Low-Dose
Naltrexone Therapy Improves Active
Crohn’s Disease
Dr. Jill Smith reported in the January
11, 2007 edition of the American Journal
of Gastroenterology (2007;102:1–9), is
the first study of LDN published in a US
medical journal. Smith, Professor of
Gastroenterology at Pennsylvania State
University's College of Medicine, found
that two-thirds of the patients in her
pilot study went into remission and
fully 89% of the group responded to
treatment to some degree. She concluded
that “LDN therapy appears effective and
safe in subjects with active Crohn’s
disease.”
A
multi-institutional clinical trial of
LDN for MS has begun in Italy.
A study of LDN in the treatment of MS at
the University of California, San
Francisco, was implemented in early
2007.
The National MS Society has awarded a
small grant for a study at Penn State of
naltrexone for an animal model of a
disease that mimics MS.
Bamako University Hospital, Mali,
Western Africa — HIV Trial
Jaquelyn McCandless, M.D., the
neurologist who is the U.S. Medical
Consultant/Coordinator for the Mali LDN
HIV+ Study, visited Mali in December
2006 and met with the clinical study
team at Bamako University Hospital as
well as the head of the Malian Ethics
Committee. She was highly impressed with
the university's research facility, and
reports that "everyone we have met so
far is very friendly, helpful, and
highly interested in the success of this
program." For further details of her
report, please see the linked Developing
Nations Project page.
The planned Mali study will involve
three groups of 50 volunteers each, all
of whom are HIV positive and each of
whom has a CD4 cell count in the range
of 275 to 475. One group will receive
LDN only, one will be treated with LDN
and antiretroviral drugs, and the third
group will receive ARV’s only. The
length of the planned study is 48 weeks.
The hope is to implement it when funding
is completed. Dr. McCandless is actively
seeking philanthropic donations (e-mail
her here).
University of California, San Francisco
— MS Trial
A study at the University of California,
San Francisco, was implemented in early
2007 by neurological researcher Bruce
Cree, MD, and colleagues. Some 80
patients with MS are involved in this
double-blind, “Randomized,
Placebo-Controlled, Crossover-Design
Study of the Effects of Low Dose
Naltrexone on Quality of Life as
Measured by the Multiple Sclerosis
Quality of Life Inventory.”
Each subject will receive either LDN or
a placebo for 8 weeks, followed by one
week without either, and then a further
8 weeks on the the alternate capsule. A
substantial contribution toward the
study has been made by the the LDN for
MS Research Fund.
Multi-Institutional Clinical Trial of
LDN for MS Has Begun in Italy
A long-awaited pilot study of low dose
naltrexone therapy in multiple sclerosis
has been implemented by the Milan
neurological researcher, Dr. Maira
Gironi. Several northern Italian
hospitals began enrolling patients for
the study during the first week of
December, 2006. Dr. Gironi anticipates
that the 6 months of LDN treatment will
have been completed by early summer
2007.
Importantly, Dr. Gironi’s research team
has long been a locus for significant
research on endorphins in relation to
illness, and this study will track
accurate assessments of the patients’
beta-endorphin levels in response to
their LDN treatment.
Penn State Phase II Trial of LDN Therapy
for Crohn's Disease
Dr. Jill Smith, Professor of
Gastroenterology at Pennsylvania State
University's College of Medicine, began
registering patients for this Phase II
study in September 2006. It is the first
Phase II clinical trial of LDN at a US
medical center, and will examine LDN’s
efficacy in the treatment of people with
Crohn's Disease. Below are brief
extracts from the Penn State trial
website:
Study Protocol Participants will have a
complete physical, blood work taken,
keep symptom diaries, complete
questionnaires and continue with
follow-up for 4 months.
Cost of medication, office visits, and
blood work are paid by the study. This
research has been approved by the
Institutional Review Board, under FDA
regulations, at Penn State's College of
Medicine. Interested patients contact
Sandra Bingaman, R.N. at 717-531-8108.
Research on Neurodegeneration at NIEHS
Suggests a Protective Naltrexone Role
J.S. Hong, Ph.D., head of the
Neuropharmacology Section of the
Laboratory of Pharmacology and Chemistry
at the National Institute of
Environmental Health Sciences, finds
that "morphinan" drugs, including
naltrexone and naloxone, are able to
reduce inflammatory reactions in
microglia brain cells in animal studies.
Such inflammation is believed to be
central to the progressive
neurodegenerative effects seen in
disorders such as Parkinson’s disease
and Alzheimer’s disease. Hong’s report,
summarizing the role of microglia in
inflammation-related neurodegeneration
and the potential of therapy using
morphinans, appears in a January 2007
issue of Nature Reviews Neuroscience
[8(1):57-69].
Research at Penn State to Use LDN and
Animal Model of MS
The National Multiple Sclerosis Society
has confirmed that the NMSS “recently
awarded a small Pilot Award to Ian Zagon
[Ph.D.] at Pennsylvania State University
in Hershey, PA for the term of
09/01/2006 through 08/31/2007 in the
amount of $44,000. The title of his
project is ‘Role of opioid peptides and
receptors in MS.’ This study will be
treating an animal model of MS daily
with either a high dose of naltrexone or
a low dose of naltrexone to determine
whether naltrexone influences disease
course.”
This research project raises the
question of whether endogenous opioids
and opioid receptors influence the
course of MS. This is a novel and
innovative concept that is valuable to
explore. To test this hypothesis, we
will subject rats to experimental
autoimmune encephalomyelitis (EAE), a
model that mimics MS. Animals will be
treated daily with a high dose of [naltrexone]
(HDN) or a low dose of [naltrexone] (LDN)....Our
expectations are that continuous opioid
receptor blockade will exacerbate the
progression of MS, whereas a low dose of
naltrexone will retard the course of
this disease. Evidence for the
involvement of endogenous opioids and
opioid receptors in MS will open a new
field of research related to the
pathogenesis of this disease, and
contribute to the development of
strategies for treatment.
The report on this groundbreaking
research—"Low-Dose Naltrexone as a
Treatment For Active Crohn's
Disease"—was presented on May 23, 2006
at Digestive Diseases Week, a
prestigious gastrointestinal conference,
by Professor Jill Smith of the
Pennsylvania State University College of
Medicine. Dr. Smith's research paper,
"Low-Dose Naltrexone Therapy Improves
Active Crohn’s Disease," has been
published by the American Journal of
Gastroenterology in its January 11, 2007
edition.
Dr. Smith and her colleagues concluded
that "LDN therapy offers an alternative
safe, effective, and economic means of
treating subjects with active Crohn's
disease."
According to the news from Penn State,
the National Institutes of Health has
already granted $500,000 for Dr. Smith's
group to continue the study. This
funding should help assure a
full-fledged placebo-controlled
scientific trial of LDN in Crohn's
disease. (Notably, Dr. Smith and her
research teams are also involved in
exploring the direct effects of using a
form of endorphin by infusion in order
to treat pancreatic and colon cancer.)
Low-Dose Naltrexone as a Treatment For
Active Crohn's Disease
J. P. Smith1; H. E. Stock1; S. I.
Bingaman1; D. T. Mauger2; I. S. Zagon3,
Medicine, The Pennsylvania State
University College of Medicine, Hershey,
PA, USA. Health Evaluation Sciences, The
Pennsylvania State University College of
Medicine, Hershey, PA, USA.
Neural and Behavioral Sciences, The
Pennsylvania State University College of
Medicine, Hershey, PA, USA.
Methods: Eligible subjects with
histologically and endoscopically
confirmed active Crohn's disease with a
Crohn's Activity Index (CDAI) score of
220-450 were enrolled in a study using
4.5 mg naltrexone/day. Subjects were
required to be off infliximab for at
least 8-weeks, and this medication was
not allowed during the trial. Other drug
therapy for Crohn's disease utilized 4
or more weeks prior to enrollment was
continued at the same dosages.... Drug [LDN]
was administered orally each evening for
a 12-week period. Laboratory tests,
erythrocyte sedimentation rates,
C-Reactive protein, and CDAI scores were
assessed monthly and 4 weeks after
discontinuing the medication.
Results: Seventeen patients with a mean
initial CDAI* score of 356 ± 27 were
enrolled in the study. CDAI scores
decreased significantly (p<0.01) with
LDN, and remained statistically lower
than baseline 4-weeks after completing
therapy (see Figure).
Eighty-nine percent of patients
exhibited a response to therapy
(>70-point decrease in CDAI, p<0.001)
and 67% achieved remission (CDAI score
<150). QOL* surveys indicated marked
improvement with LDN. No laboratory
abnormalities were noted. One subject
undergoing routine endoscopic procedures
showed healing of the intestinal mucosa.
In both subjects with open fistulas,
closure was noted with LDN. The most
common side effect of LDN was sleep
disturbances (7 patients).
Conclusions: LDN therapy offers an
alternative safe, effective, and
economic means of treating subjects with
active Crohn's disease.
In December 2005, Pain Therapeutics,
Inc. announced results of its Phase III
study with PTI-901. [Editor's Note:
PTI-901 contains only 0.5mg of
naltrexone, which is well below the
therapeutic dosage range for LDN—normally
from 1.75mg to 4.5mg every night. LDN in
the normal dosage range has been
anecdotally reported quite beneficial in
halting IBS.] Excerpt from PTI's
announcement:
This randomized, double-blinded,
multi-center U.S. study compared a daily
dose of PTI-901 against placebo in 600
women with documented IBS over a
three-month treatment period. PTI-901
showed a favorable safety profile and
patients reported statistically
meaningful relief of IBS symptoms in the
second month of treatment (p<0.02), but
the drug did not demonstrate a
meaningful benefit in the third month of
treatment, which was defined as the
primary endpoint. According to current
regulatory standards, an experimental
drug for chronic IBS needs to show
efficacy at the end of a three-month
treatment period.
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