Effectiveness of a Single Auriculotherapy Session for Smoking Cessation: A Prospective, Randomized, Single-Blind, Superiority, Multicenter Trial.

OBJECTIVE

Tobacco use is a leading cause of morbidity and mortality worldwide. Complementary therapies, such as auriculotherapy, are increasingly being explored for smoking cessation; however, inconsistent administration methods have limited definitive evidence. This study evaluated whether a single auriculotherapy session promotes smoking cessation.

METHODS

In this multicenter, randomized, single-blind, superiority clinical trial conducted at a tertiary care university hospital and two private practices in France, we enrolled cigarette smokers aged ≥18 years who were motivated to quit. Participants were randomized into two groups using centralized computer-generated allocation: auriculotherapy (AUR) and sham auriculotherapy (SHAM). In the AUR group, specific ear points were treated with cryo-auriculotherapy (nitrous oxide gas applied for 2 sec). In the SHAM group, the same points were treated using an empty canister containing only a propellant gas. The participants were blinded to their group assignment. The primary outcome was the percentage of participants who achieved smoking cessation at 1 month, defined as a urinary cotinine level of <50 μg/L. Secondary outcomes included self-reported cessation, exhaled carbon monoxide levels, anxiety, depression, stress, weight gain, and auriculotherapy side effects.

RESULTS

Between November 16, 2021, and October 23, 2023, 90 participants were enrolled (45 in each group). The primary analysis included 36 participants in the AUR group and 32 in the SHAM group. Smoking cessation rates based on urinary cotinine <50 μg/L were similar: 18.8% (95% confidence interval [CI]: 0.09-0.35) in SHAM and 33.0% (95% CI: 0.20-0.50) in AUR (p = 0.174). No significant adverse events or unintended effects were observed.

CONCLUSION

A single cryo-auriculotherapy session did not significantly enhance smoking cessation compared with the sham session.