Jacques Rene Snyman

Randomized, parallel-group, double-blind, controlled study to evaluate the efficacy and safety of carbohydrate-derived fulvic acid in topical treatment of eczema

Background The 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. Methods In 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. Results All 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. Conclusion CHD-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.

Potentiated clinoptilolite: artificially enhanced aluminosilicate reduces symptoms associated with endoscopically negative gastroesophageal reflux disease and nonsteroidal anti-inflammatory drug induced gastritis

Purpose The cation exchanger, a potentiated clinoptilolite (Absorbatox™ 2.4D), is a synthetically enhanced aluminosilicate. The aim of this study was to evaluate the possible benefits of a potentiated clinoptilolite as a gastroprotective agent in reducing the severity of clinical symptoms and signs associated with 1) endoscopically negative gastroesophageal reflux disease (ENGORD) and 2) nonsteroidal anti-inflammatory drug (NSAID) medication. Methods and patients Two randomized, double-blind, placebo-controlled, pilot studies, the ENGORD and NSAID studies, were conducted. After initial negative gastroscopy, a total of 25 patients suffering from ENGORD were randomized to receive either placebo capsules or 750 mg Absorbatox twice daily for 14 days. The NSAID study recruited 23 healthy patients who received orally either 1,500 mg Absorbatox or placebo three times daily, plus 500 mg naproxen twice daily. Patients underwent gastroscopic evaluation of their stomach linings prior to and on day 14 of the study. Gastric biopsies were obtained and evaluated via the upgraded Sydney system, whereas visible gastric events and status of the gastric mucosa were evaluated via a 0–3 rating scale. During both studies, patients recorded gastric symptoms in a daily symptom diary. Results In the ENGORD study, patients who received the potentiated clinoptilolite reported a significant reduction (P≤0.05) in severity of symptoms including reduction in heartburn (44%), discomfort (54%), and pain (56%). Symptom-free days improved by 41% compared to the group who received placebo (not significant). This was over and above the benefits seen with the proton pump inhibitor. In the NSAID study, the reduction in gastric symptom severity was echoed in the group who received the potentiated clinoptilolite. Treatment with the potentiated clinoptilolite resulted in significant prevention (P≤0.05) of mucosal erosion severity as graded by the gastroenterologist. Conclusion Absorbatox is a nonabsorbable aluminosilicate with potential gastroprotective benefits as it protected against ENGORD symptoms and NSAID-induced gastric events. The exact mechanism of action is not clear but may be due to its binding to hydrogen ions and biologically active amines and nitrates.

Phase 1 clinical study of the acute and subacute safety and proof-of-concept efficacy of carbohydrate-derived fulvic acid

Background The purpose of this research was to determine the acute and subacute safety and proof-of-concept efficacy of carbohydrate-derived fulvic acid (CHD-FA). Methods In 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. Results Safety parameters remained constant throughout the trial. A significant decrease in skin prick test results was observed. Conclusion No 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.

Clinical efficacy of potassium humate in the treatment of allergic rhinitis : double-blind placebo-controlled trial

The anti‐inflammatory properties of products that contain high levels of humic acid, such as peat, sapropeles, and mumie, are well described. The aim of this study was to establish the clinical efficacy of brown coal‐derived potassium humate, as in vivo animal models had suggested similar efficacy of humate to prednisolone. In this double‐blind, placebo‐controlled study, atopic volunteers were recruited and randomized to placebo or 1.8 g potassium humate/day (three divided dosages) when they presented with hay fever. The efficacy parameters used were skin‐prick tests for wheal and flare reactions, nasal smears for inflammatory cell accumulation, and cytokine levels. Patients also filled out daily symptom score cards to determine efficacy against symptoms of hay fever. Potassium humate resulted in a significant decrease in wheal and flare reactions as well as nasal eosinophil counts. These findings were supported by similar changes (not significant) in cytokine levels. Changes in symptom scores did not reach significance. This proof of concept study clearly demonstrated the potential of potassium humate in the treatment of inflammatory conditions such as hay fever. Drug Dev Res 71:358–363, 2010.

Potentiated clinoptilolite reduces signs and symptoms associated with veisalgia.

Introduction Abundant 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. Methods Blood 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. Results Absorbatox™ had no effect on blood alcohol levels, but it significantly reduced the symptoms and signs of veisalgia by approximately 40%–50%. Conclusion This 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.

Potassium Humate Reduces Inflammation and Clinically Improves the Outcomes of Patients with Osteoarthritis of the Knee

This research was financially supported by Unique Health Trust and a grant from the South African National Research Foundation (NRF).

Carbohydrate-derived fulvic acid wellness drink: its tolerability, safety and effect on disease markers in pre-ART HIV-1 positive subjects

Background: Many people take wellness drinks on a daily basis to enhance physical and emotional well-being. The safety and/or efficacy of these are not always known or even established in the populations likely to consume these. The safety, tolerability and clinical impact of CHD-FA in a formulated wellness drink (F0210) (a pure and novel fulvic acid) were researched in a pre-ART HIV-1 positive population in India an area where patients are known to use organic acids such as fulvic acids (Shilajit) for health enhancement. Methods: This double-blind, placebo-controlled, parallel study recruited 332 patients (n = 166 on active; n = 166 on placebo). The study outcomes recorded safety and tolerability data, as well as the time to ART and/or the time to a decrease in CD4 count of 100 cells/mm3 for subjects in each treatment group. Change in immune status is an important clinical endpoint. The secondary outcomes were CD4 count, HIV-1 viral load changes and quality of life (the latter as a further proxy for tolerability). Results: The only notable side effect of the active medication was gastrointestinal intolerance such as diarrhoea, nausea and vomiting, which were more frequently experienced compared with placebo. The study was terminated before full recruitment due to regulatory changes in India and at the time of study termination there were too few clinical study endpoints reached to demonstrate any clinical difference between active and placebo treatments (no difference in hazard of experiencing an event (reaching indication for ART) between groups; p = 0.5724). An interesting trend was that patients’ CD4 counts in the study demonstrated a slower than anticipated decline compared with trends recorded in the literature for natural progression of disease. Conclusion: The CHD FA wellness drink is well tolerated in an ART-naive study population and does not negatively affect the disease-specific parameters and hence does not adversely affect the natural progression of the HIV-1 disease or patients’ general health. Further exploration of fulvic acids is therefore warranted.

Dextropropoxyphene: is there still a therapeutic role? - YES

Dextropropoxyphene is classified as a weak opioid along with others such as codeine and tramadol.1 Like all opioid drugs, dextropropoxyphene has a dose-related efficacy and toxicity profile.