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The effect of a standardized ginger extract on chemotherapy-induced nausea-related quality of life in patients undergoing moderately or highly emetogenic chemotherapy: A double blind, randomized, placebo controlled trial

机译:标准化生姜提取物对中度或高度呕吐化疗患者化疗引起的恶心相关生活质量的影响:一项双盲,随机,安慰剂对照试验

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摘要

Ginger supplementation could be an effective adjuvant treatment for chemotherapy-induced nausea (CIN). The aim of this clinical trial was to address significant methodological limitations in previous trials. Patients (N = 51) were randomly allocated to receive either 1.2 g of standardised ginger extract or placebo per day, in addition to standard anti-emetic therapy, during the first three cycles of chemotherapy. The primary outcome was CIN-related quality of life (QoL) measured with the Functional Living Index- Emesis (FLIE) questionnaire. Secondary outcomes included acute and delayed nausea, vomiting, and retching as well as cancer-related fatigue, nutritional status, and CIN and vomiting-specific prognostic factors. Over three consecutive chemotherapy cycles, nausea was more prevalent than vomiting (47% vs. 12%). In chemotherapy Cycle 1, intervention participants reported significantly better QoL related to CIN (p = 0.029), chemotherapy-induced nausea and vomiting (CINV)-related QoL (p = 0.043), global QoL (p = 0.015) and less fatigue (p = 0.006) than placebo participants. There were no significant results in Cycle 2. In Cycle 3, global QoL (p = 0.040) and fatigue (p = 0.013) were significantly better in the intervention group compared to placebo. This trial suggests adjuvant ginger supplementation is associated with better chemotherapy-induced nausea-related quality of life and less cancer-related fatigue, with no difference in adverse effects compared to placebo.
机译:生姜补充剂可能是化疗引起的恶心(CIN)的有效辅助治疗。该临床试验的目的是解决先前试验中方法学上的重大缺陷。患者(N = 51)在化疗的前三个周期中,除标准的止吐疗法外,每天随机分配接受1.2克标准姜提取物或安慰剂。主要结果是通过功能性生活指数呕吐(FLIE)问卷测量的CIN相关生活质量(QoL)。次要结果包括急性和延迟的恶心,呕吐和呕吐,以及与癌症相关的疲劳,营养状况以及CIN和呕吐特异性预后因素。在连续三个化疗周期中,恶心比呕吐更为普遍(47%比12%)。在化疗的第1周期中,干预参与者报告与CIN相关的QoL(p = 0.029),与化疗相关的恶心和呕吐(CINV)相关的QoL(p = 0.043),总体QoL(p = 0.015)和更少的疲劳(p = 0.006)。在第2周期中没有明显的结果。在第3周期中,与安慰剂相比,干预组的整体QoL(p = 0.040)和疲劳(p = 0.013)明显更好。该试验表明,辅助性生姜补充剂可改善化疗引起的恶心相关的生活质量,并减少与癌症相关的疲劳,与安慰剂相比无不良反应。

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