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Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial

机译:电针不同穴位对化疗引起的恶心和呕吐的疗效和安全性:一项随机对照试验的研究方案

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Background Many patients experience nausea and vomiting during chemotherapy treatment. Evidence demonstrates that electroacupuncture is beneficial for controlling chemotherapy-induced nausea and vomiting (CINV). However, the acupoint or matching acupoint with the best efficacy for controlling CINV still remains unidentified. Methods/Design This study consists of a randomized controlled trial (RCT) with four parallel arms: a control group and three electroacupuncture groups (one with Neiguan (PC6), one with Zhongwan (CV12), and one with both PC6 and CV12). The control group received standard antiemetic only, while the other three groups received electroacupuncture stimulation with different acupoints besides the standard antiemetic. The intervention is done once daily from the first day (day 1) to the fourth day (day 4) during chemotherapy treatment. The primary outcome measures include frequency of nausea, vomiting and retching. The secondary outcome measures are the grade of constipation and diarrhea, electrogastrogram, assessment of quality of life, assessment of anxiety and depression, and other adverse effects during the chemotherapy. Assessments are scheduled from one day pre-chemotherapy (day 0) to the fifth day of chemotherapy (day 5). Follow-ups are done from day 6 to day 21. Discussion The aim of this study is to evaluate the efficacy and safety of electro-acupuncture with different acupoints in the management of CINV. Trial registration The register number of randomized controlled trial is NCT02195908 . The date of registration was 21 July 2014.
机译:背景许多患者在化疗期间会感到恶心和呕吐。有证据表明,电针可有效控制化疗引起的恶心和呕吐(CINV)。但是,仍无法确定控制CINV疗效最佳的穴位或相配穴位。方法/设计本研究由一个随机对照试验(RCT)组成,该试验有四个平行组:一个对照组和三个电针组(一个与内关组(PC6),一个与中药组(CV12)以及一个同时具有PC6和CV12的组)。对照组仅接受标准止吐药,而其他三组除标准止吐药外还接受不同穴位的电针刺激。从化疗治疗的第一天(第1天)到第四天(第4天)每天进行一次干预。主要结果指标包括恶心,呕吐和呕吐的频率。次要结果指标是便秘和腹泻的等级,胃电图,生活质量评估,焦虑和抑郁评估以及化疗期间的其他不良反应。评估的时间安排是从化疗前的一天(第0天)到化疗的第五天(第5天)。随访从第6天到第21天进行。讨论本研究的目的是评估不同穴位在CINV治疗中的有效性和安全性。试验注册随机对照试验的注册号为NCT02195908。注册日期为2014年7月21日。

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