Multicenter clinical trials on a novel polyherbal formulation in allergic rhinitis.

Allergic rhinitis is the most frequently occurring immunological disorder. It affects men, women and children and represents significant cost in terms of suffering and loss of productivity. Allergy is termed as an excessive reaction to an environmental allergen. Pollen, mold, dust, mite and animal allergens that contact the nasal or eye lining cause sneezing, nasal congestion and itchy, watery, swollen, red eyes. Although a broad spectrum of therapeutic options is available, the treatment of allergic rhinitis appears to be far from satisfactory. A novel polyherbal formulation (PF; Aller-7/NR-A2) comprising seven medicinal herbal extracts was assessed in a multicenter clinical trial involving 545 patients (321 males and 224 females) aged 18-59 years for 12 weeks to evaluate its clinical efficacy in patients suffering from allergic rhinitis. A total of 171 patients participated in double-blind, randomized, placebo-controlled studies in three centers, while 374 patients were included in the open-label studies in 11 centers. The three major symptoms (sneezing, rhinorrhea and nasal congestion) of allergic rhinitis were significantly reduced. Significant improvement was also observed in absolute eosinophil count, mucociliary clearance time, peak expiratory flow rate and peak nasal flow rate. No serious adverse events that warranted cessation of treatment were observed. Minor adverse effects were noted in both the treatment and placebo groups. Thus, this study demonstrates that Aller-7/NR-A2 is well tolerated and efficacious in patients with allergic rhinitis.

Prediction of airway responsiveness to allergen from skin sensitivity to allergen, airway responsiveness to histamine and serum IgE levels.

Immediate allergic reaction of the skin, non allergic airway responsiveness of the bronchi, and serum IgE levels were estimated in 25 atopic non asthmatic subjects and 15 controls. A good correlation was observed between these three parameters i.e. patients with positive skin response to allergen had increased airway responsiveness and significantly increased levels of serum IgE. However, the serum levels of IgE provided a significantly better indication of the likely presence of bronchial allergic reactivity than did the skin reactivity. The results indicate that knowledge of the airway responsiveness to histamine, skin sensitivity to allergen and serum IgE levels can predict the presence of airways responsiveness to an allergen. In all atopic non asthmatic individuals with a significant correlation between these parameters, the relevant allergen could stand identified as having the potential to provoke attacks of clinical asthma.

Histamine bronchoprovocation tests in subjects with gastro-oesophageal reflux disease.

The relationship of gastro oesophageal reflux (GER) with bronchial asthma has already been well documented in asthmatic subjects and it has been postulated that their asthma might have been caused by GER disease. Thus, it was planned to establish an association, if any, between GER and increased bronchial reactivity by histamine broncho provocation. The study was done in 25 GER disease patients and 15 controls. The difference in bronchial reactivity between the two groups was found to be significant (p less than 0.01). It was concluded that GER subjects expressed greater bronchial reactivity and it has been discussed that at a later stage of life they may be more prone to develop asthma.

Comparative study of capillary and arterial, blood gas values in plastic and glass syringes at various intervals in normal and asthmatic subjects.

Fifty-six normal healthy subjects and forty-four patients with bronchial asthma were subjected to capillary and arterial blood gas analysis. Arterial blood values were measured immediately and at two and four hours interval after storing the samples between 0-4 degrees C using glass and plastic syringes. It was observed that PO2 of arterial blood was significantly higher (P less than 0.001) than capillary PO2 values, while material of syringe and time interval of analysis did not make any significant alteration. PCO2 and pH values in arterial samples at various intervals and in different syringes were comparable in normal as well as in asthmatic subjects.