This is an English version of this post published earlier today.
Maybe the best news for a long time for ME-patients in this country – at least since the news about the XMRV-study at Lillestrøm Health Clinic – is that the ME-center at Ullevål (a subdivision of Oslo University Hospital) is doing large biomedical studies of ME.
Today the patient blog «Pasientfora» has published information about biomedical studies at the ME-center, and the full project description, and I forward the information to you with a summary, and with my own comments at the end of this article.
What is the ME/CFS-center?
The ME/CFS-center was started at Ullevål University Hospital in Oslo Norway on the 1st of December, 2008 and offers a interdisciplinary team for adults (over 18 years) with ME or chronic fatigue syndrom. The center is led by MD Barbara Baumgarten-Austrheim, and the team consists of a specialist in infectious diseases, psychologist, occupational therapist, physioterapist, clinical nutritionist and social worker. They are recruiting more physicians.
The ME/CFS-center offers to diagnose patients, a «second opinion», courses on how to master to live with the disease, thematic lectures for patients and next of kin etc. They also educate health professionals regarding the disease, and has an outpatient team that travels to the patient’s home if they are to sick to be diagnosed/treated at the hospital.
The project – some facts
The ME/CFS-center is doing a biomedical research project with the following scientific title: «Can chronic virus infections cause Chronic Fatigue syndrome?»
The full project description can be found here. (Some of the document is in Norwegian, but there is a project description in English).
Project leader and main supervisor: Prof. Emeritus Stig Jeansson (firstname.lastname@example.org)
Supervisor and contact person: MD. Barbara Baumgarten-Austrheim (email@example.com)
Supervisor: Dr. Oddbjørn Brubakk (specialist in infectious diseases), consultant at the ME/CFS-center at Oslo University Hospital, Ullevål
Publication: The project is a doctoral study project for MD Barbara Baumgarten-Austrheim. The results will be published in international and national medical journals with peer-review.
Project start/end: The project started on the 1st of March 2010, and will be ended by 29th of December 2034.
Goal: To study and find the causes of ME. A thematic biobank is being establish in a proper and safe way. The inclusion period is from 2010-2034. The project is part of the mission for the ME/CFS-center.
Short project description: The cause of Myalgic Encephalopathy (ME) is still unknown. ME is characterised by a debilitating chronic fatigue and defined additional symptoms. About 70% of the cases are developed after an infection. There is no specific diagnostic tests, and the diagnosis is set clinically with the help of defined diagnostic criteria and exclusion of other diseases that might explain the condition. Immunological studies suggest an activation of the immune system, which might fit a chronic infection.
The project has collaboration partners from St. George’s University in London (Cellular & Molecular Medicine), Uppsala University in Sweden (Medical Genetics), Karolinska University Hospital (Center for infectious medicine), Stockholm, Sweden and Department for Microbiology at Oslo University Hospital, Ullevål.
Co-workers and their role in the project:
- Amanuensis Dr. Eirik Frengen. Institute of Medical Genetics, Oslo University Hospital, Ullevål.
- Responsible for studies of human herpesvirus-6 integrated in the human chromosome.
- Chief Engineer Mona Holberg-Petersen. Department of Microbiology, Oslo University Hospital, Ullevål.
- Responsible for molecularbiological analysis.
- Professor Jonas Blomberg, Department of Medical Science, Clinical Virology, Uppsala University, Sweden
- Responsible for analysing XMRV-virus.
- Professor Jonathan R. Kerr, Department for cellular and molecular medicine, St. George’s University of London.
- Responsible for studying subgroups of ME/CFS-patients.
- Researcher Yenan T. Bryceson, Center Infectious Medicine, Karolinska University Hospital, Stockholm, Sweden.
- Responsible for immunological analysis.
More about the goals for the study
1. We will determine the prevalence of XMRV in CFS patients and matched controls. A possible relationship between XMRV infection and the presence of other viruses that are often associated with CFS (e.g. herpesviruses and enteroviruses) will be looked into.
2. a) Determine the prevalence of CIHHV-6 in CFS patients and matched controls. If CIHHV-6 is found we will subtype virus as HHV-6A or HHV-6B. The presence of free HHV-6 virus particles in plasma (viremia) will be determined in CFS patients and matched controls.
2. b) Verify that HHV-7 activation is higher in CFS patients than in controls and that a simultaneous activation of HHV-7 and HHV-6 is found in CFS patients only. Hopefully be able to show that in a subgroup of CFS patients a simultaneous active infection with these viruses is a causal factor. Do CFS patients have an increased shedding of HHV-7 in saliva?
3. We will determine the prevalence of chronic enterovirus infection in CFS patients and a control group. If a reliable diagnosis of a chronic enterovirus infection can be established in a subgroup of CFS patients the possibility of antiviral treatment will be considered.
4. Immunological parameters will be evaluated in CFS patients and healthy controls:
a. Various mediators of cytotoxic cell function.
b. Cytokine analyses
c. Gene-expression markers for immunological dysfunction
Diagnosis and patient selection
The project will use established international criteria for ME-diagnostics: Fukuda-criteria (CDC 1994) and the Canadian criteria (Carruthers et. al. 2003).
The diagnosis is made by an evaluation of the patient’s medical history, clinical evaluations and tests to ensure that the conditon/symptoms is not caused by other diseases. When a certain ME-diagnosis is made, research has shown that patients can be divided in 7 different subgroups based on their gene-expression pattern.
ME often debuts after a serious, acute infection, and signs of immunological dysfunction is often seen. The part of the immune system needed for an effective defence against viruses is often down-regulated. We want to study different viruses as possible cause for ME in certain subgroups. The virus discussed often leads to lifelong chronic infections.
You can read m0re about the different viruses to be studied in the project description, or at Pasientfora.
Patients who wished to be evaluated for ME/CFS (myalgic encephalopaty/chronic fatigue syndrome) will participate in the study with informed consent.
The diagnosis is based on a set of clinical criteria that must be fulfilled. It is a need to find agents or specific immunological findings that can be directly connected with the diagnosis, so that it is possible to develop laboratory tests to confirm the diagnosis. If a defined virus infection causes ME in a defined subgroup, it may open up the possibility of antiviral treatment with an effect on the disease’s development.
A controlgroup will be established from blood donors matched both regarding sex and age, from an assumed healthy normal population.
The project is going to use material from a biobank that is being established at the ME/CFS-center. This is a thematic biobank within the ME-field, and will collect samples over a timespan of approximately 25 years.
For each patient, a control person matched by age and sex will be sought from healthy blood donors.
Approximately 350 ME-patients will be included every year, and the inclusion period is from 2010 to 2034.
In total for the given timespan, the estimated number of participants is 15.000.
If new ideas and new information about ME should surface during the project period, applications to the regional ethics committe will be submitted to use the biobank-material for each new project.
This biobank will also have value for international cooperations within the field.
Some of the reasons for establishing such a large biobank, is that several subprojects will be carried out, and for each subproject a relatively large number of samples must be used from the biobank. It is desirable to research several scientific questions within the ME/CFS-field.
Benefits and disadvantages of the project
Benefits for each project participant is a certain diagnosis of the disease, with thorough evaluation.
If the background or causes of ME/CFS is established, this can lead to possibilities for effective treatment for some patients.
It is a benefit for patients with a ME/CFS-diagnosis to get an explanation of the mechanisms of the disease, and possible treatment options.
For society the advantages are that the prevalence of ME/CFS in an European population is about 0,5% (ca. 20.000 cases in Norway). Chronic diseases leads to large costs for society, and an improved diagnosis and treatment will reduce those costs. Despite a vast scientific work, many see ME/CFS as a mystic and controversial and disease. Therefore it is important to establish clear and objective measurable criteria for the diagnosis.
Disadvantages is that the collection of samples will take more of the patient’s time, and will not give immediate results for the patient.
It can be a strain for the patient if hereditary factors for ME-patients is detected.
ME-patients has been and still are an ignored group. The ME/CFS-diagnosis is regarded as diffuse by health professionals. There are no specific diagnostic tests or established treatment. In the mission for the ME/CFS-center, research is an important part. In the long term this project might contribute to better diagnostics and treatment of the ME-disease.
A disadvantage might be that it can take a long time before improved diagnostics and treatments are in place. Our judgement is that it is time to try to improve the conditions for this patient group.
Decision from the ethical research committe
The project is approved by the research ethics committee, but must fulfill special demands for example regarding approval from the Health Directorate and approvement of ethics for each sub-project. The establishing of the research biobank «ME/CFS – Thematic Biobank» is approved.
The full project application from the ME/CFS-center with the project description and correspondence with the research ethics committe and the approval of The Norwegian Biotechnology Advisory Board can be found here: Project description ME/CFS-center
I have not had the opportunity to read the full project description, but wants to than Pasientfora for making it available and giving us a summary of the project.
I think this sounds like a solid, comprehensive and exiting project. I am especially glad that a biobank now is established with samples (blood and hair) from ME-patients, and that it is highlighted that this also will be useful in international research collaborations.
The project will study the relation between ME/CFS and several viruses, amongst them XMRV. They are also open to that new information and new ideas in the ME research-field will be actualised during the project period, and are willing and ready to include these in new sub-projects. This is very positive.
This is also of course a clear and solid statement that the ME/CFS-center takes the disease seriously and really wants to research in depth to find the causes of this disease, and also possible treatments, for example antiviral treatments. We have not seen a biomedical research effort of this magnitude here in Norway before, and to my knowledge such an extensive and long-term project has not been carried out anywhere else either.
Together with the XMRV-research being carried out at Lillestrøm Helath Clinic in cooperation with the WPI and the San Raffaele-institute, Norway will be positioned in a positive way regarding biomedical research of the causes of ME/CFS. Uppsala University is as we know already involved in XMRV-research, and I’m glad to hear that they will cooperate with the ME/CFS-center in this project.
All in all this was a very positiv reading of the project description served to us on a Sunday afternoon, and I think we have reason to thank Barbara and the others at the ME/CFS-center for their effort for the research and the patients.
Wishing you all a happy Sunday! 🙂