Effects of a topical botanically-enriched salve on cutaneous oxygenation.

OBJECTIVE: There is a medical need to evaluate new treatments that may improve wound healing. This study aimed to determine if Original Healing Salve (OHS, Puremedy, Inc.) a topical, botanically-enriched salve (BES), changes distal leg tissue oxygenation in people with type 2 diabetes. METHOD: A randomised, controlled, crossover, double-blinded clinical trial comparing changes in cutaneous oxygen delivery (mean TcPO2) on multiple sites of the lower extremity following application of a botanically-enriched topical salve, as compared with application of the salve's base in patients with type 2 diabetes. Subjects were recruited from the general population as a convenience sample. RESULTS: A total of 16 participants were recruited. Analysis of the primary outcome demonstrated no statistically significant difference in TcPO2 at 30 minutes postapplication when comparing the BES to the base salve (BS) on the leg (-0.39±8.54mmHg; p=0.86). Analyses of secondary outcomes at 30 minutes postapplication indicated that mean TcPO2 was significantly higher than preapplication levels among subjects receiving both the BES (3.70±6.62mmHg; p=0.04) and BS on the leg (4.08±5.21mmHg; p=0.007). On the foot, mean TcPO2 at 30 minutes postapplication was higher in the BES compared with the BS, this difference was not significant (0.98±8.59mmHg; p=0.66). Mean TcPO2 was higher than preapplication levels among subjects receiving both the BES (1.21±7.70mmHg; p=0.54) and BS on the foot (2.19±7.27mmHg; p=0.25). These differences were non-significant. CONCLUSION: These findings support consideration of topical treatments containing botanical ingredients to increase cutaneous oxygen delivery in the lower extremity in patients with type 2 diabetes.

Impact of a Short-Term Naturopathic Whole-Foods-Based Nutrition Education Intervention on Dietary Behavior and Diabetes Risk Markers: A Pilot Study.

OBJECTIVE: To assess the feasibility of measuring the health impacts of a 12-week naturopathic whole foods nutrition education course among adults with or at risk for prediabetes. DESIGN: A pilot nonrandomized pre-post intervention design investigated physiological changes associated with participation in a 12-week structured naturopathic nutrition education course. Follow-up measures were assessed at 6 and 12 months from baseline. SETTINGS/LOCATION: Three community-based kitchens in Oregon. SUBJECTS: Forty-five adults with or at risk for prediabetes. INTERVENTION: Twelve weekly 90-min workshops emphasizing the health benefits of a naturopathic whole foods diet and including collective meal preparation and communal dining. OUTCOME MEASURES: Changes in biomarkers of diabetes and cardiovascular disease risk, including high-sensitivity C-reactive protein (hs-CRP), hemoglobin A1c, insulin, and lipids, and changes in dietary behaviors at baseline, postintervention (12 weeks), and 6- and 12-month follow-up. Changes in biomarkers and food consumption patterns were assessed using linear mixed models with random intercept, including data from all participants who completed the end-of-intervention assessment. RESULTS: Pre-post intervention results for 45 participants showed decreases in blood glucose and hs-CRP. Food frequency questionnaire data showed decreases in daily servings of grain, dairy, and fat postintervention. Decreases in blood glucose, hs-CRP, triglycerides, cholesterol, low-density lipoprotein, very-low-density lipoprotein, and HbA1c from baseline were observed at 12-month follow-up. Both insulin and high-density lipoprotein were decreased from baseline and 12-week levels at the 6-month follow-up but increased from all earlier levels at 12 months (all p < 0.0001). Daily servings of meat, dairy, and fat remained decreased at 6-month follow-up. Reduced grain consumption observed at 12-week and at 6-month follow-up was not sustained, and increased at 12 months, although still decreased from baseline. CONCLUSIONS: Results suggest that this naturopathic nutrition education series may promote dietary behavior change with associated changes in clinical biomarkers. Larger controlled studies are needed to confirm these results.

In vivo effects of Ashwagandha (Withania somnifera) extract on the activation of lymphocytes.

OBJECTIVE: This study investigated the immunologic effects of Ashwagandha (Withania somnifera) on four types of immune cells in a human sample to determine the immunologic mechanism. DESIGN: Five (5) participants consumed 6 mL of an Ashwagandha root extract twice daily for 96 hours. Ashwagandha was administered with anupana (whole milk). Peripheral blood samples were collected at 0, 24, and 96 hours and compared for differences in cell surface expression of CD4, CD8, CD19, CD56, and CD69 receptors by flow cytometry. RESULTS: Significant increases were observed in the expression of CD4 on CD3+ T cells after 96 hours. CD56+ NK cells were also activated after 96 hours as evidenced by expression of the CD69 receptor. At 96 hours of use, mean values of receptor expression for all measured receptor types were increased over baseline, indicating that a major change in immune cell activation occurred across the sample. CONCLUSIONS: Effects on immune cell activation with use of Ashwagandha warrant further study.