This is the press release that came out in Nov 2005 pertaining
to the GAIT study. The GAIT study stands for:
Efficacy of Glucosamine and Chondroitin sulfate in Patients with
Painful Knee Osteoarthritis (OA): The Glucosamine/Chondroitin Arthritis
Intervention Trial ( GAIT ).
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For Release at 5:30 pm PT ,
Sunday Nov. 13, 2005
AND CHONDROITIN SULFATE MAY BE USEFUL FOR PATIENTS WITH MODERATE
TO SEVERE PAIN FROM KNEE OSTEOARTHRITIS
DIEGO , CALIFORNIA – Glucosamine and chondroitin
sulfate may be an effective combination in reducing pain associated
with osteoarthritis of the knee, according to research presented
this week at the American College of Rheumatology Annual Scientific
Meeting in San Diego , California .
is an amino sugar naturally produced by the body and widely distributed
to the connective tissues, including cartilage. The body also produces
chondroitin sulfate, a complex carbohydrate molecule which, among
its other roles, helps retain water in cartilage. Over the past
25 years, oral glucosamine and chondroitin sulfate, derived from
animal products, have become popular dietary supplements with patients
attempting to combat the cartilage wear and tear associated with
osteoarthritis. The precise biologic mechanisms that enable oral
supplements to emulate the body's natural products, however, remain
(The Glucosamine/Chondroitin Arthritis Intervention Trial) funded
by the National Institutes of Health, was designed to rigorously
assess the effectiveness and safety of these supplements when taken
separately or in combination. Almost 1,600 patients with painful
knee osteoarthritis were recruited from 16 U.S. academic rheumatology
centers for the study. The patients, who had experienced significant
knee pain for more than six months and had x-ray evidence of knee
osteoarthritis, were evaluated at the beginning of the study, and
at weeks 4, 8, 16 and 24. Each was randomly assigned to receive
glucosamine hydrochloride, sodium chondroitin sulfate, both supplements,
celecoxib, or placebo therapy and allowed up to 4,000 mg daily of
acetaminophen. The primary outcome measure was a 20 percent improvement
in knee pain by week 24.
expected, celecoxib improved knee pain in patients with osteoarthritis.
For the study as a whole, the supplements were not shown to be effective;
however, an exploratory analysis suggested that the combination
of glucosamine and chondroitin sulfate might be effective in osteoarthritis
patients who had moderate to severe knee pain,” stated Daniel O.
Clegg, MD, Chief, Division of Rheumatology, University of Utah School
of Medicine, Salt Lake City, Utah. Adverse events that were seen
in GAIT were generally mild and evenly distributed across all groups.
Dr. Clegg continued, “Given the results of this study, patients
might want to discuss treatment options with their physicians.”
American College of Rheumatology is the professional organization
for rheumatologists and health professionals who share a dedication
to healing, preventing disability and curing arthritis and related
rheumatic and musculoskeletal diseases. For more information on
the ACR's annual meeting, see www.rheumatology.org/annual
Notes: Dr. Clegg will present this research during a scientific
session at the ACR Annual Scientific Meeting from 10:45 am-12:30pm
PT on Monday, November 14, 2005 in Ballroom 20 A-D of the San Diego
Convention Center . He will be available for media questions and
briefing at 8:30 am PT on Tuesday, November 15, in Room 23 A of
the Convention Center.
Efficacy of Glucosamine and Chondroitin Sulfate in Patients with
Painful Knee Osteoarthritis (OA): The Glucosamine/chondroitin Arthritis
Intervention T rial (GAIT)
O. Clegg 1, Domenic J. Reda 2, Crystal L. Harris 3, Marguerite A.
Klein 4, for the GAIT Investigators. 1 University of Utah, Salt
Lake City, UT; 2 VACSP, Hines, IL; 3 VACSP, Albuquerque, NM; 4 NCCAM/NIH,
Glucosamine (G) and chondroitin sulfate (CS) are widely promoted
to “reduce joint pain and provide support for healthy cartilage
and joint function.” GAIT was designed to rigorously assess the
efficacy and safety of these agents alone and in combination. G
and CS were required to meet pharmaceutical standards as GAIT was
conducted under an Investigational New Drug application.
Patients were =40 years of age with knee pain (WOMAC Pain 125-400
mm) of at least 6 months duration and x-ray evidence of knee OA
[Kellgren-Lawrence (KL) Grades 2 or 3]. Patients were randomly assigned
double-blind to placebo (P); G(Glucosamine HCl 500 mg) tid; Sodium
CS 400 mg tid; G+CS at the above doses tid; or celecoxib (CE) 200
mg daily. All patients were allowed up to 4000 mg daily of acetaminophen
(APAP) as rescue analgesia, except within 24 hours of study visits.
Allocation was stratified by Center and by WOMAC Pain severity (125-300mm
and 301-400mm). Patients were evaluated at baseline and weeks 4,
8, 16 and 24. The primary outcome measure was a 20% improvement
from baseline in WOMAC Pain at week 24. Adverse events were documented
at each visit. Analysis was based on intention-to-treat.
3238 patients were screened at 16 US academic rheumatology centers.
1583 were randomized and 1258 (80%) completed the study. Baseline
characteristics were: mean age 58.6 years, BMI 31.7 kg/m 2 , OA
symptoms 10 years, 64% female, summed mean WOMAC Pain 236±73mm
(206mm for 125-300mm stratum, 341mm for 301-400mm stratum), 59%
KL Grade 2, and 78% were in the 125-300mm WOMAC Pain stratum and
were evenly distributed across all arms.
response rate for CE (70.1%) was higher than the response rate for
P (60.1%) in the primary outcome analysis of all patients (p=0.008).
In the 301-400 mm WOMAC pain stratum, the response rate for G+CS
(79.2%) was higher than P (54.3%) (p=0.002). Secondary outcomes
in the 301-400 mm stratum, including 50% WOMAC Pain response, WOMAC
Stiffness, WOMAC Function, HAQ, patient assessments, and use of
rescue APAP all demonstrated changes consistent with the primary
outcome. Adverse events were generally mild and evenly distributed
among the groups.
Rates by Treatment Group and Pain Stratum
p= 0.008 CE vs. P
+ p= 0.09 G+CS vs. P
= 0.06 CE vs. P
# p = 0.002 G+CS vs. P
p= 0.04 CE vs. P
CONCLUSIONS : Combination G+CS is effective
in treating moderate to severe knee pain due to OA. The lack of
response in patients with mild pain may be due to a floor effect,
limiting ability to detect response. All study agents were well
D.O. Clegg , Pfizer 2; McNeil 5;
D.J. Reda , None; C.L.
Harris , None; M.A. Klein ,