From BMC Research Notes (downloads the provisional, full text), 7 August 2012.
Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial
Even Fagermoen (1,2), Dag Sulheim1 (3), Anette Winger(1,4), Anders M Andersen(5), Nils Tore Vethe(6), J Philip Saul(7), Erik Thaulow(1), Vegard Bruun Wyller (1,8,*) Email: brwylle@online.no
1) Department of Pediatrics, Oslo University Hospital and University of Oslo, Oslo, Norway
2) Department of Anesthesiology, Oslo University Hospital and University of Oslo, Oslo, Norway
3) Lillehammer County Hospital, Lillehammer, Norway
4) Department of Nursing Education, Oslo University College, Oslo, Norway
5) Department of Pharmacology, Oslo University Hospital, Oslo, Norway
6) Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway
7) Department of Pediatrics, Medical University of South Carolina, Charleston, SC, USA
8 ) Department of Paediatrics, Oslo University Hospital, P.O. Box 4950, Nydalen 0424, Oslo, Norway
* Corresponding author. Department of Paediatrics, Oslo University Hospital, P.O. Box 4950, Nydalen 0424, Oslo, Norway
Abstract
BACKGROUND:
This pilot study (ClinicalTrials.gov ID: NCT01507701) assessed the feasibility and safety of clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, we assessed clonidine dosage in relation to a) plasma concentration levels, b) orthostatic cardiovascular responses, and c) possible adverse effects.
FINDINGS:
Five adolescent CFS patients (14–19 years old) received 50 μg clonidine twice per day during 14 days in an open, uncontrolled design. Plasma concentration of clonidine was assayed by standard laboratory methods. Changes in orthostatic cardiovascular responses were assessed by a 20o head-up tilt-test (HUT). Adverse effects were mapped by a questionnaire.
After 14 days, C0 median (range) of clonidine was 0.21 (0.18-0.36) μg/L, and Cmax median (range) of clonidine was 0.41 (0.38-0.56) μg/L. Also, supine blood pressures and heart rate were lower during clonidine treatment, and the HUT response was closer to the normal response. No serious adverse effects were registered.
CONCLUSION:
Clonidine 50 μg BID seems to be safe enough to proceed from a pilot study to a controlled trial in a select group of adolescents with CFS (ClinicalTrials.gov ID: NCT01040429).
These 5 fatigued children were not assessed with any CFS criteria. They had no symptoms but fatigue. It is very troubling that the authors should then claim this is the same approach used by the Royal College of paediatrics and child health, and NICE.
There is no need to follow up a study when the authors here didn’t look at patients with a disease.