Stie Mette, Delmar Charlotte, Nørgaard Birgitte, Jensen Lars Henrik
Department of Oncology, University Hospital of Southern Denmark, 7100 Vejle, Denmark.
Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, 5000 Odense, Denmark.
Cancers (Basel). 2022 Feb 14;14(4):952. doi: 10.3390/cancers14040952.
Complementary alternative medicine (CAM) may reduce the symptom burden of side effects to antineoplastic treatment but also cause new side effects and non-adherence to conventional treatment. The aim of this RCT was to investigate the impact of open dialogue about complementary alternative medicine (OD-CAM) on cancer patients' safety, health and quality of life (QoL). Patients undergoing antineoplastic treatment were randomly assigned to standard care (SC) plus OD-CAM or SC alone. The primary endpoint was frequency of grade 3-4 adverse events (AE) eight weeks after enrollment. Secondary endpoints were frequency of grade 1-4 AE, QoL, psychological distress, perceived information, attitude towards and use of CAM 12 and 24 weeks after enrollment. Survival was analyzed post hoc. Fifty-seven patients were randomized to the OD-CAM group and fifty-five to the SC group. No significant difference in frequency of grade 3-4 AEs was shown. The same applied to grade 1-4 AEs and QoL, psychological distress and perceived information. A tendency towards better QoL, improved survival and a lower level of anxiety was found in the OD-CAM group. OD-CAM is not superior to SC in reducing the frequency of AEs in patients undergoing antineoplastic treatment. OD-CAM does not compromise patient safety; it may reduce psychological stress and improve QoL and overall survival.
补充替代医学（CAM）可能会减轻抗肿瘤治疗副作用的症状负担，但也可能引发新的副作用并导致患者不坚持传统治疗。这项随机对照试验（RCT）的目的是研究关于补充替代医学的开放式对话（OD-CAM）对癌症患者安全性、健康状况和生活质量（QoL）的影响。接受抗肿瘤治疗的患者被随机分配至标准护理（SC）加OD-CAM组或单纯SC组。主要终点是入组8周后3-4级不良事件（AE）的发生频率。次要终点是入组12周和24周后1-4级AE的发生频率、生活质量、心理困扰、感知信息、对CAM的态度及使用情况。对生存情况进行事后分析。57例患者被随机分配至OD-CAM组，55例被分配至SC组。结果显示3-4级AE的发生频率无显著差异。1-4级AE、生活质量、心理困扰和感知信息方面也是如此。在OD-CAM组中发现有生活质量改善、生存情况改善和焦虑水平降低的趋势。在接受抗肿瘤治疗的患者中，OD-CAM在降低AE发生频率方面并不优于SC。OD-CAM不会损害患者安全；它可能会减轻心理压力，改善生活质量和总体生存情况。
