ND: |
ME08135881 |
PMID: |
8135881 |
LR: |
20041117 |
CED: |
19940418 |
DCO: |
19940418 |
Autoren: |
Reichelt A; Förster KK; Fischer M; Rovati LC; Setnikar I |
Titel: |
Efficacy and safety of intramuscular glucosamine sulfate in osteoarthritis of the knee. A randomised, placebo-controlled, double-blind study. |
Quelle: |
Arzneimittel-Forschung; VOL: 44 (1); p. 75-80 /199401/ |
PM: |
Print |
SU: |
IM |
Sprache: |
English |
CY: |
GERMANY |
JID: |
0372660 |
ISSN: |
0004-4172 |
CO: |
ARZNAD |
Institution: |
University Clinic of Orthopedics, Freiburg/Brsg. Fed. Rep. of Germany. |
DT: |
Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
Schlagwörter |
CT: |
ADULT; AGED; DOUBLE-BLIND METHOD; FEMALE; GLUCOSAMINE/administration & dosage; GLUCOSAMINE/adverse effects; GLUCOSAMINE/*therapeutic use; HUMANS; INJECTIONS, INTRAMUSCULAR; KNEE JOINT/*; MALE; MIDDLE AGED; OSTEOARTHRITIS/complications; OSTEOARTHRITIS/*drug therapy; OSTEOARTHRITIS/pathology; PAIN/drug therapy; PAIN/etiology |
CTG: |
ERWACHSENER; ALTE MENSCHEN; DOPPELBLINDMETHODE; WEIBLICH; GLUCOSAMIN/Verabreichung & Dosierung; GLUCOSAMIN/unerwünschte Nebenwirkungen; GLUCOSAMIN/*therapeutische Anwendung; MENSCH; INJEKTIONEN, INTRAMUSKULÄRE; KNIEGELENK/*; MÄNNLICH; MENSCHEN IM MITTLEREN LEBENSALTER; OSTEOARTHROSE/Komplikationen; OSTEOARTHROSE/*Arzneimitteltherapie; OSTEOARTHROSE/Pathologie; SCHMERZEN/Arzneimitteltherapie; SCHMERZEN/Ätiologie |
TE: |
Glucosamine/3416-24-8 |
CR: |
3416-24-8 |
AB: |
Glucosamine sulfate (Dona, CAS 29031-19-4) is a drug used in the treatment of osteoarthritis. When orally given, it is more effective than placebo and at least as effective as non-steroidal anti-inflammatory drugs in relieving osteoarthritis symptoms. The aim of this multicentre, randomised, placebo-controlled, double-blind, parallel-group study was to assess the efficacy and safety of glucosamine sulfate intramuscularly given on the same parameters. 155 out-patients with knee osteoarthritis (Lequesne's criteria), radiological stage between I and III, Lequesne's severity index of at least 4 points and symptoms for at least 6 months, were treated with i.m. glucosamine sulfate (or placebo) 400 mg twice a week for 6 weeks. Clinic visits were performed at enrollment, after a 2-week baseline, at weekly intervals during treatment and 2 weeks after drug discontinuation. Responders to treatment were considered those patients with a reduction of at least 3 points in the Lequesne index, together with a positive overall judgement by the investigator. The Lequesne index was slightly over 10 points in average in both groups at the beginning of treatment. A significant decrease in the index was observed for glucosamine compared to placebo (3.3 vs. 2.0 points in average, respectively; p < 0.05, Student's t-test). The responder rate in the evaluable patients was 55% with glucosamine (n = 73) and only 33% (n = 69) with placebo (p = 0.012, Fisher's Exact Test). According to the intention-to-treat approach, considering also drop-outs, these proportions were 51% vs. 30% (p = 0.015).(ABSTRACT TRUNCATED AT 250 WORDS) |