<<snip>>
CONCLUSIONS: Combination Glucosamine and Chondroitin Sulfate is
effective in treating moderate to severe knee pain due to OA.
<<snip>>

http://tinyurl.com/f3erz

Title: The Efficacy of Glucosamine and Chondroitin Sulfate in Patients
with Painful Knee Osteoarthritis (OA): The Glucosamine/chondroitin
Arthritis Intervention Trial (GAIT)
Category: 7. Osteoarthritis-clinical aspects
Author(s): Daniel O. Clegg1, Domenic J. Reda2, Crystal L. Harris3,
Marguerite A. Klein4, for the GAIT Investigators. 1University of Utah,
Salt Lake City, UT; 2VACSP, Hines, IL; 3VACSP, Albuquerque, NM;
4NCCAM/NIH, Bethesda, MD
Presentation Number: 622
Abstract: PURPOSE: 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.
METHODS: 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.
RESULTS: 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/m2, 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.
The 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.
Response Rates by Treatment Group and Pain Stratum
 All patients WOMAC Pain 301-400mm WOMAC Pain 125-300mm
P 60.1% 54.3% 61.7%
CE 70.1%** 69.4%¶ 70.3%*
G 64.0% 65.7% 63.6%
CS 65.4% 61.4% 66.5%
G+CS 66.6%+ 79.2%# 62.9%
** p= 0.008 CE vs. P
+ p= 0.09 G+CS vs. P ¶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 tolerated.

2005 Program Planner
American College of Rheumatology
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Atlanta, GA 30345

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