Luo Ling, Liao Mo, Peng Jia-Xi, Ma Qi, Zhou Jian-Ying, Zhu Lin-Lin, Wang Xiang, Chen Sha-Sha, Yin Hai-Yan, Wu Qiao-Feng, Zhang Cheng-Shun, Lv Peng, Tang Yong, Yu Shu-Guang
School of Acupuncture and Tuina, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Suining Municipal Hospital of Traditional Chinese Medicine, Suining, Sichuan, China.
Evid Based Complement Alternat Med. 2019 Mar 14;2019:1291947. doi: 10.1155/2019/1291947. eCollection 2019.
The aim of this study was to investigate the difference of efficacy between conventional moxibustion (CM) and smoke-free moxibustion (SM) for patients with osteoarthritis of the knee (KOA).
This is a multicentre, randomized, single blinded, parallel-group clinical trial. Patients with KOA were randomly allocated to CM group (69) and SM group (69) in 7 hospitals of China. Moxibustion treatment in 12 sessions over 4 weeks was administrated at 3 acupuncture points (EX-LE4, ST35, and ST36). Patients completed standard questionnaires at baseline and after 2 weeks, 4 weeks, 8 weeks, and 12 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) from the baseline to 4 weeks. The secondary outcomes include Visual Analogue Scale (VAS) and Patient Global Assessment score (PGA).
Analyses showed that the WOMAC score improved in pain (95% CI,-0.1[-1.2 to 0.9], p=0.76), stiffness (95% CI,-0.1 [-0.5 to 0.3], p=0.71), and function (95% CI, 2.2 [-1.3 to 5.8], p=0.22) compared between the two groups at 4 weeks, as well as the VAS score (95% CI,0.1 [-0.3 to 0.6], p=0.60). Similar results presented at 8 and 12 weeks. No statistically significant difference was observed between CM and SM groups for outcome measurements.
It suggested that smoke generated during moxibustion treatment does not affect the efficacy of moxibustion in the treatment of KOA, which should be taken into account to be removed for the sake of reducing environmental pollution or moxa smoke exposure of acupuncturists or patients. This trial is registered with Clinical Trials.gov, NCT02772055.
本研究旨在探讨传统艾灸（CM）与无烟艾灸（SM）治疗膝骨关节炎（KOA）患者的疗效差异。
这是一项多中心、随机、单盲、平行组临床试验。中国7家医院的KOA患者被随机分为CM组（69例）和SM组（69例）。在3个穴位（犊鼻穴、足三里穴、上巨虚穴）进行为期4周、共12次的艾灸治疗。患者在基线时以及2周、4周、8周和12周后完成标准问卷。主要结局指标是从基线到4周的西安大略和麦克马斯特大学骨关节炎指数（WOMAC）。次要结局指标包括视觉模拟评分法（VAS）和患者整体评估得分（PGA）。
分析显示，两组在4周时的WOMAC评分在疼痛方面（95%CI，-0.1[-1.2至0.9]，p=0.76）、僵硬方面（95%CI，-0.1[-0.5至0.3]，p=0.71）和功能方面（95%CI，2.2[-1.3至5.8]，p=0.22）均有所改善，VAS评分（95%CI，0.1[-0.3至0.6]，p=0.60）也是如此。8周和12周时呈现类似结果。CM组和SM组在结局指标测量上未观察到统计学显著差异。
这表明艾灸治疗过程中产生的烟雾不影响艾灸治疗KOA的疗效，为减少环境污染或针灸师及患者的艾烟暴露，应考虑去除烟雾。本试验已在ClinicalTrials.gov注册，注册号为NCT02772055。
