By David Tuller, DrPH
The European ME Coalition (EMEC) has published a statement about and an analysis of a recently released report about ME/CFS from a Germany agency, the Institute for Quality and Efficiency in Health Care (IQWiG). With EMEC’s permission, I have re-posted the statement in full below. The original post can be found here. The in-depth analysis, a separate document that runs to 13 pages, can be found here.
The IQWiG report on ME/CFS in Germany
On 13 October 2022, the German Institute for Quality and Efficiency in Health Care (IQWiG) published its draft report on myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). This report was commissioned two years ago by the German government in part because of the European resolution on ME/CFS. The final report is thought to play an important role in future policies towards ME/CFS in Germany and beyond. All interested persons and institutions are invited to submit comments on the draft until 27 November. In this article, we provide a brief overview of the IQWiG report and share our suggestions on how it could be improved.
In 2020  the German Ministry of Health asked IQWiG to compile an overview of the current state of knowledge on ME/CFS. This resulted in a long document with 294 pages of information on the diagnosis, etiology, and treatment of ME/CFS. A summary for the general public will be published on the website www.gesundheitsinformation.de after the project is completed.
The IQWiG draft report gives an overview of multiple case definitions of ME/CFS. It is argued that older diagnostic criteria mainly focused on fatigue as a symptom and therefore captured a heterogeneous group of patients. Much like the NICE guidance, it recommends the use of more modern case definitions that require patients to have core ME/CFS symptoms such as post-exertional malaise (PEM).
In its evidence review, IQWiG focuses on studies that used modern diagnostic criteria where PEM was a required criterium. To estimate the prevalence of ME/CFS they rely on an English study in primary care where 0.1% of patients were found to have ME/CFS. Extrapolating this figure to Germany would mean that approximately 70.000 adults suffer from the illness. For children and adolescents, there was not enough reliable data to make an estimation. The report also refers to an estimate by researchers from the EUROMENE research network, which stated that the cost of ME/CFS in Europe could be around €40 billion per year.
The German report provides an overview of different gradations of ME/CFS, stating that approximately 25% of patients are severely affected. These patients can hardly ever leave their homes and are often bedridden or dependent on a wheelchair. Even small activities such as sitting upright, going to the toilet, or talking can trigger PEM and make their symptoms worse.
Although the illness may manifest itself differently for patients, the IQWiG report states that full remission is rare. Children and adolescents, however, are said to have better chances of recovery compared to adults with ME/CFS.
The document also discusses various theories about the cause of ME/CFS symptoms such as autoimmunity, metabolic defects, genetic factors, and problems in blood circulation. It concludes, however, that although ME/CFS was categorized as a neurological disease in 1969 by the World Health Organization, its causes remain unclear until this day.
It commends further biomedical research and says that the federal government of Germany has provided funding to set up a research network to study the causes and disease mechanisms of ME/CFS.
The report also highlights several shortcomings in the German healthcare system for ME/CFS patients. It states that there are no separate medical guidelines for the disease in German-speaking countries and that the topic is only addressed in a guideline on fatigue. At present, there are only two university outpatient clinics in Germany that specialize in ME/CFS: The Charité Fatigue Center in Berlin and the Klinikum Rechts der Isar at the Technical University of Munich. The report notes that ME/CFS has not yet been an explicit subject of the medical curriculum in Germany nor in other European countries.
The overview of ME/CFS that IQWiG has drafted for the website includes several positive aspects that might help the recognition of the illness. It clarifies that ME/CFS is a physical illness and that there is no evidence for a psychological cause. The draft also states that ME/CFS can lead to severe disability and offers several options for patients to apply for medical support or disability benefits. It mentions that home visits and digital communications can be helpful for ME/CFS patients and that many find it valuable to connect with other sufferers online.
The section on treatment, however, is the most controversial one. It states that ME/CFS cannot yet be cured and there are no drugs that can treat the disease. Instead, the report claims that there are various ways to manage the illness. It offers three treatment options: energy management also called pacing, cognitive behavior therapy (CBT), and graded exercise therapy (GET).
The latter two treatments are controversial as in various surveys ME/CFS patients have reported that these interventions worsened instead of improved their health. Scientists have also questioned the validity of the research on GET and CBT, stating that it suffers from multiple methodological weaknesses. The IQWiGreport nonetheless argues that GET and CBT can help some people with mild to moderate ME/CFS to reduce certain symptoms at least temporarily.
In its review of treatment studies, IQWiG only included trials that used modern diagnostic criteria where PEM is required, or trials where more than 80% of participants experienced PEM. Only 8 randomized trials met these requirements. 3 Proviced data on CBT and GET: the PACE trial, the GETSET trial, and a Dutch study on web-based CBT. The IQWiG report highlights multiple flaws in these studies and concludes that they are at high risk of bias. It also found that the data offers few hints of a treatment effect for GET and CBT. On the other hand, the draft also argues that the reports of harm in patient surveys do not offer reliable evidence. It suggests that adverse effects may have been due to improper implementation of GET and recommends that it should be done under the supervision of a physiotherapist with knowledge of ME/CFS.
EMEC disagrees with several of the conclusions above and has prepared detailed comments on how the IQWiG report can be improved. A PDF with the English version of our suggestions is provided below. We plan to submit these in German in the format that IQWiG requires. We hope that our analysis will stimulate further debate about the IQWiG draft report and that other stakeholders will submit comments as well.
3 thoughts on “Trial By Error: German Draft Report on ME/CFS Raises Alarms for Promoting CBT and GET”
My ME started with severe fly symptoms witch included severe back pain.Progressed to diagnosis of Lyme a bacterial illness When are doctors going to accept virus/ bacteria are what is making us ill
Meant severe flu symptoms
An interesting point is that the head of IQWIG, when releasing the draft version of the report, argued that the recommendation for GET – which he acknowledges may be harmful for some – was okay because “patients could choose not to participate.” Obviously, he has no idea whatsoever about the real world of patients out there.
In fact, this statement could become a real problem for IQWIG as this institution also evaluates medications and advises about their coverage by public insurance. What if they will not recommend a certain medication based on an unfavorable side effect profile – the manufacturers will then argue that this was not a problem because patients may elect not to take a prescribed medication.
What a mess they created.
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