Yu Benlu, Huang Wei, Zhang Yingrong, Wang Jiajie, Xia Chen, Zhang YanJi, Xia Hongjie, Hu Yaxin, Rao Yingyue, Zhou Zhongyu
College of Acupuncture and Orthopedics, Hubei University of Traditional Chinese Medicine, No. 01 Tanhualin, Wuchang District, Wuhan 430060, Hubei, China.
Department of Acupuncture, Hubei Provincial Hospital of Traditional Chinese Medicine affiliated to Hubei University of Traditional Chinese Medicine, No. 4 Garden Hill, Liangdao Street, Wuchang District, Wuhan 430061, Hubei, China.
Evid Based Complement Alternat Med. 2022 Aug 4;2022:9255017. doi: 10.1155/2022/9255017. eCollection 2022.
. In the past, moxibustion has been widely used to treat endocrine system disorders, but evidence of its effectiveness is scarce at this point. The aim of this multicenter, randomized, controlled trial is to evaluate the efficacy and safety of treating menopausal obesity with moxibustion. . There are six centers taking part in this randomized, controlled, parallel trial. A total of 216 patients with menopausal obesity will be randomly divided into two equal groups: the "moxibustion for harmonization of Yin and Yang" group and the gentle moxibustion group. A 12-week study period with moxibustion will be preceded by a 1-week baseline, followed by a 12-week follow-up. We will conduct an interim analysis to determine whether or not the treatment is efficacious and safe after 216 participants have completed a 12-week treatment period. Evaluations will be conducted at weeks 0, 4, 8, 12, 18, and 24. The main outcome is waist circumference (WC), and the rate of WC reduction will be compared to the baseline. An intention-to-treat analysis will be performed with a two-sided value of <0.05 considered significant. Participants who withdraw from the trial will be analyzed according to the intention-to-treat formula (ITT). . These results will be used to support selecting the right moxibustion prescription and guiding the improvement of clinical efficacy. This trial will provide convincing evidence of moxibustion's effectiveness and safety in the treatment of obesity by "moxibustion for harmonization of Yin and Yang," which will be conducive to the promotion and clinical application of the theory of "moxibustion for harmonization of Yin and Yang." . This trial is registered with Clinical Trials.gov: NCT04943705 (registered on June 27, 2021).
过去，艾灸已被广泛用于治疗内分泌系统疾病，但目前其有效性的证据稀缺。这项多中心、随机、对照试验的目的是评估艾灸治疗绝经后肥胖症的疗效和安全性。有六个中心参与了这项随机、对照、平行试验。总共216名绝经后肥胖患者将被随机分为两组，每组人数相等：“阴阳调和艾灸”组和温和艾灸组。在进行为期12周的艾灸研究期之前，先有1周的基线期，之后是12周的随访期。在216名参与者完成12周治疗期后，我们将进行中期分析以确定治疗是否有效和安全。评估将在第0、4、8、12、18和24周进行。主要结局指标是腰围（WC），并将WC减少率与基线进行比较。将进行意向性分析，双侧P值<0.05被认为具有统计学意义。退出试验的参与者将根据意向性分析公式（ITT）进行分析。这些结果将用于支持选择合适的艾灸处方并指导临床疗效的提高。本试验将为“阴阳调和艾灸”治疗肥胖症的有效性和安全性提供令人信服的证据，这将有利于“阴阳调和艾灸”理论的推广和临床应用。本试验已在ClinicalTrials.gov注册：NCT04943705（于2021年6月27日注册）。
