Early evidence of efficacy for orally administered SPM-enriched marine lipid fraction on quality of life and pain in a sample of adults with chronic pain.

BACKGROUND: Marine lipids contain omega-3 fatty acids that can be metabolized into anti-inflammatory and pro-resolving mediators-namely 17-HDHA and 18-HEPE-which can serve as modulators of the pain experience. The purpose of this study was to determine the impact of 4 weeks of oral supplementation with a fractionated marine lipid concentration, standardized to 17-HDHA and 18-HEPE, on health-related quality of life and inflammation in adults with chronic pain. METHODS: This study was a prospective, non-randomized, open-label clinical trial. Forty-four adults with ≥ moderate pain intensity for at least 3 months were recruited. The primary outcome was change in health-related quality of life (QOL) using the Patient Reported Outcomes Measurement Information System-43 Profile (PROMIS-43) and the American Chronic Pain Association (ACPA) QOL scale. Exploratory outcomes assessed safety and tolerability, changes in anxiety and depression, levels of pain intensity and interference, patient satisfaction, and impression of change. Changes in blood biomarkers of inflammation (hs-CRP and ESR) were also explored. RESULTS: Outcome measures were collected at Baseline, Week 2, and Week 4 (primary endpoint). At Week 4, PROMIS-43 QOL subdomains changed with significance from baseline (p < 0.05), with borderline changes in the ACPA Quality of Life scale (p < 0.052). Exploratory analyses revealed significant changes (p < 0.05) in all measures of pain intensity, pain interference, depression, and anxiety. There were no statistically significant changes in either hs-CRP or ESR, which stayed within normal limits. CONCLUSION: We conclude that oral supplementation with a fractionated marine lipid concentration standardized to 17-HDHA and 18-HEPE may improve quality of life, reduce pain intensity and interference, and improve mood within 4 weeks in adults with chronic pain. The consistency and magnitude of these results support the need for placebo-controlled clinical trials of marine lipid concentrations standardized to 17-HDHA and 18-HEPE. Trial registration ClinicalTrials.gov: Influence of an Omega-3 SPM Supplement on Quality of Life, NCT02683850. Registered 17 February 2016-retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02683850 .

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.

Design of a Multidisciplinary Training Program in Complementary and Integrative Health Clinical Research: Building Research Across Interdisciplinary Gaps.

Despite wide use by the public, limited evidence is available for many complementary and integrative health (CIH) practices. Thus, clinical researchers knowledgeable about CIH disciplines are necessary to study the efficacy and effectiveness of CIH practices to benefit the public health. To partially address the need for clinical researchers versed in CIH, the authors of this study report the design of an interprofessional clinical research training program focused on CIH, the Building Research across Interdisciplinary Gaps (BRIDG) program, supported by a 5-year T90/R90 grant from the National Center for Complementary and Integrative Health. The T90-supported arm of the program trains doctoral-level CIH providers in clinical research at the research-intensive University of Washington. The R90-supported arm of the program trains researchers with conventional backgrounds in the practices of CIH at the clinic-intensive National University of Natural Medicine. The "Translational Science Spectrum" provides a common conceptual framework for both programs. Specific program elements include: individualized didactic training in clinical research and CIH disciplines; placement with clinical research mentors; placement with clinical mentors in CIH disciplines; shared and independent research project development; and interdisciplinary experiences through seminars and retreats. Program evaluation includes annual completion of the Clinical Research Appraisal Inventory (CRAI), which queries confidence in research skills and methods and periodic evaluation of training elements using the Supplemental Kellogg Logic-World Health Organization model, which emphasizes relevance, adequacy, efficiency, effectiveness, process, impact, equity, and sustainability. The BRIDG program exemplifies a new standard in interprofessional clinical research training, made possible through strong collaboration between disparate research- and clinically intensive institutions.

Direct moxibustion to treat spleen qi and yang deficiency fatigue: a pilot study.

Limited research suggests that indirect moxibustion may be beneficial for treating fatigue, but no studies to evaluate direct moxibustion have been conducted in the United States. Thus, we explored the usefulness of four outcome measures for evaluating the effectiveness of direct moxibustion for patients with spleen qi and yang deficiency fatigue (SQYDF). Eleven female volunteers, ages 25-60 years, were enrolled. Three to five rice grains in thread-sized moxa cones were burned on 11 acupuncture points once per week for 8 weeks. Eight participants completed the study. The most common adverse events (AEs) were temporary worsening of fatigue, lightheadedness, and headache. Symptomatic improvement was seen on the SF-36 energy/fatigue scale (p=0.003), SF-36 social function scale (p=0.008) and Flinders fatigue scale (p=0.014). The skin conductance at acupoints showed no consistent diagnostic baseline meridian patterns. Heart rate variability data showed an improved low frequency/high frequency (LF/HF) ratio in three of four participants. Direct moxibustion is safe in patients with SQYDF. The Flinders Fatigue Scale (FFS) and the SF-36 are useful outcome measures for evaluating the effects of direct moxibustion, and the heart rate variability (HRV) may be, but the skin conductance did not correlate with SQYDF diagnosis or with symptomatic improvement.