|Year : 2021 | Volume
| Issue : 3 | Page : 243-249
Role of auricular laser acupuncture and psychological counseling in reducing nicotine dependence due to smoking: A randomized controlled trial
Chandrabhaga S Velangi1, Puja Chandrashekar Yavagal2, L Nagesh3
1 Chief Dental Surgeon, Border Security Force, Ministry of Home Affairs, Guwahati, Assam, India
2 Professor, Department of Public Health Dentistry, Bapuji Dental College and Hospital, Davangere, India
3 Professor and Head, Department of Public Health Dentistry, Dayanand Sagar College of Dental Sciences, Bengaluru, Karnataka, India
|Date of Submission||10-Sep-2020|
|Date of Decision||18-Feb-2021|
|Date of Acceptance||31-May-2021|
|Date of Web Publication||22-Sep-2021|
Puja Chandrashekar Yavagal
Department of Public Health Dentistry, Bapuji Dental College and Hospital, Davangere, Karnataka
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: Low level laser therapy is a novel noninvasive technology used to stimulate the acupoints recognized for tobacco cessation. Objective: To compare the effect of laser auricular acupuncture, psychological counseling, and combination of laser acupuncture and psychological counseling in reducing nicotine dependence due to smoking. Methods: Smokers (n = 150) fulfilling the eligibility criteria were randomly allocated to three interventional groups. Evaluation of the nicotine dependence and physical effects due to smoking were done using Fagerstrom test and Visual Analog Scale, respectively, at baseline and 1 month postintervention. Person's Chi-square, Kruskal Wallis analysis of variance, and Wilcoxon signed-rank tests were used for the statistical analysis. Statistical significance was set at P ≤ 0.05. Results: There was a statistically significant reduction in nicotine dependence (P = 0.00) and physical effects related to smoking (P < 0.05) in all the interventional groups 1 month postintervention. Reduction in Fagerstrom test scores was significantly higher (P = 0.001) in Group 3 (laser acupuncture with psychological counseling) as compared to other groups. There was significant reduction (P < 0.01) in irritability, tiredness, craving, headaches, and significant increase (P < 0.05) in the unpleasant taste due to smoking and ability to concentrate in laser acupuncture with psychological counseling group as compared to other groups. Conclusion: Auricular laser acupuncture with psychological counseling was effective in reducing nicotine dependence due to smoking.
Keywords: Auricular acupuncture, counseling, dependence, laser, nicotine
|How to cite this article:|
Velangi CS, Yavagal PC, Nagesh L. Role of auricular laser acupuncture and psychological counseling in reducing nicotine dependence due to smoking: A randomized controlled trial. Indian J Public Health 2021;65:243-9
|How to cite this URL:|
Velangi CS, Yavagal PC, Nagesh L. Role of auricular laser acupuncture and psychological counseling in reducing nicotine dependence due to smoking: A randomized controlled trial. Indian J Public Health [serial online] 2021 [cited 2021 Dec 2];65:243-9. Available from: https://www.ijph.in/text.asp?2021/65/3/243/326399
| Introduction|| |
Smoking is highly prevalent across many countries and remains a major public health challenge. Around 10.7% of adults in India and 11.8% adults in Karnataka smoke. Nicotine dependence due to smoking is a powerful biological and social process that strongly impedes achieving and sustaining smoking cessation. In a review article based on 633 studies of the most available interventions for smoking cessation, Viswesvaran and Schmidt concluded that the average observed success rate across all smoking cessation methods was approximately 19% and 6.4% for placebo controls. In conventional procedures used to treat tobacco dependence, there is a relatively high relapse rate. The effectiveness of Nicotine Replacement Therapy on smoking cessation has widely been demonstrated, but the overall efficacy was found to be 10.7%, the overall relapse rate was 30% according to a review of 12 placebo-controlled trials, with follow-ups ranging from 2 to 8 years. Some researchers consider that people who relapse should be offered more than one medication, higher doses, or various treatment combinations. A meta-analyses study concluded that alternative aids such as acupuncture, hypnotherapy, and aversive smoking were found to increase smoking abstinence. This underlines the fact that doctors should encourage the use of alternative smoking cessation aids, particularly in patients hesitant or unable to use pharmacotherapies. The World Health Organization (WHO) has classified tobacco dependence in category of “Diseases, symptoms or conditions for which the therapeutic effect of acupuncture has been shown, but for which further proof is needed.” Acupuncture therapy is invasive, carries risk of infection through contaminated needles and cannot be used in people with needle phobia. Recently, Laser acupuncture with biostimulation lasers has been investigated and used clinically for smoking cessation. They are defined by wavelengths between 600 nm and 900 nm. Acupoints used for smoking cessation are situated on the ear (auricular sites) and on peripheral sites (wrist and leg). Treatment with a painless noninvasive laser beam directed at the specific acupoints for a few minutes per point for three to five sessions is all it takes to achieve optimum results. This form of therapy being noninvasive, aseptic, and painless is advantageous over the traditional form of acupuncture. Therefore, the effectiveness of laser acupuncture for smoking cessation needs to be explored more which is justified by the Cochrane collaboration in its review. The role of the dentists is challenging as they have the dual responsibility of identifying the oral signs and precancerous lesions due to tobacco use, as well as providing smoking cessation services for preventing the harmful effects of tobacco. Literature search revealed very less research on active intervention provided by dentists for tobacco cessation. Studies conducted on laser acupuncture for smoking cessation have shown inconsistent results. Reasons being, heterogeneity in terms of the age of the subjects and control groups, Wavelength and power of laser used, duration of treatment, and the acupoints treated. None of these studies were done on the Indian population. Since there is prevailing research equipoise regarding efficacy of laser auricular acupuncture for smoking cessation, the present study was planned to test the null hypothesis that there was no difference in efficacy of laser auricular acupuncture and psychological counseling in reducing nicotine dependence due to smoking. The objective of the study was to compare the nicotine dependence of smokers in Davanagere city aged 18–74 years in the three interventional groups, namely laser auricular acupuncture, counseling, and combination of laser acupuncture with counseling, 1 month after intervention.
| Materials and Methods|| |
Study design and study area/setting
The study design was exploratory, randomized controlled trial, active arm trial with concurrent parallel design. The study period lasted for 7 months from October 2017 to April 2018. The study was carried out at peripheral centers of Bapuji Dental College and Hospital, Davanagere at primary health care centre, Bilichodu and community health center, Malebennur.
A study pro forma was designed to record demographic details, occupation, income, frequency and duration of smoking, information about alcohol consumption, and follow-up details of study participants. The investigator was trained in counseling for smoking cessation and laser acupuncture before the start of study.
Sample size estimation
The sample size was estimated based on the assumed proportions in the groups derived from a previous study by Kerr et al., using the formula n = (Zα + Zβ)2 × 2 × P (1 − P)/d2. Where, Zα =1.96, Zβ =0.84, d is the clinically expected difference = 20% or 0.2. Proportion = 0.64 (64% participants quit smoking after laser acupuncture in a previous study), Power of the study = 0.8, Type 1 error (α) = 0.05.Considering 10% dropout at 1 month, the sample size in each group was estimated to be 50.
Eligibility criteria of study participants
Definition of smokers
Current smokers – Adults (>18 years) who had smoked 100 cigarettes in their life time and currently smoked cigarettes everyday (daily) or some days (nondaily). Smokers who consented to participate and who were currently and previously not on any form of tobacco cessation therapy were included in the study. Participants <18 years of age, with known history cardiac problems, diabetes mellitus, history of epilepsy, having lack of skin sensation near the acupuncture points, suffering from undiagnosed fever or severe skin lesions, infection at and around the acupuncture points, on psychiatric medications, and unable to comply with appointment schedule were excluded.
Clinical trial registration and ethical clearance
Trial was registered under Clinical Trail Registry of India (CTRI/2018/05/013753). The committee of the institutional review board of the college where the study was conducted scrutinized the study proposal and provided the ethical clearance (Ref. No. BDC./Exam/283/2016-17 dated 23-11-2016).
Patients attending the outpatient department of dental college, fulfilling the eligibility criteria, who consented for participation in the study were recruited from October 2017 to April 2018. Patient consent declaration: Voluntary written informed consent was obtained from participants participating in the study after explaining the purpose and the procedures involved in the study in a language that was understandable by the participants.
With the help of online software, sequence of random numbers was generated followed by random allocation of subjects (concealed randomization) to the interventional groups. Random allocation was done by a separate person not involved in the study who was handed over random numbers generated within sealed opaque envelopes. Once a patient, fulfilling the eligibility criteria consented to enter the trial an envelope was opened and the patient was then offered the allocated treatment. All the interventions were done by the investigator who was not blinded to the treatment procedure.
The interventional groups were as follows:
Group 1: Participants treated with only laser auricular acupuncture at day 1, 3, 7, and 14
Group 2: Participants underwent only psychological counselling (1 session/week, total 4 sessions) for smoking cessation
Group 3: Participants treated with a combination of laser acupuncture and psychological cessation.
Assessment of nicotine dependence
The nicotine dependence was assessed with the help of widely used and standard Fagerstrom questionnaire. The validity of Fagerstrom questionnaire is established with satisfactory sensitivity (0.75) and specificity (0.80) scores. The level of nicotine dependence was categorized as low (scores 0–4), medium (score 4–6), and high (scores >6). Nicotine dependence test was administered by a trained personnel not involved in the study. The assessments were done at baseline and 1 month after intervention. One month follow-up was decided based on the previous study where significant difference was observed in smoking rate at a minimum period of 1 month between acupuncture group and counseling group.
Laser intervention details
Diode laser equipment from Silber Bauer, Austria, having following parameters was used: Power output – 36 mW, wavelength – 660 nm, Beam area – 0.3 cm2, mode of usage – continuous wave mode, energy delivered – 7.2 joules per cm/2 per point per session and method of usage is point probe (contact method) with protective eye wears. Dose was calculated based on the Litscher's guidelines. The investigator was trained to give the laser therapy by a certified laser therapist before the start of the study. Auricular acupoints that were considered on each ear were as per National Acupunture Detoxification Association (NADA) given for addictive substance abuse. They were Fei (lung) on inferior concha, Ershenmen (Shenmen) on triangular fossa, Jiaogan (sympathetic or autonomic) on antihelix, and Gan (liver) on superior concha of the tragus. The locations of these points on the external ear are standardized by the WHO. The acupoints were marked with a marker pen prior to the intervention. The laser beam was directed at eight acupoints on both the ears holding at the point. The duration of treatment was 1 min per point. The total duration of treatment was 8 min for one treatment session. A total of four treatment sessions on day 1, 3, 7, and 14 was given to every subject. During the intervention both the operator and participant wore wavelength specific eye goggles to prevent any possible side effects of laser beam on eye. The area on the ear was made aseptic by applying antiseptic solution on the skin of the ear containing 2.5% chlorhexidine gluconate and 70% Ethanol.
The counselling intervention was done by following a combination of the '5A' framework and the “Transtheoretical Model.” The participants were counselled for a duration of 30 min per week and they underwent totally four such sessions in 1 month. The stage of change of every subject was assessed at every stage of counseling. The stages of change were as follows: Stage 1: Precontemplation (Not thinking of quitting); Stage 2: Contemplation (Ambivalent, but thinking of quitting); Stage 3: Preparation (Planning to quit); Stage 4: Action (Quit); Stage 5: Maintenance (continued quit); and Stage 6: Relapse (has returned from the action or the maintenance stage to an earlier stage). At every stage of the change seen in subject, the appropriate component of 5 “A” framework was used to bring about and reinforce the tobacco cessation behavior.
Assessment of physical effects related to smoking
The physical effects experienced by the subjects before, after, and during the course of treatment were assessed with respect to irritability, tiredness, calmness, anxiety, cravings, unpleasant taste when smoking, headaches, ability to concentration, and appetite on a 10-point Visual Analogue scale.
Analysis was conducted using R version 3.4.2 (R Core Team, 2014) and figures were produced using the package ggplot2 (Wickham, 2009) software. Significance level was fixed at P ≤ 0.05. Data were not normally distributed under Kolmogorov–Smrinov normality test; hence, nonparametric tests such as Pearson's Chi-square, Kruskal Wallis analysis of variance, and Wilcoxon signed-rank tests were used for the statistical analyses. Per protocol analysis was followed. Age, years of smoking, and alcohol consumption were potential confounders which were stratified and considered under the statistical analysis.
| Results|| |
Out of 150 participants, results of 137 participants were considered for final analysis since there were dropouts in Group 1 (n = 4), Group 2 (n = 4), and Group 3 (n = 5) [Figure 1]. The mean age of the participants was 51.24 ± 19 years. Majority of the population in all the three groups belonged to the age group of 35–54 (68.6%) years, followed by 55–74 (17.5%) year age group and the least were found in 18–34 (13.9%) year age group. Majority of the study population in all the groups belonged to high nicotine dependence group (48.2%), followed by medium (27%) and low (24.8%). Majority of the study population had smoked for more than 10 years (70.1%), followed by 6–10 years (15.3%) and 1–5 years (14.6%) [Table 1]. The Chi-square test was applied to test the difference in the proportions across various demographic groups, and it was observed that there were no significant differences in the distribution of participants across groups based on age, socioeconomic status, duration of smoking, nicotine dependence, and behavioral stage (P > 0.05). There was significant reduction in nicotine dependence and significant improvement in behaviour and physical effects related to smoking in all the interventional groups 1 month postintervention (P < 0.05). Based on Kruskal–Wallis test, followed by Post hoc Man–Whitney test, reduction in nicotine dependence was significantly higher (F = 14.5, P < 0.00) in Laser Acupuncture with Counseling Group (3.88 ± 2.0), compared to only psychological counseling group (2.28 ± 1.37) and only laser acupuncture group (3.13 ± 2.09) [Table 2]. The effect size was high (Cohen's d = 0.6) demonstrating a significant effect of laser auricular acupuncture along with counseling therapy in reducing nicotine dependence [Table 2] Improvement in behavioral changes was similar across different groups. There was significant reduction (P < 0.05) in physical effects associated with smoking such as irritability, headache, craving for smoking, and tiredness in laser acupuncture with counseling group as compared to other two interventional groups and significant increase (P < 0.05) in physical effects associated with smoking such as unpleasant taste to smoking and ability to concentrate in Group 3 as compared to other groups [Table 3].
|Table 2: Comparison of Fagerstrom test scores between interventional groups|
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|Table 3: Comparison of physical effects due to smoking (Visual Analog Scale scores) between interventional groups|
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| Discussion|| |
The present study revealed that laser auricular acupuncture in combination with psychological counselling proved to be an effective treatment for nicotine dependence as shown by the reduction in Fagerstrom test scores at 1 month postintervention. Laser acupuncture alone also had considerable effect in reducing nicotine dependence as compared to only psychological counselling. The combination of laser acupuncture and counselling considerably reduced irritability, tiredness, cravings to smoke, headaches, and increased the ability to concentrate at 1 month postintervention. The unpleasant taste for smoking increased in the groups that received laser interventions. The use of laser acupuncture for smoking cessation has been explored earlier in some studies, but no other study to the best of researcher's knowledge had compared it with psychological counseling alone and in combination. Therefore, direct comparisons of the present study with other studies, where laser acupuncture was used could not be made. However, the results are in line with study conducted by Bier et al. wherein the combined effect of conventional acupuncture done on similar auricular points along with psychological counseling had a significant effect on smoking cessation. The results are similar to the findings of a study conducted by Kerr et al. wherein effective results with laser acupuncture for smoking cessation were achieved in comparison with sham acupuncture group. The similar result perhaps may be attributed to stimulation of similar auricular points as well as identical laser parameters. Study conducted by Mostyn DCR et al. arrived at similar results, but the study was uncontrolled. Contrary results were obtained by Yiming et al. who concluded that the usefulness of laser acupuncture in the cessation of smoking was not superior to that of placebo, though a substantial number of subjects had stopped smoking in both the groups. The contrary result may be attributed to different laser parameters used in the study. Cottraux et al. concluded that the overall effect of both acupuncture and behavior therapy for smoking cessation was nonspecific. Stimulation of auricular acupoints affects the limbic system of brain specifically the reward center. This modulation of reward system is mediated through auricular branches of trigeminal, vagus nerve, and superior cervical plexus leading to restfulness and management of sleep at the supraoptic chiasma. When smokers experience withdrawal systems during smoking cessation, stimulation of auricular acupoints lead to modulation of reward pathway leading to release of dopamine and serotonin thereby minimizing the withdrawal effects. Body acupuncture in combination with auricular acupuncture was not more effective than auricular acupuncture alone according to few studies. Laser acupuncture is noninvasive as compared to needle acupuncture. Laser parameters used in the study were based on the standard guidelines stated by Litscher and Opitz and reported based on World Association for Laser Therapy guidelines. Different studies on laser acupuncture have used different wavelengths. Interventions were spaced at the 1st, 3rd, 7th, and 14th day to compensate for the withdrawal symptoms caused by nicotine deprivation corresponding to low level of serotonin and dopamine. The first 2 days are crucial during smoking cessation period during which an increase in serotonin level in the brain tissue mediated by acupuncture can help reduce withdrawal symptoms.,, There was significant improvement in physical effects related to smoking. Perhaps, the reason for this could be the stimulation of the sympathetic auricular point and liver points which are associated with relaxation of internal organs and resolving aggression respectively, thereby leading to positive effects such as increased levels of endorphins secretion. Participants who underwent laser therapy experienced increased unpleasant taste for smoking postintervention. Similar findings were observed in few studies. In the present study, very few subjects reported headaches which was ill defined and irritability. These may be recognized symptoms of withdrawal due to inability of these persons to build up their own endorphin levels. Similar experiences were seen in few studies., Study had few limitations. The outcome measures were subjective in nature. The age group in the study was very wide and hence age specific effect of the treatment could not be ascertained. Furthermore, the results were assessed at the short term. Social desirability bias could have influenced the results. The strength of the study lies in the fact that it's the first study wherein, the laser dose and the reporting of laser parameters were based on the standard guidelines, and the results were compared with a standard psychological counseling group. However, it is recommended to conduct long-term studies with large sample size using sensitive objective measures of assessment of nicotine dependence. If laser auricular acupuncture is proven efficacious in reducing nicotine dependence due to smoking, then it may prove as an excellent noninvasive, aseptic, and painless therapy which can reduce the withdrawal symptoms associated with smoking cessation at a price around rupees two hundred per session which may be affordable to smokers who can afford buying cigarettes and bidis at a cost more than this. Furthermore its quite economical to have low level laser therapy units in tobacco cessation centers across our country. Health assistants at primary health care centers can be trained to identify NADA auricular points for smoking cessation and effectively give laser therapy to smokers wearing the safety eye wears as low level lasers are safe to use with minimum side effects.
| Conclusion|| |
There was significant reduction in nicotine dependence and significant improvement in behavior and physical effects related to smoking at 1-month postintervention in all the groups. The reduction in nicotine dependence was higher with combined therapy of Laser Auricular acupuncture along with counseling and laser acupuncture therapy alone compared to only counseling therapy. Hence, it may be used as an adjunct therapy along with psychological counseling. Laser acupuncture is a noninvasive, aseptic, and painless therapy which can reduce the withdrawal symptoms associated with smoking cessation and may immensely help smokers to quit smoking.
We acknowledge the help rendered by Dr. Chandrashekar M. Yavagal, Professor and Head, Department of Pediatric Dentistry, Maratha Mandal's Nathajirao G. Halgekar ,Institute of Dental Sciences & Research Centre, Belgaum, India, who trained the researcher for laser therapy.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]