ND: |
ME11548224 |
PMID: |
11548224 |
LR: |
20041117 |
CED: |
20010910 |
DCO: |
20010920 |
Autoren: |
Noack W; Fischer M; Förster KK; Rovati LC; Setnikar I |
Titel: |
Glucosamine sulfate in osteoarthritis of the knee. |
Quelle: |
Osteoarthritis and cartilage / OARS, Osteoarthritis Research Society; VOL: 2 (1); p. 51-9 /199403/ |
PM: |
Print |
SU: |
IM |
Sprache: |
English |
CY: |
England |
JID: |
9305697 |
ISSN: |
1063-4584 |
Institution: |
Department of Orthopedics-Evangelisches Waldkrankenhaus, Berlin, Germany. |
DT: |
Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
Schlagwörter |
CT: |
ADMINISTRATION, ORAL; ADULT; AGED; DOUBLE-BLIND METHOD; FEMALE; GLUCOSAMINE/*administration & dosage; GLUCOSAMINE/adverse effects; HUMANS; MALE; MIDDLE AGED; MOVEMENT DISORDERS/drug therapy; OSTEOARTHRITIS, KNEE/*drug therapy; PAIN/prevention & control; TREATMENT OUTCOME |
CTG: |
APPLIKATION, ORALE; ERWACHSENER; ALTE MENSCHEN; DOPPELBLINDMETHODE; WEIBLICH; GLUCOSAMIN/*Verabreichung & Dosierung; GLUCOSAMIN/unerwünschte Nebenwirkungen; MENSCH; MÄNNLICH; MENSCHEN IM MITTLEREN LEBENSALTER; BEWEGUNGSSTÖRUNGEN/Arzneimitteltherapie; OSTEOARTHROSE, KNIE/*Arzneimitteltherapie; SCHMERZEN/Verhütung & Bekämpfung; BEHANDLUNGSERGEBNIS |
TE: |
Glucosamine/3416-24-8 |
CR: |
3416-24-8 |
AB: |
Glucosamine sulfate is a drug used for the treatment of osteoarthritis (OA), based on its pharmacological and metabolic activities on the cartilage and chondrocytes, complemented by mild anti-inflammatory properties and a favorable pharmacokinetic profile. The aim of this study was to define the activity and safety of glucosamine sulfate on the symptoms of patients with OA, using a multicenter, randomized, placebo-controlled, double-blind, parallel-group study design. The study included 252 outpatients with OA of the knee (Lequesne's criteria), radiological stage between I and III, and Lequesne's severity index of at least 4 points and symptoms for at least 6 months. Patients were treated with either placebo or oral glucosamine sulfate 500 mg t.i.d. for 4 weeks, with weekly, with weekly clinic visits. Responders to treatment were defined as patients with a reduction of at least 3 points in the Lequesne's index with a positive overall assessment by the investigator. The Lequesne's index was 10.6 +/- 0.45 S.E.M. points in both groups at the start of the study. This decreased to 7.45 +/- 0.5 points in the treatment group (average 3.2) and 8.4 +/- 0.4 points in the placebo group (average 2.2) (P < 0.05, Student's t-test). The responder rate in the evaluable patients was 55% with glucosamine (N = 120) vs 38% with placebo (N = 121). These proportions were 52% vs 37% in an intention-to-treat analysis (P = 0.014 and 0.016, respectively; Fisher's Exact Test). The medications were well tolerated throughout the study, with no difference between the glucosamine and placebo treated groups. It is concluded that glucosamine sulfate may be a safe and effective symptomatic Slow Acting Drug for OA. |