Online Submissions: http://www.journaltcm.

com
info@journaltcm.com

J Tradit Chin Med 2013 August 15; 33(4): 428-432

ISSN 0255-2922
2013 JTCM. All rights reserved.

CLINICAL STUDY
TOPIC

Curative effect of acupuncture and moxibustion on insomnia: a randomized clinical trial

Xiyan Gao, Cuixiang Xu, Peiyu Wang, Shan Ren, Yanli Zhou, Xuguang Yang, Ling Gao
aa
Xiyan Gao, Cuixiang Xu, Peiyu Wang, Shan Ren, Yanli
Zhou, Xuguang Yang, Ling Gao, College of Acupuncture
and Massage, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, China
Supported by Chinese National Natural Science Foundation 81173335, Research into Effect of Acupuncture on Expression of Protein Difference in Brain Tissue of Rat Model
with Insomnia
Correspondence to: Prof. Xiyan Gao, College of Acupuncture and Massage, Henan University of Traditional Chinese
Medicine, Zhengzhou 450008, China. gaoxiyan@yeah.net
Telephone: +86-18703634802
Accepted: March 16, 2013

groups. However, the reduction in the experiment

group was greater than that in the control group in
sleeping quality, time to fall asleep, sleeping disorder, and daytime function (P<0.05).
CONCLUSION: Acupuncture and moxibustion at
Baihui (GV 20), Sishencong (EX-HN 1), Shenmai (BL
62), and Zhaohai (KI 6) significantly improved insomnia symptoms in the experiment group compared with the control group.
2013 JTCM. All rights reserved.
Key words: Acupuncture; Sleep initiation and maintenance disorders; Treatment outcome; Randomized clinical trials

Abstract
OBJECTIVE: To observe the effect of acupuncture
and moxibustion on insomnia and explore its
mechanism.

INTRODUCTION
Insomnia, a common sleeping disorder, manifests as an
insufficiency of sleep time and a decline in sleep quality. Therefore, insomnia greatly influences the life,
study, and work of patients. Prolonged use of sleeping
pills can bring about drug dependence and hypofunction. We have used acupuncture and moxibustion to
treat insomnia without adverse reactions. Therefore,
we sought to perform a randomized clinical trial to further explore the effect of acupuncture and moxibustion
on insomnia.

METHODS: One hundred and twenty patients

were randomly divided into an experiment group
and a control group. Sixty patients in the experiment group were treated once a day with acupuncture at Baihui (GV 20), Sishencong (EX-HN 1), Shenmai (BL 62), and Zhaohai (KI 6) and with moxibustion at Baihui (GV 20) and Sishencong (EX-HN 1).
Sixty patients in the control group were acupunctured once a day at Shenmen (HT 7), Neiguan (PC
6), and Sanyinjiao (SP 6). The Pittsburgh Sleep Quality Index (PSQI) was used to compare sleep improvement between the two groups.

MATERIALS AND METHODS

Patient data
One hundred and twenty outpatients of the Department of Acupuncture and Moxibustion in the Third
Affiliated Hospital of Henan College of Traditional
Chinese Medicine from January 2010 to December

RESULTS: The total effective rate was 87.7% in the

experiment group and 76.3% in the control group.
The PSQI scores and the total score were lower after treatment than before treatment in both
JTCM | www. journaltcm. com

428

August 15, 2013 | Volume 33 | Issue 4 |

Gao XY et al. / Clinical Study

2011 were randomly divided into an experiment group

and a control group. Among the 60 patients in the experiment group, there were 23 males and 37 females
aged (39 13) years with Pittsburgh Sleep Quality Index (PSQI) scores of 184. Among the 60 patients in
the control group, there were 26 males and 34 females
aged (40 13) years with PSQI scores of 17 4. There
was no statistical difference (P>0.05) in sex, age, or
PSQI score between the two groups.

ed the therapeutic plan in manipulation, (b) suspended

two treatments in the therapeutic period, or (c) used
other methods to help insomnia symptoms.
Standard of dropout
Patients were considered dropouts of the study if they:
(a) failed to visit, (b) willingly quit the therapeutic process or could not persist in treatment because of unexpected conditions, or (c) had poor obedience with incomplete data during the clinical trial.

Research design
This study was a single-blind randomized controlled
trial. Individuals were randomized by a computer-generated allocation list. The patients and registrar did not
know to which group the patient had been allocated.
This study met the standards of medical ethics and was
approved by the ethics committee of the Third Affiliated Hospital of Henan College of Traditional Chinese
Medicine. All patients signed an informed consent
form.

Standard of suspension
Patients who could not tolerate the treatment or had serious adverse reactions during treatment suspended the
clinical trial. Patients who refused to be treated or continued to use drugs or other treatments during the therapeutic period were also suspended.
Needles
Dispensable Hanyi needles, 0.30 mm in diameter and
25 mm or 40 mm in length, were used for acupuncture (produced by Tianjin Huahong Medical Material
Limited Company, batch number 101201, Tianjin,
China).

Standard of diagnosis
We adopted the insomnia-diagnosing standard from
the third edition of the Chinese Classification of Mental Diseases (CCMD-3)1 and the sleep-detecting method published by the World Health Organization
(WHO). Sleeping efficiency was determined with the
formula (sleeping efficiency=actual time asleep/time
from going to bed to getting up 100% ). All patients
conformed to the insomnia diagnosis standard in the
CCMD-3 and their illness course exceeded half a year.
Patients with insomnia caused by somatic or mental
diseases or by prolonged use of tranquilizers or other
drugs were excluded.

Taking acupoints
Acupoints were taken in the two groups in reference to
Acupuncture and Moxibustion, TCM teaching material for higher education.
Acupoints in the experiment group were: Baihui (GV
20), Sishencong (EX-HN 1), Shenmai (BL 62), and
Zhaohai (KI 6). Xinshu (BL 15) and Pishu (BL 20)
were added for deficiency of both heart and spleen.
Xinshu (BL 15) and Danshu (BL 19) were added for
Qi deficiency of both heart and gallbladder. Xingjian
(LR 2) and Taichong (LR 3) were added for fire-syndrome caused by stagnation of liver-Qi. Taixi (KI 3)
and Taichong (LR 3) were added for hyperactivity of
fire because of Yin deficiency.
Acupoints in the control group were: Shenmen (HT
7), Neiguan (PC 6), and Sanyinjiao (SP 6). Adjunct
acupoints were the same as in the experiment group.

Standard of inclusion
Patients were included if they: (a) conformed to the
standard for diagnosing insomnia, (b) were 18-65 years
old, (c) had no insomnia caused by substantive damage
to internal organs, (d) had not taken Chinese medicines (including Chinese patent drugs and decoctions
for nourishing the heart to calm the mind) or Western
Medicine (including bromide, Librium, or diazepam)
to treat insomnia in the past week, or if they took these
drugs for 3-5 days but stopped taking them for more
than 7 days, and e) signed an informed consent form.

Manipulation
Patients in the experiment group lay in the dorsal position. After the skin was routinely sterilized, needles
were inserted into Baihui (GV 20) and Sishencong
(EX-HN 1) 0.8 cun deep. After the needling sensation,
the uniform reinforcing-reducing method was performed. Needles were inserted into Shenmai (BL 62)
and Zhaohai (KI 6) 0.5 cun deep. After the needling
sensation, the reinforcing method was performed at
Zhaohai (KI 6) and reducing method at Shenmai (BL
62) and adjunct acupoints. After acupuncture, a doctor
held a moxa roll (produced by Nanyang Wolong
Hanyi Mugwort Floss Factory, Nanyang, China) with
one end ignited to perform moxibustion at Baihui
(GV 20) and Sishencong (EX-HN 1) for 40 min. During its retention, the needle was manipulated once ev-

Standard of exclusion
Patients were excluded if they: (a) did not conform to
the standards of diagnosis and inclusion, (b) had accepted other treatments possibly influencing the indexes of effects used in this study, (c) had serious cardio-cerebral blood vessel, liver, kidney, hematopoietic system,
or mental diseases, (d) were pregnant or lactating female patients, and (e) had other factors necessarily excluded.
Standard of rejection
Patients were removed from the study if they: (a) violatJTCM | www. journaltcm. com

429

August 15, 2013 | Volume 33 | Issue 4 |

Gao XY et al. / Clinical Study

was used for comparison between two groups. A 2 test

was used to compare enumeration data. P<0.05 is regarded as a statistical difference.

ery 10 min. The treatment was carried out once in the

afternoon every day for 15 days as a course of treatment.
Patients in the control group lay in the dorsal position.
After the skin was routinely sterilized, needles were inserted into Shenmen (HT 7) 0.5 cun deep, Neiguan
(PC 6) 0.8 cun deep, and Sanyinjiao (SP 6) 1.0 cun
deep. After the needling sensation, the uniform reinforcing-reducing method was performed. The reducing
method was practiced at adjunct acupoints. During its
retention, the needle was manipulated once every
10 min. The treatment was carried out once in the afternoon every day for 15 days as a course of treatment.

RESULTS
Comparison of clinical curative effects between the
two groups
Among the 60 patients in the experiment group, three
dropped out (two were patients with poor obedience
and one failed to visit), leaving a qualification rate of
95% . The treatment in the experiment group resulted
in cure in 27 patients, an obvious effect in 11 patients,
effectiveness in 12 patients, and ineffectiveness in seven
patients. The total effective rate was 87.7% . Among
the 60 patients in the control group, one dropped out
(failed to visit), a qualification rate of 98.3%. The treatment in the control group resulted in cure in 22 patients, an obvious effect in 13 patients, effectiveness in
10 patients, and ineffectiveness in 14 patients. The total effective rate was 76.3%. A 2 test showed that the
total effective rate in the experiment group was much
higher than that in the control group (P<0.01) (Table 1).
There was a statistical difference (texperiment group=3.12, tcontrol
group=3.22, P<0.01) in the total PSQI score before and
after treatment in the two groups. Both therapeutic
methods had curative effects on insomnia. There was a
statistical difference (t=2.89, P<0.01) in the total PSQI
score after treatment between the two groups. The improvement of the total PSQI score in the experiment
group was greater than that in the control group. The
difference of total PSQI score before and after treatment in the experiment group was better than that in
the control group (Table 2).
There was a statistical difference (P<0.05) in the score
of the various PSQIs before and after treatment in the
two groups. Both therapeutic methods had curative effects on insomnia. There was a statistical difference (P<
0.01) in the score of sleep quality, time to fall asleep,
sleep disorder, and daytime function after treatment between the two groups. There was no statistical difference (P>0.05) in the sleeping time and sleeping efficiency scores, indicating that the curative effect in the
experiment group was better than that in the control
group in sleeping quality, time to fall asleep, sleep disorder, and daytime function. Comparison of differences
in the score of various PSQIs before and after treatment between the two groups showed that the improve-

Measurements
We adopted the scale for evaluating PSQIs,2 including:
sleep quality, time to fall asleep, sleeping time, sleeping
efficiency, daytime functions, and total score. Specially
assigned persons were in charge of enquiring about illness condition and making a record before, 1 week,
and 2 weeks after treatment and a record of patients
who were clinically cured 7 days after the end of treatment.
Standard for evaluating curative effect
In reference to the standard for evaluating curative effects on insomnia in the Principle for Directing Clinical Research into New Chinese Drugs3 published by
the Health Ministry, cured insomnia includes sleeping
time returning to normal, sleeping time at night exceeding 6 h, or patients feeling rested after sound sleep.
An obvious effect means that sleep is clearly improved,
sleeping time increases by more than 3 h, and sleep becomes sounder. Effectiveness means that symptoms are
alleviated and sleeping time increases by less than 3 h.
Ineffectiveness means that insomnia is unimproved or
aggravated and the patient drops out.
Statistical analyses
Because the acupuncture and moxibustion practitioner
cannot be double-blinded in clinical experiments, the
single-blind method is used. Specially assigned persons
are independently in charge of manipulation, recording illness condition, and statistic analysis. SPSS 13.0
software (produced by SPSS China Software Shanghai
Limited Company, Shanghai, China) was used to process data. Measurement data are expressed as mean value standard difference ( x s). A t-test of paired data
was used for comparison before and after treatment in
the same group. A t-test of two independent samples

Table 1 Comparison of curative effects on insomnia in patients between two groups (n)
Group

Cure

Obvious effect

Effectiveness

Ineffectiveness

Total effective rate (%)

Control

59

22

13

10

14

76.3

Experiment

57

27

11

12

87.7

P value
0.000

Notes: experiment group were treated once a day with acupuncture at Baihui (GV 20), Sishencong (EX-HN1), Shenmai (BL 62), and Zhaohai (KI 6) and with moxibustion at Baihui (GV 20) and Sishencong (EX-HN1); control group were acupunctured once a day at Shenmen (HT 7), Neiguan (PC 6), and Sanyinjiao (SP 6). The efficiency of two groups were 76.3%, 87.7%; the Experimental group was significantly higher than that in control group (P<0.01).
JTCM | www. journaltcm. com

430

August 15, 2013 | Volume 33 | Issue 4 |

Gao XY et al. / Clinical Study

Table 2 Comparison of total PSQI score before and after treatment in two groups ( x s)
Group

Total score before treatment

Total score after treatment

Difference before and after treatment

Control

59

145

55a

84

Experiment

57

154

43ab

144c

Notes: experiment group were treated once a day with acupuncture at Baihui (GV 20), Sishencong (EX-HN 1), Shenmai (BL 62), and
Zhaohai (KI 6) and with moxibustion at Baihui (GV 20) and Sishencong (EX-HN 1); control group were acupunctured once a day at
Shenmen (HT 7), Neiguan (PC 6), and Sanyinjiao (SP 6). aP<0.01, compared with the total score before treatment in the same group; bP<
0.01, compared with the total score after treatment in the control group; cP<0.01, compared with the difference before and after treatment
in the control group.

ment in the experiment group was more obvious than

that in the control group (Table 3).

balance of the Yin heel vessel and Yang heel vessel can
people gain regular sleep. Consequently, regulation of
the heel vessels and balance of Yin and Yang can treat
insomnia. Shenmai (BL 62) and Zhaohai (KI 6) are
both in the Eight Influential Points. Zhaohai (KI 6) is
a point on the kidney meridian of foot shaoyin, which
links with the Yin heel vessel. Acupuncture should use
the reinforcing method. Shenmai (BL 62) is a point on
the bladder meridian of foot taiyang, which links with
the Yang heel vessel. Shenmai should be stimulated
with the reducing method. These two points can reinforce Yin and reducing Yang, possibly improving sleep.
The governor vessel is also closely related to the brain.
As stated in Su Wen, the governor vessel goes "up to
[the] forehead, reach [es] the top of [the] head, [the]
collateral brain." Baihui (GV 20) is located in the middle of the top of the head, which is at the intersection
of the governor vessel, the meridian of foot taiyang,
hand shaoyang, foot shaoyang, and foot jueyin. Ling
Shu says that the "brain is the sea of marrow, which
conveys up to the cover, down to Fengfu (GV 16)."
The cover in this context means Baihui (GV 20),
which has extensive contact with all parts of the body.
Sishencong (EX-HN 1), located 1 cun anterior, posteri-

DISCUSSION
In this study, we regulated defensive Qi and invigorated brain marrow using acupuncture and moxibustion
to treat insomnia. Compared with conventional methods, this method can improve sleep quality by adjusting the brain's sleep function, improving symptoms of
dreaminess, dizziness, headache, heavy head and poor
memory, and promoting the periodicity from light to
deep sleep. Traditional Chinese Medicine hypothesizes
that there is a close relationship between sleep and
wakefulness and defensive Qi movement in the body
with the alternation of day and night and the balance
of Yin and Yang heel vessels. Ling Shu that, "defensive
Qi moves in the Yang during the day, and Yin during
the night, as Yin corresponds to night, dominating
sleep people fall asleep when Yang Qi ends but Yin
Qi is grand, and vice versa Yin and Yang converge
with each other in the Yin and Yang heel vessels, Yang
joins Yin, Yin leaves Yang. As Yang reaches its limit, the
eyes open, and vice versa." That is, only when there is a

Table 3 Comparison of PSQI scores before and after treatment in two groups ( x s)
Item

Group

Before treatment

After treatment

Difference before and after treatment

Sleep quality

Control

2.40.7

1.00.8

1.60.9

Experiment

2.60.5

0.90.6

2.00.9d

Control

2.20.8

1.00.8a

1.20.9

Experiment

2.00.9

0.80.6ab

1.61.3d

Control

2.10.6

1.00.9a

1.20.7

Experiment

2.00.9

0.80.6

1.41.4d

Control

2.01.0

1.00.8a

1.10.9

Experiment

2.01.0

0.70.3ac

1.61.0d

Control

1.60.5

1.00.5a

0.60.6

Experiment

1.20.4

0.90.3

0.50.3d

Control

1.90.8

1.00.7a

1.20.8

Experiment

2.70.6

0.80.7

2.00.9d

Time to fall asleep

Sleeping time

Sleeping efficiency

Sleep disorder

Daytime function

ab

ac

ab

ab

t
1.19

0.98

0.70

1.77

1.76

2.85

Notes: experiment group were treated once a day with acupuncture at Baihui (GV 20), Sishencong (EX-HN 1), Shenmai (BL 62), and
Zhaohai (KI 6) and with moxibustion at Baihui (GV 20) and Sishencong (EX-HN 1); control group were acupunctured once a day at
Shenmen (HT 7), Neiguan (PC 6), and Sanyinjiao (SP 6). aP<0.01, compared with the data before and after treatment in the same group;
b
P<0.01, cP>0.05, compared with the data after treatment in the control group; dP<0.01, compared with the difference before and after
treatment in the control group.
JTCM | www. journaltcm. com

431

August 15, 2013 | Volume 33 | Issue 4 |

Gao XY et al. / Clinical Study

or and lateral to Baihui (GV 20), has two anterior

and posterior points that are both on the governor
vessel, and two lateral points that adjoin the bladder
meridian, which is collateral to the kidney. The meridian Qi communicates with the primary spirit,
calming the nerves and improving intelligence, reinforcing the brain and regulating the mind. Therefore,
it can promote sleep, uplift the spirit, and strengthen
memory.
5-HT, located at the head end of the raphe nucleus,
plays an important part in the maintenance of
slow-wave-sleep. The bodies of the 5-HT nerve cells
are mainly concentrated at the raphe nuclei. Therefore,
reducing the potency of 5-HT could advance sleep.
Studies have shown that moxibustion can protect the
hippocampal neurons of chronic stress rats, significantly improving the content of brain-derived neurotrophic factor. It can also significantly increase cerebral cortex 5-serotonin levels and its metabolite 5-hydroxyindoleacetic acid in presenium rats, and participate in the
signal transduction of the neurotrophic factor in the
brain. Therefore, moxibustion can resist insomnia, improve sleep quality, reduce awakening at night, reduce
sleep disorder, improve awakening, and ensure normal
functioning in daytime.

10

11
12

REFERENCES
1

13

Mental branch of Chinese Medical Association. Standard

for classifying and diagnosing mental disorder in China
(3rd edition). Jinan: Shandong Press of Science and Technology, 2001: 118-119.
Liu XC, Tang MQ, Hu L, et al. Research into confidence and efficiency of Pittsburgh sleeping quality indexes. Zhong Hua Jing Shen Ke Za Zhi 1996; 29(2):
103-107.
Health Ministry of People's Republic of China. Principle
on directing clinical research into new Chinese drugs. Beijing: Beijing People's Health Press, 1993: 186.

JTCM | www. journaltcm. com

14

15

432

Li XH, Han C, Zhang LF. Effect of moxibustion at point

Dazhui on expression of brain-derived neurotrophic factor
in chronic stress rats. Chin J of Clin Rehabi 2004; 8(1):
194-196.
Zhong L, Lan Q, Chen XL, Liao FZ, Tang Y. Influence of
electric moxibustion with drug on content of neurotransmitter of monoamine type in cerebral cortex of senile rats.
Zhong Guo Zhen Jiu 2004; 24(4): 275-278.
Zhang PL, Gao XY, Wei YL, et al. Multi-centered random control research into treatment of insomnia with acupuncture at Sishencong (EX-HN 1). Zhong Yi Za Zhi
2008; 49(8): 712-714.
Zhang SH, Fu WB. Experience in treating insomnia with
acupuncture and moxibustion. Zhong Yi Za Zhi 2011; 19
(10): 1692-1693.
Zhang Y, Wu XD. Analysis and countermeasure of insomnia factors. Shanxi Zhong Yi Xue Yuan Xue Bao 2002; 25
(5): 12-14.
He ZK. Application of acupuncture at Baihui (GV 20) to
treating diseases in brain. Zhong Yi Yao Dao Bao 2010; 16
(9): 116-117.
Ren S, Gao XY. Clinical research into optimized plan on
selecting acupoints for acupuncture to treat insomnia.
Zhong Yi Za Zhi 2009; 6(11): 46-47.
Ye RF. Assessment of insomnia. Zhong Guo Lin Chuang
Xin Li Xue Za Zhi 2004; 12(2): 207-208.
Yan XQ. Observations on curative effect of moxibustion
at Baihui (GV 20) on 49 patients with obstinate insomnia.
Zhen Jiu Lin Chuang Za Zhi 1999; 15(5): 37-38.
Zhou HQ, Gao XY. Clinical research into treatment of insomnia with moxibustion. Zhong Yi Xue Bao 2011; 26
(4): 505-506.
Zhang HZ, Jia CS, She YF. Clinical observations on treatment of obstinate insomnia with acupuncture mainly at
Zhaohai (KI 6) and Shenmai (BL 62). Sichuang Zhong Yi
2003; 21(6): 75-76.
Chen L, Sun LL, Wang X, Zhang FC. Research into modern articles on law governing acupoint selection for treatment of insomnia with acupuncture and moxibustion.
Zhong Yi Za Zhi 2012; 12(6): 1051-1054.

August 15, 2013 | Volume 33 | Issue 4 |