Summary of Knowledge for Norwegian ME/CFS patients June 2011 and The Norwegian Knowledge Centre for Health Services memoranda papers

This blogpost will give a summary of The Norwegian Knowledge Centre for Health Services publish three separate memoranda regarding: diagnostic criteria, ongoing published trials and research published in scientific journals the last ten years with Professor Kenny De Meirleir on the list of authors and an updated overview of evidence regarding treatment, rehabilitation, and care of those who suffers from chronic fatigue syndrome.

Background

The Norwegian Knowledge Centre for Health Services was commissioned by the Norwegian Directorate of Health to prepare an updated an overview of evidence regarding treatment, rehabilitation, and care of those who have chronic fatigue syndrome. Moreover, The Norwegian Knowledge Centre for Health Services publishes three separate memoranda regarding: diagnostic criteria, ongoing published trials and research published in scientific journals the last ten years with Professor Kenny De Meirleir on the list of authors.

The Norwegian Directorate of Health answered the assignment from the Ministry of Health and Care Services with the following main conclusions and recommendations with strong initiatives from two of the Norwegian Associations of ME/CFS in a letter named Summary of Knowledge for Norwegian ME/CFS patients June 2011

The Main conclusions in Summary of Knowledge are:

There is currently no evidence-based knowledge of treatment of ME/CFS to publish a national guideline for the primary health care services.

The Norwegian Directorate of Health may, in light of existing reports see that it will take time to build up strong, robust patient care for this patient group

There is no recommendation of further use of the NICE 2007 Guidelines as diagnostic criteria.

The Knowledge review does not provide a general support for recommending GET and / or CBT for patients suffers from CFS / ME

Read the English Summary of Knowledge for Norwegian ME/CFS patients June 2011 here

Memoranda papers regarding:

Treatment of chronic fatigue syndrome CFS/ME

Chronic fatigue syndrome – ongoing clinical research studies

Chronic fatigue syndrom – a search for effect and causal studies written by Kenny De Meirleir

Diagnostic criteria for chronic fatigue syndrome

Memoranda papers regarding – ongoing clinical research studies:

The main purpose of the rapid review was to identify ongoing Norwegian clinical trials assessing effects of different types of interventions for people with chronic fatigue syndrome.

We searched for ongoing clinical trials in the WHO International Clinical Trials Registry Platform Search Portal (ICTRP) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Clinical Trials Portal in March 2011.

We identified 45 registered protocols of clinical studies (see Vedlegg 2 in the pdf file) on the effect of treatment for chronic fatigue syndrome – six Norwegian, 12 Dutch, 14 American, nine English, three Australian, and one Belgian. The interventions were mainly pharmacological or behavioura-l and attitude-related. Four protocols referred to Norwegian randomised controlled trials, two about pharmacological treatment (clonidine and rituximab) and two about behavioural- and attitude-related interventions.

It is useful to assemble ongoing clinical studies to see if current research activity covers any knowledge gaps identified for different types of interventions and outcomes in systematic reviews. There is ongoing clinical research on treatment interventions for people with chronic fatigue syndrome, and the number of studies initiated in Norway is high compared to other European countries. Of the 45 registered research protocols for ongoing clinical studies, are six Norwegian.

Norwegian ongoing study protocols are:

The Norwegian study of chronic fatigue syndrome in adolescents: Pathophysiology and intervention trial. NCT01040429. ClinicalTrials.gov.

Survey and cognitive behaviour therapy (CBT) treatment of chronic fatigue syndrome/ myalgic encefalomyelitis (CFS/ME) patients. NCT00920777. ClinicalTrials.gov.

Giardia induced fatigue and functional gastrointestinal diseases. NCT00860236. ClinicalTrials.gov.

Drug intervention in chronic fatigue syndrome. NCT00848692. ClinicalTrials.gov.

Not included in the presentations of ongoing Norwegian studies:

B-cell depletion using the monoclonal anti-CD20 antibody Rituximab in very severe chronic fatigue syndrome. NCT01156922. ClinicalTrials.gov.

B-cell depletion using the monoclonal anti-CD20 antibody Rituximab in chronic fatigue syndrome. NCT01156909. ClinicalTrials.gov.

A short summary of The Norwegian study of chronic fatigue syndrome in adolescents: Pathophysiology and intervention trial can you read here

Read the paper here

Comments:

As a patient at Lillestrøm Health Clinic in Norway, which is a private health clinic specializing in the assessment, treatment, and research of chronic diseases such as chronic fatigue syndrome and myalgic encephalopathy/myelitis, chronic digestive problems, fibromyalgia/chronic pain conditions I have my own treatment protocol based on my blood- and stooltest (and more) findings and consist on several treatment initiatives.

We know that CBT/GET will for instance not cure Giardia infection.

When it comes to the Rituximab study it is likely that it will fit for subgroups with profiles that match for a good outcome of the treatment.

If the clonidine study that is part of lager study comes with positive results, it will probably have a big impact at the treatmentstrategy for the patients group of ME/CFS suffers. The studyprotocol is based on the “Sustained arousal-model”. This can exclude others treatment approaches.

In summary The Norwegian Knowledge Centre for Health Services conclusions on ongoing studyprotocols is high in Norway and increased focus on PWCs is great. We all know that research is the way for better understanding and knowledge of this disease and for better treatment.

*****

Memoranda papers regarding – a search for effect and causal studies written by Prof. Kenny De Meirleir:

The Norwegian Knowledge Centre for Health Services was commissioned by the Norwegian Directorate of Health to review scientific publications written by Professor Kenny De Meirleir. A search in relevant databases revealed 107 publications published between January 2000 and January 2011, and we considered 13 of these publications to fulfill our predefined inclusion criteria.

• We included two studies about the effects of treatment, but they did not provide a basis for drawing any conclusions.

• We included eleven case-control studies of possible biomarkers, cause and risk factors. Some of the studies reported interesting results, but did not provide a basis for drawing firm conclusions about the causes for chronic fatigue syndrome.

The studies we included did not provide a basis to draw conclusion about the effect of interventions. The included observational studies are thematically related, showing increased prevalence of active infections in patients with chronic fatigue syndrome, and do also point to possible irregularities in the patient’s immune response.

It is important to emphasize that the results presented here has important limitations compared with the results presented in systematic reviews. As only publications by De Meirleir were considered for inclusion, we have not assessed whether the findings of De Meirleir and co-workers are consistent with findings reported by other research groups. There may be a need for a systematic and thorough review of publications on the causes and risk factors associated with chronic fatigue syndrome

***

Vedlegg 3 (Appendix) provides an overview of all studies / publications that were included in this paper.

Reference: Chronic fatigue syndrom – a search for effect and causal studies written by Kenny De Meirleir

Read the paper here

Comments:

After reading through the paper where it is regarded publications where KDM is co-author, I am pleasantly surprised how much they have actually included in his presentation. Although there were only two controlled studies where it was seen on treatment efficacy and one of the studies is not published in its entirety. This is something a feared beforehand that The Norwegian Knowledge Centre for Health Services may be able to do. It is also considered and included a number of other studies looking at the findings of ME / CFS patients vs. controls, which appear as positive in this paper.

In the discussion section is said and indicates that The Norwegian Knowledge Centre for Health Services take great interest for the necessity that it should include such studies in the future. Something that seems very promising.

Since it is the health authorities, we are talking about, we hope that they follow their own ambitions and prioritize this key area of knowledge.

“Such studies are interesting for several reasons. First, the detection of disease-specific biological markers contribute to safer and more consistent diagnosis. In addition, clarification of the causes of disease open to the development of new and dedicated treatment interventions”

*****

 – Although these papers appear promising, we still struggle to be believed by our physicians

that this is a somatic disease –

*****

Legg igjen en kommentar

Fyll inn i feltene under, eller klikk på et ikon for å logge inn:

WordPress.com-logo

Du kommenterer med bruk av din WordPress.com konto. Logg ut / Endre )

Twitter picture

Du kommenterer med bruk av din Twitter konto. Logg ut / Endre )

Facebookbilde

Du kommenterer med bruk av din Facebook konto. Logg ut / Endre )

Google+ photo

Du kommenterer med bruk av din Google+ konto. Logg ut / Endre )

Kobler til %s