A preliminary placebo-controlled crossover trial of fludrocortisone for chronic fatigue syndrome
| Autor: | Goldsmith S, Schroeppel J, Carlos H. Schenck, Swan S, Phillip K. Peterson, A M Pheley, Kind A, Lambrecht Lj, Paul S. Marshall, Haugland Jm |
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| Rok vydání: | 1998 |
| Předmět: |
Adult
medicine.medical_specialty Visual analogue scale Fludrocortisone Blood Pressure Placebo Severity of Illness Index Norepinephrine Double-Blind Method Heart Rate Mineralocorticoids Heart rate Internal Medicine medicine Chronic fatigue syndrome Humans Cross-Over Studies Fatigue Syndrome Chronic business.industry Fludrocortisone Acetate medicine.disease Crossover study Blood pressure Treatment Outcome Physical therapy Female business Psychomotor Performance medicine.drug |
| Zdroj: | Archives of internal medicine. 158(8) |
| ISSN: | 0003-9926 |
| Popis: | Objective To provide a preliminary assessment of the efficacy and safety of fludrocortisone acetate treatment of chronic fatigue syndrome. Design A placebo-controlled, double-blind, random-allocation crossover trial of 6 weeks of fludrocortisone. Setting An outpatient clinical trials unit. Patients Twenty-five participants with chronic fatigue syndrome (mean age, 40 years; 19 [76] women; mean duration of illness, 7.0 years) were recruited from a research and clinic registry. Five patients withdrew from the trial. Interventions All participants were scheduled to receive fludrocortisone acetate (0.1-0.2 mg) or a placebo for 6 weeks in each treatment. Main Outcome Measures Self-administered questionnaires were completed at the beginning and end of each treatment arm that asked patients to rate the severity of their symptoms on a visual analogue scale. The Medical Outcomes Study 36-Item Short-Form Health Survey, a reaction time test, and a treadmill exercise test were used to assess functional status. Blood pressure, heart rate, and plasma norepinephrine levels were obtained at baseline. Blood pressure and heart rate were recorded at the end of the exercise test and monitored at all subsequent visits. Results At baseline, the study participants reported symptom severity greater than 5 for most symptoms, and all had evidence of marked functional impairments. No improvement was observed in the severity of any symptom or in any test of function for the 20 participants who completed both arms of the trial. Blood pressure and heart rate readings were unaffected by treatment, and plasma norepinephrine levels did not differ from those of a healthy control group. The incidence of adverse experiences was similar in the fludrocortisone and placebo arms of the trial. Conclusion Low-dose fludrocortisone does not provide sufficient benefit to be evident in a preliminary blinded trial of unselected patients with chronic fatigue syndrome. |
| Databáze: | OpenAIRE |
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