Department of Clinical Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee University, Seoul, 02447, Republic of Korea.
Department of Clinical Korean Medicine, College of Korean Medicine, Graduate School, Kyung Hee University, Seoul, 02447, Republic of Korea; Changwon Jaseng Hospital of Oriental Medicine, Changwon, 51495, Republic of Korea.
J Ethnopharmacol. 2025 Jan 30;337(Pt 2):118900. doi: 10.1016/j.jep.2024.118900. Epub 2024 Oct 4.
Approximately 52% of patients with cancer experience cancer-related fatigue (CRF), which negatively impacts both prognosis and quality of life (QoL). CRF is characterized by exhaustion, which is linked to cancer or treatment. Sipjeondaebo-tang (SDT) is an herbal medicine that is effective in alleviating fatigue and potentially easing CRF; however, there is currently insufficient clinical or scientific evidence to support the efficacy of SDT in managing CRF.
We assessed the efficacy and safety of SDT for CRF by performing a systematic literature review and meta-analysis.
We collected randomized controlled trials (RCTs) on CRF by searching nine databases, including EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials, on November 30, 2023. Based on the predefined inclusion and exclusion criteria, two reviewers independently screened and selected the literature, followed by data extraction. We assessed the quality of the selected studies using version 2 of the Cochrane Collaboration Risk of Bias tool. Review Manager software was used for the data synthesis. A meta-analysis was conducted when two or more studies shared comparable interventions and outcome measures. For all other cases, a qualitative analysis was performed. The certainty of evidence for each result was assessed employing the Grading of Recommendations, Assessment, Development, and Evaluation method.
This study contained eleven studies with a total of 754 participants. SDT significantly reduced CRF and improved QoL compared with the control group, both when used as an adjuvant therapy and as a monotherapy. Specifically, low-certainty evidence suggested that SDT, when used as an adjunctive therapy, could effectively reduce CRF, as indicated by a reduction in lack of strength (standardized mean difference = -1.28, 95% confidence interval (CI): -1.78 to -0.78, P < 0.00001). Additionally, moderate-certainty evidence indicated that SDT as an adjunctive therapy could improve QoL, as measured by Karnofsky Performance Status (mean difference = 4.67, 95% CI: 2.19 to 7.14, P = 0.0002). No serious adverse events occurred with SDT, whether it was used as an adjuvant therapy or as a monotherapy.
This systematic review elucidated the safety and efficacy of SDT in managing CRF. Nevertheless, the low quality of the included studies highlights the need for carefully planned large-scale RCTs.
约 52%的癌症患者经历癌因性疲乏（CRF），这对预后和生活质量（QoL）都有负面影响。CRF 的特征是疲劳，这与癌症或治疗有关。Sipjeondaebo-tang（SDT）是一种草药，可有效缓解疲劳，并可能缓解 CRF；然而，目前没有足够的临床或科学证据支持 SDT 对 CRF 的疗效。
通过系统文献回顾和荟萃分析评估 SDT 对 CRF 的疗效和安全性。
我们通过检索包括 EMBASE、MEDLINE 和 Cochrane 对照试验中心注册在内的 9 个数据库，于 2023 年 11 月 30 日收集了关于 CRF 的随机对照试验（RCT）。根据预先设定的纳入和排除标准，两名审查员独立筛选和选择文献，然后进行数据提取。我们使用 Cochrane 协作风险偏倚工具版本 2 评估所选研究的质量。Review Manager 软件用于数据综合。当两项或多项研究具有可比的干预措施和结果测量时，进行荟萃分析。对于所有其他情况，进行定性分析。使用推荐评估、制定与评价（GRADE）方法评估每个结果的证据确定性。
本研究包含 11 项研究，共 754 名参与者。与对照组相比，SDT 作为辅助治疗和单一疗法均能显著降低 CRF 和改善 QoL。具体而言，低确定性证据表明，SDT 作为辅助治疗时，可有效降低 CRF，表现在乏力减轻方面（标准化均数差=−1.28，95%置信区间（CI）：−1.78 至−0.78，P<0.00001）。此外，中等确定性证据表明，SDT 作为辅助治疗可改善 QoL，表现在卡诺夫斯基表现状态评分提高（平均差异=4.67，95%CI：2.19 至 7.14，P=0.0002）。无论是作为辅助治疗还是单一疗法，SDT 均未出现严重不良事件。
本系统评价阐明了 SDT 治疗 CRF 的安全性和疗效。然而，纳入研究的质量较低突出表明需要精心设计的大规模 RCT。
