Laser Acupuncture for Adolescent Smokers—A Randomized Double-Blind Controlled Trial

Laser Acupuncture for Adolescent Smokers—A Randomized Double-Blind Controlled Trial

Cai Yiming

Abstract: A double blind, randomized, placebo-controlled clinical study was conducted to evaluate the efficacy of laser acupuncture treatment in adolescent smokers. Three hundred and thirty adolescent smokers at the Smoking Cessation Clinic of Child Guidance Clinic, Institute of Health, Singapore, were randomly assigned in equal numbers to laser acupuncture treatment and sham acupuncture (control) groups. The proportions of patients with complete smoking cessation after completing treatment for four weeks were 21.9% in the treatment group and 21.4% in the control group. At three months post-treatment, the rates for complete cessation were 24.8% and 26.2%, respectively. Thus, there was no significant difference in the rates of smoking cessation in the treatment and control groups.

The 1994 report of the US Surgeon General (Elders et al., 1994), the first such report to focus on young smokers, reached six major conclusions:

(1) Nearly all first use of tobacco occurs by age 18.

(2) Most adolescent smokers are addicted to nicotine.

(3) Tobacco is often the first drug used by young people who subsequently use illegal drugs.

(4) There are identified psychosocial risk factors for the onset of tobacco use.

(5) Cigarette advertising also appears to increase young people’s risk of smoking.

(6) Community-wide efforts have successfully reduced adolescent use of tobacco.

Cigarette smoking is well recognized as difficult to treat since addiction to tobacco is very strong and a nicotine withdrawal syndrome may follow smoking cessation. Smoking cessation treatments generally require time, effort and other resources. The cost of such treatment is, therefore, an important consideration. Acupuncture treatment is simple, economical and without untoward reactions. There are numerous reports suggesting that acupuncture is effective in treating smoking in adults. There are several methods used including body acupuncture, ear acupuncture, laser acupuncture and auricular point sticking (Cui et al., 1992 & 1993; Gilbey et al., 1977; Jiang et al., 1994; Parker et al., 1977; Tan, 1990).

In a review of 64 publications by Jiang, the overall efficacy was 84.0% as measured immediately post-treatment (Jiang et al., 1994). Most of these studies, however, have design shortcomings, such as lack of a placebo control, small sample size, and the outcome measurement being non-blind. In the absence of a placebo control group, it is clearly not possible to remove the psychological bias on the outcome.

Swartz reviewed 30 reports of acupuncture treatment for smoking cessation (Swartz, 1992). He suggested that the reported efficacy of acupuncture was possibly due to a placebo effect. Swartz also reviewed 11 reports of controlled studies. Two showed a significant difference between treatment and control group (p [is less than] 0.05). The remaining nine showed no significant difference, with three actually showing a better outcome in the placebo group. Swartz suggested that the effect of acupuncture is psychological. The weakness of the latter nine studies is that there was no standardization of the intensity of stimulation applied to the acupoints nor were the same acupoints used for the treatment and control groups.

Recently, laser acupuncture has been widely used in medical treatments. It has several advantages, particularly in saving time and not causing pain or inflammation. It is simple, safe and with no side effects, while the intensity of the laser can be adjusted. It is readily acceptable to patients.

Tan conducted an acupuncture treatment study of 418 adult smokers in Singapore concluding that laser acupuncture was highly effective (Tan, 1990). He divided his subjects into various subgroups (of 10 to 42 subjects), each involving different acupoints (or group of acupoints), and differing intensities of stimulation and differing durations. He concluded that the most effective treatment group (defined as a 50% reduction or more in the number of cigarettes smoked a day) emerged from the group that received laser on the ear points, and where there was an eighty per cent response.

Zhang subjected 31 smokers to laser acupuncture on auricular points without the subjects’ knowledge, during treatment sessions for other conditions (Zhang, 1994). He claimed there was positive effect on smoking control and that the effect was not due to psychological factors. However, he did not use any control group, and the sample size (N=31) was too small to be conclusive.

Reports of using laser acupuncture treatment for smoking is not uncommon. From our knowledge, there is no report of smoking cessation using laser acupuncture in adolescents. The aim of this study was to determine if laser acupuncture is effective in the treatment of adolescent smokers, and to use a methodology that would redress shortcomings of previous studies.

Subjects and Methods

Subjects

Three hundred and thirty young smokers, aged 12 to 18, with at least three months of smoking experience and a minimum of five cigarettes smoked a day were invited to participate in the study as an alternative to the counseling workshop. The study had the approval of the Ethical Committee of Woodbridge Hospital.

Randomization

A double blind, randomized and placebo-controlled study was designed. Subjects were block randomized into two equal groups–one to undergo ear acupuncture and the other sham acupuncture as control.

Treatment Process

The subjects were told that two different forms of treatment were used. Written consent for treatment was obtained. All subjects were blindfolded when they were given either laser or placebo treatment by the same therapist. A nursing officer who was not involved in the treatment independently collected clinical data.

Laser treatment using the optical probe of the laser was placed about 1 mm away from the acupoint without touching it. The laser beam does not cause any pain or distinguishable sensation. The acupoints were Ershenmen, Ko, Fei, and Waibi on the left ear. (These are standard ear acupoints recommended by the WHO Seoul congress in 1987.) Each point was exposed to the laser ray for one minute. Therefore, each treatment lasted four minutes. A full course consists of three sessions per week with a total of 12 sessions.

The placebo treatment processes were the same as laser treatment. The only difference was that the laser probe does not emit any ray. This was to remove any bias that may result from the subject’s perception of the type of treatment they were receiving.

Carbon Monoxide smoker-lyser test was carried out during the study after the sixth and eleventh sessions of acupuncture. Although the test results do not correlate well with actual smoking habit, the process was judged as helping to enhance the truthful disclosure by the subjects of the actual number of cigarettes they smoked per day.

Reactions to treatment, if any, were asked for and recorded after each treatment.

Evaluation and Post-Treatment Follow-up

A subject would only be included in the analysis if at least six sessions were attended. If, however, a positive response (complete cessation) occurred at any time during the course and the subject did not turn up for subsequent sessions, the case is still accepted for analysis (essentially a “last observation carried forward” paradigm).

The primary positive end point was defined as a complete cessation of smoking. The secondary end point was defined as a reduction of at least 50% in the average number of cigarettes smoked per day.

Three months after the completion of the treatment, the patients were reassessed, including use of the Smoker-lyser test.

Equipment

He-Ne laser acupuncture instrument

An HY369-B2 He-Ne laser acupuncture instrument from China was used. The output power of the instrument is 2.5 ~ 3 mw producing a red colored light with a wavelength of 6328 [Angstrom] and a diameter of 1 mm.

Carbon Monoxide Smoker-lyser

This is a user-friendly, noninvasive, accurate and rapid-monitoring system for lung / breath carbon monoxide. Results appear quickly on a clear, readable digital display from a single breath. Carbon monoxide is measured in parts per million ppm CO. As a general rule of thumb, the carbon monoxide level in ambient air should not rise above four parts per million (4 ppm). The average level for smokers is about 33 parts per million (33 ppm). The reading corresponds accurately to the number of sticks of cigarettes the smoker smoked. Carbon monoxide concentration is time-related. It is higher just after smoking than two hours later. It also increases during the day with cigarette consumption.

Statistical Analysis

Power analysis

Based on the results of a previous study by Tan of adult smokers a response of 26% was expected in the control and approximately 80% in the experimental group (Tan, 1990). Allowing for a placebo effect of 25% and an effectiveness of at least 45% in the treatment group, a sample size of 165 in each group was required for this study.

Statistical analysis

Initial analysis will include the chi-square test (for categorical variables) to compare the two groups on demographic and other variables.

Results

Two hundred and sixty-eight (268) adolescent smokers finally completed the study, 200 males and 68 females. One hundred and twenty-eight received laser acupuncture treatment and one hundred and forty received sham acupuncture. Sixty-two subjects failed to complete a minimum of six treatment sessions, giving a dropout rate of almost 19%. There are 30 (48.4%) and 32 (51.6%) in the control and treatment groups respectively.

Subject characteristics showed that they had a history of smoking ranging from three months to 10 years and the number of cigarettes from 5 to 30 sticks per day. The majority was asked by school authorities to come for treatment.

Immediately after treatment, both groups showed a strong positive outcome with around 21% stopping smoking completely and around 80% reducing the average number of cigarettes smoked per day by at least half. The results are shown in Table 1.

Table 1. Effectiveness of Laser Treatment in Smoking Cessation

Immediately After Treatment

Reduction

[is greater

No. of Complete than or equal P-

Group Patients Cessation P-Value to] 50% Value

Treatment 128 28 (21.9%) 0.95 105 (82.0%) 0.90

Control 140 30 (21.4%) 113 (80/7%)

Three Months After Treatment

Reduction

[is greater

No. of Complete than or equal P-

Group Patients Cessation P-Value to] 50% Value

Treatment 101 25 (24.8%) 0.94 75 (74.3%) 0.95

Control 107 28 (26.2%) 78 (72.9%)

At follow-up three months later, the outcome of both groups was not significantly different (p [greater than] 0.05). The overall effectiveness of both groups was lowered to just over 24% (complete cessation) and 70% (reduction of cigarettes smoked per day by at least half) as shown in Table 1. Hence, there was no significant difference between the outcomes of the two groups.

Many factors, which may confound the outcome of the treatment and control groups, were measured and compared. These are shown in Tables 2 and 3.

Table 2. Comparing Characteristics of Two Groups

Related Factors

Group No. of Reactions to P-Value Family

Patients Treatment Members

Smoke

Treatment 128 26 (20.3%) 0.94 72 (56.3%)

Control 140 29 (20.7%) 83 (59.3%)

Related Factors

Group P-Value Close P-Value Asked to P-Value

Friends Come for

Smoke Treatment

Treatment 123 (96.1%) 0.63 114 (89.1%) 0.42

Control 0.70 137 (97.8%) 119 (85.0%)

Table 3. Subgroup Analyses of the Comparative Efficacy of Acupuncture Treatment and Sham Control

Motivation for Smoking Cessation

Motivation Group No. of Complete

Levels Patients Cessation P-Value

Not at all/ Treatment 74 14 (18.9%) 0.86

Ambivalent Control 73 14 (19.2%)

Quite Treatment 38 6 (15.8%) 0.85

determined Control 41 6 (14.7%)

Very Treatment 16 8 (50.0%) 0.86

determined Control 26 10 (38.5%)

Motivation for

Smoking Cessation

Reduction

[is greater

than or

Motivation equal to]

Levels 50% P-Value

Not at all/ 59 (79.7%) 0.92

Ambivalent 55 (75.3%)

Quite 32 (84.2%) 0.90

determined 35 (85.4%)

Very 14 (87.5%) 0.83

determined 23 (88.5%)

Duration of Smoking (months)

No. of Complete

Months Group Patients Cessation P-Value

3 to 12 Treatment 32 7 (21.9%) 0.87

Control 36 10 (27.8%)

13 to 36 Treatment 63 17 (27.0%) 0.85

Control 59 16 (27.2%)

> 36 Treatment 33 4 (12.1%) 0.97

Control 45 4 (8.9%)

Duration of

Smoking (months)

Reduction

[is greater

than or

equal to]

Months 50% P-Value

3 to 12 27 (84.4%) 0.97

28 (77.8%)

13 to 36 52 (82.5%)

50 (84.7%) 0.97

> 36 26 (78.8%) 0.89

35 (77.8%)

Number of Cigarettes Smoked

Per Day (sticks)

No. of Complete

Sticks Group Patients Cessation P-Value

5 to 10 Treatment 102 23 (22.6%) 0.93

Control 111 27 (24.3%)

11 to 15 Treatment 14 3 (21.4%) 0.64

Control 15 1 (6.7%)

> 15 Treatment 12 2 (16.7%) 0.69

Control 14 2 (14.3%)

Number of Cigarettes

Smoked Per Day (sticks)

Reduction

[is greater

than or

equal to]

Sticks 50% P-Value

5 to 10 81 (79.4%) 0.99

86 (77.5%)

11 to 15 12 (85.7%) 0.99

15 (100%)

> 15 12 (100%) 0.99

12 (85.7%)

Factors relating to subjects’ personal experience and behavior were analyzed, namely, reactions to treatment, motivation to stop smoking, family members being smokers, close friends being smokers and whether subjects were asked to come for treatment. The results are shown in Tables 2 and 3. No significant difference is observed in the two groups. This confirms that randomization was successful.

Both treatment and control group reported unfavorable reactions (headache, giddy, nausea, vomiting or change of odor in cigarette smoking) in around 20% of subjects during the treatment period. There was no difference between the two groups.

Table 3 shows the relationship between the outcome and smoking history, motivational level and number of cigarettes smoked per day. There was no significant difference in the outcomes between the treatment and control groups (p [is greater than] 0.05).

Discussion and Conclusion

We report a double blind, placebo-controlled study of the effect of laser acupuncture on adolescent smokers who attended the Smoking Cessation Clinic at the Institute of Health, Singapore. The effectiveness of laser acupuncture treatment was compared with control (sham acupuncture) and no difference was demonstrated. However, both groups showed a substantial number of subjects who stopped and a larger percentage who reduced their smoking. Several factors, which might have influenced the outcome of the study, were analyzed and established as controlled for in the randomization process.

The sample size was predetermined by the expected outcome of the treatment and control group, as indicated by other studies. This was to ensure that a definitive and valid conclusion could be reached overcoming a problem of many previous studies emerging from small sample sizes.

Our results show that the effectiveness for both groups was around 80 percent, similar to most previous studies. In a review of 64 publications by Jiang the overall efficacy was 84% as measured immediately post-treatment (Jiang, 1994). A main difference is that most of those studies, however, have shortcomings in the designs such as the lack of a placebo control, small sample size, and the outcome measurement being non-blind.

In the study by Tan, mentioned earlier, he reported laser acupuncture to be highly effective for adult smokers (Tan, 1990). He used a control group of 30 subjects who received sham acupuncture on auricular points for one minute, and established a positive response rate of 26.6%. This is in sharp contrast to our study outcome of 80.7%. However, it has to be pointed out that his study differs from ours in that his subjects were adults. It also was not randomized or controlled. Furthermore, the methodology of his study such as randomization and evaluation was not detailed.

It has to be pointed out that the proportion of subjects reporting unfavorable reactions to treatment were the same at around 20% in our study in each group (Table 2). This is a level expected of any placebo treatment, and this implied that in both groups the effect is predominantly psychological.

In this study, we also analyzed the data of the 62 subjects who failed to complete a minimum of six treatment sessions in both groups. Their profiles were not dissimilar.

From our results, the usefulness of laser acupuncture in the cessation of adolescent smoking is not superior to that of placebo.

Acknowledgments

The authors wish to thank the National Medical Research Council of Singapore for funding this project, Dr Askenazi for his invaluable suggestions on the design of the study, Professor Ng Tze Pin and Professor Gordon Parker for providing statistical support in the methodology and useful comments on the paper.

References

[1.] Cui, M. and A.P. Jiang. Physiological inference on effectiveness of acupuncture for smoking cessation. J. Shanghai Acup. & Moxibust. 11, 1992.

[2.] Cui, M and A.P. Jiang. Analysis of effectiveness of acupuncture on abstinence from smoking. J. Tradit. Chin. Med. 33(4), pp 243-245, 1993.

[3.] Elders, M.J., C.L. Perry, M.P. Ericksen and G.A. Giovino. The Report of the Surgeon General: preventing tobacco use among young people. Am. J. Public Health Apr: 84 (4):543-547, 1994.

[4.] Gilbey, V. and B. Neumann. Auricular Acupuncture for smoking withdrawal. Amer. J. Acupuncture, 5(3), pp 239-247, 1977.

[5.] Jiang, AP and M. Cui. Analysis of therapeutic of acupuncture on abstinence from smoking, d. Tradit. Chin. Med. 14(1), pp 56-63, 1994.

[6.] Parker, L.N. and M.S. Mok. The use of acupuncture for smoking withdrawal. Amer. d. Acupuncture, 5(4), pp 363-366, 1977.

[7.] Tan, C.H. The Use of Laser on Acupuncture Points for Smoking Cessation. International Medi-health Series 2, pp 141-145, 1990.

[8.] Zhang, S.L. Thirty-one cases of report using low power of laser on ear acupuncture points for smoking cessation. Jiangxi Traditional Chinese Medicine. 4, pp 39, 1987.

Cai Yiming(1)(*), Zhao Changxin(2), Wong Song Ung(3), Zhang Lei(4) and Lim Seuk Kean(5)

(1) Department of Child and Adolescent Psychiatry, Woodbridge Hospital/Institute of Mental Health, Institute of Health Building, Singapore 168937,

(2) Institute of Acupuncture and Moxibustion, China Academy of Traditional Chinese Medicine, Beijing, 100700,

(3) Queenstown Polyclinic, Family Health Service, Singapore 149296,

(4) Acupuncture Research Clinic, Ang Mo Kio Community Hospital, Singapore 569 766,

(5) Smoking Cessation Clinic, Institute of Health, Singapore 168 937

(*)Corresponding author

(Accepted for publication February 25, 2000)

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