1680 - Glucosamine Sulfate in the Glucosamine Unum in Die Efficacy (GUIDE) Trial

Gabriel Herrero-Beaumont1, Jaime Branco for the GUIDE investigators2. 1Fundacion Jimenez Diaz. Capio, Madrid, Spain; 2CHLO, EPE/H.E. Moniz, Lisboa, Portugal
Presentation Number: 1680

Purpose. The GUIDE trial showed the efficacy of the prescription glucosamine sulfate formulation on the symptoms of knee osteoarthritis (Arthritis Rheum 2005;52, 9 Suppl:1203). The aim of the present study was to assess its effects on Quality of Life in the GUIDE patient cohort.
Methods. GUIDE was a multicenter, prospective, randomised, double-blind, parallel-group trial. Patients with knee osteoarthritis (ACR criteria) received double-dummy oral glucosamine sulfate soluble powder 1500mg once-a-day, or acetaminophen 1000mg tablets t.i.d., or placebo for 6 months. Quality of Life was assessed by the SF-36 questionnaire in 296 patients at randomization and repeated after 6 months. The primary analysis was conducted on the changes in the SF-36 Mental Component Score (MCS, assessing the domains Mental Health, Role Emotional, Social Functioning) and Physical Component Score (PCS, with domains Bodily Pain, Role Physical, Physical Functioning, Vitality, General Health, the latter two being included also in the calculation of the MCS). Changes in each domain were secondary endpoints. GLM-ANOVA was used with the Dunnet’s test adjusting for the comparisons of each active vs placebo, in ITT by the LOCF approach. Effect sizes vs placebo were calculated as the difference between mean changes standardized on the pooled SD. The Pearson test assessed the correlation between the changes in the SF-36 and those in the previously reported primary (Lequesne index) and secondary (WOMAC index) symptom outcomes in the trial.
Results. Glucosamine sulfate showed an improvement in all PCS domains of the SF-36, that was significant vs placebo for Bodily Pain (P=0.014), Role Physical (P=0.006) and General Health (P=0.031). The difference on the aggregate PCS was therefore highly significant, with a good effect size (table). There were no significant improvements in the MCS, thus excluding direct psychological effects. Acetaminophen was not significantly different from placebo in any of the analyses.
Placebo
N=96
Acetaminophen
N=100
Glucosamine Sulfate
N=100
BaselineΔ 6 monthsBaselineΔ 6 monthsBaselineΔ 6 months
SF-36 PCS (mean±SD)33.3±8.31.7±10.334.2±9.04.2±9.132.7±9.36.7±10.4*
SF-36 MCS (mean±SD)53.3±11.40.7±11.050.0±13.20.3±11.850.9±13.00.7±10.6

*P=0.001 vs Placebo: Difference=5.0 (95% CI: 1.9 to 8.2). Effect Size=0.49 (0.20 to 0.77)
There was a highly significant correlation (P<0.01) between the improvements in the SF-36 PCS and those previously reported in the Lequesne index (r =0.58) and WOMAC total (r =0.56), pain
(r =0.51) and function (r =0.56) scales, respectively.
Conclusions. Treatment for 6 months with glucosamine sulfate 1500mg once-a-day improves Quality of Life in knee osteoarthritis by favorably affecting the physical components of well-being, in a way that is highly correlated with its efficacy on pain and function as assessed by disease specific measures.

G. Herrero-Beaumont, Rottapharm, 2 Research grants.