Auricular Acupuncture, Education, and Smoking Cessation: A Randomized, Sham-Controlled Trial
Bier et al. · American Journal of Public Health · 2002
Evidence Level
MODERATEOBJECTIVE
To examine the effect of auricular acupuncture alone and combined with education on smoking cessation
WHO
141 adult smokers with previous quit attempts
DURATION
4-5 weeks of treatment with 18-month follow-up
POINTS
Shen Men, Sympathetic, Lung, Kidney, Liver auricular points and LI-4 (Hegu) at the wrist
🔬 Study Design
Acupuncture + Education
n=45
True acupuncture + 5-week educational program
Sham + Education
n=58
Sham acupuncture + educational program
Acupuncture Only
n=38
True acupuncture only
📊 Results in numbers
Cessation rate (Acupuncture + Education)
Cessation rate (Sham + Education)
Cessation rate (Acupuncture only)
Reduction in cigarette consumption (Acupuncture + Education)
Percentage highlights
📊 Outcome Comparison
Smoking cessation rate
Percentage reduction in consumption
This study showed that auricular acupuncture can help people quit smoking, especially when combined with an educational program. The best results were found in smokers with greater smoking history, suggesting that acupuncture may be particularly helpful for more heavily addicted individuals.
Article summary
Plain-language narrative summary
This randomized controlled trial investigated the efficacy of auricular acupuncture for smoking cessation, comparing different therapeutic approaches over 18 months. The research was motivated by the need for higher-quality studies in this area, responding to the criticisms of a Cochrane meta-analysis that questioned the available evidence on acupuncture for smoking cessation. The study design included 141 adult smokers randomized into three groups: true acupuncture combined with an educational program, sham acupuncture combined with education, and true acupuncture alone. The acupuncture protocol used auricular points traditionally employed in the treatment of chemical dependence: Shen Men, Sympathetic, Lung, Kidney, and Liver, along with point LI-4 (Hegu) at the wrist.
Treatments were administered five times per week for four weeks by highly qualified acupuncturists certified by the National Certification Commission. The sham group received needling at points located up to 5 mm from the true points, maintaining participant blinding. The educational program consisted of 1.5-hour sessions twice a week during the first two weeks, then weekly, incorporating behavioral training, education, social support, and relapse prevention. Results showed significant differences between groups immediately after treatment.
The group that received acupuncture combined with education demonstrated the highest cessation rate (40%), nearly double the sham group with education (22%) and four times higher than acupuncture alone (10%). The reduction in cigarette consumption was also more pronounced in the combined group (53%). Although positive trends persisted during the 18-month follow-up, differences between groups lost statistical significance because of the high dropout rate, which reduced the statistical power of the analysis. An important finding was the significant correlation between pack-year history and treatment response.
Participants with greater smoking history (more than 20 pack-years) showed significantly greater reductions in cigarette consumption after treatment. This finding suggests that acupuncture may be particularly effective in the most heavily addicted population at greatest risk of developing smoking-related diseases, which has important clinical implications. Depression and anxiety scores, measured by the Beck Depression Inventory and the Zung Anxiety Scale, respectively, did not show significant differences between groups, although anxiety scores decreased over time across all groups. No significant adverse effects were observed except for occasional minimal bleeding upon needle removal.
The study followed rigorous safety protocols, including universal precautions for body fluids. The clinical implications suggest that combining auricular acupuncture with education can be an effective approach for smoking cessation, with results comparable to pharmacological treatments combined with behavioral support (20-25% efficacy at one year). The identification of pack-year history as a predictor of response offers valuable clinical guidance for patient selection. The study has some important limitations, including the high dropout rate that compromised the long-term follow-up analysis, the reliance on participant self-report to measure cigarette consumption without biochemical validation, and a sample size that, while adequate to detect immediate differences, proved insufficient for robust subgroup analyses.
Despite these limitations, the study represents a significant advance in the quality of research on acupuncture for smoking cessation, implementing many of the methodological recommendations suggested by the scientific literature.
Strengths
- 1Rigorous design with blinded randomization and an appropriate sham control group
- 2Highly qualified acupuncturists and standardized protocols
- 3Important finding of correlation with pack-year history
- 4Extended 18-month follow-up
- 5Absence of significant adverse effects
Limitations
- 1High dropout rate compromising follow-up analyses
- 2Lack of biochemical validation for smoking cessation
- 3Loss of statistical significance during follow-up because of reduced sample size
- 4Reliance on participant self-report
Expert Commentary
Prof. Dr. Hong Jin Pai
PhD in Sciences, University of São Paulo
▸ Clinical Relevance
Smoking cessation remains one of the most complex challenges in preventive medicine, and this randomized sham-controlled trial provides a concrete contribution to the available therapeutic arsenal. The 40% cessation rate in the group that received auricular acupuncture combined with a structured educational program exceeds, or at least matches, what we obtain with combined pharmacotherapy plus behavioral support in real-world clinical settings. The finding that most directly informs practice is the identification of pack-year history as a predictor of response: patients with a tobacco load above 20 pack-years showed greater reductions in consumption, redirecting the indication to exactly the population at highest cardiovascular and oncological risk — the patient who most needs to quit and who, paradoxically, has the greatest difficulty with conventional approaches alone. The combination with structured education is no detail: it represents the multimodal component that amplifies the specific effect of needling.
▸ Notable Findings
The contrast among the three arms of the study is revealing from a mechanistic perspective: true acupuncture alone achieved only 10% cessation, while sham combined with education reached 22%, and true acupuncture combined with education reached 40%. This gradient is not trivial — it demonstrates that the neuromodulatory effect of genuine auricular points (Shen Men, Sympathetic, Lung, Kidney, Liver, and LI-4) adds measurable value over the nonspecific effect of the therapeutic ritual, but that this effect is substantially amplified when supported by a behavioral intervention. The 53% reduction in cigarette consumption in the combined group, even among non-quitters, has clinical relevance in its own right: a reduction in tobacco load means a reduction in harm. The absence of significant adverse effects throughout the entire protocol, including the 18 months of follow-up, confirms the safety profile that characterizes auricular acupuncture administered with proper technique.
▸ From My Experience
In my practice at the HC-FMUSP Pain Center, treating smoking with auricular acupuncture requires the clinician to abandon the expectation of monotherapy results. What Bier and colleagues systematically documented, we have empirically observed for decades: the needle opens a window of neurobiological opportunity that needs to be filled with behavioral content to produce lasting cessation. I usually see significant reductions in craving after three to four sessions and routinely work with cycles of 8 to 12 sessions to consolidate cessation, with monthly maintenance sessions during the first six months. The profile that responds best, in my experience, is exactly the long-term smoker, highly dependent, who has already failed with varenicline or nicotine replacement therapy alone — data that directly echoes the pack-year finding of this study. I do not indicate auricular acupuncture as monotherapy for cessation: I always combine it with some form of cognitive-behavioral support and, when necessary, adjunctive pharmacotherapy. The patient with untreated major depression or severe withdrawal syndrome requires prior stabilization before initiating the auricular protocol.
Indexed scientific article
This study is indexed in an international scientific database. Check your institutional access to obtain the full article.
Scientific Review

Marcus Yu Bin Pai, MD, PhD
CRM-SP: 158074 | RQE: 65523 · 65524 · 655241
PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture. Scientific review and curation of every entry in this library.
Learn more about the author →Medical disclaimer: This content is for educational purposes only and does not replace consultation, diagnosis, or treatment by a qualified professional. Some information may be assisted by artificial intelligence and is subject to inaccuracies. Always consult a physician.
Content reviewed by the medical team at CEIMEC — Integrated Centre for Chinese Medicine Studies, a reference in Medical Acupuncture for over 30 years.
Related articles
Based on this article’s categories