Fibromyalgia, RCTs, and the selection of journal articles

In this month’s issue there is a letter from a colleague complaining that by publishing a recent article on the treatment of fibromyalgia with acupuncture (2004;46(1):21-23) the BCMJ may have done a disservice to the doctors of BC.

The author goes on to describe in detail the shortcomings of the manuscript. He very appropriately points out that the study suffers from being non-blinded, non-randomized, and that there was no attempt to provide controls.

All of these comments are valid and should be remembered when any of us are evaluating the usefulness of medical articles that are presented as “new science” in mainstream journals. Many disease processes are relatively easy to study with randomized controlled trials (RCTs) as there are quantifiable changes in most disease processes that lend themselves to objective reporting, and with good study design using large enough populations the results can generally be trusted.

However, there are some medical conditions that continue to defy pathological categorization but have over time (and after several name changes) achieved recognition as disease processes, some with widely accepted diagnostic criteria. Fibromyalgia is one of these modern “boutique diseases” that is extremely common but doesn’t seem to have a recognizable cellular pathological process. The reporting of the symptoms of profound fatigue associated with a wide variety of tender spots in the absence of any biochemical or physiological alterations are generally the hallmarks of fibromyalgia. For many years I was not convinced that there was a real disease process afflicting these often very disabled individuals. However, in the past decade the sheer weight of patient numbers has tipped the scales in favor of “real disease” for me, and I think as well for most physicians providing ongoing care for fairly large populations. Like most of the docs out there who have been trying to deal with fibromyalgic patients over the years, I continue to be frustrated by a limited therapeutic armamentarium that provides minimal, brief interludes of relief for the majority of patients suffering from fibromyalgic symptoms. There have been hundreds of papers written about fibromyalgia in the past decade, many describing the results of various therapeutic interventions. However, they all suffered from basically the same problems that our writer describes in his letter, as it is virtually impossible to study this disease without relying on subjectivity. I should note that very few of these articles could properly validate any of the interventions that were being assessed.

The central mandate of the BCMJ is to provide continuing medical education to our readers. If the BCMJ Editorial Board, in its collective wisdom, feels that an article has merit because it provides our readers with a new, possibly effective, safe way of dealing with a medical problem that has few useful therapeutic options, we will take a long hard look at it. If, after weighing the pros and cons, we believe that the information could be helpful to the practising docs out there, we may feel that we have a duty to publish it. It has always been our collective opinion that the BCMJ has a learned and sophisticated readership, and each individual physician scientist is quite capable of evaluating the quality of a published manuscript and deciding if a described intervention is something that could be included in his or her own therapeutic armamentarium.

The decision to publish any article in a medical journal has many components, but to my mind one of the most important is, “Is it helpful for our readers?” If the answer is yes, I won’t be apologizing because the article wasn’t properly randomized or controlled.

—JAW