Journal of Traditional Chinese Medical Sciences (2019) 6, 101e107

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Therapeutic effects of acupuncture on blood

glucose level among patients with type-2
diabetes mellitus: A randomized clinical trial
Amir Hooman Kazemi a,b, Wei Wang b,*, Yanping Wang c,
Faezeh Khodaie c, Hossein Rezaeizadeh a

a
School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran
b
School of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China
c
School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing
100029, China

Received 25 October 2018; received in revised form 1 February 2019; accepted 13 February 2019
Available online 19 February 2019

KEYWORDS Abstract Objective: To compare the therapeutic effects of acupuncture with sham acupunc-
Diabetes mellitus ture on levels of fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) among patients
type 2; with type-2 diabetes mellitus (T2DM) under treatment with metformin.
Acupuncture; Method: Eighty participants with T2DM were allocated randomly to treatment (n Z 40) and
Glycated hemoglobin control (n Z 40) groups. In addition to metformin therapy, patients in the acupuncture group
received acupoint stimulation with even manipulation at 15 acupoints, and needles were re-
tained for 20 minutes. The sham-acupuncture group was treated with very small needles in-
serted at a very shallow depth (3e5 mm) without manipulation at non-acupoints 1 cm
around the actual acupuncture points. Both groups were treated for 14 sessions during 10
weeks of treatment. The FPG level was measured before treatment as well as after 1, 2, 4,
6 and 12 weeks of treatment. The HbA1c percentage was assessed once before treatment
and once 12 weeks after treatment initiation.
Results: Levels of FPG and HbA1c in both groups were reduced significantly in comparison with
baseline measurements (both P < .01). However, acupuncture treatment led to a significant
reduction in the FPG level as compared with sham acupuncture after 4 weeks or 10 sessions
of treatment [mean difference (MD) Z 10.18, 95% confidence interval (CI) Z 1.74 to 18.6,
P Z .019], after 6 weeks or 12 sessions of treatment (MD Z 10.53, 95% CI Z 2.22 to 18.83,
P Z .014) and after 12-week follow-up (MD Z 8.8, 95% CI Z 0.66 to 16.94, P Z .034). Acupunc-
ture treatment reduced the HbA1c level significantly in comparison with that in the sham-
acupuncture group (MD Z 0.27, 95%CI Z 0.08 to 0.47, P Z .007).

* Corresponding author.
E-mail address: wangwei@bucm.edu.cn (W. Wang).
Peer review under responsibility of Beijing University of Chinese Medicine.

https://doi.org/10.1016/j.jtcms.2019.02.003
2095-7548/ª 2019 Beijing University of Chinese Medicine. Production and hosting by Elsevier B.V. This is an open access article under the CC
BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
102
Conclusion: Our study revealed that acupuncture (as a type of Chinese therapy) combined with
metformin (as a conventional hypoglycemic medication) had a greater effect on glycemic con-
trol than that elicited in the placebo control group. Consequently, acupuncture could be used
as adjuvant therapy among patients with T2DM.
ª 2019 Beijing University of Chinese Medicine. Production and hosting by Elsevier B.V. This is
an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/
by-nc-nd/4.0/).
Introduction
Diabetes mellitus (DM) involves several metabolic disorders
of abnormal carbohydrate metabolism sharing the same
phenotype of hyperglycemia.1 DM and its associated
metabolic dysregulations lead to secondary pathophysio-
logic changes in multiple organ systems. These dysregula-
tions have considerable influence on the financial loss of
individuals and their families, as well as on health systems
and national economies. Therefore, world leaders have
committed to reduce the burden of DM as one of four pri-
ority non-communicable diseases.2
Globally, the prevalence of DM among the adult popu-
lation has increased from 4.7% in 1980 to 8.5% in 2014.3 DM
has caused 1.5 million deaths worldwide, and its compli-
cations, such as cardiovascular diseases, have led to an
additional 2.2 million deaths in 2012.4 In the United States,
DM is the leading cause of end-stage renal disease, non-
traumatic amputations of the lower extremities, and vi-
sual loss in adults. Because of its increasing incidence
worldwide, DM will likely be a leading cause of morbidity
and mortality in the future.5
Type-2 diabetes mellitus (T2DM) is a heterogeneous
group of disorders characterized by insulin resistance,
abnormal metabolism of fat, excessive hepatic glucose
production and variable degrees of defects of insulin
secretion.6 T2DM accounts for most of the DM population
worldwide.7 T2DM onset is insidious, and the diagnosis is
usually delayed. Consequently, the microvascular compli-
cations of DM may be present at the time of the diagnosis.8
The most important intervention to prevent the progression
of these morbidities is glycemia management.9
Metformin therapy concurrent with lifestyle modifica-
tion should be initiated at the time of the diagnosis. Met-
formin has been reported to be beneficial against
cardiovascular complications, as well as its effect on gly-
cemic control.10 Several clinical trials have demonstrated
that intensive therapy to achieve lower levels of glucose
results in decreased rates of nephropathy, neuropathy,
retinopathy and cardiovascular diseases. Each 1% drop in
the glycated hemoglobin (HbA1c) percentage has been
suggested to be associated with improved outcomes.11e15
High-quality studies are needed to show the efficacy and
safety of traditional Chinese medicine (TCM) treatments for
DM. According to TCM theory, DM is described as "xiao ke"
(wasting thirst or wasting and thirsting) It is categorized
into three types, i.e., upper, middle and lower, and these
conditions are related to the lungs, spleen and kidneys,
respectively, and the main symptom of each type is
excessive thirst, excessive hunger, and excessive urination,
A.H. Kazemi et al.
respectively.16 According to syndrome differentiation, DM
at the initial stage is due to Yin deficiency that turns into
Heat. If DM complications occur, deficiency of Qi and Yin or,
at the late stage, Yin and Yang deficiency, are found.17
Acupuncture is an effective therapeutic method
acknowledged by the World Health Organization.
Acupuncture has been shown to have therapeutic effects on
DM symptoms, to reduce hyperglycemia, increase insulin
sensitivity, and improve lipid metabolism in animals and
humans with T2DM.18e21 A potential mechanism underlying
the effect of acupuncture on insulin resistance is upregu-
lation of the production of adipo-myokines. The latter are
secreted by skeletal muscle and adipose tissue during reg-
ular exercise, and have a role in mediating insulin resis-
tance in DM pathogenesis.22 Acupuncture is an "insulin
sensitizer" and can improve insulin sensitivity possibly by
reducing body weight and inflammation, and improving
lipid metabolism and adipokine expression.19
We wished to compare the therapeutic effects of
acupuncture with sham acupuncture on levels of fasting
plasma glucose (FPG) and HbA1c among patients with T2DM
under treatment with metformin.
Methods
Ethics review and approval
The study protocol was registered at the Clinical Trials
Registry (IRCT20180914041035N1) and was approved by the
Ethics Committee Board of Tehran University of Medical
Sciences (IR.TUMS.VCR.REC.1397.369). The study protocol
conforms to the ethical guidelines of the Declaration of
Helsinki (Version Edinburgh, 2000).
Before randomization, all participants were requested
to provide written informed consent to participate in this
RCT. They were informed of the details of the study as well
as the benefits and risks of participating in it.
Trial design
This was a prospective, double-blind, sham-controlled
randomized clinical trial (RCT) with an equal randomization
(1:1 ratio).
Participants
After initial screening, patients were enrolled in the study
if they met all of the inclusion criteria and excluded if they
had any of the exclusion criteria. A complete physical
Therapeutic effects of acupuncture on blood glucose level among patients
examination and medical history were undertaken before
the RCT was started.
Inclusion criteria: eligible participants were patients
who fulfilled all of the following conditions (1) aged 35e65
years of either sex; (2) individuals who had been diagnosed
with T2DM by an endocrinologist and had been taking
metformin to control glycemia (500e1500 mg/day)23; (3)
FPG of 140e250 mg/dL.
Exclusion criteria were individuals: (1) with renal
impairment (urinary albumin excretion 30 mg/day; esti-
mated glomerular filtration rate <60 mL/min/1.73 m2 or
edema); (2) diagnosed with known cardiovascular diseases,
history of heart failure (New York Heart Association func-
tional class IIIeIV), myocardial infarction, acute coronary
syndromes, pacemaker implantation, coronary revascular-
ization or stroke; (3) with hepatic impairment/cirrhosis; (4)
with a high HbA1C level (>9%); (5) who were pregnant or
breastfeeding; (6) receiving insulin therapy; (7) who were
receiving herbal medicines or other therapy or had a
change in metformin dose during the RCT; (8) with endo-
crine abnormalities such as thyroid disorders; (9) receiving
anti-depressant medicines or hormonal agents during the
previous month or period of the study; (10) suffering from
autoimmune diseases or other systemic disorders; (11) with
severe increases in the FPG level (>250 mg/dL) during the
study. (12) with a history of severe complications of DM or
diabetic ketoacidosis.
Study conditions
The study was conducted in patients with a diagnosis of
T2DM referred to an acupuncture clinic affiliated to the
School of Traditional Medicine, Tehran University of Medical
Sciences, from May 2015 to August 2017.
Interventions
The treatment group received acupuncture treatment
combined with metformin. The control group received
sham acupuncture plus metformin monotherapy. Both
groups were treated for 12 sessions in 6 weeks (three times
per week for 2 weeks, then two times per week for 2 weeks,
and then once-weekly for 2 weeks), and maintenance
treatment was undertaken for two sessions every other
week (in total, 14 sessions of treatment during 10 weeks).
According to textbooks, literature review, and the clin-
ical experience of the principal researcher,19,24,25 15 body
acupoints were selected: Waiguan (TE 5), Tianshu (ST 25),
Zusanli (ST 36), Fenglong (ST 40), Qihai (CV 6), Zhongwan
(CV 12), Feishu (BL 13), Pishu (BL 20), Shenshu (BL 23),
Xuehai (SP 10), Sanyinjiao (SP 6), Taichong (LR 3), Hegu (LI
4), Quchi (LI 11) and Taixi (KI 3). Sterile stainless-steel
acupuncture needles (0.25 mm  40 mm; Zhongyan Taihe
Medical Instruments, Beijing, China) were inserted
perpendicularly at a depth of 10e15 mm into the acupoints
using even manipulation. After the sensation from insertion
of needles (Deqi) had been felt, they were retained for 20
minutes. For Feishu (BL 13), Pishu (BL 20) and Shenshu (BL
23), rapid needling with even manipulation was applied,
and needles were retained for 1 minute.
103
In the sham-acupuncture group, needles
(0.16 mm  7 mm) were inserted to a very shallow depth
(3e5 mm) without manipulation at non-acupoints 1 cm
around the actual acupuncture points, and were retained
for 20 minutes.
Acupuncture treatments were undertaken by a special-
ized practitioner of western and Chinese medicine with 12
years of clinical experience as certified by the Iranian
Ministry of Health (Tehran, Iran). Adverse reactions that
occurred during acupuncture sessions were reported to the
principal investigator, who would decide if the trial should
be terminated.
Outcomes
FPG levels were measured using the same laboratory kit
before treatment, as well as after 1, 2, 4, 6 and 12 weeks of
treatment. HbA1c levels were measured using the same
laboratory kit once before treatment and once 12 weeks
after treatment initiation.
Sample size
We calculated the sample size according to the following
formula:
N Z f (a, P) 2s2/(m1 m2)2
where N is the sample size of each group, a is the signifi-
cance level (0.05), P is the power of the test (0.8), s2 is the
variance of measurements, and m1 m2 is the difference of
mean values between two groups. We calculated that a
sample size of 80 was necessary to provide 80% power to
detect a difference in the mean HbA1c level between treat-
ment groups assuming a mean difference of 0.4 and stan-
dard deviation of 0.6 according to previous studies.20,26,27
Randomization, allocation concealment, and
implementation
Patients were assigned randomly to the acupuncture group
(treatment) or sham-acupuncture group (control) using a
random number table prepared by an independent member
within our department. The allocation sequence was con-
cealed from the researchers in sequentially numbered,
sealed, opaque envelopes. After the researcher had
assessed eligibility, obtained the patient’s consent, and
completed all baseline assessments of enrolled partici-
pants, the corresponding envelopes were opened, and the
treatment allocation was revealed.
Blinding
All participants were blinded to treatment assignments.
The primary investigator was blinded to patients’ infor-
mation and measurements. However, blinding the primary
researcher from participant allocations was not possible.
Data were analyzed by an independent outcome assessor
blinded to participant allocations.
104 A.H. Kazemi et al.

Statistical methods
Table 1 Demographic features of the study cohort at
baseline (n Z 40).
Analyses were undertaken using SPSS v20.0 (IBM, Armonk,
NY, USA), Excel (Office 2016; Microsoft, Redmond, WA, Variables Acupuncture Sham P value
USA) and Prism v6.07 (Graphpad, La Jolla, CA, USA). Sta- Acupuncture
tistical analyses within groups were carried out using a Age Mean  SD 56.6  6.1 55.9  5.5 0.56
paired-sample t-test, and between-group analyses were (years)
done using an independent-sample t-test. Repeated- Gender Female 18 (45%) 16 (40%) 0.87
measures ANOVA was used for measurements in matched Male 22 (55%) 24 (60%)
groups. P < .05 was considered significant. BMI Mean  SD 29.5  4.3 28.8  5.2 0.63
FPG Mean  SD 170.4  22.2 170.5  19.9 0.32
(mg/dL)
Results HbA1c Mean  SD 7.14  0.48 7.24  0.49 0.43

In total, 143 participants were screened. Eighty patients

were recruited and randomized to 40-people each in
acupuncture and sham-acupuncture groups (Fig. 1). During
a 3-month follow-up, five patients withdrew from the
study. One person in the acupuncture group was lost to
follow-up due to traveling abroad, and another dropped out
because of new-onset albuminuria. In the sham-
acupuncture group, two patients were switched to insulin
therapy due to poor glycemic control, and one received a
herbal medicine. The primary analysis was intention-to-
treatment and involved all patients who were assigned
randomly. No adverse events were observed throughout the
study period.
Baseline demographic data are shown in Table 1. The
mean age of the patients in the acupuncture group was 56.6
years and it was 55.9 years in the control group. In the
acupuncture group, 18 participants were female and 22
were male. Sixteen cases in the control group were female
and 24 were male. The mean body mass index (BMI, kg/m2)
was 29.5  4.3 in the acupuncture group and 28.8  5.2 in
the sham-acupuncture group. The mean FPG level (mg/dL)
before treatment was 170.4  22.2 in the acupuncture
group and 170.5  19.9 in the sham acupuncture group. The
mean HbA1c before treatment was 7.14%  0.48% in the
acupuncture group and 7.24%  0.49% in the sham-
acupuncture group. No significant difference was
observed in sex, age, BMI, baseline FPG level, or HbA1c level
between the two groups.
The results of descriptive statistics in Table 2 show that
acupuncture treatment decreased the mean FPG level from
170.4 to 152.2 mg/dL during 3-month follow-up (P < .001
for all time points). In the sham-acupuncture group, the
mean FPG level decreased from 170.5 to 161 mg/dL after 3-
month follow-up (P < .01 for all time points). Thus, the
mean FPG in both groups decreased over time, and the

Figure 1 Study flowchart.

Therapeutic effects of acupuncture on blood glucose level among patients 105

mean difference from the baseline of each time point was

P value
significant. However, acupuncture treatment led to a

0.979
0.517
0.628
0.019
0.014
0.034
0.336
0.007
Comparison between two groups
significant reduction in the FPG level as compared with
sham acupuncture after 4 weeks or 10 sessions of treat-
ment [mean difference (MD) Z 10.18, 95% confidence in-

6.18 to 12.18
6.89 to 11.34
9.27 to 9.52

0.11 to 0.32
1.74 to 18.60
2.22 to 18.83
0.66 to 16.94
terval (CI) Z 1.74 to 18.6, P Z .019], after 6 weeks or 12

0.08 to 0.47
sessions of treatment (10.53, 2.22 to 18.83, 0.014) and
P value Mean Diff. 95% CI

after 12-week follow-up (8.8, 0.66 to 16.94, 0.034)

(Fig. 2).
In the acupuncture group, the mean HbA1c level fell
from 7.14% to 6.8% after 12 weeks of treatment (P < .001).
Sham acupuncture also caused a significant reduction in
10.18
10.53
0.12

2.22

0.10
0.27
the HbA1c level after 3 months from baseline measure-
8.8
ments (P < .001). Acupuncture treatment reduced the
3

HbA1c level significantly in comparison with that in the

sham-acupuncture group (MD Z 0.27, 95%CI Z 0.08 to
0.007
0.000
0.000
0.000
0.000

0.000
0.47, P Z .007) (Fig. 3).
7.9
0.4

6.4

Discussion
2
5

11.1 to

to 0.08
2.1 to
4.3 to
8.2 to
9.1 to
95% CI

0.18

Use of combination therapy over monotherapy is

increasing in DM treatment because of its complex path-
Sham Acupuncture (n Z 40)

ologic factors. In recent years, some clinical studies on

Difference

acupuncture and its effect on blood glucose levels have

Baseline

Note: FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; SD, standard deviation; CI, confidence interval.

been published. However, they had small study cohorts

0.13
Mean

from

1.2
3.1
6.6
7.7
9.5
170 0.5  19.9
169.3  19.3
167.4  19.1
163.9  18.3
162.8  18.6
161.0  17.8
7.24  0.49
0.24 0.000 7.11  0.46
Mean ± SD
value

0.000
0.000
0.000
0.000
0.000
P

18.6 to 14.7
20.6 to 15.7
20.8 to 15.5
5.1 to 3.1
6.3 to 4.2

0.36 to
95% CI
Changes in levels of FPG and HbA1c in both groups.

Figure 2 Comparison of changes in FPG levels between

from Baseline

groups.
Difference
Acupuncture (n Z 40)

16.7
18.1
18.1
Mean

4.1
5.2

0.3
170 0.4  22.2
166.3  21.8
165.1  21.7
153.7  19.6
152.2  18.7
152.2  18.7
7.14  0.48
Mean ± SD

6.8  0.42
12 weeks

12 weeks
Baseline

HbA1c (%) Baseline

2 weeks
4 weeks
6 weeks
(mg/dL) 1 week
Variables
Table 2

FPG

Figure 3 Comparison of changes of HbA1c levels between

groups.
106
and relatively short treatment durations that may have led
to inappropriate interpretation of their results. Although
acupuncture has been used widely in many clinical condi-
tions, the benefit of its application as routine treatment for
DM or as adjunctive therapy to improve glucose tolerance is
not known. In the meantime, the findings of various clinical
trials concerning the interaction between combination
therapy of acupuncture and oral hypoglycemic agents must
be assessed further. Moreover, it is important to ascertain if
acupuncture enhances or reduces the effect of oral hypo-
glycemic agents used concurrently.
We designed the present study to evaluate the clinical
efficacy of acupuncture as safe treatment with minimal
adverse reactions on FPG levels in patients with T2DM. For
this purpose, we recruited 80 patients, and randomized
them equally to two groups of acupuncture and sham
acupuncture. All participants were treated for 10 weeks
and were evaluated by FPG and HbA1c levels before and
after treatment.
The FPG level of people in the treatment group was
significantly lower than that of people in the control group
after 4 weeks of treatment until 3-month follow-up. The
HbA1c level was reduced significantly in the acupuncture
group compared with that in the control group after 3-
month follow-up. Levels of FPG and HbA1c improved in
comparison with baseline measurements.
These results are consistent with those from a study by
Zhiyuan and colleagues. They reported that transcutaneous
electric nerve stimulation at acupoints (Acu-TENS) Quchi (LI
11), Hegu (LI 4), Zusanli (ST 36), and Sanyinjiao (SP 6)
reduced HbA1c and lipid levels significantly compared with
those in the sham electrical-stimulation group.20 Those
results were also in accordance with data from Firouzjaei
and co-workers. They suggested that combined therapy
using metformin and acupuncture could improve insulin
sensitivity by reducing FPG levels, body weight and
inflammation, and improving lipid metabolism and adipo-
kine expression.19 Kumar and colleagues stated that
acupuncture at Zhongwan (CV 12) could be useful for gly-
cemic control of patients with T2DM.28 A review of 31 ar-
ticles indicated that electroacupuncture at low intensity
and low frequency can reduce insulin resistance and in-
crease insulin sensitivity.29
However, Li and colleagues demonstrated that
acupuncture was not effective for reducing levels of fasting
blood glucose and HbA1c compared with that in the sham-
acupuncture group among patients with diabetic gastro-
paresis. One possible reason could be due to the short-term
(1 week) duration of treatment because our results showed
a significant reduction in blood glucose levels 4 weeks after
treatment.30
Sham acupuncture has been used as a placebo in
acupuncture clinical trials. Sham acupuncture can be done
in different ways. One method is to insert needles into non-
acupoints. Another type of sham acupuncture uses a
method that prevents the needles from being inserted into
the body, whether at acupoints or non-acupoints. Invasive
sham acupuncture can produce a stronger placebo effect
than that elicited by a tablet because it sends inputs to the
brain via skin receptors. In the present study, we used
invasive acupuncture, whereby the participants’ skin had
been punctured and needling has been done superficially,
A.H. Kazemi et al.
but the participants did not know whether they were
receiving "true" or sham acupuncture. Invasive sham
acupuncture is probably not recognized in comparison with
true acupuncture and non-invasive sham acupuncture.
However, invasive acupuncture may have a role even in
non-acupoints because, in traditional acupuncture treat-
ment, many techniques exist (e.g., shallow insertions) that
are similar to invasive sham acupuncture.
Conclusions
Our study revealed that acupuncture (as a type of Chinese
therapeutic method) combined with metformin (as a con-
ventional hypoglycemic medication) had a greater effect on
glycemic control than that elicited in a placebo control
group. Consequently, acupuncture could be used as adju-
vant therapy among patients with T2DM. Our study lasted
only 3 months, so the effects of long-term treatment must
be explored. Besides, a study involving other acupoints, a
larger sample size, and longer follow-up should be
initiated.
Conflicts of interest
Authors declare no conflicts of interest related to the ma-
terial in this manuscript.
CRediT authorship contribution statement
Amir Hooman Kazemi: Conceptualization, investigation,
methodology, project administration, resources, valida-
tion, and visualization. Wei Wang: Supervision. Yanping
Wang: Formal analysis, and investigation. Faezeh Khodaie:
Formal analysis, software, writing ‒ original draft, review
& editing. Hossein Rezaeizadeh: Formal analysis, and
investigation.
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