Oral herbal therapies for treating osteoarthritis.
Oral herbal therapies for treating osteoarthritis.
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DOI：
10.1002/14651858.cd002947.pub2
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发表时间：
2014-05-22
影响因子：
8.4
通讯作者：
Chrubasik, Sigrun
中科院分区：
文献类型：
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作者：
Cameron, Melainie;Chrubasik, Sigrun
药用植物产品用于口服治疗骨关节炎。虽然它们的作用机制尚未被详细阐明，但与常见炎症介质的相互作用为使用它们治疗骨关节炎提供了基本原理。更新先前的Cochrane综述，评估口服药用植物产品治疗骨关节炎的利弊。我们检索了截至2013年8月29日的电子数据库（CENTRAL， MEDLINE， EMBASE， AMED， CINAHL, ISI Web of Science，世界卫生组织临床试验注册平台），不受语言限制，以及检索到的试验的参考文献列表。在骨关节炎患者中，口服草药干预与安慰剂或主动对照进行了随机对照试验。草药干预包括任何植物制剂，但不包括顺势疗法或芳香疗法产品，或任何合成制剂。两位作者使用标准方法进行试验选择和数据提取，并使用GRADE方法评估主要结局（疼痛、功能、x线关节改变、生活质量、不良事件所致停药、总不良事件和严重不良事件）的证据体质量。纳入49项随机对照研究（33项干预措施，5980名受试者）。17项验证性设计的研究（预先指定的样本和效应大小）大多具有中等偏倚风险。其余32项探索性设计研究偏倚风险较高。由于干预措施不同，荟萃分析仅限于Boswellia serrata（单草药）和牛油果-大豆不皂化物（ASU）（两种草药组合）产品。对三种不同提取物进行了五项研究。来自两项研究（85名参与者）的高质量证据表明，与安慰剂相比，用100毫克浓缩的锯齿状乳香提取物治疗90天可改善症状。在0到100分的VAS量表上，平均疼痛为40分（0为无疼痛），安慰剂，强化的锯齿状乳香杆菌平均减轻疼痛17分（95%置信区间（CI） 8至26）；获得额外有益结果所需治疗的人数（NNTB） 2；95% ci不排除有临床意义的疼痛减轻15点。身体功能在西安大略和麦克马斯特大学骨关节炎指数（WOMAC） 0到100分亚量表上为33分（0表示没有功能丧失），而安慰剂、强化的锯状博斯韦利亚改善了8分的功能（95% CI 2到14）；NNTB 4。假设最小的临床重要差异为10分，我们不能排除对某些人的临床重要益处。中等质量的证据（一项研究，96名参与者）表明，强化的锯齿状乳香杆菌可能减少了不良事件（18/48事件，安慰剂组为30/48事件；相对风险（RR） 0.60, 95% CI 0.39至0.92）。两项研究（97名参与者）对100毫克加非挥发油的锯齿状乳香（浓缩）进行了中等质量的证据证实了其他锯齿状乳香提取物可能比安慰剂有好处，而对999毫克日剂量的锯齿状乳香提取物和250毫克日剂量的浓缩锯齿状乳香提取物进行了低质量的小单项研究。由于一项小型单一研究的证据质量非常低，因此不确定99mg的日剂量是否优于伐地昔布。由于不同研究结果的不同报告，不确定是否有不良事件或停药的风险增加。这些研究没有报告严重的不良事件。没有测量生活质量和x线关节变化。6项研究检测了ASU产品Piasclidine®。来自四项研究（651名参与者）的中等质量证据表明，ASU 300mg在治疗3至12个月后，对症状产生了轻微的、临床上值得怀疑的改善，与安慰剂相比，可能没有增加不良事件。在VAS 0 - 100量表上，安慰剂组的平均疼痛为40.5分（0为无疼痛），ASU 300 mg组的疼痛平均减轻8.5分（95% CI 1 - 16分）；NNTB 8。ASU 300 mg改善功能（标准化平均差(SMD) - 0.42, 95% CI - 0.73至- 0.11）。功能估计为47毫米（0至100毫米量表，其中0为无功能丧失），安慰剂，ASU 300毫克改善功能平均7毫米（95% CI 2至12毫米）；NNTB 5（3 ~ 19）。ASU组（53%）和安慰剂组（51%）在不良事件（5项研究，1050名受试者）方面没有差异（RR 1.04, 95% CI 0.97至1.12）；不良事件导致的停药（1项研究，398名受试者）在ASU（17%）和安慰剂（15%）之间（RR 1.14, 95% CI 0.73 - 1.80）；或严重不良事件（1项研究，398名参与者）在ASU（40%）和安慰剂（33%）之间（RR 1.22, 95% CI 0.94至1.59）。在两项研究（453名参与者）中，以关节间隙宽度（JSW）变化测量的x线关节变化在ASU 300 mg治疗（- 0.53 mm）和安慰剂（- 0.65 mm）之间没有差异；平均差异为- 0.12 （95% CI - 0.43 ~ 0.19）。来自一项单一研究（156名参与者）的中等质量证据证实了ASU 600毫克可能优于安慰剂，没有增加不良事件。低质量证据（1项研究，357名参与者）表明ASU 300mg和硫酸软骨素在症状或不良事件方面可能没有差异。生活质量没有被测量。所有其他草药干预都是在单一研究中调查的，结论有限。没有与任何植物产品相关的严重副作用的报告。ASU专利产品Piasclidine®治疗骨关节炎症状的证据在短期使用中似乎是中度到高度的，但长期研究和反对明显的积极对照的研究不太令人信服。其他几种药用植物产品，包括锯齿乳香提取物，显示出有益的趋势，鉴于不良事件的风险似乎很低，值得进一步调查。没有证据表明Piasclidine®能显著改善关节结构，也有有限证据表明它能防止关节间隙变窄。没有任何其他草药干预测试结构变化。需要进一步的研究来确定产生临床效益且无不良事件的最佳日剂量。
Medicinal plant products are used orally for treating osteoarthritis. Although their mechanisms of action have not yet been elucidated in full detail, interactions with common inflammatory mediators provide a rationale for using them to treat osteoarthritic complaints. To update a previous Cochrane review to assess the benefits and harms of oral medicinal plant products in treating osteoarthritis. We searched electronic databases (CENTRAL, MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to 29 August 2013, unrestricted by language, and the reference lists from retrieved trials. Randomised controlled trials of orally consumed herbal interventions compared with placebo or active controls in people with osteoarthritis were included. Herbal interventions included any plant preparation but excluded homeopathy or aromatherapy products, or any preparation of synthetic origin. Two authors used standard methods for trial selection and data extraction, and assessed the quality of the body of evidence using the GRADE approach for major outcomes (pain, function, radiographic joint changes, quality of life, withdrawals due to adverse events, total adverse events, and serious adverse events). Forty-nine randomised controlled studies (33 interventions, 5980 participants) were included. Seventeen studies of confirmatory design (sample and effect sizes pre-specified) were mostly at moderate risk of bias. The remaining 32 studies of exploratory design were at higher risk of bias. Due to differing interventions, meta-analyses were restricted to Boswellia serrata (monoherbal) and avocado-soyabean unsaponifiables (ASU) (two herb combination) products. Five studies of three different extracts from Boswellia serrata were included. High-quality evidence from two studies (85 participants) indicated that 90 days treatment with 100 mg of enriched Boswellia serrata extract improved symptoms compared to placebo. Mean pain was 40 points on a 0 to 100 point VAS scale (0 is no pain) with placebo, enriched Boswellia serrata reduced pain by a mean of 17 points (95% confidence interval (CI) 8 to 26); number needed to treat for an additional beneficial outcome (NNTB) 2; the 95% CIs did not exclude a clinically significant reduction of 15 points in pain. Physical function was 33 points on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 0 to 100 point subscale (0 is no loss of function) with placebo, enriched Boswellia serrata improved function by 8 points (95% CI 2 to 14); NNTB 4. Assuming a minimal clinically important difference of 10 points, we cannot exclude a clinically important benefit in some people. Moderate-quality evidence (one study, 96 participants) indicated that adverse events were probably reduced with enriched Boswellia serrata (18/48 events versus 30/48 events with placebo; relative risk (RR) 0.60, 95% CI 0.39 to 0.92). Possible benefits of other Boswellia serrata extracts over placebo were confirmed in moderate-quality evidence from two studies (97 participants) of Boswellia serrata (enriched) 100 mg plus non-volatile oil, and low-quality evidence from small single studies of a 999 mg daily dose of Boswellia serrata extract and 250 mg daily dose of enriched Boswellia serrata. It was uncertain if a 99 mg daily dose of Boswellia serrata offered benefits over valdecoxib due to the very low-quality evidence from a small single study. It was uncertain if there was an increased risk of adverse events or withdrawals with Boswellia serrata extract due to variable reporting of results across studies. The studies reported no serious adverse events. Quality of life and radiographic joint changes were not measured. Six studies examined the ASU product Piasclidine®.Moderate-quality evidence from four studies (651 participants) indicated that ASU 300 mg produced a small and clinically questionable improvement in symptoms, and probably no increased adverse events compared to placebo after three to 12 months treatment. Mean pain with placebo was 40.5 points on a VAS 0 to 100 scale (0 is no pain), ASU 300 mg reduced pain by a mean of 8.5 points (95% CI 1 to 16 points); NNTB 8. ASU 300 mg improved function (standardised mean difference (SMD) −0.42, 95% CI −0.73 to −0.11). Function was estimated as 47 mm (0 to 100 mm scale, where 0 is no loss of function) with placebo, ASU 300 mg improved function by a mean of 7 mm (95% CI 2 to 12 mm); NNTB 5 (3 to 19). There were no differences in adverse events (5 studies, 1050 participants) between ASU (53%) and placebo (51%) (RR 1.04, 95% CI 0.97 to 1.12); withdrawals due to adverse events (1 study, 398 participants) between ASU (17%) and placebo (15%) (RR 1.14, 95% CI 0.73 to 1.80); or serious adverse events (1 study, 398 participants) between ASU (40%) and placebo (33%) (RR 1.22, 95% CI 0.94 to 1.59). Radiographic joint changes, measured as change in joint space width (JSW) in two studies (453 participants) did not differ between ASU 300 mg treatment (−0.53 mm) and placebo (−0.65 mm); mean difference of −0.12 (95% CI −0.43 to 0.19). Moderate-quality evidence from a single study (156 participants) confirmed possible benefits of ASU 600 mg over placebo, with no increased adverse events. Low-quality evidence (1 study, 357 participants) indicated there may be no differences in symptoms or adverse events between ASU 300 mg and chondroitin sulphate. Quality of life was not measured. All other herbal interventions were investigated in single studies, limiting conclusions. No serious side effects related to any plant product were reported. Evidence for the proprietary ASU product Piasclidine® in the treatment of osteoarthritis symptoms seems moderate to high for short term use, but studies over a longer term and against an apparently active control are less convincing. Several other medicinal plant products, including extracts of Boswellia serrata, show trends of benefits that warrant further investigation in light of the fact that the risk of adverse events appear low. There is no evidence that Piasclidine®significantly improves joint structure, and limited evidence that it prevents joint space narrowing. Structural changes were not tested for with any other herbal intervention. Further investigations are required to determine optimum daily doses producing clinical benefits without adverse events.