Complementary Therapies in Medicine (2014) 22, 2125

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The effects of auricular electroacupuncture
on obesity in female patients A
prospective randomized placebo-controlled
pilot study
Regina Patricia Schukro
a,
, Christoph Heiserer
b
,
Andrea Michalek-Sauberer
a
, Andreas Gleiss
c
,
Sabine Sator-Katzenschlager
a
a
Department of Special Anaesthesia and Pain Therapy, Medical University of Vienna, Austria
b
Department of Surgery, General Hospital Steyr, Steyr, Austria
c
Center for Medical Statistics, Informatics, and Intelligent Systems, Medical University Vienna, Austria
Available online 31 October 2013
KEYWORDS
Auricular
acupuncture;
Electroacupuncture;
Obesity
Summary
Background: Obesity is a chronic condition related to serious morbidity and mortality of increas-
ing incidence and prevalence. Several studies show a signicantly higher weight loss with
acupuncture treatment. This is the rst prospective, randomized, double-blinded study, testing
the effects of auricular electroacupuncture on weight loss in obese female patients.
Methods: 56 female obese patients (age > 18, Body Mass Index, BMI > 25) were randomized to
receive either auricular acupuncture with electrical stimulation with a P-Stim

device (verum
group, n = 28) or placebo treatment with a P-Stim

dummy (n = 28) for four days. Three auricular

acupuncture points were chosen (hunger 18, stomach 87 and colon 91). The treatment was
performed once a week for a period of six weeks. A follow-up visit was performed after 4
weeks. At each visit body weight, BMI (Body Mass Index) and body fat were measured.
Results: Relative reduction of body weight was signicantly greater in the verum group (3.73%;
CI = 4.70 to 2.76) than in the placebo group (0.70%; CI = 1.57 to +0.16; p < 0.001) In addi-
tion we also observed a signicant reduction of BMI (p < 0.001) in the verum group (3.62%;
CI = 4.39 to 2.84) compared to placebo (0.82%; CI = 1.55 to 0.10; p < 0.001). No patient
reported side effects related to acupuncture.
Conclusion: In conclusion electrical auricular acupuncture could be a safe, additive, non-
pharmacological treatment in obese patients.
2013 Elsevier Ltd. All rights reserved.

Corresponding author at: Department of Special Anaesthesia and Pain Management, Medical University of Vienna, AKH Vienna, Waehringer
Guertel 18-20, A 1090 Vienna, Austria. Tel.: +43 1 40400 4144; fax: +43 1 40400 6422.
E-mail address: regina.schukro@meduniwien.ac.at (R.P. Schukro).
0965-2299/$ see front matter 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ctim.2013.10.002
22 R.P. Schukro et al.
Introduction
Obesity is a chronic condition that is related to seri-
ous morbidity and mortality of increasing incidence and
prevalence. Excess bodyweight is associated with elevated
health risks, such as cardiovascular and cerebrovascular dis-
eases as well as diabetes.
1
The Body Mass Index (BMI) is
generally accepted as classication of obesity. According
to WHO (World Health Organization) guidelines, a BMI of
>25.00 kg/m
2
is considered as overweight, 2529.99 kg m
2
as preobese and over 30.00 kg
2
as obese. As the incidence
of obesity increases new therapies to improve weight man-
agement are looked for.
Especially the effects of complementary medicine on
obesity are under closer investigation. Recent studies
showed a positive effect of acupuncture on appetite,
metabolism, intestinal motility and emotional factors such
as stress. In addition, it can increase neural activity in
the ventromedial nuclei of hypothalamus, the tone of the
smooth muscle of the stomach and levels of encephalin
and serotonin in the plasma and brain tissue.
2,3
The clinical
effects of acupuncture on obesity have been summarized by
several meta-analyses in
4,5
suggesting a positive effect of
acupuncture on weight loss in obese patients. The authors
however criticized a lack of randomized placebo-controlled
trials on this topic.
The aim of this study was to investigate if auricular
electroacupuncture combined with moderate diet recom-
mendations based on Traditional Chinese Medicine (TCM)
can result in bodyweight reduction in obese female patients
when compared to a placebo acupuncture treatment. It is
the rst study that uses a P-Stim

auricular electroacupunc-
ture device in the indication of weight loss.
Materials and methods
Study design and patient selection criteria
This prospective randomized placebo-controlled clinical
trial was conducted at the Department of Special Anesthesia
and Pain Management at the Medical University of Vienna
(AKH Vienna). The study was approved by the local ethics
committee according to the declaration of Helsinki. All par-
ticipants were healthy, obese women (age > 18, BMI > 25)
who had no prior experience with acupuncture or auricu-
lar acupuncture. Further exclusion criteria were pregnancy,
allergy against material (metal of needles or patch), bleed-
ing disorders, anticoagulation, implanted pacemaker or
implantable cardioverter debrillators.
Fifty six patients were randomized in two groups by a
computer-generated randomization table. Randomization of
patients was stratied with respect to age (<50 or 50 years)
and BMI (<30 or 30 kg/m
2
). Patients in the verum group
(n = 28) received auricular acupuncture with electrical stim-
ulation using a P-Stim

-electroacupuncture device (Biegler

GmbH. Allhangstrasse 18a, 3001 Mauerbach, Austria) at the
auricular acupuncture points hunger 18, stomach 87 and
colon 91. The P-Stim

-device consists of a battery-powered

stimulator worn behind the ear, which was connected to
sterile, single use permanent needles (titanium, 27 gauge,
length 3 mm). Electrical stimulation consisted of biphasic
constant current (2 mA) pulses of 1 Hz every 3 s (3 h of stim-
ulation followed by a pause of 3 h to avoid development of
tolerance).
In the placebo group (n = 28) a P-Stim

dummy was used.

The dummy-device had no power supply and had been
grinded to leave only metal plates.
An electrical conductance device meter (multipoint
selection pen
TM
, Biegler GmbH, Mauerbach, Austria) which
measures skin resistance, was used to identify acupuncture
points in both groups.
Patients received auricular electro acupuncture or
placebo for 4 days (24 h) per week during a period of
6 weeks. All patients received their acupuncture needles
between 07:00 and 11:00 a.m. A follow-up was performed 4
weeks after the last treatment.
At each visit, body weight, BMI and body fat were mea-
sured. The Body Impedance Analysis (BIA formulas) from
Schindler and Ludvik
6
were used for the calculation of the
FFM (fat free mass) and BCM (body cell mass).
Diet according to TCM guidelines
At the rst visit all patients received a dietary consulta-
tion following guidelines according to Traditional Chinese
Medicine (TCM). Patients should eat regularly (e.g. 3 times
a day), avoid cold and raw food, white sugar and fast food
and should reduce intake of dairy products.
Statistical analysis
The study was planned to detect a group difference of 4 per-
cent points with respect to relative weight change between
start and end of treatment. Since the variability of relative
weight change was unknown an a priori sample size of 60
patients was targeted, a number seen in previous studies.
After the data of 40 patients were available the standard
deviation was estimated (without performing an interim
analysis of the group comparison) in order to obtain a more
reliable sample size estimate (half-sampling). Based on
this new sample size further patients were nally recruited
for the study.
In the planning phase of the study the relative reduction
of body weight between baseline and end of treatment was
selected as the primary outcome variable. Relative reduc-
tion of body weight between baseline or end of treatment
and follow-up as well as relative reduction in BMI and body
fat were dened as secondary outcome variables.
Due to asymmetric distribution of some of the variables,
continuous baseline variables are presented as group spe-
cic medians and quartiles and compared between groups
using Wilcoxons rank-sum test. Relative weight changes
are calculated such that negative signs represent reduc-
tion (e.g., of weight). Missing values are imputed using
multiple imputation (proc MI of SAS with monotone
reg statement and 200 imputations). Boxplots of relative
weight changes use the full data set, i.e. available and
averaged imputed values. Models with imputed values are
analyzed using Rubins rules as implemented in proc mian-
alyze of SAS. ANOVA models are used to compare relative
changes between groups, age and baseline BMI are used
as co-variables for group adjustment. Results of univariate
Effects of auricular electroacupuncture on obesity 23
R
e
l
a
t
i
v
e

w
e
i
g
h
t

c
h
a
n
g
e

(
%
)
-11
-10
-9
-8
-7
-6
-5
-4
-3
-2
-1
0
1
2
3
4
5
6
start to FU end to FU start to end
Figure 1 Boxplots of relative change in body weight (negative
values represent weight reduction), light boxes: verum, dark
boxes: placebo. FU = follow-up.
models (i.e. without group adjustment) are very close to
adjusted results and are not shown.
The reported p-values are the results of two-sided tests.
P-values <0.05 were considered to be statistically signi-
cant. All computations were carried out using SAS software
Version 9.3 (SAS Institute Inc., Cary, NC, USA, 2010).
Results
Patients and demographic data
Fifty six healthy obese (BMI > 25) female patients were
enrolled in the study. Baseline characteristics are summa-
rized in Table 1. Median age in the verum group was slightly
higher than in the placebo group (54.1 vs. 49.7. years,
p = 0.283). Groups did not differ signicantly with regard to
initial weight, BMI, height and body fat. During the treat-
ment period 6 patients in the verum group and 5 patients in
the placebo group refused further participation. Addition-
ally, 3 patients (1 in the verum group, 2 in the placebo group)
were lost during follow up (i.e. after end of treatment).
Primary outcome parameter
Relative change of body weight during treatment
Boxplots of relative change in body weight are shown in
Fig. 1. The mean change in body weight in the verum group
was 3.73% (CI = 4.70 to 2.76) whereas in the placebo
group a reduction of only 0.70% (CI = 1.57 to +0.16) could
be observed. The mean difference between both groups was
3.03%-points (CI 1.724.33; p < 0.001).
Secondary outcome parameters
Relative change of body weight during the follow-up
period
The difference in weight change between the treatment
groups was retained after the treatment phase. The mean
change between end of study and follow-up visit was
1.37% (CI = 1.93 to 0.82) in the verum group and +0.54%
(CI = 0.01 to +1.09) in the placebo group. The mean differ-
ence between the groups was 1.91% points (CI = 1.132.70,
p < 0.001).
The mean change between begin of study and follow-
up visit was 5.08% (CI = 6.02 to 4.13) in the verum
group and 0.16% (CI = 1.06 to +0.74) in the placebo group
respectively. The mean difference between the groups was
4.92% points (CI = 3.616.22, p < 0.001).
Relative change of body mass index
The mean change between begin of study and end of
treatment was 3.62% (CI = 4.39 to 2.84) in the verum
group whereas in the placebo group a reduction of only
0.82% (CI = 1.55 to 0.10) points could be observed.
The mean difference between both groups was 2.79%-points
(p < 0.001).
The mean change between end of study and follow-up
visit was 1.44% (CI = 1.97 to 0.92) for the verum group
and 0.56% (CI = 0.011.11) for the placebo group. The mean
difference between follow-up and end of treatment was
2.00% points (CI = 1.262.75) for both groups (p < 0.001).
The mean change between begin of study and follow-up
visit was 4.99% (CI = 6.10 to 3.88) for the verum group
and 0.26% (CI = 1.32 to 0.79) for the placebo group. The
mean difference between begin of study and follow up was
4.73% points (CI = 3.216.24) for both groups (p < 0.001)
Relative change of body fat
The mean change between begin of study and end of treat-
ment was 5.93% (CI = 7.90 to 3.96) in the verum group
whereas in the placebo group only a reduction of 0.50%
(CI = 2.42 to 1.42) points could be observed. The mean dif-
ference between both groups was 5.43%-points (p < 0.001).
The mean change between end of study and follow-up
visit was 2.02% (CI = 5.82 to -1.79) for the verum group
and 0.44% (CI = 2.29 to 3.18) for the placebo group.
The mean difference between follow-up and end of treat-
ment was 2.46% points (CI = 2.22 to 7.13) for both groups
(p = 0.302).
The mean change between begin of study and follow-up
visit was 7.65% (CI = 11.86 to 3.45) for the verum group
and 0.17% (CI = 3.45 to 3.10) for the placebo group. The
mean difference between begin of study and follow up was
7.48% points (CI = 2.1712.78) for both groups (p = 0.005)
Side effects of acupuncture
No patient reported side effects related to acupuncture.
Eight patients reported side effects related to the P-
Stim

/placebo device, namely skin irritations behind the

ear caused by the adhesive patch of the P-Stim

/placebo
device.
24 R.P. Schukro et al.
Table 1 Baseline characteristics.
Variable Verum (n = 28) Placebo (n = 28)
Lower quartile Median Upper quartile Lower quartile Median Upper quartile
Age (years) 44.5 54.1 60.7 36.7 49.7 55.7
Weight (kg) 81.1 93.0 102.2 78.6 92.6 108.6
BMI (kg/m
2
) 30.0 33.7 36.8 28.0 33.9 37.1
Body fat (%) 35.8 43.1 51.6 32.8 45.4 52.4
Discussion
This study demonstrates a signicant effect of electrical
auricular acupuncture on weight loss in obese women. In
addition, also the BMI and body fat decreased.
Auricular acupuncture was associated with some mild
side effects that resolved immediately after end of appli-
cation. The mechanism how acupuncture might be useful in
the treatment of obesity is still under investigation. One
theory refers to a vagal effect on appetite and satiety.
7
Peripheral vagal nerve stimulation (VNS) via subcutaneous
electrodes positioned between the clavicle and the mastoid
or near the esophagogastric junction has been performed
for weight loss.
7
A positive association between some block-
ing algorithms and weight loss has been reported,
7
however,
comparative studies are lacking and the clinical value of VNS
has still to be conrmed.
8
Peuker and Filler provided an overview of the inner-
vations pattern of the lateral surface of the auricle. The
auricular branch of the vagus nerve (ABNV) supplies mainly
the cymba conchae (100%), the cavity of concha (45%), the
tragus (45%) and the Antihelix (73%).
9
The vagal innerva-
tion of the auricle might contribute to a possible effect of
auricular acupuncture on body weight.
In addition the arcuate nucleus of the hypothalamus
(ARH), which is a crucial center for the modulation of
food intake, could play a role in the mode of action of
acupuncture. It contains two populations of neurons that
have opposite inuence on appetite. One neuron expresses
the anorexigenic peptide alpha-melanocyte stimulating hor-
mone (-MSH) (derived from proopiomelanocortin, POMC)
and the other the orexigenic peptide NPY (neuropeptide
Y). Tian et al. showed that electrical acupuncture (EA)
increased the expression of mRNA encoding for POMC as well
as increased levels of -MSH.
10
Fei et al. found a reduced
body weight gain associated with the inhibition of food
intake in obese rats.
11
Electrical acupuncture stimulation
increased peptide levels of -MSH and mRNA levels of its
precursor POMC in the ARH neurons. Moreover, the CSF con-
tent of -MSH was increased by EA application.
11
Lesions
of ARH by glutamate abolished the inhibition effect of EA
on food intake and body weight, which suggests that ARH
plays an important role in mediating the satiety effect of EA
stimulation.
11
Two recent systematic reviews investigated the clinical
effects of acupuncture and Chinese herbal medicine (CHM)
on obesity.
4,5
Both found a signicantly higher weight loss
in the acupuncture/CHM groups, higher BMI reduction or
even higher CRP decrease compared to placebo or common
western pharmacological therapies such as metformin or
sibutramine. Almost all reviewed studies reported side
effects of acupuncture, but all of them were classied
as mild. Limitations of most clinical trials were the small
sample size or poor methodology (e.g. no placebo/sham
control).
Our study supports these ndings, which may show a new
approach to the clinical management of obesity. P-Stim

is
easy to use; it does not require sophisticated training in Chi-
nese Medicine
12
and can be applied by any physician trained
in acupuncture.
Limitations
As this study was planned as pilot project, sample size and
the duration of observation are limited. Our further stud-
ies on the effects of P-Stim

on obesity will involve a more

detailed assessment of food intake and quality of life, a
larger sample size and a longer time of observation to dis-
play possible effects of auricular electrical acupuncture on
appetite and satiety.
In conclusion electrical auricular acupuncture could be
a safe, additive, non-pharmacological treatment of obesity.
Further studies including a larger number of patients and
a more detailed assessment of food intake need to be per-
formed.
Conict of interest
There is no conict of interest to declare.
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