Category Archives: Alternative Medicine

Five years ago today, the Food and Drug Administration issued a landmark approval for Kymriah, the first gene therapy available in the United States.

Cell and gene therapy products can transform how certain diseases are treated, offering life-extending and potentially curative benefits for patients living with life-threatening or debilitating diseases.

Propelled by significant research and development investments and scientific advances, the cell and gene therapy market has since experienced tremendous growth. Regulatory agencies around the world have approved a number of cell and gene therapy products including eight new therapies in the United States that target diseases with high unmet needs, ranging from cancer to retinal diseases.

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Based on a robust cell and gene therapy pipeline, experts forecast a wave of new approvals in the coming years, with the Alliance for Regenerative Medicine predicting 2022 could be record year for new gene therapies to treat rare diseases.

This trajectory holds substantial promise for patients worldwide. But right now the science is ahead of the U.S. health care system, leaving gaps that affect access the existence of a therapy is immaterial if patients cant access them.

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To realize the full potential of these therapies, its imperative to address existing challenges, such as payment and affordability-related barriers and reimbursement issues.

Reimbursement paying doctors and health care centers for the treatments they have administered is an important part of U.S. health care. Ensuring that cell and gene therapies are sufficiently reimbursed is essential for ensuring patient access.

Reimbursement isnt as simple as sending an invoice and receiving payment. Coverage (a payers decision to provide benefits for a specific product), coding (a unique identifier for a medicine) and payment levels (the amount an insurer will pay) affect how a product is reimbursed and each of those factors can vary based on the market, payer and therapy.

In the first few years after Kymriahs approval in the U.S., there wasnt a specific diagnosis-related group code for autologous cell therapies, a specific type of cell therapy in which a patients cells are collected, genetically modified, and then given back to the patient. The lack of a DRG code created uncertainty among providers about whether they would be appropriately reimbursed for the services they provided. The reimbursement landscape in the U.S. has since evolved: the Centers for Medicare & Medicaid Services issued and refined a diagnosis-related group code for autologous cell therapies, and a change in the status of the new technology add-on payment, which enables an additional payment to hospitals on top of the DRG payment amount.

These measures represent meaningful steps toward capturing the uniqueness of autologous cell therapies. But the frequent changes likely have contributed to confusion among health care providers about how to report the therapies and their charges.

Billing and coding errors resulted in significant differences in payment, and many hospitals were underpaid in 2019 and 2020, according to an analysis of Medicare payments by my colleagues on AmerisourceBergens consulting team. The disparities in payment underscore the importance of educating health care providers and their staff on the latest reimbursement changes and helping them master the dynamics of coding and billing, especially until a more permanent reimbursement solution is developed.

With more than 1,000 clinical trials now underway worldwide for cell and gene therapies, its increasingly important to establish solutions that address the current reimbursement challenges and establish more standardized pathways to cover the next wave of therapies and ensure they can reach the patients who need them. As regulators develop new guidance, biopharma companies should prioritize payer and stakeholder engagement earlier in the development life cycle to address questions related to payment and coverage decisions, such as:

Payers face this central question when evaluating cell and gene therapy products: How do we balance the potential long-term clinical value with the cost of the therapy and uncertainty regarding long-term durability at the time of regulatory approval? That challenge is compounded by the fact that many cell and gene therapies are one-time treatments, and patients can switch insurance carriers throughout their lifetimes, meaning the insurer that reimburses the cost of the treatment may not reap the benefits of saved health care costs down the road.

Historically, the vast majority of payers in the U.S. have used traditional techniques such as formulary or utilization management tools to manage the costs of cell and gene therapies. But payers have increasingly expressed interest in alternative payment models, such as reinsurance and outcomes-based agreements, in which payments are ultimately based on how well a treatment benefits patients. While outcomes-based agreements are particularly relevant for products with limited long-term clinical data and small patient populations, such as cell and gene therapies, certain factors including the Medicaid best price policy have prevented more widespread adoption of these agreements. A recently finalized rule by CMS aims to mitigate some of the potential challenges and concerns related to the Medicaid best price and foster more outcomes-based agreements between payers and biopharma companies for cell and gene therapies. That said, legal and compliance issues still pose barriers to these agreements.

Continued innovation in contracts and financial partnerships is essential to unlock access to cell and gene therapies. Biopharma companies and payers need to be flexible, agile, and open-minded in considering arrangements like outcomes-based agreements that better account for the long-term value and clinical outcomes over the term of the patients insurance policy. Considering the effort required to negotiate the value structure of outcomes-based agreements, I anticipate payers will be increasingly interested in participating in outcomes-based agreements for cell and gene therapies if there is a portfolio of products.

AmerisourceBergen, which I work for, provides pharmaceutical distribution services as well as solutions to help biopharma companies at every stage of the product lifecycle. The company is exploring ways to facilitate outcomes-based agreements that are objective, measurable, and easy to manage. We recently developed an outcomes-based agreement model for cell and gene therapies that aims to reduce financial exposure for biopharma companies, payers, and their client groups (namely employers with members who are eligible for these treatments) with the goal of improving patient access to cell and gene therapies.

The next five years hold tremendous promise for cell and gene therapies, including the potential to usher in allogenic cell therapies. Often referred to as off-the-shelf, allogenic cell therapies can be collected from a donor and then used to treat many patients rather than collecting and modifying each patients cells easing some of the manufacturing-related challenges associated with autologous cell therapies.

Meanwhile, the FDA continues to explore new initiatives to help accelerate the development of cell and gene therapy products. The director of the FDAs Center for Biologics Evaluation and Research, which regulates biological products for human use under applicable federal laws, recently shared his interest in establishing a gene therapy program in which sponsors would receive real-time feedback about their development programs from FDA reviewers. The program would help to inform the best approaches in developing gene therapies.

Based on the current pipeline of cell and gene therapy products, its possible that between 54 and 74 CGT products will be approved in the U.S. by 2030. Of course, even if these products receive approval and developers have the capacity to manufacture them at scale, the full potential of these therapies wont be realized unless the existing reimbursement and access barriers are addressed.

As the pipeline of cell and gene therapies continues to expand, its critical that the biopharma industry and the health care system create more standardized reimbursement pathways and introduce solutions that reduce barriers for the providers administering the therapies and the patients who need them.

Lung-I Cheng is the vice president of cell and gene therapy at AmerisourceBergen.

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Five years after Kymriah: Ensuring the next cell and gene therapies reach patients - STAT

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oi-Oneindia Staff

| Published: Tuesday, August 30, 2022, 18:08 [IST]

In present times we all are striving for better health. Healthcare professionals assist you in breathing, walking, eating, seeing, hearing, speaking, and moving correctly. They also help patients prevent illness, disease, and injury and lay down plans to fight and treat ailments of any kind.

From scientists, general physicians, neurologists, dentists, and therapists or alternative medicine practitioners, Indian doctors and other healthcare professionals have always been in the limelight for their significant achievements. Dressed in white coats, these warriors consistently make efforts toward saving lives and providing the best care to change the life of many.

Today we list the Top Healthcare professionals and leaders from different healthcare specializations who offer every patient the best clinical services based on their excellent diagnosis with medical or surgical interventions.

1. Dr. Niraj JhaDr. Niraj Jha is a well-known Neuro Physiotherapist and rehabilitation professional in the Mumbai region with global medical and social rehabilitation expertise. With over 16 years of experience in this field, Dr. Niraj Jha excels in neurorehabilitation, stroke rehabilitation, general community medicine, and other orthopaedic conditions using the latest evidence-based clinical practice. Dr. Jha has completed his Ph.D in Neurological Rehabilitation, Master of Physiotherapy in Neurology, and his Master's in Disability Rehabilitation at Tata Institute of Social Sciences, Mumbai. In addition, he has undergone and completed the Fellowship programme in Cardiac and Neurological Rehabilitation.

Presently he is serving as a District Chairperson - Medical Services of Lions Club of International. Physioworld is a Top 3 Best rated Physiotherapy Centre in Mumbai. He is also associated with premier organisations like UNICEF & WHO, as a Public health Consultant. Accredited with numerous honours, such as the best physiotherapist by the Sakal Idols of Maharashtra Award and the prestigious Front-Liners Unsung Heroes Red Carpet Award in 2022. He is considered among the best Neuro physiotherapist in India. Website - http://www.physioworld.org

2. Dr. Arvind GahlotDr. Arvind Gahlot is a name among the best Cardiothoracic Surgeons any country can have. He is a qualified M.Ch.(CVTS) and M.S(General Surgery) specialist and has outperformed 2000 successful open- heart surgeries. With over 15 years of experience, Dr. Arvind is the perfect 'Whisper to Roar' story in executing around 500 surgeries individually. He is associated with Mumbai's top hospitals like Saifee, Wockhardt, Raheja, Criticare, HN Reliance Foundation, SevenHills, AIMS, and Fortis Healthcare. He is the Most Prominent Cardiothoracic Surgeon of the Year - 2022, Mumbai. With achievements as an open-heart surgeon, he also vests his expertise in Minimally Invasive Heart Valve surgery, Bypass surgery, Vascular surgery, Valve replacement, and Repair. Dr. Arvind is an active participant in national and international conferences and his most cherished passion is being a lecturer for medical colleges. Website - http://www.drarvindgahlot.com

3. Dr. Aaditya PatakraoDr. Aaditya Patakrao, is renowned dentist from India, and known as A Celebrity Dentist.He is the owner of Dr. Aaditya's Advance Dental hospital, in Pune Maharashtra. He perform microscopic and laser root canals. Dr Aaditya has more than 10000 Root Canals surgeries and 2000 Dental Implants surgeries to his credit.

He has acquired Dental Implant course in Boston USA and Microscopic Laser skill from Germany. His Hospital is an International standardized and recognised by the European Medical Association. It has great ambience and It takes special care of the patients.Dr. Aaditya has a very skilled team to perform Dental treatments in a super advanced manner.

He has attended many international conferences to keep him upgraded in the field of dentistry.

Dr. Aaditya has been awarded many national and international awards for his quality work in Dentistry. Dr. Aaditya holds World Book of Records on his name for paying highest tax amongst all Dentist category. Recently he got Oscar of Dentistry Award. Website - http://www.aadityadentalcare.in

4. Dr Hetal Doshi, B.D.S (Mum), Post Graduate in Cosmetic Dentistry (USA), Associate Fellowship in Laser Dentistry (USA)Specialist in Cosmetic and Pediatric Dentistry.

Dr Hetal Doshi is one of the most dynamic Cosmetic Dental Surgeon and kids favourite dentist in Mumbai. With 19 years of experience Dr. Hetal is popularly known for her Painfree Dental treatments and specialises in providing Cosmetic, Laser & Implant dentistry to patients from infancy to adulthood.

Dr Hetal Doshi's Dental Care is one of the few clinics in Mumbai to provide Anxiety - Free Dentistry / Conscious Sedation commonly known as laughing gas using Nitrous oxide-oxygen sedation for a PAINFREE Dental experience for both children and adults .

Dr Hetal Doshi, director of Khandwala's Eye Hospital & Hem Polyclinic has been successful in Removing the Fear Out of Dentistry and creating 3000+ life changing smiles thereby instilling positive attitude towards dental treatments and changing the face of Dreadful, Painful Dentistry into a Painfree, Relaxed dental experience. Instagram ID - @dr.hetaldoshi

5. Dr Nikhil TariDr Nikhil Tari is the rising star in the Indian bodybuilding and fitness consultancy. Regarded as one of the most successful Indian bodybuilders, Dr Nikhil has been awarded as India's #1 bodybuilding & fitness consultant many times by various renowned institutions, including the "Health & Wellness Icon" - in Fitness & Bodybuilding by Midday. With a vast clinical experience of more than 15 years in this field and practising 24 years as a bodybuilder, he is a perfect blend of skills and experience. He successfully runs his Bodybuilding & Fitness clinic in Kandivali West Mumbai, Maharashtra. The expert professional is known for implementing different techniques for building muscle, and fitness programs, which helps curate specialized workouts and sports injury management with minimal lifestyle changes.

The pro fitness consultant actively shares deep insights on the subject related to bodybuilding fitness with thousands of his followers on multiple social media handles such as Youtube, Instagram, and Facebook.

His vision is to build an international-grade bodybuilding and fitness school in India and train world-class athletes who can win worldwide BODYBUILDING & FITNESS events. Website - http://www.drnikhiltari.business.site

6. Dr Bhasker Sharma -BHMS, MD, PhD (Homeo)Dr Bhasker Sharma is a highly-acclaimed homoeopathic doctor and physician in India and abroad. Dr Sharma hails from Siddharthnagar, Uttar Pradesh. The profound physician is on a mission to spread the world about homoeopathy and promote a healthy community through this form of holistic medicine. He continuously works hard to eradicate misconceptions related to homoeopathic treatment. He is a world-famous alternative medicine practitioner known for curing various diseases like renal stone, gastritis, leukoderma, piles, arthritis, skin diseases, diabetes, male sexual diseases, female sexual disease, ovarian cyst, PCOD, enlargement of the prostate gland, hair loss, weight loss, etc.

Dr Sharma has set over 30 dozen world records and has also been conferred with 58 dozen international and national honours in India and 12 dozen books published. He has over a dozen medical and literary works and publications to his credit. The Largest Homoeopathy Lesson is a significant feat accomplished at an event organised by Dr Sharma on August 21, 2018, in Rajkot, Gujarat. For achieving the feat, he was bestowed with the Guinness World Record. Website - http://www.drsharmafoundation.org

7. Dr Ameed Murad (Founder & MD of Vedaan)MBBS with Masters in Alternative Medicine & Applied Nutrition, Fellowship Functional Medicine, USA.A Modern Doctor powered by 450+ Years Of Heritage & Experience with Numerous national awards, scientific Patents and Disease Reversal specialist. Dr Ameed is loved & revered by millions of followers worldwide from bureaucrats, politicians, celebrities to the common man.Since 1565, The Murad family has been the bridge connecting India with the prestigious Tib-E-Unani (Greek-Arab system of medicinal science) way of Holistic natural healing through treatment of the root cause of illnesses, not just the symptoms but complete disease reversals.

Beginning his professional practice as a physician at the esteemed Apollo Hospital in New Delhi, Dr Ameed naturally developed a vision to integrate herbal remedies with modern medical science but also evolve it according to today's relevance.

With a team of doctors & scientists working alongside Dr Murad they have made discoveries in formulations & treatment methodologies. Numerous national and international pending patents in the nutraceutical arena add to the glamour. Website - http://www.Vedaan.com

8. Dr Anshuman Manaswi - MBBS, MS, DNB, M.Ch. - Senior consultant Plastic Surgery, MumbaiAnshuman Manaswi is a Senior Cosmetic and Plastic Surgeon based out of Mumbai, India with over 20 years of extensive surgical experience. He is the Founder and Director of one of the top centers for plastic surgery in India - La Transformation Plastic Surgery Centre. He is affiliated with best hospitals of Mumbai, the Nanavati Max Speciality Hospital & Bombay Hospital & Medical Research Centre.

He is quite popular with his incredible skill amonf the celebrities , but treats all his patients with equal passion He has trained many doctors in Cosmetology and Plastic Surgery.He has been accredited for many scientific research papers at international and national conferences and has scientific publications in journals of repute in his name. He is a recipient of Various Awards and accolades by reputed organisations. His name Appears in Marquis' Who's who World Bibliography as one of the top medical professionals in the world.He is one of the pioneers of Lymphedema Surgery in the country and takes pride in helping these unfortunate patients. Website - http://www.latransformatione.com

9. Dr Santosh ShettyDr Santosh Shetty is a renowned name in Orthopedics and Arthritis Care in Mumbai and has 20 plus years of experience. He is the Director Department of Joint Replacement in Surana Group of Hospitals and is amongst the top joint replacement surgeons to perform Robotic Joint Replacement Surgery in India. The doctor is a specialist in minimally invasive muscle sparing Robotic Cruciate Retaining Surgery (without cutting the muscles and the ligament ) using the Cuvis technology and is the first in the World to perform Robotic surgery of Both the Knee Joint in a single sitting using this Automatic technology and Opulent Gold CR Implants.

Dr Shetty has more than 10000 satisfied patients to his credit and has received numerous awards and accolades for his exemplary work in joint pain and arthritis and has also been recepient of the "Patient Satisfaction Award" and The Prestigious "Maharashtra Gaurav Award" for Exemplary Contribution in the field of Robotic Replacement.

Dr Shetty has pioneered Absolute PrecisionTM Technique for fast-track recovery and has been instrumental in bringing the latest cutting edge technology to offer the best to the patients suffering from arthritis. Website - http://www.drsantoshshetty.com

10. Dr. Surabhi DhanwalaDr. Surabhi Dhanwala is one of the celebrated Physiotherapists and Naturopathist in the country who is successfully running her Clinical Care and therapy centres in Pune (Maharashtra) and Dehradun (Uttarakhand). She has been in practice for over 18 years and has changed the lives of more than 19k patients. She is formally trained as BPT, MPT (Neuro), DNYS, CCH (1yr), and CHM (Thailand (1yr). In addition, the skilled doctor has received an Honorary Doctorate from South Western American University in Neuromuscular Rehabilitation and Acupressure.

The expert medical professional is known for her magical hands that can cure patients without surgeries by using treatments which are a fusion of modern science and ancient therapies. Dr Surabhi treats and heals people to heal through natural treatments and lifestyle changes.The ace doctor specialises in treating patients diagnosed with Knee or Hip Replacement, Frozen Shoulder, digestive track problems, diabetes and its associated ailments, Joint stiffness and dislocation, Retino Pigmentosa, Peripheral Neuro Pathy etc. Dr Surabhi has been bestowed with numerous awards. The most recent with the ET Change Makers Award 2022. Website - http://www.dhanwala.com

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Meet these renowned healthcare professionals who assist us in leading healthier lives - Oneindia

A depigmenting skin pathology, vitiligo leads to hypopigmentationin afflicted regions of the skin by a gradual decrease in melanocytes. Current knowledge of vitiligo pathogenesis has recently advanced and is now categorically recognized as an autoimmune disorder connected with hormonal and hereditary influences in addition to disorders involving metabolism, oxidative stress, and cell disintegration. According to new hypotheses, melanocytorrhagy and poor melanocyte viability are major factors. The hallmark lesion is an amelanotic, non-scaly, chalky-white macule with clear edges [1,2]. The skin commonly affected is that of the face, lips, hands, arms, feet, and genitalia. Additionally, affected areas typically have white hairs. However, the underlying etiopathogenic process of vitiligo is still uncertain [3]. By repairing damaged pigments or removing persisting pigments, vitiligo therapy aims to reduce its severity. Food supplements and anutrient-dense diet might be seen as essential components oftreatment for vitiligo [4]. Although vitiligo is a common condition, it was recently overlooked in dermatology and treated as an orphan illness for therapeutic development. Patients frequently claim that doctors are not up to date regarding treatment modalities, andmost view vitiligo as a "cosmetic condition [5]. According to physicians, the focus of future studies should be on novel strategies such asquality of life (QOL) assessments that assess patient satisfaction.

Vitiligo has a reported incidence of 0.5 to 1 percent worldwide [6]. With an estimated 8.8% incidence rate, Gujarat, India, has by far the highest incidence worldwide [7]. Men and women both suffer from the condition [8,9], although women have been found morelikely to seek medical assistance. Young women (up to 30 years of age) have a much higher prevalence of vitiligo than young males [8,10]. Women peak by early adolescence, whereas males reach their peak by 45-60 [5].

One of the most challenging dermatological concerns is currently treating vitiligo. Nevertheless, recent years have seen the development of safe and efficient therapies. Therapies that may slow the conditions progression, transform depigmented patches, and promote repigmentation include phototherapy, systemic and topical immunosuppressive agents, and surgical procedures [11,12]. The type of vitiligo (segmental or non-segmental), severity, distribution, frequency, age of the patient, type of skin, and willingness to be consistent with therapy are the factors influencing the effectiveness of the treatment. Lips, hands, and feet are likelymore resistant to treatment, whereas the head, neck, face, abdominal regions, arms, and legs recover favorably [12]. Repigmentation first develops either at the edges of the lesions or in a specific type of pattern known as perifollicular." The treatments efficacy must be evaluated after at least 2-3 months. The most popular kind of treatment for vitiligo involves UV radiationand, when coupled with other therapies, has been linked to better results [13].

Vitamin B12 (also known as cobalamin) constitutes one of the nine water-soluble vitamins and one of the eight vitamin B types [14]. It is one of the most common deficienciesand, if left untreated, might result in blood and nerve disorders [15]. A non-vegetarian diet, including meat, eggs, and dairy products, is a good sourceof Vitamin B12. The normal B12 consumption is 2.4 g per day. Only fifty to sixty percent is absorbed [16,17]. Vitamin B12 has been shown to be useful for repigmentation in patients suffering from vitiligo. Folic acid (or vitamin B9)has been proven to besignificant for treating vitiligo.It needs to be included in the diet as the body cannot synthesize it.According to an original study conducted in the Birmingham Medical Center, the University of Alabama, 15 patients diagnosed with vitiligo were reported to have low levels of Vitamin B12 and B9. After administering eight of these patients with vitamin B12 and B9 for three years, repigmentation was observed[14].More research is needed to identify the correct dosage of Vitamin B12 and B9 and the duration for which the skin should be exposed to the sun[18].

Vitamin C constitutes one of the water-soluble vitamins. Majorly present in citrus fruits like lemon, kiwi, oranges, and green leafy vegetables. Vitamin C should be a part of a balanced diet. It has been indicated that vitamin C has antioxidant action and immunomodulatory characteristics[19,20]. Vitamin C is not used and is contraindicated in treating vitiligo as it disrupts the melanin production pathways[21].

Vitamin D is a fat-soluble vitamin that absorbs substances like calcium and magnesium. Vitamin D acts on the skin receptors and disrupts the growth and development of melanocytes and keratinocytes[22,23]. 25-hydroxyvitamin D (calcifediol) acts on dihydroxy vitamin D3 receptors on the melanocytes to initiate melanin secretion[24]. According to research, vitamin D levels impact the immune system as the immune system has enzymes/metabolites that can metabolize vitamin D, indicating that the immune system is also contributing to converting inactive forms of vitamin to active forms of calcitriol. This establishes a relationship between the normal functioning of the bodys immune system and circulating vitamin D levels. Any impairment in vitamin D levels would result in disruption of immune system physiology. It can be assumed that dysregulation of the immune system might increase the chances of developing autoimmune diseases. Therefore, if the proper dosage of vitamin D is administered in patients showing vitamin D insufficiency, the outcome of treatment for autoimmune disorders can significantly increase the chances of favoring the patient[25]. Still, insufficient medical evidence indicates that low vitamin D could result in vitiligo. Due to this relation to the immune system, it is highly recommended to include it in the therapy for treating vitiligo. Several studies have been conducted to understand the effect of vitamin D in vitiligo patients. According to a pilot study by Finamor et al., which comprised 16 patients, 35000 IU (international unit) of vitamin D3 was regularly administered every day for six months. Out of 16, 14 patients showed 25% to 75% repigmentation, concluding that supplementation of vitamin D could decrease disease progression[26].

More than three thousand proteins, such ashormones, enzymes, and nuclear factors, require zinc as a cofactorfor their normal functioning. Superoxide dismutase, a skin antioxidant, uses zinc as an enzyme cofactor [27]. Zinc also controls gene expression. Zinc may also inhibit melanocytedestructionsince apoptotic caspases are activated when intracellular zinc concentrations drop [28]. Combined with topical steroids, zinc has been proven to be a marginal advantage in managing vitiligo.Nonetheless, this needs additional investigation. However, treatment-related gastrointestinal adverse effects are a factor that limits zinc supplementation [28]. In an experiment by Yaghoobi et al., 13.3% of zinc-taking participantsreportedgastric discomfort [29]. Table 1 outlines the properties and impact ofthe supplements mentioned above on managing vitiligo.

An ancient Chinese plant, Ginkgo biloba (GB) has recently acquired considerable attention for its contribution to the treatment of a number of ailments, particularly vitiligo, dementia, macular degeneration, anxiety, and cardiovascular disease [30]. A decrease in cyclooxygenase activity and Tumour Necrosis Factor alpha's role (TNF-a)ininducingthe production of interleukin-8 and vascular endothelial growth factor (VEGF) are hypothesized to be the mechanisms of anti-inflammatory effects shown by GB [31]. These qualities shown by ginkgo have been claimed astherapeuticdue to the pivotal role of oxidative stress in the pathogenesis of vitiligo. Furthermore, as emotional anxiety wasfound to aggravate vitiligo, ginkgos anxiolytic qualities could slow downthe spread of the condition. The majority of individuals consume GBwithout experiencing any negative side effects, however mild gastrointestinal disturbance is the most frequent side effect. Ginkgo is a viable alternative medicine that has been found to slow the advancement of the illness and enhance repigmentation, according to the findings of two trials.

A species of fern called Polypodiumleucotomos (PL) has been investigated for its significance in the treatment of a number of skin problems, particularly vitiligo, psoriasis,atopic dermatitis, and in preventing UV-induced skin damage. Investigations have been done on the anti-inflammatory, antioxidant, photoprotective, and immunomodulatory properties of PL. When used with phototherapy, ingesting PL is used to boostthe efficacy of narrowband UV-Bin treating vitiligo [32,33]. It was furtherestablished that combining PL with PUVA (psoralen plus ultraviolet-A radiation) treatment results in an increased re-pigmentation. More participants who got >50% re-pigmentation were within the group undergoing PUVA along with PL than the group undergoing PUVA with placebo. All subjects saw the successful treatment of their condition following Anopsos therapy for five months, which is a hydrosoluble lipid derivative of PL [34].

Khellin is a crystalline extract from the plant Ammi visnaga and ithas been utilized in traditional medicine throughout the Mediterranean. Orally administered activated khellin is being studied as a promoter of melanogenesis and proliferation of cultured normal human melanocytes and Mel-1 melanoma cells. These have apossible role in photosensitizing vitiligo treatment when paired with UV therapy. In comparison to no treatment, the combination of4 percent preparation of topical khellinwith monochromatic excimer laser (MEL) treatment at 308 nm,effectively reduced depigmented lesions [35]. Althoughno discernible difference has been noted in theperformance of phototherapy alone and phototherapy with topical khellin, nosupport substantiatesthe claimed advantages of topical khellin [36].

Celiac disease (referred to as CD) is an autoimmune intestinal infection characterized byindividuals who have an adverse reaction to gluten. Damage to the intestinal mucosa, mostly in the form of diarrhea, abdominal discomfort, and other gastrointestinal symptoms, can result from the condition. According to several studies [37,38], people with CD had an increased prevalence of vitiligo than those without CD. Patients who are seropositive for CD immune cells and have autoimmuneskin diseases including psoriasis, dermatitis hepatitis, and vitiligo have reportedly experienced fewer symptoms after switching to a gluten-free diet (commonly referred to as GFD) [39-41]. Such type of knowledge is crucial for treating vitiligo patients because the intestinal symptoms are typically vague and frequently disregarded by medical professionals and patients. Additionally, people with vitiligo may benefit from CD screening and CD patients with an early diagnosis of vitiligo may benefit from GFD because it may help both illnesses. To further support these observations, large-scale, long-term follow-up investigations are necessary.

The amino acid phenylalanine (Phe) is hypothesized to operate as a possible cure for vitiligo due to its crucial role in the regulation of catecholamine, antibody synthesis, and most importantly, melanin formation. These form the basis of the autoimmune and neurological pathophysiology of vitiligo. Phenylalanine is hydroxylated to tyrosine, which is then used in the process of melanogenesis. Phenylalanine and tyrosine are also closely involved in the production of catecholamines. According to the neural hypothesis, the etiopathogenesis of vitiligo was associated with catecholamines released by autonomic nerve terminals, either directly or indirectly [42]. Phenylalanine or metabolite levels that disrupt catecholamine production may impact vitiligo onset or advancement. Each participant participated as their own control in a clinical investigation that investigated phenylalanines impact on vitiligo. After four months of UV-A treatment, the subjects received oral phenylalanine (50 mg/kg) twice a week for the first four months. When the treatments were administered separately, no improvement was detected.Upon administering phenylalanine along with UV-A irradiation, 94.7 percent of individuals exhibited follicular re-pigmentation and 26.3 percent exhibiteddense repigmentation [43].

Phyllanthus embelica Linn., widely recognized as amla fruit or Indian Gooseberry is extensively spread in China, India, Indonesia, and Thailands tropical and subtropical areas. Research has indicated that P. emblica has a strong antioxidant capacity owing to its high polyphenolic component and vitamin C content. P. embelica fruit was studied further in 130 subjects in association with carotenoids and vitamin E, which are commonly utilized in vitiligo treatments. In the research, 50 % of participantsonly got traditional therapies including phototherapy and topical medications. The second section of peoplereceived traditionaltherapy which included combining dietary antioxidants, vitamin E, and carotenoids thrice daily andtreatment with topical agents or phototherapy. According to these investigations,a higher percentage of patients in the antioxidant-supplemented group saw minor re-pigmentation in the head, neck, and truck regionafter six months. Antioxidants were not used in the group that had more erythema, more vitiligous patches, more inflammation, and faster vitiligous zone expansion [44].

In vitro studies have revealed that piperine, the main alkaloid in black pepper, stimulates melanocyte replication and causes the development of melanocytic dendrites. According to many studies, when UV exposure is present, piperine is recommended. Research has shown the impact of UV light on melanocytes is stimulated by piperin. Piperine only enhanced melanocyte proliferation and dendritic production in melan-a (mouse cell line) when it was not combined with UV-A. Mice given both piperine and UV radiation (UVR) experienced more pronounced pigmentation than mice given either treatment alone. Studies havepointedout that in order to prevent photoisomerization of piperine, UVR and piperine should be used in distinct phaseswhile treating vitiligo [45-47].

Nigellasativa is a perennial species of plant yieldingblack cumin, the oil isolates of which are often used to treat a range of illnesses, especially dermatological conditions. Thymoquinone, a primary ingredient of Nigella sativa is being carefully researchedas a key element possessing avariety of benefits, particularly for its anticancer, immunomodulating, and anti-inflammatory reactions [48-50]. Topical administration with Nigella sativa oil has been demonstrated to considerably enhancethe Vitiligo Area Scoring Index score within four months [51]. This mightbe a secure and efficient supplement for conventional vitiligo therapy.

One of the first fruit trees that have been planted is the pomegranate (Punica granatum Linn.) and it is high in polyphenolic chemicals and tannins. Thus, three to six glasses of commercially accessible pomegranate juice per day could be sufficient to provide antioxidant benefits [52].

The polyphenolic molecules known as catechins, which are part of the chemical class of flavonoids, are responsible for green tea's antioxidant properties. Epigallocatechin-3-gallate (EGCG) is by far the most common and therapeutically significant constituent of green tea. It has substantial antioxidant activity as a ROS/RNS (reactive oxygen species/reactive nitrogen species) scavenger withregardto providing potent anti-inflammatory characteristics which canmodulate the T-cell-mediated immunological response [53]. Studies demonstrated in two in vitro investigations that EGCG has a potent antioxidant impact on primary human melanocytes. In fact, EGCG reduced ROS production, regenerated impaired mitochondrial function, and lowered apoptosis influenced by hydrogen peroxide. In addition to this, EGCG alsocontrolled oxidative stress-triggered pathways in melanocytes exposed to this stress. Experimental investigations on mice showed depigmentation caused by monobenzone [54]. Studies demonstrate the immune-modulating and oxidative stress-attenuating properties of 2, 5, and 10% EGCG cream. There have not been any trials conducted on how EGCG affects humans so far.Additionally, it was recommended to consume 5 to 16 cups of tea daily to achieve itsantioxidant potential. The sole option appears to be EGCG extract supplementation rather than tea infusions [55].

The main naturally occurring lipophilic polyphenol present in the rhizome of Curcuma longa (turmeric) and other Curcuma species is curcumin, known as diferuloylmethane. Numerous studies revealed that curcumin shows strong and complex antioxidant activity which enables it to influence the antioxidant system both directly and indirectly as well as inhibiting the generation of ROS and its intracellular sources. One in vivo investigation revealed that when narrowband UV-B (NB-UVB) and tetrahydro-curcuminoid were combined topically on vitiligo patients' skin, the rate of skin repigmentation was marginally greater than when NB-UVB was used alone [56]. Table 2 outlines the properties and impact of the supplements mentioned above on managing vitiligo.

Read the rest here:

Diet and Vitiligo: The Story So Far - Cureus

A version of this article originally appeared on VICE Belgium.

Years ago, I was at my gynaecologists for a checkup. Thats when she told me totally out of the blue that I would never get pregnant in my current state. That was the word she used: my state, uttered with chilling bluntness. This conversation confused me, mainly because I was very young and we hadnt been discussing the topic at all; she hadnt even performed any actual tests to discern my fertility levels.

The state she was talking about was the size of my body, which is usually referred to with a plus prefix. My experience at the doctors is far from uncommon among fat people, as confirmed by the countless messages I received from the followers of my fat activist Instagram account.

My gynaecologist forbade me from getting pregnant. She said it would be and Im quoting her here irresponsible to do so, Cline said over DMs. Like everyone I spoke to, she preferred not to share her last name for privacy reasons. Another follower, Galle, was told she was infertile without so much as an exam. It really destroyed me And after all that, it turned out to be bullshit anyway. I got pregnant on my first try, she wrote.

Galles experience points to an unfortunate truth: As a fat person, it can be difficult to trust your doctor to give you helpful medical advice. Research shows that, on average, doctors spend less time with fat patients, build less rapport with them and perceive them more negatively. These biases often result in doctors looking at fat patients only through the lens of group averages rather than at their individual health markers and needs.

British fat-positive fertility coach Nicola Salmon knows this all too well. At 16, she too was told she wouldnt be able to get pregnant due to Polycystic Ovarian Syndrome (PCOS), a disorder that makes your period irregular and is often linked with weight gain and hormonal imbalances. I was told that weight loss would help to cure it; that was the only treatment I was given, she says. So I spent my teens and 20s trying to lose the weight, regaining it, going through that whole cycle.

Despite her diagnosis, Salmon said she had no problem conceiving. I was in my biggest body and I had 100-plus-day [menstrual] cycles. It really planted the seed in me of, Oh well, if conceiving worked for me, why are we told this, and what's the evidence behind it? Thats why she got into the field: to help people who are navigating fertility spaces in bigger bodies get access to health care, she explains.

Salmon believes most of the medical research used by healthcare professionals to make decisions for their fat patients is based on the underlying assumption that being fat is unhealthy and that fatness is something that we want to move away from, she says. When you look at the evidence from a weight-neutral perspective, from this idea that being fat is just body diversity, then you have to start unpicking a lot of the puzzle pieces.

So what do we know scientifically about fertility in fat people? On average, studies have shown that fertility decreases as Body Mass Index (BMI) increases, particularly with BMIs above 30. Higher BMIs are also connected to an increased chance of miscarriage and pregnancy complications, and with a lower effectiveness of IVF. However, these statements are often misconstrued to mean that all people with higher BMIs will have problems conceiving and birthing healthy babies, when in reality it all comes down to the individual.

BMI is an imperfect way of examining someones health. It doesnt take into consideration muscle mass, nor does it make a distinction between metabolically unhealthy and metabolically healthy fat people, who do not experience health issues typically associated with being fat. On top of that, decreased fertility doesnt mean no fertility at all, Salmon notes. Age, for instance, is also a complicating factor for couples trying to conceive naturally, but alternative treatments like assisted fertilisation can help.

Science hasnt found a causal link between fatness and infertility. We dont know if excess fat cells in someones body make them infertile, or if both symptoms are the result of another cause. This is particularly important, because, even though fat loss is routinely prescribed as a treatment for fertility, we have little evidence that it actually helps fat people conceive.

A 2017 meta-analysis of 40 studies found that weight loss seemed to help fat people conceive naturally, but made no difference during IVF treatment and did not improve their chances of birthing healthy babies. Besides, none of the studies separated the effects of dieting for weight loss from those generated by health-promoting behaviours such as eating well or exercising, Salmon adds.

Another study published in 2022 looked at 379 infertile women with a BMI above 30. They divided them in two groups: one on a restrictive diet and exercise regime aimed at weight loss, the other focusing on increased physical activity without weight loss goals. All participants were given fertility treatments after the lifestyle interventions. The study found no improvement in the womens fertility, which could mean their issues were not connected to their body weight.

When I ask what other reasons could be behind increased infertility in people with bigger bodies, Salmon says multiple things could be at play. One factor that is never really taken into account in research is weight stigma, she explains. When we are under any kind of stress, we have increased levels of the stress hormone [cortisol], which we know impacts our hormone levels and how we function, our physiology.

Weight cycling which is more prevalent in people with higher BMIs is also associated with health risks, including higher levels of inflammation and hormonal fluctuations, which could upset the delicate balance necessary for conception. And yet, when a fat person has trouble getting pregnant, many doctors will refuse to send them to get additional tests or to take their individual situation into consideration. The NHS, for instance, does not provide IVF treatment to those with a BMI above 25, and anti-fat discrimination is not illegal in the UK and in the EU.

For a follower named Melody, assisted fertilisation was the only path to conception. Her partner has a condition called cystic fibrosis, which makes 98 percent of male patients infertile. I ran into fatphobia so quickly I was told, We wont start you until you lose at least 45 kilos, Melody recalled. Running out of time and with her partners sperm quality declining, Melody finally decided to undergo gastric sleeve surgery, a procedure that removed two-thirds of her stomach. I dont regret anything I did, but obviously, Im sad I had to do it, she said. That decision came with so many consequences. But I wanted my baby more than anything.

And conceiving is just the beginning of the story, as discrimination and humiliation follows fat people throughout their pregnancy. Dont forget, when youre pregnant, no need to eat for two! a gynaecologist told Cline, adding she was astounded Clines fianc wanted to marry her at all. Sonia, another follower of mine, told her obstetrician he was hurting her during a visit, only for him to reply, I cant see anything with all that fat of yours.

Pregnancy was painful. People talked to me a lot about my weight much more than they talked about my baby, Annaelle wrote in a DM. Hearing people talk about me as if I was only a body, it was so dehumanising.

The same thing happened to Diane, whose story I found particularly hard to read. My whole pregnancy, people bugged me about my weight, she said. They said Id get gestational diabetes I didnt. They said my child would be born fat he wasnt. They told me I was going to have complications I didnt. Then they forced me to induce early, so that the baby wouldnt be born too fat full-term. Since the baby wasnt ready, they ended up having to do an emergency C-section. I haemorrhaged, the baby had respiratory problems their fatphobia almost killed us.

Anna, currently pregnant, was also told by doctors she would develop gestational diabetes. When I took a test, the midwife asked me for the results, she said. I told her I was negative, and she said Are you sure? I dont believe you! Show me. And I really was negative. I still cant bring myself to tell her how humiliated she makes me feel every time I go to see her.

Its not news that fat people are treated worse than others, but it still blows my mind that the medical profession is so hostile to us. Even if fat people are generally less fertile, they still deserve help and respect. But society judges fatness to be morally unacceptable; we are sympathetic to the plight of infertility in a thin person while we tell fat people that it serves them right to be infertile all they had to do was not be fat in the first place.

It's so upsetting because its not that our bodies are wrong, its the system around us that's wrong, says Salmon. Having helped dozens of clients throughout their fertility journeys, she finds that people will usually just need a slightly more tailored approach to their treatment. I have fat clients with PCOS who might just need ovulation induction as the only piece of the puzzle to go on and grow their family, but they just cant get that healthcare access, she adds.

Many contact Salmon because they are getting rebuffed by medical staff at IVF centres, who cite studies showing that the treatment has lower success rates in fat patients. But actually when you look at the research, they usually give all patients the exact same medication at the exact same time, without taking into account that a fat person might need a higher dose of the medicine or a different protocol, she says. We know that children, as they get older, will need higher doses of medicine, but we never take that into account when we're looking at fat people's biology.

As for me, I hope this article will give you hope and help you start a conversation with your doctors. Most of all, I hope it will give you strength to demand the dignity and kindness you deserve. No caregiver has the right to mistreat you.

The rest is here:

Fatphobia Sucks, Especially If You're Trying to Have a Baby - VICE

The word orthomolecular means molecular balance and its purpose is to correct imbalances in cells. It is based on the biochemical study of each patient, to find out the causes of diseases, it is biochemistry that is applied in clinical medicine. Undoubtedly, it is the preventive medicine of the future, especially for heart attacks, strokes, osteoarthritis, memory loss or diabetes, a different way to conceive medicine, restore the bodys chemical balance, right at the right time. Giving molecules, therefore no adverse effects have been recorded in their treatment. Prioritize nutrition as treatment. Orthomolecular medicine is considered a complement to traditional medicine and vice versa. I dont think this adjective deserves alternative medicine because its not a substitute, but a requirement that we need, first of all, to repair our biology, our body, and above all to provide it with the nutrients it needs. have taken. Then, when an organism is late or continues to change a lot, whether due to injuries, poisoning or trauma, traditional medicine will come to cure it with drugs, to help with the acute, whether it is antibiotics. Be it with, anti-inflammatory, or analgesic But drugs are always foreign to our nature, so they are accompanied by adverse effects. Orthomolecular drug treatments are based on vitamins, minerals, amino acids (protein building blocks), essential fatty acids, and enzymes. Diagnosis is based on each patients individual biochemistry, considering the elements that poison us today due to environmental pollution, water and soil contamination, radiation, nutritional deficiencies and psycho-physical stress. The aim is to reach the cause of the disease and not just reduce its symptoms. Preventive and curative, when the pathology progresses silently, orthomolecular medicine comes first, capable of using micronutrients to repair the altered biochemistry. By combating pre-existing disease, the engine can be restarted, knowing how to prevent future diseases and maintain quality of life.Orthomolecular medicine is characterized by healing using only the bodys own elements, in contrast to traditional medicine which uses drugs foreign to the body, through patches for each symptom: if pain occurs, a analgesics; an anti-inflammatory if there is inflammation; And if there is depression then an antidepressantthe anti-everything prescription we can depend on and accumulate its adverse effects.Traditional medicine is very effective for acute pathologies, such as appendicitis, pneumonia, a heart attack that has already occurred, or a stroke. Orthomolecular medicine, on the other hand, is effective in preventing chronic diseases such as osteoarthritis or atherosclerosis and prevents them before a heart attack or stroke occurs.This specialty, which has evolved and provides preventive and therapeutic measures for many diseases, has been in existence for more than 40 years. With an aim to spread and share knowledge, I inaugurated the first Ibero-American School of Orthomolecular Medicine (EIMO) in the country, which provides comprehensive training through online courses.

Dr. Maria Alejandra Rodriguez ZiaClinical Physician and Endocrinologist,

Specialist in Orthomolecular Medicine (MN 70.787)

Read the original:

Orthomolecular Medicine, A Predictive Tool - Nation World News

It has been a while since Ive written about this particular topic, which is why I think it a good time to revisit it, particularly given that over the last month there seems to have been a large uptick in antivaccine rhetoric centered around portraying COVID-19 vaccines as a new Holocaust and the concomitant desire for Nuremberg-style trialscomplete with hashtags on Twitter like #Nuremberg2, #NurembergTribunal, the ominous-sounding #Nuremberg2TickTock, and related hashtags targeting Anthony Fauci, Bill Gates, and other perceived enemiesfor public health officials, with punishment meted out afterwards for their crimes. Ihn these calls for Nuremberg 2.0, the proposed punishment can range from imprisonment (lock them up!) to truly bloodthirsty calls for the gallows. While I have written about this particular narrative far more extensively at my not-so-super-secret other blog, I have mostly only alluded to it here; so I thought it would be useful to discuss how the Nuremberg Code and Holocaust have been misused by antivaxxers for a long time. What we are seeing is nothing in terms of content. What is new is the volume and broad reach of the narrative. Basically, calls for retribution disguised as justice against public health and vaccine advocates have reached places that I never would have predicted before when I first started writing about them over a decade ago.

First, however, lets provide a taste of what I mean from antivax websites and social media. I will list quite a few examples, just to give readers an idea of what Im talking about. First, attorney and longtime antivaccine advocate Mary Holland published an article on Robert F. Kennedy Jr.s website entitled Those Who Violated Nuremberg Code Must Be Prosecuted for Crimes Against Humanity, which was the inspiration (if you will) for me to write this post, which is a transcript of her speech given for a conference entitled 75 Years of the Nuremberg Code Never Again Forced Medical Procedures, a public conference held on August 20 in Nuremberg to commemorate the 75th anniversary of the Nuremberg Code. Unsurprisingly, it was hosted by Action Alliance, which appears to be a a group of German antivaccine activists. Her speech was amplified by Mike Adams on Natural News, and one of the highlights that you might have seen being shared was a speech by a Holocaust survivor named Vera Sherav, in which she likened the COVID-19 response to the Final Solution and deemed it the New Eugenics in which this time instead of Zyklon B gas, the weapons of mass destruction are genetically engineered injectable bioweapons masquerading as vaccines. Meanwhile, antivaxxers are promoting narratives that COVID-19 vaccines are killing millions of people, an example being Steve Kirsch (whom Ive written about before here) claiming that as many as 12 million have been killed by them worldwide, and that they are killing people worldwide at a rate at least 6X faster than the Germans did.. (I kid you not; if you dont believe me, click on the link.) Unsurprisingly, Mike Adams is amplifying this claim as well, with headlines like 10,000 people A DAY being killed by covid vaccines; worldwide fatalities likely larger than the HOLOCAUST and The mass culling of the HUMAN HERD is now under way heres exactly how its being accomplished to achieve mass extermination.

Feel free to scroll past if you are one of those readers who so objects to embedded Tweets.

In particular, this narrative has resurfaced since COVID-19 vaccines were approved for children:

It is, of course, not limited to that at all:

Ill discuss these principles in a moment, in particular how they do not apply to COVID-19 vaccines and vaccine mandates. In the meantime, here are a few more examples:

Such calls are not limited to just vaccine advocates. Unfortunately, COVID-19 conspiracy theorists of all stripes have taken up the call, including those who think that COVID-19 originated in a lab leak. This particular example also shows how the narrative of a Nuremberg 2.0 has reached beyond the antivaccine fringe and been taken up by a number of politicians:

Anecdotally, more and more vaccine advocates, myself included, are reporting to me that they are being targeted with threats, and here are some receipts:

And my favorite, here are threats that everything I Tweet is being saved to use as evidence against me:

I note that, even though I now have over 72K followers on Twitter, the threats and abuse that I receive are nothing compared to what a number of other vaccine advocates receive, particularly as a result of the Nuremberg 2 narrative. So lets compare what the antivax narrative about the Nuremberg Code, which was promulgated as a result of the Nuremberg Medical Trials in 1947, with reality and discuss why antivaxxers have long abused them, to the point where I once coined the term Nuremberg Code gambit, much as I coined the term pharma shill gambit, to describe a common false narrative by antivaxxers and medical science deniers. If you understand what the Nuremberg Code actually says, its role in the history of bioethics and evolving protections for human subjects in medical research, and how it has now been largely supplanted by the Helsinki Declaration, you will be better equipped to understand why the antivax narrative is so harmful.

Vera Sharav and Mary Holland appearing at an antivaccine, anti-public health event disguised as a 75th anniversary of the Nuremberg Code.

If you look at the lineup of the event commemorating the 75th anniversary of the conclusion of the Nuremberg Trials, youll probably recognize a few names other than Mary Holland. For example, Tess Lawrie, one of the foremost promoters of ivermectin as a highly effective treatment for COVID-19, was a prominent figure at the event, as was Rolf Kron, an rel=nofollowantivax homeopath (but I repeat myself) from a COVID-19 resistance group called Doctors Stand Up. There were also groups of Holocaust survivors included, which was particularly distressing to me given my history of combatting Holocaust denial online dating back to the 1990s. I didnt watch the entire event, which is archived at RFK Jr.s website, but I watched enough and read enough transcripts to get the gist of the overall theme, which was, predictably, that COVID-19 public health responses, particularly the experimental vaccines, violate the Nuremberg Code.

I note with some amusement how Mary Holland includes in her talk an expression of disappointment that representatives from the governments of the Allies (the United States, the United Kingdom, and Russia) declined to take part:

I am especially honored to be here because the authors of the Nuremberg Code were doctors and lawyers from the United States who sought to prevent future horrors. And they built on medical and legal ethics established here in Germany before the Nazi regime.

I deeply wish that U.S., British, Russian and German government representatives were here to stand with us, as well as representatives of the global mainstream media.

It is a sad commentary that they are absent.

I wonder why these nations didnt send representatives. Could it be that they recognized this farce for what it was?

Lets see what Hollands narrative is, though. Its pretty predictable if you know anything about the antivaccine movement:

Tragically, in the last two-and-a-half years, we have witnessed a global assault on the Nuremberg Code.

Governments, medical establishments, universities and the media have violated the very first principle and every other principle of the codes 10 points.

They have coerced people into being human guinea pigs.

They have forced people on penalty of their livelihoods, their identities, their health, their friendships and even their family relationships to take inadequately tested, experimental, gene-altering injections as well as experimental tests and medical devices.

Those who have intentionally, knowingly and maliciously violated the principles of the Nuremberg Code must be punished.

They must be called out, prosecuted and punished for crimes against humanity. This is one of our key tasks.

We must stop this. And we must ensure this does not happen again.

See the narrative? Vaccine advocates have committed crimes against humanity in supporting vaccination against COVID-19 and vaccine mandates for certain jobs and activities. You can watch the whole thing at RFK Jr.s website, but theres no real need given that a complete transcript was published.

Throughout the rest of the talk, Holland portrayed the vaccines as experimental and deadly, stating at one point, In the U.S. and here in Europe, no vaccine has ever remotely compared to these injections the risk and death profile of these injections is unprecedented. They are not experimental, and, contrary to the claims of mass death due to vaccines, they are not deadly; indeed, they are amazingly safe.

As Ive said many times before, even when they were authorized under emergency use authorization (EUA) in the US, they had still undergone large phase 3 randomized clinical trials involving tens of thousands of subjects demonstrating safety and efficacy. Any pharmaceutical or vaccine that has cleared such a hurdle is, scientifically speaking, not experimental anymore. The term investigational is a legal term specific to the FDA and its mandate; all it means is that the drug or vaccine has not yet gone through the entire regulatory process in order to achieve full FDA approval. The mechanism of an EUA was designed to allow the FDA to act faster in the case of an urgent situation. If a global pandemic killing (then) hundreds of thousands of people didnt qualify, I dont know what does. Oddly enough, even after the mRNA-based vaccines achieved full FDA approval, antivaxxers continued to portray them as experimental.

Moving on, Ive been meaning to write about Vera Sharav for a long time. Indeed, she warrants her own post, and what I write about her here will be far briefer than is warranted. Before I go into her background as a Holocaust survivor and founder of a group ostensibly devoted to patient rights, informed consent, and, above all, the protection of human research subjects in medical research, lets take a look at a bit of what she said in her speech, which can be viewed in its entirety, again, on RFK Jr.s website, although the antivaccine blog Age of Autism helpfully provided a transcript.

To start out her speech, Sharav recounted her history:

In 1941, I was 312 when my family was forced from our home in Romania & deported to Ukraine.

We were herded into a concentration camp essentially left to starve. Death was ever-present. My father died of typhus when I was five.

In 1944, as the Final Solution was being aggressively implemented, Romania retreated from its alliance with Nazi Germany. The government permitted several hundred Jewish orphans under the age of 12 to return to Romania. I was not an orphan; my mother lied to save my life.

I boarded a cattle car train the same train that continued to transport Jews to the death camps even as Germany was losing the war.

Four years elapsed before I was reunited with my mother.

Sharav (born Vera Roll) had fallen victim to a move by the fascist government that ruled Romania and was allied with Hitler at the time, in which some 145,000 Romanian and Hungarian Jews to an area known as Transnistria along the Ukraine border, which became one of the most notorious killing fields of the war, with as many as 250,000 Jews were killed or allowed to die of disease and starvation. The Rolls were sent to a town called Mogilev, which had been turned into a concentration camp by the Romanians and Nazis. Her father died there of typhus within weeks of their arrival there.

In her speech, Sharav made an explicit parallel between the Final Solution and COVID-19 and more or less correctly blamed eugenics for the Holocaust. I say more or less because there was more to it than just eugenics, the belief that Jews were subhuman, and that German Aryans were the master race. He also believed that the Jews were working to destroy Germany and had decided that he had to destroy them before they could destroy Germany. In any event, she was correct that the Holocaust didnt happen all at once, observing that it did not begin in the gas chambers of Auschwitz and Treblinka, had been preceded by nine years of incremental restrictions on personal freedom, and the suspension of legal rights and civil rights, and that the stage had been set by fear-mongering and hate-mongering propaganda. While this description was correct, unfortunately Sharav then pivoted to liken the current climate to the escalating restrictions and persecutions of the Jews during the Holocaust:

By declaring a state of emergencyin 1933 and in 2020, constitutionally protected personal freedom, legal rights, and civil rights were swept aside. Repressive, discriminatory decrees followed. In 1933, the primary target for discrimination were Jews; today, the target is people who refuse to be injected with experimental, genetically engineered vaccines. Then and now, government dictates were crafted to eliminate segments of the population. In 2020, government dictates forbade hospitals from treating the elderly in nursing homes. The result was mass murder. Government decrees continue to forbid doctors to prescribe life-saving, FDA approved medicines; government-dictated protocols continue to kill.

The media is silent as it was then. The media broadcasts a single, government-dictated narrative just as it had under the Nazis. Strict censorship silences opposing views.In Nazi Germany few individuals objected; those who did were imprisoned in concentration camps. Today, doctors & scientists who challenge the approved narrative are maligned; their reputations trashed. They risk losing their license to practice as well as having their homes and workplace raided by SWAT teams.

What Sharav meant when she mentioned FDA-approved medicines was clearly the repurposed and unproven drugs hydroxychloroquine and ivermectin, neither of which are actually effective in treating COVID-19. As for the rest, you can see the same narrative that many antivaxxers have promoted that likens pandemic restrictions to another Holocaust at worst or, at minimum, to incipient fascism. I do have to wonder: Who are these physicians arguing against COVID-19 vaccines and for alternative treatments like ivermectin who have had their homes and workplace raided by SWAT teams? I like to think that Im up on all the latest COVID-19 news, particularly about contrarian doctors, and I dont recall ever having encountered a news story in which any of these doctors had their home or office raided by a SWAT team. Is she referring to Dr. Simone Gold, who was sentenced to 60 days in prison for trespassing in the US Capitol Building during the January 6 insurrection? Help me out here.

Of course, Sharav concluded her speech by bringing it back to the Nuremberg Code, warning:

Those who declare that Holocaust analogies are off limitsare betraying the victims of the Holocaust by denying the relevance of the Holocaust.

The Nuremberg Code has served as the foundation for ethical clinical research since its publication 75 years ago.

The Covid pandemic is being exploited as an opportunity to overturn the moral and legal parameters laid down by the Nuremberg Code.

The Nuremberg Code is our defense against abusive experimentation.

While it is not incorrect to state that the Nuremberg Code is important as a foundation for ethical human subjects research and that it is a defense against abusive experimentation, it is not complete to say that either, as I will discuss in the next section. In the meantime, Ill simply quote from near the end of Sharavs speech:

Transhumanists despise human values, & deny the existence of a human soul. Harari declares that there are too many useless people. The Nazi term was worthless eaters

This is the New Eugenics.

It is embraced by the most powerful global billionaire technocrats who gather at Davos: Big Tech, Big Pharma, the financial oligarchs, academics, government leaders & the military industrial complex. These megalomaniacs have paved the road to another Holocaust.

This time, the threat of genocide is Global in scale.

This time instead of Zyklon B gas, the weapons of mass destruction are genetically engineered injectable bioweapons masquerading as vaccines.

This time, there will be no rescuers. Unless All of Us Resist, Never Again is Now.

Thats right. Vera Sharav directly compared COVID-19 vaccines to the Zyklon-B gas that Nazis used as one of their main tools of mass extermination of the Jews. She also repeated an old antivaccine claim, namely the portrayal of vaccines as a form of transhumanism.

I started this section by mentioning that I had long been meaning to write about Vera Sharav. The reason is that she had aligned herself with antivaxxers years before the pandemic. For example, in this STAT News story from 2016, she expressed her belief that Andrew Wakefield had been railroaded:

But her distrust of the drug industry and medical research institutions has also led her to embrace some dubious heroes, including discredited British physician Andrew Wakefield, who falsified data to imply a link between vaccines and autism.

Wakefields medical license was revoked for a series of ethics violations, and most in the mainstream medical community blame him for raising unjustified doubts about the safety of vaccines. Yet Sharav puts him on her honor roll of exemplary professionals, along with Florence Nightingale.

My research and my gut tell me that Wakefield has been wronged, she said. One thing Ive learned from early in my life is that if I dont stay true to my gut feeling, then Im lost. I dont have any control.

That same news story also described her better history, how she had been a force for protecting human subjects in medical experiments, founding the Alliance for Human Research Protection after the death of her son, who had suffered from schizophrenia, from neuroleptic malignant syndrome, an uncommon but frequently deadly side effect of antipsychotic drugs that causes muscle rigidity and fever and can ultimately lead to organ failure and death. Ive perused that the AHRP webside before, but lets take a look at one of the two articles that greet visitors to its homepage:

That illustration by David Dees on the right is a classic antivax conspiracy image that Ive seen on quack websites going back at least a decade, if not longer.

Lets just put it this way. If you use an image by David Dees to illustrate your article, you have gone far down the antivaccine road. Worse, the image is blatantly antisemitic. Notice how the vaccine enforcement officer has a badge of the Star of David with the word Zion in it. As for the article itself, its a typical antivaccine-style screed in which adverse events recorded in the Vaccine Adverse Events Reporting System (VAERS) database are represented as definitely having been caused by vaccines when, in fact, anyone who understands VAERS knows that you cant do that. Seriously, both articles are nothing but standard antivax propaganda, and not even antivax propaganda chock full of conspiracy theories about COVID-19 vaccines that could plausibly be portrayed as human subjects protection. The same is true of the other article, in which vaccination is described in typical antivax language as a medical assault. Throughout the website, vaccines are frequently referred to as child sacrifice in articles dating back more than a decade. This pivot is not a pivot, and the antivax lean of AHRP is not new, nor is her demonization of COVID-19 vaccines new. She was doing it in 2020, an example of which comes from an interview from October 2020, as COVID-19 vaccines were making their way through the regulatory process. In the interview, entitled Nazism, COVID-19 and the destruction of modern medicine: An interview with Vera Sharav, Sharav characterized the push for a vaccine as being all about the profit, saying at one point:

You dont read about it in the media because the media is very much part of the business empire thats ruling that.

Vaccines are an empire, and now they really want to do a vaccine globally.

Do you know what kind of a market that is? More than 7 billion people for a vaccine. Can you even count the kind of profits, no matter what they charge for it?

Thats what their goal is. Thats the whole allure of this COVID 19 vaccine. Its that market.

You get the idea. What Vera Sharav was saying nearly two years ago was indistinguishable from the rhetoric I was seeing on hard core antivaccine sites, such as Natural News and, yes, RFK Jr.s website, where the interview was published. Her antivax rhetoric remains indistinguishable from that of RFK Jr., Mike Adams, Del Bigtree, Andrew Wakefield, and basically all the major antivax thought leaders (if you can call it thought). Whatever her achievements in raising awareness of shoddy human subjects research practices, the dangers of certain pharmaceuticals, the frequency of nontherapeutic research, and the increasingly cozy relationship between medical academia and big pharma, Vera Sharav has clearly followed others down the road from skepticism of psychiatric drugs to extreme distrust of pharma to outright antivax.

But what about the Nuremberg Code?

Nazi doctors facing justice in Nuremberg in 1947,

With the just completed discussion in mind, lets circle back again to the Nuremberg Code, a set of principles for human subjects research that published in 1947 as part of USA vs. Brandt et al (also often called the Doctors Trial) as one result of the Nuremberg Trials. The trial involved doctors who had been involved in Nazi human experimentation and mass murder disguised as euthanasia. Of the 23 defendants, seven were acquitted, while seven were sentenced to death. The rest received prison sentences ranging from 10 years to life imprisonment.

There are ten points to the code, which was published in the section of the verdict entitled Permissible medical experiments:

It is true that the Nuremberg Code remains one of the foundations of medical ethics governing human subjects research. It is, however, old and has been largely supplanted, for all practical purposes, by newer statements of human research ethics. While it is certainly true that these newer statements (which Ill discuss in a moment) echo many of the points of the Nuremberg Code, its also true they go beyond them.

Before I do that, though, heres the key deficiency in the arguments that antivaxxers have been using that invoke the Nuremberg Code is actually quite simple, as I once wrote over a year ago on Twitter:

To reiterate, the Nuremberg Code only applies to human experimentation. Notice how each of the ten points of the Nuremberg Code mentions the experiment or experimental treatments. The Code is not about medical treatment, only medical experimentation involving human subjects. I dont know how it can be made much simpler than that. Of course, the desire to appeal to the Nuremberg Code is why antivaxxers try so desperately to misrepresent COVID-19 vaccines as being experimental. Its also why I like to retort that no one was forced, co-erced, or otherwise mandated to sign up to be a subject in any of the clinical trials of the Pfizer or Moderna vaccines (or any of the other currently approved vaccines) that led to their authorization under an EUA and ultimately to their full FDA approval. Again, vaccines that have passed phase 3 clinical trials and been shown to be safe and effective are not, from a scientific viewpoint, experimental anymore. They might still be considered investigation from a legal standpoint because all that means is that they havent gone through the full FDA process yet, but thats it. Even while they were still being distributed under an EUA and before they were granted full FDA approval, From a scientific and medical standpoint COVID-19 vaccines being used ahave been legitimate medical preventative treatments, even when they did not yet have full FDA approval.

The second part of the Nuremberg Code gambit most commonly used is the deceptive appeal to informed consent. Of course, as I like to point out, while antivaxxers like to think they are really advocating for informed consent (and probably actually do think that), in practice, what they are advocating for is something that I like to refer to as misinformed refusal. (I used to call it misinformed consent before I realized that this term didnt quite catch the essence of what antivaxxers do.) Its an antivaccine trope that Ive been dealing with at least 17 years, if not longer.

Heres the idea. Antivaxxers vastly exaggerate the risks of vaccines and even attribute nonexistent risks to them (e.g., autism, autoimmune disease, sudden infant death syndrome) that are not at all supported by science. At the same time, they deny or downplay the benefits of vaccines, portraying them as largely ineffective and claiming that natural immunity from the disease is far superior to vaccine-induced immunity. Thus, if parents listen to the antivaccine narrative about the risk-benefit profile of vaccines, they will believe that the risks of vaccines outweigh the benefits. They might even believe that vaccines are not only ineffective, but dangerous, deadly even. Thats where my term misinformed refusal comes in. Its the refusal of vaccines based on misinformation that portrays a falsely unfavorable (and even terrifying) risk-benefit ratio.

The Nuremberg Code, as important as it has been in the history and development of human subjects protections during medical research, has largely been supplanted by the Belmont Report (published in 1976) and the Declaration of Helsinki. The Belmont Report, for instance, goes beyond the Nuremberg Code by delineating the boundaries between medical practice and research. It also rests on basic ethical principles of respect for persons, beneficence, and justice, while emphasizing the importance of voluntariness (as the Nuremberg Code), a detailed discussion of benefits and risks (informed consent), and the selection of subjects. The Declaration of Helsinki, last updated in 2013, is similar, but goes into much more detail about informed consent. It also addresses the ethics of the use of placebos, post-trial provisions, and the dissemination of results. It even addresses the use of unproven interventions in clinical practice outside of clinical trials.

Finally, in the US, the federal regulations governing human subjects research are enshrined under the Common Rule, which was originally instituted in 1981 and was last significantly revised in 2018. Basically, the Common Rule is the operationalization of the principles of the Belmont Report and the Declaration of Helsinki into regulations governing human subjects research carried out by the federal government, institutions that receive federal funding, and pharmaceutical and device companies seeking FDA approval for their products. It requires Institutional Review Board (IRB) approval and oversight of human subjects research, among other requirements for ethical human research and lays out the requirements for informed consent, as well as for research compliance by institutions. In effect, the Common Rule lays out the standard of ethics that govern not just human subjects research funded by the federal government or subject to FDA regulation for FDA approval, but in essence nearly all human subjects research. Almost all US academic institutions require their researchers to adhere to the Common Rule regardless of funding sources.

So why do antivaxxers always mention the Nuremberg Code and almost never the Belmont Report, Declaration of Helsinki, or the Common Rule when claiming that vaccine mandates somehow violate human subjects research protections and/or informed consent??] The reason is simple. Neither the Belmont Report, the Declaration of Helsinki, nor the Common Rule were written or promulgated in response to Nazi war crimes. The Nuremberg Code, on the other hand, was written as part of the verdict of the Doctors Trial at Nuremberg as a first attempt to codify what principles that should govern ethical human subjects research.

In other words, the simple reason that antivaxxers point to informed consent for (or, as I like to call it, misinformed refusal of) vaccines along with the Nuremberg Code is because its a Godwin. It not-so-subtly compares physicians, public health officials, and vaccine advocates to Nazis. Thats the one and only purpose of the Nuremberg gambit. If it werent, in order to try to portray vaccines as experimental or unproven, antivaxxers would instead refer to the Helsinki Declaration, which is the most recent and most applicable set of ethical principals governing human subjects research. They dont. That should tell you all you need to know about the Nuremberg gambit other than that COVID-19 vaccine mandates do not violate the Nuremberg Code anyway.

Unfortunately, the Nuremberg Code gambit is a Godwin that has permeated not just hard core antivaccine messaging. Indeed, its spread to pretty much every corner of COVID-19 contrarianism, minimization, and resistance to any sort of pandemic-related mandate, be it lockdowns, vaccines, or masks. Ill start by invoking a Tweet that has been cited on this blog before, mainly by Jonathan Howard:

Its interesting to note that Jeffery Tucker of the Brownstone Institute could have chosen pretty much any other image for his article, but he chose that of a guillotine, the symbol of the Reign of Terror, a series of executions and massacres after the French Revolution, with the guillotine being the favored method of individual executions. In the article, shared by Martin Kulldorff, one of the three writers of the Great Barrington Declaration, that propaganda piece of anti-Lockdown hysteria that basically advocated letting COVID-19 rip through the young and healthy population, the better to achieve natural herd immunity as fast as possible, while somehowits never really specified howusing focused protection to keep the elderly and those with chronic health conditions at high risk for serious disease and death due to COVID-19.

The first time that I first saw this image, I couldnt help but ask: If Tucker wasnt calling for executions, why did he and the Brownstone Institute choose a very menacing image of a guillotine? They could have chosen literally any other image, but they didnt. They chose a view of a guillotine that emphasizes the blade ready to fall, a very ominous and threatening image. (It very much looks like the view of a guillotine that someone near the front of the crowd baying for blood during the Reign of Terror might have hador the view that someone walking up the steps to be executed might have had.) If Tucker and the Brownstone Institute were really interested in portraying justice, instead of retribution, wouldnt an image of a courtroom or a juryor of virtually anything other than a guillotinehave been more appropriate? Did Dr. Kulldorff not even see the not-so-subtle message that such an image paired with an article like Tuckers broadcasts? As an aside, Ill also ask this question: Does anyone know who else used the guillotine as a method of execution besides le tribunal rvolutionnaire during the Reign of Terror? The Nazi regime in Germany! No, seriously, look it up if you dont believe me. Members of the White Rose resistance, for example, were executed by guillotine after show trials.

Reign of Terror or Nuremberg 2? Does it matter? The idea is vengeance against enemies of antivaxxers disguised as justice. This fantasy of retribution is not new, either, as I pointed out, referencing a 2017 post by an antivaxxer named Kent Heckenlively:

Note the same sort of imagery from a man who has in the past demanded the complete surrender of vaccine advocates, promising themmaybemercy if they recant and confess their crimes. These crimes? Given that at the time the predominant misinformation believed by antivaxxers was that vaccines cause autism, the crimes were advocating policies that make children autistic.

As I often say (admittedly sometimes ad nauseam) in the age of the pandemic, everything old is new again, and the same thing applies to the Nuremberg Code gambit. The difference is not the antivax fantasy of retribution against their perceived enemies, but rather that the language and rhetoric that was, until relatively recently, only associated with the hardest of hardcore antivaxxers, has started to wend its way into the mainstream, with right wing pundits like Tucker Carlson taking up the narrative, likening COVID-19 vaccine mandates to the cruel and grossly unethical that Nazis and Japanese carried out using prisoners during World War II, while mangling what Nuremberg is about by describing such mandates as forced treatment rather than abuse of human experimentation. Misunderstanding aside, this gave his interviewee, Robert inventor of mRNA vaccines Malone, the opportunity to thank Carlson for bringing up the Nuremberg Code:

Perhaps the most frightening thing about the pandemic is how antivaccine narratives once viewed as fringe even my most antivaxxers, the province of only the hardest of the hardcore, are now being amplified by mainstream pundits with millions of viewers and used by think tanks like the Brownstone Institute to stoke fear of vaccines and potential violence against vaccine advocates. Thats always been the purpose of the Nuremberg Code gambit. Unfortunately, today the chance of the Nuremberg Code gambit resulting in actual violence is higher than its ever been.

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COVID-19 vaccines and the Nuremberg Code - Science Based Medicine

Media Contacts Julie Kiefer

Associate Director, Science Communications, University of Utah HealthEmail: julie.kiefer@hsc.utah.eduPhone: 801-587-1293

Aug 23, 2022 10:00 AM

Millions of people worldwide live with multiple sclerosis (MS), a disease in which the immune system attacks cells in the central nervous system (CNS). MS causes unpredictable symptoms that can include tremors, weakness, vision problems, and fatigue.

Treatments for MS aim to protect neurons by reining in the immune system. This slows progression of the disease, but it also leaves patients more vulnerable to infection.

Now, a discovery from scientists at University of Utah Health suggests an alternative therapeutic strategy: restabilizing a natural barricadethe blood-CNS barrierthat breaks down in MS. Ordinarily, this barrier keeps damaging molecules away from neurons.

Multiple sclerosis develops when wayward immune cells destroy the protective sheath that surrounds neurons. Its exact cause is unknown, but clearly inflammation helps drive the disease. That inflammation worsens when, early in the disease, the protective blood-CNS barrier begins to break down, allowing fluids and proteins in the blood to leak out of blood vessels and enter the brain and spinal cord.

We think the breakdown of the blood-CNS barrier is causing a real problem, says Shannon Odelberg, PhD, research associate professor in the Department of Internal Medicine. So, if you can stabilize the vasculature and reduce that leak, you can reduce those proteins that do the damage, and you can reduce the inflammatory response.

In the journal Neuron, Odelberg; Weiquan (Wendy) Zhu, PhD, research assistant professor in the Department of Internal Medicine; and colleagues report that, in mice with an MS-like condition, the blood-CNS barrier becomes leaky when the cells that line blood vessels interior walls transform and lose the ability to assemble themselves into a tight-knit layer. They found they could restore the barrier by reversing this transformation. Once the barrier was repaired and inflammation-triggering molecules from the blood could no longer enter the CNS, damaged neurons began to recover, and the animals symptoms diminished.

We think the breakdown of the blood-CNS barrier is causing a real problem.

Zhu says researchers are just beginning to recognize how changes in the blood vessels that supply the CNS contribute to the neurodegeneration characteristic of MS. But evidence is accumulating that breakdown of the blood-CNS barrier plays a role in a number of conditions. Deterioration of the barrier has also been observed in studies of Alzheimers disease, Parkinsons disease, and Huntingtons disease. We think the breakdown of the blood-CNS barrier is causing a real problem, Zhu says.

Zhu and Odelberg knew that when the blood-CNS barrier breaks down, the cells that line blood vessels walls have often lost the physical junctions that usually link them tightly to their neighbors. This keeps harmful molecules from slipping between them, much like the linked arms in a game of red rover stop advancing runners. But when postdoctoral researcher Zhonglou Sun, PhD, took a close look at the CNS in mice with the MS-like condition, he discovered that the change to those cells went beyond the loss of these structural connections. The cells appeared to have taken on a new identity.

Sun discovered that some of the cells were no longer true endothelial cells, the type of cells that line healthy blood vessels. Instead, they had characteristics of mesenchymal cells, which do not produce the hinge-like proteins that link endothelial cells together. Normally, they're really held tightly together to keep this fluid in, Odelberg explains. But they lose those tight junctions when they convert to a mesenchymal cell type, allowing the fluid and the proteins to pass into the tissue where damage can occur.

With further experiments, the team was able to trace how cellular signals that promote inflammation also trigger endothelial cells transition to be more like mesenchymal cells. Once researchers had identified those signals, they found that they could block the transition with compounds that targeted any of three different points along the signaling pathway. Even when the transformation had already occurred, they could coax the mesenchymal cells in leaky blood vessels to revert to endothelial cells. Doing so stabilized the blood-CNS barrier. Damaged neurons began to recover, and the animals symptoms became less severe.

Further experiments are needed to better understand endothelial cells transition to mesenchymal cells and how to control it. But given the critical role of the blood-CNS barrier, Zhu and Odelberg hope that reversing or preventing endothelial cells shift to mesenchymal cells could protect the CNS in people with MSand possibly other neuroinflammatory diseases.

Immunosuppressive drugs that are commonly used to treat MS can introduce some serious risks to the patient, Zhu says. But the evidence suggests that the therapeutic strategy we explored in this study does not affect the immune system, thus providing a possible way to treat MS without causing the severe side effects associated with immunosuppression. Thats the potential benefit for the future.

- Written by Jennifer Michalowski

# # #

In addition to Odelberg and Zhu, co-authors are Zhonglou Sun, Helong Zhao, Daniel Fang, Chadwick Davis, Dallas Shi, Kachon Lei, Bianca Rich, Jacob Winter, Li Guo, Lise Sorensen, Robert Pryor, Nina Zhu, Samuel Lu, Laura Dickey, Daniel Doty, Kirk Thomas, Allie Grossmann, and Robert Fujinami from University of Utah; Zongzhong Tong from ARUP Laboratories; Alan Mueller from Navigen, Inc.; Baowei Zhang from Anhui University; Thomas Lane from University of California, Irvine.

The research published as Neuroinflammatory disease disrupts the blood-CNS barrier via crosstalk between proinflammatory and endothelial-to-mesenchymal-transition signaling in Neuron on August 11, 2022, and was funded by the National Institutes of Health and the National Multiple Sclerosis Society.

Research News iii Multiple Sclerosis

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Bolstering the Blood-CNS Barrier Could Lead to New Treatment Approach for Multiple Sclerosis - University of Utah Health Care

9/19/2020

I previously discussed an article from March 2020 by Drs. Eran Bendavid and Jay Bhattacharya titled Is the Coronavirus as Deadly as They Say? In this article, they wrote that,

If its true that the novel coronavirus would kill millions without shelter-in-place orders and quarantines, then the extraordinary measures being carried out in cities and states around the country are surely justified.

While Dr. Bhattacharya later tried to pretend these words dont mean exactly what they mean, he is not the sole author of the Great Barrington Declaration who has said things about these extraordinary measures that I agree with. On 9/19/2020, Dr. Martin Kulldorff said the following:

This seems eminently reasonable. For much of the pandemic, South Korea and New Zealand kept their COVID cases low through lockdowns to buy time for a vaccine.

On 10/4/2020 the The Great Barrington Declaration was published. It said,

Current lockdown policies are producing devastating effects on short and long-term public health. The results (to name a few) include lower childhood vaccination rates, worsening cardiovascular disease outcomes, fewer cancer screenings and deteriorating mental health leading to greater excess mortality in years to come, with the working class and younger members of society carrying the heaviest burden. Keeping students out of school is a grave injustice.

Keeping these measures in place until a vaccine is available will cause irreparable damage, with the underprivileged disproportionately harmed.

The Great Barrington Declaration said that those who are at minimal risk of death should live their lives normally to build up immunity to the virus through natural infection. Even though Dr. Kulldorff recognized that vaccines might be several months away, he wanted those at minimal risk to contract COVID before they were vaccinated. It falsely claimed that For children, the COVID-19 mortality riskis less than for theannual influenza, and said that,

We have seen only a handful of reinfections. If the virus is like other corona viruses in its immune response, recovery from infection will provide lasting protection against reinfection, either complete immunity or protection that makes a severe reinfection less likely.

Happily, Dr. Kulldorffs most optimistic projection about vaccines was spot on. Though the authors of the Great Barrington Declaration feared that Keeping these measures in place until a vaccine is available will cause irreparable damage, just two months later, something amazing happened. On 12/8/2020, 90-year-old Margaret Keenan stepped into history as the first person to receive a COVID vaccine outside of a clinical trial, and over the next several months, hundreds of millions of people were vaccinated in the fortunate parts of the world. The vaccines have since proven extremely effective at keeping people alive and out of the hospital.

Keep all this in mind when answering the question at the end of this article.

The tweet that opened this essay is one example amongst many where Dr. Kulldorff acknowledged that lockdowns drastically slowed the spread of the virus. Hes repeatedly said that lockdowns postponed the inevitable,and in January 2022, he acknowledged that many people had been able to avoid the virus for nearly two years, writing the laptop class is now getting infected with Covid. Dr. Kulldorff and I fully agree that interventions such as lockdowns helped postpone SARS-CoV-2 infections for millions of people until after vaccines were available and medical care improved. We just disagree on whether or not this was a bad thing.

While limiting COVID cases seemed to be an unambiguously good thing in the fall of 2020, when the population had negligible immunity and vaccines were plausibly just around the corner, the authors of the Great Barrington Declaration argued otherwise. Normal people feel the darkest days of the pandemic were immediately after vaccinations started in the winter of 2021, when 3,000 people were dying of COVID every day. However, proponents of infecting unvaccinated, young people reserve their outrage for the pandemics first months, when lockdowns prevented the virus from spreading. They wish more people had contracted the virus in 2020, and their pro-virus stance influenced politicians in many countries. For example, one headline from December 2020 declared,

We want them infected, Trump HHS Appointee Said in Email Pushing to Expose Infants, Kids and Teens to Covid to Reach Herd Immunity.

Though Dr. Kulldorff admits lockdowns helped postpone infections until vaccines were available, he views this a strike against them. Why is this?

Were he to admit that lockdowns were beneficial for this reason, hed be conceding that the arrival of vaccines in December 2020 rendered the Great Barrington Declaration utterly obsolete, which of course, they did. Vaccines meant that those who had avoided the virus thus far had a very attractive alternative to natural immunity. In order to maintain the illusion that his plan had any relevance in a post-vaccine world, Dr. Kulldorff has been forced to disparage vaccines, lockdowns, and all other measures that limit the spread of the virus. He even had the audacity to complain on 12/19/2020thatSpring #COVID19 #lockdowns simply delayed and postponed the pandemic to the fall. The very week that vaccinations began in the US, and as the deadliest part of the pandemic was starting, he argued that it was a mistake that hundreds of millions of people had postponed their infection. Think about how ridiculous that is.

As lockdowns interfered with his plan to infect unvaccinated, young people, Dr. Kulldorff now blames them for all sorts or maladies and issues unsubtle threats to decapitate those whom he deems responsible. He preposterously anointed himself as a spokesman for marginalized people and uses histrionic language to claim they continue to be harmed by lockdowns of varying stringency, that lasted several months, and ended nearly two years ago. For example, he wrote about the devastating lockdown carnage on children, workers and the poor and said lockdowns were the worst assault on the working class since segregation and the Vietnam War. He even blames lockdowns for variants, tweeting that they Generate more contagious variants, increasing herd immunity threshold needed for endemic stage, so more people infected. This is, of course, absurd, especially considering that in the same tweet he lamented that lockdowns postpone infections.

Even though 10 million children around the world lost a parent or caregiver to COVID, and 4 million Americans may be out of work due to long COVID, Dr. Kulldorff feels the children, workers and the poor would have been better off if the virus spread more freely among them before they were vaccinated. Hell never acknowledge what the virus has done to the people for whom he imagines himself an advocate.

Vaccines also interfered with Dr. Kulldorffs plan of herd immunity through mass infection, and to avoid recognizing their benefits, he now debases himself by consorting with anti-vaccine loons and fear mongering about vaccines based on a flawed study that misrepresents trial data. He absurdly argues that unvaccinated children should contract COVID because the flu is more dangerous. This is completely false, though even if it were true, this is not a valid argument against vaccinating children. With other viruses, Dr. Kulldorff recognizes its unacceptable for any child to suffer or die for lack of a vaccine. Its only with COVID that he argues such suffering is tolerable because the old have a thousand-fold higher mortality risk than the young. This too is a ludicrous reason to let unvaccinated children suffer.

If vaccines put the Great Barrington Declarations relevance on life support, the emergence of highly contagious variants capable of reinfecting people struck the fatal blow. To evade this obvious reality, Dr. Kulldorff been forced to fetishize natural immunity, claiming that The pandemic ends when enough people have natural immunity after Covid recovery. With herd immunity, we then enter the endemic stage. Even after the arrival of variants with immune escape, hes continued to act as a cheerleader for the virus. However, with reinfections now commonplace, its clear now that the only people who deny natural immunity are those who still claim it is robust and permanent. Even people with natural immunity benefit from vaccination, though Dr. Kulldorff wont admit this either.

Because his real goal has always been to generate outrage about measures that limited natural immunity, Dr. Kulldorff never bothered to formulate a workable plan as for how societies might actuallyprotect the vulnerable. Even even though this was the central aim of the Great Barrington Declaration, its entire plan consisted of the following four sentences:

By way of example, nursing homes should use staff with acquired immunity and perform frequent testing of other staff and all visitors. Staff rotation should be minimized. Retired people living at home should have groceries and other essentials delivered to their home. When possible, they should meet family members outside rather than inside. A comprehensive and detailed list of measures, including approaches to multi-generational households, can be implemented, and is well within the scope and capability of public health professionals.

Beyond this, the Frequently Asked Questions section of the Great Barrington Declarations website contains a handful of bland suggestions, such as saying an older family member might temporarily be able to live with an older friend or sibling, with whom they can self-isolate together during the height of community transmission. However, such statements are mostly inactionable pablum that look great on paper, but in reality have the same sophistication as my childhood plan to end crime by locking up all the bad guys. As Noah Louis-Ferdinand, who actually worked in a senior center at the pandemics start, wrote in a must-read critique, There was never any evidence that these flawed interventions could maintain zero COVID in one place despite rampant spread in the community.

Despite the complete absence of any real plan to protect the vulnerable, Dr. Kulldorff incredibly claims that without lockdowns, herd immunity would have arrived in 3-6 months. Even though the Great Barrington Declaration was published after lockdowns had ended in many parts of the world and after it became clear that natural immunity didnt lead to permanent immunity, Dr. Kulldorff insists he was proven correct, and the pandemic would have been over a year ago had we only listened to him.

This too is nonsense, and Dr. Kulldorff never provides any evidence for these grandiose claims. Its was always just a fantasy that not vulnerable people could be easily identified and then completely walled off from vulnerable people until herd immunity was reached. The pandemic would not have been over in 3-6 months had we let the virus rip through unvaccinated, young people. Some places tried that. They were falsely told they had protected the vulnerable, when in fact the vulnerable had been purposefully left defenseless and exposed. One country that hoped to achieve herd immunity through pediatric infections was instead rewarded headlines that read, Children Drive Britains Longest-Running Covid Surge and Twice as Many People Died With Covid in UK This Summer Compared With 2021.

Of course its unambiguously good that measures to control the virus allowed countless millions of people to avoid it until after they were vaccinated and medical care had improved. A fully vaccinated person who contracts COVID today has much better odds of a good outcome than someone who contracted it in March of 2020. Although Dr. Kulldorff will never admit it, even children benefit from vaccination. Someone who contracts COVID in 2030 will be better off still. Its good to try to postpone the inevitable. Even Dr. Bhattacharya wisely chose to postpone the inevitable until August 2021 after he was vaccinated.

Perhaps my position reflects my experience working throughout the pandemic at Bellevue Hospital in New York City. I saw what the virus could do to unvaccinated people, even those deemed not vulnerable. While we all regret the toll the virus took on essential workers, like my co-workers, its good that measures were taken to shield everyone else. Its ridiculous to claim that essential workers would have been better off if only more hedge fund contracted COVID in 2020.

Had the laptop class been infected en masse then the catastrophe that befell us in New York City and elsewhere would have been much worse. No one had treated this virus before, hospitals were deluged as it was, and the morgues were literally overflowing with bodies. Giant refrigerated trucks were parked outside my hospital to store them all. The carnage was from the virus, not the lockdowns.

Dr. Kulldorff, himself an exemplar of the laptop class par excellance, witnessed this all from his living room, which is just where he should have been. We essential workers wanted everyone, even sheltered doctors like him, to avoid the virus. So hell have to take my word for it, but no one in the hospital at that time bemoaned the fact that lockdowns protected the laptop class. Ive still yet to hear anyone in my hospital make this complaint. Ironically, its only the laptop class that complains locksdowns prevented them from getting COVID before they were vaccinated.

Though Dr. Kulldorff disparages lockdowns by saying they merely postponed the inevitable, so do seat belts and smoking cessation programs. Beyond just not dying, there can be great value in postponing the inevitable. A core goal of medicine is to postpone the inevitable, and one analysis from May 2020 found that,

36,000 fewer people would have died if social distancing measures had been put in place across the U.S. just one week earlier.

Sadly, millions of people failed to take advantage of the gift of a few extra months before they contracted COVID. Doctors tricked them into believing they were not vulnerable and that getting the vaccine was therefore ill-advised. Some of these people turned out to be vulnerable after all, and many of them expressed regret about not getting vaccinated just before COVID killed them. Dr. Kulldorff treated exactly zero of these patients, some of whom reacted with outrage and violence towards healthcare workers who actually have real-world responsibility.

Comparisons between countries can be tricky. Countries with older, sicker populations will fare worse than countries with younger, healthier citizens. Cultural factors, such as the willingness to wear masks/get vaccinated, and the ability to stay home when sick matter tremendously. So do living arrangements, the availability of advanced healthcare, and the reliability of reporting metrics. The timing of lockdowns matters, and the word lockdown means different things in different countries. The lockdown in Florida was very different from the lockdown in China. Moreover, the pandemic is not over and its effects will take years to manifest and understand.

Nonetheless, enough time has elapsed that we can begin to get a sense of whether or not South Korea and New Zealand benefitted from their efforts to keep COVID cases low. Everyone agrees that South Korea and New Zealand acted aggressively to suppress COVID cases. Both countries had a negligible number of COVID cases the first two years of the pandemic, and Dr. Kulldorff has repeatedly acknowledged that lockdowns are the main reason why.

The numbers dont lie. South Korea and New Zealand couldnt keep the virus away forever, but, they suffered many fewer deaths per capita than the US and nearly every other country in the world. Over 800,000 Americans would be alive today if the US had their death rate.

Moreover, while no one pretends lockdowns were harmless, Im unaware of evidence that South Korea and New Zealand suffered irreparable damage from their COVID policies, at least compared to other countries. Students in all three countries (USA, South Korea, New Zealand) suffered from remote learning and school closures, which were often due to the virus, not overly-cautious politicians. Even Sweden had to close high schools for awhile. While its fashionable amongst the laptop class to blame lockdowns for everything bad that has happened since, neither South Korea nor New Zealand suffered enormous collateral damage on cancer, cardiovascular disease, diabetes, tuberculosis, mental health, education as far as I know.

So the real question is this: Did South Korea and New Zealand damage themselves by postponing the inevitable, or would the US have benefitted had it tried a bit harder to postpone the inevitable? You tell me.

Dr. Jonathan Howard is a neurologist and psychiatrist based in New York City who has been interested in vaccines since long before COVID-19.

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Lockdowns Postponed the Inevitable. Is That a Bad Thing? - Science Based Medicine

Insomnia is identified by difficulty in maintaining sleep and early morning awakenings [1]. Consequently, it further causes workplace absenteeism, accidents, and a declinein productivity which imparts tremendous societal and economic impact [2]. One-third of the general population encounter insomnia symptoms across their lifespan [3]. Insomnia should not be confused with sleep deprivation, the former being the inability to sleep adequately, either in length or quality[4]. Most studies suggested predominance rates of insomnia disorder from 5% to 15% [5-7]. Insomnia could be a persistent issue in 31% to 75% of patients, with more than two-thirds revealing side effects for at least one year [6-8]. Due to the increasing work pressure and social challenges in an advanced society, most of the masses cannot get adequate sleep and suffer from sleep disturbance [9-12]. A detailed study shows that around 30% of adults suffer from sleep disturbance [7]. It mainly affects females and is increasing with advancing age [8]. Insomnia may be acute or chronic, and primary or secondary [1]. Primary insomnia can be defined as an individual experiencing a sleep disorder due to stress or emotions, while secondary insomnia can be due to co-morbid conditions or prior illness [1]. Insomnia has been associated with many comorbidities such as hypertension, cardiovascular disease, depression, obesity, and diabetes [2]. It can also lead to alterations in attention with episodic memory, and these cognitive impairments are clinically significant [1,2].Hence, to maintain an individual's overall health, the treatment of insomnia is necessary [9, 10]. Conventional methods of treatinginsomnia generally involve either pharmacotherapies or psychological interventions [11]. The use of such kinds ofdrugs can cause serious adverse effects such as cognitive impairment, oversedation, daytime drowsiness,rebound discontinuation,and psychomotor disturbance [12].In recent years, benzodiazepines (diazepam and related drugs) or nonbenzodiazepine hypnotics (zolpidem or zopiclone} have been chosen over older barbiturates which can cause death in cases of overdose. In older patients, sedating antipsychotics, e.g., olanzapine or quetiapine, and sedating anti-depressants with older tricyclic drugs, are generally regarded as "off label" [11, 12]. The new treatment guidelines evolved for benzodiazepine include low doses of sedating antipsychotics, antidepressants, and mood stabilizers [11].Although pharmacotherapiesand psychological interventions remain essential for conventional treatment, due to various motivational factors, interest in using alternative therapies and products for insomnia has developed over the last two decades.

One common treatment group used by patients with insomnia is complementary and alternative medicine (CAM) [5-7]. Research on adult insomnia patients hasfound that 4.5% of them practised CAM to treat their condition [9]. CAM use can be seen extensively among patients with mental disorders, commonly for managing depression or insomnia. CAM generally includes extensive therapies based on different geographical regions from various schools of thought [8]. Common CAM therapies for insomnia include herbal and nutritional medicine, acupuncture, acupressure, yoga, tai chi, and mind-body practices [10]. Mind-body interventions such as yoga help manage stress and anxiety, improving sleep quality[10].Protein source herbal supplement L-tryptophan is also usedfor the treatment of insomnia [11]. Acupuncture and acupressure have been found to restore the normal sleep-wake process. They can also be employed to increase the -amino butyric acid content, enhancing sleep quality [12, 13]. Considering the growing public interest in CAM, these therapies and products have been researched over the past two decades to treat sleep disorders. Although few systematic reviews have been conducted on the use of acupuncture and valerian in treating insomnia, butcomprehensive study on all primary CAM treatments has not been conducted. The present systematic review comprehensively explored the effects of CAM on improving sleep quality to guide evidence-based clinical decision-making and inform future research. We have systematically searched and evaluated the evidence for the impact of CAM on insomnia.

Data Sources

Several electronic databases such as MEDLINE, PubMed, Scopus, EMBASE, Clinical key, Cochrane, and Research gate were explored to search the relevant articles. The references to the articles were also examined. The search strategy was only restricted to research studies in English.

The PubMed search strategy was :(((((((((((INSOMNIA) OR (insomnia[MeSH Terms])) AND (complementary medicine[MeSH Terms])) OR (alternative medicine[MeSH Terms]))) OR (complementary and alternative medicine[MeSH Terms]))) OR Natural practicesOR Manual practices OR Mind-body intervention practices OR Acupuncture ORAcupressure OR Yoga OR Tai ChiAND (The Pittsburgh Sleep Quality Index[MeSH Terms])) OR (PSQI[MeSH Terms])) OR (sleep quality[MeSH Terms])) OR (sleep latency[MeSH Terms])) OR (adjustment sleep disorder[MeSH Terms]) (((("insomnia s"[All Fields] OR "sleep initiation and maintenance disorders"[MeSH Terms] OR ("sleep"[All Fields] AND "initiation"[All Fields] AND "maintenance"[All Fields] AND "disorders"[All Fields]) OR "sleep initiation and maintenance disorders"[All Fields] OR "insomnia"[All Fields] OR "insomnias"[All Fields] OR "sleep initiation and maintenance disorders"[MeSH Terms]) AND "complementary therapies"[MeSH Terms]) OR "complementary therapies"[MeSH Terms] OR (("complementaries"[All Fields] OR "complementary"[All Fields]) AND "complementary therapies"[MeSH Terms])) AND (("Pittsburgh"[All Fields] AND ("sleep quality"[MeSH Terms] OR ("sleep"[All Fields] AND "quality"[All Fields]) OR "sleep quality"[All Fields])) AND OR "sleep quality"[MeSH Terms] OR "sleep latency"[MeSH Terms] OR "dyssomnias"[MeSH Terms]

Eligibility Criteria

Eligibility criteria have been described with the PICO framework. Inclusion and exclusion criteria for participants, intervention, comparison, and outcomes have been mentioned separately in other sections of the article.

Study Design

Randomized controlled trials reporting outcomes of the effects of CAM on insomnia and sleep quality were identified and included. Observational studies, case reports, case series, case presentations, and case-control studies were not included.

Study Participants

Regardless of health issues, adults (18 years or older) were included in the study, except for those working shifts and time zone travellers.

Interventions

For the systematic review, we have included CAM studies, classified under "manual practices," "natural practices," and "mind-body practices." All psychological and psycho-educational interventions were excluded from the review, e.g., cognitive behavioural therapy, relaxation therapy, or mindfulness (regarded as mainstream therapies). Bright-light treatment, exercise, music therapy, sensory art therapies, and aromatherapy were excluded from the study (as these therapies were not considered classical CAM interventions). Melatonin, too, was excluded from the review as the substance is a hormone, not an exogenous natural medicine. A total of eight CAM intervention RCTs met the inclusion criteria.

Comparison

For comparison, we have compared the intervention with a non-active placebo or control.

Outcome Measures

Subjective and objective sleep outcomes were evaluated, including, but not limited to, sleep quality, duration, and latency. The Pittsburgh Sleep Quality Index (PSQI) and Insomnia severity index (ISI) were used as the outcome measure in most of the studies. Duration of intervention should be 1 week.

Study Eligibility

The authors KVand AS independently screened all titles and abstracts per the inclusion and exclusion criteria. Only full-text articles that were published in English are included. Any discrepancy was resolved with discussion among other authors. The searched files were imported to the Zotero library after removing duplicate items and were freely available, and Rayyan (https:// rayyan.qcri.org), a free web-based software, was used to review articles. From the selected eligible articles, required data, including administration of intervention and control, author, year of publication, study design, follow-up, sample size, outcome measures, results, effect size and quality rating, and primary outcomes, were extracted from eligible studies.

Data Extraction

KV and AS prepared a narrative synthesis for relevant research articles, including their outcomes, variations on intervention, types, and outcomes measurement. The methodological quality assessment of the RCTs was performed using the modified Jadad scale, a scientific quality index of 5/10 (on the augmented Jadad scale) [14].

KV and DSsystematically searched the articles through different search engines, but as per inclusion and exclusion criteria mentioned previously, we have reviewed the articles through Rayyan (https:// rayyan.qcri.org), free web-based softwareto be more precise for the inclusion and exclusion criteria.As mentioned in the flow chart, among 621 identified potential studies in the field of CAM and insomnia. A total of 96 studies were removed, due to small sample size (5), different study design (7), insufficient reporting (7), only protocol/meeting abstract available (22), non-adequate control (11), different outcomes (17), non-English (19), short duration (8). This left 35 clinical trials for inclusion, primarily comprising adult samples (except for the tai chi and yoga studies, which used an older population). These CAM studies were grouped under "manual practices," "mind-body," and "natural practices." Eight CAM interventions had RCTs that met the inclusion criteria. DS and KV calculated and reported effect sizes (Cohens d) in all placebo-controlled studies with the available data(Figure 1).

Manual Practices

The systematic review revealed 11 RCTs with manual practice intervention [15-25]. These studies involved acupuncture (inserting fine needles to stimulate "acupoints") and acupressure (using digital or blunt pressure on "acupoints"). The trials were between two and 12 weeks, with an average sample size of 70 participants. Seven of the 11 studies measured the outcomes in the Pittsburgh sleep quality index (PSQI). The insomnia severity index (ISI) was adequate for the outcome measure in three of the 11 studies. The average quality score was 6.8 out of 10[15-18]. Out of the four acupressure studies, they all revealed positive results on the PSQI scale with large effect sizes ranging from 1.42 to 2.12 when measured on various PSQI subscales [15-18].

Among these four acupuncture studies, one was negative, equivalent to either placebo acupuncture or basic sleep hygiene. At the same time, one was positive, equal to the positive control (clonazepam), or more effective than placebo acupuncture or positive control (estazolam). Yin et al. stated a large effect size d = 1.14 on sleep quality outcomes [19-25](Table 1).

Mind-Body Practices

There were 12 mind-body intervention RCTs of sufficient methodological rigour in this review[26-37]. The trial length was between four and 24 weeks, with an average sample size of 90 participants. Five out of the seven studies used PSQI as the outcome measure. The average rating of the quality of the studies was eight out of 10. The yoga intervention studies revealed a positive effect on wait-list control. Manjunathet al. and Mustianet al.studies found large effect sizes (d = 1.52) and d = 2.56 on sleep quality outcome measures [31, 32]. One study (Ward et al.) found no significant difference between yoga and control groups [30].

All five tai chi trials were positive on various PSQI outcome measures compared with health education or low-impact exercise [33-37]. Large effect sizes prevailed in sleep duration d = 2.15 and sleep quality d = 1.05 in Li et al. [35]. At the same time, a marked divergence was observed in Irwin et al. with a large effect size on sleep severity (global score) d = 1.57 compared to small effect sizes on sleep duration d = 0.22, and sleep quality d = 0.44 [37] (Table 2).

Natural medicine practices

The review identified 12 RCTs of sufficient methodological rigour [38-48]. Three studies included kava and valerian interventions. Six studies included valerian intervention [38-40]. Three studies included tryptophan intervention [13,47,48]. The trials were from two to eight weeks (commonly two to four weeks) with an average sample size of 150 participants. The herbal medicine kava met the inclusion criteria compared to the placebo. The analysis of Lehrl et al.'s study showed a benefit for kava over placebo on the quality of sleep outcome [40]. The valerian studies exhibited diversified results, with three positive (more effective than placebo and equivalent to oxazepam) and three negative results (equal to placebo) [41-46]. For most of the studies, effect size calculations could not be available. For L-tryptophan trials, the average quality rating was seven out of 10, while herbal medicines studies showed a higher rating of 8 out of 10. Among the three L-tryptophan studies, two were positive on several outcomes. Hudson et al., in their analysis, mentioned a large effect size on increased sleep duration d = 1.16, and a small effect size on sleep quality d = 0.28 [13] (Table 3).

A review of all quality studies suggested that CAM may have the potential to improve sleep quality in a variety of patient populations. Although evidence is limited, this systematic review, which includes studies published till Jan. 2022, provides evidence that CAM may be useful for the treatment of both uncomplicated insomnias as well as insomnia co-morbid conditions.

Despite the substantial clinical trial literature, several studies were excluded due to methodological shortcomings. Only35 English language RCTs met the inclusion criteria. In various RCTs of herbal medicine, mostly involving valerian, researchers employed a short study duration and small sample size, restricting the study's statistical power. Moreover, several acupuncture studies had an 'active' control group, mostly involving another type of acupuncture.

Many studies could not calculate the effect size due to negative results or insufficient data (e.g., no standard deviation). As a result, the effect sizes noted in the positive studies (in natural medicine and manual practices) should be tempered concerning the negative studies. Quality grading of RCTs has been displayed in respective tables of manual, mind body and natural medicine practice. The majority of RCTs for manual practice scored 7/10 for quality of grading. Most RCTs for mind-body practices scored 6/10 while assessing quality grading. Mostly, RCTs with natural medicine practice scored 8/10 score for quality grading.

Findings revealed that the evidence for natural medicine practices in treating insomnia was also conflicting. Valerian was one of the most studied soporific natural medicines for its rich folkloric tradition of use in conditions of restlessness, hysteria, headache, nervousness, and mental depression. As detailed in Table 3, the evidence regarding valerian was quite mixed and did not support its use in treating insomnia. These results follow thesystematic reviews and meta-analyses done byBent et al. and Taibi et al. [49, 50]. The study of Bent et al., which included 16 eligible RCTs on valerian and valerian in combination with other herbal medicines, suggests that nine out of 16 studies did not have positive outcomes concerning the improvement of sleep quality [49]. The Taibi et al. review, which included 29 controlled studies, consistently stated that most studies lacked any significant difference between valerian and placebo. Valerian, combined withhopsor kava, did not seem to support the available data. Kava may provide a prospective alternative for managing insomnia [50]. However, Lehrl's studies had a different opinion, and presently as kava is withdrawn in several jurisdictions, further studies about its safety and efficacy are much needed [40].

L-tryptophan, an exogenous amino acid converted into serotonin, has been widely studied in treating insomnia and depression [51].However, the results were encouraging but varied concerning different sleep outcomes. The studies on various animals and humans consistently suggest that L-tryptophan increases sleepiness and decreases sleep latency [51, 52]. It has been observed that the best results seem to occur in cases of mild insomnia with long sleep latency and the absence of any medical or psychiatric comorbidity [51, 52]. A study by Hudson et al. determined a large effect size on increased sleep duration and a negligible effect on sleep quality [13]. A survey by Irwin et al.consistently revealed a substantial effect size for tai chi in reducing insomnia severity. In contrast, sleep duration and quality effects had poor clinical outcomes [37]. The heterogeneous nature of samples throughout the studies made these effect size differences [37].

Acupuncture and acupressure seem to contribute to treating insomnia, probably by the neurochemical modulatory activity of serotonin, dopamine, and endogenous opioids [53]. The review by Cheuk et al.concluded with seven rigorous methodological trials that acupuncture and acupressure help improve sleep quality scores. Still, the evidence for acupuncture as a hypnotic intervention was inconsistent. Compared to control or no treatment, the efficacy of acupuncture and its variants was inconsistent among studies, including many sleep parameters, such as sleep onset latency, time to wake after sleep onset, and total sleep duration [53]. Further, Yeung et al. revealed that definitive conclusions could not be derived on acupuncture's efficacy for insomnia. This conclusion was reached due to the methodological quality of RCTs as the limitations of the study designs hampered studies. For instance, publications of such studies have also provided limited information about inclusion/exclusion criteria, outcomes measured, missing baseline data, randomization methods, and the specific acupuncture approach [54].

Mind-body practices such as yoga and tai chi in insomnia and different sleep disorders are enhancing popularity, particularly in the ageing population who might prefer low-effect exercises [35]. Comparatively, findings supported the benefits of exercise in improving sleep quality and reducing the severity of insomnia in older people. However, a Li et al. study compared tai chi to low-effect exercise and found it superior to low-effect exercises in all outcomes [35]. While Manjunath et al., the yoga study included older participants with sleep issues and noted yoga was superior to both wait-list and herbal medicine on sleep latency and total sleep [31]. Mind-body practices comprise multicomponent interventions, considered to give rise to similar physiological processes to traditional relaxation methods, which have been investigated as treatment options for insomnia [26-37]. Mechanistically, yoga acutely affects the activity of the autonomic nervous system and may decrease the gamma-aminobutyric acid levels and inflammatory markers. Probably by neurobiological pathways, yoga may improve sleep quality [28, 29]. Data from small RCTs suggested that yoga improves subjective and objective sleep quality, reducing insomnia symptoms in adults with chronic medical conditions [26, 28, 29, 31]. One of the largest RCTs of Yoga illustrated reduced hypnotic medication use in cancer survivors with sleep disturbance by 21% in the yoga group compared with 5% in the control group [32]. However, several emerging clinical trials on yoga found that most participants faced a general sleep disturbance. Moreover, yoga studies includingpranayama, breathing exercises, gentle hatha, restorative yoga asanas, and meditationassessing sleep outcomes showed common methodological limitations of sample sizes and limited use of objective outcome measures [27-32]. Further studies on yoga are encouraged with participants with a confirmed diagnosis of insomnia using validated sleep assessment scales.

Similarly, in studies for tai chi intervention, the focus was more on sleep quality rather than insomnia. Several RCTs suggested improvement in reported sleep quality, with tai chi intervention, particularly among older adults. Therefore,tai chimay improve sleep quality in different populations, specifically older adults [33-37]. Its impact on objective measures in chronic insomnia needs further explained.

In reference to data from the United States National Health Interview Survey, 17.4% of adults (n= 93 386) reported insomnia or regular sleep disturbance, and 4.5% used CAM therapies to improve their sleep quality. 56% of the individuals said that CAM was essential to maintaining their overall health and well-being, while 72% observed that CAM improved insomnia disorders significantly. Younger and highly qualified persons believe in CAM to improve insomnia symptoms [55]. It has been noticed that traditional Indo-Asian therapies such as acupuncture, acupressure, and yoga were morewidely studied compared to standard Western CAM therapies. The broadly researched herbal medicine is valerian in the form of monotherapy or combination with hops or kava [13, 15-48]. Future research in other herbal medications or Western CAM therapies with potential hypnotic effects is recommended as current research in these areas is insufficient.

The strengths of this systematic review included the search and synthesis of all relevant studies across several databases, the rigorous methodological inclusion criteria, and a quality assessment of all clinical trials with calculations of the effect size of studies.

This review also had some limitations. These were language constraints, as we excluded non-English publications; several valerian studies were published in German, and acupuncture studies were published in Chinese. Secondly, it lacks appropriate clinical trials with methodological weakness, for instance, adequate sample sizes. While reporting complete data, the long-term efficacy and safety of CAM interventions should have been employed.

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Whenever we think about natural medical treatment, only one word clicks in our mind, i.e., India. Moreover, when it's about less toxic and unpainful treatment, Ayurveda treatment is one.

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How effective is Ayurveda treatment?

Detailed research is required in the specific segments of Ayurveda, especially diagnostic principles. This way, Ayurveda diagnosis can be implemented as an effective treatment with effective strategies. Ayurveda is entirely science-based with solid explanations in a logical manner termed Darshana.

The world we are living in today is becoming toxic day by day. The stressful lifestyle disturbs the equilibrium of our mind and body, which further leads to health-related issues. The adverse effects can be seen physically and emotionally, making us seek medical intervention. This is the point where Ayurveda needs an adaption by us.

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Ayurveda is founded in the belief that good health is based on a balance between the spirit, mind and body. The three most revitalising Ayurvedic forms are Ayurvedic massage, panchakarma Treatment and Ayurvedic therapy.

Another essential facet of Ayurveda is that everyone in the world is made up of five elements: air, fire, space, earth, and water. All these elements together form three different energies, also known as doshas. The three doshas are Vata Dosha, Pitta Dosha and Kapha Dosha. Vata Dosha represents air and space. Pitta Dosha represents water and fire. At the same time, Kapha Dosha means earth and water.

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Ayurveda As Alternative Medicine: Research And Development To Be Taken Ahead By Heal In India - Entrepreneur