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A recent double-blind, randomized pilot trial has found evidence that regular ginseng supplementation may reduce fatigue caused by multiple sclerosis. Researchers at the Isfahan University of Medical Sciences in Iran also found that ginseng may improve patients’ quality of life.
Over 50 participants completed the pilot study. Subjects were assigned to receive either two placebo pills or two 250 mg tablets of ginseng for a period of three months. During this time period, no adverse events were reported. Both a reduction in fatigue and an improvement in reported quality of life (measured through questionnaires) were significant for individuals taking the ginseng supplement.
Although this small trial is not conclusive, it does indicate that ginseng supplementation may be a viable option for natural treatment of certain MS side effects. Fatigue and depression commonly factor among the long list of related ailments affecting people with MS. Ginseng may interact with some pharmaceuticals, but under consultation with a physician or pharmacist, it can often be safely taken and well tolerated.
Natural relief for MS symptoms
Ginseng is not the only herbal remedy for MS symptoms or the side effects of MS medications. Many natural treatments for MS exist, including vitamins, minerals, herbs, and supplements. Other treatments, such as yoga, speech therapy, bladder control training, and meditation have also received considerable support for their effectiveness at battling certain MS-related problems.
Many individuals with MS experience symptoms such as numbness or tingling in joints, nerve degeneration, mental deterioration, walking or balance problems, bladder infections or bowel dysfunction, vision problems, pain, spasticity, and other conditions related to nerve and muscle health. In some cases, tremors, swallowing problems, seizures, hearing loss, and breathing troubles may also occur.
Kessler Foundation has been awarded a new grant by the National Multiple Sclerosis (MS) Society for a pilot study of memory and learning difficulties in individuals with MS. Scientists will test the effectiveness of using of self-generated learning in a treatment intervention to improve memory and functional performance. Yael Goverover, PhD, visiting scientist in Neuropsychology & Neuroscience Research, is the study's principal investigator. Dr. Goverover, an associate professor at New York University, will work with John DeLuca, PhD, the Foundation's senior VP for Research & Training. They will test the efficacy of self-generated learning in individuals with MS who have memory and learning difficulties and in controls.
"Past research has shown that items that are "self-generated" by an individual, such as words or concepts, are remembered better than items that are simply read or heard," said Dr. DeLuca. The aim of the clinical trial to demonstrate the effects of learning to use a self-generation strategy as a treatment intervention to improve performance of both laboratory tasks (e.g. words and concepts) as well as functional tasks (e.g. activities of daily living). Forty persons with MS with memory impairment, age 18 to 65, will be recruited. Half will receive self-generation training while learning different types of tasks (experimental group) and half (control group) will be asked to learn the same information using more conventional methods (e.g. repetitions).
"Self-generated learning is geared toward helping patients self-discover their own strengths and abilities while learning to use principles of self-generation independently in everyday life situations," noted Dr. DeLuca. "We anticipate that participants undergoing the self-generation-training intervention will show better memory performance, functional performance, quality of life, and satisfaction with treatment and life compared with controls."
A new guideline on “Assessment and Management of Psychiatric Disorders in Individuals with Multiple Sclerosis” from the American Academy of Neurology was published in the December 27 online issue of Neurology.
Emotional disorders are common in individuals with MS. If left undetected and untreated, these disorders may worsen problems with functioning caused by MS. More research is needed on identification, diagnosis, and treatment of emotional disorders. Read more about MS and depression, and other emotional changes.
The information shown above was sourced from the National Multiple Sclerosis Society
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Coughing and Shortness of Breath as Symptoms of MS
Just when you thought that the tingling
and numbness, the fatigue, the MS
hug and the memory problems were enough,
turns out that people with multiple
sclerosis (MS) are prone to respiratory problems,
as well. In fact, most of us would test pretty low on pulmonary function tests
designed to assess the strength of our respiratory muscles.
Fortunately, for most of
us, these problems are not noticeable or do not impede us in any significant
way. Even better, it turns out there may be exercises that we can do to prevent
this from getting worse.
Respiratory Problems in MS Feel Like?
MS-related respiratory problems can take
several forms, including:
·Shortness of breath
·Difficulty breathing deeply
·Not enough air
These are often described
·Trying to breathe with a blanket over your head
·Having a heavy weight on the chest
·Inability to take a deep breath
Common Are MS-Related Respiratory Problems?
Breathing difficulties are reported by 20% of
people with MS. In one study, 32% of people with MS reported mild dyspnea
(painful breathing or shortness of breath) under moderate exertion.
Causes Respiratory Problems in People with MS?
It has long been thought that respiratory
problems occur later in the disease process. However, recent studies fail to
correlate these symptoms with duration of MS. Rather it is the severity of MS
(disability levels) that is a good indication of how severe the breathing
difficulties will be. Breathing difficulties in MS can be caused by one or more
of the following factors:
·Sensory Problems It is
now thought that these symptoms may be the result of abnormal respiratory
·Muscle Weakness: Many
people with MS score low on measures of respiratory muscle strength, such as
mouth pressure tests (see below).
·Side Effect of Medications: Some
drugs prescribed to help with MS-related pain or spasticity can cause breathing
to be slower and shallower. These include muscle relaxants, tranquilizers and
opioid-based pain medications.
·Aspiration Pneumonia: This
is caused when food particles, liquid or mucus enters the lungs. This can be a
cause of breathing difficulties in people with MS, due to MS-related swallowing
difficulties or inability to clear mucus from nose or throat.
Severe Can It Get?
It is extremely rare that
MS-related breathing difficulties become so severe as to require breathing
assistance (breathing tubes or supplemental oxygen) or become life-threatening.
However, even fairly mild breathing problems can cause severe fatigue, further
contributing to other sources of MS-related
fatigue. In addition, the feeling that you can’t get
enough air can lead to panic attacks and severe anxiety.
“Panting” and MS: Patients
with MS tend to have a more superficial (shallower) and faster breathing rate
than people in the general population.
Lower Mouth Pressure: Mouth
pressure is a measure to assess the functioning and strength of respiratory
muscles by testing maximum inspiratory (breathing in) pressures and maximum
expiratory (exhaling) pressures. These were found to be between 60 and 70% of
normal even in patients with low disability (EDSS scores of 1.5 to 5.0).
Respiratory Therapy: Breathing
exercises to prevent respiratory complications during later stages of MS as
well as improve overall respiratory function appears to be successful at
improving breathing capacity.
Although I have not had my respiratory function
formally evaluated, I am pretty sure that it is impaired. The way that it
manifests itself for me is that whenever I get an infection that is accompanied
by coughing, I will continue to cough for a long time, even after the infection
has passed. Coughs that should be “productive,” meaning bringing up mucus, just
don’t seem to clear out my throat and chest like they should. I just have this
constant hacking, which sometimes turns into a big coughing fit – often making
me feel like I am on the verge of passing out. Eventually, the cough will pass,
but even physicians are surprised at how long this takes and how resistant the
cough is to different remedies or supressants.
I also need to chew
slowly and carefully, as I can set off a coughing/choking spell if I talk or
laugh too much when eating. I have also noticed that it doesn’t take much
exertion on the treadmill or going up stairs to get me winded, which I had
previously attributed to simply being out of shape. My lack of fitness probably
does play a big part of feeling winded, but it just seems out of proportion to
how hard it is to catch a breath sometimes.
Rae-Grant AD, Eckert NJ,
Bartz S, Reed JF. Sensory symptoms of multiple sclerosis: a hidden reservoir of
morbidity. Mult Scler. 1999 Jun;5(3):179-83.
Gosselink R, Kovacs L,
Decramer M. Respiratory muscle involvement in multiple sclerosis. Eur
Respir.1999; 13: 449-54.
Mutluay FK, Gürses HN,
Saip S. Effects of multiple sclerosis on respiratory functions. Clin
Rehabil. 2005 Jun;19(4):426-32.
Scientists at the Sanford-Burnham Medical Research Institute have found a possible explanation for the loss of nerve function caused by multiple sclerosis and similar neurodegenerative diseases. The research provides a new approach to finding potential therapies.
A protein called contactin-1 is required to wrap nerves with myelin, a protective sheathing that enables proper function, the scientists found. When myelin is worn away, as in multiple sclerosis, nerves in the brain and spinal cord become damaged and don’t properly transmit sensory and motor signals.
LONDON -- It's a disease that strikes down adults at their prime -- and it's found Ground Zero in Canada.
Multiple sclerosis afflicts Canadians at a rate that far outpaces anyplace else in the world, a new survey has found.
"It's really shocking … It is almost like a Canadian disease," said Karen Lee, of the Multiple Sclerosis Society of Canada.
Nearly 100,000 Canadians have the disease, a rate that's 28% higher than the country with the second-highest mark, Denmark, and nine times higher than the global average, according to the survey by the Multiple Sclerosis International Federation.
Mesenchymal stem cells (MSCs) are partially defined by their ability to differentiate into tissues including bone, cartilage and adipose in vitro, but it is their trophic, paracrine and immunomodulatory functions that may have the greatest therapeutic impact in vivo. Unlike pharmaceutical treatments that deliver a single agent at a specific dose, MSCs are site regulated and secrete bioactive factors and signals at variable concentrations in response to local microenvironmental cues. Significant progress has been made in understanding the biochemical and metabolic mechanisms and feedback associated with MSC response. The anti-inflammatory and immunomodulatory capacity of MSC may be paramount in the restoration of localized or systemic conditions for normal healing and tissue regeneration. Allogeneic MSC treatments, categorized as a drug by regulatory agencies, have been widely pursued, but new studies demonstrate the efficacy of autologous MSC therapies, even for individuals affected by a disease state. Safety and regulatory concerns surrounding allogeneic cell preparations make autologous and minimally manipulated cell therapies an attractive option for many regenerative, anti-inflammatory and autoimmune applications.
Mesenchymal stem cells (MSCs) have been suggested to be patient-specific drugstores for injured tissue, and with good reason.1 What was originally believed to be a simple differentiation or lineage cascade of mesenchymal tissue cells has proven itself to be a much more elegant and complex entity. MSCs are now known to originate as pericytes, which function as surveyors of their kingdoms, capable of responding to local environmental stimuli with a myriad of beneficial interventions.2 The availability and versatility of these remarkable cells make them an excellent treatment option for a wide variety of clinical pathologies, and it falls to the scientific community to establish clear guidelines for the optimal administration of MSC-based therapies. In the following review, we survey a brief history of MSCs, their anti-inflammatory, immunomodulatory and paracrine effects, and the current status of MSC-based therapies for a multitude of clinical applications.
CAMBRIDGE, Mass. - December 30, 2013 - Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A Complete Response Letter informs companies that an application is not ready for approval. FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Genzyme understands that the conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada in relapsing-remitting MS patients. FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada. Genzyme strongly disagrees with the FDA’s conclusions and plans to appeal the agency’s decision. “We are extremely disappointed with the outcome of the review and the implications for patients in the U.S. suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease,” said Genzyme President and CEO, David Meeker, M.D. “We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile. This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world.” Lemtrada is approved in the European Union, Canada, and Australia, and additional marketing applications for Lemtrada are under review by regulatory agencies around the world. Sanofi does not anticipate that the CVR milestone of U.S. approval of Lemtrada by March 31, 2014 will be met. About Lemtrada™ (alemtuzumab) The Lemtrada clinical development program included two pivotal randomized Phase III studies comparing treatment with Lemtrada to Rebif® (high-dose subcutaneous interferon beta-1a) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than Rebif at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Serious autoimmune conditions can occur in patients receiving Lemtrada. A comprehensive risk management program will support early detection and management of these autoimmune events. Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity. Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue. About Genzyme, a Sanofi Company Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com. About Sanofi Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). Genzyme® is a registered trademark and LemtradaTM is a trademark of Genzyme Corporation. Rebif® is a registered trademark of EMD Serono, Inc. Sanofi Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
Sanofi Media Relations
Tel: +33 (0) 1 53 77 46 46
By Simeon Bennett and David Wainer December 30, 2013
Sanofi (SAN) failed to win U.S. regulatory approval for its multiple sclerosis drug Lemtrada, denting the company’s ambitions of capturing a larger share of the $20 billion market for the disease.
The U.S. Food and Drug Administration said Sanofi’s Genzyme unit didn’t submit evidence from “adequate and well-controlled studies” showing that the benefits of Lemtrada outweigh its side effects, the Paris-based company said in a statement today. Sanofi disagrees with the conclusion and said it will appeal.
Lemtrada, which was approved in the European Union in September, was a key part of Sanofi’s $20.1 billion acquisition of Genzyme in 2011. The FDA indicated one or more additional trials comparing Lemtrada with another drug are needed for approval, Sanofi said.