Serotonergic descending inhibition in chronic pain: design, preliminary results and early cessation of a randomized controlled trial.
OBJECTIVE
We examined whether activation of serotonergic descending pathways improves pain inhibition during exercise in patients with chronic fatigue syndrome (CFS) and comorbid fibromyalgia (FM) in comparison with rheumatoid arthritis (RA) and sedentary, healthy controls in a double-blind randomized controlled trial with cross-over design.


METHODS
Three female CFS/FM patients, one female RA patient and two healthy women were randomly allocated to the experimental group (2 ml of citalopram intravenously) or the placebo group (2 ml of 0.9% NaCl intravenously). Participants performed a submaximal exercise protocol, preceded and followed by an assessment of endogenous pain inhibition. Seven days later, groups were crossed over.


RESULTS
Significant side-effects were observed in all, but one participant immediately after intravenous administration of citalopram. One CFS/FM patient withdrew because of severe post-exertional malaise.


CONCLUSIONS
It was decided that proceeding with the study would be unethical. No conclusion could be made regarding pain inhibition during exercise in CFS/FM compared to RA and controls.
Department of Human Physiology, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Building L-Mfys, Pleinlaan 2, 1050 Brussels, Belgium. Mira.Meeus@vub.ac.be
Mira
M
Meeus
Kelly
K
Ickmans
Luc S
LS
De Clerck
Greta
G
Moorkens
Guy
G
Hans
Sofie
S
Grosemans
Jo
J
Nijs
D016022:Case-Control Studies; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D010146:Pain / Q000188:drug therapy*; D010919:Placebos; D012701:Serotonin / Q000378:metabolism*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*
D010919:Placebos; D012701:Serotonin; D017367:Selective Serotonin Reuptake Inhibitors