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Forsch Komplementmed 2013;20:290–294 Published online: August 15, 2013


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 Schlüsselwörter
Smoking͐Tobacco͐Smoking cessation͐Ear acupressureand Rauchen͐Tabak͐Rauchentwöhnung͐Ohr-AkupressurXQG
ear acupuncture -Akupunktur

Summary Zusammenfassung
Background: Smoking is the largest preventable cause of death Hintergrund: Rauchen ist die weltweit größte vermeidbare To-
and disease worldwide but smokers often fail to quit due to nico- desursache und Ursache für Erkrankungen, jedoch gelingt es
tine withdrawal symptoms. Current available pharmaceutical Rauchern aufgrund von Nikotinentzugserscheinungen oftmals
therapies may assist with smoking cessation but may have side nicht, das Rauchen aufzugeben. Seit Kurzem verfügbare pharma-
effects. Ear acupressure (EAP) and ear acupuncture have been zeutische Therapien können das Aufhören zwar unterstützen,
used for smoking cessation, and some positive results have aber auch Nebenwirkungen zeigen. Ohr-Akupressur (OAP) und
been reported. The aim of the study is to assess the efficacy and -Akupunktur wurden bereits im Rahmen der Rauchentwöhnung
safety of EAP in assisting individuals to quit smoking and/or angewendet und einige positive Ergebnisse berichtet. Das Ziel
support them in the management of nicotine withdrawal symp- der vorliegenden Studie ist es, die Wirksamkeit und Sicherheit
toms. Methods: This study will be a randomised, single-blind, von OAP im Hinblick auf die Hilfestellung zur Rauchentwöhnung
sham-controlled study conducted at RMIT University in Mel- und/oder die Unterstützung der Betroffenen im Umgang mit Ni-
bourne, Australia. Adult smokers will be randomly assigned to kotinentzugserscheinungen zu bewerten. Methoden: Die hier be-
receive EAP specifically for smoking cessation or nonspecific schriebene Untersuchung ist als randomisierte, einfach verblin-
EAP treatments. After a 2-week run-in, participants will be treat- dete, mittels Scheinbehandlung kontrollierte Studie geplant, die
ed once a week for 8 weeks and followed up for 12 weeks. The an der RMIT-Universität in Melbourne, Australien, durchgeführt
primary outcome measures will be 7 day point-prevalence ces- wird. Erwachsene Raucher werden randomisiert einer Behand-
sation rate by self-report validated by expired carbon monoxide lungs- oder Scheinbehandlungsgruppe zugeteilt, die entweder
and nicotine withdrawal symptoms measured by the Mood and eine spezifische Behandlung mit OAP für Raucher oder nichtspe-
Physical Symptoms Score questionnaire. Secondary outcomes zifische OAP-Behandlungen erhalten. Nach einer 2-wöchigen
will be self-reported usage of nicotine replacement therapies, Anlaufphase werden die Teilnehmer 8 Wochen lang einmal pro
cigarette consumption, body weight change and quality of life. Woche behandelt und im Anschluss daran 12 Wochen lang nach-
The safety end point will be self-reported adverse events associ- untersucht. Der primäre Parameter ist ein 7-tägiger Punktpräva-
ated with EAP. Intention-to-treat analysis will be applied. Discus- lenzwert zur Rauchaufgabe im Rahmen eines Selbstberichts.
sion: Findings from this study will determine if this EAP inter- Dies wird validiert durch die geäußerten Kohlenmonoxid- und
vention alone can be an effective and safe therapy to assist with Nikotinentzugserscheinungen, die mit dem «Mood and Physical
smoking cessation and the management of nicotine withdrawal Symptoms Score»-Fragebogen erfasst werden. Der sekundäre
symptoms. 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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© 2013 S. Karger GmbH, Freiburg Prof. Charlie Xue


1661-4119/13/0204-0290$38.00/0 School of Health Sciences
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Information@Karger.com Accessible online at: Health Innovations Research Institute, RMIT University
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charlie.xue@rmit.edu.au
Introduction ing cessation found an inconclusive result for acupressure and
recommended high quality trials with rigorous trial methodol-
Smoking is recognised as the largest single preventable ogies [18].
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 Objectives
directly linked to lung cancer and is the most significant risk
factor for chronic obstructive pulmonary disease (COPD) [3]. This study aims to assess the efficacy and safety of EAP in
Despite the detrimental health effects, smokers often find it assisting individuals to quit smoking and/or support them in
difficult to quit. A major inhibiting factor is nicotine withdraw- the management of nicotine withdrawal symptoms.
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- Methods
pulse control of negative emotions such as anger has been as-
sociated with relapse [8, 9]. Further, an increase in body weight Study Design
The study is a randomised, single-blind, sham-controlled trial. Block
may be associated with quitting smoking [10], which may dis-
randomisation will be conducted by an independent researcher using a
courage weight-conscious smokers to quit smoking. computer generated randomisation list. The independent researcher will
Currently, the most effective methods of helping smokers to not be involved in any other trial procedures. The randomised group
quit are combinations of pharmacotherapy with advice and codes will be placed into sealed, opaque envelopes by an independent
behavioural support [11]. However, these interventions last person.
Participants, data entry and analysis personnel will be blinded to treat-
typically only a few months [12] and adverse events (AEs) re-
ment allocations. The acupuncturist, who cannot be blinded, will be
lated to pharmacotherapy have been reported. trained to perform the same procedures at each consultation and in-
Nicotine replacement therapy (NRT) is the most common structed not to discuss treatment procedures with the participants.
aid for smoking cessation and various forms are available After a 2-week run-in period and before the first treatment, partici-
over-the-counter. A systematic review on AEs associated with pants who meet all inclusion criteria will be asked to randomly select a
sealed opaque envelope with the randomisation code inside. Participants
NRT found an increased risk of heart palpitations, chest pains,
will be randomly allocated into either the smoking-specific ear acupres-
nausea and vomiting, gastrointestinal complaints and insom- sure (SSEAP) or the nonspecific ear acupressure (NSEAP) group, with a
nia [13]. The US Food and Drug Administration placed a 1:1 ratio. Participants will select a quit date before the 3rd treatment. The
‘black box’ warning label on the nicotine receptor partial ago- trial will take 22 weeks, consisting of 2-week run-in, 8-week treatment
nist varenicline and antidepressant bupropion, highlighting and 12-week follow-up periods. The recruitment process and trial proce-
dures are illustrated in figure 1.
the risk of serious neuropsychiatric symptoms in patients us-
The study will be conducted at the School of Health Sciences, RMIT
ing these products including depressed mood, suicidal thoughts University, Melbourne, Australia and has been approved by the RMIT
and behaviour and attempted suicide [14]. Therefore, the in- Human Research Ethics Committee. It is registered with the Australian
vestigation of other therapeutic options for smoking cessation New Zealand Clinical Trials Registry (no. ACTRN12611000761965). Re-
is warranted. porting of the study will be guided by the CONSORT statement [19, 20]
and reporting of acupuncture will follow the relevant extensions [21].
Ear acupuncture and ear acupressure (EAP) have been
used for smoking cessation with some positive results reported. Participants
One study (N = 141) found that the combination of true acu- Participants will be recruited by advertisements in the local newspa-
puncture and education demonstrated almost twice the cessa- per, flyers and notices on the RMIT University website. Interested par-
tion rate (40%) of education plus sham acupuncture (22%). ticipants can telephone or email the trial coordinator for further informa-
tion. Preliminary screening will occur over the telephone or through
The treatment effect trend persisted in the combined real acu-
email and eligible participants will be invited to attend an initial assess-
puncture and education group at 3-month follow-up (40 vs. ment (visit 1) at the trial site. On their first visit, participants will receive a
17%) [15]. Wing et al. [16] compared active ear plus body acu- thorough explanation of the study procedure and, if they agree to partici-
pressure (n = 38) with sham ear plus body acupressure (n = 32) pate, sign informed consent documents. Then they will be enrolled by the
in active smokers for 3 weeks with 3 weekly follow-ups and trial coordinator. Participants will complete a screening questionnaire
and the Contemplation Ladder [22].
then a follow-up at 3 months. Both groups reduced smoking
Inclusion criteria: males and females over 18 years of age, who have
but there were no significant differences between them. Wu et smoked 10 or more cigarettes a day for at least 1 year, and who intend to
al. [17] compared a treatment group (n = 59) receiving ear acu- stop smoking on the quit date chosen by themselves.
puncture with a sham acupuncture group (n = 59) for 8 weeks Exclusion criteria: pathological condition of the ear (e.g., otitis ex-
with monthly follow-up for 6 months. The treatment group 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-
showed a significant decrease in the nicotine withdrawal symp-
propion or varenicline; enrolment in a quit smoking program; partici-
tom score. There were no severe AEs associated with ear acu- pation of other persons from the same household; intake of antide-
puncture reported in either group. A systematic review of trials pressant or antipsychotic medications; current alcohol or substance
of acupuncture, acupressure and related techniques for smok- abuse; pregnancy; usage of ear acupuncture or EAP for a respiratory
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Protocol
Fig. 1. Participant flow chart.

condition and/or smoking cessation within the last 12 months; acu- or nonspecific ear acupoints on one of the participants’ ears. There will be
puncture students or practitioners; people who do not read or under- no skin penetration. Once taped on the ear, the acupuncturist will press
stand English. 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
Intervention themselves throughout the week and whenever they feel a craving for
Participants will receive SSEAP or NSEAP on a weekly basis during cigarettes. Pellet(s) that drop off during the week will not be replaced and
the 8-week treatment period. All treatments will be performed by the the remaining pellets will be removed by the acupuncturist at the subse-
same registered acupuncturist to ensure participant blinding and consist- quent visit. The 2 ears are used alternately on a weekly basis.
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 Outcome Measures
(CO1), Hunger (extra) and Liver (CO12) [23]. These points have been
used or recommended in the literature for smoking cessation [15, 16, 24]. Data will be collected through participants’ self-reported case report
Due to the large number of acupoints on the ear, it is difficult to con- forms (CRFs). Outcome measures will be evaluated at the end of treat-
struct a plausible non-EAP control. 5 EAP points which are not specific ment and follow-up periods.
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 Primary Outcome Measures
known to be used for smoking cessation or respiratory conditions [23]. Smoking cessation: The Contemplation Ladder will be administered at
Press Pellets S / stainless steel; Tan Tapes (Magrain Pellets, Acuneeds baseline, end of treatment and end of follow-up to assess participants’ de-
Co., Mount Waverley, VIC, Australia) will be used. Each pellet is 1.2 mm termination to quit smoking (table 1) [22]. Successful cessation will be
in diameter and attached to a round adhesive tape (7 mm in diameter) in defined as 7-day point prevalence (no smoking over 7 consecutive days)
a tan colour which is close to skin colour. The skin surface will be steri- [25]. It will be measured during the treatment period by self-report and
lised with a 75% alcoholic swab before 5 pellets are taped on the specific 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, Discussion
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).
This study will determine if this EAP intervention alone
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- provides an effective therapy for adult smokers who wish to
mary outcome measure. Data collected in this study could be used for stop smoking. The results will also identify if this intervention
sample size calculations in any future studies. can aid smokers in the management of nicotine withdrawal
Nicotine withdrawal symptoms: The Fagerström Test for Nicotine De- symptoms and/or reduce cigarette consumption in the smok-
pendence will be administered at baseline to assess the equivalence of
ing cessation process. The study will also assess the safety pro-
groups (table 1) [26]. Nicotine withdrawal symptoms will be assessed
using the Mood and Physical Symptoms Scale as evaluated by West and file of noninvasive EAP used continuously over an 8-week
Hijak [27], in which the participants rate the severity of depression, irrita- period in a real-world setting that allows concomitant NRT
bility, restlessness, hunger, poor concentration, anxiety, insomnia, usage. A previous study that employed a similar EAP protocol
number and levels of smoking urges and physical symptoms such as for persistent allergic rhinitis found that EAP was well-toler-
mouth sores, constipation and cough or sore throat [27].
ated by participants [28].
Secondary Outcome Measures If EAP is demonstrated to be effective and safe, smokers
NRT usage: Participants will record any use of NRTs in the CRFs, in- may consider using this intervention along with pharmaco-
cluding the form, dose and frequency. therapy to assist quitting smoking. This study may also provide
Cigarette consumption: Participants will record in the CRFs number of directions for future research into acupressure or acupuncture
cigarettes smoked daily throughout the trial period.
for smoking or other addiction conditions.
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 Acknowledgements
will complete a question on the CRF regarding their group allocation
(table 1). This study is partially supported by 2 project grants (no. 555412 and
Quality of Life: Quality of life will be evaluated using the Short-Form no. 616609) of the National Health and Medical Research Council
Health Survey 36 (SF-36). The forms will be filled out at 3 time points as (NHMRC). Trial registration: Australian New Zealand Clinical Trials
shown in table 1. Registry (no. ACTRN12611000761965). We thank the following people
for granting permission to use the following outcome measure instru-
Adverse Events ments: Prof. Karl Fagerstrom for the Nicotine Dependence Test, Prof.
Participants will report AEs throughout the study and receive advice Robert West for the Mood and Physical Symptom Score and Dr. Lois
accordingly. Participants will record any AEs in their CRFs and score Biener for the Contemplation Ladder.
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 Disclosure Statement
will be scored by the participant as follows: 1 = unrelated, 2 = possibly,
3 = probably, 4 = definitely. The authors have no financial interests or other conflicts of interest
related to the material in this manuscript. This research has not been sub-
Statistical Analysis mitted, in whole or in part, to other journals. All authors have contrib-
All data will be analysed by an independent statistician using SPSS uted to the paper.
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.
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