Safety Of Hydrocortisone As CFS Treatment Questioned
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Safety Of Hydrocortisone As CFS Treatment Questioned

CHICAGO, IL -- Sept. 22, 1998 -- Low-dose hydrocortisone may be an effective treatment for chronic fatigue syndrome (CFS), but patients experience a potentially-dangerous side effect, according to an article in the Sept. 23/30 issue of The Journal of the American Medical Association.

Robin McKenzie, M.D., of the National Institutes of Health in Bethesda, MD., and colleagues studied the effect of low-dose hydrocortisone as a treatment for CFS. Participants who received low-dose hydrocortisone reported feeling better than participants who only received a placebo treatment.

The study used a wellness score that rated overall health using a scale with zero representing the worst the participant had ever felt and 100 representing the best they had ever felt.

"The percentages of patients recording improvement of at least five, 10 or 15 points on the wellness scale were greater for hydrocortisone than placebo recipients [five points, 53 percent versus 29 percent; 10 points, 33 percent versus 14 percent; and 15 points, 20 percent versus six percent]," the researchers said. "The mean improvement on treatment in the hydrocortisone group was 6.3 points, being higher than the mean improvement of 1.7 points for the placebo group."

Although these results were promising, the study also found that patients who received hydrocortisone experienced significant adrenal suppression. It was previously believed that low doses of corticosteroids were relatively safe and would not cause this type of suppression.

"Although steps were taken to avert serious or potentially life-threatening adrenal insufficiency in the face of emergent stress, the fact that it could happen with less cautious widespread use precludes the present regimen of hydrocortisone or comparable doses of other systemic corticosteroids as acceptable choices for the prolonged treatment of chronic fatigue syndrome," they said.

The researchers have been exploring the possible connection between the endocrine system (especially the hypothalamic-pituitary adrenal axis) and CFS. Corticosteroid hormones are an important part of making nutrients and energy available to the body. The adrenal glands are the source of natural production of corticosteroid hormones, such as cortisol, commonly known as hydrocortisone.

The researchers tested the amount of hydrocortisone in patients with CFS and found that they had on average about 30 percent less hydrocortisone than healthy controls. This led the researchers to consider low-dose supplementation with hydrocortisone to possibly correct the imbalance.

The researchers used the more complex 1988 Centers for Disease Control and Prevention criteria to define the cases to be included in the study. The 1988 case definition requires debilitating fatigue and eight or more of 11 signs and symptoms occurring for at least six months. The patients also met the 1994 CDC criteria. The eight symptoms are memory or concentration complaints, sore throat, tender lymph nodes, muscle pain, multi-joint pain, a new pattern of headaches, unrefreshing sleep and malaise after exertion that lasts more than 24 hours.

The researchers conclude that though this is the first study, to their knowledge, to show an improvement in CFS due to a drug treatment, the low-dose hydrocortisone treatment probably is not viable in a clinical setting.

"What little improvement might be attributable to hydrocortisone treatment was achieved at the expense of significant adrenal suppression," they explained.

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