Yoon Jee-Hyun, Kim Eun Hye, Park Su Bin, Lee Jee Young, Yoon Seong Woo
Korean Medicine Cancer Center, Kyung Hee University Hospital at Gangdong, Seoul, South Korea.
Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul, South Korea.
Front Pharmacol. 2021 Oct 28;12:753140. doi: 10.3389/fphar.2021.753140. eCollection 2021.
Insomnia is one of the most prevalent cancer-related symptoms and has a severe impact on the quality of life. This study aimed to evaluate the efficacy and safety of traditional herbal medicine (THM) for improving sleep quality in patients with cancer. Randomized controlled trials (RCTs) evaluating orally administered THM in a cancer population with insomnia were searched using nine electronic databases up to November 30, 2020. The outcome measurements were sleep quality measured by validated questionnaire such as the Pittsburgh Sleep Quality Index (PSQI), total effective rate, and adverse effects. The included studies were appraised using the Cochrane risk of bias tool and meta-analyzed. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method. Fourteen RCTs were included in the systematic review, and 10 RCTs were analyzed quantitatively. Compared to hypnotics, THM showed a significant improvement in sleep quality by reducing the PSQI score [mean difference (MD) -2.25, 95% confidence interval (CI) -3.46 to -1.05, = 84%] and increasing the total effective rate [risk ratio (RR) 1.26, 95% CI 1.07 to 1.48, = 70%] with low quality of evidence. Compared to placebo, THM also reduced the PSQI score significantly (MD -2.56, 95% CI -3.81 to -1.31, = 91%) with moderate quality of evidence. The most frequently used herbs were Mill. No serious adverse events were observed. This review suggests that THM may be an effective therapeutic option for insomnia in patients with cancer. However, considering the limited methodological qualities and inconsistent results of the included trials, further rigorous RCTs are required. [https://www.crd.york.ac.uk/prospero], PROSPERO 2021 [CRD42021265070].
失眠是最常见的癌症相关症状之一，对生活质量有严重影响。本研究旨在评估传统草药（THM）改善癌症患者睡眠质量的疗效和安全性。截至2020年11月30日，使用九个电子数据库检索了评估口服THM对癌症伴失眠人群疗效的随机对照试验（RCT）。结局指标包括通过匹兹堡睡眠质量指数（PSQI）等经过验证的问卷测量的睡眠质量、总有效率和不良反应。使用Cochrane偏倚风险工具对纳入研究进行评估并进行荟萃分析。采用推荐分级评估、制定和评价（GRADE）方法评估证据质量。系统评价纳入了14项RCT，对其中10项RCT进行了定量分析。与催眠药相比，THM通过降低PSQI评分[平均差（MD）-2.25，95%置信区间（CI）-3.46至-1.05，I² = 84%]和提高总有效率[风险比（RR）1.26，95%CI 1.07至1.48，I² = 70%]显著改善了睡眠质量，但证据质量较低。与安慰剂相比，THM也显著降低了PSQI评分（MD -2.56，95%CI -3.81至-1.31，I² = 91%），证据质量中等。最常用的草药是 。未观察到严重不良事件。本综述表明，THM可能是癌症患者失眠的有效治疗选择。然而，考虑到纳入试验的方法学质量有限且结果不一致，需要进一步进行严格的RCT。[https://www.crd.york.ac.uk/prospero]，PROSPERO 2021 [CRD42021265070]
