United States military veterans continue to smoke at a rate higher than the general population Some veterans may not respond well to current standard treatments such as bupropion or nicotine replacement, or they may have contraindications to one or both of these drugs. In addition, veterans tend to have more co-morbid medical conditions and require higher levels of polypharmacy than many groups. Adding more drugs to an already complicated treatment regimen increases the risk for drug-drug interactions, and may compromise adherence to other medications. This pilot study is proposed in preparation for a large, double blind, randomized, placebo controlled trial of a novel treatment for smoking cessation, auriculotherapy, compared to a sham intervention (placebo). Auriculotherapy is similar to methods used in acupuncture, but relies on an electrical current undetectable by the person, to stimulate prescribed points on the ear to facilitate smoking cessation.
The objectives for this pilot study are to: (a) estimate sample size calculation for a larger trial; determine the integrity and feasibility of study protocol; (b) test data collection forms; (c) test randomization procedure; (d) estimate consent rate and barriers to recruitment; (e) determine acceptability of auriculotherapy as an intervention for smoking cessation in the veteran population, and (f) determine reliability and feasibility of the primary outcome measure - smoking abstinence. The long-term objective is to increase tobacco cessation among veterans without using a pharmacological intervention.
This study was a randomized, double-blind, placebo-controlled clinical trial pilot to determine the efficacy of auriculotherapy (stimulation of pre-determined bilateral aurical points) with 80 Hz (treatment) versus zero Hz (placebo) for smoking cessation. All participants were scheduled for five individual treatments, one week apart, using the Stim Flex 400A TENS unit. Primary outcome measures were urine cotinine and self report for abstinence which was assessed after 2 and 5 treatments. Secondary outcomes included nicotine withdrawal symptoms (pre-post MNWS score), level of stress during treatment period (pre-post PPS-4 score), level of tobacco use during treatment period. Data was analysed on intent-to-treat basis.
One hundred-twenty five participants were recruited between August 2010 to January 2011 with 85% of all participants receiving at least 4 treatments, and 11% lost to follow-up. Auriculotherapy was rated as good to excellent for both groups ( 76% intervention, 65% placebo). Abstinence rate for both groups was validated biochemically and with self report at week 3 (22% intervention, 17% placebo) and week 6 (20.5% intervention, 24.6% placebo). There was no statistical difference between groups, therefore, the results of this trial do not support the hypothesis that auriculotherapy is superior to placebo for achieving smoking cessation.
This study is consistent with Cochran Review results for "Acupuncture and Related Interventions for Smoking Cessation, 2011" which reported only little evidence from randomized controlled trials that any of these therapies work better than placebo, despite widespread positive anecdotal reports.
- Fritz DJ, Carney RM, Steinmeyer B, Ditson G, Hill N, Zee-Cheng J. The efficacy of auriculotherapy for smoking cessation: a randomized, placebo-controlled trial. Journal of the American Board of Family Medicine : JABFM. 2013 Jan 1; 26(1):61-70.