Use of autologous whole blood clot in the treatment of complex surgical wounds: a case series.

OBJECTIVE: Dehiscence and infection of hard-to-heal surgical wounds results in an increased risk of complications and mortality. A hard-to-heal surgical wound will present decreased levels of growth factors along with increased levels of debris and matrix metalloproteinases, resulting in the destruction of the extracellular matrix (ECM). ActiGraft (RedDress Ltd., Israel) is an autologous whole blood clot treatment, created at a point of care, to promote wound healing. We hereby present the efficacy of ActiGraft in a case series of hard-to-heal surgical wounds. METHOD: A registry study of patients with surgical wounds was conducted in private clinics and hospitals across the US and Israel (NCT04699305). Autologous whole blood clot was created at point of care using the patient's own blood. RESULTS: A total of 14 patients took part in the study. Autologous whole blood clot treatment resulted in a mean percent wound area reduction of 72.33% at four weeks, with 33.33% of wounds achieving complete closure by week 4. At week 12, 78.54% of the wounds achieved complete closure. CONCLUSION: Surgical wounds in patients with comorbidities may fail to initiate the natural wound healing mechanism which in turn may cause deterioration of the wound into a hard-to-heal stage. In this case series, autologous whole blood clot treatment was able to restore wound healing, avoiding the risk of infection and amputation of an affected limb. The properties of autologous whole blood clot as an ECM reduce the risk of infection, causing the wound to progress from the inflammatory phase to the proliferative phase. Autologous whole blood clot treatment in hard-to-heal surgical wounds was found to be an effective approach, reducing the risk of infection and promoting cell granulation, resulting in wound closure.

Utilization of a topical autologous blood clot for treatment of pressure ulcers.

Management and treatment of pressure ulcers (PUs) are met with great difficulty due to various factors that cause vulnerability of the soft tissue such as location, limited mobility, increased friction and shearing forces, as well as other comorbidities that may delay or halt wound healing. The topical autologous blood clot therapy (TABCT) is a point-of-care treatment used as a blood clot to assist in recreating and repairing the extracellular matrix (ECM). The mechanism of action consists of reconstruction of the ECM by incorporating into the ulcer, providing protection from further external destruction, while assisting in advancement through the wound healing phases via interaction of necessary growth factors, mediators, and chemokines. This study aims to assess the efficacy of the TABCT in the treatment of PUs in comparison to standard of care (SOC) treatment. Twenty-four patients, 18 years or older, with PUs ranging from stage 1 to 4, were included in this study. TABCT was created by using the patient's own peripheral blood in a point of care setting. Efficacy in percent area reduction (PAR) on weeks 4 and 12 with TABCT over SOC was assessed. Treatment using TABCT in PUs resulted in 77.9% of the patients achieving a 50% PAR on week 4. The mean PAR on week 12 was 96.23% with 45% of the wounds treated with TABCT achieving complete wound closure. TABCT exhibited efficacy in PAR of PUs. In addition, TABCT use prompted granulation tissue formation over vital structures, such as bone, which is often present in later stage PUs. The potential of bringing an affordable, cost-effective, advanced biologic bedside treatment that is efficacious in resolution of these complex wounds has the potential to drastically reduce the burden of treatment on the health system.

Innovative treatment utilizing an autologous blood clot for diabetic foot ulcers.

INTRODUCTION: Diabetic foot ulcer is a complex wound that requires considerable effort to restart a stalled healing process. In this study, a TABCT product was used in a point-of-care setting to treat DFUs by reconstructing the ECM and adjusting intricate phenotypes and mechanisms of mediators to progress towards complete healing. The mechanism of action consists of reconstruction of the ECM, which protects the wound area from further destruction while it incorporates into the ulcer to promote granulation over exposed vital structures (ie, tendons, bone, and neurovascular structures). OBJECTIVE: The authors evaluated the efficacy of the TABCT product in the management of DFUs. MATERIALS AND METHODS: Study participants were wound care patients in hospitals and clinics across the United States and Israel as part of a registry study (ClinicalTrials.gov: NCT04699305). Twenty-nine patients age 18 years or older with chronic DFUs were included. A blood clot was created using the patient's own peripheral blood in a point-of-care setting. An 18-mL blood sample was drawn from the patient and incorporated with calcium gluconate and kaolin to form a clot. Efficacy and superiority levels in PAR at week 4 and week 12 over the SOC treatment were established using the Agresti-Coull confidence interval. RESULTS: Treatment of DFUs using the TABCT product resulted in 22 patients (75.86%) achieving 50% PAR at week 4 and showed superiority when compared with SOC data in previously published studies. Complete closure was achieved in 28 wounds (95%) at week 12. CONCLUSION: In the current study, TABCT exhibited superiority over SOC treatment and provided granulation over vital structures with a reduction in overall wound size in a timely manner via incorporation and stimulation of the body's own healing capabilities.

Throat Spray With Blended Essential Oils Promotes Healthy Lung Function Among Women: A Randomized, Double Blinded, Placebo Controlled Clinical Trial.

INTRODUCTION: There are numerous internal and external environmental threats to lung health. Compromised respiratory health can affect a person's quality of life. This clinical trial evaluated the effects of Teramune Bronchus on lung health among healthy adult women. METHODS: The participants were women, aged 18 - 60 years old (n = 35). They sprayed either the proprietary essential oil based blended product (Teramune Bronchus) or a placebo into their throats 4-6 times per day during waking hours for 3 days. There was a baseline survey before using the spray and then follow-up data were collected at the end of day 3. The three primary outcomes for this study include a total bronchial symptom score, the chest domain in the Wisconsin Upper Respiratory Symptom Scale (WURSS), and subjective bronchial wellbeing. RESULTS: On day 3, the bronchial health of the participants who received the throat spray had significantly larger change scores when compared those with the placebo spray. All chest-related symptoms were resolved fully by the end of the trial for the participants who used Teramune. Participants using the intervention were almost twice as likely to say they felt better and believed the product helped them achieve lung health. CONCLUSION: This study provides evidence that the use of Teramune Bronchus supports respiratory health. Teramune Bronchus boosts respiratory health among healthy women through the use of plant-based essential oils.

Prevalence of endocrine disorders among children exposed to Lavender Essential Oil and Tea Tree Essential Oils.

Background: Lavender essential oil and tea tree essential oil have become popular ingredients in personal care and household products in recent decades. Questions regarding the safety of these oils in pediatric populations have been raised, proposing a link between these essential oils and endocrine disruption in children, specifically prepubertal gynecomastia. To date, no epidemiological studies have been conducted to evaluate this proposed link. Methods: This is a cross sectional study conducted among parents of children in the United States to identify the prevalence of endocrine disruption in children aged 2-15 years old. This study also evaluates the potential for a relationship between the exposure of lavender essential oil and tea tree essential oil products and endocrine disrupting outcomes. Results: In 556 children with a mean age of 6.33 (SD = 3.92), prevalence of endocrine disruption was .016 (SD = 0.13). No cases of prepubertal gynecomastia were identified in either group, and prevalence of precocious puberty, delayed puberty, growth hormone deficiency, and hypothyroidism were all consistent with population norms. Total risk of endocrine disorders among those exposed (0.0194) did not differ from the risk of those unexposed (0.0069). The risk ratio was 2.796 (95% CI: 0.352, 22.163, P = .458). Conclusion: Children who were regularly exposed to lavender or tea tree essential oils experienced the same risk of endocrine disorders as those who were not exposed.

Effects of antioxidant supplement on immune health and physical wellbeing: A randomized, controlled trial.

Background: Maintaining a healthy immune system came to the forefront of people's minds as SARS-CoV-2 (COVID-19) was introduced. Antioxidants contained in dark berries have been shown to support the physical wellbeing of otherwise healthy adults. Adding a supplement rich in dark berries and citrus essential oils contributes antioxidants to the body and serves as an aid to reduce free radicals. Aim: We evaluated the effects of an antioxidant rich supplement on immune health and overall physical wellbeing compared to a control group. Method: Participants were otherwise healthy adults, aged 18-60 years old, and were placed in either the antioxidant supplement group or control group using adaptive randomization. Data was collected at day 1 and 60. The Physical Health Questionnaire was used to measure the primary outcomes of this study. The immune health was reflected through the Jackson Symptom Scale. Results: 155 participants were analyzed. Participants who consumed the antioxidant beverage saw improvements to overall health which dramatically exceeded those of the control group. The sleep domain produced improvements which represented disturbances in sleep habits as they pertain to general health. Those in the supplement group who reported illness, had illnesses lasting 1-2 days while those in the control group had illnesses lasting from 1 to 9 days. Conclusion: Length of illness was shorter and sleep duration improved in the supplement group compared to the control group. Daily consumption of 60 ml of the antioxidant drink NingXia RedⓇ showed significant improvement after 60 days.

Aromatherapy blend of thyme, orange, clove bud, and frankincense boosts energy levels in post-COVID-19 female patients: A randomized, double-blinded, placebo controlled clinical trial.

BACKGROUND: A large proportion of individuals who have recovered from an acute COVID-19 infection continue to experience symptoms months later. Post-acute COVID-19 (long-haul COVID-19) can range from serious complications to quality of life symptoms such as fatigue or insomnia. The purpose of this study was to evaluate the potential for inhalation of essential oils to improve energy levels among otherwise healthy female survivors of acute COVID-19 who experience a lack of energy more than five months after recovery. This study was conducted in the United States in late 2021. METHOD: This was a randomized double blind, placebo controlled trial to evaluate the potential for inhalation of Longevity™, a proprietary essential oil blend manufactured by Young Living Essential Oils (Lehi, Utah, USA), on energy levels among female survivors of COVID-19 who continue to experience fatigue more than 5 months recovery from the acute infection. Forty women were randomized to two groups: intervention and placebo. Both groups inhaled the assigned product twice daily for fourteen consecutive days. Fatigue scores were measured using the Multidimensional Fatigue Symptom Inventory (MFSI). Secondary outcomes included scores on each of the MFSI's ten subscales. RESULTS: Individuals who inhaled the essential oil blend for 2 weeks had significantly lower fatigue scores after controlling for baseline scores, employment status, BMI, olfactory function, and time since diagnosis, with a large effect size (F (1,39) = 6.15, p = .020, partial eta squared = 0.198). Subscale analysis identified subscales of vigor, as well as global, behavioral, general, and mental fatigue as benefiting from the intervention. This study provides evidence that a proprietary aromatherapy blend can significantly improve energy levels among women who are experiencing fatigue after recovering from COVID-19.

Effects of Sesame Consumption on Inflammatory Biomarkers in Humans: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

OBJECTIVES: Existing evidence produces conflicting findings regarding the effect of sesame intake on inflammatory biomarkers; this knowledge gap has yet to be met through systematic review and meta-analysis. This meta-analysis of randomized, controlled clinical trials (RCTs) was conducted to evaluate the effects of sesame consumption on markers of inflammation in humans. METHODS: PubMed, Scopus, and the Cochrane Database of Systematic Reviews were searched through August 2020 to identify relevant papers for inclusion. Using the random-effects model, data were evaluated as weighted mean differences (WMD) with 95% confidence intervals (CI). Cochrane's Q and I-squared (I 2) tests were used to identify within-studies heterogeneity. RESULTS: Seven RCTs with 310 participants (157 intervention and 153 control) were included in the meta-analysis. Sesame consumption reduced serum level interleukin-6 (IL-6) (WMD - 0.90; 95% CI (-1.71, -0.09), I 2 = 80.4%) compared to the control group. However, sesame intake had no significant effects on C-reactive protein (CRP) and tumor necrosis factor-α (TNF-α) compared to the control group. Subgroup analysis identified a reduction in serum CRP, TNF-α, and IL-6 concentration among studies with participants who had a higher level of these biomarkers at baseline, those which used sesamin capsules, and those with a bigger sample size, those conducted in Asia, and studies on females. CONCLUSION: Sesame consumption reduced serum levels of IL-6 but did not affect CRP and TNF-α in humans. Additional trials should be conducted utilizing a larger and longer treatment duration, along with studies using different sesame formulations (capsule, oil, and seed) and conducting on participants with varied health conditions.

The Effects of Sesame Consumption on Glycemic Control in Adults: A Systematic Review and Meta-Analysis of Randomized Clinical Trial.

OBJECTIVES: In recent years, diabetes has become a global health problem that creates a tremendous economic burden for many countries. Clinical trials evaluating the hypoglycemic effects of sesame consumption have produced conflicting results. This systematic review and meta-analysis was conducted to evaluate the effectiveness of sesame as a popular natural herb on glycemic indices in adults. METHODS: The search for related articles in PubMed, Scopus, Google Scholar, and Cochrane library was conducted through May 2021. Results were reported as weighted mean differences (WMD) with 95% confidence intervals (CI) using a random-effects model. RESULTS: A total of 605 studies were identified through online searching, and a total of eight RCTs representing 382 participants were included in this study. The meta-analyses revealed that sesame consumption significantly decreases serum fasting blood sugar (FBS): (WMD: -28.23 mg/dl; 95% CI (-39.16, -17.13), I 2 = 97.6%; 95% CI (96, 98)), and hemoglobin A1c (HbA1c): (WMD: -1.00%; 95% CI (-1.11, -0.88), I 2 = 0%; 95% CI (0, 79)) as compared to the control group. CONCLUSION: This study provides evidence of the hypoglycemic effects of sesame consumption, particularly in diabetic patients. Additional RCTs on sesame and its preparations should be conducted in different populations to increase generalizability.

Recall and Interviewer Bias in Parental Report of Pediatric Exposure to Aromatic Plant Ingredients in Personal Care Products: Development and Validation of a More Accurate Approach.

Lavender and tea tree essential oils are traditionally considered to be mild, gentle, and safe for pediatric populations and are ubiquitous in personal care products. Recent case reports have proposed a potential association between exposure to these ingredients and endocrine disruption, but these reports contain misclassification bias. The purpose of this study is to develop a reliable and valid measurement instrument for the accurate classification of exposure to aromatic plant ingredients in personal care products to be used in epidemiological studies. This study tested the Aromatic Plant Ingredients and Child Health Survey (APICHS) for validity and reliability, contrasting it with the current approach used in clinician's offices. The APICHS was found to have exceptional sensitivity and specificity (100% and 92.86%, respectively) with a positive predictive value of 97.22%, far exceeding the sensitivity and specificity of the method currently in use. The APICHS is a valid, reliable tool for accurate classification of exposure to aromatic plant ingredients in personal care products and should be used for the avoidance of misclassification.

Effect of Persian acupressure (Ghamz) on Patients with Knee Osteoarthritis: A Single-Blinded Parallel Clinical Trial.

BACKGROUND: Many patients choose complementary and alternative medicine (CAM) to treat various conditions. Among osteoarthritis patients, acupressure is a popular CAM treatment. In Iran, Ghamz (a Persian acupressure technique) uses for musculoskeletal ailments like knee pain. AIMS: To examine the potential efficacy of Ghamz on osteoarthritis outcomes. DESIGN: Clinical Trial. SETTINGS: Randomized, single-blind, sham-controlled clinical trial. PARTICIPANTS/SUBJECTS: Eighty patients with diagnosed knee osteoarthritis, age over 35 years old. METHODS: Eighty adult patients with confirmed knee osteoarthritis from three outpatient clinics were recruited. Participants were randomly assigned either to intervention or placebo groups using sham acupressure. The primary outcomes included Knee injury and Osteoarthritis Outcome Score (KOOS) parameters and pain scores measured using the visual analog scales (VAS). RESULTS: Seventy-two individuals completed the trial and were included in the analysis. At baseline, there was no difference between the mean scores of both outcomes. After the intervention, the group receiving Ghamz therapy experienced an improvement in KOOS parameters, including symptoms, pain, activity daily livings, sport, recreation function, and quality of life. The mean pain score in the intervention group was significantly decreased from 5.89 at the beginning study to 4.11 at the end of the study, while the pain score did not change substantially in the sham group. These findings remained consistent after adjusting for covariates of age, weight, and pre-treatment. CONCLUSIONS: This study supports evidence that Ghamz therapy provides an effective option for short-term knee pain relief in patients with knee osteoarthritis. Additional studies are recommended to confirm these findings.

The effect of vitamin D supplementation on fibroblast growth factor-23 in patients with chronic kidney disease: A systematic review and meta-analysis.

This is a meta-analysis of randomized controlled trials (RCTs) investigating the effects of oral vitamin D supplementation on serum fibroblast growth factor-23 (FGF23) concentrations in patients with chronic kidney disease (CKD). Manuscripts were extracted from PubMed/MEDLINE, Scopus, and ISI Web of Science through February 2020. Subgroup analyses, sensitivity analysis, and meta-regression assessments were performed. A total of eight clinical trials with nine treatment arms were included in the final analysis. The pooled results showed no significant changes in circulating FGF23 following vitamin D supplementation compared to the control group (Standardized mean difference (SMD): 0.24; 95% confidence intervals (CIs): -0.03 to 0.50, p > 0.05). Subgroup analyses found that studies which had participants with a body mass index (BMI) higher than 25 kg/m2 , with an intervention duration shorter than 15 weeks, using phosphate binder medications, and trials that were on both patients with CKD undergoing hemodialysis and patients without hemodialysis treatment produced significant increases in FGF23 when concentration compared with the control group. This meta-analysis provides evidence that vitamin D supplementation does not have a significant effect on plasma FGF23 levels. However, further high-quality trials are required to identify the influence of oral vitamin D supplementation on FGF23 levels in patients with CKD.

Daily supplementation with aronia melanocarpa (chokeberry) reduces blood pressure and cholesterol: a meta analysis of controlled clinical trials.

BACKGROUND & OBJECTIVES: Cardiovascular disease is a leading cause of morbidity and mortality in the United States. Dietary supplements, such as those rich in antioxidants, have the potential to improve markers of cardiovascular health, but little is known about the total effect of these supplements. The purpose of this analysis is to identify the effect size of supplementation with aronia berry extracts and to evaluate how age may influence these effects. METHODS: This analysis included a literature review of controlled trials evaluating the effects of daily aronia berry supplementation for an average of 6-8 weeks on the outcomes of total cholesterol and blood pressure. Three distinct analyses were conducted: systolic blood pressure, diastolic blood pressure, and total cholesterol. The moderator of age was evaluated for each of the three outcome measures. RESULTS & CONCLUSION: Daily supplementation with aronia berry extracts for 6-8 weeks significantly reduces systolic blood pressure, which is a key risk factor for cardiovascular disease, as well as total cholesterol. These effects are most significant in adults over the age of 50 years. Supplementation with aronia berry is a safe and effective way to reduce total cholesterol and systolic blood pressure, with even larger effects among adults over the age of 50 years.

The relationship between lavender and tea tree essential oils and pediatric endocrine disorders: A systematic review of the literature.

OBJECTIVES: Essential oils are common ingredients in personal care products, little is known about the effects of chronic exposure to these ingredients in human health. It has been suggested that these two essential oils cause prepubertal gynecomastia and premature thelarche in children. The purpose of this study was to systematically review the evidence related to the proposed link between these essential oils and endocrine disruption METHODS: This study sought to investigate the proposed link between LEO and TTEO and endocrine disrupting outcomes by identifying and evaluating the clinical evidence regarding this topic. Studies qualified if the participants included prepubertal children who have experienced either prepubertal gynecomastia or premature thelarche. The Case Series Critical Appraisal Tool (CSCAT) was used to identify the reliability of the identified case series. The potential for evidence of causality was evaluated using the tool proposed by Murad. RESULTS: A total of four manuscripts were identified, describing a total of eleven cases reported to have experienced both the exposure and the outcome. Reporting of inclusion, demographic data, clinical data, and the potential for causality was found to be insufficient. This study did not find evidence to support the claim that tea tree essential oil is related to endocrine disruption in children, and little to no evidence to substantiate the proposed link between lavender essential oil and endocrine disruption in children. CONCLUSION: Because this potential link remains a concern among pediatric care providers and parents, epidemiological research to address the proposed link is needed.

The Effects of Aromatherapy on Premenstrual Syndrome Symptoms: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

ObjectivesPremenstrual syndrome (PMS) is a common disturbance among women of childbearing age. Aromatherapy is a commonly used form of complementary and alternative medicine (CAM) to treat PMS. The purpose of this study is to quantify and summarize the effects of aromatherapy on premenstrual syndrome symptoms. Methods. PubMed, Scopus, and Cochrane Library databases were searched through relevant search terms until October 2020. The effect sizes were pooled as weighted mean difference (WMD) and 95% confidence interval (CI) using the random effect model. Egger tests and visual inspection of the funnel plot were performed to identify the existence of publication bias. The I-squared (I 2) test was applied to measure heterogeneity. Results. Eight studies (n = 8) were included in this analysis. The quantitative synthesis of evidence found that aromatherapy decreases PMS scores (WMD -13.83; 95% CI (-22.04, -5.63), I 2 = 94.5%), total psychological symptoms of PMS (WMD -3.51; 95% CI (-4.84, -2.18), I 2 = 82.6%), anxiety of PMS (WMD-1.78; 95% CI (-3.17, -0.38), I 2 = 94.2%), depression of PMS (WMD-2.0; 95% CI (-3.65, -0.34), I 2 = 93.7%), and fatigue of PMS (WMD - 1.44; 95% CI (-2.44, -0.44), I 2 = 89.7%) compared to the control group. Conclusion. Aromatherapy is an effective tool for the relief of PMS symptoms. Additional randomized controlled clinical trials with different durations and essential oils should be conducted to confirm our findings.

Aromatherapy reduces fatigue among women with hypothyroidism: A randomized placebo-controlled clinical trial.

Background This randomized, blinded, placebo-controlled clinical trial identifies the effect of an aromatherapy blend of essential oils on fatigue, which is one of the most commonly unaddressed symptoms of hypothyroidism, by evaluating the effects of daily aromatherapy inhalation. Methods Participants included women aged 18-55 with a diagnosis of hypothyroidism. Women who had a history of thyroid cancer were excluded, due to the confounding effects of cancer on fatigue as the outcome of interest. Participants were randomized into two groups: the aromatherapy group, treated with inhalation of the essential oil blend, and the control group, treated with an odorless vegetable oil blend. The primary outcome was change from baseline in fatigue scores as measured by the Multidimensional Fatigue Symptom Inventory (MFSI), a validated instrument which measures multiple patterns of fatigue. Results After adjusting for baseline scores, no significant difference was found between the aromatherapy group and the control group at midpoint. Both groups experienced a reduction in symptoms during the first week of the intervention. At the endpoint, participants in the aromatherapy group had improved fatigue scores across all ten subscales, as compared to the control group. Not all improvements achieved statistical significance, indicating that the aromatherapy treatment has a greater effect on the subscales of global, affective, and general fatigue. Conclusions This is the first study to evaluate the effects of aromatherapy on fatigue among women with hypothyroidism. These findings provide evidence that regular inhalation of an aromatherapy blend may reduce fatigue among women with hypothyroidism, particularly in the areas of global, affective, and general fatigue.

Bergamot Aromatherapy for Medical Office-Induced Anxiety Among Children With an Autism Spectrum Disorder: A Randomized, Controlled, Blinded Clinical Trial.

This randomized, blinded clinical trial evaluated the effects of aromatherapy on medical office-induced anxiety in children with an autism spectrum disorder. Patients awaiting office visits were randomized into an aromatherapy group and a control group. After adjusting for baseline scores, there was no significant difference between the 2 groups.

Black elderberry (Sambucus nigra) supplementation effectively treats upper respiratory symptoms: A meta-analysis of randomized, controlled clinical trials.

Upper respiratory symptoms are often treated with over the counter drugs, antibiotics, and antiviral medications. Due to concerns about safety and efficacy, there is a demand for an alternative solution. Black elderberry (Sambucus nigra) has been used to treat cold and flu symptoms, but there are no large-scale studies or meta-analyses. This meta-analysis quantifies the effects of elderberry supplementation and evaluates moderators including vaccination status and the underlying pathology. This analysis included a total of 180 participants and evaluates moderators such as vaccination status and cause of the upper respiratory symptoms. Supplementation with elderberry was found to substantially reduce upper respiratory symptoms. The quantitative synthesis of the effects yielded a large mean effect size. These findings present an alternative to antibiotic misuse for upper respiratory symptoms due to viral infections, and a potentially safer alternative to prescription drugs for routine cases of the common cold and influenza.