Abstract | OBJECTIVE: PATIENTS AND METHODS: A 1 year prospective, multicentre, randomised, double blind, placebo controlled study of 301 patients aged >50 years with painful and radiological medial knee OA. Patients were randomly assigned into three groups receiving: (1) three courses of three IA injections of hyaluronic acid (HA) + oral placebo; (2) IA injections of saline solution + diacerein 100 mg/day; (3) IA injections of saline solution + oral placebo. Demographic data and symptomatic criteria- pain, Lequesne's index, patient's global assessment of disease activity, percentage of painful days-were obtained during the study; primary structural criterion was JSW. Efficacy criteria were changes in pain VAS, joint space narrowing (JSN), and percentage of progressors (JSN >0.5 mm). An intention to treat analysis was used for symptomatic variables, and completer analysis for structural variables. RESULTS: Baseline characteristics were similar between the three groups. Mean (SD) improvement in pain VAS was clinically relevant (-33.9 (27.3), n = 301), but with no difference between the groups (p = 0.96). JSW deteriorated (-0.09 (0.55) mm, n = 277, p = 0.01), but with no difference between the groups (p = 0.82). Percentages of progressors were 17.7, 18.9, and 20.3% (p = 0.90), in groups 1, 2, and 3, respectively. CONCLUSION: A weak but statistically significant structural deterioration occurred over 1 year, together with clinically relevant symptomatic improvement in patients receiving oral drug and iterative IA injections. Symptomatic and/or structural effects for both this new HA compound and diacerein were not demonstrated.
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Authors | T Pham, A Le Henanff, Ph Ravaud, P Dieppe, L Paolozzi, M Dougados |
Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 63
Issue 12
Pg. 1611-7
(Dec 2004)
ISSN: 0003-4967 [Print] England |
PMID | 15331394
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Anthraquinones
- Anti-Inflammatory Agents, Non-Steroidal
- NRD101
- diacerein
- Hyaluronic Acid
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Topics |
- Aged
- Anthraquinones
(adverse effects, therapeutic use)
- Anti-Inflammatory Agents, Non-Steroidal
(adverse effects, therapeutic use)
- Disease Progression
- Double-Blind Method
- Female
- Humans
- Hyaluronic Acid
(adverse effects, analogs & derivatives, therapeutic use)
- Injections, Intra-Articular
- Male
- Middle Aged
- Osteoarthritis, Knee
(drug therapy)
- Pain Measurement
- Prospective Studies
- Severity of Illness Index
- Treatment Outcome
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