70 Musculoskeletal Disorders FAMILY P RACTICE N EWS • February 15, 2005

Chronic Fatigue Syndrome Talk Therapy Reduces Specialists Overburdened Teens’ Chronic Fatigue

BY MARY ELLEN SCHNEIDER out swelling or redness; headaches of a new type, BY KATE JOHNSON passive patients were described as Senior Writer pattern, or severity; unrefreshing sleep; and post- Montreal Bureau spending most of their time lying exertional malaise lasting more than 24 hours, ac- down and as going out infre- WASHINGTON — The National Institutes of cording to the Centers for Disease Control and dolescents with chronic fa- quently. Health should increase its support for research Prevention. The symptoms must have persisted Atigue syndrome show signif- For active patients, treatment into chronic fatigue syndrome in children to or recurred during 6 or more consecutive months icant improvement with cogni- started with teaching them to match the burden and impact of the illness, Pe- of illness and must not have predated the fatigue. tive-behavioral therapy, according recognize and accept their fa- ter Rowe, M.D., said at a meeting of the Health The heterogeneous nature of the illness itself to the first randomized controlled tigue and reduce their activity and Human Services Department’s Chronic Fa- also makes it difficult to recognize and treat the trial involving this age group. level accordingly. This was fol- tigue Advisory Committee. disease. For example, how CFS affects individual “These results endorse the lowed by a gradual increase in ac- More philanthropic support is needed to ad- children depends on the child’s developmental findings of previous studies on tivity. vance the care of children and adults with chron- status, the duration of the illness, as well as the the efficacy of CBT for adults Passive patients started imme- ic fatigue syndrome (CFS), severity of the illness, Dr. with chronic fatigue syndrome,” diately with a systematic pro- said Dr. Rowe, a professor Patients are so eager for a Rowe said. And the pa- reported Maja Stulemeijer and gram of activity building. “In at Johns Hopkins Chil- tient’s response to the ill- colleagues at University Medical such patients it is thought to be dren’s Center, Baltimore, timely evaluation that they ness is affected by the qual- Centre Nijmegen (the Nether- counterproductive to reduce ac- and director of the center’s are willing to pay. ... A ity of support provided by lands). tivity levels any further or to re- chronic fatigue clinic. family, friends, and the Only one uncontrolled study in inforce the patient’s need to re- Currently, few hospital- patient can be evaluated medical profession, he said. adolescents suggests that cogni- spect limitations,” according to or university-affiliated clin- fairly quickly—but at a The heterogeneity also tive-behavioral therapy can re- the investigators. ical centers and no univer- impacts research and many duce chronic fatigue, according Measures of fatigue and func- sity research centers are price tag of $5,800. of the current studies are to the researchers (BMJ 2005; tional impairment decreased treating children with CFS, underpowered and much 330:14). more significantly in the therapy and only $1 million annually in NIH funds are larger studies are needed to detect efficacy from “We believe that our results group, compared with the un- targeted at children with CFS, he said. other changes caused by comorbid conditions, he can be generalized to other ado- treated group. School attendance “This isn’t enough to create a critical level of in- said. It’s also difficult to control for just one vari- lescents who fulfill the diagnostic improved significantly more in terest in bringing good people into the field, and able in a randomized clinical trial on CFS because criteria for chronic fatigue syn- the therapy group, with 58% of it does not make CFS seem like a viable option of the many overlapping and interacting patho- drome,” they noted. these patients returning to school to the new pediatric researcher,” Dr. Rowe said. physiologic dysfunctions associated with the The study followed 69 patients, full time, compared with 29% of As a result, it’s difficult for CFS patients to find condition, he said. Dr. Rowe proposes conduct- aged 10-17 years, who met U.S. patients on the waiting list for physicians to care for them, Dr. Rowe said. CFS ing randomized trials by withdrawing ostensibly Centers for Disease Control and therapy. specialists are usually overburdened, and patients effective therapies. For example, in an otherwise Prevention criteria for chronic fa- Participants in the therapy are so eager for a timely evaluation that they are well-managed and clinically stable patient with tigue syndrome. group also reported significantly willing to pay a premium, he said. CFS, the patient would be randomized to receive Patients were randomized to less muscle pain, headache, un- Dr. Rowe said he knows of one place where either a placebo or the active medication. either immediate therapy, or to refreshing sleep, and impaired a patient can be evaluated fairly quickly—but at Another option would be to incorporate a remain on a waiting list for ther- concentration. They were also a price tag of $5,800. “I think we have a re- “run-in period” for studies during which other apy. The intervention involved less likely to feel ill after exercise, sponsibility to protect children and young fam- influences to symptoms are brought under good 10 individual sessions over 5 compared with patients on the ilies from this kind of economic risk,” he said. clinical control before examining the efficacy of months, and therapy patients un- waiting list. To be diagnosed with CFS, patients generally a single agent. derwent one of two treatment There were no significant dif- must have severe chronic fatigue for 6 months or For example, Dr. Rowe said he had good re- protocols depending on whether ferences in outcomes between longer with other known medical conditions ex- sults treating one patient with midodrine, but he they were considered active or patients in the active or passive cluded by clinical diagnosis, and they must con- might not have noticed its dramatic effect on the passive patients. treatment protocols. However, currently have four or more of the following patient if he had started it before treating her Active patients were described the authors noted that patients in symptoms: substantial impairment in short-term pelvic congestion syndrome, since that condition as alternating between periods all arms of the study continued memory or concentration; sore throat; tender appeared to have an independent effect on her of activity and periods of rest; to report symptoms. lymph nodes; muscle pain; multijoint pain with- orthostatic tolerance. Fibromyalgia Pain Responds to Dopamine-3 Receptor Agonist

BY NANCY WALSH “I wanted to make this as close to a real- number of patients who achieve a greater Pramipexole, used for Parkinson’s dis- New York Bureau world study as possible, so patients could than 50% reduction in pain,” he said. This ease and restless legs syndrome, is thought continue other medications if they were outcome was achieved by 42% of patients to inhibit excessive autonomic stimula- S AN A NTONIO — The dopamine-3 re- clinically stable and maintained the same in the pramipexole arm compared with tion and arousal in the mesolimbic area of ceptor agonist pramipexole significantly dose for 14 weeks,” said Dr. Holman, a 14% of those in the placebo arm. the hippocampus. It is not a sedating med- improved pain, function, and fatigue in pa- rheumatologist in private practice in Ren- Moderate or greater improvement on ication. Rather, its effects on arousal may tients with severe, longstanding fi- ton, Wash. the Patients’ Global Impression of Change allow normal stage IV sleep. The result is bromyalgia, Andrew J. Holman, M.D., Other drugs taken by the patients in- questionnaire was reported by 63% of that “we’re not making them sleep; we’re said in a late-breaking abstract session at cluded anticonvulsants, antidepressants, pramipexole-treated patients, compared allowing them to sleep,” Dr. Holman said. the annual meeting of the American Col- anxiolytics, and muscle relaxants. Mean with 38% of the placebo patients. Statisti- The most pronounced side effect was lege of Rheumatology. disease duration was 8.6 years, and pa- cally significant improvements were seen weight loss, with 40% of the pramipexole In a double blind, randomized, placebo tients had taken an average of 10 different on the Fibromyalgia Impact Question- group losing between 5 and 35 pounds. controlled clinical trial that included 60 pa- medications during that time. naire and the fatigue and function scores Adverse events associated with tients, pain as measured on a 10-point visual On study entrance, 24% of the placebo of the multidimensional Health Assess- pramipexole included increased anxiety, analog scale (VAS) improved by 36%, from group and 31% of the pramipexole group ment Questionnaire. morning somnolence, diarrhea, and vom- a mean score of 7.0 at baseline to 4.5 after were clinically disabled. Moreover, 67% of Secondary end points that showed iting. The hallucinations commonly re- 14 weeks of treatment with pramipexole. the placebo group and 44% of the trends toward improvement with the ac- ported by Parkinson’s patients did not oc- By contrast, patients receiving placebo pramipexole group were taking daily nar- tive treatment include tender point scores, cur in this study. experienced only a 9% decrease in pain, cotics for pain relief. The pramipexole dose the Hamilton Rating Scale for Depres- One patient experienced unexpected from 7.54 to 6.82. At baseline, all patients was titrated up to a target of 4.5 mg/day sion, and the Beck Anxiety Inventory. amnesia that lasted for about 4 hours, but had fibromyalgia of at least 6 months’ du- orally at bedtime. “In terms of measuring “It was interesting to note that no out- there was no diagnosis and she returned ration and a VAS pain score of at least 5. efficacy for pain, we generally look at the comes favored placebo,” he said. to the study without incident.