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November 18, 2019Target Healthy Eating
2 Tablespoons butter
4 or 5 yellow onions, sliced
1 pinch black pepper
1 Tablespoon butter, to cook mushrooms
4 anchovy fillets ground with mortar & pestle with 4 garlic cloves, into a paste (not only adds a wonderful flavor, but replaces salt)
20 more fresh garlic cloves, sliced
1 pound mushrooms, cleaned then sliced, then saut?ed in butter
Splash cream sherry
2 Tablespoons butter melted in a saucepan, to room temperature. Use the lowest flame
2 1/2 Tablespoons chickpea flour
2 cups almond milk
1/2 cup cream sherry
pinch of nutmeg
1 pinch chili flakes
1/2 teaspoon dried thyme
1/2 teaspoon dried rosemary
1 pinch black pepper
2/3 cup panko
2 Tablespoons melted butter
1/2 cup freshly grated Parmesan
2 pounds green beans, trimmed, blanched, then ice bath, set aside to drain
2 cups freshly grated Gruyere cheese, divided
1. Preheat oven to 375 degrees
2. Wash and trim the green beans. Add to pot of boiling water and boil for one minute. Then, with slotted spoon, remove from boiling water and plunge into ice bath. Then drain and set aside.
3. Slice the onions, then melt the butter, and cook the onions until they turn a nice dark brown, but aren't burnt. Set aside on paper towel to drain.
4. Cook the mushrooms in same pan: First prepare the anchovy/garlic paste.
5. Slice the additional garlic cloves. Then clean the mushrooms with damp paper towel and slice them. Next, melt the butter in the pan, add the paste and whisk it with the butter. Add the sliced garlic and cook for 1 minute, stirring the whole time. Add the cream sherry and combine well with ingredients in pan. Add the mushrooms and cook until nicely brown. Set the mushrooms aside in the pan.
6. Grate the two cheeses and be sure to keep them in separate containers. Set both aside.
7. Mix the Panko topping ingredients together in a small bowl and set aside.
8. Make the sauce: to the melted butter in the mixing bowl, add the flour and slowly work the flour and butter together. Next, add the almond milk, stirring, the grated nutmeg, chili flakes, black pepper, the herbs. Add a splash of cream sherry and finally, add one cup of the gruyere and stir it into the sauce until all ingredients are well combined. Set aside.
9. Butter a large casserole or baking dish. Add some of the brown onions to the bottom of the baking dish and spread them around. Add half of the green beans, then half of the mushrooms. Move the beans around so that the mushrooms mix with the beans. Add half of the sauce and let it drip to the bottom of the baking dish.
10. Add another layer: Add the rest of the green beans, except for a few, add the rest of the mushrooms, most of the sauce. Now, the rest of the green beans.
11. Add the rest of the browned onions and spread them over the top layer.
12. Add the remainder of the gruyere; sprinkle it all over the top evenly.
13. Finally, sprinkle the Panko topping evenly, over the layer of gruyere.
14. Bake uncovered for 30 minutes. After 20 minutes, keep your eye on the Panko crumbs so they turn brown, but not burned.
15. Remove when done and serve right away while steaming hot, with the rest of your dinner.
From Our Table to Yours
Have a Great Week Everyone!
November 18, 2019Regulatory
Sickle cell disease (SCD) is an inherited blood disorder in which the red blood cells are abnormally shaped (in a crescent or sickle shape). As a result, the flow in blood vessels is restricted resulting in limited oxygen delivery to the body's tissues, leading to severe pain and organ damage. SCD is also characterized by severe chronic inflammation that results in vaso-occlusive crisis where patients experience episodes of extreme pain and organ damage. According to the Centers for Disease Control and Prevention, sickle cell disease affects approximately 100,000 Americans and occurs most often in African-Americans, where 1 out of every 365 babies born have the disease.
The FDA has approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis - a common and painful complication of sickle cell disease that occurs when blood circulation is obstructed by sickled red blood cells - for patients age 16 years and older. Adakveo is the first targeted therapy approved for sickle cell disease, specifically inhibiting selectin, a substance that contributes to cells sticking together and leads to vaso-occlusive crisis. The Adakveo approval was based on the results of a randomized clinical trial enrolling 198 patients with sickle cell disease with a history of vaso-occlusive crisis. Patients either received Adakveo or a placebo. The patients treated with Adakveo experienced fewer health care visits for vaso-occlusive crisis annually (median annual rate of 1.63 visits), compared to patients who received a placebo (median annual rate of 2.98 visits). In addition, 36% of patients who received Adakveo did not experience vaso-occlusive crisis during the study, and it delayed the time that patients first experienced vaso-occlusive crisis after starting treatment from 1.4 months to 4.1 months.
Common side effects for patients taking Adakveo were back pain, nausea, pyrexia (fever) and arthralgia (joint pain). Health care professionals are advised to monitor patients for infusion-related reactions and to discontinue Adakveo for severe reactions. Patients who receive Adakveo should be monitored for interference with automated platelet counts or platelet clumping (platelet counts reported may be much lower than the actual count in the blood). Health care professionals are advised to run tests as soon as possible or use citrate tubes (a practice to avoid platelet activation).
The FDA granted this application Priority Review and Breakthrough Therapy designation, which expedites the development and review of drugs that are intended to treat a serious disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Adakveo also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
The FDA granted approval of Adakveo to Novartis.
November 18, 2019Neurology
Early-onset Alzheimer's disease is rare, representing less than 10% of all people who have Alzheimer's. It typically occurs between a person's 30s to mid-60s. Risk for both early- and late-onset Alzheimer's disease is affected by genetic factors.
According to an article published in Nature Medicine (4 November 2019), defying the odds, an individual at high risk for early-onset Alzheimer's disease remained dementia-free for many years beyond what was anticipated. The study results suggest that a gene variant may be the key, perhaps providing a new direction toward developing a treatment. The research focused on the case of a woman who carried a gene mutation known to cause early-onset Alzheimer's. However, she did not develop signs of the disease until her 70s, nearly three decades after her expected age of onset. The authors suspect that she may have been protected because in addition to the gene mutation causing early-onset Alzheimer's in her family, she also had two copies of the APOE3 Christchurch (APOE3ch) gene variant. Findings of this case study suggest that two copies of the APOE3ch variant, named after Christchurch, New Zealand where it was first identified, may protect against Alzheimer's.
For the study, the authors looked at genetic data from a Colombian family with more than 6,000 living members. Family members who carry a rare gene mutation called Presenilin 1 (PSEN1) E280A, have a 99.9% risk of developing early-onset Alzheimer's disease. Results confirmed that the woman in this case carried the PSEN1 E280A mutation, which caused early-onset Alzheimer's in her other family members. However, she also had two copies of the APOE3ch gene variant, while no other affected family member carried two copies of this variant. Affected family members develop Alzheimer's in their 40s, but she remained disease free until her 70s. Imaging tests showed that the woman had only minor neurodegeneration. She did have large amounts of amyloid protein deposits, a hallmark of Alzheimer's disease, in her brain. But the amount of tau tangles, another hallmark of the disease, and the one more correlated with how thinking and memory are affected, was relatively low.
Experiments as part of the study showed that the APOE3ch variant may reduce the ability of APOE to bind to certain sugars called heparan sulphate proteoglycans (HSPG). APOE binding to HSPG has been implicated as one mechanism that may contribute to the amyloid and tau protein deposits that destroy the brain. The research suggests that a drug or gene therapy that could reduce APOE and HSPG binding has the potential to be a new way to treat or prevent Alzheimer's disease.
November 18, 2019Stem Cell Therapies
Cells of the retinal pigment epithelium (RPE) nourish the light-sensing photoreceptors in the eye and are among the first to die from geographic atrophy, commonly known as dry AMD. Photoreceptors die without the RPE, resulting in vision loss and a leading cause of blindness.
According to an article published in the Journal of Clinical Investigation (14 November 2019), artificial intelligence (AI) has been used to evaluate stem cell-derived patches of RPE tissue for implanting into the eyes of patients with age-related macular degeneration (AMD). The proof-of-principle study helps pave the way for AI-based quality control of therapeutic cells and tissues. According to the authors, this AI-based method of validating stem cell-derived tissues is a significant improvement over conventional assays, which are low-yield, expensive, and require a trained user.
The authors are working on a technique for making RPE replacement patches from AMD patients' own cells. To do this, patient blood cells are coaxed in the lab to become induced pluripotent stem cells (IPSCs), which can become any type of cell in the body. The IPS cells are then seeded onto a biodegradable scaffold where they are induced to differentiate into mature RPE. The scaffold-RPE patch is implanted in the back of the eye, behind the retina, to rescue photoreceptors and preserve vision. Results were successful in an animal model, and a clinical trial is planned.
The authors' AI-based validation method employed deep neural networks, an AI technique that performs mathematical computations aimed at detecting patterns in unlabeled and unstructured data. The algorithm operated on images of the RPE obtained using quantitative bright-field absorbance microscopy. The networks were trained to identify visual indications of RPE maturation that correlated with positive RPE function. Those single-cell visual characteristics were then fed into traditional machine-learning algorithms, which in turn helped the computers learn to detect discrete cell features crucial to the prediction of RPE tissue function. The method was validated using stem cell-derived RPE from a healthy donor. Its effectiveness was then tested by comparing iPSC-RPE derived from healthy donors with iPSC-RPE from donors with oculocutaneous albinism disorder and with clinical-grade stem cell-derived RPE from donors with AMD.
In particular, the AI-based image analysis method accurately detected known markers of RPE maturity and function: transepithelial resistance, a measure of the junctions between neighboring RPE; and secretion of endothelial growth factors. The method also can match a particular iPSC-RPE tissue sample to other samples from the same donor, which helps confirm the identity of tissues during clinical-grade manufacturing. According to the authors, multiple AI-methods and advanced hardware allowed for the analysis of terabytes and terabytes of imaging data for each individual patient, and do it more accurately and much faster than in the past. The authors added that that this work demonstrates how a garden variety microscope, if used carefully, can make a precise, reproducible measurement of tissue quality.
November 18, 2019History of Medicine
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Qigong is, definitively, more ancient in origin than Tai Chi and it is the over-arching, more original discipline incorporating widely diverse practices designed to cultivate functional integrity and the enhancement of the life essence that the Chinese call Qi. Both Qigong and Tai Chi sessions incorporate a wide range of physical movements, including slow, meditative, flowing, dance-like motions. In addition, they both can include sitting or standing meditation postures as well as either gentle or vigorous body shaking. Most importantly, both incorporate the purposeful regulation of both breath and mind coordinated with the regulation of the body. Qigong and Tai Chi are both based on theoretical principles that are inherent to traditional Chinese medicine (TCM).
In the ancient teachings of health-oriented Qigong and Tai Chi, the instructions for attaining the state of enhanced Qi capacity and function point to the purposeful coordination of body, breath and mind (paraphrased here): Mind the body and the breath, and then clear the mind to distill the Heavenly elixir within. This combination of self-awareness with self-correction of the posture and movement of the body, the flow of breath, and stilling of the mind, are thought to comprise a state which activates the natural self-regulatory (self-healing) capacity, stimulating the balanced release of endogenous neurohormones and a wide array of natural health recovery mechanisms which are evoked by the intentional integration of body and mind.
Despite variations among the myriad forms, we assert that health oriented Tai Chi and Qigong emphasize the same principles and practice elements. Given these similar foundations and the fashion in which Tai Chi has typically been modified for implementation in clinical research, we suggest that the research literature for these two forms of meditative movement should be considered as one body of evidence.
Qigong translates from Chinese to mean, roughly, to cultivate or enhance the inherent functional (energetic) essence of the human being. It is considered to be the contemporary offspring of some of the most ancient (before recorded history) healing and medical practices of Asia. Earliest forms of Qigong make up one of the historic roots of contemporary Traditional Chinese Medicine (TCM) theory and practice. Many branches of Qigong have a health and medical focus and have been refined for well over 5,000 years. Qigong purportedly allows individuals to cultivate the natural force or energy (Qi) in TCM that is associated with physiological and psychological functionality. Qi is the conceptual foundation of TCM in acupuncture, herbal medicine and Chinese physical therapy. It is considered to be a ubiquitous resource of nature that sustains human well-being and assists in healing disease as well as (according to TCM theory) having fundamental influence on all life and even the orderly function of celestial mechanics and the laws of physics. Qigong exercises consist of a series of orchestrated practices including body posture/movement, breath practice, and meditation, all designed to enhance Qi function (that is, drawing upon natural forces to optimize and balance energy within) through the attainment of deeply focused and relaxed states. From the perspective of Western thought and science, Qigong practices activate naturally occurring physiological and psychological mechanisms of self-repair and health recovery.
Also considered part of the overall domain of Qigong is external Qigong wherein a trained medical Qigong therapist diagnoses patients according to the principles of TCM and uses emitted Qi to foster healing. Both internal Qigong (personal practice) and external Qigong (clinician emitted Qi) are seen as affecting the balance and flow of energy and enhancing functionality in the body and the mind. For the purposes of our review, we are focused only on the individual, internal Qigong practice of exercises performed with the intent of cultivating enhanced function, inner Qi that is ample and unrestrained. This is the aspect of Qigong that parallels what is typically investigated in Tai Chi research.
There are thousands of forms of Qigong practice that have developed in different regions of China during various historic periods and that have been created by many specific teachers and schools. Some of these forms were designed for general health enhancement purposes and some for specific TCM diagnostic categories. Some were originally developed as rituals for spiritual practice, and others to empower greater skill in the martial arts. An overview of the research literature pertaining to internal Qigong yields more than a dozen forms that have been studied as they relate to health outcomes (e.g., Guo-lin, ChunDoSunBup, Vitality or Bu Zheng Qigong, Eight Brocade, Medical Qigong).
The internal Qigong practices generally tested in health research (and that are addressed in this review), incorporate a range of simple movements (repeated and often flowing in nature), or postures (standing or sitting) and include a focused state of relaxed awareness and a variety of breathing techniques that accompany the movements or postures. A key underlying philosophy of the practice is that any form of Qigong has an effect on the cultivation of balance and harmony of Qi, positively influencing the human energy complex (Qi channels/pathways) which functions as a holistic, coherent and mutually interactive system.
Tai Chi translates to mean, Grand Ultimate, and in the Chinese culture, it represents an expansive philosophical and theoretical notion which describes the natural world (i.e., the universe) in the spontaneous state of dynamic balance between mutually interactive phenomena including the balance of light and dark, movement and stillness, waves and particles. Tai Chi, the exercise, is named after this concept and was originally developed both as a martial art (Tai Chi Chuan or taijiquan) and as a form of meditative movement. The practice of Tai Chi as meditative movement is expected to elicit functional balance internally for healing, stress neutralization, longevity, and personal tranquility.
For numerous, complex sociological and political reasons, Tai Chi has become one of the best known forms of exercise or practice for refining Qi and is purported to enhance physiological and psychological function. The one factor that appears to differentiate Tai Chi from Qigong is that traditional Tai Chi is typically performed as a highly choreographed, lengthy, and complex series of movements, while health enhancement Qigong is typically a simpler, easy to learn, more repetitive practice. However, even the longer forms of Tai Chi incorporate many movements that are similar to Qigong exercises. Usually, the more complex Tai Chi routines include Qigong exercises as a warm-up, and emphasize the same basic principles for practice, that is, the three regulations of body focus, breath focus and mind focus. Therefore, Qigong and Tai Chi, in the health promotion and wellness context, are operationally equivalent.
Tai Chi as Defined in the Research Literature
It is especially important to note that many of the RCTs investigating what is described as Tai Chi (for health enhancement), are actually not the traditional, lengthy, complex practices that match the formal definition of traditional Tai Chi. The Tai Chi used in research of both disease prevention and as a complement to medical intervention is often a modified Tai Chi (e.g., Tai Chi Easy, Tai Chi Chih, or short forms that greatly reduce the number of movements to be learned). The modifications generally simplify the practice, making the movements more like most health oriented Qigong exercises that are simple and repetitive, rather than a lengthy choreographed series of Tai Chi movements that take much longer to learn (and, for many participants, reportedly delay the experience of settling into the relaxation response). A partial list of examples of modified Tai Chi forms are: balance exercises inspired by Tai Chi, Tai Chi for arthritis, movements from Sun Tai Chi, Tai Chi Six Form, Yang Eight Form Easy, and Yang Five Core Movements.
A panel of Qigong and Tai Chi experts was convened by the University of Illinois and the Blueprint for Physical Activity to explore simplification. The expert panel agreed that it is appropriate to modify (simplify) Tai Chi to more efficiently disseminate the benefits to populations regarding cost effective, safe and gentle methods of physical activity and stress reduction. These simplified forms of Tai Chi are very similar to the forms of Qigong used in health research.
For this reason, it is not only reasonable, but a critical contribution to the emerging research dialogue to review studies that explore the health benefits resulting from both of these practices together, as one comprehensive evidence base for the meditative movement practices originating from China.
Sources: nih.gov; Wikipedia
November 18, 2019Quiz
Archeological evidence suggests that the first forms of qigong can be linked to ancient shamanic meditative practice and gymnastic exercises. For example, a nearly 7,000-year-old Neolithic vessel depicts a priest-shaman (wu xi) in the essential posture of meditative practice and gymnastic exercise of early qigong. Shamanic rituals and ideas eventually evolved and formalized into Taoist beliefs and were incorporated into the field of traditional 1) ___ medicine.
The roots of Qigong and Tai Chi can be found in traditional Chinese 2) ___, philosophy, and martial arts. According to the traditional Chinese medical community, the origin of qigong is commonly attributed to the legendary Yellow Emperor (2696-2598 BCE) and the classic Huangdi Neijing book of internal medicine. Chinese scholars acknowledge Kongzi (Confucius, 551-479 BCE) and Mengzi (Mencius, 385-302 BCE) as the founders of the Scholar qigong tradition. In their writings, they alluded to the concepts of qi training as methods of moral training. In the Taoist tradition, the writings of Laozi (Lao Tzu, ca. 400 BCE) and Zhuangzi; (Chuang Tzu, ca. 300 BCE) both describe meditative cultivation and physical 3) ___ as means to extend one's lifespan, and to access higher realms of existence.
The history of qigong, the Chinese practice of aligning breath, movement, and awareness for exercise, healing, and martial arts training, extends back more than 4,000 years. Contemporary qigong is a complex accretion of the ancient Chinese meditative practice xing qi or circulating qi and the gymnastic breathing exercise tao yin or guiding and pulling, with roots in the I Ching and occult arts; philosophical traditions of Confucianism, Taoism, and Buddhism, traditional Chinese medicine and martial arts; along with influences of contemporary concepts of health, science, meditation, and exercise. Mao Zedong: Chinese medicine is a great treasure house! We must make efforts to uncover it and raise its standards, which legitimized the practice of traditional Chinese medicine and created an impetus to develop a stronger scientific basis. The subject of qigong underwent a similar process of transformation. The historical elements of qigong were stripped to create a more scientific basis for the practice.
In the early 1950s, Liu Guizhen (1920-1983), a doctor by training, used his family's method of body cultivation to successfully cure himself of various ailments. He then promoted his method to his 4) ___ and eventually published a book, Qi Gong liaofa shiyan to promote his successes. His efforts to re-define qigong without a religious or philosophical context proved to be acceptable and successful. By the middle of the 1980s, there were more than 2000 qigong organizations and between 60 and 200 million practitioners across China, almost one fifth of the Chinese population. This growth was fueled by the tacit support of small elements within the Chinese government, reduced criticism of qigong practice, pent-up demand within Chinese society for alternative belief systems, and improved methods of communication that resulted in mass adaptation of qigong practice, in what has been termed qigong fever. By the end of the 1980s, qigong practices could be found within all segments of Chinese 5) ___.
By the end of the 1990s, the explosive growth in the number of qigong practitioners had led to the revival of the old traditions that accompanied qigong development. Qigong research and practice have been officially supported in the context of health functions and as a field of study within traditional Chinese medicine. The Chinese Health Qigong Association was established in 2000 to regulate public qigong practice, requiring state approved training and certification of instructors, limiting practice to four standardized forms from the classical medical tradition, and encouraging other types of recreation and exercise such as yoga, t'ai chi, senior disco dancing, and exercise machines. Migration, travel, and exploration contributed to the spread of qigong practice beyond the Chinese community. Western societies first encountered qigong concepts through exposure to traditional Chinese medicine, Chinese philosophy and the Chinese martial arts.
Productive exchanges between China and the West, began with the visit of President Nixon in 1972. In the subsequent exchanges between China and the West, the international community became aware of 6) ___. The ideas of qigong were quickly embraced by alternative therapists. The idea of qi as a form of living energy also found a receptive audience within the New Age movement. Chinese qigong practitioners were invited to the West to demonstrate qigong concepts and practices to Americans. The American public's first exposure to qigong was in the PBS series Healing and the Mind with Bill Moyers in 1993. In the documentary, Moyers provided an in-depth look at alternatives to Western medicine and introduced the audience to 7) ___ Chinese medicine, acupuncture, and qigong. As a result, qigong practice spread to the general public in the US.
From roughly the mid-1990s onward, Tai Chi, also, has gained popularity in some countries to the point of becoming nearly as well-known as a health-oriented practice, Yoga.
Beyond the innate restorative capacities of the physical body, there are many factors of psychological nature that can influence self-healing. Hippocrates, considered by many to be the father of Western medical treatment, observed: The physician must be ready, not only to do his duty himself, but also to secure the co-operation of the patient, of the attendants and of externals. - Hippocrates. Self-healing may also be achieved through deliberately applied psychological mechanisms. These approaches may improve the psychological and physical conditions of a person. Research confirms that this can be achieved through numerous mechanisms, including relaxation, breathing exercises, fitness exercises, imagery, Meditation, Yoga, Tai Chi, Qigong, biofeedback, and various forms of psychotherapy, among other approaches.
Self-healing using Tai Chi and other forms of alternative medicine, for the sake of Health, include:
Decreases in stress 8) ___ that may impair physiological functions when there is chronic stress.
Decreases in muscle tension, which can worsen or produce pains in muscles, tendons and joints when there is chronic muscle tension due to stress.
Improved sleep that can be achieved through relaxation, which improves physiological functions.
Improvements in emotional tensions, depression, anger and other emotions that can otherwise impair social relationships and functioning in the workplace, leading to vicious circles of increased psychological symptoms.
Tai chi has been reported as being useful in treating a number of human ailments, and is supported by a number of associations, including the National Parkinson Foundation and Diabetes Australia. A 2017 systematic review found that it decreased the risk of falls in older people. A 2011 comprehensive overview of systematic reviews of Tai Chi recommended Tai Chi to older people for its various physical and psychological benefits. There was evidence of benefit for Parkinson's disease, diabetes, cancer and arthritis. By 2015, systematic reviews found Tai Chi could be performed by those with chronic medical conditions such as chronic obstructive pulmonary disease, heart failure, and osteoarthritis without worsening shortness of breath and pain, and found favorable effects on functional exercise capacity in people with these conditions.
Tai Chi, originally developed for self-defense, has evolved into a graceful form of seated exercise that's now used for stress reduction and a variety of other health conditions. Often described as meditation in motion, seated Tai Chi promotes serenity through gentle, flowing movements. Worthy of note is the growing popularity of seated Tai Chi exercises touted by the medical community and researchers. Seated Tai Chi is being used by the general public, medical practitioners, and Tai Chi instructors in a growing 9) ___ population. It would have been possible to simply take the well-known Yang short form and redesign it for seated positions. There is, however, the matter of the integrity of the form itself. Within any Tai Chi form, there lies a certain inherent logic and purpose to each of the movements. The synchronization of the upper body with the steps and the breathing exists in a very carefully crafted order developed over hundreds of years, and the transition to seated positions is an important factor in the movements themselves. Research has shown that seated Tai Chi techniques can make big improvements to a person's physical and mental well-being. Marked improvements in balance, blood pressure levels, flexibility and muscle strength, peak oxygen intake, and body fat percentages can be achieved.
According to the NIH, research examining psychological and physiological benefits of Qigong and Tai Chi is growing rapidly. The many practices described as Qigong or Tai Chi have similar theoretical roots, proposed mechanisms of action and expected benefits. Measures of cardiopulmonary function were representative of cardiopulmonary fitness and cardiovascular disease risk and included blood pressure, heart rate, ejection fraction rates, blood lipids, 6-minute walk distance, ventilatory function, and body mass index (BMI). One of the most consistent findings was the significant reduction in blood pressure reported in multiple studies, especially when Qigong or Tai Chi, were compared to inactive control groups such as usual care, educational classes, or wait-list controls.
Studies show no significant differences between Qigong or Tai Chi, thus, providing preliminary evidence that these meditative movement practices achieve positive health results. Indicators of cardiac health, as a result of doing Qigong and Tai Chi have been evaluated. Reduced heart rate is reported as well as increases in heart rate variability. These reported changes in blood 10) ___, heart rate, and heart rate variability suggest that one or several of the key components of Tai Chi and Qigong, that is body, breath, and mind, may affect sympathetic and parasympathetic balance and activity.
In summary, current research suggests a favorable effect on bone health for those practicing Tai Chi or Qigong. Resistance training and other weight bearing exercises are known to increase bone formation and have been recommended for post-menopausal women for that purpose. Interestingly, most Qigong and Tai Chi practices involve no resistance and only minimal weight bearing (such as gentle knee bends), yet the four RCTs (total sample size=427) included in a review reported positive effects on bone health. One study examined the effect of Qigong and three examined Tai Chi. Bone loss was retarded and numbers of fractures were less among post-menopausal women practicing Tai Chi compared to usual care. The 9 outcome category groupings that emerged are: bone density (n=4), cardiopulmonary effects (n=19), physical function (n=16), falls, balance and related risk factors (n=23), quality of life (n=17), self-efficacy (n=8), patient reported outcomes (n=13), psychological symptoms (n=27), and immune- and inflammation-related responses (n=6). Within each category of outcomes, there were both Qigong and Tai Chi interventions represented.
Sources: nih.gov; Wikipedia; YouTube
ANSWERS: 1) Chinese; 2) medicine; 3) exercises; 4) patients; 5) society; 6) qigong; 7) traditional; 8) hormones; 9) elderly; 10) pressure
November 18, 2019What's New
In Lysosomal Storage Diseases (LSDs), neurological complications are quite common. Advanced therapies for LSDs that have been in pipeline include gene therapy, small molecule/nanomedicine approaches, and genome editing. Although newer approaches seem promising, there is no consensus on outcome measures or specific biomarkers to define the neurological involvement in LSDs.
Target Health, LLC. Is pleased to announce that Dr. Jules Mitchel, CEO, will participate as a speaker in a workshop on "Neurological Outcomes in Lysosomal Storage Disorders" organized by Lysosomal & Rare Disorders Research & Treatment Center (LDRTC). The Genetic, Rare Immune Disorders Symposium (GRIDS) workshop will take place in Fair Oaks Marriott Hotel, Fairfax, Virginia on November 24-25, 2019. The presentation is entitled Contract research organizations in conducting clinical trials in neurological disorders. The workshop will focus on basic mechanisms behind the pathophysiology and establishing clinical outcome measures for clinical trials and disease monitoring. The program will also include discussions on emerging treatment strategies as well as the process of clinical trial development for neuropathic LSDs.
Here is some background information: Nervous system poses a major challenge not only to understand the primary pathology of a given disease state, but manage patients clinically, and conduct clinical trials for drug development. Less than 10% of newly developed drugs on the market target a primary nervous system disorder. For example, within the past 10 years, while more than 50% of cancer therapeutics in trials received an FDA approval, all drugs targeting Alzheimer disease, virtually have failed. Multiple factors, including incorrect therapeutic targets, imprecise, misleading or inaccurate clinical methodologies, and the delay from the onset of actual pathologic process to the clinical recognition of symptoms could be listed as some of reasons for the lack of success in medical field to tackle neurological disorders.
For more information about Target Health, contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Also visit the Target Health Eating Website to see all of the fantastic recipes since 2012.
Joyce Hays, Founder and Editor in Chief of On Target
Dr. Jules T. Mitchel, Editor
November 4, 2019Target Healthy Eating
Grind 5 anchovy fillets in mortar & pestle with 5 garlic cloves
25 more garlic, sliced
1 butternut squash cut in half (remove seeds) or 2 to 3 cups cut up raw butternut squash
1 cup baby spinach, rinsed & drained 3 times, then pat dry with paper towels
1 teaspoon cardamom
1 teaspoon turmeric
1 pinch chili flakes
1 pinch black pepper
1/2 cup fresh tarragon, chopped well
1 pound cremini mushrooms (or button or baby bella), wipe clean with damp paper towel
1 big Tablespoon, dollop soft, unsalted butter
1 Tablespoon low sodium soy sauce
1/2 cup cognac or white wine (never use cooking wine)
1 dollop sour cream
1/2 cup heavy cream
1 Heaping Tablespoon chickpea flour
1 cup freshly grated gruyere
Garnish: before baking, add a ring of mushroom slices all around the baking dish. Just before serving, add tiny green leaves in between the mushroom slices
1. Do all your grinding, chopping, grating, rinsing, now.
2. Cut the butternut squash in half and roast until soft, or roast cubes of squash on baking sheet, until soft, then set aside.
3. Cook 1 chopped onion with 5 garlic cloves & 5 anchovies
4. Add 25 more garlic, sliced
5. Add 1 teaspoon cardamom, turmeric, pepper, chili flakes & ? cup fresh tarragon, chopped well
6. Add all the mushrooms in butter & some low sodium soy sauce. Add some cognac or white wine & stir well.
7. Add dollop sour cream
8. Add 1 cup baby spinach and stir in
9. Pour contents of pan into large casserole, then add the cubes of roasted squash to the casserole and stir everything together
10. Beat 12 eggs with some heavy cream and add 1 Tablespoon chickpea flour
11. Stir well and pour this mixture over the veggies
12. Sprinkle the grated gruyere over the top
13. Arrange the garnish mushroom slices, all around the baking dish. Then add tiny green leaves between the mushrooms.
14. Bake in 375 oven for 20 minutes
This veggie pie would be perfect on a Thanksgiving table. Since we've been experimenting with my new recipe, we've had it with Dover sole and green bean salad, and it made for a delicious dinner party. It's also just right for lunch or a weekday dinner on its own. We've also served it with the number one veggie burger in the country (The New York Times, tested and rated), called The Impossible Burger. This veggie pie stands on its own or goes well with just about anything. A chilled white wine pairs best.
From Our Table to Yours
Have a Great Week Everyone!
November 4, 2019Regulatory
The FDA is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. The changes will allow the FDA to access and review both pre- and post-market safety information in the same system and with the same data standard.
According to the FDA, the Technology Modernization Action Plan (TMAP) includes modernizing FDA's technical infrastructure in ways that allows FDA to receive, analyze, and use data in new ways to advance the FDA's regulatory mission. Creating standard, digital IND safety reports is an important step toward more sophisticated data and technology solutions at the FDA to support efficient development of safe and effective medical products.
The guidance outlines the FDA's intent to implement a standard digital framework for the electronic submission, review and tracking of certain IND safety reports in FAERS. The publication of the draft guidance and technical documents should assist sponsors in beginning preparations for when the draft guidance is finalized and effective. IND safety reports will be submitted using a data standard known as ICH E2B. This will provide sponsors with a reporting format that is consistent with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and consistent with reports used by other regulatory agencies. The FDA will soon announce when sponsors can begin to voluntarily submit IND safety reports to FAERS.
IND safety reporting via FAERS will be voluntary until two years after the finalization of the guidance, at which point it will be mandatory for sponsors of commercial INDs that make electronic submissions. Once the requirement is in effect, sponsors will be required to submit certain IND safety reports to FAERS instead of in eCTD format. There will be two options for submission, directly to FAERS and via the Safety Reporting Portal, a web-based submission system that feeds into FAERS. This guidance does not affect the criteria sponsors must use to determine if an IND safety report must be submitted, timelines for reporting, or other elements of IND safety reporting requirements. Because IND data, including clinical trial information, is proprietary and generally not releasable from the FDA, IND safety reports will not be made publicly available. The FDA has created a separate submission path to FAERS for IND safety report submissions so that they remain designated as investigational in FDA's internal recordkeeping system.
The digital framework for IND safety reports was conceived and piloted under the FDA's Information Exchange and Data Transformation (INFORMED) Program. Working with the FDA's Oncology Center of Excellence, in collaboration with the FDA's Center for Drug Evaluation and Research's Office of Surveillance and Epidemiology and the FDA's Center for Biologics Evaluation and Research, several sponsors submitted IND safety reports using the piloted digital framework in parallel to the standard submission process to inform the process. The FDA analyzed results and used the feedback from sponsors to optimize the process for submitting safety reports electronically using the new framework.
As part of the TMAP, the FDA is expanding its capability to develop technology products through a series of projects that demonstrate new ways of applying technology and data to the FDA's regulatory mission. These projects will span the FDA's broad regulatory responsibilities - from supporting innovation in medical product development to bringing new ways to ensure food safety and increase the effectiveness of the FDA's field operations. This work will build on the success of INFORMED and similar programs through a new, forward-looking program called CoInnovate@FDA. Designed to be an incubator of modern technology and data projects, CoInnovate@FDA will connect work from across the FDA and the broader learning health system.
November 4, 2019Neurology
Attention deficit/hyperactivity disorder (ADHD) is marked by a pattern of hyperactivity and impulsive behavior. Autism spectrum disorder (ASD) is a complex developmental disorder that affects how a person behaves, interacts with others and learns.
According to an article published JAMA Psychiatry (30 Oct 2019), exposure to acetaminophen in the womb may increase a child's risk for ADHD and ASD. For the study, the authors analyzed data from the Boston Birth Cohort, a long-term study of factors influencing pregnancy and child development. They collected umbilical cord blood from 996 births and measured the amount of acetaminophen and two of its byproducts in each sample. By the time the children were an average of 8.9 years, 25.8% had been diagnosed with ADHD only, 6.6% with ASD only and 4.2% with ADHD and ASD. The authors then classified the amount of acetaminophen and its byproducts in the samples into thirds, from lowest to highest. Compared to the lowest third, the middle third of exposure was associated with about 2.26 times the risk for ADHD. The highest third of exposure was associated with 2.86 times the risk. Similarly, ASD risk was higher for those in the middle third (2.14 times) and highest third (3.62 times).
The authors conclude that their results support earlier studies linking acetaminophen exposure in the womb with ADHD and ASD and underscore the need for additional research. The FDA urges careful consideration before using any pain-relieving medication during pregnancy.