Researchers at the Annapolis Research Center For Effective FMS/CFIDS Therapies have developed a comprehensive treatment protocol based on aggressively looking for and treating the “perpetuating factors” associated with these conditions. This was according to a recent study published in the Journal of Chronic Fatigue Syndrome (vol. 8, issue. 2, 2001).
The researchers suspect hypothalamic dysfunction as a possible factor in the development of Chronic Fatigue Syndrome and Fibromyalgia. Jacob E. Teitelbaum, MD, and colleagues believed that this dysfunction could produce disordered sleep with associated pain, hormonal deficiencies, and immunologic changes. Their study approaches treating these symptoms by exploring the side effects, dosing, and effectiveness of simultaneously treating these problems with a single protocol. The study examined the protocol using a double-blind design with an intent-to-treat analysis.
The study included 72 Fibromyalgia patients who were entered into the study between November 1995 and November 1997. Thirty-eight of these patients were placed in the active group, and 34 were in the placebo group. Sixty-nine of these patients met the 1994 Center for Disease Control criteria for Chronic Fatigue Syndrome. Each group received all active or all placebo therapies as a unified intervention. Patients were treated, as indicated by symptoms and/or lab testing, for subclinical thyroid, gonadal, and/or adrenal insufficiency, disordered sleep, Neurally Mediated Hypotension (NMH), opportunistic infections, and suspected nutritional deficiencies.
To improve a patient’s quality of sleep the researchers administered medications that were intended to restore stages three and four sleep, the stages that include Rapid Eye Movement. Some medications used were amitriptyline, cyclobenzaprine, Melatonin and Valerian. Sleep deprivation suppresses the immune system and may cause the decline in growth hormone levels that are associated with FMS patients.
To improve autonomic dysfunctions such as Neurally Mediated Hypotension (NMH) the researchers found that this condition may be alleviated by increasing salt and water intake, or by administering the medication fludrocortisone (Florinef) that may help improve NMH symptoms.
The researchers concluded that by treating all the symptoms of FMS at the same time, they were able to mitigate the bias toward testing each individual treatment separately. Through the use of an integrated treatment the researchers found significantly greater benefits in the active group than in the placebo group for all primary outcomes. They feel that treatment is more effective when all of the processes are treated simultaneously as an integrated whole, and that an effective treatment for FMS and CFIDS is now available.
After each group’s final consultation, sixteen of the active patients reported feeling “much better,” fourteen felt “better,” two felt the “same,” no patients reported feeling “worse” and only one reported feeling “much worse.” Of the placebo group three felt “much better”, nine felt “better”, eleven felt the “same”, six patients felt “worse”, and four felt “much worse.” A long term follow up of the active group (approximately one year eleven months) showed continuing and increasing improvement over time, despite patients being able to discontinue most treatments.
The team of researchers that produced the study are: Jacob E. Teitelbaum, MD; Barbara Bird, M.T.,C.L.S.; Robert M. Greenfield, MD; Alan Weiss, MD; Larry Muenz, Ph.D; and Laurie Gould, BS.