WEDNESDAY, Aug. 11 (HealthDay News) -- A new study appears to
dash hopes that the psychiatric drug lithium can benefit patients
with amyotrophic lateral sclerosis (ALS).
The investigation involving 171 people with ALS was stopped
early, in November 2009, because of high dropout rates from death,
side effects or because patients thought the drug was
ALS -- sometimes called Lou Gehrig's disease after the N.Y.
Yankee who died of the condition -- is a progressive nervous system
disorder that causes weakness in muscles, including those
controlling breathing and swallowing. Median survival is three
years, and only one drug -- riluzole -- is approved for ALS
treatment in the United States.
Interest in lithium, which is often used to treat bipolar
disorder, increased after a small Italian study was published two
years ago, suggesting a beneficial effect for ALS patients, said
Dr. Adriano Chio, an associate professor of neurology at the
University of Torino, Italy. In that study, lithium was thought to
have prolonged survival of 16 ALS patients, Chio said.
How might lithium have helped?
"Lithium could have an effect on one of the mechanisms supposedly related to the motor neuron degeneration in ALS, the accumulation of pathological proteins in the neuron," said Chio, who led the new study, noting subsequent research has not confirmed this effect.
In the new study, published in the Aug. 17 issue of
Neurology, the drop-out rate, at 68 percent, was two times higher than the drop-out rate reported by previous trials, Chio said.
All participants received lithium, but in two different doses,
and the drug was not well-tolerated by either group. Patients died
or lost their autonomy at the same rate in both groups.
In an editorial accompanying the study, Dr. Carmel Armon of
Tufts University said one limitation of the Chio study, which Chio
acknowledges, is that it didn't use a true placebo, but rather
different doses. Other ongoing studies that are comparing the
active drug to placebo may give the definitive answers, Armon
"This study [by Chio] shows there are toxic doses of lithium," said Lucie Bruijn, chief scientist for the ALS Association in Washington, D.C.
"We knew lithium has to be monitored carefully in terms of dose," Bruijn said. "What's shown here [in the new study] is a toxic level in some cases and not a strong benefit."
Even at what was termed "subtherapeutic doses," the lithium was
poorly tolerated, Chio found. All 71 patients reported at least one
adverse event, some as serious as heart disturbance, cerebral
hemorrhage or deep vein blood clots.
Chio said two other trials are assessing the effect of lithium
in ALS, but he doubts any positive effect of lithium will be
In the future, Chio added, stem cell therapy may prove useful
To learn more about ALS, visit the
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