Clinical and immunological effects of a treatment with desentizating low-dose multicomponents in IgE mediated and non IgE mediated food allergies: observational retrospective pilot study.

BACKGROUND: Alimentary allergy has high impact on the quality of life (Qol) of patients and their families: it represents an economic burden for individuals and National Health System. The disease, particularly frequent in pediatric age, recognizes different pathogenetic mechanisms and expresses itself through the production of IgE (IgE mediated form) antibodies or through cell-mediated immunune responses (non IgE mediated forms). The aim of this clinical observational retrospective study is to evaluate the effect of a long-term treatment with Low Dose Medicine (LDM) drugs in pediatric patients affected by IgE and non IgE mediated food allergy. OBJECTIVE: The purpose of the study is to determine the efficacy of the treatment with Allergy Plex (Guna Laboratory, Milan, Italy) to induce clinical and/or immunological tolerance both to IgE mediated and non IgE mediated food allergy; the secondary endpoint is to investigate the treatment tolerability, the reduction of positivity to Skin Prick test and Patch test to food allergens and the decrease on the peripheral blood of the specific IgE to food allergens. The treatment efficacy was measured through a clinical score. METHODS: In this study the immunomodulant activity of Allergy Plex 13, Allergy Plex 7 and Allergy Plex 10 (Guna S.p.A., Milano, Italy) was evaluated. In every patient the state of allergical clinical responses and the immuno-allergological state were evaluated by means of specific parameters letting know the regulatory response to the allergical Th fenotype. RESULTS: Data about Clinical tolerance to food, Symptomatological clinical score, ECP, ACTH, Cortisol; IL-4, IL-10 was collected. There was evidence of improvement of clinical score, reduction of the diameter of cutaneous pomphus obtained through the Prick test and a decrease of IgE specifics values. CONCLUSIONS: The data issued from this study seem to confirm the efficacy of treatment with Allergy Plex in allowing the restoration of immune tolerance and the definite reduction of the clinical score.

Long-term treatment with low-dose medicine in chronic childhood eczema: a double-blind two-stage randomized control trial.

BACKGROUND: The efficacy of low-dose medicine (LDM) in childhood mild/moderate eczema is not known. We conducted a double-blind, two-stage, randomized, placebo-controlled clinical trial, lasting 23 months, to address this issue. METHOD: Eighty children with chronic mild/moderate eczema were randomly allocated to Group A (placebo) or Group B (treatment group; Galium-Heel®, a low-dose multicomponent medicine based upon natural substances; Guna-Interleukin 12 and Guna-Interferon-γ administered twice a day for six non-consecutive months for each stage). LDM is characterized by the use of biological molecules, such as cytokines, neuropeptides, growth factors, hormones at very low concentrations, which correspond to physiological levels within the human body. The dosage of the cytokines used in this trial (IFN-γ and IL-12) is 10 fg/ml. The SCORAD index was evaluated by the same operator: subjects with a SCORAD index below 20 were considered to have mild eczema (61/80; mean: 10.79), whereas a SCORAD index between 20-50 indicated moderate eczema (19/80; mean: 26.84). The data of 66/80 children were analyzed in stage 1 and those of 62/66 children in stage 2. The primary outcome measure was reduction of eczema severity assessed by the SCORAD index. Secondary outcomes were disease-free interval, and treatment safety and tolerability. RESULTS: The decrease in disease severity was greater in Group B than in Group A already in stage 1 (a decrease 63.9% versus 53.2%), but the difference was not significant (p = 0.16). Moreover, subjective symptoms (itching and sleep disturbances) initially decreased and then worsened in Group A, whereas itching decreased linearly and sleep disturbances decreased significantly (p=0.049) in Group B. CONCLUSIONS: Preliminary evidence suggests potential benefit, but further work is needed to validate this approach. TRIAL REGISTRATION: The trial was registered with EudraCT number 2010-018640-13 through the database of the National Clinical Trials Monitoring Centre Database (Osservatorio delle Sperimentazioni Cliniche, OsSC) of the Italian Medicines Agency.

Immunomodulating treatment with low dose interleukin-4, interleukin-10 and interleukin-11 in psoriasis vulgaris.

Psoriasis is a chronic inflammatory skin disease affecting approximately 2-3 percent of the world population; it is characterised by hyperproliferation and hyperplasia of the superficial layers of the epidermis. Inappropriate signals released by the immune system determine an altered keratinocyte differentiation, resulting in the formation of desquamating, thickened, inflamed and erythematous plaques. The aim of this investigation was to study the pharmacological activity and safety of three low dose cytokines, Guna-Interleukin 4, Guna-Interleukin 10 and Guna-Interleukin 11 at the concentration of 10 fg/ml in patients affected by moderate to slight psoriasis vulgaris. The multicenter, double-blind, randomized, placebo-controlled clinical trial involved 48 patients who were enrolled and followed up according to a 8-month experimental project. All patients received, according to a cross-over model, either the experimental treatment or placebo, alternatively. Globally, in the 41 evaluated patients it was observed a PASI significant reduction (Friedman test: p=0.00960). The DLQI too decreased significantly in all subjects compared to baseline (Friedman test: p=0.00007). The safety of the treatment with three low dose cytokines administered simultaneously was proved; no adverse event was reported during the whole trial.