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by John W. Addington
February 6, 2002
An extensive review of medical studies on CFS therapies published last September in the Journal of the American Medical Association (JAMA) has caused somewhat of a stir. Of the thirty-one different therapies included in the review, only cognitive behavioral therapy (CBT) and graded exercise therapy (GET) were determined to be of much benefit. Many CFS advocates are alarmed by how this conclusion could be interpreted. Nonetheless, the benefits of the reviewers' exposé of the shortcomings of CFS research generally may well outweigh any potential harm from the article.
Review Conclusions
The JAMA review used stringent scientific standards to determine which studies were even worth considering. Because of this the majority of studies initially assessed were excluded. In fact, out of the 350 studies first identified, only 44 were found worthy to be included in the review.
Besides CBT and GET, the studies reviewed included various treatments targeting either the immune system disturbances, hormone imbalance, or faulty brain signals. Trials involving alter-native therapies including various supplements, homeopathic remedies and massage therapy were also assessed.
Only CBT and GET, however, were described by the authors as having "shown promise." This is because more than one study for each of these treatments showed similar positive results. Immu-noglobulins and hydrocortisone were described as having "shown some limited effects but for which overall evidence is inconclusive." Besides these, essential fatty acids, magnesium, NADH, and massage therapy all showed overall beneficial effects, but only in one study each.
Shortcomings of CFS Research
Perhaps the greatest benefit of the JAMA review, however, is what it teaches about the problems with CFS research. The reviewers forthrightly confessed to numerous shortcomings in this area. For instance, that so many studies had to be excluded shows that consistent criteria and methods for trials are not being used by all CFS investigators.
Another issue that worked against fair comparisons in the studies was the varied case definitions used to establish whether the participants actually had CFS. For the majority of studies re-viewed, 4 different primary definitions for CFS were involved. A few studies, however, used various other diagnostic criteria for having the ailment. Also patients with varying levels of se-verity were used in the studies, and often the sickest were excluded because of their inability to travel to the clinic hosting the trial. Thus it cannot be said with certainty that all patients in the studies even suffered from the same disorder.
Additionally since there is no consensus as to a cause for CFS, treatments involved did not uni-formly target one particular body system (hormones, immune system, etc.). Similarly with no agreed clear biological marker, the myriad symptoms of the ailment were variously used as ba-rometers of improvement. Thus for the studies reviewed 38 different symptom outcomes were used. And if that is not bad enough, the scale or measurements of improvement also varied greatly for any given symptom studied.
Another shortcoming of CFS clinical trials evidenced by this review is the inconsistencies in treatment duration and follow-up periods. In the studies appraised, the period of treatment varied from 2 weeks to 1 year. Likewise, the follow-up periods in the studies varied from 2 weeks to several months; seldom ever was there a follow-up time as long as one year.
Given the irregular nature of symptom severity, the authors of this review found the shorter fol-low-up periods particularly troublesome. They explain, "The relapsing nature of CFS suggests that follow-up should continue for at least an additional 6 to 12 months after the [treatment] pe-riod has ended, to confirm that any improvement observed was due to the [treatment] itself and not just to a naturally occurring fluctuation in the course of the illness."
Because of the large variations existing in CFS therapeutic trials, no large pool of evidence exist for any one treatment or symptom. Noting this and other difficulties encountered, the JAMA re-viewers state, "There is a need for standard outcome measures to be used in trials evaluating [therapies] for CFS so that results can be meaningfully compared across studies."
Misinterpreting the CBG/GET Findings
CFS advocates fear this survey could have unintended but negative consequences. That CBT and GET were found to be the most successful may be interpreted by some that CFS has a psycho-logical not physical cause. Thus doctors could feel their suspicions are confirmed; the problems of CFS patients lie in their heads. Yet Dr. Simon Wessley wrote in an accompanying article in the same issue of JAMA, that, "such views are misguided."
Commenting further on the review, Dr. Wessley cautioned that "neither approach of [CBT or GET] is remotely curative" and thus researchers should "continue their efforts to develop better treatments." On the topic of CBT as a therapy for CFS, Dr. Anthony Komaroff explains "'It helps people cope with the illness, but it's not curative." CBT should thus be viewed as one means to help manage the symptoms and not an attempt to treat the cause of the ailment. In a similar vein, CBT has shown to be of benefit for the care of patients with heart disease and multiple sclerosis, despite the physical nature of these ailments.
In an earlier issue of JAMA last year, Dr. Benjamin Natelson also discussed the positive out-comes in the use of CBT for CFS. He said that "this does not mean that CFS is necessarily psy-chological in origin. For instance, CBT can improve the symptoms of patients with other chronic diseases such as rheumatoid arthritis."
Dr. Natelson also explained that "CBT is not always effective in treating CFS." This may be sub-stantiated by findings in the JAMA review of CFS studies. The researchers noted high drop-out rates in the CBT trials. Although the reasons for patient withdrawals from the trials were not clear, it could be that the treatment did not work or worsened their symptoms.
Kim Kenny the president of the CFIDS Association of American has commented on how CBT can exacerbate some patients' condition. She says, "behavioral therapy has the potential to cause severe relapses, especially when not administered by skilled professionals." Noting this concern Dr. Wessley warned that "the skilled CBT practitioners who delivered the interventions that … have been shown to provide benefit in the clinical trial setting must not be replaced by enthusias-tic amateur therapists."
Kenny details another issue she has with the review. "Inferring from this paper that exercise, as the general public understands it-such as 'hitting the gym'-may help CFS patients would be a se-rious mistake." Rather the exercise found beneficial in the studies is carefully tailored to each individual, slowly increased as can be tolerated without harm, and orchestrated under the care of a skilled therapist.
With these concerns in mind, hopefully the JAMA review will make a positive impact on the quality of CFS research, without bringing harm to patients. As simply put by the CFIDS Asso-ciation of America, the review "highlights the need for more and better CFS research."
Sources:
Behavioral Therapies Are No Cure for Chronic Fatigue Syndrome, CFIDS Association of America Press Release (Sept. 19, 2001)
Chronic Fatigue Syndrome - How To Treat It?, National Electronic Library for Health, National Health Service (NHS) (Sept. 25, 2001) http://www.nelh.nhs.uk/hth/fatigue.asp
Defining and Managing Chronic Fatigue Syndrome, Evidence Report/Technology Assessment: Number 42, Agency for Healthcare Research and Quality (Sept. 2001)
http://www.ahcpr.gov/clinic/epcsums/cfssum.htm
JAMA Study May Be Misleading: Behavioral Therapies No Cure for CFS, CFIDS Association of America, http://www.cfids.org/archives/2001-rr4-article01.asp
Report on CFS Treatment is Misleading and Potentially Harmful, U.S. Newswire (Sept. 20, 2001) http://listserv.nodak.edu/scripts/wa.exe?A2=ind0109D&L=co-cure&P=R641
Natelson, B., Chronic Fatigue Syndrome, JAMA 285(20):2557-2559 (May 23/30, 2001)
Sherman, N., Chronic Fatigue: Do Sweat It, Healthscout (Sept. 20, 2001)
http://www.healthscout.com/template.asp?page=newsdetail&ap=1&id=501705
Tanner, L., Behavior Therapies May Help Fatigue, Associated Press (Sept. 18, 2001) http://dailynews.yahoo.com/h/ap/20010918/hl/chronic_fatigue_1.html
Wessely S. Chronic fatigue syndrome: trials and tribulations, JAMA, 286(11):1378-1379 (Sept. 19, 2001)
Whiting P, et. al, Interventions For The Treatment And Management of Chronic Fatigue Syndrome: A Systematic Review, JAMA, 286(11):1360-1368 (Sept. 19, 2001)
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