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针灸减少美沙酮用量的效果:一项随机临床试验。

Effect of Acupuncture for Methadone Reduction : A Randomized Clinical Trial.

机构信息

Clinical Research and Big Data Laboratory, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China (L.L., Y.C., Y.D., C.Tao, C.L., Y.W., B.F.).

Department of Chinese Medicine, Jiangsu Vocational College of Medicine, Yancheng, and Clinical Research and Big Data Laboratory, South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China (C.C.).

出版信息

Ann Intern Med. 2024 Aug;177(8):1039-1047. doi: 10.7326/M23-2721. Epub 2024 Jul 9.

Abstract

BACKGROUND

Methadone maintenance treatment (MMT) is effective for managing opioid use disorder, but adverse effects mean that optimal therapy occurs with the lowest dose that controls opioid craving.

OBJECTIVE

To assess the efficacy of acupuncture versus sham acupuncture on methadone dose reduction.

DESIGN

Multicenter, 2-group, randomized, sham-controlled trial. (Chinese Clinical Trial Registry: ChiCTR2200058123).

SETTING

6 MMT clinics in China.

PARTICIPANTS

Adults aged 65 years or younger with opioid use disorder who attended clinic daily and had been using MMT for at least 6 weeks.

INTERVENTION

Acupuncture or sham acupuncture 3 times a week for 8 weeks.

MEASUREMENTS

The 2 primary outcomes were the proportion of participants who achieved a reduction in methadone dose of 20% or more compared with baseline and opioid craving, which was measured by the change from baseline on a 100-mm visual analogue scale (VAS).

RESULTS

Of 118 eligible participants, 60 were randomly assigned to acupuncture and 58 were randomly assigned to sham acupuncture (2 did not receive acupuncture). At week 8, more patients reduced their methadone dose 20% or more with acupuncture than with sham acupuncture (37 [62%] vs. 16 [29%]; risk difference, 32% [97.5% CI, 13% to 52%];  < 0.001). In addition, acupuncture was more effective in decreasing opioid craving than sham acupuncture with a mean difference of -11.7 mm VAS (CI, -18.7 to -4.8 mm;  < 0.001). No serious adverse events occurred. There were no notable differences between study groups when participants were asked which type of acupuncture they received.

LIMITATION

Fixed acupuncture protocol limited personalization and only 12 weeks of follow-up after stopping acupuncture.

CONCLUSION

Eight weeks of acupuncture were superior to sham acupuncture in reducing methadone dose and decreasing opioid craving.

PRIMARY FUNDING SOURCE

National Natural Science Foundation of China.

摘要

背景

美沙酮维持治疗(MMT)对治疗阿片类药物使用障碍有效,但不良反应意味着最佳治疗效果出现在控制阿片类药物渴求的最低剂量。

目的

评估针刺与假针刺对美沙酮剂量减少的效果。

设计

多中心、2 组、随机、假对照试验。(中国临床试验注册中心:ChiCTR2200058123)。

地点

中国 6 个 MMT 诊所。

参与者

年龄在 65 岁以下的阿片类药物使用障碍成年人,每天到诊所就诊,并且接受 MMT 治疗至少 6 周。

干预措施

每周 3 次接受针刺或假针刺治疗,共 8 周。

测量

主要结局指标为与基线相比,参与者中达到美沙酮剂量减少 20%或更多的比例,以及通过 100 毫米视觉模拟量表(VAS)从基线变化来衡量的阿片类药物渴求程度。

结果

在 118 名符合条件的参与者中,60 名被随机分配到针刺组,58 名被随机分配到假针刺组(2 名未接受针刺)。在第 8 周,与假针刺相比,接受针刺治疗的患者有更多的患者减少了 20%或更多的美沙酮剂量(37 [62%] 比 16 [29%];风险差异,32% [97.5%CI,13%至 52%]; < 0.001)。此外,与假针刺相比,针刺在降低阿片类药物渴求方面更有效,平均 VAS 差值为-11.7 毫米(CI,-18.7 至-4.8 毫米; < 0.001)。未发生严重不良事件。当参与者被问及他们接受的是哪种类型的针刺时,两组之间没有明显差异。

局限性

固定的针刺方案限制了个性化治疗,并且在停止针刺后只有 12 周的随访。

结论

8 周的针刺治疗在减少美沙酮剂量和降低阿片类药物渴求方面优于假针刺。

主要资金来源

国家自然科学基金。

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