TCM Internal Medicine Department, Chengdu University of Traditional Chinese Medicine, #39 Shi-er-qiao Road, Chengdu, Sichuan, China.
J Altern Complement Med. 2010 Aug;16(8):889-98. doi: 10.1089/acm.2009.0470.
This meta-analysis aimed to assess the effectiveness and safety of Chinese herbal medicine (CHM) as an adjunctive method to standard therapy for patients with diabetic foot ulcers (DFU).
Randomized controlled trials (RCTs) of CHM to treat DFU were searched in the following electronic databases: MEDLINE; EMBASE; Chinese Biomedical Database (CBM); Cochrane Central Register of Controlled Trials (CENTRAL); Allied & Complementary Medicine Resources (AMED); and Cumulative Index to Nursing and Allied Health Literature (CINAHL). Two (2) researchers independently assessed the quality and validity of included trials and extracted outcome data for synthesis.
Six (6) trials were included for analysis. Compared to using standard therapy alone, CHM combined with standard therapy significantly increased the number of patients whose ulcers healed (risk ratio [RR], 0.62, [95% confidence interval (CI), 0.39-0.97]) and number of patients with at least a 30% reduction in the ulcer area (RR, 0.81 [95%CI, 0.71-0.92]). In addition, the two therapies combined significantly decreased the number of patients without any improvement (RR, 0.34 [95%CI, 0.21-0.53]). However, with respect to blood flow volume in the dorsal artery of the foot, no significant difference between the two therapies was observed (standardized mean difference, 1.71 [95% CI -1.25-4.67]), but the result favored the CHM combined with standard therapy group. Only 2 of 6 trials reported adverse events, which included nausea, epigastric pain, and dry mouth.
CHM may be effective and safe as an adjunctive therapy for treating DFU. However, a firm conclusion could not be reached because of the poor quality of the included trials. Further trials with higher quality are justified.
本荟萃分析旨在评估中药（CHM）作为糖尿病足溃疡（DFU）标准治疗辅助方法的有效性和安全性。
检索 MEDLINE、EMBASE、中国生物医学文献数据库（CBM）、Cochrane 对照试验中心注册库（CENTRAL）、补充与替代医学资源（AMED）和护理学及相关健康文献累积索引（CINAHL）等电子数据库中关于 CHM 治疗 DFU 的随机对照试验（RCT）。两名研究人员独立评估纳入试验的质量和有效性，并提取数据进行综合分析。
纳入 6 项研究进行分析。与单独使用标准疗法相比，CHM 联合标准疗法显著增加了溃疡愈合的患者人数（风险比 [RR]，0.62 [95%置信区间（CI），0.39-0.97]）和溃疡面积至少减少 30%的患者人数（RR，0.81 [95%CI，0.71-0.92]）。此外，两种疗法联合应用可显著减少无任何改善的患者人数（RR，0.34 [95%CI，0.21-0.53]）。然而，对于足底背动脉血流量，两种疗法之间没有观察到显著差异（标准化均数差，1.71 [95%CI -1.25-4.67]），但结果倾向于 CHM 联合标准疗法组。仅有 2 项研究报告了不良反应，包括恶心、上腹痛和口干。
CHM 可能是一种有效的辅助治疗方法，可安全用于治疗 DFU。然而，由于纳入研究的质量较差，无法得出确定的结论。需要进行更高质量的进一步试验。
