New therapy for chronic fatigue syndrome to be tested at Stanford
STANFORD, Calif. — A preliminary study suggests there may be hope in the offing
some sufferers of chronic fatigue syndrome with a new therapy being tested by
researchers at the Stanford University School of Medicine.
José Montoya, MD, associate professor of medicine (infectious diseases), and
scholar Andreas Kogelnik, MD, PhD, have used the drug valganciclovir — an
used in treating diseases caused by human herpes viruses — to treat a small
The researchers said they treated 25 patients during the last three years, 21 of
responded with significant improvement that was sustained even after going off
medication at the end of the treatment regimen, which usually lasts six months.
patient has now been off the drug for almost three years and has had no
relapses. A paper
describing the first dozen patients Montoya and Kogelnik treated with the drug
published in the December issue of Journal of Clinical Virology.
"This study is small and preliminary, but potentially very important," said
Komaroff, MD, professor of medicine at Harvard Medical School, who was not
the study. "If a randomized trial confirmed the value of this therapy for
patients like the
ones studied here, it would be an important landmark in the treatment of this
Montoya has received a $1.3 million grant from Roche Pharmaceutical, which
manufactures the drug under the brand name Valcyte, to conduct a randomized,
controlled, double-blind study set to begin this quarter at Stanford. The study
the effectiveness of the drug in treating a subset of CFS patients.
Montoya is speaking about
his efforts at the biannual meeting of the
Association for Chronic Fatigue Syndrome in Fort Lauderdale on Jan. 11 and 12.
Chronic fatigue syndrome has baffled doctors and researchers for decades,
from debilitating fatigue, it lacks consistent symptoms. Although many genetic,
psychiatric and environmental factors have been proposed as possible causes,
been nailed down. It was often derided as "yuppie flu," since it seemed to occur
in young professionals, though the Centers for Disease Control and Prevention
most common in the middle-aged. But to those suffering from it, CFS is all too
real and its
effects are devastating, reducing once-vigorous individuals to the ranks of the
with an all-encompassing, painful and sleep-depriving fatigue.
More than 1 million Americans suffer from the disorder, according to the CDC.
disease often begins with what appears to be routine flulike symptoms, but then
subside completely — resulting in chronic, waxing and waning debilitation for
Valganciclovir is normally used against diseases caused by viruses in the herpes
including cytomegalovirus, Epstein-Barr virus and human herpes virus-6. These
usually affect patients whose immune systems are severely weakened, such as
and cancer patients. Montoya, who had used the drug in treating such patients
decided to try using it on a CFS patient who came to him in early 2004 with
levels of antibodies for three of the herpes family viruses in her blood. At the
had been suffering from CFS for five years.
When a virus infects someone, the levels of antibodies cranked out by the immune
in response typically increase until the virus is overcome, then slowly diminish
But Montoya's patient had persistently high antibodies for the three viruses. In
the lymph nodes in her neck were significantly enlarged, some up to eight times
normal size, suggesting her immune system was fighting some kind of infection,
though a comprehensive evaluation had failed to point to any infectious cause.
the unusual elevations in antibody levels as well as the
swelling of her
lymph nodes, Montoya decided to prescribe valganciclovir. "I thought by giving
that was effective againstherpes viruses for a relatively long period of time,
could impact somehow the inflammation that she had in her lymph nodes," said
Within four weeks, the patient's lymph nodes began shrinking. Six weeks later
Montoya from her home in South America, describing how she was now exercising,
bicycling and going back to work at the company she ran before her illness. "We
really shocked by this," recalled Montoya.
Of the two dozen patients Montoya and Kogelnik have since treated, the 20 that
responded all had developed CFS after an initial flulike illness, while the
had suffered no initial flu.
Some of the patients take the drug for more than six months, such as Michael
whose battle with CFS has lasted more than 18 years. The former triathlete was
with a viral infection a year after his marriage. After trying unsuccessfully to
what he thought were lingering effects of the flu, he had no choice but to
all his activities and eventually stop working.
During his longest period of extreme fatigue, 13½ weeks, Manson said, "My wife
thought I was passing away. I could hear the emotion in her voice as she tried
to wake me,
but I couldn't wake up to console her. That was just maddening."
Now in his seventh month of treatment, Manson is able to go backpacking with his
children with no ill after-effects. Prior to starting the treatment, Manson's
ages 9 to 14, had never seen him healthy.
Montoya and Kogelnik emphasized that even if their new clinical trial validates
the use of
valganciclovir in treating some CFS patients, the drug may not be effective in
all cases. In
fact, the trial will assess the effectiveness of the medication among a specific
CFS patients; namely, those who have viral-induced dysfunction of the central
"This could be a solution for a subset of patients, but that subset could be
said Kristin Loomis, executive director of the HHV-6 Foundation, which has
helped fund a
significant portion of the preparatory work for the clinical trial. "These
viruses have been
suspected in CFS for decades, but researchers couldn't prove it because they are
difficult to detect in the blood. If Montoya's results are confirmed, he will
have made a real
"What is desperately needed is the completion of the randomized, double-blind,
controlled clinical trial that we are about
to embark on," Montoya said.
People interested in participating in the clinical trial must live in the San