergic rhinitis.

Methods: 30 children-19 boys and 11 girls- with mean age 10,33±3,71 years who had allergic rhinitis according to the ISAAC criteria and at least double value of total IgE immunoglobulin were included. All children received treatment with 1 caps BSS*/BSSG* 3 times a day for 6 months. Before starting and at the end of the treatment all children had clinical examination and won a clinical score (0-4) according to their symptoms (nasal obstruction, rhinorroia, sneezing, itching). All children had measurements of Peak Inspiratory Flow Rate (PIFR), Peak Nasal Inspiratory Flow Rate (PNIFR) using Youlten rhinomanometer, total IgE immunoglobulin, determination of blood eosinophils and eosinophils of nasal secretion. The statistic analysis was performed using SPSS.

Results: The mean of the clinical score was 3,06±0,83 at the beginning and 1,23±0,86 at the end of the treatment (p<0,01). The mean of PIFR at the beginning and at the end of the study was 220,17±85,48 l/min and 253,34±87,58 l/min respectively (p<0,001). The mean of PNIFR was 123,33±52,03 l/min and after 6 months of treatment was 144,67±72,05 l/min (p=0,014). The number of blood eosinophils was 525,56±324,89 at first and 397,83±222,98 at the end (p=0,032). Finally, the eosinophils of the nasal secretion decreased from 25,6±16% to 16,12±13,5% (p=0,018) at the end of the treatment with BSS*/BSSG*.The total IgE immunoglobulin decreased at 13 out of the 30 children of our study (43,3%) while the others presented a stability or a small increase in their IgE levels.

Clinical Summary: The findings of this study prove the improvement of the children's clinical features and their better evolution after 6 months of treatment with BSS*/BSSG*.The medicine which includes the previously mentioned combination has been well accepted from the children without any complications .The results of the study are encouraging for BSS*/BSSG* when tested to children with major symptoms of allergic rhinitis. More intense study and further attendance of the patients, though, is necessary for the best possible evaluation and to concluding in safer conclusions.