ABSTRACT
Background: As an anti-inflammatory and antioxidant, sodium pyruvate significantly reduces inflammatory cytokines and oxygen radicals such as interleukin (IL) IL-6, IL-8, Monocyte Chemoattractant Protein-1, and hydrogen peroxide. Thus, sodium pyruvate holds promise as a treatment for many respiratory diseases, including allergic rhinitis (AR). Novel treatments for AR are needed as current medications, including steroids, often fail to treat severe symptoms. Methods: The data from five human clinical studies were analyzed to determine the effect of 20 mM sodium pyruvate nasal spray (N115) in patients with AR. Nasal inflammation scores were compared to a placebo control or a no-treatment baseline control. Three studies were open-labeled and two were appropriately blinded to both patients and clinicians using computer randomization of subjects. Results: The intranasal administration of sodium pyruvate significantly improved nasal inflammation scores in all five clinical trials of patients with AR (p < 0.0001 in all trials). Conclusions: These results give credence to the overall ability of sodium pyruvate, administered by nasal spray, to treat inflammation of the nasal airways.
Subject(s)
Rhinitis, Allergic, Seasonal , Rhinitis, Allergic , Humans , Administration, Inhalation , Administration, Intranasal , Inflammation/drug therapy , Nasal Sprays , Pyruvates/therapeutic use , Rhinitis, Allergic/drug therapy , Rhinitis, Allergic, Seasonal/drug therapy , Sodium/therapeutic useABSTRACT
OBJECTIVE: To evaluate the combination of rhubarb, astragalus, red sage, ginger, and turmeric (mixture referred to as "NT") together with gallic acid for evidence of reproductive toxicity in rats. METHODS: Fifty virgin female rats were cohabited with male rats. Day 0 of potential pregnancy was evidence of spermatozoa on vaginal smear. The presumably pregnant rats were randomized to five groups of 10 individuals and were fed by daily gavage on days 6-20 of presumed gestation with one of the following: deionized water placebo, 21.6 mg/kg per day, 215 mg/kg per day, 430 mg/kg per day, or 860 mg/kg per day of a mixture of NT (20%) and gallic acid (80%). Cesarean section was performed on day 21. RESULTS: All 50 rats had one or more live fetuses and survived until they were killed. Body weight was reduced in the 860 mg/kg per day group compared with placebo: mean (SD), 406.8 (23.0) vs. 430.1 (27.7) g, P<0.05. There were no dose-related adverse events or differences between groups in uterine size, food intake, corpora lutea, implantations, litter size, number of live fetuses, and gender distribution of fetuses or fetal resorptions. There were no dead fetuses, and all placentae appeared normal. All rats and tissues were normal at necropsy. Fetal weights did not differ between groups, and there were no fetal abnormalities. CONCLUSION: The combination of NT and gallic acid gave no evidence of reproductive toxicity at 430 mg/kg per day or below, which is reassuring should this combination be used in the future as a dietary herbal supplement for the treatment of obesity.
Subject(s)
Gallic Acid/toxicity , Plant Preparations/toxicity , Pregnancy, Animal/drug effects , Animals , Astragalus Plant/toxicity , Curcuma/toxicity , Female , Zingiber officinale/toxicity , Male , Pregnancy , Rats , Rheum/toxicity , Salvia officinalis/toxicityABSTRACT
The objective of this study was to test the safety and efficacy of NT, a dietary herbal supplement made from rhubarb, ginger, astragulus, red sage, and turmeric, combined with gallic acid (GA) to reduce food intake and cause weight loss. A total of 105 healthy subjects, 18-60 years old with a body mass index of 25-35 kg/m(2) and on no chronic medication, were randomized to a 300 mg/1.2 g NT-GA combination, a 600 mg/2.4 g NT-GA combination, or placebo in three divided doses daily for 24 weeks. Food intake was measured at baseline and 2 weeks, and safety parameters were followed regularly. Pharmacokinetic studies of a 200 mg/800 g NT-GA combination and 800 mg GA alone were performed with and without food. There was no dose-related weight loss or reduction in food intake at the 8-week analysis, and the study was terminated early. Pharmacokinetic studies showed plasma levels of GA did not increase above 10 microM and were not dose-related. The NT-GA at all concentrations was well tolerated, but was ineffective in causing weight loss or in suppressing food intake. Pharmacokinetics suggested that GA plasma levels were limited by oral absorption, and may be the reason for lack of efficacy.
