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ND: | ME13129692
PMID: | 13129692
LR: | 20041117
CED: | 20030917
DCO: | 20031215
Autoren: | Pavelka K; Bruyere O; Rovati LC; Olejárova M; Giacovelli G; Reginster JY
Titel: | Relief in mild-to-moderate pain is not a confounder in joint space narrowing assessment of full extension knee radiographs in recent osteoarthritis structure-modifying drug trials.
Quelle: | Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society; VOL: 11 (10); p. 730-7 /200310/
PM: | Print
SU: | IM
Sprache: | English
CY: | England
JID: | 9305697
ISSN: | 1063-4584
Institution: | Department of Medicine and Rheumatology, Charles University, Prague, Czech Republic.
DT: | Journal Article
Schlagwörter
CT: | FEMALE; GLUCOSAMINE/therapeutic use; HUMANS; KNEE JOINT/pathology; KNEE JOINT/*radiography; MALE; OSTEOARTHRITIS, KNEE/drug therapy; OSTEOARTHRITIS, KNEE/pathology; OSTEOARTHRITIS, KNEE/*radiography; PAIN/*drug therapy; PAIN/pathology; PAIN MEASUREMENT/methods; RANDOMIZED CONTROLLED TRIALS
CTG: | WEIBLICH; GLUCOSAMIN/therapeutische Anwendung; MENSCH; KNIEGELENK/Pathologie; KNIEGELENK/*Röntgenuntersuchung; MÄNNLICH; OSTEOARTHROSE, KNIE/Arzneimitteltherapie; OSTEOARTHROSE, KNIE/Pathologie; OSTEOARTHROSE, KNIE/*Röntgenuntersuchung; SCHMERZEN/*Arzneimitteltherapie; SCHMERZEN/Pathologie; SCHMERZMESSUNG/Methoden; RANDOMISIERTE KONTROLLIERTE STUDIEN
TE: | Glucosamine/3416-24-8
CR: | 3416-24-8
AB: | OBJECTIVE: To assess whether improvement in knee pain biased the determination of the structure-modifying effect reported for glucosamine sulfate in two recent 3-year, randomised, placebo-controlled clinical trials, in which conventional standing antero-posterior full extension knee radiographs were used for the measurement of joint space narrowing, and in which pain relief might have improved knee full extension. DESIGN: Patients completing the 3-year treatment course were selected based on a WOMAC pain decrease at least equal to the mean improvement in the glucosamine sulfate arms in either of the original studies, irrespective of treatment with glucosamine sulfate or placebo (drug responders or placebo responders). In a second approach, 3-year completers were selected if their baseline standing knee pain (item #5 of the WOMAC pain scale) was 'severe' or 'extreme' and improved by any degree at the end of the trials. In both cases, changes in minimum joint space width were compared between treatment groups. RESULTS: Global knee pain was mild-to-moderate in the two study populations and in all patient subsets identified. There were obviously more pain improvers in the glucosamine sulfate subsets (N=76 in the two studies combined) than in the placebo subsets (N=57), but WOMAC pain scores improved to the same extent, which was as large as over 50% relative to baseline. Nevertheless, the placebo subsets in both studies underwent an evident mean (SD) joint space narrowing, which in the pooled analysis of both studies was -0.22 (0.80) mm, and was not observed with glucosamine sulfate: +0.15 (0.60) mm (P=0.003 vs placebo). Similar results were found in the smaller subsets with > or = severe baseline standing knee pain that improved after 3 years, with a joint space narrowing nevertheless of -0.28 (0.76) mm with placebo (N=26), not observed with glucosamine sulfate: +0.21 (0.68) mm (N=31; P=0.014 vs placebo). CONCLUSIONS: Knee pain relief did not bias the report of a structure-modifying effect of glucosamine sulfate in two recent long-term trials using conventional standing antero-posterior radiographs, possibly due to the mild-to-moderate patient characteristics.

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