S Fuchs1, R Mönikes, A Wohlmeiner, T Heyse. 1. Department of Orthopaedic Surgery and Rheumatology, Philipps-University Marburg, Baldingerstrasse, 35043 Marburg, Germany.
Abstract
OBJECTIVE: Prospective assessment of the efficacy and tolerability of intra-articular sodium hyaluronate (SH; Ostenil mini) and triamcinolone acetonide (TA; Volon A10) for treatment of osteoarthritis (OA) of the carpometacarpal (CMC) joint of the thumb in a 26-week, controlled, randomized, on an intention to treat, masked-observer study. METHODS: Patients were treated with three intra-articular injections of either SH (n = 28) or TA (n = 28). Primary assessments were pain according to a 100mm visual analogue scale and extensive clinical and functional parameters such as swelling, grip power and range of motion. The population was analysed using one- and two-sided Mann-Whitney (MW) estimators. RESULTS:Maximum pain relief occurred at 2-3 weeks for TA and at week 26 for SH after the first intra-articular injection. At weeks 2-3 TA was significantly better than SH (MW: 0.3319 and 0.3063; P = 0.9827 and 0.9929). At week 26 a slight superiority of SH could be observed (MW: 0.53; P = 0.3624) and non-inferiority could be proven. After 26 weeks lateral pinch power was significantly better in the SH-group (MW: 0.6331; P = 0.0226). In all, 88.0% of patients treated with SH and 79.1% of the TA-group described pain improvement after 26 weeks. Both agents were well tolerated. No adverse events with causal connection to the investigational products occurred. CONCLUSION: A single course of three SH injections is effective in relieving pain and improving joint function in patients with OA of the CMC joint of the thumb. Although in comparison with triamcinolone its effects are achieved more slowly, the results indicate a superior long-lasting effect of hyaluronan at 6 months after end of treatment period.
RCT Entities:
OBJECTIVE: Prospective assessment of the efficacy and tolerability of intra-articularsodium hyaluronate (SH; Ostenil mini) and triamcinolone acetonide (TA; Volon A10) for treatment of osteoarthritis (OA) of the carpometacarpal (CMC) joint of the thumb in a 26-week, controlled, randomized, on an intention to treat, masked-observer study. METHODS:Patients were treated with three intra-articular injections of either SH (n = 28) or TA (n = 28). Primary assessments were pain according to a 100mm visual analogue scale and extensive clinical and functional parameters such as swelling, grip power and range of motion. The population was analysed using one- and two-sided Mann-Whitney (MW) estimators. RESULTS: Maximum pain relief occurred at 2-3 weeks for TA and at week 26 for SH after the first intra-articular injection. At weeks 2-3 TA was significantly better than SH (MW: 0.3319 and 0.3063; P = 0.9827 and 0.9929). At week 26 a slight superiority of SH could be observed (MW: 0.53; P = 0.3624) and non-inferiority could be proven. After 26 weeks lateral pinch power was significantly better in the SH-group (MW: 0.6331; P = 0.0226). In all, 88.0% of patients treated with SH and 79.1% of the TA-group described pain improvement after 26 weeks. Both agents were well tolerated. No adverse events with causal connection to the investigational products occurred. CONCLUSION: A single course of three SH injections is effective in relieving pain and improving joint function in patients with OA of the CMC joint of the thumb. Although in comparison with triamcinolone its effects are achieved more slowly, the results indicate a superior long-lasting effect of hyaluronan at 6 months after end of treatment period.
Authors: Nazim Karalezli; Tunc Cevat Ogun; Senay Kartal; Sacide Nur Saracgil; Mustafa Yel; Ibrahim Tuncay Journal: Clin Rheumatol Date: 2006-06-24 Impact factor: 2.980
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