Clinical observation study on the efficacy of acupuncture for smoking cessation

BACKGROUND AND OBJECTIVE: Tobacco harm is one of the most serious public health problems in the world today, and the harm of smoking to health has become a consensus in medicine and across society. The harm of smoking to health is a long-term, chronic process, and smoking is often one of the causative factors of many diseases. Since China joined the WHO Framework Convention on Tobacco Control, the government has paid increasing attention to tobacco control. China has the largest number of smokers in the world, and the incidence and mortality of related diseases are also rising; smoking has become a public health hazard behavior with an enormous impact on health in China. Acupuncture is a safe, effective and inexpensive new approach to smoking cessation. As a distinctive and advantageous item of traditional Chinese medicine, acupuncture for smoking cessation has received increasing attention from international smoking cessation researchers and public health service departments; for example, on 1 December 2011, Ms. Rosie Henson, senior policy advisor to the Deputy Secretary of the US Department of Health and Human Services, led a delegation to the State Administration of Traditional Chinese Medicine for a thematic exchange on acupuncture for smoking cessation, hoping that China could play a leading and exemplary role internationally in research on acupuncture for smoking cessation. Acupuncture for smoking cessation has become a new field of international exchange and cooperation in traditional Chinese medicine. Therefore, research on acupuncture methods for smoking cessation has important practical significance. In recent years, some research progress has been made on acupuncture for smoking cessation in China and abroad. Although traditional Chinese medicine therapies represented by acupuncture have, since ancient times, been characterized by good clinical efficacy, few side effects, simple and easy-to-perform methods and low cost, and clinical literature research has found that acupuncture has a good effect on smoking cessation, domestic clinical literature mostly consists of single-sample observations, lacks randomized controlled trials, and does not describe the specific operational details of clinical studies in a sufficiently specific and standardized way. Therefore, this study used a rigorous randomized controlled clinical trial design, with acupuncture combined with auricular acupressure, commonly used in clinical practice, as the treatment group and nicotine patch therapy as the control group, to compare and analyze the efficacy of acupuncture for smoking cessation. METHODS: Ninety voluntary smokers wishing to quit who received acupuncture and related treatments at the Acupuncture Hospital of the China Academy of Chinese Medical Sciences between September 2013 and November 2014 and met the inclusion criteria were enrolled. After signing informed consent, all eligible participants were randomly assigned in a 1:1 ratio, using a random number table, to the acupuncture combined with auricular acupressure group (treatment group) or the nicotine patch group (control group), with 45 participants in each group. In the acupuncture combined with auricular acupressure therapy, the acupuncture points were Lieque, Hegu, Baihui, Zusanli, Sanyinjiao and Taichong. Procedure: before needling, the selected points were routinely disinfected with 75% medical alcohol; for needle insertion, Baihui was needled horizontally, and Lieque, Hegu, Zusanli, Sanyinjiao and Taichong were needled with the fingernail-pressing insertion method; needling depth was 0.5-0.8 cun for Baihui and 1.0-2.0 cun for the other points; during needle manipulation, the even reinforcing-reducing method was used at all points (no manipulation was needed at Zusanli), until sensations of soreness, numbness, distension and heaviness (deqi) appeared at the points; on withdrawal, the needle site was pressed to avoid bleeding or hematoma as far as possible; electroacupuncture with a disperse-dense wave (about 5 Hz) was applied to bilateral Zusanli using a pulse electrotherapy device, at an intensity tolerable to the smoker. Course of treatment: continuous treatment for 8 weeks, 5 times per week in weeks 1-2, 3 times per week in weeks 3-4 and twice per week in weeks 5-8; needles were retained for 30 minutes each session and manipulated once every 10 minutes. Auricular acupressure points: Shenmen, Lung, Stomach, Endocrine, Subcortex and Sympathetic. Procedure: the auricular points and the surrounding area were routinely disinfected with 75% medical alcohol; one hand (pressing hand) fixed the auricle while the other hand (attaching hand) taped disposable Vaccaria seeds onto the points, which, once secured, were pressed several times until pain was felt in the ear. Course of treatment: Vaccaria seeds were applied to the points and pressed for 1 minute, on both sides at the same time, and replaced every 3-4 days. In the nicotine patch therapy, patches of three strengths, 7 mg/24 hours, 14 mg/24 hours and 21 mg/24 hours, were applied to the participant's skin, such as the chest, back and upper arm, one patch per day, with the course of patches of different doses selected according to daily cigarette consumption. Treatment in this study lasted 8 weeks, with a follow-up visit at week 20 to complete data collection and efficacy assessment. Clinical outcome measures included participants' general data, abstinence rate, Fagerström Test for Nicotine Dependence (FTND), Heaviness of Smoking Index (HIS), Minnesota Nicotine Withdrawal Scale (MNWS), Questionnaire of Smoking Urges-Brief (QSU-Brief) and reduction in cigarette consumption, recorded at enrollment and at weeks 1, 2, 4, 8 and 20. RESULTS: 3.1 General data: before treatment there were no obvious differences between the two groups in age, sex, educational level, occupation, smoking history, etc., nor in years of smoking, degree of nicotine dependence, heaviness of smoking index, carbon monoxide and cotinine tests, average daily cigarette consumption, reasons for smoking and difficulty in quitting; participants in both groups came from the same population and were comparable. 3.2 Comparison of abstinence rates: in the treatment group, the self-reported point abstinence rate, the carbon monoxide-verified abstinence rate and the cotinine-verified abstinence rate were 40.0%, 53.3% and 46.7%, respectively, at the end of treatment at week 8, and 36.7%, 53.3% and 46.7%, respectively, at the end of follow-up at week 20. The self-reported continuous abstinence rate of the treatment group was 20.0% at both week 8 and week 20. Compared with the control group, abstinence rates in the treatment group were all higher, but the differences were not statistically significant. 3.3 Comparison of nicotine dependence, withdrawal symptoms, craving and reduction in cigarette consumption. Nicotine dependence: FTND and HIS scores in both the treatment and control groups gradually decreased from enrollment to the end of treatment at week 8, with a slightly greater decrease in the control group than in the treatment group, but the difference between the groups was not statistically significant. Withdrawal symptoms and craving: MNWS scores in both groups gradually decreased from week 1 of treatment to the end of follow-up at week 20, and the decrease in the treatment group from week 1 to week 4 was markedly greater than in the control group; QSU-Brief scores in both groups also showed a decreasing trend, slightly higher in the treatment group than in the control group at week 2 and slightly lower at the other time points. Reduction in cigarette consumption: from the start of treatment at week 1 to the end of treatment at week 8, the proportion smoking 10 cigarettes or fewer gradually increased in both groups, while the proportions at the levels of 11-20, 21-30 and 30 or more cigarettes decreased, with similar magnitudes of increase or decrease in the two groups; there was no obvious difference between the two groups in reduction of cigarette consumption at any time point during treatment. CONCLUSION: This clinical study leads to the following conclusions: 1. No adverse reactions to acupuncture combined with auricular acupressure were found in this study; it is highly safe and suitable for clinical practice. 2. Acupuncture combined with auricular acupressure is markedly effective in voluntary quitters: it can effectively increase abstinence rates, relieve withdrawal symptoms and craving for smoking, relieve nicotine dependence and reduce cigarette consumption. 3. Acupuncture combined with auricular acupressure is markedly better than nicotine patch therapy in improving withdrawal symptoms. 4. Future research could turn to evaluating the health economics of acupuncture for smoking cessation. 5. This study used a non-intention-to-treat analysis; because of the small sample size, differences in some indicators were not prominent. The large-sample, multicenter randomized controlled clinical trial "Special Research Project for the Traditional Chinese Medicine Industry: Acupuncture for Smoking Cessation" is still ongoing.