Effectiveness, safety and tolerability of a complex homeopathic medicinal product in the prevention of recurrent acute upper respiratory tract infections in children: a multicenter, open, comparative, randomized, controlled clinical trial

Background: The present study was initiated to investigate the effectiveness, safety and tolerability of complex homeopathic CalSuli-4-02 tablets on prevention of recurrent acute upper respiratory tract infections (URTIs) in children, in comparison to another complex homeopathic product. Methods: The study was designed as a prospective, multicenter, randomized, open, clinical trial with two parallel treatment groups at four outpatient pediatric clinics in Russia. Children aged <= 6 years with susceptibility to acute URTIs (>= three occasions during the last 6 months) were randomized to receive either CalSuli-4-02 or a comparator homeopathic product (control group) for 3 weeks. Primary outcome was the frequency of acute URTIs after 3 and 6 months post-treatment follow-up. Secondary endpoints were changes in complaints and symptoms (total and individual scores), treatment satisfaction, antibiotic use, safety and tolerability. Results: The intention-to-treat analysis involved 200 children (CalSuli-4-02: N = 99, Control: N = 101). In both treatment groups, the median number of acute URTIs was one for 3 months and two, respectively, for the full 6 months post-treatment (Relative Risk: 0.86 (95 %-CI: 0.72-1.03), p = 0.1099). Seasons had no influence on the outcome. At the end of study, CalSuli-4-02 had overall higher odds of getting lower complaints severity total score (Odds ratio: 1.99 (95 %-CI: 1.31-3.02), p = 0.0012) and showing symptom improvement (Odds ratio: 1.93 (95 %-CI: 1.25-3.00), p = 0.0033). Specifically, the complaint "appetite disorder" and the symptom "child's activities" significantly improved more in the CalSuli-4-02 group (p = 0.0135 and p = 0.0063, respectively). Antibiotic use was decreased in both treatment groups at the study end. Overall assessment for satisfaction with and tolerability of treatment was higher with CalSuli-4-02. A low number of non-serious adverse drug reactions was reported (CalSuli-4-02: N = 4, Control: N = 1). Conclusions: Both complex homeopathic products led to a comparable reduction of URTIs. In the CalSuli-4-02 group, significantly less URTI-related complaints and symptoms and higher treatment satisfaction and tolerability were detected. The observation that the use of antibiotics was reduced upon treatment with the complex homeopathic medications, without the occurrence of complications, is interesting and warrants further investigations on the potential of CalSuli-4-02 as an antibiotic sparing option

Treatment tactics for functional disorders of the gastrointestinal tract in infants

Functional disorders of the gastrointestinal tract (GIT) represent one of the most common problems in newborns. These conditions have a common distinctive feature: clinical symptoms are manifested in the absence of any organic changes in the GIT (structural abnormalities, inflammatory changes, infections or tumors) or metabolic disorders

Prevention and prediction of food allergy in children in the antenatal and postnatal periods

According to different authors, the rates of food allergy range from 4 to 7,5% in a pediatric population. The paper presents the current aspects of the prevention and prediction of food allergy in infants in the antenatal and postnatal period. Identification of babies at increased risk of allergic reactions allows appropriate prevention before birth. The efficiency of primary prevention increases when the specific features of the immune status and immune reactions in the neonatal period are considered in babies with a family history of allergy. The postnatal risk factors of allergy include maternal non-compliance with hypoallergenic and elimination diets during lactation; smoking; late attachment to the breast; formula feeding, early use of age-inappropriate complementary foods; frequent viral and parasitic infections, and chronic infection foci. The basic principles in the antenatal prevention of food allergies are laid down, which include a balanced diet in a healthy pregnant woman; a hypoallergenic diet in a pregnant woman with allergic disorders; improvement of the environment; and creation of hypoallergenic living conditions. Postnatal prophylaxis is to limit excessive neonatal drug therapy and early bottle-feeding, and to prevent viral infections

POLYMORPHIC VARIANTS OF THE GENE OF INTERFERON LAMBDA 3 AND FEATURES OF IMMUNE RESPONSE IN CHILDREN WITH CHRONIC VIRAL HEPATITIS C

To study the immune manifestations of the interferon-lambda 3 genepolymorphism in chronic viral hepatitis C, 110 Russian children (54 girls and 56 boys) with chronic HCV infection aged from 3 to 17 years were examined. All children were on combined therapy (pegylated interferon + ribavirin). It was found that among the studied polymorphic variants of the IFN-λ 3 gene in children with chronic HCV infection, T allele of the marker rs12979860 is associated with infection and chronization of HCV. The T/T rs12979860 genotype of the IFN-λ3 gene is unfavorable for the course of chronic HCV infection due to low levels of activated T-lymphocytes, intactness of the proinflammatory cytokines TNF-α, IL-6, IL-1α, and interferon-γ inducible protein IP-10. The revealed relation of the polymorphic variants of C/C + C/T locus rs12979860 of INF-λ3 gene with the expression of activated T-lymphocytes discloses the protective nature of these genotypes to the development of chronic HCV infection in children

Delayed Immunological Effects of the Acute Radiation Syndrome

Objective. From 237 cases of ARS registered after Chornobyl 134 diagnoses were confirmed. The rest of 103 exposed were regarded as non-confirmed ARS (ARS-0) due to the absence of supportive diagnostic materials or other reasons. Long-term follow-up was performed of 192 survivors who are citizens of Ukraine. Methods. Delayed immunologic effects were studied in 57 ARS grade 0-III survivors 20 years after exposure. Cellular immunity was studied by peripheral blood mononuclear cells and early progenitors subset analysis, p53, bcl2, Bax, CD95 expression, spontaneous and verapamil-induced apoptosis, proliferation tests with Con A, microbial and tissue antigens; oxidative status was studied by MDA, catalase, SOD, β-glucosidase, β-galactosidase activity, antioxidant factor, lipid peroxidation, GSH and ceruloplasmin concentration. Results. Combined radiation induced immune deficiency was demonstrated as the early changes with a period of recovery of 7 to 20 years depending of the exposure dose. In ARS-0 and 1 wavy variations of basic immunity parameters were shown with the tendency to normalization. In ARS-1 and 2 (group doses: 1,34; 1,75 Sv) we registered normal mean parameters of T- and B-cell subsets and oxidative status except of ceruloplasmin. Low expression was shown for CD123w antigen. Immune function deviations were demonstrated in activation tests and induced apoptosis. In ARS-3 (mean dose: 5,6 Sv) a marked immune system deficiency was demonstrated at the group levels (low CD4+, NK-cell counts, high CD8+ with significantly smaller cytotoxic T-cell subset) accompanied with low oxidative stress markers and significantly higher MDA and GSH. Analysis of confounding factors such as endocrine and nervous systems influence and blood viral infections carriage showed a prevalent role of the radiation exposurel a marked dose-effect dependency remained at the late period at individual and group levels. Number of TCR-variant cells correlated with the decreased immune function. Radiation-induced depression of immunity was characterized by the non-stability of CD34+ cells with presence of committed primitive early progenitors not capable for terminal differentiation and apoptosis. High proliferative activity and accumulation of CD34+ cells as an adaptive reaction to radiation exposure in combination with the decreased apoptosis, cytotoxic and NK-cell activity could be the basis for radiation-induced oncologic effects