title: Ear acupressure for smoking cessation: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Smoking is the largest preventable cause of death and disease worldwide but smokers often fail to quit due to nicotine withdrawal symptoms. Current available pharmaceutical therapies may assist with smoking cessation but may have side effects. Ear acupressure (EAP) and ear acupuncture have been used for smoking cessation, and some positive results have been reported. The aim of the study is to assess the efficacy and safety of EAP in assisting individuals to quit smoking and/or support them in the management of nicotine withdrawal symptoms.
  
  
  METHODS
  This study will be a randomised, single-blind, sham-controlled study conducted at RMIT University in Melbourne, Australia. Adult smokers will be randomly assigned to receive EAP specifically for smoking cessation or nonspecific EAP treatments. After a 2-week run-in, participants will be treated once a week for 8 weeks and followed up for 12 weeks. The primary outcome measures will be 7 day point-prevalence cessation rate by self-report validated by expired carbon monoxide and nicotine withdrawal symptoms measured by the Mood and Physical Symptoms Score questionnaire. Secondary outcomes will be self-reported usage of nicotine replacement therapies, cigarette consumption, body weight change and quality of life. The safety end point will be self-reported adverse events associated with EAP. Intention-to-treat analysis will be applied.
  
  
  CONCLUSIONS
  Findings from this study will determine if this EAP intervention alone can be an effective and safe therapy to assist with smoking cessation and the management of nicotine withdrawal symptoms.
authors.affiliation: School of Health Sciences, and Traditional and Complementary Medicine Research Program, Health Innovations Research Institute, RMIT University, Bundoora, Australia.
authors.forename: Anthony L
authors.initials: AL
authors.lastname: Zhang
authors.forename: Yuan Ming
authors.initials: YM
authors.lastname: Di
authors.forename: Christopher
authors.initials: C
authors.lastname: Worsnop
authors.forename: Brian H
authors.initials: BH
authors.lastname: May
authors.forename: Charlie C L
authors.initials: CC
authors.lastname: Xue
mesh_terms: D019050:Acupressure / Q000592:standards*; D000328:Adult; D004423:Ear; D005260:Female; D006801:Humans; D008297:Male; D016037:Single-Blind Method; D016540:Smoking Cessation / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult