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Tramadol in the fibromyalgia (FM) syndrome: a controlled clinical trial versus placebo

  [ 31 votes ]   [ Discuss This Article ]
By Biasi G, Manca S, Manganelli S, Marcolongo R • • January 5, 1998

This study assessed the analgesic action of tramadol compared
with placebo in patients suffering from fibromyalgia syndrome.
Twelve patients (11 females, one male) were treated according
to a double- blind crossover experimental design. Each
patient, after signing informed consent, was randomly
allocated to either tramadol (100 mg ampul in 100 ml given
intravenously in 15 min doses) or placebo for a single dose
treatment. At the second visit, patients crossed over to the
other drug for a further single dose treatment. There was a
wash- out period of 1 week. Nine patients completed the study,
while in three cases (two tramadol, one placebo) the study was
discontinued due to the onset of side effects. The assessment
of efficacy, carried out at the baseline and 15 min and 2
hours after administration of each dose, involved the use of a
visual analog scale (VAS 100 mm) for spontaneous pain and
pressure dolorimetry (kg/cm2) at 12 "symptomatic" tender
points and nine "control" tender points for fibromyalgic pain.
During the first treatment cycle effective control of
spontaneous pain was achieved with tramadol, which determined
a reduction of 20.6% while with the placebo spontaneous pain
increased by 19.8%. With pressure dolorimetry there were no
clinically important differences observed after either active
treatment or placebo. The contrasting results found in the
present study could be a stimulus for the organization of new
projects, which may lead to the identification of an optimal
therapeutic approach for fibromyalgic patients, also using
tramadol for long periods.

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