THE CARER TIMES

Evidence -based medicine and ME

One of the greatest barriers that people with ME face are the lack of Randomized Control Trials (RCT's) to back up whatever treatment a Consultant might recommend. The awful nightmare is this : there are currently no treatment or tests available on the NHS for ME, so any request for new tests and treatments inevitably have to go through a special funding panel. Apart from psychiatry's few hopeless studies, there are no other RCT's to go on, so the request for funding is bound to be turned down. Is this right ?

Professor Malcolm Hooper makes the point that evidence-based medicine is not restricted to RCT's and meta-analyses. Rather it involves tracking down the best external evidence with which to answer clinical questions

As Hooper says : "there is a serious deficiency of good-quality research" on ME.

The Chief Medical Officer's Report (2002) reviewed how :

• Patients’ voices are not being listened to and understood.
• Every patient’s experience is unique, and the illness should be managed individually and flexibly.
• Review of the evidence highlights the lack of good quality research to support effectiveness of various therapies.
• Patients of all ages with ME must receive care and treatment commensurate with their health needs and the disability resulting from the illness.
• Healthcare professionals should have sufficient awareness, understanding, and knowledge of the illness to enable them to recognise, assess, manage, and support the patient with CFS/ME.
• Health service commissioning must ensure that local provision for these patients is explicitly planned and properly resource, and that health professionals are aware of the structure and locale of provision.
• A programme of research on all aspects of ME is required.

The CMO Report was published almost ten years ago !! Nothing's changed .

RCT's an an inadequate foundation to make clinical decisions upon in ME

That is because of the limitations of the RCT base. As Hooper states : if there is a dearth of RCTs on the treatment of ME, then there is a wealth of treatment regimes described in leading international medical journals, textbooks and patient manuals, which must be taken into account, when making a clinical decision. As ME Research point out : the accepted strategy of looking at formal "evidence" is flawed in ME/CFS because the evidence‐base is skewed towards the small group of mildly positive RCTs :

It is not a case of finding the “best” evidence garnered from the work of a range of biomedical and biopsychosocial scientists working on a level playing field, but rather finding quite modest evidence in a forgotten field put there by proponents of one model of the illness – the biopsychosocial model – a construct which contrasts with the biomedical model which implies that a primary disease entity exists and that biopsychosocial aspects are secondary (the two models discussed in the report to the UK Chief Medical Officer in 2002). Contrast this situation with, say, breast cancer which has been well supplied with funding for biomedical trials, and in which meta‐analysis can arrive at a best estimate of treatment effects from a large number of different studies, including replicate investigations on different populations by different research groups (vide NICE Guidance on Cancer Services Improving Outcomes in Breast Cancer, 2002).

Breast cancer with the formal evidence‐base that currently exists for ME/CFS would be no less a physical illness, and the non‐specific management and coping strategies would be no more specifically effective for the underlying disease. Our point is that a NICE guideline on the diagnosis and treatment of breast cancer in the face of such an evidence‐base would not be meaningful, or fair to the patients. A corollary of this is that the importance of evidence from non‐RCT scientific studies is diminished or discounted. There is no need for us to list here the range of biomedical investigations already conducted on people with ME/CFS – these have already been flagged for the attention of the GDG, and a full database of over 3000 abstracts exists at http://www.meresearch.org.uk/. Most are not RCTs or controlled trials, and come lower in the hierarchy of research evidence, but given the paucity of clinical trials in ME/CFS (a function of lack of the basic funding needed to test hypotheses) and the skewing of the small RCT evidence‐base that exists, they do, in fact, represent a considerable body of evidence that biomedical investigation can uncover, within subgroups of people with ME/CFS, biological anomalies that might well help to explain many of the clinical features associated with the illness and indicate areas for therapeutic treatment.

Neglect and Abuse

We are exhausted. After fighting for 17 years for my wife to be seen by a biomedical consultant at home, who described her symptoms as a "torture and a nightmare" the local NHS disregarded the test results he ordered, and rejected his treatment recommendations. Meanwhile my wife's health deteriorates. It goes beyond a nightmare.

Dr Stilgoe of Demos, and Prof. Irwin and Dr Jones wrote in the Guardian "The experiences of patients and the professional judgments of doctors are important. It is not a simple battle between evidence and anecdote." Neither was my wife's long, long experience of 17 years of illness nor the consultant's world-class expertise, taken into account, by our local NHS.

In 2003 Hooper stressed how : " In the UK, patients with myalgic encephalomyelitis (ME, also known as Chronic Fatigue Syndrome or CFS), particularly children, have suffered gross and barbaric abuse and persistent denigration as a consequence of the beliefs of certain psychiatrists who are attempting to control the national agenda for this complex and severe neuro-immunological disorder. These psychiatrists are shown to be clearly in breach of the first tenet of medicine --- first do no harm--- in that by their words and deeds they have wreaked havoc in the lives of ME/ICD-CFS patients and their families by their arrogant pursuit of a psychiatric construct of the disorder which ignores the abundant clinical and scientific evidence (widely presented in the international medical and scientific literature) of the organic nature of ME/ICD-CFS .To the serious disadvantage of patients, these psychiatrists have propagated untruths and falsehoods about the disorder to the medical, legal, insurance and media communities, as well as to Government Ministers and to Members of Parliament, resulting in the withdrawal and erosion of both social and financial support.

As a consequence, Government funding into the biomedical aspects of the disorder is non-existent This coterie of psychiatrists has proven affiliations with corporate industry and has insidiously infiltrated all the major institutions, directing funding for research into an exclusively psychiatric model of the disorder, focusing on "management strategies" involving psychiatric techniques, even though such techniques have been shown to be at best of no lasting value and at worst to be harmful to patients with ME/ICD-CFS. (Hooper 2003 )"

Our local NHS Medical Director himself phoned me , after I met him back in 2008, and offered to send Linda for CBT and GET. He was a member of the Funding panel that subsequently turned down the recommendations of an ME Specialist . Our local NHS promised us that they would provide a proper biomedical services for ME patients; all they have done is set up a new therapy-led clinic. It feels as if you are completely stitched up. No matter which way you try and turn, you come up against those brick walls of denial and deceit, built by the psychiatrists .

As Marshall & Williams (2006 ) ask : " Why is the existing evidence of biomedical anomalies in ME/CFS continually ignored by “Wessely School” psychiatrists, who claim that the only disorders that they will “accept” are those supported by “evidence-based” medicine? And yet their “de-conditioning” model of ME/CFS is not evidence-based, nor can it ever be so: it is a hypothesis that cannot be tested, let alone proven, which contrasts with the biomedical model of ME/CFS that is supported by respected literature of solid scientific evidence."

Back in 2004 Erik Johnson made the most profound point in a letter to the BMJ : " Why did it take a housewife to discover the Lyme epidemic? What lack of scientific method, behavioral problem or mental flaw made doctors oblivious to what a Polly Murray, a housewife armed only with an arsenal of common sense could see so clearly?; That the "genetically induced Juvenile Rheumatoid Arthritis" that doctors were diagnosing in Lyme Connecticut occurred at a rate of increasing prevalence distinctly uncharacteristic of a "genetic" illness. Polly Murrays book "The Widening Circle" describes her battle against doctors who insisted that the Lyme epidemic was "All In Your Head" despite unimpeachable evidence to the contrary. Even after the contradiction of the "statistically almost impossible" increasing prevalence was pointed out to doctors, they still failed to respond in a scientific manner.

Physicians have the audacity to produce "scholarly" papers on the mental behaviors of obstinate patients who refuse their recommendations for mental health interventions while evidence continues to mount that the entire crisis of patient confidence is being created by the inexplicable behaviors of the physicians themselves. Where are the studies that explain these repetitive failures of a "common sense" approach in doctors?

In ME, all things are not equal

The future looks very grim for people with ME, unless there is a commitment to provide and fund new treatments, currently not available on the NHS, based upon Clinical Judgment , Patient experience and the willingness to examine the much wider evidence base .

As Neil Abbot points out : "RCTs (random controlled trials) are the best evidence of efficacy, all things being equal. But in ME/CFS the majority of RCTs are biopsychosocial trials of non-specific management strategies (ie. CBT/GET). Such trials are expensive to conduct, and it is the biopsychosocial experts who have been able to access the funding to conduct them. This means that any time a ‘review’ of the literature is done, the dominant ‘therapies’ are psychosocial ones. The fact that these trials of CBT and GET have had relatively unspectacular results is less important to reviewers than that fact they are ‘positive’. This is very nice indeed for the psychosocial professionals, but a disaster for the large number of patients with signs and symptoms of a biomedical illness who need detailed clinical assessment and biomedical investigation instead of strategies to manage their ‘illness beliefs’. In short, the accepted strategy of looking at formal ‘evidence’ is flawed in the case of ME/CFS because the evidence-base is skewed".