Double-blind placebo-controlled study of the efficacy of oral terfenadine in the treatment of chronic fatigue syndrome☆,☆☆,★,★★
Section snippets
Patients
Thirty patients with CFS 18 years of age or older were recruited from the registry of the Minnesota Regional CFS Research Program established at Hennepin County Medical Center, Minneapolis, in 1988.2 Study volunteers were selected from patients who responded to a letter sent to all members of the registry. All patients lived in Minnesota or neighboring communities of Wisconsin or Iowa, and most had been referred by infectious disease specialists or rheumatologists. The study was conducted in
Demographics
The demographic features of the 30 study participants are shown in Table I. Two patients (one receiving treatment, one receiving placebo) were excluded from the evaluation of treatment efficacy because they withdrew from the study because of their perception of no improvement. Twenty-three of 30 (77%) were women. The 30 subjects ranged in age from 19 to 74 years (mean age, 36.2 years). There were no significant differences between the treatment and placebo groups with regard to age, sex,
DISCUSSION
The mean age (36 years) and female-to-male ratio (3:3) of the patients with CFS in this trial were similar to that of our entire CFS registry, 38 years and 3.7, respectively, and to that described in the literature.1, 31 The 90% with positive histories of allergy and/or positive immediate skin tests is also similar to the 83% observed in a CFS study group reported by Straus et al.4 The immediate cutaneous reactivity rate to selected allergens of 16 of 30 (53.3%) is similar to the 50% rate
Acknowledgements
We thank Stacey Larson for help with preparation of the manuscript and the staff of the Drug Evaluation Unit for care of the patients.
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Cited by (51)
Pharmaceutical Interventions in Chronic Fatigue Syndrome: A Literature-based Commentary
2019, Clinical TherapeuticsCitation Excerpt :However, the results did not show a statistically significant improvement in patients with ME/CFS receiving hydrocortisone compared to control subjects. Another study, conducted by Steinberg et al42 in 1996, tested oral dosages of terfenadine, an antihistamine, in 30 patients with ME/CFS in a placebo-controlled manner, but found no evidence of improvement in any patients. A 2014 study of coenzyme Q and NADH supplementation in 73 patients with ME/CFS was attempted based on evidence of decreased energy production via depleted coenzyme Q and ATP levels, and decreased mitochondrial function in ME/CFS.43,44
Chronic Fatigue Syndrome
2017, Principles and Practice of Pediatric Infectious DiseasesA Systematic Review of Drug Therapies for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
2016, Clinical TherapeuticsCitation Excerpt :Publications were assessed to determine if inclusion criteria were met. Twenty-six studies were identified,7,13–36 and 13 reported statistically significant results (Appendix A1 presents, in greater depth, the key findings from these included trials). Twenty drug therapies were trialed in these studies (Table II) and, of the 26 studies, 18 applied the Fukuda diagnostic tool as the primary inclusion criteria.
Treating Chronic Fatigue states as a disease of the regulation of energy metabolism
2008, Medical HypothesesAnaesthesia for patients with idiopathic environmental intolerance and chronic fatigue syndrome
2008, British Journal of AnaesthesiaCitation Excerpt :The immunological status of patients with CFS and IEI is complex and not well-characterized scientifically. Various studies have described T cell abnormalities including decreased T cell numbers,36 increased incidence of atopy,37 38 no increased incidence of atopy,39 increased delayed hypersensitivity allergy skin tests,40 no difference in allergen-specific IgE skin tests for common environmental allergens,41 decreased delayed hypersensitivity and immunoglobulin levels,36 no difference in IgE levels,42 and no immunological changes.43 It was noted in a review of evidence for immunological dysfunction in CFS that there was ‘remarkable inconsistency of results for each of the immunological parameters that were reported by the various laboratories’.44
Prevalence of atopy in chronic fatigue syndrome
2005, Allergologia et Immunopathologia
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From the Departments of aMedicine, cPsychiatry and the dProgram in Clinical Epidemiology, Effectiveness and Policy, Hennepin County Medical Center, Minneapolis; and b Marion Merrell Dow Inc., Kansas City, Mo.
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Supported in part by a grant from Marion Merrell Dow Inc., Kansas City, Mo.
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Reprint requests: Paul Steinberg, MD, Department of Internal Medicine, Hennepin County Medical Center, 701 Park Avenue, Minneapolis, MN 55415.
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0091-6749/96 $5.00 + 0 1/1/65251