Abstract
OBJECTIVE:
To observe the effect of different acupuncture frequencies on the abstinence rate which could be used as a reference for optimizing acupuncture cessation programs.
METHODS:
From July 2018 to June 2022, a total of 220 smokers were recruited based on inclusion criteria and randomly divided into the high-frequency acupuncture group (HF group, n = 110): 5 times a week from the 1st to the 4th week, from weeks 5 to 8, three times a week and the low-frequency acupuncture group (LF group, n = 110): 3 times a week from the 1st to the 4th week, from weeks 5 to 8, twice a week, then treated for 8 weeks and follow-up at 1 month in Beijing.
RESULTS:
In total, 162 subjects completed the whole study with a drop-out rate of 20.45%. The expiratory CO point abstinence rate was HF group 53/110 (48.18%) vs LF group 41/110 (37.27%) in Week 8 (P = 0.102) and HF group 46/110 (41.82%) vs LF group 45/110 (40.91%) in Week 12 (P = 0.891) and the HF acupuncture and LF acupuncture were nearly equal in the 8-week abstinence rate. In addition, both HF and LF acupuncture significantly reduced Fagerstrőm test for nicotine dependence scale (FTND) scores (P < 0.05), Minnesota nicotine withdrawal scale (MNWS) scores (P < 0.05), and Brief Questionnaire of Smoking Urges scale (QSU-Brief) scores (P < 0.05), but HF acupuncture showed some superiority over LF acupuncture in relieving patients' smoking cravings (P < 0.05).
CONCLUSIONS:
The study initially showed that both high-frequency acupuncture and low-frequency acupuncture treatment were safe and effective on smoking cessation for 8 weeks, but high-frequency acupuncture was advantageous in reducing smoking cravings. More accurate acupuncture frequency needs to be validated through larger clinical studies to optimize acupuncture smoking cessation programs.
Keywords: acupuncture, acupuncture frequency, tobacco dependence, smoking cessation
1. INTRODUCTION
Tobacco dependence is a chronic disease, with the International Classification of Diseases 10 (ICD-10), encoded as F17.2,1 and smoking is currently the greatest threat to human health. It could cost more than 8 million lives each year, of which more than 7 million are due to direct tobacco use and approximately 1.2 million are non-smokers exposed to secondhand smoke.2 While smoking has decreased significantly in recent years in China which is a major tobacco consumer country, it remains one of the most preventable causes of chronic disease.3 Acupuncture, one of the characteristic therapeutic methods of Traditional Chinese Medicine (TCM), was used for smoking cessation as early as the 1970s.4,5 Nowadays, acupuncture has become a new non-pharmacological approach to help people to quit smoking.
Recently, some randomized controlled trials (RCTs) have been conducted to test the effectiveness of acupuncture for smoking cessation.6 However, there is no relevant guideline standard recommendation for the frequency of acupuncture cessation in domestic and international acupuncture studies, and great variation in acupuncture treatment parameters has emerged in these RCTs, which were found that the highest frequency of acupuncture for smoking cessation was 5 times a week and the lowest was 1 time a week,7,8 with little consensus on the optimal choice of parameters.9 Previous systematic reviews have shown that the effectiveness of physiotherapeutic interventions is entirely dependent on the treatment parameters or dosage employed,10 therefore suggesting that further exploration of the dosage of acupuncture treatment might be important to guide the clinical management of tobacco-dependence subjects.
For most diseases, when the frequency of treatment is fixed and reasonable, the treatment effect tends to gradually enhance with the increase of acupuncture treatment.11,12 Previous studies have shown a relationship between the frequency of acupuncture and the success abstinence rate of smoking cessation by acupuncture, especially the frequency of acupuncture in the first month.13 Though it may be assumed that more frequent treatment might lead to greater effects, this is not in accordance with the study by Wang et al 14 which suggested that acupuncture was more successful when given twice a week than five times a week, for a total of 20 sessions.
Due to the lack of trials addressing the question of acupuncture frequency for smoking cessation, we are currently conducting a pilot study to explore the feasibility of the effect of two different acupuncture frequencies for smoking cessation at the same treatment time, so as to be used as a reference for optimizing the acupuncture cessation program.
2. METHODS
2.1. Study design
This was a prospective, two‐arm randomized controlled pilot trial, which was aimed to evaluate the 8-week and 1-month follow-up effect of high-frequency (HF) acupuncture and low-frequency (LF) acupuncture for smoking cessation. The trial protocol was approved by the Chinese Registered Clinical Trials Ethics Review Committee (ChiECRCT-20180135) and retroactively registered on the China Clinical Trial Registry (No. ChiCTR1800018196). Informed written consent was obtained from all subjects. The study was conducted in the Acupuncture Hospital of Chinese Academy of Traditional Chinese Medicine and Wangjing Hospital of Chinese Academy of Traditional Chinese Medicine. From July 2018 to June 2022, all the subjects were recruited via local newspapers, telephone hotlines for smoking cessation, community events, hospital websites, and recommendations from other medical institutions.
2.2. Participants
2.2.1. Inclusion criteria
(a) Subjects who are willing to give up smoking; (b) subjects aged 18 to 70 years; (c) subjects who were daily smokers (≥ 1 year); (d) smoking amount ≥ 10 cigarettes/d; (e) voluntarily participate and sign informed consent; (f) if already received other smoking cessation treatments, the washout period should be more than 30 d.
2.2.2. Exclusion criteria
(a) Subjects with serious heart, lung, brain, hematological disorders, and diabetes; (b) suffering from mental disorders and drug addicts; (c) subjects with undiagnosed diseases; (d) subjects with coagulation mechanism disorders or are taking anticoagulant drugs; (e) pregnant women.
2.2.3. Drop out and suspension criteria
(a) Subjects have poor compliance, withdraw on their own during treatment, or combine treatments prohibited by this study protocol; (b) subjects withdraw informed consent; (c) serious adverse events or complications occur and it is not appropriate to continue treatment.
2.3. Randomization and Blinding
A central randomized system hosted by the Evaluation Center of the Institute of Clinical Basic Theory, Chinese Academy of Chinese Medical Sciences, was applied for randomization. The random numbers were obtained by telephone, with a proportion of 1:1, all the subjects were randomly divided into a HF group and a LF group, with 110 subjects in each group.
Because of the particularity of acupuncture, it was impossible to blind acupuncture operators, so the efficacy evaluators and data analysis personnel were blinded in this study.
2.4. Sample size calculation
According to the formula for calculating the sample size of the two groups of superiority test, α = 0.05 and β = 0.2 were taken, and n1 = n2 = 98 were calculated using PASS 15 software (NCSS LL Company, Ulaanbaatar, Mongolia). Considering the 10% dropping rate, then 110 cases were taken from each group, and a total of 220 people were recruited.
2.5. Intervention
2.5.1. Basic smoking cessation counseling assistance
Basic smoking cessation counseling is given to all smokers using the "5A" regimen of the WHO Clinical Cessation Intervention,15 which includes asking about smoking, advising, assessing willingness to quit, assisting, and arranging follow-up visits for at least 15 min each session. After treatment, all were followed up at the 8th weeks and 12th weeks.
2.5.2. Acupuncture procedures
The acupuncture applied in this study was body acupuncture.
Selection of Acupoints. Baihui (DU20), Lieque (LU7), Hegu (LI4), Zusanli (ST36), Sanyinjiao (SP6), Taichong (LR3). Yintang (EX-HN3) when there are withdrawal symptoms such as cough and runny nose and dry eyes during the withdrawal process, and add Neiguan (PC6) when there are withdrawal symptoms such as irritability, depression, and insomnia.
Acupoint Location. Refer to the Acupuncture Point Locations in the Western Pacific Region by World Health Organization.16
Needle Specification. 0.25 mm × 40 mm disposable sterile needles were used (Suzhou Medical Appliance Factory, Suzhou, China).
Manipulation of Acupuncture. 75% medical ethanol cotton ball was used for local routine disinfection. Needles were horizontally inserted at Baihui (GV20), Lieque (LU7) and Yintang (EX-HN3) while vertically inserted at other acupoints to a depth of 0.3 to 0.5 cun. The mild reinforcing reducing method was applied at all acupoints.
Based on the previous research17,18 on the selection of acupuncture points for smoking cessation, it was found that the Lieque (LU7) and Zusanli (ST36) were frequently used in clinical practice and were commonly associated with acupoints. Therefore, connect these acupoints with electroacupuncture to ensure a better therapeutic effect. The arrival of needle sensation was required and the same side Zusanli (ST36) and Lieque (LU7) was connected to a KWD-808 pulse electroacupuncture device (Changzhou Wujin Great Wall Medical Equipment Co., LTD, Changzhou, China) with continuous-wave at a frequency of 15 Hz for 30 min. Meanwhile, the needles were withdrawn quickly to avoid bleeding or hematoma.
HF group. The treatment lasted for 8 weeks, 5 times a week from the 1st to the 4th week, from weeks 5 to 8, three times a week.
LF group. The treatment lasted for 8 weeks, 3 times a week from the first week to the fourth week. From weeks 5 to 8, twice a week.
2.5.3. Quality control of acupuncture
All acupuncturists who participated in this study were certified by the China Administration of TCM, with the collective acupuncture experience of 5 years to guarantee the consistency of acupuncture treatment. A study researcher and an acupuncturist performed the acupuncture treatment. The acupuncturist was responsible for the clinical treatment while the study researcher recorded the data to maintain the accuracy and consistency of this study.
2.6. Outcome measures
2.6.1. Primary outcome
The primary outcome was continuous abstinence for 8 weeks, which was validated biochemically by expiratory carbon monoxide (CO) at the final treatment visit and 12th Week follow-up.19 It was considered successful when the expiratory CO level was < 6 ppm20 (device purchased from Bedfont Scientific Company, Maidstone, UK).
2.6.2. Secondary outcome
The degree of tobacco dependence was assessed by the Fagerstrőm test for nicotine dependence (FTND),21 which consists of 6 questions and was obtained by asking subjects at two visits before and after 8 weeks of treatment. 0-3: mild tobacco dependence; 4-6: moderate tobacco dependence; ≥7 points: severe tobacco dependence.
Subjects' withdrawal symptoms were evaluated by the Minnesota nicotine withdrawal scale (MNWS) scores, and subjects' smoking craving was evaluated by the Brief Questionnaire of Smoking Urges scale (QSU-Brief). The MNWS scale consists of nine questions on a scale of 0-4, including the urge to smoke, depressed mood, irritability, frustration or anger, anxiety, difficulty concentrating, restlessness, increased appetite, difficulty sleeping, and wakefulness during withdrawal. The QSU-Brief scale consists of 10 questions that test the subject's immediate craving for smoking, and each question is scored on a scale of 1 to 7. The higher the score, the higher the craving for smoking.
All results were acquired by inquiring and testing subjects at each visiting point weeks 1, 2, 4, 8, 12.
Besides, the safety of acupuncture was assessed. Blood clotting was tested before acupuncture, while blood pressure, pulse, breath, and body temperature were measured before and after treatment as well as in follow-up visits; adverse events were recorded during the study, including the symptoms, occurrence date, and intervention and its relationship with the treatment.
2.7. Data analyses
Intent-to-treat analysis (ITT) was applied in this study. This type of analysis is considered the most conservative and is the standard for smoking cessation studies.22 All data were analyzed by using SPSS software version23(IBM Corp., Armonk, NY, USA). The measurement data were represented with mean ± standard deviation (). t-test was used for comparisons that met Gaussian distribution and homogeneity of variance, while the nonparametric test was used for comparisons that did not meet homogeneity of variance. The χ 2 test was used for enumeration data. Non-parametric tests were used for not satisfying normal distributions or inconsistent variances, expressed as median and interquartile spacing M (IQR), with statistics and corresponding P values given. Hypothesis tests were all two-sided, and unless otherwise stated, overall comparisons between groups were tested at α = 0.05, and P<0.05 was taken as statistical significance.
3. RESULTS
3.1. Study process and baseline data of the subjects
A total of 238 subjects were recruited. After a preliminary evaluation, 220 subjects were included in the study and randomly divided into the HF group and the LF group according to the ratio of 1:1. After 8 weeks of treatment, a total of 175 subjects completed the treatment, and 45 fell off. 162 subjects completed a 4-week follow-up, and 13 were lost to follow-up with a drop-out rate of 20.45%. Figure 1 shows the flow chart of the subjects.
Figure 1. Flow chart of the subjects.
The analysis included 220 subjects characterized predominantly by male gender (95.9%), with a mean age of 48.5 years (SD = 11.7), and a primary education level of college school (55.5%).The average smoking duration was (27.1 ± 12.1) years, the number of cigarettes smoked per day was (18.5 ± 10.5), and the confidence index was (78.34 ± 13.75) indicating a strong intention to smoke cessation. The mean FTND score was (4.48 ± 2.32), and exiratory CO content was (11.96 ± 4.10) ppm. There were no significant differences between groups for any of these variables (Table 1).
Table 1.
Baseline smoking characteristics
| Characteristic | HF group (n = 110) |
LF group (n = 110) |
Overall (n = 220) |
P value | |
|---|---|---|---|---|---|
| Gender [n (%)] | Male | 105 (95.5) | 106 (96.4) | 211 (95.9) | 1.000 |
| Female | 5 (4.5) | 4 (3.6) | 9 (4.1) | ||
| Age (years) [n (%)] | 20-30 | 9 (8.2) | 5 (4.5) | 14 (6.4) | 0.414 |
| 31-40 | 18 (16.4) | 24 (21.8) | 42 (19.1) | ||
| 41-50 | 35 (31.8) | 32 (29.1) | 67 (30.5) | ||
| > 51 | 48 (43.6) | 49 (44.5) | 97 (44.1) | ||
| mean±SD | 47.3±13.2 | 48.7±11.7 | 48.0±12.5 | ||
| Ethnicity [n (%)] | Han Chinese | 102 (92.7) | 106 (96.4) | 208 (94.5) | 0.235 |
| Other minorities | 8 (7.3) | 4 (3.6) | 12 (5.5) | ||
| Marital status [n (%)] | Unmarried | 14 (12.7) | 14 (12.7) | 28 (12.7) | 0.928 |
| Married | 93 (84.5) | 92 (83.6) | 185 (84.1) | ||
| Other | 3 (2.7) | 4 (3.6) | 7 (3.2) | ||
| Educational status [n (%)] | None school | 3 (2.7) | 0 (0.0) | 3 (1.4) | 0.138 |
| Primary school | 5 (4.5) | 4 (3.6) | 9 (4.1) | ||
| Lower/higher secondary school | 46 (41.8) | 40 (36.4) | 86 (39.1) | ||
| University and above | 56 (50.9) | 66 (60.0) | 122 (55.5) | ||
| Self-rated physical condition | 40-60 | 15 (13.6) | 17 (15.5) | 32 (14.5) | 0.788 |
| [n (%)] | 61-80 | 57 (51.8) | 60 (54.5) | 117 (53.2) | |
| 81-100 | 38 (34.5) | 33 (30.0) | 71 (32.3) | ||
| mean±SD | 78.6±14.3 | 78.1±13.2 | 78.3±13.7 | ||
| No. of cigarettes smoked per day | 1-10 | 29 (26.4) | 26 (23.6) | 55 (25.0) | 0.332 |
| [n (%)] | 11-20 | 61 (55.5) | 68 (61.8) | 129 (58.6) | |
| >21 | 20 (18.2) | 16 (14.5) | 36 (16.4) | ||
| mean±SD | 19.1±10.7 | 17.9±7.1 | 18.5±9.1 | ||
| Age of smoking initiation (years) | 1-10 | 16 (14.5) | 7 (6.4) | 23 (10.5) | 0.771 |
| [n (%)] | 11-20 | 18 (16.4) | 28 (25.5) | 46 (20.9) | |
| >21 | 76 (69.1) | 75 (68.2) | 151 (68.6) | ||
| mean±SD | 26.8±12.3 | 27.3±11.9 | 27.0±12.1 | ||
| FTND score before treatment | mild | 45 (40.9) | 36 (32.7) | 81 (36.8) | 0.392 |
| [n (%)] | moderate | 42 (38.2) | 51 (46.4) | 93 (42.3) | |
| severe | 23 (20.9) | 23 (20.9) | 46 (20.9) | ||
| mean±SD | 4.412.5 | 4.5±2.2 | 4.5±2.3 | ||
| HSI score before treatment | 2.9±1.7 | 3.0±1.5 | 3.0±1.6 | 0.739 | |
| Expiratory CO before treatment | 12.2±3.9 | 11.7±4.3 | 12.0±4.1 | 0.325 | |
| Self-scored smoking cessation confidence | 78.6±14.3 | 78.1±13.2 | 78.3±13.7 | 0.788 | |
Notes: HF group: high-frequency acupuncture group; LF group: low-frequency acupuncture group. FTND: Fagerstrőm test for nicotine dependence, The FTND scale contains 6 questions to assess nicotine dependence among smokers; HSI: Heaviness of Smoking Index, to assess the severity of smoking in smokers; CO: carbon monoxide, expiratory CO test by a dedicated tester, used to assess the severity of smoking in smokers. SD: standard deviation. t-test was used for comparisons that met gaussian distribution and homogeneity of variance, while the nonparametric test was used for comparisons that did not meet homogeneity of variance. Compared with HF group, P < 0.05.
3.2. Key outcomes
Comparison of point abstinence rate based on expiratory CO contents at the end of 8 weeks of treatment showed that the total abstinence rate was higher in the HF group than in the LF group, with no statistically significant difference (P = 0.102); the comparison of point abstinence rate based on expiratory CO contents during follow-up at 12th week showed that the total abstinence rate was higher in the HF group than in the LF group, with no statistically significant difference (P = 0.891) (Table 2).
Table 2.
Comparison of point and continuous abstinence rates at 8th week and 12th week in two groups [n (%)]
| Type | Viewpoint | Index | HF group (n = 110) |
LF group (n = 110) |
P value |
|---|---|---|---|---|---|
| Point abstinence rate | 8th week | expiratory CO | 53 (48.2) | 41 (37.3) | 0.102 |
| 12th week | expiratory CO | 46 (41.8) | 45 (40.9) | 0.891 | |
| Continuous abstinence rate | 8th week | self-report | 27 (24.5) | 17 (15.5) | 0.092 |
| 12th week | self-report | 28 (25.5) | 20 (18.2) | 0.192 |
Notes: HF group: high-frequency acupuncture group; LF group: low-frequency acupuncture group. The χ 2 test was used for enumeration data, compared with HF group at 8th and 12th week, P < 0.05.
Since the FTND scale, MNWS scale, and QSU-Brief scale scores did not follow a normal distribution, median and interquartile spacing was used to describe them, and nonparametric tests were used for statistical analysis.
The differences in FTND scores before treatment between the two groups were not statistically significant and were comparable. The FTND scores of subjects in both groups decreased at 1, 2, 4, and 8 weeks of treatment and at the follow-up period compared with those before treatment (all P < 0.05), but the difference between the scores before and after treatment was not statistically significant between the groups (P > 0.05) (Table 3).
Table 3.
Comparison of FTND scores before and after treatment in two groups [Score, M (IQR)]
| Group | n | 1st week | 2nd week | 4th week | 8th week | 12th week |
|---|---|---|---|---|---|---|
| HF | 110 | 3.00 (4.00) | 3.00 (3.00)a | 2.50 (4.00)a | 2.00 (4.00)a | 2.00 (3.00)a |
| LF | 110 | 4.00 (3.00) | 3.00 (4.00)b | 2.50 (3.00)b | 2.00 (3.00)b | 2.00 (3.00)b |
Notes: HF group: high-frequency acupuncture group; LF group: low-frequency acupuncture group. FTND: Fagerstrőm test for nicotine dependence, it was used to evaluate by subjects' nicotine dependence degree. Non-parametric tests were used for not satisfying normal distributions or inconsistent variances, expressed as median and interquartile spacing M (IQR). Compared with HF group 1st week (intragroup comparison), aP < 0.05; compared with LF group 1st week (intragroup comparison), bP < 0.05.
The MNWS scores of subjects in both groups with different frequencies of participation in acupuncture smoking cessation treatment decreased after and during the follow-up period compared with the initial evaluation, with statistically significant results (all P < 0.05) and no statistically significant inter-group differences (P > 0.05) (Table 4).
Table 4.
Comparison of MNWS scores before and after treatment in two groups [scores, M (IQR)]
| Group | n | 1st week | 2nd week | 4th week | 8th week | 12th week |
|---|---|---|---|---|---|---|
| HF | 110 | 6.00 (5.00) | 6.0 (4.00) | 4.0 (3.50) | 3.00 (5.00)a | 3.00 (5.00)a |
| LF | 110 | 6.00 (6.00) | 6.0 (5.00) | 4.5 (4.00) | 3.00 (4.00)b | 3.00 (4.00)b |
Notes: HF group: high-frequency acupuncture group; LF group: low-frequency acupuncture group. MNWS: Minnesota nicotine withdrawal, it was used to evaluate by subjects' withdrawal symptoms. Non-parametric tests were used for not satisfying normal distributions or inconsistent variances, expressed as median and interquartile spacing M (IQR). Compared with HF group 1st week, aP < 0.05; compared with LF group 1st week, bP < 0.05.
The Qsu-Brief scale mainly evaluated the subjects' smoking cravings, and the subjects in both groups had significantly lower smoking cravings at the end of treatment and during the follow-up period than the scores measured at the first time of treatment. Additionally, the HF group experienced a greater decrease in withdrawal craving than the LF group at 8th and 12th week, and the difference was statistically significant (P < 0.05) (Table 5).
Table 5.
Comparison of Qsu-Brief scores before and after treatment between two groups of subjects with different NMR degrees [score, M (IQR)]
| Group | n | 1st week | 2nd week | 4th week | 8th week | 12th week |
|---|---|---|---|---|---|---|
| HF | 110 | 24.00 (19.00) | 22.00 (16.00) | 21.00 (11.00) | 17.00 (12.00)a | 17.00 (15.00)a |
| LF | 110 | 22.00 (16.00) | 21.00 (12.00) | 18.00 (10.00) | 16.00 (12.00)bc | 16.00 (11.00)bd |
Notes: HF group: high-frequency acupuncture group; LF group: low-frequency acupuncture group; Qsu-Brief scores: brief questionnaire of smoking urges scale, it was used to evaluate by subjects' smoking craving. Non-parametric tests were used for not satisfying normal distributions or inconsistent variances, expressed as median and interquartile spacing M (IQR). Compared with HF group 1st week, aP < 0.05; compared with LF group 1st week, bP < 0.05; compared with another group at 8th week, cP < 0.05; compared with the same group at 12th week, dP < 0.05.
3.3. Adverse events
During the trial, a total of 8 subjects reported adverse events, mainly including local hematoma, bruising, dizziness, etc. Among them, 3 subjects had skin hematoma, 3 subjects had local bruising after acupuncture, and 2 subjects had mild dizziness due to excessive tension during acupuncture treatment, and 1 subject experienced local tingling after acupuncture. If local hematoma and bruising occur, the subjects should be instructed to press for a long time on the area prone to bleeding after acupuncture or apply a hot compress to the bruised area. Adverse reactions disappeared during follow-up.
4. DISCUSSION
This study aimed to explore the effect of comparing high-frequency and low-frequency acupuncture on smoking cessation. We found that 8 weeks of acupuncture for smoking cessation was safe and effective, the effect of high-frequency acupuncture was nearly equal to low-frequency acupuncture in terms of 8-week abstinence rate, and smoking craving was reduced better with high-frequency acupuncture than with low-frequency acupuncture.
The results showed that 8-week acupuncture cessation was safe, and the abstinence rate was consistent with the results of previous trials by Chai et al 22 and Wang et al.24 It was also similar to the abstinence rate of nicotine patch therapy,25 which showed that the abstinence rate of "nicotine replacement therapy" was 24% to 46%,26 demonstrating the efficacy of acupuncture for smoking cessation. In addition, acupuncture significantly reduced FTND scale scores, MNWS scale scores, and Qsu-Brief scale scores, indicating that both high-frequency and low-frequency acupuncture can effectively reduce nicotine dependence, alleviate withdrawal symptoms during smoking cessation, and reduce smoking cravings, which initially ensures the efficacy of acupuncture for smoking cessation in this study.
On the precondition that the study initially showed the efficacy of 8 weeks of acupuncture for smoking cessation, there was no statistically significant difference (P = 0.102) between 48.2% of the HF group and 37.3 % of the LF group, and results showed a trend of higher abstinence rates in the HF group than in the LF group, but were not statistically significant, suggesting that the effects of high-frequency and low-frequency acupuncture stimulations may be equal in terms of 8-week abstinence rates. In terms of improving nicotine dependence and withdrawal symptoms, both low-frequency and high-frequency acupuncture stimulations were effective, especially after 2 weeks, when HF group and LF group tended to be the same in improving symptoms, which indicated that the frequency of acupuncture may not have a significant effect on the degree of improvement. As for relieving smokers' craving for smoking, high-frequency acupuncture showed some superiority over low-frequency acupuncture (P < 0.05). Whereas studies have shown that smoking craving is one of the important factors in relapse to smoking cessation,27 in terms of long-term efficacy, high-frequency acupuncture may have some advantages in preventing relapse, which needs to be supported by further high-quality evidence.
The similar abstinence success rates for the two groups with different frequencies of acupuncture thought to be mainly due to the high proportion of mild to moderate tobacco-dependent subjects (79.1%) in the included population. Compared to mild tobacco-dependent subjects, their own tobacco dependence is less severe, so either low-frequency acupuncture or high-frequency acupuncture can effectively alleviate the various withdrawal symptoms that occur during the smoking cessation process and achieve a good short-term withdrawal result.28
In addition, a study has shown that the "total number of acupuncture treatments" is significantly associated with smoking cessation outcomes,29 which means that whether or not 8 acupuncture treatments were completed in the first month and whether or not a total of 8 acupuncture treatments were completed is a key factor influencing the efficacy of acupuncture for smoking cessation. In this study, whether in the HF group (a total of 32 acupuncture treatments by the end of treatment) or in the LF group (a total of 20 acupuncture treatments by the end of treatment), the number of acupuncture met the requirement of 8 or more acupuncture treatments in the first month, and subjects in both groups completed 2 or more acupuncture treatments per week, which may also be the reason the abstinence rates in both groups were equal and the difference was not statistically significant, while tobacco dependence is a chronic addictive psychiatric disease,30 and for such chronic diseases, acupuncture treatment needs to reach a certain frequency to exert therapeutic effects.
However, this study showed that the HF group had a significantly higher dropout rate than the low-frequency acupuncture group at the end of treatment. Therefore, to some extent, taking a low-frequency acupuncture stimulation for the same treatment time may achieve a similar abstinence rate as high-frequency acupuncture stimulation, which could effectively save time and healthcare costs for smokers who quit, while helping to maintain their compliance. Therefore, it is proposed that the frequency and number of acupuncture treatments per week could be appropriately reduced under the condition of ensuring the efficacy of cessation. Considering that high-frequency acupuncture will be better in relieving smoking cravings, high-frequency acupuncture is also appropriate if smokers want to "ease" past the withdrawal period. Of course, furthermore, accurate frequency and periodicity of acupuncture still need a more rigorous and large sample of clinical data to carry out validation.
Firstly, the strength of our study was thatconsidering the best short-term efficacy of acupuncture for smoking cessation at 2 months,4,31 we designed an 8-week acupuncture treatment, 32 set two viewing points after 8 weeks and 12 weeks, and went further to conduct a study of acupuncture frequency with the assurance of effective short-term abstinence rates. A rigorous study design and the use of conservative outcome measures were adopted and the risk of bias was minimized.
In this trial, the setting of acupuncture frequency was carried out with reference to the design of domestic acupuncture clinical studies,33-35 combined with the team's previous literature studies on acupuncture for smoking cessation and the evaluation of the efficacy of acupuncture for smoking cessation.17,18 Considering the characteristics of nicotine withdrawal, withdrawal symptoms begin 2 to 3 hours after smoking withdrawal, peak in the first week, and can last 2 to 4 weeks.36 And according to the pattern of decreasing pharmacological treatment for nicotine cessation,37 therefore, the frequency of acupuncture was intensive from 1 to 4 weeks and decreasing from 4 to 8 weeks.38 Combined with the highest frequency of 5 times/week in the study, but the frequency of acupuncture (1 time per week) is lower than the traditional acupuncture theory, which may have a negative impact on the efficacy, so the low frequency was taken 2 times/week, taking the same treatment time and different acupuncture frequencies (HF group: 5 times per week in weeks 1-4, 3 times per week in weeks 5-8; LF group: 3 times per week in weeks 1-4; 2 times per week in weeks 5-8) to explore the effect of higher acupuncture frequency on the efficacy of smoking cessation under the same therapeutical time.
Secondly, we selected the expiratory CO point abstinence rate as the primary outcome indicator.19 The expiratory CO content was tested for the subject's abstinence rate in the 24 h prior to the follow-up visit to ensure the objectivity and accuracy of biochemical tests, and CO could provide more sensitive and timely feedback on the effect of acupuncture frequency on the cessation effect.
Our study has several limitations. First, there are few standards for the frequency of acupuncture for smoking cessation in China and abroad, so it is difficult to design an acupuncture control group with an appropriate frequency. In this study, the needling design in this study used relatively decreasing, relatively high and low frequency of acupuncture treatment, the results initially demonstrated that for mild to moderate tobacco dependence, the high-frequency and low-frequency acupuncture abstinence rates were similar under the same 8-week treatment, but only the effect of the relative two acupuncture frequencies on the effect of smoking cessation was compared, and it is not yet known for achieving the optimal frequency. Secondly, this study was selected to observe 8 weeks of short-term smoking cessation efficacy, for a more long-term treatment, the smoking cessation efficacy remains to be explored. Smoking characteristics of different populations, such as confidence in smoking cessation and different degree of tobacco dependence, are important factors affecting abstinence rate, and the population included in this study is mainly middle-aged subjects with moderate tobacco dependence, and further subgroup analysis is needed in future studies to observe the relationship between acupuncture frequency and population characteristics and abstinence rate. Thirdly, the sample size of this trial is relatively small, and a larger study should be conducted in the future to observe and compare the effect of more acupuncture frequencies on the efficacy of smoking cessation for clinical promotion. In addition, it was found during the trial that subjects with higher acupuncture frequency had better results in relieving smoking cravings, but high-frequency acupuncture treatment tended to lead to decreased compliance.
In conclusion, the results showed that both high-frequency acupuncture and low-frequency acupuncture treatment were safe and effective on smoking cessation for 8 weeks, but high-frequency acupuncture was advantageous in reducing smoking cravings. More accurate acupuncture frequency needs to be validated through larger clinical studies to optimize acupuncture smoking cessation programs.
Funding Statement
Supported by the Fund of Science and Technology Innovation Project of Chinese Academy of Chinese Medical Sciences Project: Self-service Acupuncture Smoking Cessation Research and Development (No. CI2021A03506) ; Fund of Capital Health Development Special Research Project: Research on Development and Clinical Applicalion of Wrist Acupuncture Smoking Cessation Instrument (No. 2022-1-4281)
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