School of Pharmacy, Faculty of Medicine, the Chinese University of Hong Kong, Hong Kong, China.
Department of Paediatrics, Faculty of Medicine, the Chinese University of Hong Kong, Hong Kong, China; Hong Kong Hub of Paediatric Excellence, the Chinese University of Hong Kong, Hong Kong, China; Department of Paediatrics & Adolescent Medicine, Hong Kong Children's Hospital, Hong Kong, China.
J Integr Med. 2022 Sep;20(5):402-415. doi: 10.1016/j.joim.2022.06.003. Epub 2022 Jun 10.
Traditional Chinese medicine (TCM) is becoming a popular complementary approach in pediatric oncology. However, few or no meta-analyses have focused on clinical studies of the use of TCM in pediatric oncology.
We explored the patterns of TCM use and its efficacy in children with cancer, using a systematic review, meta-analysis and data mining study.
We conducted a search of five English (Allied and Complementary Medicine Database, Embase, PubMed, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov) and four Chinese databases (Wanfang Data, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and VIP Chinese Science and Technology Periodicals Database) for clinical studies published before October 2021, using keywords related to "pediatric," "cancer," and "TCM."
We included studies which were randomized controlled trials (RCTs) or observational clinical studies, focused on patients aged < 19 years old who had been diagnosed with cancer, and included at least one group of subjects receiving TCM treatment.
The methodological quality of RCTs and observational studies was assessed using the six-item Jadad scale and the Effective Public Healthcare Panacea Project Quality Assessment Tool, respectively. Meta-analysis was used to evaluate the efficacy of combining TCM with chemotherapy. Study outcomes included the treatment response rate and occurrence of cancer-related symptoms. Association rule mining (ARM) was used to investigate the associations among medicinal herbs and patient symptoms.
The 54 studies included in this analysis were comprised of RCTs (63.0%) and observational studies (37.0%). Most RCTs focused on hematological malignancies (41.2%). The study outcomes included chemotherapy-induced toxicities (76.5%), infection rate (35.3%), and response, survival or relapse rate (23.5%). The methodological quality of most of the RCTs (82.4%) and observational studies (80.0%) was rated as "moderate." In studies of leukemia patients, adding TCM to conventional treatment significantly improved the clinical response rate (odds ratio [OR] = 2.55; 95% confidence interval [CI] = 1.49-4.36), lowered infection rate (OR = 0.23; 95% CI = 0.13-0.40), and reduced nausea and vomiting (OR = 0.13; 95% CI = 0.08-0.23). ARM showed that Radix Astragali, the most commonly used medicinal herb (58.0%), was associated with treating myelosuppression, gastrointestinal complications, and infection.
There is growing evidence that TCM is an effective adjuvant therapy for children with cancer. We proposed a checklist to improve the quality of TCM trials in pediatric oncology. Future work will examine the use of ARM techniques on real-world data to evaluate the efficacy of medicinal herbs and drug-herb interactions in children receiving TCM as a part of integrated cancer therapy.
传统中医(TCM)在儿科肿瘤学中作为一种流行的补充治疗方法。然而,很少有或没有荟萃分析专门关注 TCM 在儿科肿瘤学中的临床研究。
我们通过系统评价、荟萃分析和数据挖掘研究,探讨了 TCM 在儿童癌症中的应用模式及其疗效。
我们对五个英文数据库(辅助与补充医学数据库、Embase、PubMed、Cochrane 对照试验中心注册库和 ClinicalTrials.gov)和四个中文数据库(万方数据、中国国家知识基础设施、中国生物医学文献数据库和 VIP 中文科技期刊数据库)进行了检索,检索时间截至 2021 年 10 月,使用与“儿科”、“癌症”和“TCM”相关的关键词。
我们纳入了随机对照试验(RCT)或观察性临床研究,研究对象为年龄<19 岁、被诊断为癌症的患者,并至少有一组接受 TCM 治疗的受试者。
使用 6 项 Jadad 量表和有效公共医疗保健综合评价工具分别评估 RCT 和观察性研究的方法学质量。Meta 分析用于评估 TCM 联合化疗的疗效。研究结果包括治疗反应率和癌症相关症状的发生情况。关联规则挖掘(ARM)用于研究草药与患者症状之间的关联。
本分析共纳入 54 项研究,包括 RCT(63.0%)和观察性研究(37.0%)。大多数 RCT 专注于血液系统恶性肿瘤(41.2%)。研究结果包括化疗诱导的毒性(76.5%)、感染率(35.3%)以及反应、生存或复发率(23.5%)。大多数 RCT(82.4%)和观察性研究(80.0%)的方法学质量被评为“中等”。在白血病患者的研究中,将 TCM 联合常规治疗可显著提高临床反应率(优势比[OR] = 2.55;95%置信区间[CI] = 1.49-4.36)、降低感染率(OR = 0.23;95% CI = 0.13-0.40)和减少恶心呕吐(OR = 0.13;95% CI = 0.08-0.23)。ARM 显示,最常用的草药(58.0%)黄芪与治疗骨髓抑制、胃肠道并发症和感染有关。
越来越多的证据表明,TCM 是治疗儿童癌症的一种有效辅助治疗方法。我们提出了一个检查表,以提高儿科肿瘤学中 TCM 试验的质量。未来的工作将研究使用 ARM 技术对真实世界数据进行评估,以评估儿童在接受 TCM 作为综合癌症治疗一部分时草药的疗效和药物-草药相互作用。