Healthcare Costs and Healthcare Utilization Outcomes of Vitamin D3 Supplementation at 5000 IU Daily during a 10.9 Month Observation Period within a Pragmatic Randomized Clinical Trial.

Vitamin D insufficiency has been linked to multiple conditions including bone disease, respiratory disease, cardiovascular disease, diabetes, and cancer. Observational studies indicate lower healthcare costs and healthcare utilization with sufficient vitamin D levels. The secondary aims of our previously published pragmatic clinical trial of vitamin D3 supplementation were comparisons of healthcare costs and healthcare utilization. Comparisons were made between the vitamin D3 at 5000 IU supplementation group and a non-supplemented control group. Costs of care between the groups differed but were not statistically significant. Vitamin D3 supplementation reduced healthcare utilization in four major categories: hospitalizations for any reason (rate difference: -0.19 per 1000 person-days, 95%-CI: -0.21 to -0.17 per 1000 person-days, p < 0.0001); ICU admissions for any reason (rate difference: -0.06 per 1000 person-days, 95%-CI: -0.08 to -0.04 per 1000 person-days, p < 0.0001); emergency room visits for any reason (rate difference: -0.26 per 1000 person-days, 95%-CI: -0.46 to -0.05 per 1000 person-days, p = 0.0131; and hospitalizations due to COVID-19 (rate difference: -8.47 × 10-3 per 1000 person-days, 95%-CI: -0.02 to -1.05 × 10-3 per 1000 person-days, p = 0.0253). Appropriately powered studies of longer duration are recommended for replication of these utilization findings and analysis of cost differences.

Remote and semi-automated methods to conduct a decentralized randomized clinical trial.

Introduction: Designing and conducting clinical trials is challenging for some institutions and researchers due to associated time and personnel requirements. We conducted recruitment, screening, informed consent, study product distribution, and data collection remotely. Our objective is to describe how to conduct a randomized clinical trial using remote and automated methods. Methods: A randomized clinical trial in healthcare workers is used as a model. A random group of workers were invited to participate in the study through email. Following an automated process, interested individuals scheduled consent/screening interviews. Enrollees received study product by mail and surveys via email. Adherence to study product and safety were monitored with survey data review and via real-time safety alerts to study staff. Results: A staff of 10 remotely screened 406 subjects and enrolled 299 over a 3-month period. Adherence to study product was 87%, and survey data completeness was 98.5% over 9 months. Participants and study staff scored the System Usability Scale 93.8% and 90%, respectively. The automated and remote methods allowed the study maintenance period to be managed by a small study team of two members, while safety monitoring was conducted by three to four team members. Conception of the trial to study completion was 21 months. Conclusions: The remote and automated methods produced efficient subject recruitment with excellent study product adherence and data completeness. These methods can improve efficiency without sacrificing safety or quality. We share our XML file for researchers to use as a template for learning purposes or designing their own clinical trials.

Vitamin D3 Supplementation at 5000 IU Daily for the Prevention of Influenza-like Illness in Healthcare Workers: A Pragmatic Randomized Clinical Trial.

Vitamin D supplementation has been shown to reduce the incidence of acute respiratory infections in populations at risk. The COVID-19 pandemic has highlighted the importance of preventing viral infections in healthcare workers. The aim of this study was to assess the hypothesis that vitamin D3 supplementation at 5000 IU daily reduces influenza-like illness (ILI), including COVID-19, in healthcare workers. We conducted a prospective, controlled trial at a tertiary university hospital. A random group of healthcare workers was invited to receive 5000 IU daily vitamin D3 supplementation for nine months, while other random healthcare system workers served as controls. All healthcare workers were required to self-monitor and report to employee health for COVID-19 testing when experiencing symptoms of ILI. COVID-19 test results were retrieved. Incidence rates were compared between the vitamin D and control groups. Workers in the intervention group were included in the analysis if they completed at least 2 months of supplementation to ensure adequate vitamin D levels. The primary analysis compared the incidence rate of all ILI, while secondary analyses examined incidence rates of COVID-19 ILI and non-COVID-19 ILI. Between October 2020 and November 2021, 255 healthcare workers (age 47 ± 12 years, 199 women) completed at least two months of vitamin D3 supplementation. The control group consisted of 2827 workers. Vitamin D3 5000 IU supplementation was associated with a lower risk of ILI (incidence rate difference: -1.7 × 10-4/person-day, 95%-CI: -3.0 × 10-4 to -3.3 × 10-5/person-day, p = 0.015) and a lower incidence rate for non-COVID-19 ILI (incidence rate difference: -1.3 × 10-4/person-day, 95%-CI -2.5 × 10-4 to -7.1 × 10-6/person-day, p = 0.038). COVID-19 ILI incidence was not statistically different (incidence rate difference: -4.2 × 10-5/person-day, 95%-CI: -10.0 × 10-5 to 1.5 × 10-5/person-day, p = 0.152). Daily supplementation with 5000 IU vitamin D3 reduces influenza-like illness in healthcare workers.

Rapid resolution of concussion related symptoms in an 11-month-old male with integrative medicine assessment and treatment: Case report.

Neural therapy may have promise as a helpful, fast acting, and safe method of treating concussion symptoms.

Successful Treatment of Dyspareunia with an Integrative Medicine Approach: A Case Report.

A 50-year-old woman with a five-and-a-half-year history of dyspareunia was successfully treated with an integrative medicine approach, including Neural Therapy, osteopathic therapy, acupuncture, and trigger point therapy, resulting in complete resolution which has been maintained to the present day, nineteen years later. Further research is justified and recommended.

Resolving bulimia nervosa using an innovative neural therapy approach: two case reports.

Conventional treatment of Bulimia Nervosa is long term, expensive, and often ineffective. Neural therapy holds promise for treating Bulimia Nervosa in a shorter term, lower cost, and more effective manner. Much of neural therapy involves the superficial injection of local anesthetic injections. Implementation into current practice would be feasible.

Autonomic Response Testing Compared With Immunoglobulin E Allergy Panel Test Results: Preliminary Report.

Context • Chronically ill patients who have failed standard medical assessment and therapies are often assessed by integrative medical providers for atypical manifestations of allergies as the possible source or contributing factor(s) to their condition. Skin testing and immunoglobulin E (IgE) allergy panels increase the cost of care in these patients. Objective • The objective of this study was to determine the accuracy of autonomic response testing (ART) as compared with IgE allergy panel blood tests. Design • This study was a retrospective chart review of patients who had ART and blood drawn for an IgE allergy panel at the same office visit. Outcome Measures • Sensitivity, specificity, positive predictive value, negative predictive value, overall accuracy, phi coefficient, and Cohen's kappa were calculated. Results • A total of 14 charts were reviewed. All measures of accuracy were of either useful or excellent strength. The strength of association measures of the phi coefficient and Cohen's kappa were strong. Conclusion • This first and preliminary evaluation of the allergy assessment utility of ART is very promising and reveals the need for more vigorous follow-up studies.

Successful Integrative Medicine Assessment and Treatment of Chronic Pain Associated With Breast Surgery: A Report of 3 Cases.

Presented is the first reported case series of chronic neck and back pain associated with breast scars from breast surgery and successfully treated with an integrative medicine assessment and treatment approach, which included the assessment technique of autonomic response testing and the scar therapy technique of neural therapy. Implications for nursing practice are discussed.

Integrative Medicine Approach to Pediatric Obsessive-Compulsive Disorder and Anxiety: A Case Report.

Pediatric obsessive-compulsive disorder (OCD) is prevalent in 1% to 2% of the population. Emerging studies have correlated non-celiac gluten sensitivity with psychiatric conditions such as schizophrenia, depression, mania, and anxiety. This case study is the first reported case of OCD associated with non-celiac gluten sensitivity. The objectives of this case report are to (1) identify gluten sensitivity as a possible contributing factor to OCD in some patients; and (2) point out the possible benefit of an integrative medicine approach to the management of OCD in a patient with suboptimal benefit from a standard treatment regime. A 7-year-old male treated at a multi-physician integrative medicine practice in the United States had marked reduction of OCD symptoms and anxiety along with marked improvement of social behavior and school work after treatment consisting of gluten avoidance and other integrative medicine modalities. The patient's rapid response without side effects behooves the medical research community to further investigate the association of non-celiac gluten sensitivity and pediatric OCD.

El trastorno obsesivo compulsivo (TOC) en niños es prevalente en entre un 1 % y un 2 % de la población. Los estudios emergentes han relacionado la sensibilidad al gluten no celíaca con trastornos psiquiátricos como la esquizofrenia, la depresión, la manía y la ansiedad. Este estudio de un caso es el primer caso comunicado de TOC asociado a la sensibilidad al gluten no celíaca. Los objetivos de este informe de caso son (1) identificar la sensibilidad al gluten como un posible factor que contribuye al TOC en algunos pacientes; y (2) apuntar el posible beneficio de una aproximación de la medicina integral al tratamiento del TOC en un paciente con un beneficio subóptimo a partir de una pauta posológica del tratamiento de referencia. Un niño de 7 años al que se trató en una policlínica de medicina integral de los Estados Unidos tuvo una reducción marcada de los síntomas del TOC y de la ansiedad junto con una mejora del comportamiento social y del trabajo escolar tras el tratamiento que consistía en evitar el gluten y otras modalidades de medicina integral. La rápida respuesta del paciente sin efectos secundarios conmina a la comunidad de investigación médica a indagar exhaustivamente en la asociación de la sensibilidad al gluten no celíaca y el TOC en niños.

Successful treatment of chronic nausea and vomiting related to body piercing and tattooing with integrative medicine interventions.

Chronic nausea and vomiting of uncertain etiology can be debilitating and uncomfortable for patients while frustrating for clinicians. This article presents the case of a young woman with chronic nausea and vomiting of unknown etiology resulting from body piercing and tattoo scars on body areas that Chinese Medicine asserts are related to the gastrointestinal system. The patient had long-term total resolution after 1 treatment session consisting of neural therapy for scars resulting from a tongue ring, belly ring, and tattoo near her left wrist along with acupuncture treatment. The research community is called to further evaluate the possible association of body piercing and tattooing with nausea and vomiting along with the possible treatment options of neural therapy and acupuncture.

Tongue piercing and chronic abdominal pain with nausea and vomiting--two cases.

Chronic upper gastrointestinal (GI) symptoms of unclear etiology are frustrating to patients and physicians alike. The integrative medicine procedures of acupuncture and neural therapy may provide treatment options. Tongue piercing, which is prevalent in 5.6% of the adolescent population, may be a contributing factor in upper gastrointestinal symptoms. The objectives of the study were as follows: (1) To demonstrate the usefulness of an integrative medicine treatment approach in two cases of patients with chronic abdominal pain, nausea, and vomiting of unclear etiology who had failed standard medical management. (2) To identify scars from tongue piercings as a possible contributing factor in chronic upper GI symptoms of unclear etiology. Two retrospective case studies are presented of young adult females who were seen in a private multi-physician integrative medicine practice in the US. The patients were treated with neural therapy and acupuncture. The desired outcome was the cessation or reduction of the frequency of abdominal pain, nausea, and vomiting. Both patients had resolution of their symptoms. From this study, we have concluded the following: (1) Tongue scars from tongue rings may be causes of chronic upper gastrointestinal symptoms. (2) Neural therapy and acupuncture may be helpful in the treatment of chronic upper GI symptoms related to tongue scars.

A short guide to peer-reviewed, MEDLINE-indexed complementary and alternative medicine journals.

Complementary and alternative medicine (CAM) comprises a multitude of disciplines, for example, acupuncture, ayurvedic medicine, biofeedback, herbal medicine, and homeopathic medicine. While research on CAM interventions has increased and the CAM literature has proliferated since the mid-1990s, a number of our colleagues have expressed difficulties in deciding where to publish CAM articles. In response, we created a short guide to peer-reviewed MEDLINE-indexed journals that publish CAM articles. We examined numerous English-language sources to identify titles that met our criteria, whether specific to or overlapping CAM. A few of the resources in which we found the journal titles that we included are Alternative Medicine Foundation, American Holistic Nurses Association, CINAHL/Nursing Database, Journal Citation Reports database, MEDLINE, PubMed, and Research Council for Complementary Medicine. We organized the 69 selected titles for easy use by creating 2 user-friendly tables, one listing titles in alphabetical order and one listing them in topical categories. A few examples of the topical categories are Acupuncture, CAM (general), Chinese Medicine, Herbal/Plant/Phytotherapy, Neuroscience/Psychology, Nursing/Clinical Care. Our study is the first to list general CAM journals, specialty CAM journals, and overlapping mainstream journals that are peer reviewed, in English, and indexed in MEDLINE. Our goal was to assist both authors seeking publication and mainstream journal editors who receive an overabundance of publishable articles but must recommend that authors seek publication elsewhere due to space and priority issues. Publishing in journals indexed by and included in MEDLINE (or PubMed) ensures that citations to articles will be found easily.

The effect of OPC Factor on energy levels in healthy adults ages 45-65: a phase IIb randomized controlled trial.

OBJECTIVE: To determine the efficacy of the food supplement OPC Factor to increase energy levels in healthy adults aged 45 to 65. DESIGN: Randomized, placebo-controlled, triple-blind crossover study. SUBJECTS: Twenty-five (25) healthy adults recruited from the University of Pennsylvania Health System. INTERVENTIONS: OPC Factor,trade mark (AlivenLabs, Lebanon, TN) a food supplement that contains oligomeric proanthocyanidins from grape seeds and pine bark along with other nutrient supplements including vitamins and minerals, was in the form of an effervescent powder. The placebo was similar in appearance and taste. OUTCOME MEASURES: Five outcome measurements were performed: (1) Energy subscale scores of the Activation-Deactivation Adjective Check List (AD ACL); (2) One (1) global question of percent energy change (Global Energy Percent Change); (3) One (1) global question of energy change measured on a Likert scale (Global Energy Scale Change); 4. One (1) global question of percent overall status change (Global Overall Status Percent Change); and (5) One (1) global question of overall status change measured on a Likert scale (Global Overall Status Scale Change). RESULTS: There were no carryover/period effects in the groups randomized to Placebo/Active Product sequence versus Active Product/Placebo sequence. Examination of the AD ACL Energy subscale scores for the Active Product versus Placebo comparison revealed no significant difference in the intention-to-treat (IT) analysis and the treatment received (TR) analysis. However, Global Energy Percent Change (p = 0.06) and Global Energy Scale Change (p = 0.09) both closely approached conventional levels of statistical significance for the active product in the IT analysis. Global Energy Percent Change (p = 0.05) and Global Energy Scale Change (p = 0.04) reached statistical significance in the TR analysis. A cumulative percent responders analysis graph indicated greater response rates for the active product. CONCLUSIONS: OPC Factor may increase energy levels in healthy adults aged 45-65 years. A larger study is recommended. Clinical Trials.gov identifier: NCT03318019.

Cerebral blood flow effects of pain and acupuncture: a preliminary single-photon emission computed tomography imaging study.

BACKGROUND: The purpose of this study was to investigate the cerebral blood flow changes associated with the analgesic effect of acupuncture in patients with chronic pain. METHODS: Seven patients presenting with a chronic pain syndrome and 5 healthy controls were included. All single-photon emission computed tomography (SPECT) scans were acquired with a uniform protocol. The patient group was injected with the radioisotope hexamethyl propyleneamine oxime (HMPAO) while experiencing their usual level of pain. A baseline scan was acquired approximately 20 minutes after administration of the HMPAO. The patient then underwent acupuncture therapy with needles placed in points specifically selected to relieve pain. When the pain improved, as determined by a 10-digit score for pain assessment, the patient was reinjected with HMPAO and imaged 20 minutes later for the acupuncture scan. The reference group also had a baseline and acupuncture scan, although the acupuncture itself was performed using a standardized set of needle points. RESULTS: The reference group participants were found to have significant increases in the thalamic and prefrontal cortex activity on the acupuncture scan compared to the baseline. The baseline scans of the pain patients showed significant asymmetric uptake in the thalami compared to controls. This asymmetry reversed or normalized after the acupuncture therapy. Significant correlations were observed between the change of activity in the prefrontal cortex and ipsilateral sensorimotor area. CONCLUSION: The results from these cases show that HMPAO-SPECT is capable of detecting changes in cerebral blood flow associated with pain and that acupuncture analgesia is associated with changes in the activity of the frontal lobes, brain stem, and thalami.