Song Liang, Zhou Qi-Hui, Wang Hui-Lin, Liao Feng-Jiao, Hua Liang, Zhang Hong-Feng, Huang Li-Bo, Lin Yan, Zheng Guo-Qing
Department of Neurology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.
Department of Neurology, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325027, China.
Complement Ther Med. 2017 Apr;31:71-81. doi: 10.1016/j.ctim.2017.02.004. Epub 2017 Feb 21.
Many patients with multiple sclerosis (MS) resort to complementary and alternative medicine, which is used in 33%-80% of MS patients in the developed country. The purpose of this study is to assess the efficacy and safety of Chinese herbal medicine (CHM) as an adjunct therapy of patients with acute relapse of MS.
Six databases were searched for randomized-controlled trial of CHM for acute relapse of MS. The risk of bias was assessed by using the twelve criteria recommended by the Cochrane Back Review Group. The primary outcome measures of interest are the Expanded Disability Status Score, annual relapse frequency, annual relapse rate, and annual relapse interval. The secondary outcome measures are the clinical efficacy rate and adverse events. The selection criteria of high-frequency herbs for MS are those with cumulative frequency over 50%. We analyzed the data using Review Manager (version 5.3).
A total of 1100 participants were included in the 20 studies from 2004 to 2015. The number of risk of bias which met the criteria varied from 5/12 to 7/12. The top 5 most frequently used herbs are ordinally Radix Angelicae Sinensis, Radix Glycyrrhizae, Radix Paeoniae Rubra, Radix Rehmanniae Preparata, and Bombyx Batryticatus. The meta-analysis showed a significant effect of CHM for improving Expanded Disability Status Score (P<0.01), annual relapse frequency (P<0.01) and the total clinical efficacy rate (P<0.01) compared with western conventional treatment. In analysis of annual relapse rate and annual relapse interval, there was a significant difference between CHMs and western conventional treatment (P<0.01). Adverse effects were monitored in 6 studies, and were well tolerated in all MS patients.
The available evidence from present study supported but limited to recommend the routine use of CHM adjuvant therapy for MS because of the poor methodological quality and clinical heterogeneity. However, we identified an area that is worthy of further study. Furthermore, we selected high frequent use of CHMs as a promising candidate for further clinical application and MS trials. Further rigorous randomized-controlled trials are needed.
许多多发性硬化症(MS)患者求助于补充和替代医学,在发达国家,33%-80%的MS患者使用这种医学。本研究的目的是评估中药(CHM)作为MS急性复发患者辅助治疗的疗效和安全性。
检索六个数据库,查找关于CHM治疗MS急性复发的随机对照试验。采用Cochrane循证医学协作网推荐的12条标准评估偏倚风险。主要观察指标为扩展残疾状态评分、年复发频率、年复发率和年复发间隔。次要观察指标为临床有效率和不良事件。MS高频用药的选择标准是累计频率超过50%的药物。我们使用Review Manager(5.3版)分析数据。
2004年至2015年的20项研究共纳入1100名参与者。符合标准的偏倚风险数量从5/12到7/12不等。最常用的前5种药物依次为当归、甘草、赤芍、熟地黄和僵蚕。荟萃分析显示,与西医传统治疗相比,CHM在改善扩展残疾状态评分(P<0.01)、年复发频率(P<0.01)和总临床有效率(P<0.01)方面有显著效果。在年复发率和年复发间隔分析中,CHM与西医传统治疗有显著差异(P<0.01)。6项研究监测了不良反应,所有MS患者对不良反应耐受性良好。
由于方法学质量差和临床异质性,本研究的现有证据支持但仅限于推荐将CHM辅助治疗常规用于MS。然而,我们确定了一个值得进一步研究的领域。此外,我们选择高频使用的CHM作为进一步临床应用和MS试验的有前景的候选药物。需要进一步进行严格的随机对照试验。