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Chronic Fatigue Syndrome Clinical Trials

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Chronic Fatigue Syndrome: Advancing Research and Clinical Education

CFS can be debilitating both physically and mentally. Suffering from persistent exhaustion, reduced brain cognition, chronic muscle and joint pain, stress, and even guilt takes a toll on the body, and psyche.

Long-term stress control and relaxation must be a vital portion of any protocol used to overcome chronic fatigue syndrome. While seemingly impossible, its imperative that sufferers of CFS do their best to effectively manage stress, and rest.

The Power of Rest

Rest means more than just sleep. Dedicate one day per week when you dont have any responsibilities or commitments. Truly commit to a full day of rest. This gives your body and mind a much-needed respite helping to fight stress, anxiety and exhaustion. Its also important during the week, if you are having a particularly difficult day, to not overtax yourself.

While regular exercise supports wellness and helps to diminish stress, individuals with chronic fatigue syndrome need to exercise at a controlled intensity. High-intensity workouts can leave you drained for several days.

Exercise Therapy

Exercise therapy has been shown to help with fatigue, mental clarity and depression in patients with chronic fatigue syndrome. According to a study released in the European Journal of Clinical Investigation, individuals with CFS were recommended to perform aerobic activities, at the clinic twice per month, in combination with at-home exercises for roughly 5-15 minutes in duration, five days per week.

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Worldwide Brings Four Decades Of Cns Research To Your Chronic Fatigue Syndrome Study

Chronic fatigue syndrome is a condition characterized by persistent pain and is often accompanied by musculoskeletal weakness, cognitive impairment, and sleep disturbance. Because the disease undermines so many aspects of wellness, the implications on an individuals ability to function fully are significant. With so little currently known about the condition, there is ample opportunity for advancement in knowledge related to epidemiology, treatment, and cure of the condition.

Worldwide Clinical Trials has been researching central nervous system disorders since the 1970s, when many of todays most commonly known conditions were not yet identified. We bring our wealth of experience in clinical trial development and execution to neurological disorders, exploring not only the symptoms of conditions but also looking at biomarkers for specific indications. Our intimate knowledge of regulatory requirements and our broad global reach enables us to employ patient groups in remote areas and identify those most likely to meet enrollment criteria and compliance protocols.

Limitations Of The Hypothesis That Ebi2 Upregulation Is Important In A Subset Of Cfs/me Patients

The raw data underpinning the present review were generated by only one research group. Therefore, it would be important that these findings are replicated in additional CFS/ME patients and normal controls by independent research groups.

Elevated levels of antibodies to EBV VCA, EA, and DNase have been reported to occur in CFS/ME patients albeit inconsistently . However, it is important to understand that EBV antibody markers may associate with CFS/ME, but this does not prove that EBV has triggered the disease in those particular cases. The seroprevalence of EBV in the general population and in CFS/ME patients is ~90%. And the proportion of CFS/ME patients with EBI2 upregulation was found to be between 38 and 55% CFS/ME patients, all of whom had IgG to EBV VCA. For a disease in which a variety of microbial triggers are recognized, our findings are consistent with the hypothesis that upregulation of EBI2 is important in the pathogenesis of disease in a subset of CFS/ME patients. However, this hypothesis remains wholly unproven and it is not understood what factors, in addition to EBV infection, are required for upregulation of EBI2 in an individual patient.

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Future Drugs For Fibromyalgia And Chronic Fatigue Syndrome A Clinical Trials Survey

by Cort Johnson | May 17, 2019 | Ampligen, Cortene, Dextromethorphan, Electromagnetic Radiation, Flexeril, Homepage, Ivabradine, Ketamine, Lyrica, Metformin, Mifepristone, Stimulants, Suramin, Tomnya, Treatment |

Which will be the next drug to be FDA-approved for FM or ME/CFS?

Both fibromyalgia and chronic fatigue syndrome clearly need better treatments. The FDA-approved drugs for these diseases are too often ineffective, come with too many side effects or just arent available at all .

Too many people remain in pain, unable to work , be active, get out and visit and do the things they used to love to do. Alternative health treatments and mind/body techniques can certainly help, but for most of us significant relief or a cure is probably going to take the form of a drug or other FDA-approved treatment that insurance companies will pay for. Hence the focus of these overviews on drugs.

In part one of this series, we looked at the recent disappointing drug trial failures and one drug thats managed to revive itself after a near-death experience. In this one, we look to the future at clinical trials underway or reported to begin shortly.

Characteristics Of Rcts Meeting The Inclusion Criteria

(PDF) Guided graded exercise self

From the PubMed and Cochran databases, a total of 513 articles were initially identified, and 56 articles ultimately met the inclusion criteria for this study . Fifty-one RCTs were conducted for adult patients, while 5 RCTs were conducted for the adolescent population . The majority of RCTs were conducted in 3 countries: the UK , the Netherlands , and the USA . Regarding interventions, 29 RCTs conducted non-pharmacological interventions, 25 RCTs conducted pharmacological interventions and 2 RCTs conducted a combination of pharmacological and non-pharmacological interventions .

Fig. 1

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Chronic Fatigue Treatment: Whats Next

Theres currently no cure for chronic fatigue syndrome, nor have prescription drugs been developed to relieve the condition. Healthcare providers instead talk about managing CFSa challenge because it affects each patient in a different way. Plus, symptoms can vary over time, further complicating matters.

The most effective treatment of CFS, experts say, involves a team approach: doctors who specialize in different areas working with the patient himself. By working together, they have a better chance of creating a customized treatment program.

Doctors typically set out to relieve the most disruptive symptoms in a chronic fatigue syndrome patient. For example, some patients may experience a serious sleep disorder as one of their symptoms, whether its insomnia, restless leg syndrome, or nocturnal myoclonus . A sleep specialists treatment might involve the establishment of a hard-and-fast bedtime routine, the elimination of napping during the day, regular exercise, and the avoidance of caffeine after lunch and of alcohol and tobacco altogether.

If those steps dont resolve sleep issuesif the patient is still experiencing unrefreshing sleepdoctors may test for sleep apnea or narcolepsy and/or prescribe medication.

Acute Infection And Fatigue

Multiple co-infections

Nicolson et al. reported on the incidence of co-infections in 200 CFS patients and 100 controls by PCR analysis of whole blood. A total of 52% of CFS patients versus 6% of controls had evidence for the presence of at least one Mycoplasma species. A total of 7% were PCR positive for C.pneumoniae versus 1% in the controls and 30.5% positive for HHV-6 and 9% in the controls. Evidence for co-infection in Mycoplasma positive blood had similar incidences although there was no evidence of co-infections with these pathogens in the control cohort. One might logically expect a mixed non-cleared infection to respond to rintatolimod variably similar to the current mid-third minimal responders.

Despite two decades of attempts to identify specific infectious agents as the initiator of the signs and symptoms of CFS/ME, it is apparent that a multiplicity of obligate intracellular pathogens are capable of disease initiation. Although the pathogenesis of persistence in a minority of affected individuals has remained unclear, dysfunctional genetic responses involving the immune system and energy metabolism have been linked to the CFS/ME phenotype.

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Magnetic Stimulation Of The Brain

The rapidly evolving magnetic stimulation field holds the promise of safely and effectively turning down overactive parts of the brain involved in pain processing and/or ramping up parts of the brain involved in executive functioning

$8 Million Clinical Trial Of A Mitochondrial Booster Underway In Me/cfs

Beyond the Data Chronic Fatigue Syndrome: Advancing Research and Clinical Education

by Cort Johnson | Apr 23, 2022 | Autonomic Nervous System, Cardiovascular, Energy Production, Homepage, Mestinon, Metabolism, Research |

An $8 million clinical trial of a mitochondrial enhancer, no less, in ME/CFS? I thought I was hearing things but it was so, and, in the end, it even makes sense given how rapidly some parts of this field are moving forward. But first, a little backstory.

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Data Extraction And Synthesis

Using the predefined inclusion and exclusion criteria, 2 assessors independently screened abstracts and full texts, and reviewed each article at the appropriate phase. Data of interest were extracted on demographic and outcome-related data, including first author, publication year, country, condition, population, sample size, intervention type, control or comparator, dosage, treatment duration, follow-up duration, and effectiveness and/or safety-related measures.

Prevalence And Clinical Features

It is difficult to establish the prevalence of CFS, since it depends on the diagnostic criteria used and the study population. Initial research suggested a prevalence between 0.002% and 0.04%. . However, latest epidemiological studies in the USA and in the United Kingdom show prevalence rates ranging from 0.007% to 2.5% of the general population. These rates increase up to 0.5-2.5% when the population assessed includes individuals seen in primary care facilities instead of the global population. In the United Kingdom, according the Oxford criteria , the prevalence in the global population has been estimated in 0.6%. In Japan the prevalence has been found to be 1.5% in the general population. Thus, the prevalence in the general population appears to be much higher than previously indicated. Even with strict criteria for CFS, it is estimated that approximately 1% of the adult population experiences this condition. Interestingly, a large part of this group remains unrecognized by the general practitioner. A striking similarity in lifestyle pattern between SF, CF and CFS calls for further research.

CFS mainly affects young adults from 20 to 40 years, although the symptoms also exist in childhood, adolescence and in the elderly . It has a 2-3 times higher prevalence in women than in men. No evidence exists showing that any socio-economic group is more affected than others .

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Judgment Of The Statistical Efficiency Of The Intervention

We judged the intervention efficacies as Significant or Not significant based on the data presentations of the original articles. In general, Significant meant that the intervention reached statistical significance according to the primary measurement at the planned time point outcome assessment. We defined partially significant for the following cases: only part of the main outcomes was statistically significant, or statistical significance was observed only at certain time points without a description of the fixed period for final assessment.

Physio And Heat Therapy

(PDF) Clinical and cost

Dr. Ginerva Liptan has said that massage is amongst the most effective treatments for her patients.

  • Bowen Therapy for Pain Management in FM Bowen Therapy uses specific sequences of gentle cross-fiber moves over muscles, tendons, ligaments, and fascia to stimulate or improve the flow of blood and lymph, and thus activate the bodys healing mechanisms that enhances tissue repair. As a result, it can lessen pain and tension, restore more optimal body function, and subsequently alleviate emotional and psychological stress associated with the pain. Would this be helpful for the muscoskeletal problems Dr. Rowe finds in ME/CFS?
  • Effects of Mobilization and Perceptive Rehabilitation on Patients with Fibromyalgia Syndrome the tool consisted of cones made from a latex material which were placed under the patients back during treatment sessions. These cones were intended to improve tactile response and proprioception, the so-called perceptual surface.

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Psychological Stress Is Key To Virus Transmission Infection And Cfs/me

For any given virus infection, outcomes vary according to many factors. However, for the purposes of CFS/ME, the key factor is psychological stress. It has been shown for a variety of viruses that psychological stress is necessary for successful virus transmission from one person to another . Furthermore, it has been shown that psychological stress is necessary for symptoms to develop after successful transmission, as opposed to asymptomatic infection . It is well known that psychological stress is key in the reactivation of herpes viruses, and this precedes the recurrence of cold sores , shingles , and Epstein-Barr virus . Psychological stress has been shown to be important in triggering a large proportion of cases of CFS/ME, and this fits perfectly with a viral pathogenesis. Psychological stress is universal and is expected under various circumstances, for example, student examinations, loss of a parent or partner, etc.

Rintatolimod And Cfs/me Markers Of Disease

Rintatolimod is clearly active in improvement of ET and quality of life in a subset of patients with CFS/ME. Moreover, the clinical evidence suggests that rintatolimod inhibits disease deterioration in a minority of patients who fail to show improvement from activation of TLR3. The basis for this differential response to rintatolimod is unknown but may be secondary to a variety of microbes coupled with a combination of genetic polymorphisms resulting in an immune response unable to clear either a productive microbial infection or an activated non-replicative intracellular microbe. The diagnosis of CFS/ME remains a diagnosis of exclusion. To date, there have been no laboratory-based markers for CFS/ME diagnosis although there have been potential candidates that unfortunately have not been adapted by clinical reference laboratories. Prime examples include a dysfunctional 2-5 adenylate synthetase and functionally inactive NK cells reported in CFS/ME by multiple investigators. RNAse L has been observed by De Meirlier to be corrected by rintatolimod in patients .

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Nih Me/cfs Clinical Study

The NIH intramural clinical study on ME/CFS to take place at the NIH Clinical Center will focus on post-infectious ME/CFS in order to closely examine the clinical and biological characteristics of the disorder and improve our understanding of its cause and progression. The eligibility criteria for this study includes three groups of adults that either: 1) have ME/CFS with post exertional malaise fulfilling multiple consensus criteria 2) had Lyme disease, were treated, and don’t have fatigue symptoms or 3) are healthy volunteers. These groups were selected so that comparisons can be made between the groups to look for differences and similarities that may exist, using the unique resources of the NIH Clinical Center. All individuals will be very carefully characterized for all of the symptoms of ME/CFS using multiple criteria. The narrow scientific focus of this study is only the first step of what NIH hopes will be a broader national approach to better understand the biological basis of ME/CFS and the development of effective therapies. Learn more about this study: http://mecfs.ctss.nih.gov.

To find all NIH-funded clinical trials on ME/CFS, conduct an advanced search on ClinicalTrials.gov. Search term: Chronic Fatigue Syndrome or Myalgic Encephalomyelitis select NIH as the funder type.

Set Priorities For Improvement

Chronic Fatigue Syndrome Metabolomics and Future Clinical Trials

Some people can hinder their recovery by trying to become their normal selves in every aspect of their life straight away.

What you really need to do is work out what the most important things in life are to you and what you want to achieve, and deal with these as a priority over the less significant ones.

You can use a profit and loss system, where you give something an importance rating out of a hundred, and then give it a difficulty rating . Try and do the things that will leave you in profit first.

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Role Of The Funding Sources

The research group for ME/CFS at Department of Oncology and Medical Physics has received funding from the Kavli Trust and the Norwegian Ministry of Health and Care Services. The HLA sequencing has received funding from the Kavli Trust and Norwegian Research Council. The funders had no role in trial design, data collection, analysis, decision to publish, or preparation of the manuscript.

The Aetiology And The Pathogenic Mechanisms Of Cfs

As the criteria for CFS diagnosis are not based on the understanding of aetiopathogenic mechanisms, some patients present similar clinical manifestations but are diagnosed with other conditions because fatigue is not the primary symptom. Some of those conditions are fibromyalgia, irritable bowel syndrome, and temporomandibular joint syndrome. Furthermore, in addition to sharing several symptoms with CFS, currently available evidence suggests that those diseases also share similar pathophysiologic mechanisms .

Although the aetiology and the pathogenic mechanisms of CFS are not fully understood, several hypotheses have been postulated and described below, being the disorders of the central nervous system neuromodulator the one supported by more evidence to explain the possible pathogenic mechanisms involved in CFS .

Infectious theory

Epstein Barr virus, Candida albicans, Borrelia burgdorferi, Enterovirus, Citomegalovirus, Human Herpesvirus, Espumavirus, Retrovirus, Borna virus, Coxsackie B virus, and hepatitis C virus have been associated to CFS, but their pathogenic relationship with the syndrome has not been demonstrated .

Immunological theory

Neuroendocrinological theory

In patients with fibromyalgia, the research on neurotransmitter disorders has started to yield positive findings, and it is known that different clinical manifestations will appear according the type and the site of action of affected neurotransmitters .

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What Can I Expect

Having chronic fatigue syndrome can be hard. But for most people, the symptoms are most severe in the beginning. Later, they may come and go. Teens with CFS generally get better faster and recover more completely than adults do. Most teens get partial or full recovery within 5 years after symptoms began.

Many new and experimental treatments for CFS are available. But dont use any unproven treatments until checking with your doctor.

CFS is a misunderstood illness. But scientists continue to learn about it through research and clinical trials. Theyre trying to better understand its symptoms and causes in kids and teens.

Good medical care and coping techniques are the keys to helping your child manage chronic fatigue syndrome. It can also help to find support sites and groups, such as:

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