Chronic fatigue syndrome reality conflicts with medical study

Medical research is a funny thing. I don’t say that in the literal sense: research generally is as much fun as having a tooth pulled. It is in regard to the statistical analysis required of any medical study that I refer.

As the cliche goes ‘numbers can lie’. The term “Evidenced Based Medicine” basically refers to the use of medical studies to indicate whether some treatment is beneficial or worthwhile. When a scientist or physician has some theory or method they want others to utilize (regardless of the motivation, be it profit or something beneficent), they construct a study which explores and evaluates this new method……although, as most people realize, statistics can be manipulated to reveal most anything.

Take Samantha, for example. She was a healthy middle-aged woman, a vital productive member of society, who came down with some sort of viral infection, which changed everything. Samantha developed a condition so debilitating that any activity whatsoever was impossible. Her days of mountain biking and painting became days, then weeks, of lying in bed, unable to even sit up or answer the door. She began experiencing severe joint pain, and constant unremitting exhaustion, so profound that turning over in bed had to be planned hours in advance. Whenever she did try to push herself, her symptoms got worse, so she lay there for months, staring at the walls in the room, wondering what had happened.

Samantha was diagnosed with chronic fatigue syndrome, a complicated disorder characterized by extreme fatigue that can’t be explained by any underlying medical condition. Chronic fatigue syndrome is one of the most controversial conditions known. Researchers, doctors and patients struggle to agree on its name, its definition or even whether it exists. But to those diagnosed with CFS, the prognosis is not good. A recent analysis, which followed patients for up to five years, concluded that the recovery rate is 5 percent.

Because there is no clear biological mechanism, the condition has often been claimed to have a psychological cause: psychiatrists in the 1970s put it down to “mass hysteria”, while in the 1980s the press cruelly nicknamed it “yuppie flu”. This latter term implied that sufferers were spoilt young people too lazy to work. Diagnosing chronic fatigue syndrome is made difficult by the fact the symptoms can mimic so many other health problems, and even more so because there is no single test to confirm it. A physician must rule out a number of other illnesses before a diagnosis of chronic fatigue syndrome can be made.

To meet the diagnostic criteria of chronic fatigue syndrome, someone must have unexplained, persistent fatigue for six months or more, along with various other signs and symptoms. These can include loss of memory or concentration, sore throat, enlarged lymph nodes, unexplained muscle pain, extreme exhaustion lasting more than 24 hours after physical or mental exercise, and others. The fatigue may worsen with physical or mental activity, but doesn’t improve with rest. It has also been called myalgic encephalomyelitis and, more recently, systemic exertion intolerance disease, although there is notable variation between these disorders

So much remains unknown about chronic fatigue syndrome. Many theories abound concerning an actual mechanism. One particular proposal, now considered unlikely, proposes a combination of triggers – genetic, environmental, psychological – overwhelming the body, throwing the nervous system out of balance, causing the brain to reduce massively what it considers a safe level of exertion. One of the most common theories proposed is that it is the result of a viral infection. A number of viruses are suspected, including Epstein-Barr and others.

Many of those suffering from more severe cases of chronic fatigue syndrome were shocked and astounded by a study published several years ago in the respected medical journal, the Lancet, claiming psychotherapy and a gradual increase in exercise were lasting, effective treatments that could lead to recovery. Therapy had certainly helped Samantha to keep her sanity in the face of such a debilitating illness, but it had never made her any healthier. And the hallmark symptom of the illness is that exertion can make patients much, much worse, conflicting radically with this report.

Headlines were made with that study, and spread around the world. News sources, eager for drama, picked it up in various forms and ran with it. But many individuals with knowledge of CFS could not believe what they were reading. Its conclusion was that those afflicted were out of shape, afraid of exercise, and obsessed about their symptoms.

The study purportedly proved that patients could “recover” from the illness through treatment with one of two rehabilitative, non-pharmacological interventions: graded exercise therapy, involving a gradual increase in activity, and a specialized form of cognitive behavior therapy. In essence, the path to wellness was to stop thinking that one had a physical disease, and steadily increase exercise levels, regardless of how bad it made the sufferer feel.

Despite the many errors in study methods and statistical analyses, the study (known as the PACE trial) became part of the recommendations by such influential institutions as the CDC and the Mayo Clinic. That is, until a major investigation lead to an expose published by a San Francisco journalist, in which deep methodological flaws in the entire PACE trial put its validity in serious doubt.

A follow-up paper by the PACE investigators was met with intense criticism by many, and not just those who have first-hand knowledge of the condition. Scientists internationally demanded an independent review of the PACE trial, calling the whole study “unbelievably amateur”, stating the trial was useless. To make matters worse, the PACE investigators refused repeated requests for the data they had collected….generally not a good sign for a research study.

American physicians have been strongly influenced by the PACE trial. This may be the result of our devotion to the concepts of “Evidence Based Medicine.” One simply has to publish a study, whether well-constructed or not, biased though it may be, perhaps even deeply flawed, and the results can be adopted and repeated as gospel.

The research community, on the other hand, has rejected the psychiatric model epitomized by PACE. They instead are looking for a physiologic explanation, whereby there is some actual, physical phenomenon at work.

Funding for sound research on chronic fatigue syndrome has been incredibly limited, and has hampered efforts to better understand this disease, despite the fact that this appears to be more common than once thought. Estimates indicate that as many as 800,000 adults may have CFS. Unfortunately, fewer than 20 percent of these individuals have been officially diagnosed with CFS, and received medical attention for their fatiguing illness. Yet, now there is hope in the form of a recent announcement by the National Institute of Health that it is starting a program to study CFS.

Samantha has recovered somewhat, and she is able to work part-time, although a challenging bike ride or a stressful day at work can still trigger her symptoms. At least now there is hope in the form of new funding for research. Still, definitive treatment is relatively non-existent.

But the stigma created by bad research continues to haunt many suffering from chronic fatigue syndrome. Perhaps the take-home message is that not all medical studies are accurate: biases exist in all facets of human life. Prejudices remain an integral part of human existence, no matter how strongly we deny, or claim we are above it.

Editor’s note: Dr. Conway McLean is a podiatric physician now practicing foot and ankle medicine in the Upper Peninsula, having assumed the practice of Dr. Ken Tabor. McLean has lectured internationally on surgery and wound care, and is board certified in both, with a sub-specialty in foot orthotic therapy. Dr. McLean welcomes questions, comments and suggestions at drcmclean@penmed.com.