Category Archives: Alternative Medicine

SOUTH SAN FRANCISCO, Calif., March 18, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction will be presented in a Late Breaking Clinical Trial session at the American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21) by John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, GALACTIC-HF.

Title: 410-16 Impact Of Ejection Fraction On The Therapeutic Effect Of Omecamtiv Mecarbil In Patients With Heart Failure And Reduced Ejection Fraction: A Secondary Analysis From GALACTIC-HF (Global Approach To Lowering Adverse Cardiac Outcomes Through Improving Contractility In Heart Failure)Presenter: John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, GALACTIC-HFDate: May 17, 2021Session Title: Late-Breaking Clinical Trials IVSession Time: 8:00 9:15 AM ETPresentation Time: 9:00 9:10 AM ET

About Cytokinetics

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is preparing for regulatory interactions for omecamtiv mecarbil, its novel cardiac muscle activator, following positive results from GALACTIC-HF, a large, international Phase 3 clinical trial in patients with heart failure. Cytokinetics is conducting METEORIC-HF, a second Phase 3 clinical trial of omecamtiv mecarbil. Cytokinetics is also developing CK-274, a next-generation cardiac myosin inhibitor, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics is also developing reldesemtiv, a fast skeletal muscle troponin activator for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is preparing for the potential advancement of reldesemtiv to a Phase 3 clinical trial in ALS. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.

For additional information about Cytokinetics, visit http://www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the GALACTIC-HF clinical trial, statements indicating that the actual top-line results of the GALACTIC-HF clinical trial will be available or presented at the Late Breaking Clinical Trial session at the American Heart Association (AHA) Scientific Sessions 2020 or at any other specific time or event; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the timing and likelihood of any regulatory submissions or approval of omecamtiv mecarbil, Cytokinetics' and its partners' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics' other drug candidates. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; standards of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including milestones and royalties on future potential product sales under Cytokinetics' collaboration agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.

Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Communications, Investor Relations(415) 290-7757

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Cytokinetics Announces Secondary Analysis From GALACTIC-HF to Be Presented in Late Breaking Clinical Trial Session at American College of Cardiology...

Dr. Catherine Claunch is pelted with rain as she walks out into the parking lot. She doesn't have a jacket, because she was in too much of a hurry to speak with her client. As she strides towardthe SUV, the dog inside barks for attention. A veterinarian at Holden Animal Clinic, Claunch has done her fair share of talking about cancer never an easy topic, even when she didnt have to do it in all kinds of weather. She could have called from inside, but she firmly believes there are some things that should be discussed face to face. With COVID restrictions and owners unable to come into the clinic, she goes out to them. She taps on the window before stepping back the requisite six feet.

Vets have never shut down during the pandemic and despite restrictions, they have tried to ensure the same quality of care that they provided before the pandemic. This places them in the category of essential workers who, according to the Centers for Disease Control, provide a range of services for which remote work is not practical. To limit exposure, owners call the front desk upon arrival in the parking lot, staff meet them briefly outside and the patient is handed off. Any other interactions between the clinic staff and owner are done remotely except perhaps in situations like Claunchs. After a year, this has become the new normal for both sides, but familiarity does little to make the system any less cumbersome.

Building trust needs to be done face to face and cannot be done over the phone, said Claunch. Zoom and other video conferencing tools are often not practical due to spotty internet, so the pick-up, drop-offand communication systems have had to be continuously refined balancing safety, efficiency, as well as patient and owner comfort. I try to work with them in whatever way makes them more comfortable, she said, like with speaker phone calls and spending time talking in the parking lot in all kinds of weather, rain and snow.

Thanks to an architectural quirk, Dr. Karen Fine of Central Animal Hospital in Leominster has been able to see her four-legged patients while at the same helping her two legged clients deal with their separation anxiety. Im lucky because my clinic has two exam rooms with windows that clients can look through and see their animal on the table I can open the window to have a conversation, while meeting social distancing guidelines.Even though winter has cut down on this practice, Fine said many still find it easier in some cases to deal with the chilly temperatures than talking on the phone before and after the exam.

While clinic visits may be easier for Fine, COVID restrictions have affected her practice in other ways. Fine practices a holistic approach which integrates both conventional veterinary medicine with alternative treatments such as acupuncture and herbal therapies. I used to leave the dogs with the needles with the owners for 20 minutes while I saw other patients, she explained. Now that clients can no longer come into the clinic, alternative treatments have become much more time consuming, as the pet needs to stay with an assistant. Its just one of all these little logistical things that are affected by the owner not being there, said Fine.

Even though not being physically present is rough for both clients and vets, Claunch is amazed how many pet owners, especially new ones who have never met her face to face, have been willing to work with her on the restrictions. On the whole, people have been very understanding, she said, but we still have pushback from some who say Im not going to bring my animal in if I cant be with them.' These individuals will often ask if she can make an exception, not realizing how many others before them have made this exact same request.

As a small practice of about 15 people, Holden Veterinary Clinic has little room for error. It really just comes down to safety, Claunch said. Were all on top of each other. So if one of us gets sick or exposed, theres a high likelihood it will spread amongst the staff so well have to shut down and then no one gets help. She appreciates that clients have extended their trust, especially since she is a pet parent herself, and knows firsthand about the very special bond between pet owners and veterinarians.

In addition to the trickier logistics of acupuncture, Fine has also had to suspend her 25 year practice of house calls. It was really, really hard to stop back at the beginning when everything was just being canceled, she recalled. It could have been worse, however as COVID struck at something of a transition point in her career. Currently, Fine divides her time between the Leominster clinic for two days a week, where a lot of her house call clients now visit, and writing a textbook on narrative medicine in the veterinary field. She will also be teaching a course on the topic at the Cummings School of Veterinary Medicine at Tufts in Grafton.

Though the window set-up that Fine implemented made clinic visits less stressful on both owners and pets, Fine still receives her share of problematic clients in terms of COVID protocols, especially since the clinic has been busier than ever. When youve been working nonstop with no lunch break or even a bathroom break, its hard when someone gives you attitude when youre just trying to be safe, she said.

There are two primary reasons for the increased caseload. The first is more new animalcompanions being added to families, who now need their check-ups and vaccines. The one bright spot of COVID is that people adopted more animals, said Sheryl Blancato, president and founder of Second Chance Animal Services, an adoption and community veterinary organization.

Another is that remote working people are spending more time with their animals and notice more potential issues. Claunch can readily attest to this for a while, we were so overwhelmed with people bringing current patients that we had to shut down new clients for a while. Everyone was home, paying attention to their animals and noticing things they wouldnt have before.

Everything from breathing funny to finding new lumps on their bodies patients were brought in with symptoms their worried owners had never seen before, if only because they had not been around to observe them until now. One case is a perfect example of both this phenomenon and the occasional absurdity and humor that comes with working in pandemic conditions. Claunch received a call saying a dogs stomach was making wheezing noises. She initially thought it was a respiratory issue but the dog was breathing fine and not making the same noises at the clinic, so the only thing to do was wait until he did. After about 20 minutes, she heard a gurgle. Since the owner wasnt there to identify if this was indeed the sound, Claunch had to call her up and do her best with her vocal chords to imitate the dogs stomach.

Thats how far weve come imitating noises over the phone. Im used to coughing and hairballs but stomach noises were a new one for me, she said laughing, but it turned out the dog had gas. [The owner] was worried since shed never heard this noise before, said Claunch, but when you think about it, the dog probably makes this noise during the 12 hours a day the owners out. A simple probiotic sorted the issue.

In some cases, problems can be caused by more time spent with animals. Claunch has seen more knee injuries in dogs because they are getting so much more playtime, sometimes more than their bodies are used to extended ball or frisbee sessions raising the probability of injury. Adding new clients to the mix opened up a floodgate I think I had five new pets in one day. Three puppies and two kittens and at least three of those were with new pet owners altogether, said Claunch.

As Americans found themselves at home, with their lives seemingly at a standstill, many chose to combat the isolation with a new companion animal. Others found they finally had the time to train and care for that dog or cat they always wanted. Some were first-time owners while others had not had a pet in years both meant new clients for veterinarians across the country.

The animals who share our homes play an important role in supporting our physical and mental wellbeing during the pandemic. Everyone has this different lifestyle [with COVID], so every pet is an emotional support animal right now, said Fine with achuckle.

However, while many days it may feel like life will never return to normal, with the vaccine rollout in full swing, there will come a time when people are no longer at home as much as their pets have grown to expect. So what will be the reaction of pets who have known nothing but the round the clock company of their owners?

I am extremely worried about separation anxiety when people go back to work, Claunch admitted. She strongly recommended that both new and experienced owners begin practicing now for that eventuality, though admitted its hard to not want to spend every possible minute with an eight-week-old puppy.

Fine agrees that return to work routines, home renovation, or kids going back to college can stress animals, dogs especially. She recounted an incident where a family dog had been vomiting, not acting like himself and going into his crate to rest. The owner was surprised when Fine said it was more emotional than anything else the sudden departure of a family member was a major disruption in the dogs routine, with the stress manifesting in physical symptoms.Not only was the dog missing the boy, Fine said, but he was also likely reacting to the mothers stress over her son returning to college. When we get stressed, they get stressed. Were more like dogs now, and change is a little harder for us.

Regarding easing into post-COVID life, Fine agrees with Claunch. Im a fan of crate training because it keeps them safe and keeps your house safe, she said. Sherecommends making the crate a really fun place such as using a reward they dont get anywhere else be it a special toy or particularly tasty treat (she personally uses baby carrots cooked in chicken broth).

All that being said, both vets agree that its still not a bad time to get a puppy as there is more time than ever to focus on essential behavior training. Work with their paws every day, practice brushing teeth, Claunch encouraged. All those things that you used to run out of time for during the day. Teaching the sit and stay commands are especially important and will pay dividends when homes start receiving visitors again, so a dogs enthusiastic greeting doesnt cause problems."

Throughout the pandemic, the primary concern of most veterinarians has been how to maintain smooth, uninterrupted communications with their clients. For instance, if Claunch finds a new lump, she can turn to the owner and ask "have you seen this, how long has it been there, can I evaluate this further?"and so on. Instead, I have to finish the exam and take notes to review, then call the owner about the lump, ask about more testing, run the tests; so its much more of a piecemeal feeling and doesnt have the smooth flow that we used to have.

Owners are also looking for an alternative to current clinic protocols and Dr. Cindy McGinn offers one. If pet owners cant come into the vet clinic, the vet will come to them. McGinn runs Homecare Veterinary Service in Worcester, and travels to the homes of clients in neighboring towns. Her practice has been excessively busy since the pandemic began with clients calling on her, when they could not accompany their animals into other clinics. Were a small business and cant afford to just stop so we never did, said McGinn.

Initially, McGinn had appointments outdoors but in the cold weather, she had to go inside homes. People didnt want to do curbside care, but being inside their homes, she has to constantly remind people to keep their masks on. She recounted how she struggled with emotional burnout when she received calls for euthanasia because owners did not want to hand their pet over at the door, wanting to be with them at the end.McGinn said, its a stressful job when your patients need you and you cant be there for them when you want to be.

Weve realized how much our animals mean to us, observed Claunch. I think we sort of knew but didnt quite know just how important until we had people taken away during the shutdowns. Theres nothing like going home on a hard day for me and having a little snuggle. Unfortunately, with the economic fallout of the pandemic, many people have had to give up the emotional lifeline provided by pets, being unable to keep them due to job loss or having to pay for their own healthcare.

All animals provide emotional support, saidBlancato. To that end, Second Chance Animal Services offers subsidized veterinary care at their three, soon to be four, different animal hospitals. Like other operations, Second Chance has seen a marked increase in clients since COVID. Blancato said numbers have been two to three times higher than usual, requiring them to hire more vets and techs. The initial months of the pandemic were the hardest, as supplies (personal protective equipment and medicine) became hard to come by.

After about six to eight weeks, things started to ease back, she said, and Second Chance began to find its feet, focusing on under-resourced areas and providing access to vet care so people could keep their pets during the time they needed them most. However, to do this safely required them to get creative.

Second Chance proved they could do that when they adapted their existing mobile vet service, which offered free vaccines for pets in low-income areas. It was extremely popular and could attract as many as 400 people at a time. However, under pandemic circumstances, social distancing was impossible. Rather than suspend it, Blancato said they implemented a pre-registration protocol where people chose time windows to maintain social distancing and when we go back out this year, were going to keep using that. It helped streamline the system, staff love it and people dont have to stand in line for hours.

While it is clear that we need veterinarians to be creative and keep doing what they do for us, it is a heavy lift and they put themselves and their staff at risk. In terms of vaccination priority, veterinarian status varies by state. In California, they were included in phase one, along with other healthcare workers. In Massachusetts, they are listed under phase three with the general public.

Honestly, its really upsetting, said Claunch, Out of all of the industries in this state and all the places that are essential services, we have never stopped. Holden Veterinary Clinic has not taken even one day off from COVID-related causes. While they have been able to limit exposure through rigorous safety and cleaning protocols, the constant stress added to their regular work takes a toll. I feel very strongly that we are providing an essential service, said Claunch.

While the state vet association has been working to raise their priority, Fine agrees that the current situation is frustrating. We are in close contact with both the public and with each other, she said. There is no question for her that the vaccine would help everything go smoother and safer.

So next time you take your companion to the vet, and want to grumble about the hand-off ritual and phone calls from the parking lot, bear in mind that you and your pet do this once. Were doing this 20 to 40 times a day, said Claunch.

Everyone Fine knows is exhausted as well. Were doing the best we can," she said,"but between the vaccine and spring coming up, theres light at the end of the tunnel.

Blancato agrees that things have come a long way and the outlook is brighter now. When this first started, I didnt know what we were going to do. Everybody was in panic mode at the beginning and worried for themselves and their families, but we were inventive and were able to continue when others couldnt. So proud of my staff now.

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Dogged determination: Central Mass. veterinarians on the front lines of COVID - Worcester Mag

Introduction

There has been a growing unmet need in veterinary medicine to provide solutions that do more than just address symptoms. To address this unmet need, autologous devices which process and concentrate a patients own blood have been explored. While some have called this area of practice regenerative medicine we prefer to use the term orthobiologics as it more accurately describes the devices and their outputs. Whole blood contains growth factors and cytokines which play a role in inflammation, tissue, and joint healing. There are distinct classes of blood concentrating devices in veterinary medicine including Platelet-Rich Plasma (PRP),1 Autologous Conditioned Serum (ACS),2 and Autologous Protein Solution (APS) devices.3 They isolate and concentrate different factors from blood and have been historically used for varying applications. Traditionally, PRP has been used for tendon and ligament disease or injuries in human and veterinary medicine.47 PRP devices have been explored and used in canine medicine for the longest time period, particularly in dental reconstruction research.810 ACS devices were introduced for injection into the joint to address osteoarthritis (OA).11,12 In typical ACS device processing, blood is clotted with glass beads in an incubator for up to 24 hours. The device is then processed in a centrifuge and the serum is extracted. ACS devices have been extensively explored in large animal medicine, and a study characterizing the cytokines in canine ACS has recently been published.13 ACS clinical impressions in equine medicine have been disappointing and now it appears that ACS is mainly used as a maintenance injection in mild lameness and performance problems.14 The APS device was designed to address the inflammation associated with osteoarthritis. The APS device has been adopted in large animal medicine, notably equine, and a more recent addition to the canine veterinarians tool-kit.3,1518 We have incorporated leukocyte-rich PRP (L-PRP) and APS devices into our practice since 2012 with good clinical outcomes for a variety of orthopedic applications.

PRP in canine medicine is produced by commercial devices or laboratory centrifuge tubes to concentrate platelets in a small volume of plasma. Some devices also concentrate white blood cells (leukocytes).1921 PRP is a catch-all term that could include many different formulations. Using these different cell separation systems, PRP provides growth factors to aid in tissue repair by stimulating cell proliferation, migration, differentiation, and blood vessel growth. Platelets deliver more than just growth factors: they also deliver chemokines which recruit white blood cells. Inflammation is part of the wound healing process and the first step of tissue repair involves platelets releasing their growth factors and cytokines to recruit white blood cells as the next step in tissue healing (Figure 1).22

Figure 1 The timing and cell types involved in wound repair demonstrating the role of WBC (including neutrophils, macrophages, and lymphocytes) in successful healing.

Note: Adapted from King W, Toler K, Woodell-May J. Role of White Blood Cells in Blood-and Bone Marrow-Based Autologous Therapies. BioMed Res Int. 2018;2018. Creative Commons license and disclaimer available from: http://creativecommons.org/licenses/by/4.0/ legalcode.22

Several cell culture in vitro studies have suggested that L-PRP could contain inflammatory cytokines.2327 However, these in vitro studies have not translated to adverse clinical outcomes in human2830 or veterinary clinical studies.18,31,32 In human clinical studies, OA patients who had higher concentrations of WBC in their autologous concentrates were more likely to be OMERACT-OARSI high pain responders indicating they had the most improvement.33 Some PRP systems in canine medicine market that they make a pure PRP (P-PRP) containing only platelets. However, removing neutrophil and monocytes from PRP actually lowers the concentration of anti-inflammatory cytokines like interleukin-1 receptor antagonist (IL-1ra or IRAP).34 This is because IL-1ra comes from monocytes and neutrophils.35 Indeed, studies have shown that P-PRP does not have high concentrations of IL-1ra because it does not contain WBCs.36 IL-1ra is present (in high concentrations) in formulations containing leukocytes (L-PRP21 and APS) or from ACS devices in which leukocytes are cultured with glass beads for 624 hours to stimulate the production of IL-1ra.37 There currently is no correlation between platelets or cell concentrations and clinical outcomes known in canine medicine. Research should seek to characterize the relationship between the concentration of platelets and cells in canine medicine.

The L-PRP device we use in our clinic was designed to capture a high concentration of platelets and white blood cells to aid in the tissue repair process (Restigen PRP Device, Owl Manor, in veterinary medicine; GPS III Platelet Concentration System, Zimmer Biomet, in human medicine). This device has been used in human medicine since 2007 and is the most clinically studied PRP.38 The concentrations of growth factors in PRP are lower than their recombinant forms in drug products and are thought to still induce tissue repair by their combinatorial effect. Key growth factors in PRP are shown below in Table 1.

Table 1 Growth Factors and Their Proposed Functions in PRP

PRP has been explored in small animal medicine for a wide variety of applications including surgical bone repair,39,40 soft tissue repair,41 osteochondral injuries,42 and osteoarthritis.43,44 Although PRP has had an excellent safety profile in these studies, the efficacy of PRP across different indications have been mixed. These mixed clinical results could be attributed to the varying outputs of different devices, patient-to-patient differences, and different biochemical requirements for different diseases and injuries. Most small animal studies are also limited by a small number of study subjects (< 25). Therefore, a goal of this manuscript was to compile our clinical experience with L-PRP to provide evidence to small animal veterinarians about areas we have had clinical success and to suggest areas of future research for randomized and controlled clinical studies.

OA was traditionally thought of as a purely mechanical disease. The last 20 years of research has shown that there is a strong biochemical component of OA driven primarily by inflammation. Inflammation in canine OA can be induced by trauma or genetics. Inflammatory cytokines bind to cells in the joint and induce the secretion of matrix metalloproteases (MMPs). MMPs degrade extracellular matrix (ECM) in the joint. The resulting ECM fragments bind to cells in the joint and induce the secretion of even more inflammatory cytokines. This creates a destructive feed-forward cycle that drives osteoarthritis.45,46 A tool to address this feed-forward cycle would require both anti-inflammatory cytokines and growth factors.

The APS device was designed to rapidly produce anti-inflammatory cytokines and growth factors to block the inflammatory cycle that drive OA (Pro-Stride APS Device, Owl Manor, in veterinary medicine; nSTRIDE APS Kit, Zimmer Biomet, in human medicine). APS contains anti-inflammatory cytokines in addition to the growth factors from PRP (Appendix Table 1). APS has been shown to block the release of MMPs from chondrocytes,15 inflammatory cytokines from macrophages,17 and prevent ECM molecule release in inflammatory cell-culture conditions.16 In a rat meniscal tear OA model, APS decreased collagen and cartilage degeneration, resulting in a significantly improved total joint score compared to saline control.47 APS has shown to decrease osteoarthritis pain in canine,18,32 equine,31 and human2830,33 clinical trials. In summary, APS has blocked inflammation in cell culture in vitro studies, experimental animal studies, and decreased pain in clinical trials.

There have been three randomized and controlled trials using APS in veterinary medicine. In the first trial, 40 horses with naturally occurring OA were injected with either APS (n = 20) or saline control (n = 20). Two weeks post-injections, APS treated horses had statistically significant reductions in lameness compared to saline controls. The 20 horses originally injected with saline received APS and then all 40 horses were sent home. These horses still had statistically improved lameness, according to owner surveys, one year after APS injection.31 In the first canine clinical trial of APS, 21 dogs with OA and single limb lameness in their stifles or elbows were injected with either APS or saline. Compared to pre-treatment values, APS treated dogs showed a significant improvement in pain scores, lameness scores, and peak vertical force 12 weeks post-injection.18 In the second canine APS clinical trial, five dogs with bilateral hip dysplasia were injected in one hip with APS and in the contralateral hip with saline. One month after injection, hips treated with APS improved significantly in their total pressure index and put significantly more weight than the hips treated with saline indicating pain relief.32 Later in this manuscript we will describe our clinical experience with APS to address different orthopedic conditions to encourage further research in canine medicine.

In this study, lameness evaluations were performed by reviewing a patients pertinent medical history including the following survey given to owners below in Table 2.

Table 2 Survey for Canine Owners at Beginning of Lameness Evaluations

In this study, physical examinations were performed using the steps in Table 3 as well as neurological examinations.

Table 3 Physical/Neurologic Examination Steps

Neurological conditions were discerned from orthopedic conditions if there appeared to be no nerve deficits and loss of proprioception. Diagnostics such as radiographs, CT/MRI scans were used to determine the origin of the condition. Radiographs, MRI and CT scans were used to look for bone and soft tissue involvement. Bloodwork was used to help diagnose tick borne diseases, and infections. Biopsies were used to help diagnose types of masses that could have caused lameness. Each limb was evaluated, as dogs can present with lameness in more than one limb.

Synovial fluid was evaluated by sending the fluid to the laboratory. The technician observed the thickness of the fluid, color, and evaluated the white and red blood cells (RBC) under a microscope. The presence of crystals or bacterial infections were also evaluated. Nucleated cell counts, RBC, glucose, proteins, uric acid, and lactic dehydrogenase were measured.

Autologous blood was obtained by performing a peripheral blood draw mixed with anti-coagulant citrate dextrose solution A (ACD-A) (Citra Labs, Braintree, MA). The blood draw volume was based on the technology used, technique, and output volume desired. For canine patients in this study, blood draws were either 30 or 60mL (based on the device used).

Blood was drawn by clipping an area over the jugular vein and then the skin was aseptically cleaned. The ACD-A anti-coagulant was pre-loaded in a syringe and connected to a winged-blood collection needle-tube set. The anti-coagulant was drawn down the syringe and then up to the tube so that all blood contacting surfaces had been coated with anti-coagulant. The syringe was gently inverted while pulling blood and after removing the needle to prevent clotting. If possible, sedation was performed after the blood draw to maintain the patients blood pressure. One technician drew the blood and one technician held and comforted the patient (Figure 2). Canine patients were sedated using 5 g/kg Dexmedetomidine (Zoetis, Parsippany-Troy Hills, NJ) and 0.2 mg/kg of Butorphanol (Zoetis, Parsippany-Troy Hills, NJ) administered intravenously while the device was processed. A pain free and immobile patient was required.

Figure 2 Blood draw process from canine patients. (A) Blood draw sites were prepared by clipping area over the jugular vein and then the skin was aseptically cleaned. (B) The needle was inserted into the jugular vein and the syringe was slowly pulled back to check for a flash of blood to confirm needle placement. (C) The blood was slowly drawn while rocking syringe to ensure mixture of blood and anti-coagulant.

30mL or 60mL devices (Restigen PRP Device, Owl Manor, Warsaw, IN) were used to prepare L-PRP. The amount of blood and ACD-A anti-coagulant was decreased when blood was drawn from patients who were less than 10kg. The APS device (Pro-Stride APS Device, Owl Manor, Warsaw, IN) was only available in a 60mL version. The PRP device took 15 minutes to process (Figure 3) and the APS device used an additional 2-minute processing step. The 60mL L-PRP device output 6mL of PRP. The 30mL L-PRP device output 3mL of PRP. The APS device processed 60mL of blood through a two-step procedure that produced 2.5mL of APS (Figure 4). Both devices are processed using the Owl Manor Centrifuge (Owl Manor, Warsaw, IN). The entire process from starting a blood draw to being ready to use the PRP or APS took about 30 minutes and was performed by veterinary technicians in our practice.

Figure 3 Representative pictures of 60mL L-PRP device processing: 1) a 18-gauge needle was attached to a 60mL syringe and 58mL of ACD-A was withdrawn. 2) The cap was unscrewed on center port of the L-PRP device and the green packaging post was discarded. Blood was slowly loaded into the center port. The syringe was removed and the tethered cap was attached to its port. 3) The L-PRP device was placed into the centrifuge and balanced with a counterbalance. 4) The L-PRP device was spun in centrifuge at 3200 RPM for 15 minutes. 5) The yellow cap was removed on the side port and a 30mL syringe was connected. The device was tilted at an angle, avoiding inverting to keep top blue vent dry, and all of the platelet-poor plasma (PPP) was removed. The yellow cap was replaced. 6) The red cap was removed on the side port and a 10mL syringe was connected. 2mL of PRP was withdrawn and syringe was left attached. With the 10mL syringe attached, the PRP was suspended by gently shaking L-PRP device for 30 seconds. The remaining PRP suspension was extracted into the attached 10mL syringe.

Figure 4 Representative pictures of APS device processing: 1) The APS Concentrator device was gently shaken to ensure beads were evenly distributed across bottom of top chamber. The yellow cap was unscrewed on the APS Concentrator device and filled with the output of L-PRP device from the 10mL syringe. The 10mL syringe was removed and the tether cap on port was attached. The paddle was spun until the cell solution was fully mixed with beads. 2) The concentrator was placed into the centrifuge. The centrifuge was balanced with a counterbalance. The concentrator device was spun for 2 minutes at 2000 RPM. 3) The APS was gently resuspended in the bottom of the APS Concentrator. The red cap was unscrewed and connected to a sterile 10mL syringe. The APS was extracted.

The volume of L-PRP used depended on the size of the joint. Very commonly we divided the output of the kit to address multiple joints (ie bilateral stifles, bilateral elbows, elbow and a shoulder, etc).

The volume of APS used per condition was chosen by the volume of the joint and the number of joints injected. For most bilateral OA, the output of the APS kit was divided in half and half was injected in both joints. In post-surgical applications, the surgery was completed and the APS was injected right before final bandaging.

Gloves were worn and the injection site was prepared like surgery. The joint was entered with an appropriately sized needle attached to a syringe (Table 4). Placement in the joint was always confirmed by aspiration of all available joint fluid which was submitted for laboratory testing if desired. While the needle was still in the joint, the first syringe was replaced with a second syringe containing the L-PRP or APS. The injections were smooth and without resistance. For intra-articular (IA) injections approaches we followed guidance from Fossum et al.48 Owners were instructed to restrict the patients activity for 57 days post-injections before resuming normal activity level. We also recommended an NSAID (Carprofen, Deracoxib, or Meloxicam) for at least 7 days post-injections.

Table 4 Procedures Used During Canine Joint Injections

Tendon or ligament cases started with tendons or ligaments that had mechanical integrity but were not compromised beyond general use. Patients who received tendon/ligament injections failed standard treatments like rest, physical therapy, or NSAIDs. For subcutaneous (SQ) injections the skin was palpated and anatomical landmarks were used to locate the soft tissue to inject (the areas of maximal tenderness). The skin was prepared for injection and then the tissue was locally blocked. The PRP or APS was then slowly injected using either a 22 or 25-G needle using a peppering technique in which small volumes of PRP or APS were placed in the tendon or fascia covering the tender area. Owners were instructed to restrict patients activity for 57 days post injections before resuming normal activity level. It was also recommended for patients to take an NSAID (Carprofen, Deracoxib, or Meloxicam) for at least 7 days post-tendon/ligament/SQ tissue injection. Owners were given post-surgical discharge sheets to follow.

Over the reviewed period, 5 years, L-PRP and APS devices have been used in 146 treatments on 133 dogs. Before treatment with L-PRP or APS owners were counseled on expected outcomes and rehab procedures, as well as the importance of compliance with post-injection protocols. From February March 2020 medical records were reviewed and owners were followed-up with. Results reported in this study were based on veterinarian and owner evaluations (See Appendix Tables 23). Outcomes were segmented as: 1) the patients were doing well (complete improvement), 2) had mixed results (improvement but still on non-steroidal anti-inflammatory drugs (NSAIDS) after the transient post-injection period), or 3) had unsatisfactory results (no improvement). The safety profile of L-PRP and APS was also evaluated with owners by asking if their dogs had any short-term or long-term complications post-treatment. Clinical success was evaluated in these cases by performing a follow up call on all patients 2448 hours after surgery as well as a recheck exam 68 weeks post operatively to access how the patient was recovering. Owners were contacted periodically, including at suture removal in 2 weeks, to get updates early on and further out to record how long the clinical benefits of the injections last.

We have used L-PRP in our clinic for a broad spectrum of orthopedic conditions listed below in Table 5. The average age of patients treated with L-PRP was 6.4 3.5 years old (Range 0.512 years old). Of the patients treated with L-PRP, 15 were spayed, 16 were neutered, 1 was female, and 3 were male. Our most common applications for L-PRP included IA and SQ injections for patellar luxation, lumbosacral pain, ACL surgery (lateral imbrication surgery), and bicipital tendonitis. Post ACL surgery, both stifles were injected with APS to reduce pain and inflammation, improve healing time, and return to function quicker, as well as minimize the chances of the opposite stifle from tearing its anterior cruciate ligament. We do the same process for our patients who have TPLO surgery to reduce pain and inflammation and help with healing of the TPLO site. While the number of cases presented here are relatively small per condition, many of these are the first published cases using an orthobiologic in canine medicine. The data presented in this manuscript could be used to statistically power randomized and controlled trials.

Table 5 Frequency of L-PRP Applications in Our Practice Including Tendon/Ligament Applications, OA, and Joint Applications

In the cases with unsatisfactory outcomes, patients typically presented with severe pathologies. L-PRP injections have been able to tighten soft tissues with SQ injections. There has been limited success in the distal limbs with SQ tarsus and carpal injections (Table 5). L-PRP has had positive clinical outcomes for tendon/ligament applications including patellar luxation and after ACL surgery. Repeat injections have been performed on some patients. For example, in one patient, L-PRP was injected SQ around both stifles which produced satisfactory results for 21 months before the patient was injected again. In a separate patient with bilateral stifle OA, satisfactory results were observed for 13 months before a second injection of L-PRP.

The average age of patients treated with APS was 6.8 3.3 years old (Range 1.315 years old). Treatments were performed on, 48 spayed, 44 neutered, 3 female, and 3 male patients. The most common applications for APS included injection post-ACL surgery (lateral imbrication surgery), bilateral hip OA, and bilateral stifle OA (Table 6). In some cases, repeat injections have been performed on the same patient. One 3 year-old patient with bilateral hip OA was injected with APS and responded well. Over time more NSAIDs were required and a second injection was performed 6 months later. One 11 year-old patient with bilateral stifle OA was injected with APS and responded well for 15 months and was re-injected with APS. In another case, starting at age 4, a patient received yearly APS injections in its stifles to manage its OA for the last 4 consecutive years (Table 6).

Table 6 Description of APS Use in for a Variety of Orthopedic Conditions Including Tendon/Ligament Applications, OA, and Joint Applications

In general, L-PRP and APS treatments were well-tolerated with transient inflammation that resolved over several days without intervention. No serious adverse events including infection or complications that required surgical intervention were recorded.

The results of this case series suggested that L-PRP and APS have been clinically beneficial for OA in canine joints, tendon/ligament repair, and in post-surgical applications based on the number of positive owner-reported performance and safety outcomes. In general, a year or more of durable pain relief is seen after treatment with L-PRP or APS. Although there has been published research on L-PRP with the system used in this retrospective study in large animal medicine,4,5 this is the first study to characterize clinical outcomes in canine medicine. Historically, L-PRP has been used successfully in tendon/ligament applications.4,5 The results of this case series indicate that L-PRP is beneficial in tendon/ligament applications like patellar luxation and post-TPLO surgery. The data from this case series could be used to statistically power a randomized and controlled clinical trial with better defined endpoints.

Previous APS research has shown its positive short-term clinical benefits in addressing canine OA.18,32 Our case review shows that APS may have longer-term benefits in canine OA with patients with mild to moderate OA; with some cases receiving repeat injections yearly to manage symptoms. This mirrors the year-long benefit observed for equine subjects in a randomized and controlled study of APS.31 Although mostly successful, there have been some cases where APS has not produced clinically successful results. In most of these unsuccessful cases, patients presented with severe OA, as was noted in the records of 3/4 unsatisfactory bilateral hip patients. Similar results have been observed in horses,31 suggesting that APS is best suited for patients with mild to moderate OA. Additional studies are indicated to determine if these modalities are superior to other clinically relevant treatments and better define the durability of L-PRP and APS in longer-term randomized and controlled trials.

The management of canine OA with NSAIDs is standard practice for many veterinarians. However, their continued use is not without drawbacks. Common adverse effects are associated with the gastrointestinal (GI) tract, renal and hepatic adverse effects have been reported less frequently, while lethargy and inhibition of coagulation have been infrequently reported.49 Long-term NSAID use requires routine blood tests to check for these side effects. Studies reporting long-term safety data are lacking and adverse event reporting may be incomplete.50 These concerns have been cited as a barrier to their use by veterinarian surgeons.51 Furthermore, veterinary surgeons have described difficulty in recognizing, managing, and avoiding adverse events associated with NSAIDs.52 Survey data has indicated that there is a link between owner safety concerns and poor compliance.53 There are pragmatic concerns on the oral delivery of medications including palatability concerns by the patient and therefore, challenging delivery of the medication for the owner.54 These combined drawbacks have motivated many to seek alternative treatments to NSAIDs for canine osteoarthritis. L-PRP and APS do not require daily delivery of an oral medication, blood tests, and they have had an excellent safety profile in clinical trials. Although there have not been any head-to-head studies comparing the safety and effectiveness of the L-PRP or APS, we have had clinical success using these autologous orthobiologics as alternatives to NSAIDs. Future statistically powered clinical trials will be required to ultimately determine the differential safety and efficacy of the different modalities available to veterinarians.

There have been efforts to provide standardizing nomenclature to classify the outputs of orthobiologics devices. Most standardization systems classify products based on their centrifuge processing parameters (ie hard vs soft spin), if the product is clotted, platelet concentration, and white blood cell concentration.5557 The outputs of orthobiologic devices can be altered with freezing, sonication, and other mechanical disruption methods.58 Further confounding classification, device output from the same individual can vary from the same patient if they have been exercising,59 have underlying health conditions,3 or have been taking medications.60 The products discussed in this paper were L-PRP, ACS, and APS devices. The L-PRP device in this study produces an output with a high concentration of platelets and WBC with a normal concentration of plasma proteins.61,62 ACS devices produce an output of a serum that contains plasma proteins and the WBC secretome when incubated in a clot with glass beads. ACS devices contain very little/no platelets or WBC.13 APS devices produce outputs with concentrated platelets, white blood cells and plasma proteins.62 Each one of these products contain different concentrations of different cells, cytokines, and growth factors.

There are a few limitations to our review. First, this study was a retrospective analysis of the procedures performed using L-PRP and APS in our practice over the last 5 years and was not a prospective or controlled study. Also, the evaluation was not quantitative but rather based on our evaluation and owner feedback. The time from treatment to follow-up varies from months-years in our review and is not standardized. For many of the conditions we used L-PRP or APS there are limited case numbers which makes it challenging to perform statistical analysis. Low sample number comparisons are susceptible to bringing people to incorrect decisions across disciplines.63 For some of the conditions we injected IA, SQ, or both depending on pathology. Finally, although most patients were instructed to stay off NSAIDs and other medications it is possible owners had their dogs on non-prescription medications we were unaware of during follow-up, started seeing different veterinarians, or moved. Despite these limitations, we feel this retrospective analysis adds additional information about the clinical application of L-PRP and APS in canine medicine.

This retrospective case series study demonstrated that L-PRP and APS have had beneficial clinical outcomes in canine medicine. The logistics of performing blood draws and joint injections are relatively simple and could be adopted into many small animal veterinary practices. In several patients OA has been managed with yearly injections of APS. Future randomized and controlled studies will be required to demonstrate the superiority of L-PRP and APS to other clinically relevant options in canine medicine.

ACD-A, anticoagulant Citrate Dextrose Solution, Solution, A; ACL, anterior cruciate ligament; ACS, Autologous Conditioned Serum, APS, Autologous Protein Solution; CT, computed tomography; extracellular matrix, ECM; gastrointestinal, GI; IA, intra-articular; interleukin-1 receptor antagonist, IL-1ra or IRAP; L-PRP, leukocyte-rich platelet rich plasma; matrix metalloproteases, MMPs; magnetic resonance imaging, MRI; non-steroidal anti-inflammatory drugs, NSAIDS; OA, osteoarthritis; OCD, osteochondral dissecans; OMERACT-OARSI, Outcome Measures in Rheumatology - Osteoarthritis Research Society International; PRP, Platelet -rich plasma; P-PRP, pure platelet-rich plasma; RBC, red blood cells; SQ, subcutaneous; TPLO, tibial-plateau-leveling osteotomy; WBC, white blood cells.

We thank the staff at Indian Creek for supporting this study and enabling treatment of our clients.

The authors declare that this retrospective analysis received funding from Owl Manor. The funder was involved in reviewing and approving the study. WK is an employee of Owl Manor. KC is a consultant veterinarian for Owl Manor and has received research support from multiple orthopedic and regenerative medical companies. MB is a Registered Veterinary Technician consultant for Owl Manor with extensive interest and experience in surgical management and regenerative medical procedures. The authors report no other conflicts of interest in this work.

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[Full text] The use of autologous protein solution and leukocyte-rich pl | VMRR - Dove Medical Press

Have you ever asked yourself how people used to be treated before the coming hospitals, trained doctors and diagnostic machines? Alternative medicine and traditional herbs were the way to go. Some foods, such as the Adaptogenic mushrooms, were also known to be medicinal and people used to consume it when they sick. Despite the coming of modern medicine, alternative and traditional medicine is still being practiced in many parts of the world. What are some of the practices of traditional and alternative medicines? Here some of the collections of alternative medicine practices.

Diet and Herbs

Let your medicine be your food and your food be your medicine. That is a slogan that probably is known by everyone and it holds to be true. The use of supplements, certain foods like mushrooms and certain plants such as Aloe Vera has been a common practice. People believe that the herbs are therapeutic. Use of supplements to treat diseases is still in use up to today. Take of example the use of iron supplements to treat iron deficiency anemia. The use of vitamin supplements for people who are immunocompromised is also a good example of use of alternative medicine. The use of medicinal mushroom extracts has also been on the rise because of its improved effectiveness.

Traditional or Alternative Medicine

This type of medicine practice was majorly used by the Chinese and the Indians and later spread to the other parts of the world. Indians for example made use of Yoga to keep fit and eliminate diseases. In China, the use of Acupuncture and chiropractor medicine became so common to the extent that people begun to believe the two methods were the final healing methods. Other forms of traditional medicine included the homeopathy and naturopathy which all included improving the body wellness and prevent it from diseases and illnesses.

Use of the Mind to Treat People

Before the coming of modern medicine, healers used to believe that disease and illnesses start in the mind. Mental health and emotions were regarded as part of the causers of illnesses and ailments if they were tampered in one way or another. Healing methods such as the hypnosis, meditation and biofeedback were used to make people heal from illnesses. The only drawback was that there was no defined dose for each of these interventions so people couldnt really know how much to administer to clients. Practically, some people used to feel better and it became an order of the day in treating the sick.

External Energy

The use of external energy and stimulation to bring a state of normalcy in the body were among the methods used to treat diseases. An example is the use of electroconvulsive therapy to treat mental health issues because it tends to correct the abnormal firing of the brain. Involvement of people in sports, dance and other activities is also known to bring a perfect kind of healing to the people. Such practices are now being sidelined by modern medicine and people are embarking on the use of modern therapeutic interventions to get healed.

Conclusion

Alternative medicine was one of the best ways to heal people before the coming of modern medicine. Even now as modern medicine is predominant, people still use the traditional medicine because there is still Yoga in India and there are still Chiropractor services in China. Mushrooms are used as medicines these days especially the ones that are organically engineered to have medicinal properties. The fact that they have low calorie, low fats and have a low glycemic index make them a health and fitness food for people with conditions such as diabetes and hypertension. Other medicinal plants include the Aloe Vera and Digitalis plant.

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Types of Alternative and Traditional Medicine Available - - VENTS Magazine - VENTS Magazine

Global Alternative Medicines Market: Overview

Alternative medicines include treatments other than allopathic. Alternative medicine treatments include systems with healing ability such as acupuncture, acupuncture, naturopathy, herbal remedies, and homeopathy. The medical profession does not regard these healing systems as orthodox treatment systems. Some of these treatments are accepted to be of value for certain conditions. Herbal medicines include drugs that are derived from plants. Herbal medicines are either used for therapeutic purpose, or as supplements to improve well-being or health. Herbal products are available as teas, extracts, powders, capsules, tablets, and others. These products are natural, hence considered to be safe. Herbal medicines have the ability to cure almost all the types of diseases.

Nutraceutical is a combination of the words nutrition and pharmaceutical. Nutraceutical medicines or products are fortified food or food products that provide supplementary diet and also help in prevention and treatment of diseases except anemia. Nutraceuticals are not regulated and tested to the extent of pharmaceutical drugs. These have the ability to treat diseases including ADHD, amyotrophic lateral sclerosis, anemia, sickle cell, anxiety, aphthous ulcer, carnitine deficiency, depression, dietary supplementation, dyspareunia, eye conditions, fibromyalgia, herbal supplementation, herpes simplex, herpes simplex, suppression, high cholesterol, Huntingtons disease, hypertriglyceridemia, insomnia, jet lag, muscle pain, nonalcoholic fatty liver disease, osteoarthritis, Parkinsons disease, peripheral neuropathy, premenstrual dysphoric disorder, rheumatoid arthritis, short bowel syndrome, and smoking cessation.

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Alternative Medicines Market Snapshot

Probiotics are live yeasts and bacteria that benefit the health of individuals. These are referred as healthy, helpful, or good bacteria. An imbalance of natural yeasts or bacteria within the body has been associated with a range of indications including suppressed immune system, yeast infections, skin rashes, weight gain, diarrhea, and constipation. Probiotics may be taken orally to restore any imbalance in the normal urogenital or intestinal flora. These are available as contained naturally, or dietary supplements or added to foods such as kefir, sauerkraut, or yogurt. Increase in inclination toward safe and lesser side effects boosts the global alternative medicines market. Rise in side effects and adverse drug reactions due to usage of allopathic medicines drives the market. Surge in awareness about the benefits relating to alternative medicines is a key driver of the market. However, slow healing ability of alternative medicines restrains the market.

The global alternative medicines market can be segmented based on drug class, dosage form, disease indication, distribution channel, and region. In terms of drug class, the market can be categorized into herbal products, nutraceutical products, and probiotics. Based on dosage form, the global alternative medicines market can be classified into tablets, powder, syrup, capsules, teas, extracts, and others. In terms of disease indication, the market can be divided into ADHD, amyotrophic lateral sclerosis, anemia, sickle cell, anxiety, aphthous ulcer, carnitine deficiency, depression, dietary supplementation, dyspareunia, eye conditions, fibromyalgia, herbal supplementation, herpes simplex, herpes simplex, suppression, high cholesterol, Huntingtons disease, hypertriglyceridemia, insomnia, jet lag, muscle pain, nonalcoholic fatty liver disease, osteoarthritis, Parkinsons disease, peripheral neuropathy, premenstrual dysphoric disorder, rheumatoid arthritis, short bowel syndrome, smoking cessation, and others. Based on distribution channel, the global alternative medicines market can be categorized into online pharmacies, retail pharmacies, and hospital pharmacies.

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Global Alternative Medicines Market: Regional Outlook

Geographically, the global alternative medicines market can be segmented into Latin America, Asia Pacific, Europe, North America, and Middle East & Africa. North America held the largest market share in 2016 due to extensive awareness and acceptance by the large population in the region. Europe held the second largest market share in 2016 owing to increased awareness and sale of alternative medicines in drug stores. The global alternative medicines market in Asia Pacific is projected to grow at a rapid pace during the forecast period from 2017 to 2025. The market in Middle East & Africa and Latin America are expected to witness moderated growth during the forecast period due to rise in demand for food supplements and natural health.

Companies Mentioned in Report

Key players in the global alternative medicines market include Dr. Willmar Schwabe India Pvt. Ltd., GUNA S.p.a., BIORON GmbH, Ainsworth, Inc., Kanak Drishti Infotech Pvt. Ltd., and Random Beauty, Inc.

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Alternative Medicines Market Analysis Share, Volume, Top Key Players, Growth and forecast 2018-2026 KSU | The Sentinel Newspaper - KSU | The Sentinel...

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From Netdoctor

Ashwagandha is considered to be one of the most important herbs in Ayurvedic medicine. Native to India, ashwagandha is often referred to as Indian ginseng thanks to its strength and vitality boosting benefits.

While some might be sceptical when it comes to herbal or alternative medicines, ashwagandha comes with a number of scientifically-proven health benefits.

But what exactly is ashwagandha? What are the benefits of this popular herb, and does Ayurvedic medicine come with any side-effects? We asked the experts:

Also known as winter cherry or Ayurvedic ginseng, ashwagandha is a plump evergreen shrub which produces orange or red berries about the size of raisins. It flourishes in the dry areas of India and North America.

The roots are the part most commonly used in herbal medicine although the leaves and flowers also have therapeutic properties.

Ashwagandha is used in medicine because it's an adaptogenic herb. 'From a herbal perspective, there is nothing better at restoring vitality and bringing body back to balance than adaptogens,' says Jenya Di Pierro, a professional herbalist and founder of wellness club Cloud Twelve.

'Many adaptogens have medicinal roots that take many years to mature,' she continues. 'The concentrated energy and nutrients of the plants that have been stored in mature roots are the culmination of years of growth and adaptation. Hence the term "adaptogens".'

Photo credit: Moyo Studio - Getty Images

Ashwagandha is an ancient medicinal herb with multiple proven health benefits. Here are 13 scientifically-backed uses and advantages:

We all suffer from stress occasionally, and ashwagandha might be able to help. In one study, which pharmacist Mike Wakeman from Nature's Way points to, found that adults with chronic stress who took two capsules of ashwagandha root a day for 60 days helped decrease stress levels by 44 per cent and reduced the stress hormone cortisol by 28 per cent.

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Ashwagandha is effective for managing anxiety, according to Di Pierro. 'Most adaptogens are tonifying, but ashwagandha is a bit unusual as it is also calming,' she says.

Meanwhile, research published in the Journal of Alternative and Complementary Medicine found that taking ashwagandha resulted in improvements (significantly in most cases) with anxiety management.

The herbal medicine also comes with immunity boosting benefits. 'Ashwagandha increases resistance to infections, relieves allergies, boosts an under-active immune system while also assisting with auto-immune conditions such as lupus, MS and others,' says Di Pierro.

If you're a woman and your sex drive has dipped or something is amiss in the bedroom, ashwagandha might be able to help.

'In one study 50 healthy women who took concentrated oral doses of ashwagandha reported having more orgasms and more satisfying sex,' says Wakeman. 'The authors suggest this could have been due to the herbs stress-reducing effects as well as its role in boosting the sex hormone, testosterone.'

Ashwagandha has long been used in Ayurvedic medicine to help promote restful sleep.

'Indeed, the somnifera part of its botanical name, Withania somnifera is derived from the Latin word for sleep,' says Wakeman. 'A recent study in animals suggests that triethylene glycol, another plant chemical found in its leaves, may be the magic ingredient that improves sleep quality.'

A number of studies have found that taking ashwagandha can reduce blood sugar levels - in both people who have diabetes and those who don't.

Research, including data published in the Journal of Ayurveda and Integrative Medicine[vi] suggests that ashwagandha may help soothe joint pain and swelling associated with arthritis a result the authors attribute to the pain-relieving and cartilage-protective effects of withanolides and other plant chemicals.

Studies have also shown ashwagandha may help with weight loss. Chronic stress is often associated with weight gain and in a study, cited by Fito, 52 people under chronic stress received either a placebo or ashwagandha for eight weeks.

Those participants taking ashwagandha were found to be less stressed, had less food cravings, were happier and their body weight had reduced, compared to those taking the placebo.

Photo credit: marilyna - Getty Images

An eight week study, involving 57 men, saw participants consuming either an ashwagandha extract or a placebo while undergoing resistance training.

The results showed, compared to the placebo group, those taking the ashwagandha extract had significantly greater increases in muscle strength, as measured when bench-pressing and doing leg-extensions, and significantly greater muscle size increase in their arms and chest.

If you're trying to get pregnant, ashwagandha might be the solution. 'Ashwagandha is a famous fertility tonic,' says Di Pierro. The science is there to back it up, too. In one study which looked at 75 infertile men, those treated with ashwagandha showed an increase in both sperm count and motility.

Ashwagandha is often used by athletes to help boost physical performance.

'This appears to be confirmed in a study of 57 young men aged between 18-50 years old who took ashwagandha root extract twice daily,' says Wakeman. 'They saw significant increases in muscle mass and strength when they undertook a resistance training programme compared with those who took a placebo.'

Several studies have shown that taking ashwagandha can reduce cholesterol levels. This is beneficial to our heart health as high cholesterol can lead to heart disease.

While the research is still limited, there are a few promising studies that indicate ashwagandha may reduce symptoms of depression.

However, if you think you might be suffering from depression, speak to your doctor as ashwagandha should not be used to replace treatments recommended by your GP.

It's clear there are a number of health benefits to ashwagandha, and it is believed to be one of the safest herbs out there. However, as will all medicine - both traditional and herbal - it comes with precautions and long-term effects are not known.

'Higher doses of ashwagandha taken for insomnia may cause drowsiness in the morning,' warns Di Pierro.

Meanwhile, ashwagandha may cause some stomach upset such as diarrhoea and vomiting, although this tends to be if you've taken a higher dose.

There isn't much evidence to suggest ashwagandha can cause weight gain. As for your hormones, ashwagandha might increase how much thyroid hormone the body produces, and other evidence suggests it promotes testosterone, meaning if you already have a condition such as PCOS, you might want to avoid it.

Ashwagandha can be consumed in a number of different ways. It can be taken as a tablet, in a capsule or as powder stirred into warm milk.

Is ashwagandha safe to take daily? 'Yes, ashwagandha can be taken daily,' says Di Pierro.

Taking ashwagandha as a supplement may be an effective way to improve various health concerns, but speak to your GP or a registered herbal expert before you proceed and remember to follow the instructions on labeled products.

Ashwagandha is generally considered to be safe for most people. However, according to the experts, the following people should avoid the herbal supplement:

Pregnant women.

Those who are breastfeeding.

Those with diabetes, as it might interfere with the medicines already being taken to reduce blood sugar levels.

Those with with thyroid disorders.

Last updated: 15-03-2021

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Queensland, Australia, March 15, 2021 (GLOBE NEWSWIRE) -- Rayont Inc. (Rayont or the Company) (OTC PINK: RAYT), an international healthcare company specializing in the manufacturing of alternative medicine products and services across the entire value chain today announces the appointment of Mr. Reyad Fezzani as non-executive director and chairman of its Board of Directors.

We welcome our Chairman of the Board of Directors to Rayont Inc and look forward to capitalizing on his extensive expertise and deep insight to support our strategic priorities and seek ways to further enhance shareholder value. We remain committed to engaging with all shareholders as we continue to pursue value-enhancing opportunities for Rayont said Marshini Thulkanam, President and CEO of Rayont Inc.

Reyad Fezzani Chairman and Board Director

Reyad Fezzani has over 30 years of experience in Energy, Finance and Technology with a significant part of his career spent at BP p.l.c. including global roles as the CEO of BP Wind and Solar, and CEO of BP Chemicals. He is currently Chairman and CEO of Regenerate Power LLC, and a Managing Partner of Energy Finance Company LLC. He has served as an Independent Director on the boards and advisory boards of several private technology companies, as well as the Swiss industrial public company Oerlikon A.G where he was also a member of the Audit Committee.

Mr Fezzani is a Chartered Engineer and a Fellow of the Institute of Chemical Engineers, the Energy Institute, and the Institute of Materials, Minerals & Mining. He holds a masters degree (MEng) in Chemical Engineering and Chemical Technology from Imperial College, London.

About Rayont Inc.

Rayont, Inc. (RAYT) is a public traded company incorporated in Nevada, USA since its inception in 2011. In 2018, the Company repositioned itself to focus on healthcare including the manufacturing of alternative medicine products and services across the entire value chain.

Longer term, it has also invested in a groundbreaking cancer treatment technology through an exclusive license arrangement for the Sub-Saharan African territories.

Headquartered in Australia with expanding operations internationally, Rayont`s purpose is Making Natural Products to Improve People`s Health. We do this by investing in early research and development, establishing high quality manufacturing assets for regional distribution and operating across the alternative medicine value chain.

Our underlying strategy is to grow organically, selectively acquire, scale profitable assets and improve efficiency through digitalization.

For further information, please visitwww.rayont.com

SAFE HARBOR

Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933, are subject to Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbors created by those rules. All statements, other than statements of fact, included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and other results and further events could differ materially from those anticipated in such statements. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements.

Company Contact:Investor Relationsir@rayont.com

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Rayont Inc appoints Mr. Reyad Fezzani as Non-Executive Director and Chairman of the Board to strengthen its Corporate Governance in line with Best...

Brazil complementary and alternative medicines was valued at US$ 2,498.24 million in 2018 and is expected to reach US$ 9,759.38 million by 2027, growing at an estimated CAGR of 16.4% over the forecast period. Complementary and alternative medicines are general terms used for complementing the medical products and methodologies that were not been a part of the conventional medical treatments. Complementary and Alternative Medicine Market in Brazil is currently undergoing a booming period mainly due to the high prevalence of cancer patients in the country. There has been a total number of 278607 cases of cancer reported in males and 280764 cases reported in females in Brazil in 2018.

Integration of acupuncture and electromagnetic therapy is major factor driving the growth of the Complementary and Alternative Medicine Market. According to a published article, in a study conducted in Brazil on temporomandibular disorders, integration of acupuncture and electromagnetic therapy has successful outcomes (96 Patients). Another major factor which positively affects the market is the increasing prevalence of non-communicable ailments such as Parkinsons disease, osteoarthritis, osteoporosis amongst others. It has been reported that electroacupuncture treatment reduced knee pain in just 24 hours. The effect of the same lasts as long as four months after the treatment process.

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This market research report on the Complementary And Alternative Medicine Market is an all-inclusive study of the business sectors up-to-date outlines, industry enhancement drivers, and manacles. It provides market projections for the coming years. It contains an analysis of late augmentations in innovation, Porters five force model analysis and progressive profiles of hand-picked industry competitors. The report additionally formulates a survey of minor and full-scale factors charging for the new applicants in the market and the ones as of now in the market along with a systematic value chain exploration.

Top Key Players:

Some of the players operating in Brazil Complementary and Alternative Medicine Market are Optum, Inc., Ach, Quantum-Touch, and Herboflora.

Global Complementary And Alternative Medicine Market Research Report and accelerates a wide-ranging and focused look into this market. Market size is concluded through detailed study and examination through subordinate research. The report is an in-depth study of the key dynamics of the Global Market. The report includes primary research alongside comprehensive investigation of subjective as well as quantitative perspectives by different industry specialists, key supposition pioneers to gain profound understanding and industry execution.

Global Complementary And Alternative Medicine Market Report delivers a complete study on Global Market, providing detailed market information and penetrating insights. No matter the consumer is industry insider, potential entrant or investor, the report will provide valuable data and information about Global Market.

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The report answers important questions that companies may have when operating in the global Complementary And Alternative Medicine market. Some of the questions are given below:

What will be the size of the global Complementary And Alternative Medicine market in 2027? What is the current CAGR of the global Complementary And Alternative Medicine market? What products have the highest growth rates? Which application is projected to gain a lions share of the global Complementary And Alternative Medicine market? Which region is foretold to create the most number of opportunities in the global Complementary And Alternative Medicine market? Which are the top players currently operating in the global Complementary And Alternative Medicine market? How will the market situation change over the next few years? What are the common business tactics adopted by players? What is the growth outlook of the global Complementary And Alternative Medicine market?

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Booming Growth in Complementary And Alternative Medicine Market Analysis Report 2021 and Forecast to 2029 with different segments, Key players KSU |...

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Gynesonics, a womens healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that Health Care Service Corporation (HCSC) has released a coverage policy for The Sonata Procedure. The addition of HCSC policy allows another 16 million covered lives access to this minimally invasive procedure. The Sonata technology platform integrates the first and only commercial intrauterine ultrasound system with a proprietary advanced radiofrequency ablation device, providing an incision-free, uterus-preserving, transcervical treatment for symptomatic uterine fibroids. The Sonata Treatment is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes, and locations. Fibroids are treated from inside the uterus, so the Sonata Treatment requires no incisions, no tissue is surgically removed, and the uterus is preserved.

I am extremely pleased to see health insurance plans, such as HCSC, recognize the impact uterine fibroids have on a womans life and the importance of providing minimally invasive treatment options. As a surgeon, it is my responsibility to determine the best treatment option based on a patients symptoms. Sonata should be made available to all women who need it. It is time local and national health plans follow suit with other carriers that have included Sonata in their coverage policies, said Charles Miller, Director of Minimally Invasive Gynecologic Surgery at Advocate Lutheran General Hospital in Park Ridge, IL; Professor, Obstetrics & Gynecology - Department of Clinical Sciences, Rosalind Franklin University of Medicine and Science, North Chicago, IL; and a past President of the American Association of Gynecological Laparoscopists (AAGL) and International Society of Gynecological Endoscopy (ISGE). I have seen the evolution of minimally invasive fibroid treatment options. The Sonata procedure is one that I choose for a specific patient population whose life has been impacted by this disease. Sonata is the least invasive approach to fibroids wholly or partially within the myometrium of the uterus. Minimally invasive treatments for uterine fibroids have advanced and provide women a safe and effective alternative to more invasive treatments.

In the SONATA clinical trial, within three months following their Sonata Treatment, 86 percent of women experienced a reduction in heavy menstrual bleeding and 95 percent of patients experienced a reduction in menstrual bleeding by 12 months. Additionally, 50 percent of women return to normal activities the next day. The overall impact of treatment with Sonata was significant for these women, with 97 percent of women at 12 months indicating they would recommend the procedure. Women in the study experienced significant durable symptom relief through three years.

The announcement of this coverage policy from HCSC is an exciting milestone for both patients and providers to expand the options available to women suffering with symptomatic uterine fibroids. Data reports nearly 80 percent of women prefer to avoid invasive surgery for fibroids and prefer a less invasive option, said Chris Owens, President and CEO of Gynesonics. The health insurance companies are listening to patients and providers, and then addressing their needs by creating access to a less invasive treatment option with the Sonata System. The addition of coverage policies nationwide reflects the robustness of the clinical evidence supporting the Sonata treatment as a safe, effective, and durable option.

About Sonata System

The Sonata System uses radiofrequency energy to ablate fibroids under real time sonography guidance from within the uterine cavity, utilizing the first and only intrauterine ultrasound transducer. The System includes a proprietary graphical user interface (SMART Guide), enabling the operator to target fibroids and optimize treatment. The Sonata system provides incision-free transcervical access for a uterus-preserving fibroid treatment. This intrauterine approach is designed to avoid the peritoneal cavity. The Sonata System is CE marked and is approved for sale in the European Union and the United States.

About Gynesonics

Gynesonics is a womens healthcare company focused on advancing womens health, by developing minimally invasive, incision-free, uterus-preserving, transcervical technologies for diagnostic and therapeutic applications. Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. Gynesonics headquarters is in Redwood City, CA. For more information, go to http://www.gynesonics.com.

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Gynesonics Announces Positive Payer Coverage Issued by Health Care Service Corporation (HCSC) for the Sonata Treatment - Business Wire

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced a strategic, exploratory immunotherapy sponsored research agreement with the Johns Hopkins University to study the potential of checkpoint inhibitors combined with RTGel in glioblastoma multiforme, or GBM, an aggressive and difficult to treat brain cancer. Johns Hopkins researchers expect to begin nonclinical research of RTGel combined with a PD-1 and a CTLA-4, respectively, in the second quarter of 2021.

UroGens proprietary RTGel technology is a reverse-thermal hydrogel that may increase dwell time of current therapies and exposure of active drugs, potentially improving the therapeutic effects of existing products.

Local delivery of checkpoint inhibitors has the potential to fundamentally change the treatment paradigm for some of the most devastating cancers. We are excited to work with Johns Hopkins investigators on this exciting frontier in immunotherapy, said Dr. Mark Schoenberg, Chief Medical Officer of UroGen Pharma. This research will be an exciting addition to our current immuno-oncology pipeline, including UGN-302 which combines UGN-201, a toll-like receptor 7/8 agonist, with UGN-301, a CTLA-4 antagonist, for the treatment of high-grade non-muscle invasive bladder cancer. With our expanding programs in this field of research, we look forward to extending the potential of our RTGel platform in immunotherapy.

The goal of this research is to further understand the efficacy of local delivery of immunotherapy to tumor draining lymph nodes, where anti-tumor T cells are primed by antigen presenting cells. Based on research at the Johns Hopkins University, sustained release of immunotherapy such as anti-PD-1 delivered directly to the lymph nodes, may target myeloid cells and T cells with PD-1 expression to enhance proliferation and anti-tumor activity of T cells. Successful use of lymph-node targeting therapies may reduce the toxicities associated with systemic administration of immunotherapy.

GBM is an aggressive malignant brain tumor with a five-year survival rate of less than five percent. GBM is difficult to treat and treatment options today are limited, and typically include surgery followed by radiation and chemotherapy. It is the most common primary brain tumor, with around 12,000 cases diagnosed per year in the United States.

About UroGen Pharma Ltd.

UroGen is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs. UroGens sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. UroGens first commercial product, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means. UroGen is headquartered in Princeton, NJ with operations in Israel. Visit http://www.urogen.com to learn more or follow us on Twitter, @UroGenPharma.

Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation: the potential of UroGens proprietary RTGel technology platform to improve therapeutic profiles of existing drugs; the potential to expand the use of the RTGel platform in immunotherapy; the timing of expected initiation of the nonclinical research of RTGel combined with a PD-1 and a CTLA-4; the potential for local delivery of checkpoint inhibitors to fundamentally change the treatment paradigm for some cancers; and the potential for successful use of lymph-node targeting therapies to reduce the toxicities associated with systemic administration of immunotherapy. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential safety and other complications thereof; the ability to obtain regulatory approval within the timeframe expected, or at all; the ability to maintain regulatory approval; complications associated with commercialization activities, including complications resulting from the ongoing COVID-19 pandemic; the labeling for any approved product; the scope, progress and expansion of developing and commercializing UroGens product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis--vis alternative therapies; UroGens ability to attract or retain key management, members of the board of directors and personnel; and any negative effects on UroGens business, commercialization and product development plans caused by or associated with COVID-19. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGens Form 10-Q filed with the SEC on November 9, 2020, and other filings that UroGen makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGens actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.

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UroGen Pharma Announces Sponsored Research Agreement with the Johns Hopkins University School of Medicine to Expand Immuno-Oncology Pipeline -...