Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study.
Efficacy and safety of Curcuma domestica extracts compared with ibuprofen in patients with knee osteoarthritis: a multicenter study.
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DOI：
10.2147/cia.s58535
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发表时间：
2014
影响因子：
3.6
通讯作者：
Laongpech S
中科院分区：
文献类型：
--
作者：
Kuptniratsaikul V;Dajpratham P;Taechaarpornkul W;Buntragulpoontawee M;Lukkanapichonchut P;Chootip C;Saengsuwan J;Tantayakom K;Laongpech S
确定姜黄提取物在减轻疼痛和改善功能方面的有效性和安全性。367例疼痛评分为5分或更高的原发性膝关节骨关节炎患者随机接受布洛芬1，200 mg/天或C.青蒿提取物1，500毫克/天4周。主要结局为西安大略和麦克马斯特大学骨关节炎指数（WOMAC）总分、WOMAC疼痛、WOMAC僵硬度和WOMAC功能评分。还记录了不良事件（AE）。185例和182例患者随机分为C组。分别为白术提取物组和布洛芬组。两组的基线特征无差异。与基线相比，两组在第0、2和4周的所有WOMAC评分的平均值均显示出显著改善。使用非劣效性检验后，第4周WOMAC总分、WOMAC疼痛和WOMAC功能评分的平均差异（95%置信区间）经第0周C值调整后。除了WOMAC硬度子量表显示出显著性趋势（P = 0.060）外，白术提取物不劣于布洛芬组（分别为P=0.010、P=0.018和P=0.010）。发生AE的患者数量在组间无差异。然而，布洛芬组腹痛/不适事件的数量显著高于C组。黄芪提取物组（P=0.046）。大多数受试者（96%-97%）对治疗感到满意，三分之二的受试者在总体评估中认为自己有所改善。C.白术提取物与布洛芬一样有效治疗膝关节骨关节炎。副作用特征相似，但C组胃肠道AE报告较少。白术提取物组。
To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement. 367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks. The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total, WOMAC pain, WOMAC stiffness, and WOMAC function scores. Adverse events (AEs) were also recorded. 185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups, respectively. The baseline characteristics were no different between groups. The mean of all WOMAC scores at weeks 0, 2, and 4 showed significant improvement when compared with the baseline in both groups. After using the noninferiority test, the mean difference (95% confidence interval) of WOMAC total, WOMAC pain, and WOMAC function scores at week 4 adjusted by values at week 0 of C. domestica extracts were noninferior to those for the ibuprofen group (P=0.010, P=0.018, and P=0.010, respectively), except for the WOMAC stiffness subscale, which showed a trend toward significance (P=0.060). The number of patients who developed AEs was no different between groups. However, the number of events of abdominal pain/discomfort was significantly higher in the ibuprofen group than that in the C. domestica extracts group (P=0.046). Most subjects (96%–97%) were satisfied with the treatment, and two-thirds rated themselves as improved in a global assessment. C. domestica extracts are as effective as ibuprofen for the treatment of knee osteoarthritis. The side effect profile was similar but with fewer gastrointestinal AE reports in the C. domestica extracts group.