Frontiers in public health · 2026
Harmonizing mind acupuncture combined with nicotine replacement therapy for tobacco use disorder: a protocol for a pragmatic randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Li Chuanxiong, Wang Binyang, Zhao Song, Ruan Qianwen, Pan Lei, Qiu Meihua
Аннотация
BACKGROUND: Tobacco use disorder (TUD) remains a leading cause of preventable morbidity and mortality worldwide. Although nicotine replacement therapy (NRT) is recommended as a first-line treatment, its effectiveness is limited by persistent craving and withdrawal symptoms, resulting in high relapse rates. Acupuncture has been investigated as an adjunctive therapy; however, existing evidence is inconsistent and limited by methodological heterogeneity. High-quality pragmatic randomized controlled trials are needed. The co-primary outcomes are nicotine craving reduction (VAS) and biochemically verified 7-day point prevalence abstinence (PPA).
METHODS: This is a single-center, pragmatic, randomized, parallel-group controlled trial. A total of 220 participants with TUD will be randomly assigned (1,1) to receive either harmonizing mind acupuncture (HMA) plus NRT or NRT alone. The intervention period will last 6 weeks, with follow-up to 24 weeks. The co-primary outcomes are: (1) the change in nicotine craving measured by a visual analog scale (VAS) from baseline to week 6; and (2) 7-day point prevalence abstinence (PPA) biochemically verified by exhaled carbon monoxide at week 6. Secondary outcomes include exhaled carbon monoxide (as a continuous measure), quality of life, sleep quality, depressive symptoms, anxiety symptoms, and safety outcomes. Analyses will be conducted according to the intention-to-treat principle.
DISCUSSION: This pragmatic randomized controlled trial will evaluate the effectiveness and safety of HMA as an adjunct to NRT under real-world clinical conditions and provide clinically relevant evidence to inform integrative treatment strategies for TUD.
ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Ethical approval has been obtained from the Ethics Committee of the Affiliated Hospital of Yunnan University (Approval No.: KJR#20251111-R1-055). The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.
CLINICAL TRIAL REGISTRATION: This trial has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR) under registration number: ITMCTR2026000683 (https://itmctr.ccebtcm.org.cn/).
METHODS: This is a single-center, pragmatic, randomized, parallel-group controlled trial. A total of 220 participants with TUD will be randomly assigned (1,1) to receive either harmonizing mind acupuncture (HMA) plus NRT or NRT alone. The intervention period will last 6 weeks, with follow-up to 24 weeks. The co-primary outcomes are: (1) the change in nicotine craving measured by a visual analog scale (VAS) from baseline to week 6; and (2) 7-day point prevalence abstinence (PPA) biochemically verified by exhaled carbon monoxide at week 6. Secondary outcomes include exhaled carbon monoxide (as a continuous measure), quality of life, sleep quality, depressive symptoms, anxiety symptoms, and safety outcomes. Analyses will be conducted according to the intention-to-treat principle.
DISCUSSION: This pragmatic randomized controlled trial will evaluate the effectiveness and safety of HMA as an adjunct to NRT under real-world clinical conditions and provide clinically relevant evidence to inform integrative treatment strategies for TUD.
ETHICS APPROVAL AND CONSENT TO PARTICIPATE: Ethical approval has been obtained from the Ethics Committee of the Affiliated Hospital of Yunnan University (Approval No.: KJR#20251111-R1-055). The study will be conducted in accordance with the Declaration of Helsinki. Written informed consent will be obtained from all participants prior to enrollment.
CLINICAL TRIAL REGISTRATION: This trial has been registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR) under registration number: ITMCTR2026000683 (https://itmctr.ccebtcm.org.cn/).