TREATMENT OF OSTEOARTHRITIS WITH A HERBOMINERAL FORMULATION - A DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY
TREATMENT OF OSTEOARTHRITIS WITH A HERBOMINERAL FORMULATION - A DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY
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DOI：
10.1016/0378-8741(91)90167-c
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发表时间：
1991-05-01
影响因子：
5.4
通讯作者：
PATWARDHAN, B
中科院分区：
文献类型：
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作者：
KULKARNI, RR;PATKI, PS;PATWARDHAN, B
在骨关节炎患者中进行的一项随机、双盲、安慰剂对照、交叉研究中评价了含有睡茄根、乳香茎、姜黄根茎和锌复合物（Articulin-F）的草药制剂的临床疗效。在一个月的单盲导入期后，42名骨关节炎患者被随机分配接受药物治疗或匹配的安慰剂治疗三个月。在15天的洗脱期后，患者被转移到另一种治疗，再持续3个月。每两周根据疼痛严重程度、晨僵、里奇关节指数、关节评分、残疾评分和握力评估临床疗效。其他参数如红细胞沉降率和放射学检查每月进行一次。用草药制剂治疗产生了疼痛严重程度（P < 0.001）和残疾评分（P < 0.05）的显著下降。然而，放射学评估并未显示两组中有任何显著变化。使用该制剂观察到的副作用不需要停止治疗。
The clinical efficacy of a herbomineral formulation containing roots of Withania somnifera, the stem of Boswellia serrata, rhizomes of Curcuma longa and a zinc complex (Articulin-F), was evaluated in a randomized, double-blind, placebo controlled, cross-over study in patients with osteoarthritis. After a one-month single blind run-in period, 42 patients with osteoarthritis were randomly allocated to receive either a drug treatment or a matching placebo for a period of three months. After a 15-day wash-out period the patients were transferred to the other treatment for a further period of three months. Clinical efficacy was evaluated every fortnight on the basis of severity of pain, morning stiffness, Ritchie articular index, joint score, disability score and grip strength. Other parameters like erythrocyte sedimentation rate and radiological examination were carried out on a monthly basis. Treatment with the herbomineral formulation produced a significant drop in severity of pain (P < 0.001) and disability score (P < 0.05). Radiological assessment, however, did not show any significant changes in both the groups. Side effects observed with this formulation did not necessitate withdrawal of treatment.