Documentation · Dokumentation
Forsch Komplementmed 2013;20:290–294
DOI: 10.1159/000354597
Ear Acupressure for Smoking Cessation: Study Protocol
for a Randomised Controlled Trial
Anthony L. Zhanga Yuan Ming Dia Christopher Worsnopb Brian H. Maya Charlie C.L. Xuea,c
a
School of Health Sciences, and Traditional and Complementary Medicine Research Program, Health Innovations Research Institute,
RMIT University, Bundoora,
b
Department of Respiratory and Sleep Medicine, Austin Hospital, Heidelberg, Australia
c
Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China
Keywords
Smoking͐Tobacco͐Smoking cessation͐Ear acupressureand
ear acupuncture
Summary
Background: Smoking is the largest preventable cause of death
and disease worldwide but smokers often fail to quit due to nico-
tine 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 symp-
toms. Methods: This study will be a randomised, single-blind,
sham-controlled study conducted at RMIT University in Mel-
bourne, 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 treat-
ed once a week for 8 weeks and followed up for 12 weeks. The
primary outcome measures will be 7 day point-prevalence ces-
sation 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 associ-
ated with EAP. Intention-to-treat analysis will be applied. Discus-
sion: Findings from this study will determine if this EAP inter-
vention alone can be an effective and safe therapy to assist with
smoking cessation and the management of nicotine withdrawal
symptoms.
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Published online: August 15, 2013
Schlüsselwörter
Rauchen͐Tabak͐Rauchentwöhnung͐Ohr-AkupressurXQG
-Akupunktur
Zusammenfassung
Hintergrund: Rauchen ist die weltweit größte vermeidbare To-
desursache und Ursache für Erkrankungen, jedoch gelingt es
Rauchern aufgrund von Nikotinentzugserscheinungen oftmals
nicht, das Rauchen aufzugeben. Seit Kurzem verfügbare pharma-
zeutische Therapien können das Aufhören zwar unterstützen,
aber auch Nebenwirkungen zeigen. Ohr-Akupressur (OAP) und
-Akupunktur wurden bereits im Rahmen der Rauchentwöhnung
angewendet und einige positive Ergebnisse berichtet. Das Ziel
der vorliegenden Studie ist es, die Wirksamkeit und Sicherheit
von OAP im Hinblick auf die Hilfestellung zur Rauchentwöhnung
und/oder die Unterstützung der Betroffenen im Umgang mit Ni-
kotinentzugserscheinungen zu bewerten. Methoden: Die hier be-
schriebene Untersuchung ist als randomisierte, einfach verblin-
dete, mittels Scheinbehandlung kontrollierte Studie geplant, die
an der RMIT-Universität in Melbourne, Australien, durchgeführt
wird. Erwachsene Raucher werden randomisiert einer Behand-
lungs- oder Scheinbehandlungsgruppe zugeteilt, die entweder
eine spezifische Behandlung mit OAP für Raucher oder nichtspe-
zifische OAP-Behandlungen erhalten. Nach einer 2-wöchigen
Anlaufphase werden die Teilnehmer 8 Wochen lang einmal pro
Woche behandelt und im Anschluss daran 12 Wochen lang nach-
untersucht. Der primäre Parameter ist ein 7-tägiger Punktpräva-
lenzwert zur Rauchaufgabe im Rahmen eines Selbstberichts.
Dies wird validiert durch die geäußerten Kohlenmonoxid- und
Nikotinentzugserscheinungen, die mit dem «Mood and Physical
Symptoms Score»-Fragebogen erfasst werden. Der sekundäre
Parameter umfasst einen Selbstbericht über Nikotinersatzthera-
pien, Zigarettenkonsum, Veränderungen des Körpergewichts
und Lebensqualität. Die Studienteilnehmer werden dazu ange-
halten, die Studie abzubrechen, sobald mit OAP assoziierte un-
erwünschte Nebenwirkungen auftreten. Eine Intention-to-Treat-
Analyse wird angewendet. Diskussion: Die Erkenntnisse der
Studie werden ergeben, ob die OAP allein eine effektive und
sichere Therapieoption zur Unterstützung des Versuchs, das
Rauchen aufzugeben und des Umgangs mit Nikotinentzugs-
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erscheinungen bei erwachsenen Rauchern sein kann.
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Prof. Charlie Xue
School of Health Sciences
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Traditional and Complementary Medicine Research Program
Health Innovations Research Institute, RMIT University
PO Box 71, VIC 3083 Bundoora, Australia
charlie.xue@rmit.edu.au
 Introduction
Smoking is recognised as the largest single preventable
cause of death and disease worldwide [1]. Tobacco kills nearly
6 million people each year, of which more than 600,000 are
non-smokers exposed to second-hand smoke [2]. Smoking is
directly linked to lung cancer and is the most significant risk
factor for chronic obstructive pulmonary disease (COPD) [3].
Despite the detrimental health effects, smokers often find it
difficult to quit. A major inhibiting factor is nicotine withdraw-
al symptoms [4–6], including emotional distress, depressed
mood, anxiety and sleep disturbances. In the USA, more than
80% of quitting efforts are unsuccessful [7]. Notably, poor im-
pulse control of negative emotions such as anger has been as-
sociated with relapse [8, 9]. Further, an increase in body weight
may be associated with quitting smoking [10], which may dis-
courage weight-conscious smokers to quit smoking.
Currently, the most effective methods of helping smokers to
quit are combinations of pharmacotherapy with advice and
behavioural support [11]. However, these interventions last
typically only a few months [12] and adverse events (AEs) re-
lated to pharmacotherapy have been reported.
Nicotine replacement therapy (NRT) is the most common
aid for smoking cessation and various forms are available
over-the-counter. A systematic review on AEs associated with
NRT found an increased risk of heart palpitations, chest pains,
nausea and vomiting, gastrointestinal complaints and insom-
nia [13]. The US Food and Drug Administration placed a
‘black box’ warning label on the nicotine receptor partial ago-
nist varenicline and antidepressant bupropion, highlighting
the risk of serious neuropsychiatric symptoms in patients us-
ing these products including depressed mood, suicidal thoughts
and behaviour and attempted suicide [14]. Therefore, the in-
vestigation of other therapeutic options for smoking cessation
is warranted.
Ear acupuncture and ear acupressure (EAP) have been
used for smoking cessation with some positive results reported.
One study (N = 141) found that the combination of true acu-
puncture and education demonstrated almost twice the cessa-
tion rate (40%) of education plus sham acupuncture (22%).
The treatment effect trend persisted in the combined real acu-
puncture and education group at 3-month follow-up (40 vs.
17%) [15]. Wing et al. [16] compared active ear plus body acu-
pressure (n = 38) with sham ear plus body acupressure (n = 32)
in active smokers for 3 weeks with 3 weekly follow-ups and
then a follow-up at 3 months. Both groups reduced smoking
but there were no significant differences between them. Wu et
al. [17] compared a treatment group (n = 59) receiving ear acu-
puncture with a sham acupuncture group (n = 59) for 8 weeks
with monthly follow-up for 6 months. The treatment group
showed a significant decrease in the nicotine withdrawal symp-
tom score. There were no severe AEs associated with ear acu-
puncture reported in either group. A systematic review of trials
of acupuncture, acupressure and related techniques for smok-
Acupressure for Smoking Cessation Study
Protocol
ing cessation found an inconclusive result for acupressure and
recommended high quality trials with rigorous trial methodol-
ogies [18].
Objectives
This study aims 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
Study Design
The study is a randomised, single-blind, sham-controlled trial. Block
randomisation will be conducted by an independent researcher using a
computer generated randomisation list. The independent researcher will
not be involved in any other trial procedures. The randomised group
codes will be placed into sealed, opaque envelopes by an independent
person.
Participants, data entry and analysis personnel will be blinded to treat-
ment allocations. The acupuncturist, who cannot be blinded, will be
trained to perform the same procedures at each consultation and in-
structed not to discuss treatment procedures with the participants.
After a 2-week run-in period and before the first treatment, partici-
pants who meet all inclusion criteria will be asked to randomly select a
sealed opaque envelope with the randomisation code inside. Participants
will be randomly allocated into either the smoking-specific ear acupres-
sure (SSEAP) or the nonspecific ear acupressure (NSEAP) group, with a
1:1 ratio. Participants will select a quit date before the 3rd treatment. The
trial will take 22 weeks, consisting of 2-week run-in, 8-week treatment
and 12-week follow-up periods. The recruitment process and trial proce-
dures are illustrated in figure 1.
The study will be conducted at the School of Health Sciences, RMIT
University, Melbourne, Australia and has been approved by the RMIT
Human Research Ethics Committee. It is registered with the Australian
New Zealand Clinical Trials Registry (no. ACTRN12611000761965). Re-
porting of the study will be guided by the CONSORT statement [19, 20]
and reporting of acupuncture will follow the relevant extensions [21].
Participants
Participants will be recruited by advertisements in the local newspa-
per, flyers and notices on the RMIT University website. Interested par-
ticipants can telephone or email the trial coordinator for further informa-
tion. Preliminary screening will occur over the telephone or through
email and eligible participants will be invited to attend an initial assess-
ment (visit 1) at the trial site. On their first visit, participants will receive a
thorough explanation of the study procedure and, if they agree to partici-
pate, sign informed consent documents. Then they will be enrolled by the
trial coordinator. Participants will complete a screening questionnaire
and the Contemplation Ladder [22].
Inclusion criteria: males and females over 18 years of age, who have
smoked 10 or more cigarettes a day for at least 1 year, and who intend to
stop smoking on the quit date chosen by themselves.
Exclusion criteria: pathological condition of the ear (e.g., otitis ex-
terna); wearing of a hearing aid (which could interfere with the EAP);
history of allergy to adhesive dressing; usage of NRT or intake of bu-
propion or varenicline; enrolment in a quit smoking program; partici-
pation of other persons from the same household; intake of antide-
pressant or antipsychotic medications; current alcohol or substance
abuse; pregnancy; usage of ear acupuncture or EAP for a respiratory
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Fig. 1. Participant flow chart.
condition and/or smoking cessation within the last 12 months; acu-
puncture students or practitioners; people who do not read or under-
stand English.
Intervention
Participants will receive SSEAP or NSEAP on a weekly basis during
the 8-week treatment period. All treatments will be performed by the
same registered acupuncturist to ensure participant blinding and consist-
ency of treatment.
Five EAP points are used for each participant. In the SSEAP group,
pressure pellets are placed at: Shen Men (TF4), Lung (CO14), Mouth
(CO1), Hunger (extra) and Liver (CO12) [23]. These points have been
used or recommended in the literature for smoking cessation [15, 16, 24].
Due to the large number of acupoints on the ear, it is difficult to con-
struct a plausible non-EAP control. 5 EAP points which are not specific
for smoking cessation are chosen. The NSEAP points are: Lun 2 (HX10),
Jian (SF4,5), Suogu (SF6), Zhen (AT3), Ya (LO1). These points are not
known to be used for smoking cessation or respiratory conditions [23].
Press Pellets S / stainless steel; Tan Tapes (Magrain Pellets, Acuneeds
Co., Mount Waverley, VIC, Australia) will be used. Each pellet is 1.2 mm
in diameter and attached to a round adhesive tape (7 mm in diameter) in
a tan colour which is close to skin colour. The skin surface will be steri-
lised with a 75% alcoholic swab before 5 pellets are taped on the specific
292 Forsch Komplementmed 2013;20:290–294
or nonspecific ear acupoints on one of the participants’ ears. There will be
no skin penetration. Once taped on the ear, the acupuncturist will press
each pellet for 10 sec, or until the ear became reddish and/or slightly sore.
The participants will be instructed to press the pellets 3 times daily by
themselves throughout the week and whenever they feel a craving for
cigarettes. Pellet(s) that drop off during the week will not be replaced and
the remaining pellets will be removed by the acupuncturist at the subse-
quent visit. The 2 ears are used alternately on a weekly basis.
Outcome Measures
Data will be collected through participants’ self-reported case report
forms (CRFs). Outcome measures will be evaluated at the end of treat-
ment and follow-up periods.
Primary Outcome Measures
Smoking cessation: The Contemplation Ladder will be administered at
baseline, end of treatment and end of follow-up to assess participants’ de-
termination to quit smoking (table 1) [22]. Successful cessation will be
defined as 7-day point prevalence (no smoking over 7 consecutive days)
[25]. It will be measured during the treatment period by self-report and
validated by an exhaled carbon monoxide (CO) concentration of ) 10 ppm
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Table 1. Measurements taken during the study
Visit/week 1/0 2/2 3–8/3–9 9/10 10/22
period
Contemplation ladder 9 9 9
Fagerström Test for Nicotine Dependence 9
SF-36 9 9 9
Body weight 9 9 9 9 9
Exhaled carbon monoxide 9 9 9 9 9
Credibility of blinding 9 9

SF-36 = Short-Form Health Survey

using the piCO + Smokerlyser (Bedfont Scientific Ltd., Upchurch, Kent,
UK). Measurement of exhaled CO will occur each time the participants
are on site and will be recorded in their CRF (visit 1 to visit 10, table 1).
Based on existing literature, there was no study with a comparable design
that could provide data to perform a sample size calculation for this pri-
mary outcome measure. Data collected in this study could be used for
sample size calculations in any future studies.
Nicotine withdrawal symptoms: The Fagerström Test for Nicotine De-
pendence will be administered at baseline to assess the equivalence of
groups (table 1) [26]. Nicotine withdrawal symptoms will be assessed
using the Mood and Physical Symptoms Scale as evaluated by West and
Hijak [27], in which the participants rate the severity of depression, irrita-
bility, restlessness, hunger, poor concentration, anxiety, insomnia,
number and levels of smoking urges and physical symptoms such as
mouth sores, constipation and cough or sore throat [27].
Secondary Outcome Measures
NRT usage: Participants will record any use of NRTs in the CRFs, in-
cluding the form, dose and frequency.
Cigarette consumption: Participants will record in the CRFs number of
cigarettes smoked daily throughout the trial period.
Weight change: Each time the participants are on site (visit 1 to visit 10)
their body weight will be measured and recorded in their CRF (table 1).
Credibility of blinding: To evaluate the credibility of the blinding pro-
cedure, at the end of the first and the last treatment week, participants
will complete a question on the CRF regarding their group allocation
(table 1).
Quality of Life: Quality of life will be evaluated using the Short-Form
Health Survey 36 (SF-36). The forms will be filled out at 3 time points as
shown in table 1.
Adverse Events
Participants will report AEs throughout the study and receive advice
accordingly. Participants will record any AEs in their CRFs and score
these using a 3-point scale, 1 = mild (easily tolerated, causing minimal
discomfort), 2 = moderate (discomfort significant enough to interfere
with daily activities) and 3 = severe (incapacitating and/or requiring ther-
apeutic intervention). The relationship between the AEs and the EAP
will be scored by the participant as follows: 1 = unrelated, 2 = possibly,
3 = probably, 4 = definitely.
Statistical Analysis
All data will be analysed by an independent statistician using SPSS
version 18.0. Baseline characteristics of the groups will be assessed for
equivalence using independent samples t tests or chi-squared (Ǔ2) tests.
Intent-to-treat analysis will be applied. For primary and secondary out-
come measures, Ǔ2 tests, independent samples t tests and general linear
model will be used to compare group differences. SF Health Outcomes
Scoring software 4.0 will be used for SF-36 scores.
Discussion
This study will determine if this EAP intervention alone
provides an effective therapy for adult smokers who wish to
stop smoking. The results will also identify if this intervention
can aid smokers in the management of nicotine withdrawal
symptoms and/or reduce cigarette consumption in the smok-
ing cessation process. The study will also assess the safety pro-
file of noninvasive EAP used continuously over an 8-week
period in a real-world setting that allows concomitant NRT
usage. A previous study that employed a similar EAP protocol
for persistent allergic rhinitis found that EAP was well-toler-
ated by participants [28].
If EAP is demonstrated to be effective and safe, smokers
may consider using this intervention along with pharmaco-
therapy to assist quitting smoking. This study may also provide
directions for future research into acupressure or acupuncture
for smoking or other addiction conditions.
Acknowledgements
This study is partially supported by 2 project grants (no. 555412 and
no. 616609) of the National Health and Medical Research Council
(NHMRC). Trial registration: Australian New Zealand Clinical Trials
Registry (no. ACTRN12611000761965). We thank the following people
for granting permission to use the following outcome measure instru-
ments: Prof. Karl Fagerstrom for the Nicotine Dependence Test, Prof.
Robert West for the Mood and Physical Symptom Score and Dr. Lois
Biener for the Contemplation Ladder.
Disclosure Statement
The authors have no financial interests or other conflicts of interest
related to the material in this manuscript. This research has not been sub-
mitted, in whole or in part, to other journals. All authors have contrib-
uted to the paper.
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Protocol
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