Accepted Manuscript

Efficacy and safety of acupuncture treatment on primary insomnia: a randomized

controlled trial

Xua Yin, Minghui Gou, Jian Xu, Bo Dong, Ping Yin, Fernand Masquelin, Junyi Wu,
Lixing Lao, Shifen Xu

PII: S1389-9457(17)30093-X
DOI: 10.1016/j.sleep.2017.02.012
Reference: SLEEP 3320

To appear in: Sleep Medicine

Received Date: 23 September 2016

Revised Date: 19 December 2016
Accepted Date: 6 February 2017

Please cite this article as: Yin X, Gou M, Xu J, Dong B, Yin P, Masquelin F, Wu J, Lao L, Xu S, Efficacy
and safety of acupuncture treatment on primary insomnia: a randomized controlled trial, Sleep Medicine
(2017), doi: 10.1016/j.sleep.2017.02.012.

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 ACCEPTED MANUSCRIPT

Efficacy and safety of acupuncture treatment on primary

insomnia: a randomized controlled trial

XuaYin a,*, Minghui Gou b,*, Jian Xu a, Bo Dong a, Ping Yin a, Fernand Masquelin a,
JunyiWu a, Lixing Lao c,d,†, Shifen Xu a,†

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a
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of
Traditional Chinese Medicine, Shanghai, China

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b
Beijing Fengtai Hosptial of Traditional Chinese and Western Medicine, Beijing, China

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c
University of Maryland School of Medicine, Baltimore, MD, USA
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d
School of Chinese Medicine, The University of Hong Kong, Hong Kong
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* These authors contributed equally to this work.

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†
Corresponding authors.
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E-mail addresses: xu_teacher2006@126.com (S. Xu) and lxlao1@hku.hk (L. Lao).

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ABSTRACT
Objective: The objective of this study was to evaluate the efficacy and safety of
acupuncture treatment for primary insomnia.

Methods: We conducted a single-center, single-blinded, and randomized controlled clinical

trial. Seventy-two patients with primary insomnia were randomly assigned into two groups

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– the acupuncture group, who received acupuncture treatment, and the control group, who
received sham acupuncture treatment. The treatment was given three times a week for 4

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weeks. Patients were asked to wear sleep monitors and complete questionnaires every 2
weeks for a total of 8 weeks. The primary outcome was the Insomnia Severity Index (ISI).

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The secondary outcomes were sleep parameters including sleep efficiency (SE), sleep
awakenings (SA) and total sleep time (TST) recorded by the Actigraphy, as well as scores
of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS).

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Results: Compared with pretreatment baseline, patients in both groups had varying degrees
of improvements in their sleep conditions. Paired t-test showed that there was a significant
difference in all indicators in the acupuncture group before and after acupuncture treatment.
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One-way analysis of covariance adjusted for baseline scores indicated that the ISI improved
dramatically in the acupuncture group at 2 weeks post-treatment (F=11.3, p=0.001), 4
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weeks post-treatment (F=33.6, p<0.001), 2 weeks follow-up (F=39.4, p<0.001) and 4

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weeks follow-up (F=34.1, p<0.001). Similar significant improvements can also be observed
in the SE, TST and SDS scores. Although no differences in SA and SAS were shown
between the two groups until the end of the treatment, remarkable decrements in SA and
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SAS were found in the acupuncture treatment group after the 2 week and 4 week
follow-ups.
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Conclusion: Acupuncture treatment is more effective than sham acupuncture treatment in

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increasing insomnia patients’ sleep quality and improving their psychological health.

Trial Registration: Chinese Clinical Trial Registry: Chi CTR-TRC-14004859.

Key words: Acupuncture, Primary insomnia, RCT, ISI, Actigraphy

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1. Introduction

Insomnia is a great challenge to the physical and mental health of individuals. Primary
insomnia (PI) is commonly defined as sleep difficulties that affect daytime functioning; it
does not occur in the presence of another sleep disorder, mental disorder, or as the direct
physiological effect of a substance or medical condition [1]. Primary insomnia is usually
caused by sleep initiation or maintenance disorders, including difficulty in falling asleep,

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dreaminess, and restless sleep [2]. The incidence of insomnia is increasing in the world;
about 23.2% of the adult population in the United States suffer from insomnia [3].

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Moreover, the incidence rate of insomnia in the Chinese population is up to 45.4% [4].
Sleep disorders are considered to be closely related to fatigue, decreased alertness and

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concentration disturbances, etc. [5–7]. Clinical epidemiological studies have also suggested
that insomnia is a risk factor for hypertension [8], stroke [9], mental disorders, including
anxiety and depression [10], as well as reduced human body immunity [11]. Insomnia as a

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public health problem has not received adequate recognition and has not been effectively
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resolved [12].

Currently, the primary treatment for insomnia is psychological treatment complemented

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with medications [13]. Psychological treatment mainly refers to cognitive behavioral

therapy (CBT) for insomnia, which has been proven to be efficient but is still inadequately
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available and accessible to meet the population needs [14]. Benzodiazepines, barbiturates
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and other sedatives are the first-line pharmacological treatment for primary insomnia [15].
Despite their short-term efficacy for symptomatic relief, long-term use of these medications
may cause residual symptoms such as excessive sedation, tolerance, addiction and
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neurological toxicity [16,17].

Acupuncture is one of the most popular and safest therapies; it has been used to treat
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primary insomnia since antiquity in China. Acupuncture balances the body and restores its
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physiological function by inserting thin needles at specific acupoints. Therefore, it does not
affect the natural sleep–wake cycle. It is found that acupuncture can increase the content of
serotonin and aminobutyric acid [18], and reduce glutamate levels [19]. Thus, acupuncture
treatment can improve the function of central inhibition and help people sleep [20].

However, many of the relevant studies seem far less compelling due to some important
limitations, including imperfections in design, poor quality of primary studies and lack of
objective sleep assessments [21]. Their results are far from uniform and fail to arrive at a
positive verdict about the effectiveness of acupuncture [22]. Therefore, it is important to
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implement high-quality randomized controlled trials (RCTs) of acupuncture treatment for

insomnia, with appropriate sham acupuncture and blind method. To address some design
defects and logic problems of acupuncture research, we designed a randomized,
parallel-group, and single-blinded clinical trial with a 1-month treatment period and a
1-month follow-up period.

In this study, we aim to observe the therapeutic effect of acupuncture treatment on primary

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insomnia and try to eliminate the placebo effect of acupuncture by setting up a control
group with reasonable placebo conditions.

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2. Methods

2.1 Design

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This is a patient-assessor-blinded, randomized and sham controlled trial. Outcome
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measurements were assessed at baseline, 2 weeks post-treatment, 4 weeks post-treatment, 2
weeks follow-up and 4 weeks follow-up. On June 2014, the protocol was approved by the
ethics committee of Shanghai Municipal Hospital of Traditional Chinese Medicine. We
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followed the Consolidated Standards of Reporting Trials (CONSORT) and Standards for
Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines for
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designing and reporting controlled trials [23,24].

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2.2 Participants and recruitment

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The patients were recruited by hospital-based advertisements from the outpatient clinic and
the website of Shanghai Municipal Hospital of Traditional Chinese Medicine (TCM) from
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September 2014 until January 2015.

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The inclusion criteria were as follows: (1) aged 18–65 years; (2) met the diagnostic criteria
of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders (Fourth
Edition, DSM-IV) [25]; (3) experienced insomnia for more than a month but less than 2
years before the trial started; (4) the Insomnia Severity Index (ISI) score was more than 8
points but less than 21 points and the sleep efficiency (SE) recorded by the Actigraphy
(wActiSleep-BT. LLC, Pensacola, USA) was less than 85%; (5) voluntarily agreed with the
investigation and signed a written informed consent form before the clinical trial started.

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The exclusion criteria were as follows: (1) the patient had serious cardiovascular, liver,
kidney or hematopoietic system disease; (2) the patient’s insomnia was caused by nervous
system disease (e.g. stroke, Parkinson’s Disease); (3) the patient’s insomnia was caused by
mental disorders including depression or anxiety; (4) the patient had a history of sleep
apnea; (5) the patient was a pregnant or lactating woman; (6) the patient had taken
antidepressant drugs or antipsychotic drugs 2 weeks before the trial; (7) the patient did not

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want to take the actigraphy.

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2.3 Sample size calculation

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Referring to the previous trial on electro-acupuncture for primary insomnia published in
Sleep [26], we determined that a sample size of 30 in each group would provide a power of

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80% and an alpha level of 0.05 allowing us to detect the difference in ISI score between the
two groups. Allowing a 20% dropout rate, a sample size of 36 in each group was needed in
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this trial.
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2.4 Randomization and allocation

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Patients who were interested in participating in the trial were initially screened by phone
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and then were asked to do a face-to-face interview to conduct further surveys. After
recruiting all the participants, a random number table was generated to divide the
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participants into two groups in a ratio of 1:1 using the statistical software SPSS20.0.
Randomization numbers were sealed in opaque envelopes, with patients’ screening
sequence numbers printed outside. All envelopes were numbered consecutively. Another
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researcher, who screened the eligible patients after baseline, opened the envelopes and then
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assigned the patients to either the treatment group or the control group.

2.5 Blinding

Participants were not aware of their group assignments in the trial. Researchers including
statisticians, outcome assessors and data analysts were all blinded to the patients’ group
assignments as well. Although acupuncturists were not blinded to the group assignments,
they were not involved in the outcome assessments or data analyses. Participants were

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asked to wear an eye mask to get a good rest and a better therapeutic effect. To validate the
successful implementation of the blinding method, we conducted each treatment in a closed
unit with the use of screen separation. The same needle tubes, acupoints and skin
disinfection process were used for both the real and sham acupuncture groups. In addition,
all researchers had accepted training for the specific operation before the trial started. They
were asked to strictly adhere to the separation principle.

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2.6 Intervention

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The intervention began on the day after the randomization finished. All participants

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received 12 treatments (three times a week for 4 weeks). Treatments were performed after
skin disinfection with 75% alcohol. Patients were asked to lie supine, wearing eye masks
for better curative effect. Each participant received acupuncture treatment by the same

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acupuncturist who had more than 5 years of clinical experience in acupuncture therapy. The
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temperature of the treatment room could not be lower than 25°C. Patients were allowed to
take orally 0.5–2 mg of the sedative-hypnotic medicine, Estazolam (Approval number:
H31021534, Shanghai Xinyi Medicine Co., Ltd) when they found it extremely difficult to
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fall asleep.
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2.6.1 Acupuncture group

Patients in the acupuncture group received acupuncture treatment on Baihui (GV20),

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Shenting (GV24), Yintang (GV29), bilateral Anmian (EX-HN22), bilateral Shenmen (HT7),
and bilateral Sanyinjiao (SP6). Tube-guided acupuncture needles were inserted to a depth
of 17–25 mm at each acupoint. After insertion, rotating manipulation or lifting-thrusting
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manipulation was applied for ‘deqi’ sensation (Table 1 and Fig. 1). Each acupuncture
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treatment lasted 30 min.

2.6.2 Control group

The major difference between the interventions for the two groups was the tube needling
method. Otherwise, the procedure was the same as that performed in the acupuncture group.
There was no needle in the tube when performing treatments for patients in the control
group. The acupuncturist placed the tube close to the skin at the acupoint, and then tapped
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the top of the tube in order to give patients the sensation of a ‘real’ needle being inserted
into the body. Each treatment also lasted 30 min. At the end of the treatment, the
acupuncturist also used a dry cotton ball to press the acupoints so that patients could feel
the withdrawal of ‘real’ needles.

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2.7 Quality control

The trial was conducted under the supervision of two departments, Shanghai Municipal

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Hospital of Traditional Chinese Medicine and Shanghai Academy of Education Science.
Researchers inputted the collected data immediately on the ResMan website. The Clinical

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Research Center of Drugs of Shanghai University of TCM worked as the data monitoring
team to identify problems during the trial, examine collected data, and control bias.
Meanwhile, a qualified clinical trial expert was invited to monitor the study.

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2.8 Outcome measures
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2.8.1 Primary outcome

ISI: ISI is a reliable and valid instrument to detect cases of insomnia and is sensitive to
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treatment response in clinical patients [27]. According to the results, 0–7 points indicates
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insomnia without clinical significance; 8–14 points indicates mild insomnia; 15–21 points
indicates moderate insomnia; 22–28 points indicates severe insomnia.
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2.8.2 Secondary outcomes

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2.8.2.1 Objective sleep quality measured by the wActiSleep-BT monitor: the Actigraphy is
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a small-sized wrist watch worn on a patient’s wrist, monitoring his or her sleep quality,
including sleep onset, sleep latency, the number of awakenings during the night, duration of
sleep, etc. The main sleep parameters are SE, total sleep time (TST) and sleep awakenings
(SA).

2.8.2.2 Self-Rating Anxiety Scale (SAS): the main indicator is the total score. The sum of
20 items, a score of more than 40 points illustrates anxiety; the greater score indicates the
higher degree of anxiety.

2.8.2.3 Self-rating Depression Scale (SDS): the total score is the main statistical indicator.
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We calculated the standard score first, 1.25 multiplied by the raw score (the sum of 20
questions). We then rounded to the nearest integer to calculate the total score. The dividing
point of the depression judgment is 50 points; the higher the score is, the more significant
the depressive tendency is.

2.8.2.4 Estazolam dose: patients were asked to inform the assessment researcher and record
the dose and the time of taking Estazolam on the CRF table.

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2.9 Statistical analysis

All analyses were performed on the intention-to-treat (ITT) population of participants who had at least

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one treatment. Missing data were replaced according to the principle of the last observation carried
forward. Data analyses were performed with the use of the statistical software R version 3.1.0. The t-test

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was used to compare the measurement data between the two groups from the baseline to the 4th week
follow-up; rank sum test was used for ranked data while χ 2 test was adopted to analyze categorical data.
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A one-way analysis of covariance (ANCOVA) with the baseline measurement as the covariate was used
to investigate differences between the acupuncture and sham acupuncture group at post-treatment and
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follow-up. The significance level used for statistical analysis with two-tailed testing was 5%. Data
values were mainly presented as mean±SD.
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3 Results

3.1 Number of participants

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A total of 137 participants were recruited in initial recruitment (Fig. 2). When the
researcher contacted them to perform preliminary screening by phone, 43 participants were
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excluded (four were older than 65 years old; 13 refused to participate when told about the
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long duration of weekly participation; eight had depression or other sleep disorders; 18 had
other reasons to refuse participation). The other 94 participants were asked to come to the
acupuncture outpatient clinic where they were requested to undergo further screening.
Twenty-two participants were excluded during the face-to-face screening (six failed to meet
the ISI or SE criteria and 16 dropped out before randomization). As a consequence, 72
participants were recruited and randomly assigned to two groups. A total of 10 participants
dropped out during the 8-week study period (three went abroad for personal reasons, four
went on business trips during the treatment period for more than 1 week, and three asked

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for other medication treatment due to the unsatisfactory effect of their acupuncture
treatment). There were no missing data in the remaining 62 participants who completed the
study. None of the participants withdrew due to adverse events.

3.2 Demographic and clinical characteristics

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Baseline features of the two groups are presented in Table 2. There were no significant
differences identified in demographic and clinical characteristics between the two groups

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(p>0.05) except for the TST and SAS score. The TST was higher and the SAS score was
lower in the acupuncture group.

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3.3 Outcomes

3.3.1 Sleep quality

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The one-way ANCOVA analytic method adjusted for baseline characteristics was used in
the published study to investigate differences between groups and prove certain feasibility
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[26]. The results of our study showed that there was significant between-group variation in
ISI score, SE, SA and TST (Tables 3 and 4). Outcome analysis showed that there was a
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remarkable decrease in ISI total score in both groups.

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Results of paired t-test for the ISI score in the acupuncture group showed that there was
significant difference before and after intervention (all p<0.01), indicating that the ISI score
of patients with primary insomnia was significantly improved after receiving acupuncture
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treatment. Similar results could also be observed in SE, SA and TST in the acupuncture
group. Compared with the control group, the acupuncture group showed significant
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reduction in ISI score at 2 weeks post-treatment (F=11.3, p=0.001), 4 weeks post-treatment

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(F=33.6, p<0.001) and 2 weeks follow-up (F=39.4, p<0.001) and 4 weeks follow-up
(F=34.1, p<0.001). Participants in the acupuncture group had significantly higher SE
recorded by the Actigraphy at 2 weeks post-treatment (F=4.6, p=0.036), 4 weeks
post-treatment (F=27.0, p<0.001), 2 weeks follow-up (F=29.0, p<0.001) and 4 weeks
follow-up (F=22.1, p<0.001) than those receiving sham acupuncture treatment. No
between-group difference in SA was found at 2 weeks post-treatment (F=0.22, p=0.888). At
4 weeks post-treatment (F=30.5, p<0.001), 2 weeks follow-up (F=30.0, p<0.001) and 4
weeks follow-up (F=20.2, P<0.001), the participants’ SA in the acupuncture group were

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significantly lower than those in the sham acupuncture group. The TST in the acupuncture
group showed significantly greater improvement at all four observation points (all p<0.01).

3.3.2 Psychological health

Table 5 shows the SDS and SAS scores of the two groups. One-way ANCOVA adjusted for

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baseline scores showed there was a significant difference in between-group SDS and SAS
scores. Paired t-test for SDS and SAS in the acupuncture group indicated that there were

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significant differences in these scores before and after acupuncture treatment (all p<0.05).
The results suggested that acupuncture could effectively improve the insomnia patients’

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mental state. Participants in both groups had lower SDS and SAS scores than baseline.
Compared with the control group, the acupuncture group showed significant reduction in
SDS at 2 weeks post-treatment (F=7.7, p=0.007), 4 weeks post-treatment (F=13.0,

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p=0.001), 2 weeks follow-up (F=9.6, p=0.003) and 4 weeks follow-up (F=5.9, p=0.018).
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There were no significant differences in SAS scores between the two groups at 2 weeks
post-treatment (F=0.24, p=0.627); the remarkable between-group differences were found at
4 weeks post-treatment (F=25.5, p<0.001), 2 weeks follow-up (F=12.7, p=0.001) and 4
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weeks follow-up (F=6.8, p=0.011).

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3.3.3 Adverse effect and medication

One participant in the acupuncture group suffered local hematoma and another complained
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of headache during the trial. Participants in the control group reported no adverse events.
The patient with local hematoma was treated with cold compress and recovered in 3 days;
the patient with headache was told to rest and she felt better the next day. Neither of them
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quit the trial. There was no statistical significance in the incidence of adverse events
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between two groups (p=0.164>0.05). No participant in either group was reported to take
Estazolam for insomnia during the trial.

4 Discussion

In this study, we conducted a strictly randomized, controlled research to observe the effect
and safety of acupuncture for primary insomnia and to overcome some methodological
challenges in present clinical researches of acupuncture.
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According to the results, acupuncture can improve insomnia patients’ SE, prolong TST,
improve insomnia severity, and relieve depressive or anxious moods. There was no severe
adverse effect reported during the trial. It is suggested that acupuncture treatment can be
safely applied in insomnia treatment. It is also indicated that acupuncture treatment was
more effective than sham acupuncture treatment in improving insomnia patients’ sleep
quality and psychological health. Compared to the control group, improvements in ISI,

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SDS, SAS and sleep quality recorded by the Actigraphy of the acupuncture group were
more significant. Differences between the two groups were well maintained from the

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treatment period to the follow-up period. The control group with the proper sham
acupuncture operation method was set to eliminate the placebo effect of acupuncture. As

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expected, the better effect of acupuncture over placebo provided strong evidence against
the misunderstanding that acupuncture is a placebo therapy and has no real effect [28].

Primary insomnia is a chronic and recurrent disease with multiple factors [2]. Studies

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reported that depression and anxiety symptoms may manifest prior to and increase risk for
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the development of adult insomnia [29,30]. Acupuncture is considered to have a unique
advantage not only in improving sleep disorders, but also in regulating a healthy mental
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state. Our results implied that acupuncture had antidepressive effects for insomnia patients.
These findings may also have implications for the etiology of insomnia and the therapeutic
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mechanism of acupuncture for insomnia.

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The number of RCT studies on insomnia by acupuncture treatment increases every year,
but their results remain heterogeneous due to the stagnant methodology quality. Some
previous studies suggested that the effect of acupuncture for insomnia was equal or a little
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superior to sham acupuncture [31]. These studies tend to have short treatment duration;
most of them were less than 4 weeks. They did not follow up for a long time to assess any
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lasting effects of acupuncture. Besides, few of them selected the acupoints based on
syndrome differentiation. Almost none of them put emphasis on the experienced
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acupuncturists’ manipulation for ‘deqi’ sensation. In our study, we tried to readdress these
problems and achieve positive results with acupuncture treatment, helping to emphasize
that acupuncture is far more effective than placebo treatment. We designed a 4-week
treatment duration with a 4-week follow-up period to evaluate and compare the therapeutic
and lasting effects of acupuncture and sham acupuncture on patients’ sleep quality.

Acupoint selection is one of the crucial factors for the effects of acupuncture [32]. A
comprehensive consideration of different TCM syndromes of insomnia is needed during

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treatment. Thus, we selected several main acupoints on the Governor Vessel and other
highly recommended acupoints for treating insomnia. According to TCM theory, insomnia
is a consequence of the vicious cycle of ‘daytime low-spirit’ and ‘nighttime hyper-arousal
state’. Also, the Governor Vessel is closely related to the occurrence of insomnia [33]; it
governs all ‘yang’ meridians and connects all ‘yin’ meridians in the human body.
Regulating the Governor Vessel can correct the imbalance of ‘yin–yang’ at night and

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restore the normal day–night cycle. ‘Deqi’ sensation is considered to be another important
factor in achieving therapeutic effectiveness in acupuncture treatment [34]. It is the

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patient’s subjective sensation, manifested as soreness, fullness, heaviness and numbness
when receiving acupuncture treatment. Experienced acupuncturists in our trial performed

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rotating, lifting and thrusting, needle-handle scraping or flicking, and other manipulations
for seeking ‘deqi’ sensation and, thus, offered better results. Among the acupuncture studies
for primary insomnia, few of them applied objective sleep assessment devices to monitor

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participants’ sleep quality. To avoid the bias caused by subjective assessment, the
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wrist-worn Actigraphy was employed to record patients’ sleep onset, SE, TST, SA, sleep
latency and other indicators in our study. The Actigraphy is a newly developed monitoring
device for collecting objective measures of sleep [35]. Because of its small size, it brings no
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limit or discomfort for patients’ activities and has no bad effect on their sleep quality.
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One of the limitations of our trial is the small sample size, which may result in the
statistical bias of the baseline and outcome assessments. Therefore, we found that it was
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difficult to completely eliminate all disturbances during the trial due to the patients’
variable mental states. The relatively short intervention and follow-up period in this trial is
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another limitation. For further research, conducting a larger sample study to demonstrate
long-term effects of acupuncture is warranted. Prospective, multi-center, cohort studies
with multifactor statistical analysis can also be conducted to provide more practical and
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stricter clinical research modalities in acupuncture clinical studies.

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Conclusion

Acupuncture is an effective and safe method to improve insomnia patients’ sleep quality
and promote their psychological health.

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Conflict of interests

The authors declare that they have no competing interests.

Acknowledgements

The study was partly supported by grants from the Science and Technology Committee in

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Shanghai, China (14401930900) Shanghai Municipal Commission of Health and Family
Planning (ZY3-CCCX-3-3022) and the State Administration of Traditional Chinese

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Medicine, China (JDZX2015024). We would like to thank Mr Andrew Zeng from the
International Education College, Shanghai University of Traditional Chinese Medicine, for

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his editorial support.

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Fig. 1. Location of acupoints

Fig. 2. Participant flowchart. ISI, Insomnia Severity Index; SE, sleep efficiency.

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Table 1. Acupuncture method for each acupoint.

No. Acupoint Needling method Needles

1 Baihui The angle between the needle tip and the scalp is 0.3*40 mm
(GV20) 30°. Move the needle tip backward along the

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anterior–posterior midline, and then insert the
needle 0.5 cun.

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2 Shenting The angle between the needle tip and the scalp is 0.3*25 mm
30°. Move the needle tip backward along the

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(GV24)
anterior–posterior midline, and then insert the
needle 0.5 cun.

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3 Yintang Pinch the local skin, and then puncture obliquely 0.3*25 mm
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(GV29) 0.5 cun

4 Anmian The angle between the needle tip and the scalp is 0.3*40 mm
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(EX-HN22) 30 degrees. Puncture perpendicularly 0.5 cun with

the needle tip pointed toward the nose tip
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5 Shenmen Puncture perpendicularly 0.5 cun. 0.3*25 mm

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(HT7)

6 SanYinjiao Puncture perpendicularly 1–1.5 cun. 0.3*40 mm

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(SP6)

cun., ???
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Table 2. Demographic and clinical characteristics of the intention-to-treat population.

Variables Acupuncture group Control group p

(N=36)
(N=36)

Age (years) 39.7±12.9 37.3±15.1 0.163*

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Gender (male/female) 17/19 15/21 0.608*

Education attainment 16.4±3.3 14.8±3.9 0.483*

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(years)

Marital status 0.621*

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Never married 9 (25.0) 12 (33.3)

Married 22 (61.1) 21 (58.3)

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Divorced/widowed 5 (13.9) 3 (8.3)

Alcohol use 4 (11.1) 1 (2.8) 0.179*

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Cigarette use 3 (8.3) 1 (2.8) 0.296*

ISI total score 17.1±4.1 17.0±4.5 0.798*

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SE (%) 74.4±14.8 74.9±8.8 0.165*

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TST (min) 334.5±69.6 282.4±69.3 0.003

SA 20.1±7.4 22.6±7.6 0.460*

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SAS total score 44.0±8.0 48.4±8.0 0.011

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SDS total score 47.3±10.4 48.6±11.1 0.381*

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Data were presented as mean±SD. ISI, Insomnia Severity Index; SA, Sleep Awakenings;
SAS, Self-Rating Anxiety Scale; SD, standard deviation; SDS, Self-Rating Depression
Scale; SE, Sleep Efficiency; TST, Total Sleep Time.

*p>0.05.

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Table 3. Changes in Insomnia Severity Index of two groups from 2 weeks post-treatment to
4 weeks follow-up.

Control group
Acupuncture group ANCOVA ANCOVA

F p

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Mean SD 95% CI Paired
Mean SD
t-test

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p

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ISI

baseline 17.1 4.1 17.0 4.5

2 weeks post-treatment 13.4 3.9

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-4.40, -0.88 0.004** 16.0 4.3 11.3 0.001**
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4 weeks post-treatment 10.5 3.8 -6.86, -3.08 <0.001** 15.5 4.3 33.6 <0.001**

2 weeks follow-up 9.9 4.1 -6.82, -3.79 <0.001** 15.2 4.1 39.4 <0.001**
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4 weeks follow-up 9.6 4.2 -6.32, -3.45 <0.001** 14.4 3.8 34.1 <0.001**
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Data were presented as mean±SD. ANCOVA, one-way analysis of covariance; CI,

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confidence interval; ISI, Insomnia Severity Index; SD, standard deviation.

* p<0.05; ** p<0.01.
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Table 4. Changes in sleep efficiency, sleep awakenings and total sleep time of two groups
from 2 weeks post-treatment to 4 weeks follow-up

Acupuncture group Control group ANCOVA ANCOVA

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F p

Mean SD 95% CI Paired

Mean SD

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t-test

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SE

baseline 74.4 14.8 74.9 8.8

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2 weeks post-treatment 82.0 8.5 -0.73,8.34 0.098 78.2 9.8 4.6 0.036*
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4 weeks post-treatment 89.3 8.2 6.13,14.54 <0.001** 79.0 9.4 27.0 <0.001**

2 weeks follow-up 89.1 8.0 6.83,16.12 <0.001** 77.6 10.9 29.0 <0.001**
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4 weeks follow-up 87.0 8.5 5.72,15.28 <0.001** 76.4 11.1 22.1 <0.001**

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baseline 20.1 7.4 22.6 7.6

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2 weeks post-treatment 18.5 7.6 -4.91,1.85 0.37 20.0 7.4 0.02 0.888

4 weeks post-treatment 10.2 6.8 -12.22,-6.39 <0.001** 19.5 7.5 30.5 <0.001**
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2 weeks follow-up 10.8 6.6 -11.78,-5.95 <0.001** 19.6 7.3 30.0 <0.001**

4 weeks follow-up 11.3 7.3 -10.76,-4.85 <0.001** 19.1 6.9 20.2 <0.001**
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TST
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baseline 334.5 69.6 282.4 69.3

2 weeks post-treatment 361.2 65.2 43.35,110.93 <0.001** 284.0 80.7 8.1 0.006**

4 weeks post-treatment 397.3 55.3 85.63,142.43 <0.001** 283.3 63.7 49.8 <0.001**

2 weeks follow-up 393.4 53.0 51.54,131.40 <0.001** 301.9 108.4 10.6 0.002**

4 weeks follow-up 385.9 55.4 69.06,137.94 <0.001** 282.4 79.7 25.8 <0.001**

Data were presented as Mean±SD;* p<0.05; ** p<0.01; CI, confidence interval; SA, sleep
awakenings; SD, standard deviation; SE, sleep efficiency; TST, total sleep time.

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Table 5. Changes in SDS, SAS of two groups from 2 weeks post-treatment to 4 weeks
follow-up

Acupuncture group Control group ANCOVA ANCOVA

F p

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Mean SD 95% CI Paired
Mean SD
t-test

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p

SDS

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baseline 47.3 10.4 48.6 11.1

2 weeks post-treatment 43.4 9.8 -9.70, -0.63 0.027* 48.6 9.5 7.7 0.007**

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4 weeks post-treatment 37.3 9.9 -12.41, -3.48 <0.001** 46.6 11.5 13.0 0.001**
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2 weeks follow-up 38.8 8.0 -10.5, -2.22 0.004** 46.0 11.3 9.6 0.003**

4 weeks follow-up 39.7 9.5 -10.68, -1.32 0.013* 45.4 14.5 5.9 0.018*
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SAS

baseline 44.0 8.0 48.4 8.0

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2 weeks post-treatment 41.7 10.5 -8.42, -0.36 0.034* 46.1 7.9 0.24 0.627
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4 weeks post-treatment 35.6 6.3 -12.83, -6.95 <0.001** 45.5 7.8 25.5 <0.001**

2 weeks follow-up 36.3 6.2 -12.04, -4.90 <0.001** 44.7 9.2 12.7 0.001**
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4 weeks follow-up 35.9 7.2 -11.33, -3.56 <0.001** 43.4 9.6 6.8 0.011*

Data were presented as mean±SD. ANCOVA, one-way analysis of covariance; CI,

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confidence interval; SAS, Self-Rating Anxiety Scale; SD, standard deviation; SDS,
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Self-Rating Depression Scale;

* p<0.05; ** p<0.01.

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Figure 1. Location of acupoints

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Participant recruitment（N=137）
Enrollment

Screening by phone (N =137) Excluded (N =43)：

Age＞65 years（N =4）

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With other sleep disorders（N =2）

Screening in the clinic (N =94) With depressive insomnia（N =6）

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Excluded (N =22)：

Not meeting ISI criterion (N =2)

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Randomization（N =72） Not meeting SE criterion（N =4）

Allocation

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Baseline assessment

Intervention
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Acupuncture (N =36） Sham/Control (N =36）

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3/ wk * 4 wk 3/wk * 4 wk
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Outcome assessment at 2 week, 4 week

post-treatment, 2 week, 4 week
follow-up
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Completed（N =32） Completed（N =30）

Withdrew (N =4) Withdrew (N =6)

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Analysis
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Analyzed（N =36） Analyzed（N=36）

Figure 2. Participant flowchart

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Highlights

Acupuncture treatment can be safely applied in insomnia treatment.

Acupuncture treatment is more effective than sham acupuncture treatment in

improving insomnia patients’ sleep quality and psychological health.

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Acupuncture could be an effective therapy instead of sedative–hypnotic medicine

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in insomnia.

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