Chantre P, Cappelaere A, Leblan D, Guedon D, Vandermander J, Fournie B
Laboratoires Arkopharma, Carros, France.
Phytomedicine. 2000 Jun;7(3):177-83. doi: 10.1016/S0944-7113(00)80001-X.
In a double-blind, randomized, multicentre clinical study, the efficacy and tolerance of a herbal medicine product, Harpadol (6 capsules/day, each containing 435 mg of powdered cryoground powder Harpagophytum procumbens), was compared with diacerhein 100 mg/day in the treatment, for 4 months, of 122 patients suffering from osteoarthritis of the knee and hip. Assessments of pain and functional disability were made on a 10 cm horizontal visual analogue scale; severity of osteoarthritis was evaluated by Lequesne's index. Spontaneous pain showed a significant improvement during the course of the study and there was no difference in the efficacy of the two treatments. Similarly, there was a progressive and significant reduction in the Lequesne functional index and no statistical difference was found between Harpadol and diacerhein. At completion of the study, patients taking Harpadol were using significantly less NSAIDs and antalgic drugs. The frequency of adverse events was significantly lower in the Harpadol group. The most frequent event reported was diarrhea, occurring in 8.1% and 26.7% of Harpadol and diacerhein patients respectively. The global tolerance assessment by patients at the end of treatment favoured Harpadol. The results of this study demonstrate that Harpadol is comparable in efficacy and superior in safety to diacerhein.
在一项双盲、随机、多中心临床研究中,将一种草药产品哈帕多(Harpadol,每日6粒胶囊,每粒含435毫克冷冻研磨的南非钩麻粉末)与双醋瑞因100毫克/日进行比较,对122例膝和髋骨关节炎患者进行为期4个月的治疗。采用10厘米水平视觉模拟量表对疼痛和功能障碍进行评估;通过勒凯斯内指数评估骨关节炎的严重程度。在研究过程中,自发疼痛有显著改善,两种治疗方法的疗效没有差异。同样,勒凯斯内功能指数也有逐步且显著的降低,哈帕多和双醋瑞因之间未发现统计学差异。在研究结束时,服用哈帕多的患者使用非甾体抗炎药和镇痛药的量显著减少。哈帕多组不良事件的发生率显著较低。报告的最常见事件是腹泻,分别发生在8.1%的哈帕多患者和26.7%的双醋瑞因患者中。治疗结束时患者的总体耐受性评估更倾向于哈帕多。这项研究的结果表明,哈帕多在疗效上与双醋瑞因相当,在安全性上优于双醋瑞因。