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Study Abstract Effective Treatment of Chronic Fatigue Syndrome and Fibromyalgia :
STUDY ABSTRACT
Effective treatment of Chronic Fatigue Syndrome and Fibromyalgia – A Randomized, Double Blind, Placebo-Controlled Intent to Treat Study, Journal of Chronic Fatigue Syndrome Vol. 8, No. 2, 2001, p3-28.
Jacob E. Teitelbaum, MD *1, Barbara Bird, M.T.,C.L.S. Robert M. Greenfield, MD, Alan Weiss, MD1, Larry Muenz PhD2, Laurie Gould, BS 3 (Annapolis Research Center for Effective FMS/CFIDS Therapies, 466 Forlands Road, Annapolis MD 21401; Anne Arundel Medical Center, Annapolis, MD 2) Gaithersburg MD 3) USDA Beltsville MD No outside funding
Background: Hypothalmic dysfunction has been suggested in Fibromylgia (FMS) and Chronic Fatigue Syndrome (CFS). This dysfunction may result in disordered sleep, subclinical hormonal deficiencies, and immunologic changes. Our previously published open trial showed that patients usually improve by using a protocol which treats all the above processes simultaneously. The current study examines this protocol using a randomized, double-blind design with an intent-to-treat analysis.
Methods: Seventy-two FMS patients (thirty eight active: thirty four placebo; sixty nine also met CFS criteria) received all active or all placebo therapies as a unified intervention. Patients were treated, as indicated by symptoms and/or lab testing, for (1) subclinical thyroid, gonadal, and/or adrenal insufficiency, (2) disordered sleep, (3) suspected NMH, (4) opportunistic infections and (5)suspected nutritional deficiencies.
Results: at the final visit, sixteen active patients were “much better”, fourteen “better,” two “same, ”zero “worse”, and one much “worse,” versus three, nine, eleven, six and four, respectively, in the placebo group (p ..0001, Cochran-Mantel-Haenszel trend test). Significant improvement in the FMS Impact Questionnaire (FIQ) scores (decreasing) from 54.8 to 33.2 versus 54.4 to 47.7) and Analog scores (improving from 176.1 to 310.3 versus 177.1 to 211.9) (both with p <.0001 by random effects regression), and Tender Point Index (TPI) (31.7 to 15.5 versus 35.0 to 32.3, p<.0001 by baseline adjusted linear model) were seen. Long-term follow-up (mean 1.9 year) of the active group showed continuing and increasing improvement over time, despite patients being able to wean off most treatments.
Conclusions: Significantly greater benefits were seen in the active group than in the placebo group for all primary outcomes. Using an integrated treatment approach, effective treatment is now available for FMS/CFS.
Editorial: “Effective Treatment of Fibromylgia and Myofascial Pain Syndrome: A Clinician’s Perspective” by Hal Blatman, M.D., Journal of the American Academy of Pain Management
Editorial: Journal of the American Academy of Pain Management
April 2002
By Hal Blatman, M.D.
Effective Treatment of Fibromyalgia and Myofascial Pain Syndrome:
A Clinician’s Perspective
In 1983 Drs. Janet Treavell and David Simons published the first volume of their work Myofascial Pain and Dysfunction, The Trigger Point Manual. Their textbooks have become the foundation of education for treating myofacial pain syndrome (MPS). Although much of the text focused on anatomical and structural aspects of MPS, chapter 4 was dedicated to a discussion of the numerous metabolic perpetuating factors that contribute to the disorder. These factors are thought to contribute to causation as wall as preventing recovery, Chapter 4 offers 294 references that support the importance of metabolic perpetuating factors 1.
During the last several years, public awareness of Fibromyalgia has greatly increased. Practitioners have noted that much of the pain of FMS is related to myofascial trigger points, and that MPS plays a critical role in the disorder. Many physicians have postulated that FMS represents a generalized MPS that is perpetuated by the metabolic factors. Clinical experience and the scientific literature suggest that may of these perpetuating factors need to be treated despite laboratory blood testing falling within the normal range.
With this in mind, it was very exciting to read the recent randomized, double-blind, placebo-controlled study by Teitelbaum et al, 2 which, years later, finally validates the work of Drs. Travell and Simons. Titled “Effective Treatment of Chronic Fatigue Syndrome and Fibromyalgia – a Randomized Double-blind Placebo-controlled Study,” the study found that treating Fibromyalgia patients for the perpetuating factors below resulted in a dramatic improvement vs. placebo
(P<0.0001):
1.Hormonal deficiencies. Dr. Teitelbaum postulated that hypothalamic dysfunction is a key process in the etiology of Fibromyalgia. Patients with lab tests for thyroid, adrenal and ovarian /testicular function that fell in the normal range were still treated if their clinical picture suggested a hormonal deficiency.
1. Opportunistic infections. As a number of infections can perpetuate MPS, and since FMS is associated with immune dysfunction and opportunistic infections, possible parasitic and fungal infections were treated this very aggressively.
2. Nutritional inadequacies Nutritional deficiencies were suspected to contribute to chronic, pathologic muscle shortening despite lab testing sometimes being in the normal range. In this study, nutritional needs were aggressively considered and treated.
In the history of medicine, people with undiagnosed and unrecognized disease
such as rheumatoid arthritis, polio and Lyme’s disease were often considered to be hypochondriacs until diagnostic tests were developed. Tests are now in development that will likely be specific for the diagnosis of FMS. In the interim, this study by Dr. Teitelbaum et al. confirms what years of clinical success have shown – that the treatment approach described in chapter 4 of The Trigger Point Manual is effective, that subclinical abnormalities are important and that the comprehensive metabolic approach to treatment in Teitelbaum’s study et al. and years of clinical experience makes this approach an excellent and powerfully effective part of the standard of practice for treatment of people who suffer from FMS and MPS – both of which are common and devastating syndromes. It is very exciting that this research helps to usher in a new, more effective era in medical care by treating the patient and not only the laboratory tests!
1. Travell J. Simons DG, Simons L:: Perpetuating Factors. Chapter 4. In: Myofascial Pain and Dysfunction: The Trigger Point Manual, Ed.2. Williams and Wilkins, Baltimore MD, 1999
2. Teitelbaum JE, Bird B, Greenfield RM, Weiss A., Muenz, L. Gould L, Effective Treatment of CFS and Fibromyalgia –A Randomized, Double-blind, Placebo-controlled, Intent to Treat Study. The Journal of Chronic Fatigue Syndrome. Volume 8(2), 2001,p 3-28.
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