School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing 100029, China.
School of Persian Medicine, Tehran University of Medical Science, Tehran, Iran.
Pain Res Manag. 2020 Jun 29;2020:2504674. doi: 10.1155/2020/2504674. eCollection 2020.
This pilot study aims to evaluate the effectiveness and safety of acupuncture in the treatment of chemotherapy-induced peripheral neuropathy (CIPN).
This study was a pilot randomized controlled trial, which was conducted with cooperation between Beijing University of Chinese Medicine (BUCM), China, and Tehran University of Medical Science (TUMS), Iran. Forty participants with CIPN were randomly assigned (1 : 1) to receive twelve sessions of acupuncture (20 minutes each session over 4 weeks) or take one 300 mg tablet of vitamin B1 and three 300 mg capsules of gabapentin per day for 4 weeks, after which both groups were followed up for 4 weeks. The primary endpoint was CIPN symptom severity measured by the Numerical Rating Scale (NRS). The secondary endpoints included sensory neuropathy grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE), neurophysiological assessment of CIPN by the nerve conduction study (NCS), and the patient overall satisfaction with treatment. Safety was assessed at each visit.
The NRS and NCI-CTCAE sensory neuropathy grading scales decreased significantly over time in both groups (both < 0.001), with a significantly higher reduction in the acupuncture group ( < 0.001 and = 0.03, respectively). In addition, the acupuncture group showed a higher overall satisfaction with the treatment at the end of treatment and after 4 weeks follow-up, in comparison with the vit B1 and gabapentin group ( = 0.01 and = 0.001, respectively). The NCS (except for the latency of the sural nerve) in the acupuncture group improved significantly ( < 0.05), while improvement in the vit B1 and gabapentin group was not observed ( > 0.05).
Our study revealed that acupuncture, as a kind of traditional Chinese therapeutic method, is significantly effective and safe in the treatment of CIPN. Moreover, acupuncture is more effective than using vitamin B1 and gabapentin as the conventional treatment. This trial is registered with the Iranian Registry of Clinical Trials (IRCT20190615043900N1).
本研究旨在评估针刺治疗化疗引起的周围神经病变(CIPN)的有效性和安全性。
这是一项由北京中医药大学(BUCM)与伊朗德黑兰医科大学(TUMS)合作开展的试点随机对照试验。将 40 名 CIPN 患者随机分为(1:1)接受 12 次针刺(每次 20 分钟,共 4 周)或每天服用 1 片 300mg 维生素 B1 和 3 粒 300mg 加巴喷丁,持续 4 周,两组均随访 4 周。主要终点为数字评分量表(NRS)评估的 CIPN 症状严重程度。次要终点包括美国国家癌症研究所常见不良事件毒性标准(NCI-CTCAE)评估的感觉神经病变分级、神经传导研究(NCS)评估的 CIPN 神经生理学、患者对治疗的总体满意度。每次就诊时评估安全性。
两组的 NRS 和 NCI-CTCAE 感觉神经病变分级量表均随时间显著降低(均<0.001),针刺组降低更显著(均<0.001 和=0.03)。此外,与维生素 B1 和加巴喷丁组相比,针刺组在治疗结束和 4 周随访时对治疗的总体满意度更高(分别为=0.01 和=0.001)。针刺组的 NCS(除腓肠神经潜伏期外)显著改善(<0.05),而维生素 B1 和加巴喷丁组未观察到改善(>0.05)。
本研究表明,针刺作为一种传统的中医治疗方法,在治疗 CIPN 方面具有显著的有效性和安全性。此外,针刺的疗效优于维生素 B1 和加巴喷丁等常规治疗。本试验已在伊朗临床试验注册中心(IRCT20190615043900N1)注册。