Camhi, Stephanie

Dong, Jianxun

Huang, Feng

Kong, Jian

Li, Shaoyuan

Li, Xia

Liao, Xing

Meng, Hong

Rong, Peijing

Spaeth, Rosa B.

Wang, Hongcai

Zhai, Xu

Zhu, Bing

BMC Complementary and Alternative Medicine

Feng Huang

Jianxun Dong

Jian Kong

Hongcai Wang

Hong Meng

Rosa B. Spaeth

Stephanie Camhi

Xing Liao

Xia Li

Xu Zhai

Shaoyuan Li

Bing Zhu

Peijing Rong

Springer - Publisher Connector

Erratum to: Effect of transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance: a pilot randomized study

Harvard University - DASH 

Huang et al. BMC Complementary and Alternative Medicine  (2016) 16:218 
DOI 10.1186/s12906-016-1190-1ERRATUM Open AccessErratum to: Effect of transcutaneous
auricular vagus nerve stimulation on
impaired glucose tolerance: a pilot
randomized study
Feng Huang1,2, Jianxun Dong3, Jian Kong4, Hongcai Wang1, Hong Meng1, Rosa B. Spaeth4, Stephanie Camhi4,5,
Xing Liao6, Xia Li2, Xu Zhai1, Shaoyuan Li1, Bing Zhu1 and Peijing Rong1*Erratum
In response to concerns raised by readers of this paper
[1], the authors have accepted that corrections are re-
quired in order to clarify aspects which are unclear and/
or potentially misleading as presently reported. The cor-
rections do not affect the underlying results of the study,
but may affect the interpretation of the findings.
Abstract
The Methods section in the Abstract should more ex-
plicitly state the nature of this study as not simply a ran-
domized control trial, but a trial with a related
observational study.
The original text reads as:
In this pilot randomized clinical trial, we compared
the efficacy of transcutaneous auricular vagus nerve
stimulation (taVNS) and sham taVNS on patients with
IGT. 72 participants with IGT were single-blinded and
were randomly allocated by computer-generated enve-
lope to either taVNS or sham taVNS treatment groups.
In addition, 30 IGT adults were recruited as no-
treatment control so as to monitor the natural fluctu-
ation of glucose tolerance in IGT patients.
The revised text reads as:
In this pilot randomized clinical trial with an add-
itional observation group, we first compared the efficacy
of transcutaneous auricular vagus nerve stimulation
(taVNS) and sham taVNS on patients with IGT. 72 par-
ticipants with IGT were single-blinded and were ran-
domly allocated by computer-generated envelope to
either taVNS or sham taVNS treatment groups. Then, an
additional 30 IGT adults were recruited separately as a* Correspondence: drrongpj@163.com
1Institute of Acu-Mox, China Academy of Chinese Medical Sciences, 16#
Nanxiao Street, Dongzhimennei, Beijing 100700, China
Full list of author information is available at the end of the article
© 2016 The Author(s). Open Access This artic
International License (http://creativecommons
reproduction in any medium, provided you g
the Creative Commons license, and indicate if
(http://creativecommons.org/publicdomain/zecontrol population and not assigned treatment so as to
monitor the natural fluctuation of glucose tolerance in
IGT patients.
Methods
The authors wish to clarify the statistical analyses and
comparisons performed in their Methods sections.
The original text reads as:
Statistical analysis
Our analyses were based on the intention-to-treat
principle. Statistical analysis was performed using SPSS
19.0 Software (SPSS Inc., Chicago, IL, USA). Repeated
measurements were applied to compare primary and
secondary outcomes. First, we compared the taVNS and
sham taVNS groups; then, we separately compared real
and sham taVNS with the no-treatment control popula-
tion, to further assess and isolate the treatment effects of
taVNS and sham taVNS.
The revised text reads as:
Our analyses were based on the intention-to-treat
principle, and only subjects who had completed a
data set were included in data analysis. Statistical ana-
lysis was performed using SPSS 19.0 Software (SPSS
Inc., Chicago, IL, USA). Repeated measurements were
applied to compare primary and secondary outcomes.
First, we compared the taVNS and sham taVNS
groups; then, we separately compared real and sham
taVNS with the no-treatment control condition (data
from observational group) to further assess and iso-
late the treatment effects of taVNS and sham taVNS.
For repeated measurements, Mauchly’s Test of Spher-
icity were applied, if assumptions of sphericity were
violated, Greenhouse Geisser corrected degrees of
freedom were applied. In addition, we also repeated
the above analysis to include age, gender and BMI as
covariates to adjust for the effects of factors.le is distributed under the terms of the Creative Commons Attribution 4.0
.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
ive appropriate credit to the original author(s) and the source, provide a link to
changes were made. The Creative Commons Public Domain Dedication waiver
ro/1.0/) applies to the data made available in this article, unless otherwise stated.
Huang et al. BMC Complementary and Alternative Medicine  (2016) 16:218 Page 2 of 4Results
The results section should more explicitly separate the
comparisons between groups from solely the randomised
controlled trial, and the observational comparisons
which made use of both the randomised and observa-
tional data.
The original text reads as:
Comparison between the taVNS and sham taVNS
Comparison by Independent Samples t-test showed
that the two groups did not differ in age (t(70) = 1.51, p
= 0.14), weight (t(70) = −0.83, p = 0.41) systolic blood
pressure (t(70) = 1.42, p = 0.16), diastolic blood pressure
(t(70) = 0.22, p = 0.16), or BMI (t(70) = 64.07, p = 0.61) at
baseline (Table 1). The gender distribution also did not
differ significantly across groups (χ2 (2, n = 72) =3.29, p
= 0.07). Measures of FPG (t(70) = 0.3, p = 0.77), 2hPG
(t(70) = 1.96, p = 0.054) and HbAlc (t(70) = 1.12, p = 0.27)
similarly did not differ between groups at baseline.
Comparison of the taVNS and sham taVNS groups using
repeated measures analysis of variance (ANOVA) indi-
cated a significant difference in 2hPG between groups
over the course of the experiment (F(2) = 5.79, p = 0.004)
(Figure 4 and Table 2). The decrease in 2hPG was sig-
nificantly greater in the taVNS group compared to that
in the sham taVNS group (Table 3). After adjusting for
age, gender, and BMI, the effect remained significant
(Table 2). Measures of FPG (FGG (1.84) = 2.48, p =
0.093) and HbAlc (F(1) = 0.23, p = 0.63) did not differ
significantly between the taVNS and sham taVNS
groups over time in both crude analysis and after
adjusting for age, gender, and BMI (Table 2). For
FPG, Mauchly’s Test of Sphericity indicated that as-
sumptions of sphericity were violated, thus Green-
house Geisser corrected degrees of freedom were
used. Further analysis of other secondary outcomes
indicated that the taVNS and sham taVNS groups dif-
fered significantly in systolic blood pressure over time
(F(1) = 4.21, p = 0.044). In the taVNS group, systolic
blood pressure dropped from 123.69 ± 14.14 (mean ±
SD) to 118.64 ± 13.34, while in the sham taVNS
group, systolic blood pressure remained at 119 ± 12.
No significant differences were observed for changesTable 2 Comparison of 2-hPG, FPG and HbAlc between taVNS
and sham taVNS groups. Adjusted values reflect age, gender,
and BMI as covariates
Measurements P-value
2hPG Crude .004
Adjusted .006
FPG Crude .093
Adjusted .11
HbAlc Crude .63
Adjusted .681in diastolic blood pressure (F(1) = 0.75, p = 0.39) or
BMI (F(1) = 0.069, p = 0.79).
Comparison between taVNS, sham taVNS and notreat-
ment control
In this study, we added a separate no-treatment control
group recruited from a free community clinic physical
exam program. This group was included to better under-
stand the natural fluctuation of outcomes in patients with
IGT and to isolate the pure treatment effects from other
naturally occurring factors. Analysis of variance indicated
that the three experimental groups did not differ in age
(F(2) = 1.95, p = 0.15), weight (F(2) = 0.85,p = 0.43), diastolic
blood pressure (F(2) = 1.05, p = 0.37), gender distribution
(χ2(2, n = 102) = 3.29, p = 0.2), or BMI (F(2) = 2.96, p =
0.057) at baseline. Measures of FPG (F(2) = 2.86, p = 0.06),
2hPG (F(2) = 2.03, p = 0.14) and HbAlc (F(2) = 1, p = 0.37)
also did not differ between groups at baseline. There was,
however, a significant difference in systolic blood pressure
(F(1) = 1.02, p = 0.01). Repeated measures ANOVA between
the taVNS and no-treatment control indicated significant
differences in FPG (F(2) = 10.62, p < 0.001), 2hPG (F(2) =
25.18, p < 0.001) and HbAlc (F(1) = 12.79, p = 0.001) be-
tween groups over the course of the 12 weeks. All effects
remained significant after adjusting for age, gender, and
BMI (Table 4). Analysis of other secondary outcomes, with
comparison between the taVNS and no-treatment control
groups, indicated that there were no significant differences
between the two groups in systolic blood pressure (F(1) =
0.99, p = 0.32). diastolic blood pressure (F(1) = 1.27, p =
0.27), or BMI (F(1) = 0.003, p = 0.96) over time. Repeated
measures ANOVA between the sham taVNS and no-
treatment control groups showed that the two groups dif-
fered significantly in their levels of 2hPG (FGG(1.72) =
10.51, p < 0.001) and HbAlc (F(1) = 5.94, p = .018) over the
course of the experiment. Measures of both 2hPG and
HbAlc increased over the 12 weeks in the control group,
and decreased over the course of the 12 weeks in the sham
taVNS treatment group. After controlling for age, gender,
and BMI, only the effect for change in 2hPG remained sig-
nificant (Table 5). Analysis of other secondary outcomes be-
tween the sham taVNS and no-treatment control indicated
that there were no significant differences between the twoTable 4 Comparison of 2-hPG, FPG and HbAlc between taVNS
and no-treatment control groups. Adjusted values reflect age,
gender, and BMI as covariates
P-value
2hPG Crude <.001
Adjusted <.001
FPG Crude <.001
Adjusted <.001
HbAlc Crude .001
Adjusted .002
Table 5 Comparison of 2-hPG, FPG and HbAlc between the
sham taVNS and no-treatment control groups. Adjusted values
reflect age, gender, and BMI as covariates
Measurements P-value
2hPG Crude <.001
Adjusted .003
FPG Crude .055
Adjusted .3
HbAlc Crude .018
Adjusted .07
Huang et al. BMC Complementary and Alternative Medicine  (2016) 16:218 Page 3 of 4groups in systolic blood pressure (F(1) = 1.44, p = 0.24), dia-
stolic blood pressure (F(1) = 0.047, p = 0.83), or BMI (F(1)
= 0.024, p = 0.88) over time.
The revised text reads as:
Comparison between the taVNS and sham taVNS (re-
sults based on data from randomized trials)
Comparison by Independent Samples t-test showed that
the two groups did not differ in age (t(70) = 1.51, p = 0.14),
weight (t(70) = −0.83, p = 0.41) systolic blood pressure
(t(70) = 1.42, p = 0.16), diastolic blood pressure (t(70) =
0.22, p = 0.16), or BMI (t(70) = 64.07, p = 0.61) at baseline.
The gender distribution also did not differ significantly
across groups (X2 (2, n = 72) =3.29, p = 0.07). Measures of
FPG (t(70) = 0.3, p = 0.77), 2hPG (t(70) = 1.96, p = 0.054)
and HbAlc (t(70) = 1.12, p = 0.27) similarly did not differ
between groups at baseline.
Comparison of the taVNS and sham taVNS groups
using repeated measures analysis of variance (ANOVA)
indicated a significant difference in 2hPG between groups
over the course of the experiment (F(2) = 5.79, p = 0.004)
(Figure 3 and Table 2). The decrease in 2hPG was signifi-
cantly greater in the taVNS group compared to that in the
sham taVNS group (Table 3). After adjusting for age, gen-
der, and BMI, the effect remained significant (Table 2).
Measures of FPG (FGG (1.84) = 2.48, p = 0.093) and
HbAlc (F(1) = 0.23, p = 0.63) did not differ significantly be-
tween the taVNS and sham taVNS groups over time in
both crude analysis and after adjusting for age, gender,
and BMI (Table 2). For FPG, Mauchly’s Test of Sphericity
indicated that assumptions of sphericity were violated,
thus Greenhouse Geisser corrected degrees of freedom
were used.
Further analysis of other secondary outcomes indi-
cated that the taVNS and sham taVNS groups differed
significantly in systolic blood pressure over time (F(1)
= 4.21, p = 0.044). In the taVNS group, systolic blood
pressure dropped from 123.69 ± 14.14 (mean ± SD) to
118.64 ± 13.34, while in the sham taVNS group, sys-
tolic blood pressure remained at 119 ± 12. No signifi-
cant differences were observed for changes in
diastolic blood pressure (F(1) = 0.75, p = 0.39) or BMI
(F(1) = 0.069, p = 0.79).Comparison between taVNS, sham taVNS and no-
treatment control (results based on randomized trial and
additional observational group)
In this study, we added a separate no-treatment con-
trol group recruited from a free physical exam program
at a community clinic. This group was included to better
understand the natural fluctuation of outcomes in pa-
tients with IGT and to isolate the pure treatment effects
from other naturally occurring factors.
Analysis of variance indicated that the three experi-
mental groups did not differ in age (F(2) = 1.95, p =
0.15), weight (F(2) = 0.85,p = 0.43), diastolic blood pres-
sure (F(2) = 1.05, p = 0.37), gender distribution (χ2(2, n =
102) = 3.29, p = 0.2), or BMI (F(2) = 2.96, p = 0.057) at
baseline. Measures of FPG (F(2) = 2.86, p = 0.06), 2hPG
(F(2) = 2.03, p = 0.14) and HbAlc (F(2) = 1, p = 0.37) also
did not differ between groups at baseline. There was,
however, a significant difference in systolic blood pres-
sure (F(1) = 1.02, p = 0.01).
Repeated measures ANOVA between the taVNS and
no-treatment control indicated significant differences in
FPG (F(2) = 10.62, p < 0.001), 2hPG (F(2) = 25.18, p <
0.001) and HbAlc (F(1) = 12.79, p = 0.001) between
groups over the course of the 12 weeks. All effects
remained significant after adjusting for age, gender, and
BMI (Table 4).
Analysis of other secondary outcomes, with compari-
son between the taVNS and no-treatment control
groups, indicated that there were no significant differ-
ences between the two groups in systolic blood pressure
(F(1) = 0.99, p = 0.32), diastolic blood pressure (F(1) =
1.27, p = 0.27), or BMI (F(1) = 0.003, p = 0.96) over time.
Repeated measures ANOVA between the sham taVNS
and no-treatment control group showed that the two
groups differed significantly in their levels of 2hPG
(FGG(1.72) = 10.51, p < 0.001) and HbAlc (F(1) = 5.94, p
= .018) over the course of the experiment. Measures of
both 2hPG and HbAlc increased over the 12 weeks in
the control group, and decreased over the course of the
12 weeks in the sham taVNS treatment group. After
controlling for age, gender, and BMI, only the effect for
change in 2hPG remained significant (Table 5).
Analysis of other secondary outcomes between the
sham taVNS and no-treatment control group indicated
that there were no significant differences between the two
groups in systolic blood pressure (F(1) = 1.44, p = 0.24),
diastolic blood pressure (F(1) = 0.047, p = 0.83), or BMI
(F(1) = 0.024, p = 0.88) over time.
Tables 2, 4 and 5
A repeated measures analysis of variance (ANOVA) at
three time points was applied, and the p values in Ta-
bles 2, 4, and 5 corresponding to the test of significance
of the group by time interaction. Since these do not test
the significance at a signal time point, the authors accept
Huang et al. BMC Complementary and Alternative Medicine  (2016) 16:218 Page 4 of 4that confidence intervals are not appropriate for these
hypotheses. The confidence intervals have therefore
been removed from Tables 2, 4 and 5:
Corrected tables:
Discussion
The authors accept that the nature of their study as a
pilot was unclear. The section of their Discussion deal-
ing with limitations has therefore been amended.
The original text reads as:
Secondly, the treatment was only 12 weeks in dur-
ation, thus the results obtained only represent its short
or mid-term effects. Further study is warranted to evalu-
ate the long-term effects of this treatment option.
The revised text reads as:
Secondly, as a pilot study, the treatment was only
12 weeks in duration. Thus the results obtained only
represent its short or mid-term effects. Further study is
warranted to evaluate the long-term effects of this treat-
ment option.
Author details
1Institute of Acu-Mox, China Academy of Chinese Medical Sciences, 16#
Nanxiao Street, Dongzhimennei, Beijing 100700, China. 2Beijing University of
Chinese Medicine, Beijing 100029, China. 3Beijing Hospital of T.C.M Affiliated
to Capital University of Medicine Sciences, Beijing 100010, China.
4Department of Psychiatry, Massachusetts General Hospital, Harvard Medical
School, Boston, MA, USA. 5Department of Psychology, Endicott College,
Beverly, MA, USA. 6Institute of Basic Research in Clinical Medicine, China
Academy of Chinese Medical Sciences, Beijing 100700, China.
Received: 1 July 2016 Accepted: 1 July 2016
References
1. Huang F, Dong J, Kong J, Wang H, Meng H, Spaeth RB, et al. Effect of
transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance:
a pilot randomized study. BMC Complement Altern Med. 2016;14:203.•  We accept pre-submission inquiries 
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Erratum to: Effect of transcutaneous auricular vagus nerve stimulation on impaired glucose tolerance: a pilot randomized study

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