A double-blinded, randomized, parallel grouped, phase III comparative study of Japanese White Turmeric extract and placebo in patients with mild to moderate osteoarthritis of the knee and or hip

Kaj Winther, Frank H Pedersen, Peter Winther Hansen, Joan Campbell- Tofte, Mahsa Jalili, S. H. Christensen
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Abstract

Background: Osteoarthritis is a common disease among middle aged and elderly people and paracetamol and NSAIDs, which can both cause side effects, are often used to manage symptoms like pain. This study aimed to test if Japanese White Turmeric (JWT), a new variant of turmeric, containing labdane terpenoid and hardly any curcumin, would lessen symptoms from osteoarthritis and reduce the consumption of rescue medication, without causing side effects. Methods: Volunteers (n=120) with osteoarthritis of the knee and/or hip were randomly allocated to either daily treatment with JWT (12.8 mg) or placebo for 6 months. Primary effect variables, pain and physical function and secondary effect variables, stiffness and global severity of the disease (PGAD) were scored on WOMAC questionnaires initially and after 1, 2, 3 and 6 months of treatment. Rescue medication taken by participants were self-registered in a diary. Results: JWT treatment showed a statistically significant reduction in WOMAC pain after 1, 2 and 3 months (p<0.0003). After 6 months this decline was still statistically significant and superior to placebo (p<0.041). Effect size was 4.961±2.366 (n=40) for treatment group vs (n=27) for placebo), 95% confidence interval was 9.686 to -0.2359, p< 0.039. An identical pattern was observed when testing physical function, joint stiffness and PGAD. The consumption of paracetamol was significantly lowered after 3 and 6 months of active treatment (p<0.014 and p<0.050) respectively vs placebo. A similar pattern was observed for NSAIDs. No serious side effects were reported and minor side effects were equally represented in both groups. Conclusion: Our data suggests that the herbal remedy, Japanese White Turmeric significantly alleviates symptoms of osteoarthritis, including pain and lower the consumption of rescue medication.
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日本白姜黄提取物和安慰剂对轻度至中度膝关节或髋关节骨关节炎患者的双盲、随机、平行分组 III 期比较研究
背景:骨关节炎是中老年人的一种常见疾病,扑热息痛和非甾体抗炎药都会产生副作用,通常被用来控制疼痛等症状。本研究旨在测试日本白姜黄(JWT)--一种姜黄的新变种,含有拉伯烷萜类化合物,几乎不含姜黄素--是否能减轻骨关节炎的症状,并在不产生副作用的情况下减少治疗药物的用量。研究方法患有膝关节和/或髋关节骨关节炎的志愿者(n=120)被随机分配到每天服用 JWT(12.8 毫克)或安慰剂,为期 6 个月。在治疗初期以及治疗 1、2、3 和 6 个月后,通过 WOMAC 问卷对主要效应变量疼痛和身体功能以及次要效应变量僵硬和总体疾病严重程度 (PGAD) 进行评分。参与者服用的解救药物均自行登记在日记中。结果JWT治疗1个月、2个月和3个月后,WOMAC疼痛明显减轻(P<0.0003)。6 个月后,这一下降仍具有统计学意义,且优于安慰剂(p<0.041)。治疗组的效应大小为 4.961±2.366(n=40),安慰剂组的效应大小为(n=27),95% 置信区间为 9.686 至 -0.2359,p< 0.039。在测试身体功能、关节僵硬度和 PGAD 时也观察到了相同的模式。与安慰剂相比,在积极治疗 3 个月和 6 个月后,扑热息痛的用量明显减少(p<0.014 和 p<0.050)。非甾体抗炎药的使用情况与此类似。两组患者均未出现严重副作用,轻微副作用的比例相当。结论我们的数据表明,日本白姜黄这种草药能明显缓解骨关节炎的症状,包括疼痛,并能降低治疗药物的用量。
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