Department of Integrative Medicine, Lanzhou General Hospital of the People's Liberation Army, Lanzhou, 730050, China.
Department of Oncology, Xijing Hospital, The Fourth Military Medical University, Xi'an, 710032, China.
Support Care Cancer. 2016 Jan;24(1):11-17. doi: 10.1007/s00520-015-2737-2. Epub 2015 Apr 19.
Bone cancer pain presents a clinical challenge with limitations of current treatments. Many patients seek additional therapies that may relieve pain. Many external applications of traditional Chinese medicines (EAs-TCMs) have been evaluated in clinical trials, but fewer are known about them outside of China. The objective of this study is to assess the efficacy for bone cancer pain.
A systematic literature search was conducted in seven databases until December 2014 to identify randomized controlled trials (RCTs) about EAs-TCMs in the treatment of bone cancer pain. The primary outcome was total pain relief rate. The secondary outcomes were adverse events at the end of treatment course. The methodological quality of RCTs was assessed independently using six-item criteria according to the Cochrane Collaboration. All data were analyzed using Review Manager 5.2.0. We included any RCTs evaluating an EA-TCM for the treatment of bone cancer pain. We conducted a meta-analysis.
We included six RCTs with 534 patients. In general, the reporting of methodological issues was poor. Compared with morphine sulfate sustained release tablets (MSSRTs) or radiotherapy or bisphosphonates, we analyzed data from five trials reporting on complete response effect score (relative risk (RR) = 5.38, 95% confidence interval (CI) = 2.80-10.31, P < 0.00001) and partial response (RR = 1.18, 95% CI = 1.02-1.37, P = 0.02) and six trials reporting on total pain relief rate (RR = 1.49, 95% CI = 1.43-1.67, P < 0.00001). Six RCTs showed significant effects of EA-TCM for improving pain relief in patients with bone cancer pain. In addition, no severe adverse events were found.
This systematic review showed positive but weak evidence of EA-TCM for bone cancer pain because of the poor methodological quality and the small quantity of the included trials. Future rigorously designed RCTs are required.
癌症骨痛的临床治疗存在局限性。许多患者寻求额外的治疗方法来缓解疼痛。许多中药外用(EAs-TCMs)已在临床试验中进行了评估,但在中国以外的地区知之甚少。本研究旨在评估其对癌症骨痛的疗效。
系统检索了 7 个数据库,截至 2014 年 12 月,以确定治疗癌症骨痛的 EAs-TCMs 的随机对照试验(RCTs)。主要结局为总疼痛缓解率。次要结局为治疗结束时的不良事件。根据 Cochrane 协作组的 6 项标准,独立评估 RCTs 的方法学质量。所有数据均采用 Review Manager 5.2.0 进行分析。我们纳入了任何评估 EAs-TCM 治疗癌症骨痛的 RCTs。我们进行了荟萃分析。
我们纳入了 6 项 RCTs,共 534 例患者。一般来说,方法学问题的报告较差。与硫酸吗啡控释片(MSSRTs)或放疗或双膦酸盐相比,我们分析了 5 项报告完全缓解效应评分的试验数据(相对风险(RR)=5.38,95%置信区间(CI)=2.80-10.31,P<0.00001)和部分缓解(RR=1.18,95%CI=1.02-1.37,P=0.02),以及 6 项报告总疼痛缓解率的试验数据(RR=1.49,95%CI=1.43-1.67,P<0.00001)。6 项 RCTs 表明 EAs-TCM 对改善癌症骨痛患者的疼痛缓解有显著效果。此外,未发现严重不良事件。
由于方法学质量差和纳入试验数量少,本系统评价显示 EAs-TCM 对癌症骨痛的疗效为阳性但较弱。需要未来设计更严格的 RCTs。