ND: |
ME17265490 |
PMID: |
17265490 |
CED: |
20070222 |
DCO: |
20070309 |
SEC: |
ClinicalTrials.gov; NCT00110474 |
Autoren: |
Herrero-Beaumont G; Ivorra JA; Del Carmen Trabado M; Blanco FJ; Benito P; Martín-Mola E; Paulino J; Marenco JL; Porto A; Laffon A; Araújo D; Figueroa M; Branco J |
Titel: |
Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. |
Quelle: |
Arthritis and rheumatism; VOL: 56 (2); p. 555-67 /200702/ |
PM: |
Print |
SU: |
AIM IM |
Sprache: |
English |
CY: |
United States |
JID: |
0370605 |
ISSN: |
0004-3591 |
CO: |
ARHEAW |
Institution: |
Rheumatology Department, Fundación Jiménez Díaz-Capio, Madrid, Spain. gherrero@fjd.es |
DT: |
Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Schlagwörter |
CT: |
ACETAMINOPHEN/*therapeutic use; AGED; ANALGESICS, NON-NARCOTIC/*therapeutic use; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; GLUCOSAMINE/*therapeutic use; HUMANS; MALE; MIDDLE AGED; OSTEOARTHRITIS, KNEE/*drug therapy; PROSPECTIVE STUDIES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME |
CTG: |
ACETAMINOPHEN/*therapeutische Anwendung; ALTE MENSCHEN; ANALGETIKA, NICHTNARKOTISCHE/*therapeutische Anwendung; DOSIS-WIRKUNGSBEZIEHUNG, ARZNEIMITTEL-; DOPPELBLINDMETHODE; WEIBLICH; GLUCOSAMIN/*therapeutische Anwendung; MENSCH; MÄNNLICH; MENSCHEN IM MITTLEREN LEBENSALTER; OSTEOARTHROSE, KNIE/*Arzneimitteltherapie; PROSPEKTIVE STUDIEN; SCHWEREGRADINDEX EINER KRANKHEIT; BEHANDLUNGSERGEBNIS |
TE: |
Analgesics, Non-Narcotic; Acetaminophen/103-90-2; Glucosamine/3416-24-8 |
CR: |
103-90-2; 3416-24-8 |
AB: |
OBJECTIVE: To assess the effects of the prescription formulation of glucosamine sulfate (1,500 mg administered once daily) on the symptoms of knee osteoarthritis (OA) during a 6-month treatment course. METHODS: Three hundred eighteen patients were enrolled in this randomized, placebo-controlled, double-blind trial in which acetaminophen, the currently preferred medication for symptomatic treatment of OA, was used as a side comparator. Patients were randomly assigned to receive oral glucosamine sulfate 1,500 mg once daily (n = 106), acetaminophen 3 gm/day (n = 108), or placebo (n = 104). The primary efficacy outcome measure was the change in the Lequesne index after 6 months. Secondary parameters included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and response according to the Osteoarthritis Research Society International criteria. These outcome measures were assessed using an intent-to-treat analysis. RESULTS: At baseline, the study patients had moderately severe OA symptoms (mean Lequesne index approximately 11 points). Glucosamine sulfate was more effective than placebo in improving the Lequesne score, with a final decrease of 3.1 points, versus 1.9 with placebo (difference between glucosamine sulfate and placebo -1.2 [95% confidence interval -2.3, -0.8]) (P = 0.032). The 2.7-point decrease with acetaminophen was not significantly different from that with placebo (difference -0.8 [95% confidence interval -1.9, 0.3]) (P = 0.18). Similar results were observed for the WOMAC. There were more responders to glucosamine sulfate (39.6%) and acetaminophen (33.3%) than to placebo (21.2%) (P = 0.004 and P = 0.047, respectively, versus placebo). Safety was good, and was comparable among groups. CONCLUSION: The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating knee OA symptoms. Although acetaminophen also had a higher responder rate compared with placebo, it failed to show significant effects on the algofunctional indexes. |