Bee venom therapy—or BVT—
has also been claimed to be
effective for many medical conditions. BVT is given by placing
bees on specific body parts with
tweezers and allowing the bees
to sting.
This therapy was proposed
as an arthritis treatment in
the early 1900s. It was later
claimed—without any supportive evidence—that the anti-inflammatory response mounted
by the body to bee stings would
relieve other types of inflammation, such as that which occurs
with MS.
BVT is actually well toler-
ated, in general. Swelling and
redness at the sting sites are
common, and stings may cause
itching, hives, fatigue and anxi-
ety. Very rarely, BVT can spark
potentially fatal allergic reac-
tions. For decades, there were
no formal studies of the safety
or effectiveness of BVT in MS.
But starting in the late 1990s,
several investigations were
conducted. Small studies in an
animal model of MS indicated
that BVT might actually worsen
the condition. In the highest
quality clinical trial conducted
to date, investigators in
the Netherlands evalu-
ated BVT over a whole
year in 26 people
with MS. This study,
published in Neurol-
ogy in 2005, found that BVT
did not have a beneficial effect
on frequency of MS attacks,
But starting in the late 1990s, conducted. Small studies in an animal model of MS indicated the condition. In the highesto date, investigators in o date, investigators in the Netherlands evalu-in 2005, found that BVT in 2005, found that BVT on frequency of MS attacks,
progression of disability, disease
activity as seen on MRI scans,
fatigue, or overall quality of life.
Although this was a small study
and thus lacked the power to be
considered absolutely definitive,
the results were so consistently
negative on so many different
measures that it seems unlikely
larger studies would produce
significant positive findings.
Pemoline
Pemoline, known by its trade
name, Cylert, is a prescription medication that was once
used for MS-related fatigue.
Pemoline was first approved by
the FDA in 1975 primarily for
attention-deficit hyperactivity
disorder (ADHD) and excessive
sleepiness (narcolepsy). As with
Provigil, a more recent drug for
narcolepsy, it quickly drew the
attention of MS clinicians eager
to try anything with an acceptable safety profile that might
relieve this difficult symptom.
In the 1990s, some studies
suggested that pemoline might
improve MS fatigue, but the
studies were not particularly
convincing. A relatively small
1992 clinical trial showed a
trend for beneficial effects on
MS fatigue, but the findings
were not quite statistically significant. (For those who know
statistics, the “p value”—which
should be 0.05 or less—was
0.06.) Then another clinical
trial, reported in 1996, found
that pemoline was no better
than an inert placebo for MS
fatigue.
There was worse to come.
Between the 1970s and the
1990s, it was believed that
pemoline was generally well
tolerated. However, there were
intermittent reports of liver
toxicity in children, some of
which were fatal or required
liver transplantation. In 2005,
the FDA concluded that the
medication’s risks exceeded its
benefits for any condition and
pemoline was withdrawn from
the U.S. market.
The long delay in
addressing pemoline
safety issues helped
point out some deficien-cies in the FDA’s safety
monitoring practices.
Since that time, there have been
significant improvements in
drug safety monitoring.
e
toxicity in children, some of
which were fatal or required
the FDA concluded that the
medication’s risks exceeded its
pemoline was withdrawn from
r
monitoring practices.
Since that time, there have been
