Wang Yuhang, Zhou Mingfei, Shen Jianmei, Wang Dongsheng, Xu Na, Song Yafang, Sun Mengzhu, Chen Lu, Pei Lixia, Sun Jianhua
Department of Acupuncture and Rehabilitation, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Acupuncture and Tuina Academy, Nanjing University of Chinese Medicine, Nanjing, China.
Transl Cancer Res. 2021 May;10(5):2516-2524. doi: 10.21037/tcr-20-3400.
Chemotherapy-induced diarrhea (CID) is one of the side effects of chemotherapy. Diarrhea not only affects the overall treatment effectiveness but also reduces patients' quality of life. Severe diarrhea can lead to electrolyte imbalance and even be life-threatening. Although acupuncture has been widely used in clinical practice and its effectiveness for managing functional diarrhea has been recognized, there is no sound evidence of its efficacy in managing CID. Therefore, the aim of the proposed randomized controlled trial is to examine the effectiveness and potential risks of using acupuncture for the management of CID and to describe its protocol herein.
This trial will be conducted in a double-blinded manner and comprise two arms that will be investigated across multiple centers in parallel. The study cohort will comprise 168 outpatients who have CID from six Chinese hospitals. The patients will be randomly and equally divided between an intervention group (electroacupuncture) and a control group (micro-electroacupuncture). In the former, acupuncture will be performed with the conventional method to induce the de qi sensation, and in the latter group, acupuncture will be performed with a sham procedure that does not involve the insertion of needles. The acupoints ST25, SP14, SP6, and ST37 will be applied in the two methods. These procedures will be performed three times a week for four consecutive weeks. The number of days on which CID occurred, the incidence of CID, and fecal characteristics are considered as the primary outcomes, and the Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea subscale score and the World Health Organization Quality of Life assessment are considered as secondary outcomes. The patients will be closely observed for complications and fluctuations in vital signs.
If the findings from the trial demonstrate the effectiveness and safety of using acupuncture to treat CID, they could serve as evidence for the clinical application of acupuncture as a complementary treatment for cancer patients during chemotherapy.
Chinese Clinical Trial Registry, ChiCTR2000035715, registered on August 16, 2020.
化疗引起的腹泻（CID）是化疗的副作用之一。腹泻不仅会影响整体治疗效果，还会降低患者的生活质量。严重腹泻可导致电解质失衡，甚至危及生命。尽管针灸已在临床实践中广泛应用，其治疗功能性腹泻的有效性也已得到认可，但尚无确凿证据表明其对CID的疗效。因此，本拟进行的随机对照试验旨在研究针灸治疗CID的有效性和潜在风险，并在此描述其方案。
本试验将采用双盲方式进行，包括两个组，将在多个中心并行研究。研究队列将包括来自六家中国医院的168例患有CID的门诊患者。患者将被随机且等分为干预组（电针）和对照组（微电针）。在干预组中，将采用传统方法进行针灸以诱导得气感，而在对照组中，将采用不涉及针刺的假手术进行针灸。两种方法均应用穴位ST25、SP14、SP6和ST37。这些操作将每周进行三次，连续四周。CID发生的天数、CID的发生率和粪便特征被视为主要结局，腹泻患者慢性病治疗功能评估子量表评分和世界卫生组织生活质量评估被视为次要结局。将密切观察患者的并发症和生命体征波动情况。
如果试验结果证明针灸治疗CID的有效性和安全性，它们可作为针灸作为化疗期间癌症患者辅助治疗临床应用的证据。
中国临床试验注册中心，ChiCTR2000035715，于2020年8月16日注册。
