Article Figures & Data
Figures
- Figure 1.
Participant flow (ITT, intent to treat).
Tables
- Table 1. Baseline Medical, Smoking, and Demographic Characteristics by Treatment Group (N = 125)
Characteristics Treatment Group P Control (n = 61) Intervention (n = 64) Demographics Sex (% female) 14 (23.0) 16 (25.0) .79 Age (years) 55.3 ± 9.1 55.8 ± 10.0 .81 Race .67* 1 (African-American) 42 (68.9) 38 (59.4) 2 (American Indian) 0 (0.0) 0 (0.0) 3 (Asian-American) 1 (1.6) 1 (1.6) 4 (Hispanic) 0 (0.0) 1 (1.6) 5 (Non-Hispanic white) 18 (29.5) 24 (37.5) 6 (Other) 0 (0.0) 0 (0.0) Married 22 (36.1) 26 (40.6) .60 Education (>12 years) 56 (91.8) 58 (90.6) .82 Currently employed 18 (30.0) 16 (25.8) .61 Medical General health rating .87* 0 (Poor) 6 (10.0) 9 (14.1) 1 (Good) 51 (85.0) 52 (81.3) 2 (Excellent) 3 (5.0) 3 (4.7) Comorbidities Anxiety 5 (8.2) 10 (16.4) .17 Asthma 9 (14.8) 9 (15.0) .97 CAD 11 (18.0) 9 (14.8) .62 Cancer 5 (8.2) 3 (4.9) .72* COPD 9 (14.8) 9 (15.0) .97 Depression 17 (27.9) 25 (41.0) .13 Diabetes 20 (32.8) 19 (31.2) .85 PTSD 6 (9.8) 11 (18.3) .18 Other 12 (19.7) 15 (24.6) .51 Smoking history Age started smoking (years) 16.8 ± 4.1 17.6 ± 5.1 .34 Years smoked 35.4 ± 13.0 34.2 ± 12.6 .62 Packs per day 1.7 ± 3.9 1.8 ± 5.3 .89 Times quit for >24 hours during the past month 0.5 ± 1.1 0.9 ± 1.5 .14 Has a spouse or significant other who smokes 16 (30.8) 25 (45.4) .12 Questionnaires Transtheoretical Model of Change category .60 1 (Precontemplation) 4 (7.3) 6 (10.5) 2 (Contemplation) 21 (38.2) 17 (29.8) 3 (Preparation) 30 (54.6) 34 (59.7) Fagerstr|f-m Test of Nicotine Dependence .19* 1 (Low) 0 (0.0) 4 (6.3) 2 (Medium) 47 (79.7) 47 (73.4) 3 (High) 12 (20.3) 13 (20.3) Motivation to quit smoking (on a scale of 1–10) 7.5 ± 2.4 8.6 ± 1.7 .003 Minnesota Nicotine Withdrawal Scale Score 19.0 ± 10.2 19.6 ± 10.9 .75 Patient Health Questionnaire Score 5.1 ± 4.5 5.9 ± 5.5 .36 Perceived Stress Scale Score 5.4 ± 2.8 5.8 ± 2.9 .45 Continuous variables are reported as (mean ± standard deviation). Categorical variables represent number of patients (%).
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↵* Fisher exact test.
CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; PTSD, posttraumatic stress disorder.
- Table 2. Premature Study Termination, Patient Safety, and Treatment Compliance by Treatment Group (N = 125)
Characteristic Treatment Group P Control (n = 61) Intervention (n = 64) Premature study termination Number reported 8 (13.1) 6 (9.4) .51 Primary reason .12* A (Unable to contact) 4 (6.6) 6 (9.4) B (Dropped out) 3 (4.9) 0 (0.0) C (Uncooperative or nonadherent) 1 (1.6) 0 (0.0) Patient safety Reported study-related serious AEs (n) 2 2 No 2 2 Yes 0 0 Unknown 0 0 Reported study-related AEs (n) No 6 5 Yes 0 1 Unknown 3 0 Treatment compliance Treatments received during the study .13* 0 1 (1.6) 0 (0.0) 1 4 (6.6) 1 (1.6) 2 3 (4.9) 2 (3.1) 3 1 (1.6) 7 (10.9) 4 12 (19.7) 9 (14.1) 5 (All) 40 (65.6) 45 (70.3) Surveys completed during the study .93* 0 0 (0.0) 0 (0.0) 1 3 (4.9) 3 (4.7) 2 6 (9.8) 8 (12.5) 3 (All) 52 (85.3) 53 (82.8) 1Patient satisfaction with control/auriculotherapy .13* 1 (Waste of time) 3 (5.9) 1 (1.8) 2 (Poor) 4 (7.8) 2 (3.6) 3 (Fair) 11 (21.6) 10 (18.2) 4 (Good) 10 (19.6) 23 (41.8) 5 (Excellent) 23 (45.1) 19 (34.6) Patient recommends auriculotherapy for family/friends† 46 (75.4) 52 (81.3) .45 - Table 3. Effect of Auriculotherapy on Self-Reported and Cotinine-Defined Abstinence at Weeks 3 and 6
Outcome Measure Treatment Group P Control (n = 61) Intervention (n = 64) Self-reported abstinence Week 3* 12.9 (4.0–21.7) 12.3 (4.0–20.7) .93 Week 3† 1.0 0.81 (0.23–2.83) .74 Week 6* 17.9 (7.2–28.6) 20.9 (10.2–31.6) .69 Week 6† 1.0 1.19 (0.40, 3.53) .75 Cotinine-defined (< 200 ng/mL) abstinence Week 3* 17.0 (6.9–27.2) 22.3 (11.0–33.6) .50 Week 3† 1.0 1.44 (0.48–4.36) .51 Week 6* 24.6 (12.2–37.0) 20.5 (9.9–31.0) .61 Week 6† 1.0 0.75 (0.28–2.01) .56 -
↵* Values represent the proportion (95% confidence interval) of patients who were abstinent in each group.
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↵† Abstinence (yes/no) was regressed in the treatment group and for the following covariates in logistic regression models: patient age, sex, education, comorbid anxiety, depression, posttraumatic stress disorder, number of cigarettes smoked per day at baseline, model of change category, and perceived stress scale score. Values are shown as odds ratio (95% confidence interval) estimates and represent the odds of abstinence in the auriculotherapy group compared with the control group.
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- Table 4. Effect of Auriculotherapy on Interval-Scaled Nicotine Withdrawal, Perceived Stress, and Tobacco Use at Weeks 3 and 6
Outcome Measure Treatment Group 4P* Control (n = 61) Intervention (n = 64) G T G × T Minnesota Nicotine Withdrawal Scale score Unadjusted mixed model† Week 3 14.7 (12.7–16.7) 13.4 (11.4–15.3) .56 .06 .42 Week 6 15.6 (13.5–17.7) 15.5 (13.5–17.5) Adjusted mixed model‡ Week 3 14.4 (12.2–16.8) 12.9 (10.7–15.1) .46 .10 .58 Week 6 15.4 (13.0–17.8) 14.8 (12.5–17.1) Perceived Stress Scale score Unadjusted mixed model† Week 3 5.2 (4.5–5.9) 4.8 (4.1–5.5) .42 .05 .75 Week 6 5.6 (4.9–6.3) 5.3 (4.6–6.0) Adjusted mixed model‡ Week 3 5.0 (4.3–5.8) 4.8 (4.0–5.5) .61 .16 .99 Week 6 5.4 (4.6–6.2) 5.1 (4.4–5.9) Cigarettes smoked among nonabstinent patients§ (n) Unadjusted mixed model† Week 3 9.5 (6.7–12.2) 6.8 (4.1–9.5) .17 .34 .73 Week 6 10.0 (7.3–12.7) 8.0 (5.3–10.7) Adjusted mixed model‡ Week 3 7.9 (4.9–10.9) 7.0 (3.9–10.1) .76 .29 .79 Week 6 8.7 (5.7–11.7) 8.3 (5.2–11.4) -
↵* Reported P values for each measure represent overall tests about type 3 fixed effects for both unadjusted and adjusted models.
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↵† Values represent least squares mean (95% confidence interval) estimates from an unadjusted mixed model in which each outcome was regressed for treatment group (G), time occasion (T), the interaction between group and time (G × T), and the value of the outcome measure before measurement.
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↵‡ Values represent least squares mean (95% confidence interval) estimates from an adjusted mixed model that controls for age, sex, and the motivation to quit smoking at baseline.
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↵§ Study participants that remained nonabstinent at weeks 3 and 6, according to urine cotinine levels.
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