BackgroundThe purpose of this study was to evaluate the efficacy and safety of carbohydratederived fulvic acid (CHD-FA) in the treatment of eczema in patients two years and older.MethodsIn this single-center, double-blind, placebo-controlled, parallel-group comparative study, 36 volunteers with predetermined eczema were randomly assigned to receive either the study drug or placebo twice daily for four weeks.ResultsAll safety parameters remained within normal limits, with no significant differences in either group. Significant differences were observed for both severity and erythema in the placebo and CHD-FA treated groups, and a significant difference was observed for scaling in the placebo-treated group. With regard to the investigator assessment of global response to treatment, a significant improvement was observed in the CHD-FA group when compared with the placebo group. A statistically significant decrease in visual analog scale score was observed in both groups, when comparing the baseline with the final results.ConclusionCHD-FA was well tolerated, with no difference in reported side effects other than a short-lived burning sensation on application. CHD-FA significantly improved some aspects of eczema. Investigator assessment of global response to treatment with CHD-FA was significantly better than that with emollient therapy alone. The results of this small exploratory study suggest that CHD-FA warrants further investigation in the treatment of eczema.

BackgroundThe purpose of this research was to determine the acute and subacute safety and proof-of-concept efficacy of carbohydrate-derived fulvic acid (CHD-FA).MethodsIn this double-blind study, 30 male volunteers with predetermined atopy were randomly assigned to either Group A or Group B, each consisting of 15 participants. In part 1 of the study, the groups were administered increasing amounts of CHD-FA, ranging from 5 mL to 40 mL, provided that no adverse events had occurred at the previous dosage. In part 2, Group A participants received 20 mL of 3.8% CHD-FA twice daily for 3 days and were monitored for a week. Because no adverse events occurred, Group B received 40 mL of 3.8% CHD-FA twice daily for a period of 3 days. In part 3, both groups received either 40 mL of 3.8% CHD-FA or placebo twice daily for a period of one week, followed by a one-week washout period before crossover to the alternative treatment schedule. Parameters used to establish safety were electrocardiography, a physical examination, a health questionnaire, and hematology and biochemistry, determined at baseline, during regular calculated intervals, and at the end of each part of the study. A skin prick test was done as part of the screening process and, from the result, the allergen the participant was most allergic to was then selected, along with the positive histamine and negative control to be repeated at the start and end of each respective stage.ResultsSafety parameters remained constant throughout the trial. A significant decrease in skin prick test results was observed.ConclusionNo severe adverse events occurred, establishing that CHD-FA to be safe at doses up to 40 mL twice daily for a week and that at this dosage CHD-FA acts as an anti-inflammatory agent. These findings confirm earlier animal data.

A pilot study was done to determine if potassium humate, a natural substance derived from brown coal, with known anti-inflammatory properties, is safe and effective in reducing pain and inflammation in osteoarthritis of the knee. This was conducted as a randomized, double-blind, placebo-controlled, single centre, cross-over. Participants were enrolled for a total of 14 weeks, starting with an initial 1-week washout period, after which they were randomly assigned to either potassium humate or lactose, administered orally for 6 weeks at a dosage of 600mg three times daily. Following another 1-week washout period, participants were crossed over to the other treatment for another 6 weeks. Participants were not permitted the use of anti-inflammatory medications. Paracetamol was allowed as rescue medication for the duration of the trial. The primary efficacy variable were the WOMAC™ scores (visual analogue version) for pain, stiffness, physical function and total score and health related issues using the RAND 36 levels, rescue medication use, adverse effects and tolerability. 28 participants were enrolled and 21 participants successfully completed the protocol. A carry-over effect in the stiffness subscale was observed. There was a significantly greater clinical benefit with potassium humate over placebo with reduction in all the WOMAC subscale scores for pain. After adjusting for baseline, potassium humate showed a greater reduction in hs-CRP levels when compared to placebo. Tolerability was good for all groups. Safety parameters remained unchanged, except for an increase in the GGT-levels (n=4 in potassium humate group, n=2 in the placebo group). Levels of GGT returned to baseline within 2 weeks of discontinuation of therapy. In conclusion, potassium humate showed possible benefit over placebo in patients with OA of the knee, with a statistically significant reduction in hs-CRP levels. The small sample size and the carry-over effect limited further interpretation of data.

IntroductionAbundant anecdotal evidence for products claiming to reduce veisalgia after alcohol overindulgence are available on the Internet and as many advertisements in journals. None of these claims are, however, substantiated by research. The aim of this research was to ascertain the validity of such claims for the substance Absorbatox™, a potentiated aluminosilicate (cation exchanger able to bind NH4+, histamine, and other positively charged ions) by investigating the signs and symptoms, as well as blood or breath alcohol levels, in healthy volunteers.MethodsBlood or breath alcohol levels were measured in all volunteers in initial controlled experiments, and symptoms were scored on a diary card for gastrointestinal tract symptoms, as well as other symptoms such as headache and light sensitivity. Eighteen volunteers completed the initial blood alcohol study, which investigated the effect of Absorbatox™ on blood alcohol levels after fasting. The follow-up studies researched the effects of the symptoms and signs of alcohol overindulgence. The “night out” study was completed by ten volunteers in a typical controlled environment, which was followed by the real-life four-leg crossover study. In the crossover study, volunteers (number =25 completers) had to fill matching diary cards to containers of two placebo and two active drugs after a night out where they themselves decided on the container (color coded) to be used and the amount of alcohol to be consumed.ResultsAbsorbatox™ had no effect on blood alcohol levels, but it significantly reduced the symptoms and signs of veisalgia by approximately 40%–50%.ConclusionThis research indicates that Absorbatox™ does not have an effect on blood- or breath-alcohol levels. Furthermore, treatment with Absorbatox™ resulted in an overall significant reduction in central nervous system and gastrointestinal tract symptoms associated with veisalgia, warranting further investigation.

Background: The anti-inflammatory properties of products which contain high levels of humic