Chen Bo, Guo Yang, Zhao Xue, Gao Li-Li, Li Bo, Zhao Tian-Yi, Zhang Qi-Wen, Zou Jin-Xing, Li Ming-Yue, Guo Yong-Ming, Guo Yi, Pan Xing-Fan
Acu-moxibustion and Tuina Department of Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, China.
Acupuncture Research Center of Tianjin University of Traditional Chinese Medicine, 88 Yuquan Road, Nankai District, Tianjin, 300193, China.
Trials. 2017 Oct 13;18(1):477. doi: 10.1186/s13063-017-2186-y.
Previous studies have shown that acupuncture is beneficial for the alleviation of chemotherapy-induced nausea and vomiting. However, there is a lack of clinical evidence concerning the effects of acupoint-matching on chemotherapy-induced nausea and vomiting.
METHODS/DESIGN: This is a parallel randomized controlled trial to evaluate the occurrence of nausea and vomiting after chemotherapy (the incidence of nausea and vomiting, frequency, VAS score, RINVR rating) as the main outcome for cancer. Quality of life, anxiety and depression scores are the secondary outcomes. Quality of life, anxiety and depression scores are the secondary phase. Use of remedy drugs, routine blood examination, and blood biochemical tests are the safety evaluation. We also compare the different effects of ST36 (single acupoint), CV12 (single acupoint), and ST36-CV12 matching groups.
The results of this trial are expected to explore the effects of matching different acupoints and to offer biologic plausibility for the use of acupuncture in the treatment of chemotherapy-induced nausea and vomiting (CINV).
This trial is registered with clinicaltrials.gov NCT02195921 , The date of registration was 17 July 2014.
既往研究表明，针灸有助于缓解化疗引起的恶心和呕吐。然而，关于穴位配伍对化疗引起的恶心和呕吐的影响，目前缺乏临床证据。
方法/设计：这是一项平行随机对照试验，以评估化疗后恶心和呕吐的发生情况（恶心和呕吐的发生率、频率、视觉模拟评分法（VAS）评分、国际神经毒性反应发生率分级（RINVR））作为癌症的主要结局指标。生活质量、焦虑和抑郁评分作为次要结局指标。生活质量、焦虑和抑郁评分作为次要阶段。补救药物的使用、血常规检查和血液生化检查作为安全性评估。我们还比较足三里穴（单穴）、中脘穴（单穴）和足三里-中脘穴配伍组的不同效果。
本试验结果有望探索不同穴位配伍的效果，并为针灸用于治疗化疗引起的恶心和呕吐（CINV）提供生物学合理性依据。
本试验已在clinicaltrials.gov注册，注册号为NCT02195921，注册日期为2014年7月17日。
