End Fatigue

Natural Treatments Effective for Fibromyalgia and Chronic Fatigue Syndrome

Teitelbaum J, Bird B, Greenfield R, Weiss A, Muenz L, Gould L. Effective treatment of chronic fatigue syndrome (CFIDS) & fibromyalgia (FMS) - A randomized, double-blind, placebo-controlled, intent to treat study. Journal of Chronic Fatigue Syndrome. 201; 8(2):.

Fibromyalgia (FMS; any of a group of nonarticular rheumatic disorders characterized by pain, tenderness, and stiffness of muscles and associated connective tissue structures) and Chronic Fatigue Syndrome (CFS; a group of symptoms of unknown cause including fatigue, cognitive dysfunction, and sometimes fever and lymphadenopathy that affect especially young adults between the ages of 20 and 40) often coexist. Common symptoms include severe persistent fatigue, diffuse migratory pain, cognitive dysfunction, and sleep disorders. The hypothalamus is an area of the brain that helps regulate weight and appetite, body temperature, salt and water balance, and emotions. It is involved in growth, milk production, childbirth, and sleep. It is thought that hypothalamic dysfunction may be partially responsible for FMS and CFS. Macro and micro nutrient deficiencies may also play a role. In the authors' pilot study, researchers found that simultaneously treating many symptoms resulted in significant clinical improvement. They believe that each patient requires a different combination of treatments. The current study tests whether an integrated treatment approach based on simultaneously treating CFS and FMS symptoms will be clinically beneficial. This study tests the efficacy of this therapeutic approach using a randomized, double-blind, placebo-controlled protocol in an outpatient setting.

Seventy-two men and women with FMS participated. All but 3 patients had CFS. Thirty-eight patients were randomized to the active intervention and 34 to the placebo intervention. Each patient received either all active or all placebo treatments as a unified intervention. (All ingredients in the active treatments are now available in Daily Energy Infusion™ powder [Enzymatic Therapy, Green Bay, WI].) In the active treatment group, all patients received 3/10 mg melatonin orally at bedtime, 1-2 tablets 180mg valerian (Valeriana officinalis)/90mg melissa aka lemon balm (Melissa officinalis) combination (Valerian Rest™ by To Your Health, Fountain Hills, Arizona) orally at bedtime, 1 tablet Daily One Cap™ Multivitamin (Twinlab, Hauppauge, NY) every morning, and 2 tablets magnesium with malic acid (Fibrocare™ by To Your Health) 3 times a day. The active group may have also been treated with a combination of conventional pharmaceutical sleep aids and, depending on each individual's clinical history, they received a combination of antidepressants, DHEA, testosterone, estrogen, antifungals, vitamins, steroids, antibiotics, etc. When possible, identically appearing placebos were obtained. When not available, placebos were made by the pharmacist to approximate the medications' appearance. To test efficacy, patients described their overall response to treatment, answered a Fibromyalgia Impact Questionnaire, had their Tender Point Index calculated (a measure of pain), and were asked the following questions on a visual analog scale: How is your energy? Sleep? Mental clarity? Overall sense of well being? And how bad is your achiness? Patients were followed for a median duration of 101 days in the active group and 96 days in the placebo group.

At the final visit the active patients showed a significant trend toward overall improvement compared to placebo group (p<.0001). Likewise there was a significant improvement in Fibromyalgia Impact Questionnaire, Tender Point Index, and analog scores (p<.0001). At follow-up (mean 1.9 years after beginning treatment), the active group showed continued improvement, a benefit that persisted after some or most of the treatment had ended. It should be noted that the follow-up observations were not blinded.

Several other controlled studies have shown that antidepressants benefit patients with FMS/CFS. The benefits seen in this study were not predominantly caused by antidepressant therapy as antidepressants were not significantly more effective than placebo.

The authors believe that FMS/CFS occurs as a cascading series of events, where each dysfunction may trigger several others. This study suggests that treatment is more effective when all of the processes are treated simultaneously as an integrated whole. Some physicians may be uncomfortable because the study uses multiple interventions adjusted for each patient and treats patients based on symptoms despite lab values being within the normal range. The authors believe that these concerns have no significant impact on the scientific or clinical validity of the study. The improvement in the severe debilitation experienced by many patients speaks in favor of this unconventional approach.

There are several limitations to the study. The results may not be applicable to secondary FMS (e.g., patients who also have lupus or rheumatoid arthritis), a pediatric population, or to CFS patients without FMS. The authors have found that these smaller subsets of patients usually improve with the treatment protocol, but there is a higher incidence of treatment failures. The authors do not recommend that the protocol be used in patients with multiple sclerosis. Another limitation of the study was the inability to get identical placebos for some study medications. A final limitation was a lack of objective measures to monitor the effectiveness of treatment.

An independent, randomized, multi-center, replicative study of the findings is currently being developed. Table 2 in the study provides the treatment protocol. The full citation is available online at www.endfatigue.com. A computerized assessment program that patients can fill out and can be tailored to each individual is also available at this site as well.

Heather S. Oliff, Ph.D.