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CLINICAL REVIEW

A systematic review of the effects of acupuncture


in treating insomnia
Wei Huang
a,
*, Nancy Kutner
b
, Donald L. Bliwise
c
a
VA Medical Center at Atlanta, Department of Physical Medicine and Rehabilitation,
Emory University School of Medicine, 1670 Clairmont Road, Decatur, GA 30033, USA
b
Department of Rehabilitation Medicine, Emory University School of Medicine, Atlanta, GA 30322, USA
c
Department of Neurology, Emory University School of Medicine, Atlanta, GA 30322, USA
KEYWORDS
Acupuncture;
Insomnia;
Sleep;
Traditional Chinese
Medicine
Summary To examine the extent to which research supports the use of acupunc-
ture in treating insomnia, a systematic review was conducted that included not only
clinical trials, but also case series in both English and Chinese literature. Thirty
studies were included in the review, 93% of which showed positive treatment
effects of acupuncture in improving various aspects of sleep. Although acupuncture
has been demonstrated to be safe and holds great potential to be an effective
treatment modality for insomnia, the evidence is limited by the quality of these
studies and mixed results from those with sham (or unreal treatment) controls.
Of the thirty studies, twelve were clinical trials with only three double-blinded.
Only ve used sham controls, and of these, four showed statistically signicant
differences favoring real treatments; however, none evaluated the adequacy of
sham assignment. Three studies used actigraphy or polysomnography as objective
outcome measures. The considerable heterogeneity of acupuncture techniques
and acupoint selections among all studies made the results difcult to compare
and integrate. High-quality randomized clinical trials of acupuncture in treating
insomnia, with proper sham and blinding procedures will be required in the future.
This review highlights aspects of acupuncture treatments important to guide future
research and clinical practice.
Published by Elsevier Ltd.
Introduction
Insomnia is dened as sleep onset, sleep mainte-
nance, and early awakening problems in the
presence of adequate opportunity and circum-
stance for sleep.
1
It affects more than 60 million
Americans each year. Approximately 1/3 of
* Corresponding author.
E-mail addresses: wei.huang@emoryhealthcare.org (W.
Huang), nkutner@emory.edu (N. Kutner), dbliwis@emory.edu
(D.L. Bliwise).
1087-0792/$ - see front matter Published by Elsevier Ltd.
doi:10.1016/j.smrv.2008.04.002
Sleep Medicine Reviews (2009) 13, 73e104
www.elsevier.com/locate/smrv
general population
2
and half of managed care
patients report insomnia.
3
Many risk factors have
been identied for insomnia including female
gender, older age, comorbid chronic medical
conditions and psychiatric disorders, various
medications, and life style factors, e.g., caffeine
intake, smoking, and reduced physical activity.
1
Due to limitations and concerns with current
available insomnia treatments, a sizable propor-
tion of the population, especially in Europe and
China, has turned to complementary alternative
medicine, including acupuncture, in searching for
a treatment modality with potential efcacy and
few side effects.
4
In the US, acupuncture has seen
very limited use in sleep and there have been
limited literature reviews to examine this modal-
ity.
5e7
The most recent review of acupuncture in
sleep
5
attempted a meta-analysis and failed to
demonstrate signicant efcacy of acupuncture
compared with various control treatments. That
review was limited because the studies included
were selected from English literature only and
different acupuncture techniques, control groups,
and outcome measures were not reviewed
systematically.
Acupuncture is a clinical treatment modality in
an independent medical system of Traditional
Chinese Medicine (TCM),
8
which was developed
over 3000 years ago under the inuence of oriental
philosophical theories, such as Yin-Yang, Five
Elements and Dialectical Unity. It has progressed
through many years of clinical observations and
practice. In TCM, there is no concept of isolated
organ function but rather a focus on interactions
among different organ systems. TCM diagnoses
connote syndromes in Western medicine, with
a combination of symptoms. For instance, heart
is not just the 4-chambered blood-pump. It not
only controls vascular circulation but also is
dened as the center of life as well as mind, with
its external manifestations on tongue and face.
Although these connections are not intuitive in
Western medicine, they arise from long-term
clinical observations. For example, TCM teaches
that people with cardiac conditions often have
abnormal facial complexion and tongue color,
anxiety, sleep problems and cognitive dysfunc-
tion.
9
Heart deciency is one of the TCM
diagnoses for insomnia (Table 1). Interestingly,
in Western medicine, such associations also play
a role in physical diagnosis. For instance, blue lips
and ngers in children may indicate cyanosis as
a part of congenital heart disease. In addition,
Western medicine increasingly acknowledges the
relationship of insomnia to both cardiovascular
diseases and psychological disturbances.
10,11
In TCM, poor sleep can also be associated with
other organ system dysfunction. By performing
a complete review of all symptoms, in combination
with physical examination, particularly pulse and
tongue examinations, one arrives at a TCM diag-
nosis for insomnia (Table 1).
9,12
The TCM diag-
noses can also change from time to time due to
progression or resolution of various symptoms.
Therefore, TCM treatments, including acupunc-
ture, are targeted towards regulating and
balancing the functions of different organ systems.
In clinical practice, patients with the same sleep
problem can get different acupuncture treat-
ments, depending on individual differences in both
presumed etiology and dynamic changes of symp-
toms over time.
Basic acupuncture technique is to insert
acupuncture needles into selected acupoints along
meridians, which are the channels believed to
guide the ow of bio-energy in human bodies.
Through many years of practice, with various
interpretations and innovations worldwide,
acupuncture has evolved into numerous treatment
techniques with acupoint selections varying from
practitioner to practitioner
13
(see Table 2 for those
techniques included in this review).
Given the challenge of this complex diagnostic
and therapeutic system for treating insomnia
using acupuncture, a more complete and
systematic review of available literature is
necessary to further guide future clinical and
research directions. By widening our perspective
on the range of study designs and types of broadly
dened acupuncture techniques, we hope, in this
review, to highlight critical areas that should be
addressed in future clinical trials and studies of
underlying mechanisms.
Materials and methods
Search methods for identication of studies
Computerized databases, including MEDLINE
(1950e2007), All Evidence-Based Medicine (EBM)
ReviewsdCochrane Database of Systematic
Reviews (DSR), American College of Physicians
(ACP) Journal Club, Database of Abstracts of
Reviews of Effects (DARE), and Cochrane
Controlled Trials Register (CCTR) (through July
2007), PsycINFO (1806e2007), CINAHLdCumula-
tive Index to Nursing & Allied Health Literature
(1982e2007) were searched under key words
acupuncture, and insomnia or sleep. In
addition, relevant references in the reviewed
articles were also included, if obtainable via
74 W. Huang et al.
Table 1 Traditional Chinese Medicine insomnia diagnoses and acupuncture treatment rules
TCM diagnoses Common clinical symptoms and signs Common sleep
problems
Possible disease condition Acupuncture treatment rules
Heart and spleen deciency Palpitation, easy fatigue, vertigo/dizziness, sweaty,
no taste in mouth, anorexia, amnesia, females with
menstruation abnormalities; pale complexion, pale
tongue proper with thin-whitish covering, ne and
weak pulse
Insomnia with difculty
remaining asleep: frequent
dreams and awakenings,
hard to go back to sleep
once awake
Acute (from extreme
worries and fatigue),
chronic
To nourish heart and to
strengthen spleen
Incoordination between the
heart and the kidney; or
kidney Yin deciency; or
Yin deciency leading to
excessive re
Vexation, vertigo/dizziness, tinnitus, palpitation,
amnesia, low back ache, nocturia, feverish
sensation in the chest, palms and soles, dry mouth,
sore throat, impotence if severe; abscesses over
the mouth and tongue, red tongue proper,
thready pulse
Insomnia of
all kinds
Chronic, usually
from long-term
medical
conditions
To nourish Yin and drain re
Heart and gallbladder Qi
a
deciency
Palpitation, alertness, fearful, shortness of breath,
lassitude; pale tongue proper,
thin-whitish covering, taut-ne pulse
Insomnia with frequent
dreams and mid-sleep
startling awakenings
Acute, chronic To nourish Qi, calm down
spirits and mind
Disturbance of liver yang; or
excessive liver re due to
emotional suppression
Anxiety/depression, angry (internal or external),
irritable, dry mouth or having bitter taste in mouth,
dizziness/headaches, bloating feeling or pain in the
chest, constipation; red eyes, dark yellow urine, red
tongue proper, yellowish covering, taut-rapid pulse
Insomnia with onset difculty,
if asleep,
wakes up early
Acute, chronic To drain liver re, calm down
mind
Liver and kidney
Yin deciency
Dizziness, headaches, anxiety and irritability, back
and leg soreness and weakness, yellowish urine;
tongue proper red with thin yellow coating, deep
and ne pulse
Insomnia with frequent
dreams
Chronic To nourish kidney and liver
Yin, drain re if present
Disturbance of heart due
to phlegm heat
Always feeling bad, worrisome, c/o vertigo/dizziness,
fullness in the head/chest, bitter taste in mouth,
sputum production, aversion to food, acid
regurgitation, hypochondria; reddish tongue proper
(tip), yellow and greasy coating, slippery and rapid
pulse
Insomnia Chronic To drain heat, dissolve
sputum, regulate stomach
function, and calm the mind
Unsynchronized spleen
and stomach
Fullness in the stomach, anxious and cannot
calm down, hiccups/belching, regurgitation.
If chronic: bad breaths, thick and greasy
tongue coating, slippery pulse
Sleep onset difculty Acutedusually food
stagnation; if
chronicdusually long-
term GI conditions
To stimulate stomach
motility, assist in digestion
All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.
a
Qi: a concept in Traditional Chinese Medicine that refers to the vital energy that sustains life activities and physiological functions of viscera and organs.
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Table 2 Introduction of acupuncture techniques mentioned in the included studies
Acupuncture
techniques
Description
Regular body
acupuncture
Fine gauge acupuncture needles, usually of gauge 28e38*, penetrate the skin at selected acupoints out of 14 main meridians and extra-meridian points
to achieve desired treatment effects. Different schools of acupuncture practice use different manipulations, such as manual thrusting and twirling,
electrical stimulation, or simply leaving the needles in for certain amount of time. In TCM, the depth of the needles depends on the chosen acupoint,
goal of treatment, age of the patients, and other variables.
*A regular injection needle is of gauge 22e25; the larger the number, the smaller the needle size.
Special body acupuncture
Intradermal needle This technique leaves acupuncture needles embedded in the acupoints for prolonged period of time, from 24 h to a week.
Plum blossom needle A piece of equipment made of 5e7 needles at one end (plum blossom shaped) and a handle at the other end is used to tap usually a large skin area,
such as back, shoulder, or gluteal region. The stimulation intensity depends on the tapping intensity. The goal result ranges from skin redness to slight
bleeding.
Rolling needle A new type of multiple-needle equipment with dull needle-shaped spikes attached to a round shaft, which can be rolled to stimulate an entire
meridian, for instance back gall-bladder meridian. The goal is to produce skin redness.
Hydro-needle Instead of dry needle, hydro-needle technique injects various medications, such as herbal medications or local anesthetics into acupoints.
Herbal acupoint
taping
Use herb soaked tapes to cover acupoint(s). The idea is to have the herb penetrating into the body and produce treatment effects. Because skin is
impermeable to outside material, this technique is only commonly used at umbilical region.
Dual-acupoints
needling
Use one needle to penetrate two acupoints at the same time.
Auricular acupuncture Auricular acupoints, initially described in TCM and later advanced into a microsystem by a French physician, Paul Nogier, can be used to treat diseases
with various techniques. The ones used in the reviewed studies include needling, semen vaccariae seeds taping and pressing to produce pressure,
magnetic pearls taping to give presumed continuous magnetic eld stimulation, lidocaine injection, laser irradiation, blood letting, all of which are
designed to induce or block stimulation at the auricular acupoints.
Scalp acupuncture Although there are many scalp points along some traditional acupuncture meridians, scalp acupuncture is a specic terminology used internationally to
describe a specic acupuncture treatment system, developed initially by Chinese acupuncturists and later systematized by a Japanese physician,
Toshikatsu Yamamoto. This system is similar to the auricular system where zones of the body are reected on the scalp regions. Needles are usually
inserted within a thin layer of loose tissue beneath the scalp surface at a low angle, many times with electro-stimulation. The most used applications
are neurological conditions.
Moxibustion Moxa is made of dry and grounded mugwort herb, which is believed to increase blood circulation. Moxibustion is the burning of moxa directly or
indirectly at acupoints. Direct application can cause scarring, which was used originally but is now less acceptable. Indirect application is more
commonly used to transmit heat from moxibustion to the acupoints via various ways. In TCM, this technique is commonly used to purge cold and warm
up meridian for the treatment of certain conditions.
Sham acupuncture A technique that is only used in acupuncture research to mimic similar psychological experience for the subjects that could happened when they
interact with the interventionist, assuming the acupuncture is done to them. Various ways of achieving this have been adopted throughout the
acupuncture research history, such as applying pressure or needling at different points than real acupoints, using the same acupoints but without
needle penetration, using fake needles, and etc. The details of sham acupuncture that were used in the studies included in this review
15,19,20,22,24
are
listed with each of those individual studies in Table 3.
All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.
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interlibrary loan within the US. Due to the limita-
tion on Chinese databases access, we were unable
to retrieve the entire body of Chinese literature on
acupuncture and insomnia and only included
studies published in peer-reviewed journals that
are searchable through the above-mentioned
databases. A total of 332 articles were screened
initially according to the following selection
criteria:
Inclusion criteria:
1. Articles written in English or Chinese
languages.
2. Human studies.
3. Original case series or clinical trials published
in peer-reviewed journals.
Exclusion criteria:
1. Although acupuncture was mentioned, the
main treatment modality was complemen-
tary alternative medicine.
2. Treatments focused on other sleep disorders
such as sleep apnea, night terrors, or
somnambulism.
3. Multiple publications reporting the same group
of participants or their subsets.
After applying these criteria, 30 articles of
insomnia treated with acupuncture were selected
and reviewed in detail in the following
categories:
1. Clinical trials with or without blinding (n12).
2. Case series (n18).
Methods of review
We attempted to extract the following data when
possible:
1. Author, year of publication
2. Country
3. Study design:
a. Clinical trials: group assignment method,
control groups, blinding (single, double) and
blinding process assessment, risk of bias.
b. Case series: control of confounders, expo-
sure bias, attrition bias, measurement bias,
risk of bias.
4. Population studied: age, gender, referral
sources, sleep difculty description or
insomnia diagnosis criteria, duration of the
condition
5. Total number of subjects
6. Study groups and number of subjects in each
group
7. Detailed regimen for intervention or control
8. Acupoints used, including acupuncture
techniques
9. Outcome measurements
10. Evaluation time points
11. Results
12. Notes: dropouts description, missing data and
other relevant notes
Quality assessment
The quality of the studies was assessed in the
following areas according to the Cochrane Hand-
book for Systemic Reviews of Interventions
14
:
1. Selection bias: systematic differences in
comparison groups (adequacy of randomiza-
tion process or control of confounders).
2. Performance bias: systematic differences in
care provided apart from the intervention
being evaluated (treatment blinding process or
measurement of exposure).
3. Attrition bias: systematic differences in with-
drawals/dropouts from the trial or complete-
ness of follow-up.
4. Detection bias: systematic differences in
outcome assessment (outcome measure
blinding process or the bias of measurements).
The overall quality of the studies is summarized
into the following three categories after assessing
the above four areas:
A. Low risk of bias: all the validity criteria were
met.
B. Moderate risk of bias: at least one validity
criterion was only partly met.
C. High risk of bias: at least one validity criterion
was completely not met.
Results
Clinical trials of acupuncture in treating
insomnia (details see Table 3)
1. Included studies: 12.
15e26
2. Groupassignment method: 8/12
16,18,20e24,26
not
reported; for the remaining 4 studies,
15,17,19,25
reported methods vary signicantly from
participation date convenience to computer-
ized randomization.
Acupuncture for insomnia 77
Table 3 Clinical trials of acupuncture in treating insomnia
Author
(year,
area)
Study design Population N Study groups Treatment Acupoints Eval F/U Results Notes
Chen (1999,
Taiwan)
15
RCT: Group
assignment
method:
Randomized
block; Control:
a. sham
acupressure,
b. conversation;
Blinding:
single blinding
of real and
sham groups
(subjects);
Risk of bias:
category B.
Age: 61e98 yr;
Gender:
F:M32:52;
Referral:
a public assisted-
living facility;
Sleep difculty:
insomnia with
PSQI >5;
Duration of the
condition: NR.
84 3 groups
(n28 for
each group):
acupressure
group (ACU);
sham
acupressure
group (SHAM),
and control
group (CON).
Both ACU &
SHAM groups:
5 min nger &
10 min
acupoint
massage,
Rx 1e10 pm,
5 per wk for
3 wks (total
15Rx); ACU: real
acupoints with
Deqi
a
. SHAM:
1 cm to 3cun
b
away from true
ones. CON: talk
only.
GV20,
GB20, Anmian,
Shenmen
in the ears and
hands.
Subjective:
PSQI Chinese
version.
Pre- and
post-
intervention.
Signicant
differences in
PSQI scores of
nocturnal
awakening and
night wakeful
time in the ACU
group in
comparison to
the other two
groups, which
did not have
statistical
difference.
However, there
were
improvements
in all groups.
84 out of 124
subjects nished
the project.
Each group had 6
dropouts, other
22 unnished
NR.
Cui (2003,
China)
16
CT: Group
assignment
method: NR;
Control:
medication
control;
Blinding: Not
blinded; Risk
of bias:
category C.
Age: 28e67 yr;
Gender:
F:M58:72;
Referral: outpt;
Sleep difculty:
insomnia of TCM
Dx interior-
stirring by
phlegm-heat,
self-report SE
<60%; Duration
of the condition:
NR.
120 2 groups
(n60 for
each group):
acupuncture
treatment
group (ACU);
and medication
control group
(MED).
Both groups:
estazolam
1e2 mg daily;
ACU:
acupuncture
with manual
manipulations
(duration NR),
daily Rx10
days1 course,
total 3 courses
(30Rx). MED:
medication only.
GV20, GV24,
Sishen cong,
HT7, PC6, CV12,
ST40, SP4.
Subjective:
Therapeutic
effects:
cureddSE>
75% without
med; markedly
effectivedSE
improve by
10e20% without
med; improvede
SE improve by
<10% with
reduced med
dose by 3/4;
ineffectived
no obvious
improvement.
Post-
intervention.
Cured and
markedly
improved
signicantly
more in the ACU
group than the
MED group.
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da Silva (2005,
Brazil)
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CT: Group
assignment
method:
participation day
of the week;
Control: study/
education
control; Blinding:
Not blinded; Risk
of bias: category
C.
Age: 15e39 yr;
Gender:
Females;
Referral:
pregnant women
attending
prenatal
program; Sleep
difculty:
insomnia due to
pregnancy and
not taking
hypnotics;
Duration of the
condition:
15e30 wks of
gestation.
22 >2 groups:
acupuncture
(ACU, n17
initial); control
(CON, n13
initial).
Both groups:
sleep hygiene
education;
ACU: plus
acupuncture
1e2x/wk for
8 wks, each
session average
12 needles for
25 min, Deqi
with
manipulation.
Total 8e12Rx.
CON: education
only.
HT7, PC6, GB21,
GV20, CV17,
Anmian, and
Yintang
optional (up to
4 points each
session).
Subjective:
numerical rating
scale from 0 to 10
for severity of
insomnia.
Baseline, q2wks
(5 evals).
The change in
the insomnia
scores during
the course of
acupuncture
treatment was
signicantly
higher than the
control group;
no difference in
new-born
babies data and
no severe side
effects.
Dropouts (27%):
5 from ACU
group, 3
from CON group.
Gao (1995,
China)
18
CT: Group
assignment
method: NR;
Control: a.
body
acupuncture,
b. medication;
Blinding: none;
Risk of bias:
category C.
Age: 18e62 yr;
Gender:
F:M76:180*;
Referral: outpt
clinic; Sleep
difculty:
insomnia;
Duration of the
condition: 5 days
to 21 yr.
258* 3 groups:
auricular
seeds
pressure
(AUR,
n128);
body
acupuncture
(BOD,
n65);
medications
(MED,
n65).
AUR: auricular
vaccaria seeds
pressing 2e3x
per day, each 3e
5 min (qhs
more), every
other or 2 days
change; 1e12Rx.
BOD:
individualized
daily body
acupuncture 20e
30 min; 5e20 Rx.
Both groups: No
meds. MED:
Surazepam 2e
4 mg qhs; 10
days1 course.
AUR: Main:
shenmen, HT,
brain; adjunct
(1e2): SP, LR,
GB, ST, KI.
BOD:
individualized
treatments.
Subjective:
curedd
shortened
sleep onset,
symptoms
resolve,
and sleep 6e8 h
per night;
improvedd
improved
symptoms, sleep
4e5 h per night;
no responsedno
symptom
improvements;
sleep <4 h/night.
One case
reported in the
article had 2 yr
of f/u.
Statistical
signicant
difference
in clinical
effectiveness:
best in AUR
group, then in
BOD group, then
MED group.
*Inconsistent
totals on number
of cases.
(continued on next page)
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Table 3 (continued)
Author
(year,
area)
Study design Population N Study groups Treatment Acupoints Eval F/U Results Notes
Kim (2004,
Korea)
19
RCT: Group
assignment
method: random
digits; Control:
sham
acupuncture
control; Blinding:
independent
evaluator single
blinded, no
blinding process
evaluation
reported; Risk of
bias: category B.
Age: RA
65.19.0, SA
68.310.4;
Gender:
F:M13:17;
Referral: stroke
inpatients; Sleep
difculty:
persistent
insomnia > 3
nights in a row,
ISI > 15, patients
on hypnotics
were excluded.
Duration of the
condition: post
stroke-onset.
30 2 groups (n15
each group): real
acupuncture
group (RA); and
sham
acupuncture
group (SA).
Real:
intradermal
acupuncture
needle taped
down for 2 days;
Sham: same
points and
taping but
needles did not
penetrate the
skin. Total 1 Rx.
b/l HT7 and
PC6.
Subjective:
Questionnaires,
Insomnia Severity
Index (ISI), and
Athens Insomnia
Scale.
Morning before,
1 and 2 days
after.
All assessed
sleep outcomes
improved
signicantly in
the RA group
compared to the
SA group, except
for sleep latency
and ease of
falling asleep
after wakening.
Li (2005,
China)
20
CT: Group
assignment
method: NR;
Control: sham
and medication
control; Blinding:
single blinded
(subjects), no
blinding process
evaluation
reported; Risk of
bias: category B.
Age: 58e79 yr;
Gender:
F:M28:22;
Referral:
outpatient
acupuncture
clinic; Sleep
difculty:
primary
insomnia*
Duration of the
condition: 2
months to 9 yr.
50 2 groups (n25
each): treatment
group and control
group.
Treatment:
gingkgo leaf
preparation
taped on
acupoint,
VitC po daily;
Control: starch
taped on the
same acupoint,
estazolam
(regular
dosage) po
daily. Both
groups: tape
change every 3
days, total 7Rx.
CV8 Subjective:
SEsleep time/
bed time (%). 5
stages: stage 0:
SE>80%; stage 1:
SE 70e80%; stage
2: SE 60e70%;
stage 3: SE 50e
60%; stage 4 SE
40e50%; stage 5
SE <40%.
Pre and post-
treatments.
Sleep
improvement
rates (changes
of stages):
treatment group
84% and control
group 68% (no
statistical
signicance).
Sleep quality,
however, is
signicantly
better in the
treatment
group.
*Dx by WHO
International
Statistical
Classication of
Diseases and
Related Health
Problems (10th
edition, 1993).
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Lian (1990,
China)
21
CT: Group
assignment
method: NR;
Control:
medication
control group;
Blinding: none;
Risk of bias:
category C.
Age: mean 21-
over 51; Gender:
F:M92:68;
Referral: outpts;
Sleep difculty:
insomnia;
Duration of the
condition: 20
days to 7 yr.
160 2 groups (n80
each): auricular
pressing (AP)
group and
medication (MED)
group.
AP: semen
vaccariae seeds
taped at
auricular points
bilaterally,
changed every 3
days, patients to
press the points
1 h before sleep
qhs, total 30
days. MED:
diazepam 10 mg
qhs30 days.
b/l ear points:
shenmen, HT,
LR, Endocrine,
sub-cortex,
sympathetic,
cervical
vertebrae.
Subjective:
Clinical effective
criteria:
cureddsleep well
7e8 h/night with
symptoms
disappeared;
improvedd
sleep 4e5 h/
night;
ineffectived
insomnia not
ameliorated.
Post-treatments. During initial
stage, MED was
more effective,
but efcacy
reduced with
time; on the
contrary, AP
could be
enhanced with
time. At the end,
there was
signicantly
increased
response rate in
the AP group.
Suen (2002,
Hong-Kong)
22
CT: Group
assignment
method: NR;
Control: a. seed
taping with
pressure, b. no
pressure sham
control; Blinding:
double blinded
(both evaluator
and
participants), no
blinding process
evaluation
reported; Risk of
bias: B.
Age: 60 yr
(mean 81.7);
Gender: F:
M110:10;
Referral: 12
homes for the
elderly; Sleep
difculty: 3
nights qw;
actigraphic
SE<85%; no
severe medical
or psych
conditions.
Duration of the
condition: 6
months to >
20 yr.
120 3 study groups:
Junci Medulla (no
weight or active
physiology-sham,
n30); Semen
Vaccariae
(pressure, n30);
experimental:
auricular
magnetic pearls
(n60).
Subjects were
asked not to
take any
sleeping pills
during the study
period; all three
groups had
taping of
material to the
auricular
acupoints on
alternating ear
every 3 days for
3 wks total.
Ear points:
Shenmen, HT, KI,
LR, SP, occiput,
sub-cortex.
Objective: wrist
actigraphy
monitoring,
Subjective: Sleep
questionnaire
(including daily
habits that might
potentially affect
sleep), and sleep
diary lled out by
staff of the homes
for the elderly.
3 days baseline,
3 days during the
intervention, 3
days post-
intervention.
1. Signicant
improvement in
actigraphic SE,
and nocturnal
sleep time only
in the
experimental
group. In
addition, a
signicant Y
sleep latency
and wake after
sleep, [ total
wake time.
There was no
difference b/w
the 2 control
groups. 2. TCM
dx did not affect
Rx results; 3. the
younger age the
better result.
Dropouts were
all replaced;
Suen 2003
27
followed 15
subjects at 1-,
3-, and 6-month
and showed
sustained
effects.
(continued on next page)
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1
Table 3 (continued)
Author
(year,
area)
Study design Population N Study groups Treatment Acupoints Eval F/U Results Notes
Tsay (2004,
Taiwan)
23
CT: Group
assignment
method: NR;
Control: a. TEAS:
transcutaneous
electrical
acupoint stim,
b. usual care;
Blinding: double
blinded
(subjects, care
providers and
interviewer),
blinding process
evaluation NR;
Risk of bias:
category B.
Age:
58.1612.19;
Gender:
F:M66%:34%;
Referral: ESRD
outpt on HD 3
months, c/o
fatigue, with no
major chronic
and psych
conditions, or
dementia; Sleep
difculty: PSQI
5, BDI 10;
Duration of the
condition: NR.
106 3 groups (n36
to start with
each group):
acupressure
(ACU), TEAS,
and usual care
control.
Both ACU &
TEAS: 3x/wk4
wks (12 Rx),
each session of
relaxation
massage
(5 min)Rx
3 min at each
acupoint. ACU:
nger
acupressure (3e
4 kg) with Deqi
sensation; TEAS:
2/100 Hz stim.
b/l KI1, ST36,
GB34, SP6.
Subjective: Piper
Fatigue Scale,
PSQI, and BDI.
Pre-baseline,
11 data points
during Rx, and
post-
intervention.
No difference
b/w ACU and
TEAS groups,
both signicantly
better than
control group in
fatigue level,
PSQI total score,
self-reported
sleep quality,
and depression
scores.
Dropouts: 1 in
ACU, 1 in usual
care control.
Tsay (2003,
Taiwan)
24
CT: Group
assignment
method: NR;
Control: a. sham
control, b. usual
care; Blinding:
double blinded
(subjects, care
providers and
interviewer), no
blinding process
evaluation
reported; Risk of
bias: category B
Age:
55.5212.98;
Gender:
F:M56:42;
Referral: ESRD
outpt on HD,
with no major
chronic and
psych
conditions, or
dementia; Sleep
difculty: PSQI
5; Duration of
the condition:
NR.
98 3 groups (n35
each to start
with): real
acupressure
group, sham
acupressure
group, and usual
care control
group.
Both real and
sham: 3x/wk4
wks (12 Rx),
each session of
relaxation
massage 5 min
plus acupressure
3 min each point
(total 14 min);
nger pressure
of 3e4 kg. Real:
at acupoints;
Sham: 1 cm away
from real points
HT7, KI1, and
ear Shenmen
Subjective: PSQI,
subject sleep log,
Medical outcome
study SF-36.
Pre-treatment;
8 data points
during
intervention;
post-treatment.
Acupressure
group did
signicantly
better than the
control; no
difference b/w
real and sham;
quick
improvement
was observed
after 2e3
sessions.
Dropouts: 3 in
sham, 4 in
control.
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Wang (2006,
China)
25
RCT: Group
assignment
method:
computerized
random number
generation;
Multicenter: 3;
Control:
medication
control group;
Blinding: none;
Risk of bias:
category C.
Age: mean
16e75; Gender:
F:M108:72;
Referral: outpts;
Sleep difculty:
primary
insomnia with
sleep latency >
30 min more
than 3x/wk, PSQI
> 7; Duration of
the condition:
NR.
180 2 groups (n90
each): rolling
needle and
medication.
Rolling needle:
slow rolling 10
for 15e20 min to
produce skin
redness, 5x/wk
for 4 wks (20 Rx),
while tapering
down/off
sleeping
medications;
medication
group:
Clonazepam
4e6 mg qhs.
Along the back
Bladder meridian
1st and 2nd line
(rolling up to
down) and GV
Meridian (rolling
down to up).
Subjective:
Spitzer QoL
Index; clinical
eval: cured e[ SE
>75% with
disappearance of
symptoms;
improvede[
sleep duration
and [ SE 25e74%,
with
improvement of
symptoms; no
effecte[
SE<25%, no
obvious symptom
improvement.
Before, after,
and 3 months f/u
Signicantly
improved CGI in
the rolling
needle group
compared to
medication
group in the
post-treatment
eval but NOT at
3 months f/u;
QoL was
improved
signicantly in
the rolling
needle group,
lasting through
f/u.
Dropout 1 case
during 3 months
f/u in the
control group.
Yang (1988,
China)
26
CT: Group
assignment
method: NR;
Control: non-
herbal soaked
seeds in a.
specic and b.
non-specic
treatment
groups; Blinding:
NR; Risk of bias:
category C.
Age: 62e91 yr;
Gender: Only
reported on
treatment
group:
F:M39:23;
Referral: outpts;
Sleep difculty:
insomnia;
Duration of the
condition: 2 wks
to 20 yr.
127 3 groups:
treatment group
(TG, n62);
control group I
(CG-I, n40);
control group II
(CG-II, n25).
TG: compositus
Semen Vaccariae
(cooked and
soaked in herbs)
and taped
according to
specic TCM dx;
CG-I: Semen
Vaccariae seeds
taped according
to specic TCM
dx; CG-II: Semen
Vaccariae seeds
taped at xed
points. All
groups: 2e3 min
qhs auricular
seeds pressing
(Purging or
tonication)
alternating ear
2e3x/wk, 10
Rx1 course;
total 1e3courses.
TG & CG-I: LR,
KI for LR and KI
Yin deciency;
HT, SP for HT
and SP
deciency; HT,
KI for Yin
re due to Yin
deciency; HT,
SP, LU for
phlegm-re.
Frontal points if
HA and
dizziness. CG-II:
HT, Shenmen,
occiput, Sub-
cortex.
Subjective:
markedly
effective: Y
latency, sleep 6e
8 h/night,
resolved
symptoms;
improved: sleep
>5 h/night,
alleviation of
symptoms;
ineffective: no
evident
improvements.
In the one case
reported, 6
months f/u.
There was
signicant
difference of
therapeutic
effects in the
treatment group
compared to the
2 control groups.
There was no
statistical
difference b/w
the 2 control
groups.
All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.
a
Deqi: a term in acupuncture to describe the sensation of feeling energy owing through the inserted needle. See page 95 for detail and discussion.
b
cun: a measurement used in acupuncture to nd acupoints in relation to the patients own body size. For instance, the distance between the centre of the patella and the lateral
malleolus is 16 cun and this 16 cun can be used to nd acupoints on the legs. Here, 3 cun is 4 nger breadths.
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3
3. Control groups: 5/12 employed sham control
(with or without other control
groups)
15,19,20,22,24
; other studies include usual
care,
23,24
conversation,
15
education,
17
medi-
cation,
16,18,20,21,25
or other active
treatments.
22,26
4. Blinding process: 3/12
22e24
double-blinded and
3/12
15,19,20
single-blinded, but none of these
studies reported an evaluation process of the
adequacy of the blinding.
5. Subject age range: above 15 years old.
6. Sample size: 22e258.
7. Insomnia conditions:
a. Primary insomnia (n2).
20,25
b. Comorbid insomnia (n4): e.g., post-
stroke,
19
pregnancy,
17
and end-stage renal
disease (ESRD) patients on hemodialysis
(HD).
23,24
c. Unspecied insomnia (i.e., neither primary
or comorbid specied) (n5)
15,18,21,22,26
: 2
of which employed TCM diagnoses during
treatments.
18,26
d. Insomnia associated with a particular TCM
diagnosis (n1): e.g. interior-stirring by
phlegm-heat.
16
8. Study quality: 6 studies
15,19,20,22e24
with cate-
gory B evidence, and 6 studies
16e18,21,25,26
with
category C evidence.
9. Acupuncture treatments: techniques varied,
including regular body acupuncture,
16,17
roll-
ing needle or intradermal needle,
19,25
acu-
point taping with herbal preparation,
20
auricular treatment with seed pressing or
magnetic pearls,
18,21,22,26
and acupres-
sure.
15,23,24
Points varied from 1 to entire
meridian, including body or auricular treat-
ments. Most of these studies used a standard-
ized treatment paradigm, except for three
studies
17,18,26
which employed an individual-
ized approach. Duration ranged from 1 to 30
treatments.
10. Sleep outcomes: Most used subjective evalua-
tions alone (n11), e.g., single administration
sleep questionnaires, including the Pittsburgh
Sleep Quality Index (PSQI),
15,17,19,22e24
some
form of a clinical global impres-
sion,
16,18,20,21,25,26
and sleep diary.
22,24
Only 1
study
22
also used actigraphy as an objective
sleep evaluation; none used polysomnography
(PSG).
11. Effects of acupuncture for sleep:
a. Compared to education control: da Silva
et al.
17
treated pregnancy insomnia with
sleep hygiene education alone versus
a combination of acupuncture and educa-
tion; they showed the combination therapy
being more effective. However, without
a sham acupuncture group, one cannot
conclude whether this additional effect was
due to acupuncture itself or from the moti-
vational/placebo effects due to the
perception that something had been per-
formed by physicians to help.
b. Compared to medication control: medica-
tions used for comparison in the included
studies were benzodiazepine receptor
agonists, e.g., estazolam,
16,20
sur-
azepam,
18
diazepam.
21
These studies all
showed better treatment effects of
acupuncture compared to medications,
although Lian et al.
21
indicated that medi-
cation had shorter duration of treatment to
achieve benet and acupuncture required
more treatments to surpass the effective-
ness of medication.
c. Compared to sham control: results are
mixed. Chen et al.
15
used acupressure at
sham versus real acupoints, Kim et al.
19
used sham versus real acupuncture nee-
dles, Li et al.
20
used our (sham) versus
Gingkgo leaf preparation (real) taping at
acupoint, and Suen et al.
22
used Junci
Medulla (sham) versus magnetic pearls
(real) auricular treatments; all showed
signicant sleep improvements in the real
groups. However, Tsay et al.
24
showed no
difference between sham and real
acupressure, although both groups signi-
cantly improved sleep when compared to
the usual care control.
d. Compared to other types of control: Gao
18
compared auricular and body acupuncture
and showed better clinical effectiveness in
the auricular group. Tsay et al.
23
compared
acupressure and transcutaneous electrical
acupoint stimulation (TEAS) and showed no
difference between the two groups,
although both did signicantly better than
the usual care group. Yang
26
compared herb-
soaked seeds at specic acupoints according
to TCM diagnoses and two controls with
regular Semen Vaccariae seeds at specic
versus non-specic acupoints, and demon-
strated stronger treatment effects with
herb-soaked seeds but with no difference
between the two control groups.
12. Maintenance of efcacy: only 2 studies
25,27
reported follow-up periods of 3e6 months;
both maintained the improvements found at
the end of intervention. Anecdotal cases
18
reported benecial effects lasting for 2 years
at follow-up.
84 W. Huang et al.
Case series of acupuncture in treating
insomnia (details see Table 4)
1. Included studies: 18.
28e45
2. Subject age range: 12e83 years old.
3. Sample size: 16e2485.
4. Insomnia that was treated by acupuncture:
a. Primary insomnia (n2)
32,34
: both employed
TCM diagnoses during treatments.
b. Comorbid insomnia (n2): e.g., AIDS,
35
anxiety.
40
c. Unspecied insomnia (i.e., neither primary or
comorbidspecied) (n13)
28e31,33,36e39,41,43e45
:
6 of which had TCM diagnoses.
28,30,36,38,44,45
d. One study used the same acupuncture
treatments for patients with either insomnia
or excessive sleep.
42
5. Study quality: all studies with category C
evidence.
6. Acupuncture treatments: techniques varied;
half of the studies used auricular treatments,
e.g., seeds taping and pressure applica-
tions,
31,36,42
in combination with education
32
or auricular blood letting,
29
lidocaine injection
at auricular points,
33
laser irradiation,
44
in
combination with body acupuncture.
35,38
The
other half used body acupuncture alo-
ne,
30,37,39e41
in combination with plum
blossom needle tapping
45
or adjunct thera-
pies,
43
or combination acupuncture (e.g.,
body, scalp and moxibustion).
28,34
Points
varied from 2 to entire meridian. All except 4
studies
37,40,41,43
reported individualized treat-
ment paradigms. Duration ranged from 3 to 60
treatments in the reported data.
7. Sleep outcomes: most of these stu-
dies
28e34,36e39,41e45
used some formof a clinical
global impression alone (n16). Only 2 st-
udies
35,40
used objective sleep evaluations, PSG
or wrist actigraphy, in addition to single admin-
istration questionnaires including PSQI.
8. Effects of acupuncture for sleep:
a. Case series: demonstrated positive treatment
effects of acupuncture in reducing sleep
latency,
36,40
improving sleep and wake ratio/
sleep efciency,
35,39,40
increasing sleep dura-
tion and quality
28e30,32,33,35e37,39e45
and reso-
lution of insomnia symptoms
28e30,37,39e43,45
using clinical global impression. Interestingly,
the two studies that used objective
measurements showed different results in
sleep latency. Phillips study
35
in AIDS patients
used wrist actigraphy and showed no signi-
cant difference in sleep latency after
acupuncture treatments; while Spence
et al.
40
used PSG recording and showed
signicant improvement in sleep onset
latency in insomnia with anxiety as a comor-
bid condition. The difference could be due to
different comorbidities, or different out-
come measures with different measurement
sensitivity.
b. Case series with controls: Lu
34
showed
signicantly better outcome with acupunc-
ture, compared to the combination of
Western and herbal medications.
c. Wu
42
used the same primary acupoints to
treat either insomnia or excessive sleep and
showed improvements in both groups with
85% and 100% effective rates, respectively.
9. Maintenance of efcacy: 4 studies
33,34,41,45
reportedfollow-upperiods of 2 months toa year;
all maintained the improvements found at the
end of intervention. Anecdotal cases
29,36,37
reported benecial effects lasting for 2e3.5
years at follow-up.
Discussion
What are the methodological limitations of
existing studies of acupuncture treatment
for insomnia?
Inconsistent sham controls and deciency in
blinding
Very few studies
15,19,20,22,24
have used sham control
groups. Four of these studies demonstrated positive
impact on sleep with real treatments relative to
sham; one study,
24
although showing signicant
improvements over usual care, reported absence of
differences between real and sham acupressure.
However, in this study, relaxation massage was also
applied in the sham group, which may have exerted
treatment effects. Furthermore, the shamacupoints
were only 1 cmaway fromthe true meridians, which
represents a small distancebetweensites, especially
when using nger acupressure technique. Because
wedonot knowhowfar away thetreatment gradient
would extend fromthe true acupoints (in distance or
depth), manipulations such as nger pressure may
still have elicited physiological effects in this study.
This could explain why another study
15
using the
same technique found signicant differences
between real and sham acupressure treatments. In
that study, the sham points were up to 3 cun (about
four nger breadths) away from the true acupoints
on the body. The inconsistencies of choosing sham
acupoints may have led to inconsistent results.
Another relevant study was Suen et al.,
22
who
Acupuncture for insomnia 85
Table 4 Case series of acupuncture in treating insomnia
Author
(year, area)
Study design Population N Treatment Acupoints Eval F/U Results Notes
Cheng (1986,
China)
28
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 12e83 yr;
Gender:
F:M892:1593;
Referral: outpts
since 1954;
Sleep difculty:
insomnia of
various etiology
and divided into
5 TCM dx: a.
deciency of HT
and SP; b. HT
and GB Qi
deciency; c. KI
deciency; d.
disharmony b/w
ST and mid-Jiao;
e. upward
invasion of LR
Yang; Duration
of the
condition: mean
149 days.
2485 Daily
acupuncture
with manual
stimulation and
Deqi, needles
retained for 20e
40 min,
12e15x1
course, plus
moxibustion of
selected points
in certain
conditions. Total
Rx NR.
Main: HT7*,
GB12, ST36.
Adjunct: a. PC7,
SP6; b. GB40,
GV20*; c. KI6,
KI3; d. CV12,
PC6; e. LR2,
BL18, CV20.
*20 min
moxibustion in
long-term
decient
patients.
Subjective: Clinical
evaluation:
cureddnormal sleep
with resolution of
daytime symptoms;
improveddsubjective
improvements in sleep
quality and quantity as
well as some
amelioration of
symptoms;
ineffectivedno change.
After one
month
All 327 patients
who were on
hypnotic meds
went off meds
after 10 Rx.
Simple insomnia
with averaged
disease course
29days, the
treatment
effective rate
was 74.65%;
Other etiologies
averaged 167
days, the
effective rate
was 41.18%
statistically
signicant
difference b/w.
Prior to the
study, 1274
cases failed to
respond or
maintain the
response to
hypnotic meds,
herbs, or
physical
therapy.
Dang (1995,
China)
29
Case series:
Control of
confounders:
none. Exposure
bias: no.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 16e68 yr;
Gender:
F:M30:28;
Referral:
outpts; Sleep
difculty:
insomnia;
Duration of the
condition: 7
days to 30 yr.
58 Bloodletting at
auricular tip;
then other b/l
auricular
acupoints with
vaccaria seeds
taping, pressed
5e6 x/day, more
intensity at qhs,
once a week
visit to change
out the seeds.
All sleep related
meds are
stopped during
treatment.
5Rx1 course
(Total NR).
Auricular tip
plus the
following
auricular
acupoints:
shenmen, sub-
cortex,
occipital, HT,
shenshuai;
adjunct points
were used if
with symptoms,
e.g., LR, GB, KI,
ST.
Subjective: Clinical eval:
cureddnormal sleep
with no recurrence after
stop of Rx; improvede
signicant improvements
with >5 h per night
sleep, slight recurrence
after stop of Rx but
improved with
reinforcement Rx;
ineffectivedno obvious
improvements.
One case
reported in the
article had 2 yr
of f/u.
38 cases cured;
19 cases
improved; 1
case no
response.
Unknown total
Rx that were
needed, for
instance for 7-
day insomnia
versus for 30 yr
of insomnia.
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Gao (1997,
China)
30
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
no.
Measurement
bias: yes. Risk of
bias: category C.
Age: 16e72 yr;
Gender: NR;
Referral: outpt
form June 1991
to May 1994;
Sleep difculty:
insomnia divided
into 5 TCM dx: a.
deciency of HT
and SP; b.
incoordination
b/w HTand KI; c.
insufciency of
HT and GB; d.
disturbance of LR
Yang due to
emotional
distress; e.
phlegm heat;
Duration of the
condition: 7 days
to 6 yr.
288 Daily
acupuncture
with needles
retained for
30 min, 25 min
of which the
needles were
manually
manipulated.
Total Rx NR.
Main: HT7, KI7;
Adjunct: a.
BL15, BL14,
BL20; b. BL15,
BL23, KI3, SP6;
c. BL15, BL19,
PC7, GB40; d.
BL18, PC5, LR3;
e. BL21, ST36.
Subjective: Clinical
effects: cureddsleep 7e
8 h/night with resolution
of all symptoms;
excellentd6e7 h/night
with resolution of all
symptoms;
improveddsleep 5 h/
night with occasional
symptoms; no effecteno
change or worse.
In the one case
reported, f/u 1/
2 yr.
90.96% case
cured, 5.56%
cases with
excellent
effect, 2.08%
cases improved,
1.39% with no
effect.
Gao (1996,
China)
31
Case series:
Control of
confounders:
none. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias; category C.
Age: NR;
Gender: NR;
Referral:
outpts; Sleep
difculty:
insomnia;
Duration of the
condition: NR.
25 Auricular
vaccaria seeds
taping change Qd
with alternating
ear, pressed 3e
4x/day, each
time 1e2 min
with moderately
strong
stimulation. 10
changesone
course (10 days).
Resting for 3e5
days. Then next
course if needed.
Ear points:
Shenmen, HT,
sub-cortex
(which can be
eliminated if no
pain on
probing).
Additional
points (2e3):
brain,
sympathetic,
endocrine, SP,
LR, ST, KI.
Subjective: Clinical
evaluation details NR.
18 cases cured
with 1 course; 3
cases cured with
2 courses; 2
cases received 3
courses but still
with 2 h of sleep
onset latency; 2
cases no
response.
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Author
(year, area)
Study design Population N Treatment Acupoints Eval F/U Results Notes
Ju (1997,
China)
32
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 14e55 yr;
Gender:
F:M32:21;
Referral:
outpts; Sleep
difculty:
primary
insomnia with 4
TCM dx-a. re
due to LR
depression; b.
phlegm heat; c.
excessive re
due to Yin
deciency; d.
deciency of HT
and SP; Duration
of the
condition: 2
months to 11 yr.
53 Education:
modication of
life style, such
as the use of
tea, coffee.
Auricular
vaccaria seeds
taping: one ear/
alternating q5
days, massage
each point 2e
3x/day, each at
least 50 times,
more qhs, till
Deqi. 10 Rx1
course. Total Rx
NR.
Main: Shenmen,
sub-cortex,
endocrine,
brain,
sympathetic;
Adjunct:
according to
TCM dx-a. LR,
GB; b. HT, SP,
ST; c. KI, BL; d.
HT, SP, SI. If
female add Jing
Gong.
Subjective: Clinical eval:
cureddsleep return to
pre-morbid condition;
effectivedboth sleep
duration and depth
improved;
ineffectivedno change
of insomnia symptoms.
NR 29 cases cured,
19 cases
effective, 3
cases
ineffective.
2 dropouts.
Lee (1977,
USA)
33
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
no.
Measurement
bias: no. Risk of
bias: category C.
Age: 26e69 yr;
Gender:
F:M7:9;
Referral: outpts
with insomnia as
chief complaint,
with or without
medical
comorbidities;
Sleep difculty:
sleep 3e4 h/
night with
daytime
symptoms;
Duration of the
condition: 2 wks
to 34 yr.
16 All sleep meds
discontinued
prior to the
treatments.
Lidocaine
injection at
auricular
acupoints
(alternating
ear); frequency
initially 3x/wk
later changed
depending on
responses.
Patients to be
active physically
for about
20 min post-
injection.
Ear points:
Main: HT, KI,
adrenal, sub-
cortex,
endocrine, TH,
Shenmen;
adjunct:
sympathetic,
occiput, GB
depending on
individual
patient.
Objective: heart rate;
Subjective: Sleep
duration.
Pre- and post
treatments, 3
months f/u.
Total Rx vary
from 2 to 28,
mostly below 15
(only one
28)dnot
correlated with
severity of
insomnia. All
patients
reported
substantial
improvement.
68.7% cases had
>7 h sleep per
night without
meds which
sustained during
f/u and were
considered to be
cured.
Hypothesis was
that lidocaine
(blocking
sensory input)
is good for
relative
excess of Yang
and also good
for those who
did not respond
to regular
acupuncture.
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34
Case series:
Control of
confounders:
comparable
b/w group
acupuncture
(ACU) and group
medication
(MED) but
statistical data
NR. Exposure
bias: unknown.
Attrition bias:
unknown.
Measurement
bias: yes. Risk of
bias: category C.
Age: 53e79 yr;
Gender:
F:M35:48;
Referral: outpt;
Sleep difculty:
primary insomnia
of 4 types TCM
dx: a. deciency
of HT and SP
(n25 vs. 11), b.
incoordination of
HT and KI (n24
vs. 10), c. LR re
aming up (n17
vs. 8), d.
disharmony of ST
(n17 vs. 6);
Duration of the
condition: 1e
20 yr.
118
(ACU
83;
MED
35)
ACU: TCM Dx-
specic body
and scalp
acupuncture,
with manual
manipulation
and
moxibustion* in
certain cases
qd10d1
course, total of
30Rx. MED: 2.5e
5.0 mg qhs of
nitrazepam and
10 ml bid of An
Shen Bu Nao Ye
(herb).
Treatment
duration NR.
All: scalp MS1,
MS2, plus a.
scalp anterior
2nd line, body
BL20*, BL*, HT7,
ST36. b. scalp
MS3, body KI3,
HT7, PC7, LR3.
c. scalp MS5,
body LR2, GB44,
20, HT7. d. scalp
MS5, body CV12,
ST40, 45, SP1.
Subjective: Clinical
eval: Cureddsleep
normally with no
recurrence during
f/u; markedly
effectivedsleep
normally but with
occasional insomnia;
effectiveds/s
improved; no
effectdno
improvement at all.
f/u 1 yr. There was
signicant
difference of
effective rates
b/w groups.
There was also a
tendency to
favor excess
syndromes than
deciency
syndromes.
Phillips (2001,
USA)
35
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
no.
Measurement
bias: no. Risk of
bias: category C.
Age: 29e50 yr;
Gender: NR;
Referral: AIDS
support
organization and
a private
medical clinic;
Sleep difculty:
with sleep
disturbances 3
nights/wk and
PSQI > 5.
Duration of the
condition: NR.
21 Individualized
acupuncture
(combined body
and auricular)
with 10e15
needles, for 30e
45 min, Deqi
senses, 2
evenings/
wk5wks
(delivered in
group sessions).
Total of 10 Rx.
Body: HT7, SP6,
KI3, PC6;
auricular:
Shenmen, HT,
LU,
sympathetic.
Adjunct: points
are selected if
with peripheral
neuropathy and
pain.
Objective:
Wrist actigraph;
Subjective: PSQI,
CSQI, visual analog
pain rating and
demographic data
form.
2 nights before
and 2 nights
after
treatments.
In addition to
subjective sleep
improvements,
signicant
improvements
seen in
actigraphy TST,
# of min spent
awake, and SE.
Not signicant in
sleep latency, #
of mid-sleep
awakenings, and
WASO.
Dropouts: 1 died
and 1 left due to
distance. Pain
measurement
comparison NR.
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Table 4 (continued)
Author
(year, area)
Study design Population N Treatment Acupoints Eval F/U Results Notes
Qiu (1996,
China)
36
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: NR;
Gender: NR;
Referral:
outpts; Sleep
difculty:
insomnia with 4
TCM dx-a.
deciency of HT
and SP; b.
disharmony of
HT and KI; c.
deciency of HT
Qi; d. LR Qi
stagnation;.
Duration of the
condition: NR.
65 Auricular
vaccaria seeds
taping one
ear/alternating
q3e5 days,
massage each
point 25 x/day
till Deqi. 10
Rx1 course.
Total Rx NR.
Main: Shenmen,
occiput, HT,
sub-cortex,
insomnia;
Adjunct: a.
SP, SI; b. LR,
KI; c. LR, KI,
GB; d. LR, TE
Subjective: cureddsleep
onset normal,
sleep normal;
signicantly
improveddsleep
onset improved,
sleep normal but
easy midnight
wakening;
improveddsleep
improved;
ineffectivedno
obvious
improvements
after 1 course.
In the one
case reported,
2 yr f/u with no
reoccurrence.
32 cases cured,
18 cases
signicantly
improved, 11
cases improved,
4 cases
ineffective and
were stopped
after 1 course.
Ren (1985,
China)
37
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: NR;
Gender: NR;
Referral: outpt
clinic; Sleep
difculty:
insomnia;
Duration of the
condition: NR.
86 Needling 2
acupoints with
1 needle and
manually
stimulated to
get Deqi
sensation, then
the needle was
retained for 5e
15 min with
manual stim
q5 min; Rx qd7
days1 course,
then 3 days of
rest. In the one
case reported,
total 5 courses;
others NR.
PC7 towards
TE5.
Subjective: Clinical
effects:
curedd>6 h/night
sleep with complete
relief of symptoms;
markedly
improvedd>4 h/night
sleep, with marked
diminution
of symptoms;
improveddable to
get some sleep but
awakens often with
some improvement
of symptoms;
unimproveddno
change.
In the one
case reported,
f/u 3.5 yr.
Of the 86 cases,
39 cured, 36
markedly
improved, 11
improved.
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Shen (2004,
China)
38
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 17e54 yr;
Gender:
F:M94:106;
Referral: outpt
clinic; Sleep
difculty:
insomnia,
primary n156
and secondary
n44, divided
into 4 TCM dx: a.
incoordination
b/wHTand KI; b.
ST disorders; c.
deciency
syndrome; d.
deciency of HT
and SP; Duration
of the condition:
2e245 days.
200 Combination of
1. auricular
pressure and 2.
acupuncture
(for cases with
duration of more
than 2 months).
1. Vaccaria
seeds taping
alternating ear
q3e4 d, points
pressed 3e4x/
day. 2. Daily Rx
with manual
manipulation,
needles retained
for 5e20 min.
Both: 5 days1
course; total 3e
4 courses (15e
20Rx).
Main ear
Shenmen, HT,
Shenshuai,
brainstem.
Optional ear LR,
ST, HT, KI,
endocrine. a.
HT7, SP6; b.
BL21, ST36,
Yintang, GB20,
HT7; c. Anmian,
SP6, HT7, BL23;
d. ST36, GV20,
Yintang,
Anmian.
Subjective: Clinical eval
details NR.
Post-
treatments.
75% cases were
cured, 15% cases
were effective,
7% were
improved, and
3% were
ineffective.
Better results in
patients with
shorter duration
of disease, but
detailed analysis
NR.
Shi (2003,
China)
39
Case series:
Control of
confounders:
none. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: no. Risk of
bias: category C.
Age: 18e69 yr;
Gender:
F:M17:11;
Referral:
outpts; Sleep
difculty:
insomnia;
Duration of the
condition: 3
months to 1 yr.
28 Individualized
body
acupuncture
according to
TCM Dx.
Detailed
frequency and
total Rx NR.
Main points:
HT7, GB13, SP6,
PC6. Adjunct
points
depending on
TCM diagnoses
(5 examples
given): e.g.,
LR3, LI4, KI7,
ST36, LU7, BL20.
Subjective: Clinical
effects*: cureddgrade
1 sleep with no med,
symptoms resolved;
markedly
effectivedgrade 2 sleep
with no med, symptoms
greatly improved;
improveddgrade 3 sleep
with over 3/4 Y of med
doses, and symptoms
improved; faileddstage
4 or 5 sleep, med
dependence, symptoms
still exist.
In the one case
reported, 6
months f/u.
17 cases cured,
7 cases
markedly
improved, 4
cases improved,
0 failed.
*5 grades of
sleep quality by
WHO standard:
1: SE 70e80%; 2:
SE 60e70%,
sleep onset
difculty; 3: SE
40e50%, mild
sleep dis; 4: 40e
50%, moderate
sleep dis; 5: 30e
40%, severe
sleep dis.
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Table 4 (continued)
Author
(year, area)
Study design Population N Treatment Acupoints Eval F/U Results Notes
Spence (2004,
Canada)
40
Case series:
Control of
confounders:
yes. Exposure
bias: yes.
Attrition
bias: NR.
Measurement
bias: no. Risk
of bias:
category C.
Age: 18e55 yr;
Gender:
F:M11:7;
Referral:
volunteers;
Sleep difculty:
insomnia
associated with
anxiety, scoring
>50 on the Zung
Scale but not
meeting DSM-IV
criteria for
anxiety dis.
Duration of the
condition: at
least 2 yr.
18 2x/wk
acupuncture5
wks (total of 10
Rx)
NR Objective: PSG
recordings, urine aMT6s
measurements
(metabolite of
melatonin); Subjective:
questionnaires on
sleepiness, fatigue,
alertness, anxiety,
depression; complex
verbal reasoning task.
Before and
after
treatments.
Signicant
[melatonin
secretion with
improvements
in PSG sleep
onset latency,
arousal index,
TST, SE, stage 3
sleep; reduction
in morning
fatigue and
sleepiness,
anxiety, and
depression; and
decreased
performance
time for
complex verbal
reasoning task.
Also seen
decreased
daytime
alertnesse
hypothesized
as being more
adaptive.
Wang (1992,
China)
41
Case series:
Control of
confounders:
no. Exposure
bias: yes.
Attrition bias:
no.
Measurement
bias: yes. Risk of
bias: category C.
Age: 16e63 yr;
Gender:
F:M21:29;
Referral: outpt
clinic; Sleep
difculty:
insomnia;
Duration of the
condition: 0.5
month to 13 yr.
50 All sleep meds
were
discontinued
prior to Rx. Daily
acupuncture
with needle tips
reaching
periosteum and
needles retained
for 20 min;
10x1 course
with 3 days in b/
w courses. Total
Rx NR.
CV20, and
Sishencong.
Subjective: cureddsleep
[ of 4 h/night, and
>6 h/night at 2 months
f/u, with all symptoms
relieved. Excellentd
sleep [ of 3 h/night, and
>4 h/night at 2 months
f/u with remarkedly
improved symptoms;
improvedd temporary
improvements of sleep
and symptoms with Rx;
no effectdno noted
improvements.
Post-
treatments
and f/u at 2
months.
40% cases cured,
46% cases with
excellent
response, 10%
cases improved
during
treatments, 4%
cases with no
response.
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Wu (1998,
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42
Case series:
Control of
confounders:
none. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 19e68 yr;
Gender:
F:M22:38;
Referral:
outpts; Sleep
difculty: 2
groups:
insomnia (INS,
n40) and
excessive
daytime
sleepiness (EDS,
n20); Duration
of the
condition: 3
days to 5 yr.
60 Auricular
vaccaria seeds
taping, pressed
5e6 x/day, each
time 2e3 min
(until feeling
warm or barely
painful), no
heavy massage.
QOD alternating
ear. 3
changes1
course. 1e3
courses (total
3e9 Rx). No
medication
during Rx.
Main: HT,
Shenmen,
endocrine,
sub-cortex.
Additional
points were
used only
when very
typical
symptoms
occur: LR,
Jiang ya
groove, ST,
KI, LI.
Subjective: INS:
cureddsleep >7 h
per night with
disappearance of
symptoms;
effectivedsleep >5 h
per night; EDS:
cureddsleep 8 h/day
with disappearance of
symptoms;
effectivedsleep about
10 h/day; Both Groups:
no responsedno obvious
improvements.
Two cases
reported in the
article had 2e3
months of f/u.
INS: 23 cases
cured; 11
effective; 6 no
response; EDS:
16 cases cured;
4 cases
effective; 0 case
no response
Difference of
the condition
duration b/w
the groups NR.
Xie (1994,
China)
43
Case series:
Control of
confounders:
none. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 21e48 yr;
Gender:
F:M67:57;
Referral:
outpts; Sleep
difculty:
dyssomnia failed
prior therapies,
including med
(n92), herbal
drugs (n69), PT
(n12),
breathing
exercises
(n12);
Duration of the
condition: 1 wk
to 4 yr.
124 30 min Rx of
acupuncture
with manual
manipulations
q10 min, 7e10
Rx1 course,
rest 3 days.
Total 1e4
courses (7e
40Rx), averaging
3 courses. If no
improvements
after 2 courses,
other adjuvant
modalities were
administered
(details NR).
Main points:
Sishencong,
GV20; Adjunct
points:
HT7, KI3.
Subjective: Therapeutic
effects: cureddnormal
sleep with resolution of
symptoms; markedly
improvedd[ sleep by
2 h/night, signicant
amelioration of
symptoms;
effectivedsome
improvements of sleep
and symptoms;
ineffectivedeno
improvements or short-
lasting benets.
In the one
case reported,
3 months f/u.
73 cases cured,
26 cases
markedly
improved, 10
cases effective,
15 cases
ineffective (7 of
which did not
nish the 1st
course).
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Table 4 (continued)
Author
(year, area)
Study design Population N Treatment Acupoints Eval F/U Results Notes
Yao (1999,
China)
44
Case series:
Control of
confounders:
none. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 23e55 yr;
Gender:
F:M27:19;
Referral:
outpts; Sleep
difculty:
insomnia with 3
types of TCM dx:
deciency of HT
and SP (n18),
disharmony of
HT and KI
(n15), LR re
upward invasion
(n13);
Duration of the
condition: 1
month to 12 yr.
46 Daily b/l
auricular
semiconductor
laser irradiation
of 1 min at each
acupoint till
a local warm
sensation was
felt, 12 Rx1
course with 5e7
days b/w
courses. Total of
1e3 courses.
Auricular main:
Shenmen,
Endocrine,
Sub-cortex,
Brain; Adjunct
points were
according to
TCM diagnoses:
e.g., HT, KI, SP,
ST, LR.
Subjective: Clinical eval:
cureddsleep >7 h/
night; improveddsleep
5e6 h/night;
ineffectivedsleep <3 h/
night.
32 cases cured;
13 cases
improved; 1
case ineffective.
No side effects.
Zhang (2003,
China)
45
Case series:
Control of
confounders:
none. Exposure
bias: yes.
Attrition bias:
yes.
Measurement
bias: yes. Risk of
bias: category C.
Age: 20e68 yr;
Gender:
F:M21:14;
Referral:
outpts; Sleep
difculty:
insomnia with 3
types of TCM dx:
deciency of HT
and SP (n12),
incoordination
of HT and KI
(n15), upward
attack by LR re
(n8); Duration
of the
condition: 10
days to 10 yr.
35 Daily body
acupuncture
with Deqi
sensation,
manipulation
q10 min, total
40 min; then,
Plum blossom
needle tapping
till ush of the
local skin. 10
Rx1 course. 1e
6 courses (10e
60Rx) with 2e3
days b/w
courses. Quit
other therapies
during Rx.
Body points:
Anmian, GV20,
HT7, SP6, BL62,
KI6; adjunct
points were
chosen by TCM
dx e.g., ST36,
KI3, GB20, LR3.
Tapping was
along back
Huatuojiaji
and the 1st
and 2nd lines
of BL meridian
(from top
downward).
Subjective: Clinical eval:
cureddsleep >5 h/night
without med, all
symptoms resolved, and
no recurrence in 6
months f/u;
improveddsleep 3e5 h/
night without med,
alleviation of symptoms;
ineffectivedsleep <3 h/
night without obvious
symptom improvements.
6 months f/u. 27 cases cured,
6 cases
improved, 2
cases
ineffective
All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.
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showed signicant treatment effects when active
treatment (magnetic pearls) was compared to sham
(Junci Medulla). However, Suen et al. also reported
no difference when Semen Vaccariae (typically used
in auricular acupressure treatments) was compared
to Junci Medulla (sham). These data suggest that
there is not a simple and consistent answer regarding
the effects of acupuncture or acupressure when
compared to sham. They also raise a methodological
and an ethical question: if sham control did better
than usual care, no matter how the effects were
produced, would that imply that sham acupuncture
could be used for treatment?
Another major decit of the reviewed studies
was lack of blinding or lack of evaluation of the
blinding process. Three studies
22e24
were double-
blinded and three
15,19,20
single-blinded; no study
reported assessment of blinding effects. Obviously,
in reviewing these studies, one must consider the
high likelihood of reporting and/or evaluating bias.
Heterogeneity in study designs and outcomes
Inmanystudies, therewas lackof consistent denition
of insomnia leading to non-specied primary versus
comorbid insomnia
15,18,21,22,26,28e31,33,36e39,41,43e45
and a mixture of acute and chronic condi-
tions,
18,21,26,29,30,33,38,41e43,45
all of which could
contribute to lack of equivalence across the
studies. There was also signicant heterogeneity
in acupuncture techniques and acupoint selec-
tions, although most produced positive effects on
sleep. Does this mean that the treatments
produce non-specic effects so that the tech-
niques or acupoint choices do not matter?
Only 3 of the 30 studies
22,35,40
included in this
review utilized wrist actigraphy or PSG. Most
studies used some form of a clinical global
impression (n22) as the outcome measure, which
varied widely. For instance, the outcome of the
study
45
using the criterion of sleeping over 5 h/
night as being cured is obviously different from
the outcome of the study
30
that used the criterion
of sleeping 7e8 h/night as being cured,
although the reported effective rate was
similar (94.28% versus 98.61%).
What are the factors that need to be
considered in future research studies when
using acupuncture to treat insomnia?
Acupuncture has great potential to be used to
treat insomnia, although the support is limited by
the quality of current available studies. Future
vigorous research is needed to clarify acupuncture
effects and the clinical indications. In order to
help guide the technical directions for future
studies, we consider the following.
Technical factors
Acupuncture techniques: Acupuncture techniques
vary widely from study to study included in
this review (Table 2). The selection of the tech-
niques depends on the practitioners preference
and practice feasibility. Is there any acupuncture
technique that is most effective in treating
insomnia?
Auricular treatments were used alone or in
combination with body acupuncture in 14 studies.
Gao
18
showed better results with auricular treat-
ments compared to body treatments. Among
auricular treatments, techniques varied, such as
auricular acupuncture,
35
vaccaria seeds taping and
pressing,
18,21,26,31,32,36,38,42
magnetic pearls,
22
blood letting in addition to auricular pressure,
29
lidocaine injection,
33
and laser irradiation.
44
All
produced similar results, except in two studies
where better results were obtained with magnetic
pearls (Suen et al.
22
) and herb-soaked seeds
(Yang
26
), when compared to vaccaria seeds. Nine
studies
16,17,28,30,34,39e41,43,45
used mainly tradi-
tional body acupuncture, with or without combi-
nation of other treatments, such as moxibustion,
scalp acupuncture, or plum blossom needle
tapping. They also showed positive treatment
effects.
Other special treatments, such as intradermal
needle
19,20,25,37
also showed good results in
selected patient populations. Acupressure treat-
ments,
23,24
on the other hand, showed good results
compared to usual care, but not signicantly better
when compared to sham or electrical stimulation.
The heterogeneity of treatment techniques
poses a challenging question for future research. A
reasonable recommendation would be to focus on
the most commonly used auricular treatments with
or without body acupuncture to search for the best
treatment combination.
Elicitation of Deqi: All body acupuncture studies
tried to elicit Deqi (da Chee, meaning getting the
energy) sensation with manual manipulations of
needles. Is this a vital determinant of responsiveness?
In acupuncture practice, Deqi sensation
describes patients feeling of soreness, heaviness,
and many times, a radiating sensation when the
needle is inserted, which can be associated with
practitioners feeling of needle being dragged. In
TCM, it is believed that when Deqi sensation
occurs, the energy is guided towards the needle,
and thus better treatment response. However, it is
less acceptable and tolerable by patients and also
Acupuncture for insomnia 95
creates difculty in conducting studies with sham
control. Moreover, whether or not Deqi is the vital
determinant of responsiveness is still debatable.
For instance, Lees study using lidocaine injection
33
obviously eliminated any feeling in the acupoint
but still produced treatment effects. Psychometric
studies of the sensation elicited by Deqi would aid
in understanding its clinical efcacy.
Acupoints selection: From the current insomnia
studies, we can see that although acupoints
selection varies signicantly, certain points are
used more frequently than others (Table 5). Do
specic acupuncture points produce the best
treatment effects for insomnia?
In TCM, acupoints can have different treatment
functions when used in different conditions. Some-
times the same acupoints can be used to affect two
contrasting conditions, as shown in the study of
insomnia versus excessive sleep.
42
One approach to
answer the question of whether certain points can
specically produce sleep benets is to examine the
studies in which acupuncture was used to treat
other conditions, using the same acupoints as in the
insomnia studies. If sleep also improved in those
studies as a secondary outcome, this might imply
treatment specicity of these acupoints.
Table 6 lists such studies in adults
46e54
but
excluded pain studies, because pain and sleep
have a particularly complex interdependence.
55
Most of these studies demonstrated efcacy in
improving sleep; however, there were exceptions.
In Cohens study of menopausal symptoms
48
some
acupoints that are used for insomnia were applied
(e.g., GV20, HT7, PC6, SP6, LR3; auricular shen-
men, LR, KI); however, their effects on sleep in
post-menopausal women seemed to be dependent
on their different combinations. Schneider et al.
51
reported no signicant improvements in sleep with
either real or sham acupuncture in irritable bowel
syndrome. Therefore, the question of acupoint
specicity for insomnia remains and can be
possibly explored further in future studies using
acupuncture to treat two different conditions.
Treatment paradigm: As mentioned previously,
in most clinical practice, acupuncture treatments
are individualized. Most of the studies included in
this review (17/30) used individualized treatments.
Nevertheless, standardized treatments also have
emerged and are particularly preferred in research
protocols to further generalizability. Yang
26
demonstrated that there was no signicant differ-
ence between individualized and standardized
auricular treatments. On the basis of this single
study, however, we cannot yet discount that the
differential diagnoses guided by TCM, taking into
account each individuals symptom composition
and physiological conditions, are useful in affecting
the treatment effects of acupuncture on insomnia.
Further comparison of these two treatment para-
digms is needed in future research.
Treatment duration: How many treatment
sessions are needed to produce acupuncture
effects?
Table 5 Acupoints selection in treating insomnia
Use frequency Acupoints
Body
acupuncture
Most commonly used (in >75% of studies) HT7
Commonly used (in 25e75% of studies) SP6, ST36, GV20, PC6, KI3, PC7, LR3
Sometimes used (in 10e25% of studies) Sishencong, Anmian, CV12, BL20, GB20,
Yintang, ST40, KI1, GB40, KI6, LR2, BL18, CV20,
KI7, BL15, BL23, BL21, entire back bladder and
GV meridians
Rarely used (in <10% of studies) GV24, SP4, GB21, CV17, CV8, GB34, GB12,
BL14, BL19, PC5, GB44, ST45, SP1, TE5, GB13,
LI4, LU7, BL62
Auricular
acupuncture
Most commonly used (in >75% of studies) HT, Shenmen, LR, KI
Commonly used (in 25e75% of studies) Sub-cortex, SP, ST, endocrine
Sometimes used (in 10e25% of studies) GB, sympathetic, occiput, brain
Rarely used (in <10% of studies) LU, Shenshuai, SI, TE, cervical vertebrae, BL,
Jinggong, adrenal, insomnia, brainstem,
Jiangya groove, LI
Scalp
acupuncture
Only one study used scalp acupuncture MS1, 2, 3, 5, scalp anterior 2nd line
Note: The percentages were calculated with the reviewed studies.
All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.
96 W. Huang et al.
Table 6 Studies of acupuncture in treating various non-sleep conditions with sleep as a secondary outcome
Author
(year, area)
Study design Population N Study groups Treatment Acupoints Eval F/U Results Notes
Alraek
(2001,
Norway)
46
Prospective case
series.
Age: 18e60 yr;
Gender: all
females; Referral:
subjects with
recurrent cystitis
(3 episodes in
past 12 months);
Duration of the
condition: NR.
67 NA Prophylactic
acupuncture
treatments:
2x/wk for 4 wks,
each session
20 min,
Deqi with
intermittent
manual
manipulation.
Main: ST36,
SP6, SP9, LR3,
KI3, BL23,
BL28; Adjunct:
vary depending
on TCM dx.
Open-ended,
free text
questionnaire.
2 wks after
intervention.
39 reported
improvements,
including bladder
emptying, bowel
movements,
abdominal
discomfort, stress
level, sleep
pattern, relief of
painful conditions,
menstrual pain, and
more free ow of
menstrual blood.
Only 46 were sent
a questionnaire
at the end.
Berman
(2004,
Sweden)
47
RCT:
Randomization
method: manual
lottery; Control:
comparison
acupuncture;
Blinding: NR.
Age: mean 33.5 yr;
Gender:
F:M61:97;
Referral: inmates
in two prisons with
substance abuse
history; Duration
of the condition:
NR.
163 2 groups:
1. National
Association
for Detox
Acupuncture
(NADA)
Auricular
acupuncture
(specic);
2. Helix
auricular
acupuncture
(non-specic).
5x during
rst wk,
3x/wk for
3 wkstotal
of 14 sessions
in 4 wks, each
lasts 40 min.
NADA: b/l
Shenmen,
sympathetic,
KI, LR, LU;
Helix: b/l 5
points on the
helix, not
avoiding the
liver yang
points.
Drug use
questionnaire,
SCL-90, TCS.
ATAS before
and after each
treatment. Urine
drug tests every
other day.
Interviews before
and after 4 wk.
Before and
after each
4 wk
treatments.
No major
differences b/w
groups. Better
abstinence from
helix, condence
in treatment
grows with NADA.
For sleep: 77%
with better sleep
in NADA; 50% with
better sleep in
helix.
Randomization
results were
lost for 5 subjects
and therefore they
were excluded.
Out of 158, 76
completed the Rx.
Cohen
(2003,
USA)
48
RCT:
Randomization
method: priori
determined
assignment per
participant
number in sealed
envelopes;
Control:
comparison
acupuncture;
Blinding: double
blinded (subjects
and evaluators),
blinding
evaluation NR.
Age: NR; Gender:
all females;
Referral: post-
menopausal
women, off other
treatments for
3 months;
Duration of the
condition: 3
months to 2 yr.
17 2 groups:
experimental
acupuncture (EA)
group (n8);
comparison
acupuncture (CA)
(n9).
Intervention:
qw3 wks,
then qow3
(total of 6Rx),
each treatment
20e30 min. EA:
needling of
acupoints related
to treatment of
menopausal
symptoms; CA:
designed for
general
tonication.
EA: BL15, BL23,
BL32, GV20,
HT7, PC6, SP6,
LR3, SP9; CA:
HT7 LR4, KI7,
ear Shenmen,
sympathetic,
KI, LR, LU.
Daily diary
monthly for
4 months, scores
0e3 given to
various symptom
categories, mean
monthly scores
among subjects
were used for
statistical
analysis.
Baseline,
every month4
(including
3 wks post-
intervention).
EA: signicant
Yhot ushseverity,
but rebound at
f/u; signicant
improvements in
sleep and mood,
lasting through
f/u; CA: Mood
borderline
improved during
Rx. No change in
hot ush severity or
sleep during Rx but
both improved
during f/u.
1 dropout after
baseline. Baseline
data not
comparable b/w
groups. No
statistical analyses
b/w groups.
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Table 6 (continued)
Author
(year, area)
Study design Population N Study groups Treatment Acupoints Eval F/U Results Notes
Jackson
(2006,
UK)
49
n1 design
controlled trials;
control: within
subject.
Age: 32e79 yr;
Gender: F:M1:5;
Referral: outpts
with tinnitus;
Duration of the
condition: 12
months to over
20 yr.
6 NA Individualized
acupuncture at
6e13 points each
session.
Moxibustion and
auricular
acupuncture were
also applied. 5x/
wk2wks (total of
10 treatments).
Main: TE17,
GB2; either KI3
and BL23, or
LR3. Other
points were
selected
according to
other
symptoms.
Daily diary
to score 4
tinnitus-
related symptoms
including quality
of sleep in 0e10
scale. THI and
MYMOP at 5 times
points.
14 days pre-,
at the start,
at the end,
14days post-,
and 6 wks
post-Rx.
Total of
5 time
points.
The combined
treatment
effects of
acupuncture
supported a
more consistent
and signicant
improvement in
the reduction
of waking hours
and improved
quality of sleep.
The THI and
MYMOP showed
a trend of
improvement.
A hierarchical
Bayesian model
for analysis of
n1 trials was
used.
Janssen
(2005,
Canada)
50
Prospective case
series.
Age: 30e49 yr;
Gender: M>F;
Referral:
Canadian poorest
urban population
with high use of
drugs;
acupuncture
offered at 2
community
agencies; Duration
of the condition:
NR.
39 NA Voluntary
drop-in up to
5 days/wk;
each session
35e40 min.
b/l ear
points:
sympathetic,
shenmen,
LR, KI, LU.
Weekly
questionnaire on
Fridays.
Once a week
during Rx.
Signicant
reduction in
self-reported
frequency of
substance use.
Signicant
decrease in
intensity of
withdrawal
s/s, including
insomnia, shakes,
stomach cramps,
hallucinations,
muddle-
headedness,
muscle aches,
nausea, sweating,
feeling suicidal,
heart
palpitations.
*3months period
with total 2755.
visits; 39 subjects
nished all 4 wks
of Rx.
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Schneider
(2006,
Germany)
51
RCT:
Randomization
method: block
randomization;
Control: sham
control; Blinding:
double blinded
(subjects and
evaluator), no
blinding process
evaluation
reported.
Age: mean for AC
47.63 and SAC
47.14; Gender:
F:M34:9;
Referral: Outpt GI
clinic; Condition:
Rome II
classication for
IBS; Duration of
the condition:
over 55% >10 yr.
43 2 groups:
acupuncture
(AC; n22); sham
acupuncture
(SAC; n21).
Intervention: 2x/
wk for 5 wks
(total 10 Rx). AC:
with Deqi
sensation at
acupoints, SAC:
Streitberger
needle at 2 cm
away from
acupoints.
LR3, ST36, SP6,
CV12, ST21,
ST25, HT7,
GV20.
FDDQL (including
sleep eval),
SF-36.
Pre-, post-
treatment,
3 months
f/u.
Many areas of
FDDQL
got signicant
improvements in
both groups, not
including sleep.
SF-36 improved
signicantly only
in pain in both
groups. There
was with no
difference
b/w groups.
2 female subjects
dropout during the
course of study.
Poor sleep and low
coping capacity
predict non-
response to
placebo effects.
Shulman
(2002,
USA)
52
Pilot study Age: mean 68 yr;
Gender:
F:M8:12;
Referral: Outpts
with diagnosis of
Parkinsons
Disease stages Ie
III, on stable med
dose 1 month;
Duration of the
condition: mean
8.5 yr.
20 NA Rx:
Combination
of body, scalp,
and electro-
acupuncture.
1 h/session,
2x/wk. First 7
subjects received
10 Rx; last 13 pts
received 16 Rx.
Body: LI4,
GB34, ST36;
KI3, KI7, SP6,
SI3, TE5.
(*main)
Scalp: 9
needles in
chorea-
trembling
control area.
Electro: NR.
Patient
questionnaires,
SIP, UPDRS, H&Y,
S&E, BAI, BDI,
quantitative
motor tests,
and adverse
events.
Before,
within
5 days
after all
treatments.
The only
signicant
improvement
seen post-
acupuncture is
sleep and rest.
85% patients
reported also
subjective
improvements in
other s/s, e.g.,
tremor,
handwriting, pain,
walking, slowness,
anxiety,
depression. No
adverse effects.
Subjective
improvements not
veried by
objective
assessments.
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Table 6 (continued)
Author
(year, area)
Study design Population N Study groups Treatment Acupoints Eval F/U Results Notes
Wang (2006,
China)
53
RCT:
Randomization
method:
according to
the admission
date (odd-
treatment vs.
even-control);
Control:
medication
only; Blinding:
None.
Age: 21e68 yr;
Gender:
F:M23:22;
Referral: inpt
diagnosed with
depression
according to
CCMD-3, with
HDS > 18;
Duration of the
condition: NR.
45 2 groups: 1.
treatment
group:
acupuncture
with
medication
(n23); 2.
control group:
medication
only (n22).
Acupuncture with
Qi conducting
maneuver:
2e3 min per
acupoints along
the GV, plus
adjunct body
points by TCM dx;
Qd4 wks (28Rx);
medications:
individualized
Sertraline 50e
100 mg/day,
Venlafaxine 75e
100 mg/day, or
Remeron 15e
45 mg/day.
Main: GV24,
GV20, GV14,
GV11, GV9;
Adjunct points
vary to TCM dx.
HDS; PSQI Pre- and
post-
treatments.
Both groups
had signicant
decrease of
HDS scores, but
only the
treatment group
had signicant
decrease of PSQI.
Comparability of
med use in the two
groups: NR. Article
also reported
more signicant
YHDS scores in the
treatment group
than the control
group, but no
data.
Yang (2007,
Taiwan)
54
Within subject
crossover.
Age: over 65 yr;
Gender:
F:M7:13*;
Referral: NH
residents 13 wks,
with dementia and
severe agitation
(CMAI 40);
Duration of the
condition: 12
months to over
20 yr.
31* Within subject
crossover: 1.
Study: pretest
1wk, acupressure
treatment 4 wks,
post
1 wk; 2.
Washout: rest
1 wk; 3. Control:
pretest 1 wk,
visiting and
conversation 4
wks, post 1 wk.
Acupressure:
5 min warm-up
(rubbing palms/
ngers of both
hands), 2 min
massage each
acupoint (10 min)
with average force
of 3.68e3.82 kg;
2x/day for 5 days,
rest 2 days, total
of 4 wks (40Rx).
Control: daily visit
and conversation
for 15 min/each.
GB20, GV20,
HT7, PC6,
SP6.
CMAI, and
ease of care
inventory were
evaluated
4 times during
the study. Also,
daily agitated
behaviors were
recorded.
1 wk pre-test,
1 wk post-
test. 2 rounds
during the
study, before
and after
crossover.
All aspects of
agitation behavior
were signicantly
improved;
although after
6wks control,
scores worsened,
most trends of
improvement
lasted till the end.
Patients were also
observed to fall
asleep naturally
with acupressure
(no specic
measurements).
During the
13wksdstudy
period, there were
11 dropouts: due
to hospitalization
or discharge * of
subjects do not
match.
All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.
* # of subjects do not match.
1
0
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The reported number ranges from 1 to 60, with
a median of 11 and a mean of 15 treatments,
although the most optimal treatment duration
remains an uncertain issue.
Insomnia diagnosis
What is the association between insomnia diag-
nosis and acupuncture efcacy?
Insomnia can be diagnosed according to
Western or TCM systems. In Western medicine,
insomnia is divided into primary and comorbid
insomnia. Both in studies that specied primary
insomnia
20,25,32,34
and comorbid insomnia, e.g.,
AIDS,
35
anxiety,
40
pregnancy,
17
stroke,
19
and ESRD
patients on HD,
23,24
acupuncture treatments were
shown to be effective. In addition, Lees study
33
illustrated that a positive response to acupuncture
treatments was not affected by multiple concur-
rent medical problems.
In TCM, however, there are many insomnia
diagnoses, according to the involvement of
different organ systems in excessive or decient
forms. Lu
34
reported that certain TCM syndromes
(e.g., excess) were more easily treated with
acupuncture than other types (e.g., deciency).
This nding is very interesting and is consistent
with the rst authors (WH) clinical practice
experience.
It remains to be seen whether research proto-
cols employing Western insomnia diagnoses versus
those based on TCM differentials will lead to the
most successful clinical trials and possibly eluci-
date underlying mechanisms.
How safe is acupuncture in treating
insomnia?
Studies that reported side effects of acupuncture
have reported local ecchymoses at needle inser-
tion points,
17
and skin irritation and mild pain at
vaccaria seeds taping area.
42
There have been no
serious side effects reported to be associated
with acupuncture treatments for insomnia. This
could be one of the unique features of acupunc-
ture in comparison with other medical treat-
ments, especially in selected populations such as
the elderly and patients with multiple medical
comorbid conditions and taking multiple
medications.
What are possible underlying mechanisms of
acupuncture in treating insomnia?
Acupuncture offers great potential for enhancing
our understanding of the pathophysiologic basis for
insomnia that may not be available using other
treatment modalities. For example, acupuncture
treatments that were targeted at other medical or
psychological conditions (see Table 6) also improved
sleep, indicatingpossiblecommonendocrinemarkers
and/or neurotransmitter systems across these
conditions that can be regulated by acupuncture.
Melatonin was suggested in one study
40
as such
a factor.
Perhaps the most intriguing aspect of insomnia
that could be elucidated by the use of acupuncture
treatment would be direct manipulation of the
autonomic nervous system (ANS). ANS dysregula-
tion of cardiac function may be particularly rele-
vant for poor sleep
56,57
; individuals with insomnia
have also been recognized to have higher heart
rates than good sleepers
58,59
and short sleep
duration may be associated with hypertension.
60,61
To the extent that TCM has long suggested that
heart is a main organ system controlling sleep,
this opens up many avenues of research. For
example, Lee
33
demonstrated that modulation of
heart rate correlated with improvements of
insomnia. Sleep also improved when stimulating
the paraspinal bladder meridian in some
studies,
25,45
while Teitelbaum
62
observed a corre-
lation between this meridian and the anatomical
ANS efferent locations along the spine. ANS
involvement in acupuncture treatment of insomnia
is also implicated by the use of auricular acu-
points, which are thought to be able to regulate
autonomic sympathetic/parasympathetic tone,
63
and, as a consequence, produce benecial effects
on sleep. These ndings warrant further investi-
gational efforts in clinical trials, to both test
acupunctures efcacy and to enhance our under-
standing of pathophysiologic mechanisms contrib-
uting to poor sleep.
Conclusion
The currently available studies have demonstrated
the safety and potential benecial effects of
acupuncture in treating most forms of insomnia.
However, the evidence is severely limited by study
bias and signicant heterogeneity of acupuncture
techniques and acupoint selections. Future
acupuncture research will require more vigorous
study designs to evaluate not only the effects of
acupuncture in treating insomnia in comparison to
sham acupuncture, but also to search for better
treatment paradigms and to understand possible
underlying mechanisms, all of which can elucidate
whether acupuncture can contribute to the clinical
care of patients with insomnia.
Acupuncture for insomnia 101
Acknowledgment
Supported in part by the Southeast Center of
Excellence in Geriatric Medicine, Hartford Foun-
dation Grant #97333-G.
Practice points
1. Current evidence does not yet provide
unequivocal support of theuseof acupuncture
intreatinginsomniaas mainmedical modality,
although there has been some observed clin-
ical effectiveness in certain patients.
2. Acupuncture is safe when used to treat
insomnia; auricular and body acupuncture or
their variants, withanaverage 15 treatments,
are the most commonly used treatment
techniques.
Research agenda
1. More vigorously designed randomized clin-
ical trials will be needed to demonstrate the
effectiveness of acupuncture in treating
insomnia, with particular attention to
insomnia denition, sham control process,
blinding, treatment paradigm, outcome
measurements and follow-up periods.
2. Mechanistic evaluation of acupuncture in
treating insomnia should also be pursued.
Appendix I. Acupuncture nomenclature
used in this review
BL bladder
CV conception vessel meridian
GB gall bladder
GV governing vessel meridian
HT heart
KI kidney
LI large Intestine
LR liver
LU lung
PC pericardial
SI small intestine
SP spleen
ST stomach
TE triple energizer (triple heater)
Note: when these are used alone, they represent acupoints
(usually auricular); when these are used with a number
following, they represent meridians, e.g., HT7 is the 7th point
on the Heart meridian.
Appendix II. Abbreviations in alphabet-
ical order
# number
AHI Apnea/Hypopnea Index
AI Apnea Index
AIDS Acquired Immune Deciency Syndrome
ATAS Acupuncture Treatment Assessment
Scale measuring worry, muscle tension,
drug craving, physical well-being,
and psychological well-being
b/l bilateral
b/w between
BAI Beck Anxiety Inventory
BDI Beck Depression Inventory
bid twice a day
c/o complain of
CCMD-3 China Classication of Mental Disorders
Third Revision
CGI Clinical Global Impression
CMAI Cohen-Manseld Agitation Inventory
CSQI Current Sleep Quality Index
CT clinical trial
dis disorder/disease(s)
Dx diagnosis
ESRD end-stage renal disease
eval evaluation
f/u follow-up
FDDQL Functional Digestive Diseases Quality
of Life Questionnaire
GI gastroenterology
h hour(s)
H&Y Hoehn and Yahr
HA headache(s)
HD Hemodialysis
HDS Hamilton Depression Scale
IBS Irritable Bowel Syndrome
Inpt Inpatient
ISI Insomnia Severity Index
med medication(s)
min minute(s)
MYMOP Measure Your Medical Outcome Prole
NA not applicable
NH nursing home
NR not reported
Outpt Outpatient(s)
PGS polysomnography
po take by mouth
PSQI Pittsburgh Sleep Quality Index
psych psychiatric
PT physical therapy
Qd once a day
qhs every night before bedtime
QOD every other day
QoL quality of life
qow once every other week
qw once a week/per week
RCT randomized clinical trial
Rx treatment
102 W. Huang et al.
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NIH Consensus and State-of-the-Science Statements 2005;
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