Chen Xia, Huang Wei, Wei Dan, Zhao Ji-Ping, Zhang Wei, Ding De-Guang, Jiao Yang, Pan Hong-Ling, Zhang Jia-Jia, Zhong Feng, Gao Feng, Jin Yi-Ting, Zheng Yi-Wei, Zhang Yan-Ji, Huang Qiao, Zeng Xian-Tao, Zhou Zhong-Yu
Hubei University of Chinese Medicine, Wuhan, China.
Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan, China.
Evid Based Complement Alternat Med. 2022 Feb 27;2022:4780019. doi: 10.1155/2022/4780019. eCollection 2022.
This study aimed to examine the efficacy and safety of acupoint catgut embedding (ACE) for obesity over a 16-week treatment period using sham stimulation as the control.
A multicenter, randomised, parallel, sham-controlled trial was conducted from February 10, 2017, to May 15, 2018. Men with waistlines ≥85 cm and women with ≥80 cm at three sites were randomised to receive eight sessions (over 16 weeks) of ACE ( = 108) or sham ACE ( = 108) with skin penetration at sham acupoints. The catgut was embedded once every two weeks using two alternating sets of acupoints. The follow-up lasted for an additional 24 weeks. The primary outcome was the percentage waistline reduction from baseline to week 16.
We included 216 individuals in the intention-to-treat analysis. At 16 weeks, the rate of waistline reduction was 8.80% (95% confidence interval (CI), 7.93% to 9.66%) in the ACE group and 4.09% (95% CI, 3.18% to 5.00%) in the sham control group, with a between-group difference of 4.71% (95% CI, 3.47% to 5.95%; < 0.0001). This difference persisted throughout the entire follow-up period (between-group difference after 24-week additional weeks, 4.94% (95% CI, 3.58% to 6.30%); < 0.001). The subgroup analyses of waistline by sex (male/female) revealed treatment effects of 1.93 (95% CI, -0.37 to 4.23, = 0.1) in the male group and 3.19 (95% CI, 1.99 to 4.39, < 0.001) in the female group. The adverse event analysis suggested that ACE and laboratory tests confirmed the safety of ACE. . ACE for 16 weeks could decrease the waistline and weight and was safe for the treatment of obesity. Further research is needed to evaluate the long-term efficacy and sex differences. This trial is registered with NCT02936973.
本研究旨在以假刺激为对照,考察穴位埋线(ACE)治疗肥胖16周的疗效和安全性。
2017年2月10日至2018年5月15日进行了一项多中心、随机、平行、假对照试验。腰围≥85厘米的男性和三个部位腰围≥80厘米的女性被随机分为接受8次(16周内)穴位埋线治疗组(n = 108)或假穴位埋线组(n = 108),假穴位埋线组在假穴位进行皮肤穿刺。使用两组交替的穴位,每两周埋线一次。随访持续另外24周。主要结局是从基线到第16周腰围减少的百分比。
在意向性分析中纳入了216名个体。16周时,穴位埋线组腰围减少率为8.80%(95%置信区间(CI),7.93%至9.66%),假对照组为4.09%(95%CI,3.18%至5.00%),组间差异为4.71%(95%CI,3.47%至5.95%;P < 0.0001)。在整个随访期间,这种差异持续存在(额外24周后的组间差异为4.94%(95%CI,3.58%至6.30%);P < 0.001)。按性别(男性/女性)进行的腰围亚组分析显示,男性组的治疗效果为1.93(95%CI,-0.37至4.23,P = 0.1),女性组为3.19(95%CI,1.99至4.39,P < 0.001)。不良事件分析表明穴位埋线及实验室检查证实了穴位埋线的安全性。穴位埋线16周可减小腰围和体重,治疗肥胖安全。需要进一步研究评估长期疗效和性别差异。本试验已在ClinicalTrials.gov注册,注册号为NCT02936973。