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Single-blind, placebo phase-in trial of 2 escalating doses of selegiline in the Chronic Fatigue Syndrome (CFS)

  [ 68 votes ]   [ Discuss This Article ]
By Natelson BH, Cheu J, Hill N, Bergen M, Korn L, Denny T, Dahl K • www.ProHealth.com • April 15, 1998


AIM: To perform a clinical trial of selegiline in 25 patients
with chronic fatigue syndrome (CFS) where patients were told
they would receive placebo or active agent at different times
during the 6-week trial. We chose selegiline, a specific
monoamine oxidase (MAO) B receptor inhibitor, because a prior
trial of lowdose phenelzine, a nonspecific MAO inhibitor,
showed a small but significant therapeutic effect.

METHODS:
Questionnaires comprised of 19 tests of mood, fatigue,
functional status and symptom severity were collected at the
start and end of the trial as well as 2 weeks after its start.
The trial was done in three 2-week blocks: in the first, 2
placebo pills were given per day; in the next, one 5-mg tablet
of agent and one placebo were given per day, and in the last,
a 5-mg tablet of agent was given twice a day. The plan was to
compare the changes in the 19 tests during the placebo phase
to those found in the active treatment phase in 19 patients
completing the trial.

FINDINGS: Significant improvement in 3
variables- tension/anxiety, vigor and sexual relations-was
found. A significant pattern of improvement compared to
worsening was found for the 19 self- report vehicles during
active treatment as compared with placebo treatment. Evidence
for an antidepressant effect of the drug was not found.

CONCLUSIONS: Selegiline has a small but significant
therapeutic effect in CFS which appears independent of an
antidepressant effect.




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