Glucosamine and chondroitin Research
Glucosamine is a popular over-the-counter
supplement that appeals to older people suffering
with arthritic pain and sports enthusiasts.
Users typically suffer chronic pain caused by
joint trauma (meniscal tears or other knee dam-
age) and also those who expose their knees to po-
tential risk who wish to reduce or avoid joint dam-
For More Information About the Study
What is the Glucosamine/chondroitin Arthritis
Glucosamine and chondroitin are frequently
used in combination are on the “alternative”
GAIT is the first large-scale, multicenter clini-
medications list, as there was no conclusive evi-
cal trial in the United States to test the effects of
dence that it works. At the end of 2005 a US gov-
the dietary supplements glucosamine hydrochlo-
ernment research team announced the results of
ride (glucosamine) and sodium chondroitin sulfate
a huge controlled trial undertaken in 2000.
(chondroitin sulfate) for the treatment of knee os-
teoarthritis. The study tested whether glucosa-
The answers about glucosamine are contained
mine and chondroitin sulfate used separately or in
in the study posted by the National Institutes of
combination reduced pain in participants with
Health, The National Center for Complementary
and Alternative Medicine (NCCAM) web site:
http://nccam.nih.gov/research/results/gait/qa.htm
The University of Utah, School of Medicine co-
ordinated this study, which was conducted at 16
Questions and Answers: NIH Glucosa-
rheumatology research centers across the United
mine/chondroitin Arthritis Intervention Trial
States. The National Center for Complementary
Primary Study
and Alternative Medicine (NCCAM) and the Na-
tional Institute of Arthritis and Musculoskeletal
and Skin Diseases (NIAMS), two components of
the National Institutes of Health (NIH), funded
What was the purpose of the study?
Previous studies in the medical literature had
conflicting results on the effectiveness of glucosa-
mine and chondroitin sulfate as treatments for
osteoarthritis. GAIT was designed to test the
short-term (6 months) effectiveness of glucosa-
mine and chondroitin sulfate in reducing pain in a
large number of participants with knee os-
What doses were used for the varioustreatments?
The basic design of the study -
In GAIT, participants were randomly assigned
(3) glucosamine and chondroitin sulfate in
(5) a placebo (an inactive substance that looks
How many people participated in the studyand who were they?
Glucosamine and chondroitin sulfate and their
Were there any side effects from the treat-
combination were compared with a placebo to
evaluate whether these substances significantly
improve joint pain. Celecoxib, which is a prescrip-
tion drug effective in managing osteoarthritis pain,
Should people with osteoarthritis use glu-
was also compared with placebo to validate the
To reduce the chance of biased results, the
study was double-blinded—neither the research-
ers nor the participants knew which of the five
treatment groups the participants were in. Partici-
pants received treatment for 24 weeks.
Participants were evaluated at the start of the
study and at weeks 4, 8, 16, and 24 and closely
monitored for improvement of their symptoms as
well as for any possible adverse reactions to the
study agents. X-rays documented each partici-
Participants were also stratified into two pain
subgroups— 1,229 participants (78 percent) with
mild pain and 354 participants (22 percent) with
A positive response to treatment was defined
as a 20 percent or greater reduction in pain at
week 24 compared to the start of the study. All
participants had the option to use up to 4000 mg
of acetaminophen, as needed, to control pain from
osteoarthritis throughout the study, except for the
24 hours prior to having their knee assessed.
Acetaminophen use was low: on average, par-
ticipants used fewer than two 500 mg tablets per
What did GAIT cost?
The primary GAIT study cost just over $12.5
Study Background What is osteoarthritis?
An estimated 27 million adults in the United
States live with osteoarthritis—the most common
type of arthritis. Osteoarthritis, also called degen-
erative joint disease, is caused by the breakdown
of cartilage, which is the connective tissue that
cushions the ends of bones within the joint.
Osteoarthritis is characterized by pain, joint
damage, and limited motion. The disease generally
occurs late in life, and most commonly affects the
hands and large weight-bearing joints, such as the
knees. Age, female gender, and obesity are risk
Image provided by the National Institute of Arthri-
tis and Musculoskeletal and Skin Diseases
Illustrations of a Joint with Osteoarthritis and a
What are glucosamine and chondroitin sul-
natural substances found in and around the cells
of cartilage. Glucosamine is an amino sugar that
the body produces and distributes in cartilage and
other connective tissue, and chondroitin sulfate is
a complex carbohydrate that helps cartilage retain
In the United States, glucosamine and chon-
droitin sulfate are sold as dietary supplements,
which are regulated as foods rather than drugs. What is celecoxib?
Celecoxib (brand name Celebrex) is a type of
nonsteroidal anti-inflammatory drug (NSAID),
called a COX-2 inhibitor. Like traditional NSAIDs,
celecoxib blocks the COX-2 enzyme in the body
Unlike traditional NSAIDs, however, celecoxib
does not block the action of COX-1 enzyme, which
is known to protect the stomach lining. As a re-
sult, celecoxib reduces joint pain and inflamma-
tion with reduced risk of gastrointestinal ulcera-
Recent reports have linked possible cardiovas-
cular side effects to COX-2 inhibitors. Although
GAIT was not designed to study the safety of cele-
coxib, participants were monitored for adverse
events and no increase in such side effects was
What doses were used for the various treat-
doses seen in the prevailing scientific literature:
Glucosamine alone: 1500 mg daily given as
Glucosamine plus chondroitin sulfate com-
to take up to 4000 mg (500 mg tablets) per
day to control pain, except for the 24 hours
Who provided the source materials for making the glucosamine and chondroitin sulfate products used in GAIT?
Pfanstiehl Laboratories, Inc., Waukegan, IL,
The study agents were manufactured by Albu-
querque Veterans Affairs (VA) Cooperative Studies
Where did the other study products come
Celecoxib was purchased from Pfizer.
The new england journal of medicine This Journal feature begins with a case vignette highlighting a common clinical problem. Evidence supporting various strategies is then presented, followed by a review of formal guidelines, when they exist. The article ends with the author’s clinical recommendations. A 50-year-old black American has a blood pressure of 160/110 mm Hg on repeated
Curriculum Vitae Mark J. Sarno, BA eJD Scientist, Biostatistician, Inventor, Licensed Patent Agent 19833 Fortuna Del Este Road Escondido, CA 92029 (760) 591-4945 [email protected] http://www.visionbiotechconsulting.com PROFESSIONAL EXPERIENCE Vision Biotechnology Consulting and Vision Clinical Research President and Founder May 1996-Present Established a consulting practice