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Classification of Insomnia Using the Traditional Chinese Medicine System: A

Systematic Review

Article in Evidence-based Complementary and Alternative Medicine · July 2012

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 Classification of insomnia using traditional Chinese
Title medicine diagnostic system : a systematic review

Author(s) Poon, Man-ki; 潘敏琪

Citation

Issue Date 2010

URL http://hdl.handle.net/10722/57704

Rights unrestricted
 Classification of insomnia using

Traditional Chinese Medicine diagnostic system:

A systematic review

by

POON Man Ki

(潘敏琪)

BCM, HKU

A thesis submitted in partial fulfillment of the requirements for

the Degree of Master of Medical Sciences

at The University of Hong Kong

December 2009
 1

Abstract

Objective: Previous reviews regarding Traditional Chinese Medicine (TCM) diagnosis

for insomnia were either limited to non-systematic search of Chinese language

literature or a particular TCM syndrome pattern. A comprehensive review of Chinese

and English language literatures was therefore conducted to review the classification

of insomnia using TCM diagnostic system.

Methods: We performed systematic review of all studies on insomnia that used TCM

diagnostic system. Two independent researchers were responsible for paper retrieval.

At the second phase, data from the final set of relevant papers was extracted using a

standardized data extraction form.

Results: The search yielded 4795 potential articles titles; after going through our

inclusion and exclusion criteria for paper selection, a total of 103 studies and 9499

insomniac subjects were included in the second phase review. We found a total of 69

different TCM syndrome patterns for insomnia. The most common pattern was

Deficiency of both the heart and spleen, which was mentioned in 93.2% of the articles,

followed by Hyperactivity of fire due to yin deficiency (63.1%), Liver-qi stagnation

transforming into fire (42.7%), Internal disturbance of phlegm-heat (34.0%),

Heart-kidney noninteraction (30.1%) and Qi deficiency of the heart and gallbladder

(29.1%). Although only 5 TCM diagnostic patterns are listed in the standard TCM

textbook, our review suggested that Heart-Kidney noninteraction, which was not

listed in the standard textbook, was ranked between second to sixth commonest TCM

diagnostic patterns by different selection criteria. We found 23 different terms for

sleep-related symptoms and 89 different non-sleep-related symptoms associated with

the TCM syndrome patterns for insomnia. The most common sleep-related symptoms
 2

in the TCM literature were dream-disturbed sleep, easy awakening from sleep and

restless sleep. The most common non-sleep-related symptoms were dizziness,

palpitation and poor memory. There were also tongue and pulse features mentioned in

the TCM literature. We found some overlaps in symptom and sign among the

common TCM patterns for insomnia. For example, dream disturbed sleep and

dizziness were present in 5 of the 6 most common patterns. Comparing TCM patterns

with insomnia diagnoses in the Western classification systems, we found that primary

insomnia can probably be matched with Deficiency of both the heart and spleen and

Hyperactivity of fire due to yin deficiency; insomnia related to anxiety disorders is

compatible with Qi deficiency of the heart and gallbladder and Liver-qi stagnation

transforming into fire; insomnia related to depressive disorder may resemble Qi

deficiency of the heart and gallbladder; while insomnia due to obstructive sleep apnea

syndrome has some similarities with Deficiency of both the heart.

Conclusion: We identified some common TCM syndrome patterns related to insomnia

that were worthy of further studies, in particular, Heart-Kidney noninteraction, which

was not listed in the TCM textbook. Some sleep-related symptoms including dream

disturbed sleep and restless sleep are not frequently used in the Western diagnostic

systems, but are commonly mentioned in the TCM system. It is worthwhile to further

examine the clinical importance of those sleep-related symptoms. Our review showed

that many different Chinese terms were used in the TCM literature to describe similar

phenomenon. This lack of standardization in the terminology can definitely affect the

scientific studies of TCM. Lastly, we found some similarities between the TCM and

Western classification for insomnia. Further studies are needed to examine the

integration of TCM and Western classification systems in the diagnosis of insomnia

disorder.
 3

Declaration

I declare that the thesis hereby submitted for the Degree of Master of Medical

Sciences at the University of Hong Kong is my own work and has not been previously

submitted by me at another University for any degree. I cede copyright of the thesis in

favor of the University of Hong Kong.

 4

Acknowledgements

I would like to gratefully acknowledge the enthusiastic supervision of Prof. KF Chung

during my research. I thank Mr. Jerry Yeung for the technical discussions and advice

on data retrieval methodology. In particular, I would like to acknowledge the help of

Mr. Verdi Yau for data extraction and database analysis model.

I am grateful to all my friends at the Faculty of Medicine, University of Hong Kong,

for being my surrogate family during the many years I stayed there and for their

continuous moral support thereafter.

Finally, I am forever indebted to my family for their understanding, endless patience

and encouragement when it was most required.

 5

Contents

Abstract 1

Declaration 3

Acknowledgements 4

Contents 5

List of Figures and Tables 7

Chapter 1 Introduction 8

1.1 Definition of insomnia 8

1.2 Epidemiology of insomnia 9

1.3 Traditional Chinese Medicine (TCM) theory of insomnia 9

1.4 TCM diagnostic approach 11

1.5 Syndrome differentiation 12

1.6 Qi, Blood and Body-fluid Differentiation 12

1.7 Zang Fu Organs Differentiation 13

1.8 Classification of insomnia using TCM diagnostic system 15

1.9 Aim of study 18

Chapter 2 Methods 19

2.1 Databases searched 19

2.2 Paper selection process 20

2.3 Data extraction process 21

Chapter 3 Results 22

3.1 Excluded papers 22

3.2 Description of the included studies 22

 6

3.3 Types of study 23

3.4 Types of journal 23

3.5 Diagnosis of insomnia disorders 23

3.6 TCM syndrome diagnostic patterns mentioned in the 25

reviewed papers
3.7 TCM syndrome diagnostic patterns in RCT study design 25
papers and papers published in high impact factor
3.8 TCM syndrome diagnostic patterns in subjects with 27
insomnia
3.9 Clinical features of the TCM syndrome diagnostic 28
patterns
3.10 Clinical features of TCM syndrome patterns based on 29
our review vs. TCM textbook description
3.11Comparing the clinical features among the top 6 TCM 33
diagnostic patterns
3.12 Comparing TCM syndrome diagnostic patterns with 36
insomnia diagnoses in the Western Classification
Chapter 4 Discussion 41

Chapter 5 Reference 47
 7

List of Figures and Tables

Figure 1. Selection of trials for inclusion in the review. 59

Table 1. Studies reviewed for TCM diagnostic pattern of insomnia. 60

Diagnostic criteria for insomnia used in the 103 included

Table 2. 66
studies.
The top 10 TCM syndrome diagnostic patterns used in the
Table 3.1. 67
103 reviewed papers. (Total N = 103)
The top 12 TCM syndrome diagnostic patterns in subjects
Table 3.2. 68
with insomnia in the 26 reviewed RCT paper. (Total N = 26)
The top 11 TCM syndrome diagnostic patterns in subjects
Table 3.3. with insomnia in the 46 reviewed paper with impact factor 69
above 0.5. (Total N = 17)
The top 10 most common TCM syndrome diagnostic
Table 3.4. 70
patterns in subjects with insomnia (Total N = 9499)
Summary of the TCM syndrome diagnostic patterns in Table
Table 4. 71
3.1-3.4
Sleep-related symptoms in the top 6 TCM syndrome
Table 5. 72
diagnostic patterns for insomnia. (Total N = 37)
Non-sleep-related symptoms in the top 6 TCM syndrome
Table 6. 74
diagnostic patterns for insomnia. (Total N = 37)
Tongue features in the top 6 TCM syndrome diagnostic
Table 7. 79
patterns for insomnia. (Total N = 37)
Pulse features in the top 6 TCM syndrome diagnostic
Table 8. 80
patterns for insomnia. (Total no. of paper = 37)
TCM syndrome diagnostic patterns according to “Traditional
Table 9. Chinese Internal Medicine” recommended by the Ministry of 81
Health of China.
The top 6 TCM syndrome diagnostic patterns found in this
Table 10. 82
review.

Appendix A. Data Extraction Form 83

 8

Chapter 1

Introduction

1.1 Definition of insomnia

According to the American Academy of Sleep Medicine Work Group, the research

diagnostic criteria for insomnia include one or more of the following sleep related

complaints: difficulty initiating sleep, difficulty maintaining sleep, waking up too

early or sleep that is chronically nonrestorative or poor in quality. The above sleep

difficulties occur despite adequate opportunity and circumstances for sleep. Moreover,

at least one or more of the following forms of daytime impairment related to the

nighttime sleep difficulties are reported by the individual: fatigue or malaise; attention,

concentration or memory impairment; social or vocational dysfunction or poor school

performance; mood disturbance or irritability; daytime sleepiness; motivation, energy

or initiative reduction; proneness for errors or accidents at work or while driving;

tension headaches and/or gastrointestinal symptoms in response to sleep loss; and

concerns or worries about sleep1.

In the revised edition of the International Classification of Sleep Disorders (ICSD),

more than 100 differential diagnoses of insomnia are listed 2. The recent report of the

American Academy of Sleep Medicine Work Group found that several insomnia

phenotypes that appear most valid and defensible1. Standardized research criteria for

the most valid phenotypes are developed, which include primary insomnia, insomnia

due to a mental disorder, psychophysiological insomnia, paradoxical insomnia,

 9

idiopathic (childhood onset) insomnia, insomnia related to periodic limb movement

disorder, insomnia related to sleep apnea, insomnia due to medical condition, and

insomnia due to drug or substance2.

1.2 Epidemiology of insomnia

Concluding from more than 50 studies of insomnia based on data collected in various

representative community-dwelling samples, about one-third of the general population

presents at least one of the insomnia symptoms3. If daytime consequences of insomnia

are taken into account, the prevalence of insomnia is between 9% and 15%3. The

prevalence of insomnia disorder according to the Diagnostic and Statistical Manual of

Mental Disorders, Forth Edition (DSM-IV) criteria is roughly 6% 3. Moreover, there is

a trend of increasing insomnia symptoms with age; women are shown to have a higher

prevalence of insomnia than men 3.

1.3 Traditional Chinese Medicine (TCM) theory of insomnia

TCM is one of the longest history medical systems in the world. Over the past two

thousand years, the TCM medical system has become more conceptual and less

technologically driven while the TCM treatment becomes more individualistic than

Western medical therapies. The TCM theory originates from doctors’ experience on

patients in ancient times 4; some TCM diagnostic issues regarding insomnia are not

considered in Western medicine theory.

In term of the TCM theory, insomnia is due to a disharmony of Yin and Yang in their
 10

daily cycle in human body. Quoting from chapter 80 of “Spiritual Axis” in “Huang Di

Nei Jing”: “If Defensive Qi does not enter into Yin at night and remains in Yang,

Yang-Qi will become full and Yang Qiao Mai in excess, Yin becomes deficient and the

eyes cannot close.”5 There is physiological decline of Qi and Blood in the elderly;

they normally have less sleep than younger people. Chapter 18 of “Spiritual Axis” in

“Huang Di Nei Jing” says: “Young people have abundant Qi and Blood ….. they are

energetic in the daytime and sleep well at night. Old people have declining Qi and

Blood ….. they are less active in daytime and cannot sleep at night.”5

There are other quotes in TCM literature mentioned about sleep disturbances. Chapter

34 of “Simple Questions” in “Huang Di Nei Jing” says: “If Stomach is not in peace,

sleep will not sound.”6 Body position also has a significant implication in sleep. If a

person could not sleep in a supine position, it means an excess condition, usually the

Lung or Heart. Chapter 46 of “Simple Questions” in “Huang Di Nei Jing” says: The

Lung is the “lid” of the other organs. When Lung-Qi is in excess, the Channels and

Blood Vessels are full and the person cannot lie on his back. This condition often

occurs in asthma patients, for example, when the Lung is obstructed by Phlegm. If a

person can only sleep on one side, it indicates that there is either a deficiency of Qi

and Blood on that side of the body or an excess Qi and Blood on the opposite side.

This condition especially applies to problems related to the Heart or Lung and can be

checked by testing the pulse. By rolling the finger medially and laterally on the Lung

pulse, one can feel the state of Qi in right (lateral) and left (medial) Lung. If there is

an imbalance in pulse, the person is only able to sleep on the Deficiency side 6.

In term of TCM theory, noisy breathing is usually due to Phlegm affecting the
 11

Stomach Channel or caused by rebellious Qi in the three Yang Channels of the leg.

Chapter 34 of “Simple Questions” in “Huang Di Nei Jing” says: “Those who suffer

from rebellious Qi cannot sleep well and have noisy breathing; this is due to

rebellious Qi in the Yang Ming Channels. When the Qi of the three Yang Channels of

the leg cannot flow down and rebels upwards, it causes insomnia and noisy

breathing.”6

Sleep problems are mentioned in TCM literatures two thousand years ago5-6. TCM is

largely based on philosophical concepts. Sophisticated and interconnected systems

work in balance to maintain the healthy function of the human body5-6. Although most

of the TCM concepts cannot be proven by scientific methods, the diagnostic system of

the TCM continues to be practiced nowadays.

1.4 TCM diagnostic approach

TCM diagnostic process relies entirely on recognition of clinical symptoms by the

practitioners. The use of technological aids to verify the findings is seldom necessary.

The two diagnostic approaches in TCM are “disease differentiation” and “syndrome

differentiation”7. Disease differentiation aims to identify different diseases, for

example, stroke, diabetes, frozen shoulder or insomnia disorder. Syndrome

differentiation aims to identify different patterns of disease and provide specific

treatment plan. There are four diagnostic techniques - observation, auscultation and

olfaction, interrogation and palpation7. Practitioners discern subtle symptoms and

signs, and describe patients’ disharmony using the TCM diagnostic pattern that most

interferes with optimal state of wellness7.

 12

1.5 Syndrome differentiation

Syndrome differentiation describes patients’ disharmony in term of eight parameters:

Yin and Yang, External and Internal, Hot and Cold, and Excess and Deficiency7. Some

diagnostic patterns are given by a combination of the above eight parameters and

others principles, such as Qi, Blood and Body-fluid differentiation, Zang Fu Organ

differentiation7. Using these different parameters and principles, the TCM syndrome

diagnostic pattern can be worked out. Overall, the TCM diagnosis is characterized by

its comprehensive symptom-based approach and emphasis on imbalance of body

elements and functional status. Because the diagnosis is based on the presence of a

group of subtle symptoms and signs, changes in only one symptom or sign can alter

the diagnostic pattern. In addition, the TCM diagnostic pattern can change over time8.

Yin and Yang are complementary opposites within a greater whole. Everything has Yin

and Yang aspects that constantly interact and never exist in absolute stasis. Yin and

Yang have several properties: opposing to each other, rooted together, transformed to

each other, and are in a dynamic equilibrium. External refers to skin and hair while

Internal refers to internal organs, bone marrow, Qi and blood. Excess is usually

caused by pathogenic factors; while Deficiency refers to dysfunction or lowering of

body function. Hot refers to heat due to Yang excess or Yin Deficiency; while Cold

can be due to Yang Deficiency or Yin Excess7.

1.6 Qi, Blood and Body-fluid Differentiation

 13

According to TCM theory, Qi refers to the essential energy flow that maintains the

vital body function. If Qi is Excess or Deficiency, it may cause energy-related

disorders. Disorder of the flow of Qi may cause stagnation, which can transform into

Fire; it is one of the common cause of insomnia9.

Blood is the most important nutrient that maintains vital body function. According to

TCM theory, Spleen produces Blood and is responsible for the normal function of

Blood. Blood is stored in the Liver, while Heart governs Blood Vessels. The pathology

of Blood includes Blood Deficiency, Blood Stasis and Bleeding9.

Body-fluid includes Phlegm and Fluids. Phlegm can be tangible or intangible. The

symptoms of Phlegm Excess may include chest oppression, gastric fullness, nausea,

vomiting, diarrhea, vertigo, palpitation, skin numbness, joint swelling, subcutaneous

lumps and mania. Phlegm Excess results from dysfunction of the Lung, Spleen and

Kidney or Fire due to Yin Deficiency of the Zang Fu organs. After mixing with Qi,

Phlegm can travel upward to disturb the Heart, causing sleep disturbances9.

1.7 Zang Fu organs Differentiation

Zang Fu organs are consisted of five “Zang” and six “Fu”. The five “Zang” refers to

Liver, Heart, Spleen, Lung and Kidney, while the six “Fu” refers to Large intestine,

Small intestine, Gall bladder, Stomach, Urinary bladder and Pericardium. The

common sleep abnormalities involve dysfunction of Spleen, Stomach, Liver,

Gallbladder, Kidney, Heart and Pericardium 9.

 14

Spleen and Stomach work together to generate Qi and Blood from food. Spleen

controls Blood and governs the transportation and transformation of the water, food

and body fluids. Spleen-Qi Deficiency may cause bleeding and retention of water

(tangible or intangible). Stomach governs the intake and decomposition of food.

Either dysfunction of Spleen or Stomach can cause malnutrition of the body. Worry,

over thinking, overwork will harm the Spleen and Stomach 9.

Liver governs the flow of Qi. Emotional distress can cause damage to the Liver.

Chronic Liver-Qi stagnation, Liver-Blood Deficiency, Liver-Yin Deficiency, Liver-Fire

and Liver-Yang Excess are common Liver problems that cause insomnia9.

Phlegm Fire and Gallbladder-Qi Deficiency are common causes of insomnia caused

by Gallbladder problem. Gallbladder Overact may cause Fire, while Fire consumes

Fluids and produces Phlegm. Phlegm-Fire always disturbs the Heart, which results in

insomnia. Gallbladder is responsible for decision making. Gallbladder-Qi Deficiency

may cause difficulty in decision making, which may cause insomnia. Gallbladder is

attached to the Liver; hence problems of Liver may lead to Gallbladder problems9.

Kidney is considered as the congenial base, which stores the primordial Yin and Yang

and Essence that are essential for the human growth. Constitutional weakness,

overstrain, and malnutrition due to chronic disease will damage the Yin, Yang and

Essence of the Kidney. The pathology of Kidney includes Kidney-Qi Deficiency,

Kidney-Yin Deficiency, Kidney-Yang Deficiency and Kidney-Yin-Yang Deficiency and

Fire declining of the Vital Gate (right Kidney)9.

 15

Heart governs Blood Vessels and stores the Mind. Pericardium is the outside

protection of the Heart; hence it is sometimes attacked by exogenous pathogenic

factors, e.g., insomnia occurring after a contagious disease is always caused by

residue of pathogens in the Pericardium. Heart Deficiency mostly refers to Heart-Yin

Deficiency and Heart-Yang Deficiency 9.

1.8 Classification of insomnia using TCM diagnostic system

The recognition of insomnia as a major medical problem by TCM practitioners has

been more than 2000 years. The first written text about insomnia is Huang Di Nei Jing

first published around 100B.C. , insomnia was classified as the disharmony of Yin and

Yang, disharmony in stomach, due to aging or secondary to other diseases such as

cough, vomit...5-6 Zhang Zhongjing (~220) classified insomnia into two types:

External and Internal. 10 Dai Yuenli (~1400) states insomnia mainly classified into two

types, first type is due to sickness or Yang Deficiency caused by aging, second type is
11
due to Disturbance of phlegm in Gall bladder causing Deficiency in Heart Qi.

Zhang Jiebin (1624) classified insomnia into with or without exogenous factors,

insomnia caused by exogenous factors mostly are expressed in excess syndrome and

for all insomnia not caused by exogenous factors are expressed in deficiency
12
syndrome. Li Zhongzi (1637) first classified insomnia into five syndromes clearly:

Deficiency of Qi, Deficiency of Yin, Stagnation of Phlegm, Water distention, Stomach

13
Disharmony. A recent review of 176 articles on TCM syndrome diagnosis of

insomnia found that there were 45 possible TCM syndrome patterns14. The standard

textbook Traditional Chinese Internal Medicine recommended by the Ministry of

Health of China listed five TCM syndrome diagnostic patterns of insomnia9. Another
 16

standard textbook Internal Medicine of Traditional Chinese Medicine also listed five

TCM syndrome diagnostic patterns15; however, the two standard textbooks used

different terminology for the diagnostic patterns. The five TCM syndrome diagnostic

patterns listed in Traditional Chinese Internal Medicine are Liver-qi stagnation

transforming into fire, Internal disturbance of Phlegm-Heat, Deficiency of both the

heart and spleen, Hyperactivity of fire due to yin deficiency and Heart-gallbladder qi

Deficiency. The first two syndrome diagnostic patterns are Excess patterns, while the

other three are Deficiency patterns9.

The common sleep problems of Liver-qi stagnation transforming into fire include

sleeplessness and dream disturbed sleep, while the common symptoms and signs are

irritability, thirst with desire to drink water, hypochondriac distension, poor appetite,

red face, bitter taste, constipation and bloody urine. The tongue feature is red tongue

with a yellow coating, and the pulse is wiry and rapid. The treatment principle is to

clear the Liver Fire and calm the Heart Mind 9.

Regarding Internal disturbance of phlegm-heat, the common sleep problem is

sleeplessness. Other common symptoms and signs include heavy sensation in the head

profuse sputum, chest stuffiness, nausea, belching, restlessness, bitter taste and

blurred vision. The tongue features are red with a yellow and greasy coating. The

pulse is slippery and rapid. The treatment principle is to resolve Phlegm, clear Heat

and calm the Mind 9.

The common sleep problem of Deficiency of both the heart and spleen is dream

disturbed sleep, while other common symptoms and signs include palpitation, poor
 17

memory, dizziness, blurred vision, weakness of the limbs, lassitude, poor appetite and

lusterless complexion. The tongue features are pale tongue with thin and white

coating. The pulse is thready and weak. The treatment principle is to tonify the Heart

and Spleen, nourish Blood and calm the Mind 9.

For Hyperactivity of fire due to yin deficiency, the common sleep problems are

restlessness and sleeplessness and other common symptoms and signs include

palpitation, uneasiness, dizziness, tinnitus, poor memory and weakness in the lumbar

region and knee joints, feverish sensation in the palms, soles and chest, and dry mouth.

The tongue is red with scanty coating. The pulse is thready and rapid. The treatment

principle is to nourish Yin, reduce Fire, nourish the Heart and calm the Mind 9.

The common sleep problems of Qi deficiency of the heart and gallbladder are

sleeplessness, dream disturbed sleep and frequent waking with a start. Other common

symptoms and signs are timidity, palpitation, susceptibility to fright, shortness of

breath, lassitude and clear and profuse urine. The tongue is pale and the pulse is wiry

and thready. The treatment principle is to supplement Qi, relieve fright and calm the

Mind 9.

There are some problems with TCM syndrome diagnostic pattern, including the lack

of standardization in the terminology of symptoms and signs and the lack of

agreement between TCM practitioners in the presence or absence of specific

symptoms and signs. Another problem is the lack of standardization in the

terminology of syndromes. Overall, the agreement between practitioners in syndrome

diagnostic pattern and treatment recommendation remains uncertain.

 18

TCM is one of the longest history medical systems in the world, however further

development is hindered by the lack of standardization in the terminology of

symptoms, signs and syndrome diagnostic patterns. As many studies of TCM

diagnostic patterns on insomnia have been published in Chinese and English scientific

literatures, and have not been systematic reviewed, it is therefore worthwhile to

undertake a systematic review on the TCM diagnostic patterns of insomnia.

1.9 Aim of study

We aimed to find out the most common TCM diagnostic patterns given by TCM

practitioners for subjects with insomnia and the core symptoms and signs agreed by

TCM practitioners for the TCM diagnostic patterns. We would also compare the TCM

diagnostic patterns with the insomnia phenotypes of the Western diagnostic system.
 19

Chapter 2

Methods

This systematic review used a 2-stage approach. The first stage was to retrieve

relevant literatures and textbooks using a standardized search strategy. The second

stage was to retrieve the information regarding TCM diagnostic issues of insomnia

using a standardized record form.

2.1 Databases searched

We searched the English language literatures using computerized databases, including

the Cochrane Central Register of Controlled Trials (CENTRAL) (1999-2009),

MEDLINE (1966-2009), EMBASE (1980-2009), PsycINFO (1887-2009), PUBMED

(1948-2009), Dissertation Abstracts International (1861-2009), Cumulative Index to

Nursing and Allied Health Literature (CINAHL) (1982-2009), Allied and

Complementary Medicine Database (AMED) (1985-2009), National Center for

Complementary and Alternative Medicine (1991-2009), and National Institute of

Health Clinical Trials Database (1997-2009). The keywords used were “Chinese

Medicine or TCM or acupunc* or acupress* or electroacupunc* or meridian* or

acupoint* or tuna*” and “sleep* or insomnia* or wakeful* or sleepless* or

somnambul*”. The reference lists of the retrieved papers were further searched for

relevant articles.
 20

We searched the China Journals Full-text Database from inception in 1915 to

November, 2008. Equivalent Chinese terms that were used to search the English

language databases are “中醫 or 中藥 or 針 or 推拿 or 穴 or 經絡 or 證型 or

診斷 or 辨證 or 分類” and “失眠 or 不寐 or 不得臥 or 睡眠困難”. The China

Journals Full-text Database was one of the major Chinese language literature

databases containing over 1143 medical journals including 129 major TCM journals.

The reference lists of the retrieved papers were further searched for relevant articles.

Studies included in this review were clinical trials that examined participants with

chief complaint of insomnia who have been classified with TCM diagnostic patterns.

The participants using TCM treatments, placebo, Western medication or no treatment

will be included. We did not set any specification for the treatments, outcome

measures, study quality and validity for our review.

2.2 Paper selection process

The authors (M.K.P. and H.K.Y.) searched the databases and independently examined

titles and abstracts of the retrieved papers and selected all potentially relevant

publications. The investigators were not blind to the authors’ name and affiliation, or

journal name. Full paper of the relevant publications were obtained and reviewed in

details against the inclusion and exclusion criteria. We included all studies involving

participants with a chief complaint of insomnia. The exclusion criteria were: (1)

discussion papers or magazine articles; (2) studies with less than 30 subjects; (3)

studies of male or female only; (4) studies that focus on a specific medical and

psychiatric condition; (5) studies that focus on a particular life transition period; (6)
 21

studies that focus on subjects aged >70 or <18 years; (7) studies that focus on a

specific TCM diagnostic pattern; (8) studies without statistical information regarding

TCM diagnostic pattern; and (9) duplicate publications reporting the same group of

participants. The authors then discussed the selected articles; any disagreement about

the eligibility of articles was resolved by consensus and a final set of relevant papers

was confirmed.

We have excluded those papers on either sex, specific medical/ psychiatric conditions,

life transition period and a specific TCM pattern were excluded in order to obtain a

representative picture of the frequency of various TCM syndrome for insomnia.

Further studies may be needed to examine specific diagnostic pattern in specific

patient groups.

2.3 Data extraction process

At the second phase, data from the final set of relevant papers was extracted using a

standardized data extraction form. Study design, diagnostic criteria, participants’

characteristics including mode of recruitment, sampling procedure, inclusion and

exclusion criteria, number of subjects, age and sex distribution, duration of insomnia

and TCM diagnostic patterns including types of TCM diagnosis, symptoms of each

TCM diagnosis were extracted. All Chinese to English translations in this paper were

deduced from the book Traditional Chinese Internal Medicine published by People’s

Medical Publishing House in 20079 and WHO International Standard Terminologies

on Traditional Medicine in the Western Pacific Region published by World Health

Organization in 200716.
 22

Chapter 3

Results

3.1 Excluded papers

The search yielded 4795 potential articles titles for review; of which 1058 articles

were duplicate papers (Figure 1). A total of 1972 articles were excluded for reasons of

irrelevancy to insomnia or TCM; while 336 articles were excluded due to non-study

design. Among the remaining 1423 studies, 95 studies with subjects aged below 18 or

above 70 years, 33 studies focus on either male or female only, 73 studies focus on a

specific medical and psychiatric condition, and 19 studies focus on a particular life

transition period. There were 145 papers focusing on a specific TCM diagnostic

pattern, 264 papers with less than 30 subjects, and 364 studies without specific TCM

diagnostic patterns. In addition, 16 papers were written neither in Chinese nor English,

310 studies without statistical information regarding TCM diagnostic pattern, and 1

paper could not be retrieved in full text. A total of 103 studies were included in this

review17-119. Full details of the excluded studies are available from the authors upon

request.

3.2 Description of the included studies

Table 1 presents the characteristics of the 103 reviewed studies17-119. Sample size of

the studies ranged from 30 to 856, with a total of 10035 subjects. A total of 56.5% of

the sample was female. The mean age of the subjects was 44.0 years, based on the 51
 23

studies that had the demographic data. The duration of insomnia reported in the

reviewed studies ranged from 3 days to 51 years. The 103 reviewed studies were all

conducted in China; only 5 studies (4.9%) were published in English language

literature.

3.3 Types of study

Twenty-six (25.2%) of the 103 reviewed studies were RCT, 12 (11.7%) were

controlled non-randomized studies, 16 (15.5%) were case studies, 48 (46.6%) were

uncontrolled trials, and 1 (1.0%) was an epidemiological study.

3.4 Types of journal

The 103 reviewed studies were published in 63 different journals; 7 studies were

extracted from English computerized databases, 96 studies were extracted from China

Journals Full-text Database. Fifty-two of the 63 journals (82.5%); of which 85

reviewed studies were published, were known to have impact factor; while 17 journals

had impact factor higher than 0.5120.

3.5 Diagnosis of insomnia disorders

Ninety-nine of the 103 reviewed studies (96.1%) had not used structured interview,

questionnaires, or polysomnography for the assessment of insomnia disorder. Only 4

studies27, 65, 69-70 reported the use of standardized assessment procedure. Gao27 and

Shi65 used the Pittsburgh Sleep Quality Index (PSQI)121 to assess the severity of
 24

insomnia. Tian70 used the Spiegel Sleep Questionnaire122. Tang69 used

polysomnography for diagnosis and assessment of insomnia.

Table 2 presents the diagnostic criteria for insomnia used in the reviewed studies.

Sixty-nine of 103 studies (67.0%) mentioned that TCM diagnosis was based on the

criteria of a particular textbook. Twelve of the 103 studies (11.7%) used the insomnia

criteria of the Diagnosis and Therapeutic Effect of Diseases and Syndromes in

Traditional Chinese Medicine (TCM-NJ) published by the State Administration of

Traditional Chinese Medicine of the People’s Republic of China123, which include: (1)

either difficulty falling asleep, frequent awakening, or difficulty falling asleep after

awakening, and (2) the sleep disturbance is the patients’ major concern and is

associated with daytime consequences. The TCM-NJ criteria further classifies

insomnia into different subtypes based on TCM theory.

Eleven of the included studies (10.7%) used the criteria for insomnia in the Chinese

Classification of Mental Disorder (CCMD) published by the Chinese Psychiatric

Association124, which include: (1) either difficulty falling asleep, frequent dreaming or

early awakening that occurs at least three nights per week for at least 1 month, and (2)

the sleep disturbance is the patients’ major concern and is associated with daytime

consequences.

Nine studies used the Clinical Research Guidelines of New Chinese Herbal Medicine

(CRG) for diagnosis of insomnia; it includes a quantitative criterion of total sleep time

less than five hours per day and classifies insomnia into different subtypes based on

TCM theory125. One study used both the CCMD and CRG as diagnostic criteria, two
 25

studies used Hollister Diagnostic Criteria126, one study used the diagnostic criteria

published by the World Health Organization and one of the TCM textbook -

Traditional Chinese Medicine Internal Medicine127. The remaining 33 studies did not

report the diagnostic criteria used. None of the studies used DSM-IV criteria for

diagnosis of insomnia disorders. Although both TCM-NJ and CRG criteria use

quantitative measures to define insomnia, the rest of their criteria are no different

from other traditional TCM diagnostic criteria.

3.6 TCM syndrome diagnostic patterns mentioned in the reviewed papers

A total of 74 different TCM syndrome patterns were reported in the 103 reviewed

papers. The number of TCM syndrome patterns used in individual study varied from 2

to 7. We found that some syndrome patterns were similar, for example, Heart

deficiency with timidity (心虛膽怯) and Heart-gall bladder deficiency and timidity

(心膽虛怯). After grouping similar TCM syndromes as one single syndrome, we

found 69 different TCM syndrome patterns as etiology of insomnia. Table 3.1 shows

the 10 most common TCM syndrome patterns. The six most common patterns were

Deficiency of both the heart and spleen (93.2%), Hyperactivity of fire due to yin

deficiency (63.1%), Liver-qi stagnation transforming into fire (42.7%), Internal

disturbance of phlegm-heat (34.0%), Heart-kidney noninteraction (30.1%) and Qi

deficiency of the heart and gallbladder (29.1%).

3.7 TCM syndrome diagnostic patterns in RCT study design papers and papers

published in high impact factor journals

 26

We found 28 different TCM syndrome patterns mentioned in the 26 included papers

with RCT study design. In order to compare the number of TCM syndrome patterns

for insomnia in RCT study design papers vs. non-RCT papers, we randomly selected

26 of the 77 non-RCT papers for the comparison. We found 34 different TCM

syndrome patterns, which was slightly greater than the number of TCM patterns in

RCT papers. Table 3.2 presents the 12 most common TCM syndrome diagnostic

patterns reported in the RCT papers. The six most common patterns were Deficiency

of the heart and spleen (92.3%), Hyperactivity of fire due to yin deficiency (61.5%),

Liver-qi stagnation transforming into fire (50.0%), Heart-kidney noninteraction

(38.5%), Internal disturbance of phlegm-heat (34.6%), Heart deficiency with timidity

(23.1%) and Qi deficiency of the heart and gallbladder (23.1%).

Researches of the high quality papers and RCT studies were probably more stringent

in the diagnostic process; hence, they tend to follow the major diagnostic system with

the hypothesis number of TCM syndrome less than other papers. Table 3.3 presents

the top 11 TCM syndrome diagnostic patterns in the 17 papers that were published in

journals with impact factor ≥0.5. We found that the papers with impact factor ≥0.5

had included 32 TCM syndrome diagnostic patterns. In order to compare the number

of TCM syndrome patterns for insomnia in papers with impact factor ≥0.5 vs. papers

with no impact factor or impact factor <0.5, we randomly selected 17 of the 86 papers

with no impact factor or impact factor <0.5 for the comparison. We found 16 different

TCM syndrome patterns in the papers published in journals with no or low impact

factor, which was much less than that the number of syndrome patterns in papers with

impact factor ≥0.5. The six most common TCM syndrome patterns in the papers

published in journals with impact factor ≥0.5 were Deficiency of both the heart and
 27

spleen (94.1%), Heart-kidney noninteraction (52.9%), Hyperactivity of fire due to yin

deficiency (41.2%), Liver-qi stagnation transforming into fire (35.3%), Qi deficiency

of the heart and gallbladder (29.4%) and Internal disturbance of phlegm-heat

(23.5%).

3.8 TCM syndrome diagnostic patterns in subjects with insomnia

A total of 9499 subjects in the reviewed studies had data on their TCM syndrome

diagnostic patterns. Table 3.4 presents the 10 most common TCM syndrome patterns

in subjects with insomnia. The most common pattern was Deficiency of both the heart

and spleen, which was diagnosed in 2365 subjects (25.0%), followed by Hyperactivity

of fire due to yin deficiency (17.1%), Liver-qi stagnation transforming into fire (9.7%),

Heart-kidney noninteraction (8.1%), Qi deficiency of the heart and gallbladder (5.7

%), and Internal disturbance of phlegm-heat (4.9%). About 70% of the subjects were

diagnosed with Deficiency of both the heart and spleen, Hyperactivity of fire due to

yin deficiency, Liver-qi stagnation transforming into fire, Heart-kidney noninteraction,

Internal disturbance of phlegm-heat, or Qi deficiency of the heart and gallbladder –

the 6 most common syndrome diagnostic patterns; and roughly 10% of the subjects

were diagnosed with the next 5 most common syndrome patterns.

Table 4 shows a summary of the top 10 TCM syndrome diagnostic patterns in

different types of paper. The top 6 patterns were the same regardless of the type of

papers, namely Deficiency of both the heart and spleen, Hyperactivity of fire due to

yin deficiency, Liver-qi stagnation transforming into fire, Heart-kidney noninteraction,

Internal disturbance of phlegm-heat, and Qi deficiency of the heart and gallbladder

or Heart deficiency with timidity.

 28

3.9 Clinical features of the TCM syndrome diagnostic patterns

Thirty-seven reviewed papers had presented the symptoms and signs of individual

TCM syndrome diagnostic patterns. Most of the terminology of the symptoms and

signs were in Chinese. We translated all the Chinese terms to English. Table 5

presents the sleep-related symptoms of the 6 most common TCM syndrome

diagnostic patterns. There were a total of 51 different Chinese terminologies for

sleep-related symptoms; some of them appeared to be very similar. For example, 入

睡困難, 不易入寐, 不易入睡, 難以入眠, and 難以入睡 were used to describe

difficulty falling asleep. After grouping some similar Chinese terminologies, the

number of terminology in English for the sleep-related symptoms was 23. We further

simplified the 23 different terminologies in English by grouping some similar terms,

for example, sometimes shallow sleep and shallow sleep, frequently wakes up with a

start and sometimes wakes up with a start, late night difficulty in falling asleep and

difficulty in falling asleep. Finally, we found 21 terminologies in English for the

sleep-related symptoms. The most frequently mentioned sleep-related symptom in the

TCM syndrome diagnostic patterns was dream-disturbed sleep (43.6%), followed by

easy awakening from sleep (34.3%), restless sleep (21.3%), and difficulty falling

asleep (13.9%).

There were a total of 158 different Chinese terminologies for non-sleep-related

symptoms; some of them also appeared to be very similar. The number of different

terminologies in English for the non-sleep-related symptoms was reduced to 109. We

grouped some similar English terminologies, for example, little saliva and dry mouth,
 29

loss of strength and tiredness, reduction in luster complexion and lusterless

complexion. Finally, we found 89 terminologies in English for the non-sleep-related

symptoms. The most frequently mentioned non-sleep-related symptom was dizziness

(53.7%), followed by palpitation (44.4%), poor memory (42.6%), restlessness

(32.4%), bitter taste (28.7%), tinnitus (28.7%), blurred vision (26.9%), lassitude of

spirit (26.9%), sore waist (24%), and feverish sensations in the palms, soles and chest

(21.3%).

There were 18 different Chinese terminologies for the tongue features; after

translation into English, it was reduced to 13. The most frequently mentioned tongue

feature was red tongue (50%), followed by pale tongue (36.2%), yellow coating

(29.6%), thin coating (26.9%), slimy coating (13.9%), scanty coating (11.1%), and

white coating (10.2%).

There were 7 different pulse features in both Chinese and English terminologies. The

most frequent pulse feature was thready pulse (66.7%), followed by rapid pulse

(52.8%), weak pulse (28.7%), wiry pulse (25%), and slippery pulse (14.8%).

3.10 Clinical features of TCM syndrome patterns based on our review vs. TCM

textbook description

We summarized the common sleep-related, non-sleep-related, tongue and pulse

features of the top 6 TCM diagnostic patterns reported in the reviewed papers (Table

9). Table 10 presents the TCM syndrome diagnostic patterns according to the
 30

textbook Traditional Chinese Internal Medicine recommended by the Ministry of

Health of China 9.

For the syndrome Deficiency of both the heart and spleen, the most common

sleep-related symptoms found in our review were easy awakening from sleep (80.0%)

and dream-disturbed sleep (74,3%). The common non-sleep-related symptoms were

palpitation (82.9%), lassitude (80%), poor memory (74.3%), reduction in luster

complexion or lusterless complexion (62.9%), dizziness (60%), blurred vision

(42.9%), lack of strength (40%), tasteless (31.4%) and fatigue of the limbs (22.9%).

The common tongue features were pale tongue (85.7%) with thin (65.7%) coating.

The common pulse features were thready pulse (85.7%) and weak pulse (82.9%).

The clinical features of Deficiency of both the heart and spleen based on our review

were mostly similar to those listed in the textbook Traditional Chinese Internal

Medicine. Easy awakening from sleep, lassitude of spirit, tasteless were found in our

review but not in the textbook; whereas poor appetite was mentioned in the textbook

but not in our review.

Based on our review, dream-disturbed sleep (85.7%) and frequent awakening with a

start (57.1%) were the most common sleep-related symptoms of Qi deficiency of the

heart and gallbladder. The common non-sleep-related symptoms included palpitation

(100%), susceptibility to fright (100%), timidity (85.7%), shortness of breath (57.1%),

tiredness (57.1%), prolonged and clear urine (42.9%). The common tongue feature

was pale tongue (70.0%). The pulse was reported to be thready (100.0%) and wiry
 31

(70.0%). The clinical features of Qi deficiency of the heart and gallbladder based on

our review were the same as the textbook description.

Our review showed that, for Liver-qi stagnation transforming into fire, difficulty

falling asleep (31.6%) and dream-disturbed sleep (10.5%) were the most common

sleep-related symptoms; non-sleep-related symptoms included irritability (89.5%),

bitter taste (84.2%), constipation (73.7%), reddish eyes (68.4%), yellow urine (52.6%),

agitation (52.6%), hypochondriac distension (47.4%), headache (42.1%), thirst

(36.8%), restlessness (36.8%), dizziness (31.6%), impatience (26.3%), red face

(26.3%), poor appetite (21.1%), oppression in the chest (21.1%), and tinnitus (21.1%).

The tongue was reported to be red (89.5%) and had yellow coating (84.2%). The

common pulse features were rapid (94.7%) and wiry pulse (89.5%). Comparing the

textbook description with our review, some of the clinical features were the same,

such as dream-disturbed sleep, irritability, bitter taste, constipation, thirst,

hypochondriac distension, poor appetite, red face, red tongue with yellow coating,

rapid and wiry pulse. According to our review, difficulty falling asleep, reddish eyes,

agitation, headache, restlessness, dizziness, impatience, oppression in the chest,

tinnitus, and yellow urine were used to describe Liver-qi stagnation transforming into

fire, but they were not mentioned in the textbook, while bloody urine was mentioned

in the textbook but not in our review.

Our review showed that restless sleep (41.7%), easy awakening from sleep (33.3%),

dream-disturbed sleep (29.2%), sometimes shallow sleep (12.5%) were the most

common sleep-related symptoms of Hyperactivity of fire due to yin deficiency; other

symptoms were tinnitus (83.3%), poor memory (79.2%), palpitation (79.2%),

 32

dizziness (75%), dry mouth (70.8%), sore waist (54.2%), restlessness (50%), feverish

sensations in the palms, soles and chest (75.0%), scant fluid (41.7%), emission of

semen during dreaming (20.8%), acid regurgitation (16.7%), dry throat (16.7%), and

sweating (16.7%). The tongue was reported to be red (83.3%) with scanty coating

(33.3%). The common pulse features were thready (87.5%) and rapid pulse (83.3%).

Comparing the textbook description with our review, some of the terms were the same,

such as restless sleep, tinnitus, poor memory, palpitation, dizziness, dry mouth,

soreness and weakness in the lumbar region and knee joints, restlessness, feverish

sensations in the palms, soles and chest, red tongue with scanty coating, thready and

rapid pulse. However, easy awakening from sleep, dream-disturbed sleep, sometimes

shallow sleep, emission of semen during dreaming, acid regurgitation and sweating

found in our review were not mentioned in the textbook.

For Internal disturbance of phlegm-heat, we found that restless sleep (46.2%) was the

most common sleep-related symptom; other symptoms were restlessness (100%),

blurred vision (100%), oppression in the chest (84.6%), profuse sputum (76.9%),

bitter taste (92.3%), dizziness (61.5%), stuffiness in the stomach (46.2%), anguish in

the heart (46.2%), heavy sensation in the head (30.8%), acid regurgitation (23.1%),

anorexia (23.1%), belching (23.1%). The tongue was reported to be red (69.2%) and

with yellow slimy coating (92.3%). The common pulse features were slippery

(100.0%) and rapid pulse (84.6%). Comparing the textbook description with our

review, some of the terms were the same, such as restlessness, blurred vision, profuse

sputum, bitter taste, belching, heavy sensation in the head and oppression in the chest,

red tongue with yellow slimy coating, slippery and rapid pulse. Similar symptoms

included nausea in the textbook and stuffiness in the stomach in our review. Some
 33

clinical features found in our review, such as restless sleep, anguish in the heart,

dizziness acid regurgitation and anorexia were not mentioned in the textbook.

For Heart-kidney noninteraction, our review showed that restless sleep (30%) and

dream-disturbed sleep (20%) were the most common sleep-related symptoms; other

symptoms were tinnitus (60%), dizziness (50%), feverish sensations in the palms,

soles and chest (40%), palpitation (40%), night sweating (30%), emission of semen

(30%), restlessness (20%) and restlessness of deficiency type (20%). The common

tongue feature was red tongue (70.0%). The pulse was reported to be thready (100.0%)

and rapid (70.0%). This pattern was not included in the textbook Traditional Chinese

Internal Medicine as a TCM diagnostic pattern for insomnia. Heart-kidney

noninteraction was ranked 4th among the common TCM diagnostic patterns

prescribed in subjects with insomnia and accounted for 8.1% among 9499 patients

complaining of insomnia (Table 3.4).

3.11 Comparing the clinical features among the top 6 TCM syndrome diagnostic

patterns

We found that some sleep-related symptoms, such as dream-disturbed sleep, restless

sleep, easy awakening from sleep were found in more than 1 TCM syndrome patterns.

We found that dream-disturbed sleep was found in 5 of the 6 most common patterns,

except Heart-Kidney noninteraction; restless sleep was present in Internal

disturbance of phlegm-heat, Hyperactivity of fire due to yin deficiency, and

Heart-kidney noninteraction; while easy awakening from sleep was present in

Deficiency of both heart and spleen and Hyperactivity of fire due to yin deficiency.
 34

Three sleep-related symptoms were only present in 1 pattern. The symptom

sometimes shallow sleep was mentioned in Hyperactivity of fire due to yin deficiency,

difficulty falling asleep in Liver-qi stagnation transforming into fire and frequent

awakening with a start in Qi deficiency of the heart and gallbladder.

Comparing the non-sleep-related symptoms among the top 6 TCM diagnostic patterns,

we found that dizziness, palpitation, restlessness, tinnitus, acid regurgitation, bitter

taste, blurred vision, oppression in the chest, poor memory, and feverish sensations in

the palms, soles and chest were present in more than 1 TCM syndrome patterns.

Dizziness was present in 5 of the 6 patterns, except Qi deficiency of the heart and

gallbladder. Palpitation was present in the 4 deficiency patterns. Restlessness was

found in the 2 excess patterns, Hyperactivity of fire due to yin deficiency and

Heart-kidney noninteraction. Tinnitus was present in Liver-qi stagnation

transforming into fire, Hyperactivity of fire due to yin deficiency and Heart-kidney

noninteraction. Acid regurgitation, bitter taste, and oppression in the chest were

present in the 2 excess patterns. Blurred vision was present in Internal disturbance of

phlegm-heat and Heart-kidney noninteraction. Feverish sensations in the palms, soles

and chest were present in Hyperactivity of fire due to yin deficiency and Heart-kidney

noninteraction. Poor memory was found in Deficiency of both the heart and spleen

and Hyperactivity of fire due to yin deficiency.

Some symptoms were found in 1 pattern only. Anguish in the heart, anorexia,

belching, heavy sensation in the head, profuse sputum and stuffiness in the stomach

were found in Internal disturbance of phlegm-heat. Agitation, constipation, headache,

 35

hypochondriac distension, impatience, irritability, poor appetite, red face, reddish eyes,

thirst and yellow urine were found only in Liver-qi stagnation transforming into fire.

Fatigue of the limbs, lack of strength, lassitude, reduction in luster complexion or

lusterless complexion and tasteless were present in Deficiency of both the heart and

spleen. Emission of semen and night sweating were found in Heart-kidney

noninteraction. These 2 symptoms, emission of semen and night sweating were also

found in Hyperactivity of fire due to yin deficiency, but with a slightly different term,

emission of semen during dream and sweating. Other symptoms only found in

Hyperactivity of fire due to yin deficiency were dry mouth or throat, scant fluid and

sore waist. Prolonged and clear urine, shortness of breath, susceptibility to fright,

timidity and tiredness were found only in Qi deficiency of the heart and gallbladder.

The tongue features of the 2 excess patterns were red tongue with yellow coating,

however, the tongue feature in Internal disturbance of phlegm-heat was different from

that in Liver-qi stagnation transforming into fire because the former pattern had a

slimy tongue coating. Red tongue was also found in deficiency patterns with Yin

Deficiency, including Hyperactivity of fire due to yin deficiency and Heart-kidney

noninteraction, but the former pattern had a scanty coating. Pale tongue was present

in both Deficiency of both the heart and spleen and Qi deficiency of the heart and

gallbladder, but the former pattern had thin and white tongue coating.

The pulse feature of the 2 excess TCM syndrome patterns was rapid pulse, while in

the 4 deficiency patterns; the pulse feature was fine pulse. Rapid pulse also found in

the 2 Yin deficiency patterns, Hyperactivity of fire due to yin deficiency and Heart-

kidney noninteraction. The pulse features of Deficiency of both the heart and spleen
 36

and Qi deficiency of the heart and gallbladder were different from those in other

deficiency patterns because the former had weak pulse, while the latter had wiry

pulse.

3.12 TCM syndrome diagnostic patterns for insomnia vs. Western insomnia

diagnoses

There are many diagnostic systems for insomnia, such as the DSM-IV, ICD-10 and

ICSD-2. This review only compared the TCM syndrome patterns with the DSM-IV

classification system. We focused on 6 most common DSM-IV insomnia diagnoses,

namely, primary insomnia, substance-induced sleep disorder – insomnia type,

insomnia related to another mental disorder – anxiety disorders, insomnia related to

another mental disorder – depressive disorder, insomnia due to a general medical

condition, and insomnia due to specific sleep disorders, e.g. OSAS, PLMD.

Primary insomnia

Comparing the common TCM syndrome patterns of insomnia with the DSM-IV

primary insomnia, we found that difficulty initiating sleep was similar to difficulty

falling asleep in Liver-qi stagnation transforming into fire; difficulty maintaining

sleep in the DSM-IV system was similar to easy awakening from sleep in Deficiency

of both the heart and spleen and Hyperactivity of fire due to yin deficiency;

nonrestorative sleep was comparable to lassitude, lack of strength, fatigue of limbs in

Deficiency of both the heart and spleen. The DSM-IV primary insomnia diagnosis128

also states that sleep disturbance and the associated daytime fatigue causes clinically
 37

significant distress or impairment in social, occupational, or other important areas of

functioning. These daytime symptoms of primary insomnia are comparable to the

non-sleep-related symptoms in the TCM syndrome patterns. The tongue and pulse

features mentioned in the TCM patterns are not reported in the DSM-IV primary

insomnia diagnosis. As a whole, all common TCM syndrome patterns for insomnia

seem to be compatible with the DSM-IV primary insomnia diagnosis.

Substance-induced sleep disorder – insomnia type

The DSM-IV diagnosis of substance-induced sleep disorder – insomnia type would

require the subjects’ sleep disturbance to be sufficiently severe to warrant independent

clinical attention and there is evidence from the history, physical examination, or

laboratory findings that the sleep disturbance is developed during, or within a month

of, substance intoxication or withdrawal; or medication use is etiologically related to

the sleep disturbance. Moreover, the sleep disturbance causes clinically significant

distress or impairment in social, occupational, or other important areas of

functioning128. It seems that none of the common TCM diagnostic patterns for

insomnia mentioned about sleep disturbance associated with substances use. We

concluded that none of the TCM syndrome patterns was compatible with the DSM-IV

substance-induced sleep disorder – insomnia type.

Insomnia related to another mental disorder – anxiety disorders

The diagnostic criteria for insomnia related to another mental disorder – anxiety
128
disorders from DSM-IV are basically the same as those for primary insomnia, but
 38

in addition, for example, in generalized anxiety disorder, the subjects need to have

excessive anxiety and worry, occurring more days than not for at least 6 months,

about a number of events or activities (such as work or school performance) and the

subjects find it difficult to control the worry. Moreover, the anxiety and worry are

associated with three or more of the following six symptoms, restlessness or feeling

keyed up or on edge, being easily fatigued, difficulty concentrating or mind going

blank, irritability and muscle tension128. The symptoms in DSM-IV insomnia

associated with anxiety disorder, such as excessive anxiety, difficult to control the

worry, restlessness or feeling keyed up or on edge, difficulty concentrating or mind

going blank, being easily fatigued are also described in the common TCM syndrome

patterns for insomnia. For example, susceptibility to fright, tiredness and timidity in

Qi deficiency of heart and gall bladder, irritability and restlessness in Liver-qi

stagnation transforming into fire. As a whole, we considered that insomnia associated

with anxiety disorder according to the DSM-IV had some similarities with the TCM

syndrome patterns Qi deficiency of heart and gall bladder and Liver-qi stagnation

transforming into fire.

Insomnia related to another mental disorder – depressive disorder

The diagnostic criteria for insomnia related to another mental disorder – depressive

disorder according to the DSM-IV are basically the same as primary insomnia, but in

addition, the subjects need to have features of major depressive episode128. The

melancholic features of depressive disorder, such as loss of pleasure in all, or almost

all activities; lack of reactivity to usually pleasurable stimuli, marked psychomotor

retardation and motoric immobility are comparable to susceptibility to fright, tiredness

 39

and timidity in Qi deficiency of heart and gall bladder. We considered that insomnia

related to depressive disorder to be similar to the TCM syndrome pattern Qi

deficiency of heart and gall bladder.

Sleep disorder due to a general medical condition, insomnia type

None of the TCM syndrome patterns for insomnia mention about insomnia related to

another medical condition. In term of TCM theory, if a subject suffers from insomnia

and a medical condition, the subject will probably be diagnosed only with that

particular medical condition.

Insomnia due to obstructive sleep apnea syndrome

Patients with obstructive sleep apnea syndrome would complain of unintentional sleep

episodes during wakefulness, daytime sleepiness, unrefreshing sleep, fatigue and

insomnia; or the patients wake with breath holding, gasping, or choking; the bed

partners would report the patients had loud snoring, breathing interruptions, or both2.

None of the TCM syndrome patterns for insomnia in our review mention about

snoring and breathing difficulties during sleep. The daytime symptoms of obstructive

sleep apnea, such as unintentional sleep episodes during wakefulness, daytime

sleepiness, unrefreshing sleep and fatigue may be comparable to lassitude and fatigue

of limbs in Deficiency of both the heart and spleen. We considered that the TCM

syndrome pattern Deficiency of both the heart and spleen was comparable to insomnia

due to obstructive sleep apnea.

 40

Insomnia due to periodic limbs movement disorder

Patients with periodic limbs movement disorder would have repetitive, highly

stereotyped limb movements detected in polysomnography study; and the periodic

limbs movement index has to exceed five per hour in children and 15 per hour in most

adult cases2. None of the TCM syndrome pattern mention about periodic limbs

movement during sleep. The daytime symptoms associated with periodic leg

movement disorder are similar to lassitude and fatigue of limbs in Deficiency of both

the heart and spleen. As a whole, we considered none of the TCM syndrome patterns

to be compatible with insomnia due to periodic limbs movement disorder.

 41

Chapter 4

Discussion

This is the first systematic review examining both English and Chinese literatures on

the classification of insomnia using TCM diagnostic system. We conducted an

extensive review of 103 articles involving 9499 subjects with insomnia. We were able

to find out the most common TCM syndrome diagnostic patterns used by Chinese

Medicine practitioners for diagnosis of insomnia; we had also reviewed the common

symptoms and signs of each of the common TCM diagnostic patterns.

Our systematic review showed that 69 different TCM syndrome patterns were

mentioned in previous studies of insomnia. We analyzed the included studies in term

of the nature of study design and whether they were published in high impact factor

journals. We also examined the TCM syndrome patterns in subjects with insomnia. In

addition, we compared the TCM syndrome patterns obtained in our review with those

described in the standard TCM textbooks. We considered that the 6 most common

TCM diagnostic patterns for insomnia, namely, Deficiency of both the heart and

spleen, Hyperactivity of fire due to yin deficiency, Liver-qi stagnation transforming

into fire, Internal disturbance of phlegm-heat, Heart-kidney noninteraction and Qi

deficiency of the heart and gallbladder, accounting for roughly 70% of the diagnosis

in subjects with insomnia, were worthy for further studies.

Although only 5 TCM diagnostic patterns are listed in the standard textbook 9, our

review suggested that the pattern, Heart-Kidney noninteraction, which was not listed
 42

in the standard textbook was ranked between second to sixth commonest TCM

diagnostic patterns for insomnia by different selection criteria. About 8.1% of subjects

with insomnia were diagnosed with Heart-Kidney noninteraction. Our findings

suggested that Heart-Kidney noninteraction should be included as one of the common

TCM diagnostic pattern for insomnia in the TCM textbook, such that more attention

could be given to this pattern.

Our study demonstrated that there was a lack of standardization in the terminology of

symptoms and signs in the current TCM literature. It was possible that there was

disagreement between TCM practitioners in symptoms, signs and diagnostic patterns.

We found there are a total of 51 different Chinese terminologies for sleep-related

symptoms, after translating similar Chinese terms into one single English term, 21

English terminologies are found for sleep-related symptoms. For non-sleep-related

symptoms, we found a total of 158 different Chinese terminologies, after translating

similar Chinese terms into one single English term, it was reduced to 89. We

considered that it is necessary to standardize some common terminologies so that

communication between practitioners would be easier. Lack of standardization in the

terminology of symptoms and signs can also hinder the modernization of TCM. The

number of sleep-related terms used in the TCM classification is much more than that

used in the Western diagnostic system. A few sleep symptoms are not particularly

mentioned in the Western system, such as dream disturbed sleep, restless sleep. It is

worthwhile to further examine the clinical importance of the sleep symptoms used in

the TCM classification system.

 43

We found that papers of RCT design had slightly less TCM syndrome patterns to

describe insomnia; while papers published in journals with high impact factor had

more TCM syndrome patterns to describe insomnia than those published in journals

with no impact factor or impact factor <0.5. We considered that RCT study design

papers and papers published in high impact factor journals did not significantly

improve the consistency in TCM syndrome diagnosis

All translations in this review were deduced from the book WHO International

Standard Terminologies on Traditional Medicine in the Western Pacific Region

published by the World Health Organization in 200716 and the standard textbook

Traditional Chinese Internal Medicine recommended by the Ministry of Health of

China as mentioned in introduction 9. The Chinese and English terms in the two books

are very different. Some of the frequently used terms were not found in the WHO

textbook; and some terms were difficult to understand, for example, dizzy vision

(WHO textbook, p.95). There are definitely rooms for improvement for future edition

of the WHO textbook.

Comparing TCM syndrome diagnostic patterns with insomnia diagnoses in the

Western classification systems, primary insomnia may compare with Deficiency of

both the heart and spleen and Hyperactivity of fire due to yin deficiency; insomnia

related to another mental disorder – anxiety disorders may compare with Qi deficiency

of the heart and gallbladder and Liver-qi stagnation transforming into fire; insomnia

related to another mental disorder – depressive disorder may compare with Qi

deficiency of the heart and gallbladder, insomnia due to obstructive sleep apnea

syndrome may compare with Deficiency of both the heart. We considered none of the
 44

TCM syndrome patterns compatible with the clinical features of insomnia due to

periodic limbs movement disorder, or it is related to Deficiency of both the heart and

spleen and Hyperactivity of fire due to yin deficiency.

There were no TCM syndromes diagnostic patterns comparable to substance-induced

sleep disorder – insomnia type, sleep disorder due to a general medical condition -

insomnia type, and sleep disorder due to obstructive sleep apnea syndrome - insomnia

type.

There are a lot of difference between the TCM and Western diagnostic system for

insomnia. The following similarities between TCM and Western diagnostic system

should be tested as preliminary. Comparing TCM and Western diagnostic system,

there are some places that are similar, but most of the diagnostic criteria are very

different. Stool, urine, pulse, and tongue features are very important information in

TCM system, while they are only important for some diagnoses in Western diagnostic

system, and none for insomnia diagnoses. In term of TCM theory, the stool, urine,

pulse and tongue features are very useful for diagnosis if sleep problems are

non-specific, for example, sleeplessness, the other symptoms are the key to TCM

syndrome pattern diagnosis. The TCM treatment is based on the syndrome diagnostic

patterns, so there is no need to have very clear concept of the insomnia symptoms. To

conclude, the TCM diagnostic system considers all the presenting symptoms

including stools, color of urine, although the etiologies play an important role to the

diagnostic process. The TCM therapies are mainly directed by the diagnostic

syndrome and the presenting symptoms that constitute the syndrome; while the

Western system places more emphasis on the etiology of insomnia and relies on
 45

laboratory investigation, such as polysomnography, magnetic resonance imaging, and

others.

Strengths and limitations of the study

We conducted a systematic review on the diagnosis of insomnia in a more than 100

publications involving almost 10,000 subjects with insomnia. The information will be

useful for the future development of TCM. The clinical features for the TCM

syndrome diagnostic patterns were based on the description in the papers and not

obtained by examining each individual patient. It is possible that some TCM

practitioners may have misinterpreted the clinical features and that the symptoms and

signs had not actually present. The translation of some Chinese terms were not

available in the standard textbooks, Traditional Chinese Internal Medicine published

by People’s Medical Publishing House9 and WHO International Standard

Terminologies on Traditional Medicine in the Western Pacific Region16, and had to

rely on the author’s own interpretation. Our study was limited by the lack of statistical

analysis. Further studies of the symptoms distribution by cluster analysis may be

needed.

Future direction

A major obstacle for modernization of TCM is that TCM diagnoses greatly rely on the

experience of the TCM practitioners. The treatment plan is based on diagnostic

patterns and judgment of individual practitioner, so it is highly variable. More work is

needed to develop better standardization of TCM terminology. It is necessary to

 46

conduct experiments to explore the importance of the TCM diagnostic patterns in the

efficacy of TCM treatment approaches, such as Chinese herbal agents, acupuncture. It

is necessary to conduct further validation and reliability studies on TCM syndrome

patterns in subjects with insomnia. It is important to examine the similarities and

differences between TCM syndrome patterns and Western medicine diagnostic

categories for insomnia. Furthermore, with more advanced technology, building a

systematic model could facilitate data mining concept on TCM diagnosis.

 47

Chapter 5

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 54

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 55

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 56

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 57

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 59

Figure 1. Selection of trials for inclusion in the review.

Number of articles retrieved in the above

database according to the search strategy
(n = 4795)

∗ Articles unrelated to insomnia (n = 1922)

∗ Articles unrelated to TCM (n = 56)
∗ Duplicated articles (n = 1058)

Articles remain which related to

insomnia and TCM (n =1759)

∗ Discussion papers (n = 65)

∗ Magazine articles (n = 271)

Articles with a study design

(n = 1423) ∗ Age > 70 or <18 (n = 95)
∗ Male or female only (n = 33)
∗ On a specific medical and psychiatric
condition (n = 73)
∗ On a particular life transition period
(n =19)
∗ On a specific TCM diagnostic pattern (n =
145)
∗ Less than 30 subjects (n = 264)
Articles remain (n = 413) ∗ Without TCM diagnostic pattern (n = 364)
∗ Paper written neither in Chinese nor
English (n = 16)
∗ Unavailable (n = 1)

∗ Without number of cases in each TCM

diagnostic pattern (n = 310)

Articles included in our review (n = 103)

 60

Table 1. Studies reviewed for TCM diagnostic pattern of insomnia.

Mean Sample % Duration of Impact Book for

Author (year) Type of case Design Intervention Journal
Age Size Female insomnia (Range) Factor inclusion
Hubei Journal of Traditional Chinese
1 Yin Y (2008) 54 40 60.0 1 year - 10 years NR. RCT Acup. + CM / CM 0.365 CCMD
Medicine
0.5 months - 18 Shanghai Journal of Acupuncture
2 Cheng HF (2008) NR. 78 52.6 NR. Case Series Acup. 0.485 TCM-D
years and Moxibustion
Journal of Clinical Acupuncture and
3 Wang Y (2008) NR. 50 52.0 18 days - 9 years In and Outpatients RCT Acup./ WM 0.409 CRG
Moxibustion
1 month - 3 Uncontrolled Abdomen Acup. and Journal of Clinical Acupuncture and
4 Xie WX. et al.(2007) NR. 80 52.5 Outpatients 0.409 CCMD
months Trial Body Acup. Moxibustion
1 month - 18 Acup. + Acupoint Chinese Journal of Convalescent
5 Zhong XL (2007) NR. 35 62.9 NR. Case Series 0.073 TCM-D
years Injection Medicine
1 month - 3.8 Uncontrolled Forum on Traditional Chinese CCMD
6 Jiao SH (2007) 42.3 78 62.8 Outpatients Footbathing and WM 0.262
years Trial Medicine & CRG
14 days - 17 Acup. + Auri. Acup. / Lishizhen Medicine and Materia
7 Li XJ (2007) NR. 133 60.2 Outpatients RCT 0.199 CRG
years WM Medica Research
2 weeks - 20 Uncontrolled
8 Liu ZL (2007) 41.8 32 71.9 NR. Abdomen Acup. World Chinese Medicine NA TCM-D
years Trial
Scraping on selected
Acupoint and
9 Li G (2007) NR. 60 53.3 NR. NR. RCT Journal of Nursing Science 0.741 CRG
accommodating emotion /
WM
10 Xu M, et al. (2007) 32 78 64.1 NR. NR. Case Series Tuna + Acupress Journal of Changchun University 0.154 NR.

1 month - 18 Uncontrolled Guangming Journal of Chinese

11 Lian Y (2007) 52 72 61.1 Outpatients CM 0.148 TCM-D
years Trial Medicine
Suppedaneous massage
1 month - 30
12 Zhou Q, et al. (2007) 45.3 118 53.4 Inpatients Controlled Trial combined with sleep Chinese Nursing Research 0.678 TCM-D
years
hygiene / sleep hygiene
0.5 years - Chinese Journal of Integrated
13 Tang SC, et al. (2007) 42.5 276 54.0 Outpatients RCT Acup./ WM 1.582 TCM-NJ
12years Traditional & Western Medicine
Acup.+ Auri. Acup. / Chinese Acupuncture &
14 Gao XY, et al. (2007) 39.7 200 47.5 NR. NR. RCT 1.058 CCMD
Acup. Moxibustion
10 years - 51 Journal of Yunnan University of
15 Ding YW (2006) 73.3 80 31.3 Outpatients RCT CM / CM 0.274 CRG
years Traditional Chinese Medicine
2 months - 10 Journal of Shaanxi College of
16 Wang YX (2006) NR. 80 55.0 Outpatients Case Series Acup. + CM 0.215 TCM-D
years Traditional Chinese Medicine
15 days - 20 Guangxi Journal of Traditional
17 Zhao WD (2006) 35.9 93 62.4 In and Outpatients Controlled Trial CM / WM 0.318 CRG
years Chinese Medicine
 61

Mean Sample % Duration of Impact Book for

Author (year) Type of case Design Intervention Journal
Age Size Female insomnia (Range) Factor inclusion
4 months - 5 Acup.+ Acupoint Shaanxi Journal of Traditional
18 Zhong GY (2006) NR. 55 54.5 NR. Case Series 0.291 NR.
years Injection Chinese Medicine
2 months - 3 Journal of Sichuan of Traditional
19 Xu YY (2006) 45.7 68 52.9 Inpatients Case Series Acup. 0.334 TCM-D
years Chinese Medicine
Sleep Hygiene + Auri.
Uncontrolled International Medicine & Health
20 Yan AQ (2006) 36.2 80 60.0 3 weeks - 5 years NR. Acup.+ Plum Blossom NA TCM-D
Trial Guidance News
Needle
3 months - 20 Journal of Youjiang Medical College
21 Tan JF (2006) NR. 125 56.8 NR. Case Series Auri. Acup. + Acup. 0.094 TCM-D
years For Nationalities
1 month - 10 Chinese Archives of Traditional
22 Tian HZ (2006) NR. 78 53.8 Outpatients RCT Acup.+ CM / CM 0.355 TCM-D
years Chinese Medicine
University Journal of Sichuan of Traditional
23 Tan B (2006) NR. 80 NA. NR. Controlled Trial CM / WM 0.334 CCMD
Students Chinese Medicine
Journal of Chinese Medicinal
24 He XF (2006) 39.1 72 58.3 NR. Outpatients RCT Acup./ Acup. + CM 0.669 TCM-D
Materials
0.5 months - 2 Uncontrolled Journal of External Therapy of
25 Guo RY (2005) 38 36 55.6 Outpatients Footbathing 0.619 NR.
years Trial Traditional Chinese Medicine
5 weeks - 15 Chinese Acupuncture &
26 Wang SG (2005) NR. 78 55.1 Outpatients RCT Acup. / Acup. 1.058 TCM-NJ
years Moxibustion
14 days - 17 Shaanxi Journal of Traditional
27 Guo ZP (2005) NR. 111 45.0 Outpatients RCT Auri. Acup./ CM 0.291 NR.
years Chinese Medicine

28 Yao L (2005) NR. 100 77.0 7 days - 15 years Outpatients Case Series CM Henan Traditional Chinese Medicine 0.312 NR.

1 month - 20 Shanxi Journal of Traditional

29 Zhong CL (2005) 48 50 54.0 Outpatients Case Series CM 0.371 TCM-NJ
years Chinese Medicine
Guangxi Journal of Traditional
30 Tan LR (2005) 34.6 125 68.8 NR. Outpatients RCT CM / WM 0.318 CCMD
Chinese Medicine
Sleep Hygiene / Sleep
31 Huang J, et al. (2005) 45.2 120 28.3 NR. Outpatients RCT Hebei Medicine 0.102 TCM-D
Hygiene
3 months - 8 Tuna & CM placed in Chinese Manipulation & Qi Gong
32 Wu YF (2005) 41 100 67.0 Outpatients Case Series 0.171 NR.
years navel Therapy
2 months - 3 Uncontrolled Practical Journal of Clinical
33 Wu BY (2005) 44 30 70.0 Outpatients Acup. + Mould backbone NA TCM-NJ
years Trial Medicine
2 months - 8 Acup. + CM / Acup. + Journal of Clinical Acupuncture and
34 Wang HB (2004) NR. 78 64.1 Outpatients Controlled Trial 0.409 TCM-D
years CM Moxibustion
 62

Mean Sample % Duration of Impact Book for

Author (year) Type of case Design Intervention Journal
Age Size Female insomnia (Range) Factor inclusion
3 months - 20 Chinese Manipulation & Qi Gong
35 Bian LJ (2004) 40 140 64.3 NR. Controlled Trial Acup. / Acup. 0.171 TCM-D
years Therapy
1 month - 22 Journal of Sichuan of Traditional
36 Pan H (2004) 38.1 192 53.6 Outpatients Controlled Trial Acup. / WM 0.334 TCM-D
years Chinese Medicine
Uncontrolled Journal of Shaanxi College of
37 Chen H (2004) NR. 60 61.7 3 days - 20 years Outpatients Acup. 0.215 TCM-D
Trial Traditional Chinese Medicine
Journal of Hebei Traditional Chinese
38 Li Q (2004) NR. 72 59.7 8 days - 5 years NR. RCT Acup. + CM / CM 0.228 NR.
Medicine and Pharmacology
3 months - 5 Journal of Practical Traditional
39 Zheng Y (2004) NR. 58 65.5 Outpatients RCT Tuna + CM / CM 0.404 NR.
years Chinese Internal Medicine

40 Shi YQ (2004) 19.6 518 45.9 NR. Athletes Epidemiological NA Chinese Journal of Sports Medicine 0.716 CCMD

Uncontrolled Sleep hygiene + Acup. +

41 Zhou SP (2004) NR. 132 78.0 NR. NR. Shanxi Clinical Medicine NA NR.
Trial WM
0.5 months - 23 Uncontrolled Shanghai Journal of Acupuncture
42 Peng L (2004) NR. 85 38.8 NR. Acup. 0.485 NR.
years Trial and Moxibustion
Uncontrolled Chinese Journal of Clinical
43 Chen LX (2003) NR. 83 96.4 7 days - 10 years Inpatients Acup. + Auri. Acup. NA TCM-D
Trial Rehabilitation
Uncontrolled Military Medical Journal of South
44 Wu SG (2003) 38 40 70.0 3 weeks - 4 years NR. CM 0.145 NR.
Trial China
2 months - 20 Uncontrolled Journal of Clinical Acupuncture and
45 Liang YR (2003) NR. 56 64.3 Outpatients Acup. + Cupping 0.409 NR.
years Trial Moxibustion
Uncontrolled Journal of Integrated Traditional and
46 Li HY (2003) 45.3 139 NA. 1 year - 15 years NR. Auri. + Acup. 0.227 WHO
Trial Western Medicine in modern China
Uncontrolled Lishizhen Medicine and Materia
47 Yang TH (2003) NR. 70 64.3 1 year - 15 years Outpatients Hidden String 0.199 Hollister
Trial Medica Research
Shanghai Journal of Acupuncture
48 Chen XH (2003) 50.5 80 55.0 0.6 years - 1 year Outpatients RCT Acup. + CM / WM 0.485 NR.
and Moxibustion

49 Guo YM (2003) 40.7 55 67.3 1 year - 15 years Outpatients RCT CM / WM Henan Traditional Chinese Medicine 0.312 CCMD

6 months - 15 Uncontrolled
50 Wang CJ (2003) 41 42 57.1 NR. CM Journal of Zhejiang College of TCM NA TCM-NJ
months Trial
1 month - 20 Uncontrolled Chinese Manipulation & Qi Gong
51 Gui J (2003) 50 40 80.0 NR. Tuna 0.171 NR.
years Trial Therapy
 63

Mean Sample % Duration of Impact Book for

Author (year) Type of case Design Intervention Journal
Age Size Female insomnia (Range) Factor inclusion
Uncontrolled Clinical Journal of Anhui Traditional
52 Meng FZ (2003) NR. 56 28.6 1 month - 1 year Outpatients CM NA NR.
Trial Chinese Medicine
Uncontrolled Zhejiang Journal of Traditional
53 Meng ZZ (2003) 32 185 75.7 NR. Outpatients CM 0.527 NR.
Trial Chinese Medicine
10 days - 10 Acup. + plum blossom Journal of Traditional Chinese
54 Zhang Q (2003) 68 35 60.0 NR. Case Series 0.059 NR.
years needle Medicine
1.5 years - 20 Journal of Clinical Acupuncture and
55 Liu M (2002) 45.8 80 56.3 Outpatients Case Series Acup + CM 0.409 Hollister
years Moxibustion
1 month - 10 Chinese Journal of Information on
56 Shi YQ (2002) NR. 105 56.2 NR. RCT CM + Auri. Acup./ WM 0.287 CCMD
years TCM
Liaoning Journal of Traditional
57 Chen LY (2002) 53.6 400 67.0 NR. In and Outpatients Controlled Trial CM / CM 0.487 TCM-D
Chinese Medicine
Jiangsu Journal of Traditional
58 Chen LH (2002) NR. 56 NA. NR. Outpatients RCT CM/ CM / WM 0.395 TCM-NJ
Chinese Medicine
2 months - 15 Journal of Beijing University of
59 Qian YF (2002) 26.2 90 44.4 NR. Controlled Trial CM / CM 0.741 TCM-D
years Traditional Chinese Medicine
Scalp and body Acup. / Journal of Traditional Chinese
60 Lu Z (2002) 65 118 41.5 1 year - 20 years NR. Controlled Trial 0.059 NR.
WM and CM Medicine
3 months - 12 Uncontrolled
61 Wang YP (2001) NR. 134 56.0 NR. Acup. China s Naturopathy 0.139 NR.
years Trial
Uncontrolled Journal of Clinical Acupuncture and
62 Wang HY (2001) NR. 100 66.0 NR. NR. Acup. 0.409 NR.
Trial Moxibustion
3 months - 20 Chinese Journal of Information on
63 Li T (2001) 48.4 20 65.0 Outpatients RCT CM/ CM 0.287 CRG
years TCM
Uncontrolled Shanghai Journal of Acupuncture
64 Xu HJ (2001) 38.6 73 53.4 21 days - 6 years NR. Plum blossom needle 0.485 TCM-D
Trial and Moxibustion
Uncontrolled Jiangsu Journal of Traditional
65 Wang XP (2001) NR. 75 66.7 1 month - 3 years NR. CM 0.395 TCM-NJ
Trial Chinese Medicine
3 months - 3 Uncontrolled Heilongjiang Journal of Traditional
66 Wang YB (2001) NR. 30 76.7 NR. Acup. 0.12 TCM-D
years Trial Chinese Medicine
3 months - 2 Uncontrolled Hebei Journal of Traditional Chinese
67 Wang WH (2001) NR. 60 43.3 NR. CM 0.271 TCM-NJ
years Trial Medicine
Uncontrolled Hebei Journal of Traditional Chinese
68 Gong SY (2001) 47.7 60 63.3 1 year - 10 years In and Outpatients CM 0.271 CRG
Trial Medicine
2 months - 34
69 Han ZL (2001) 32.3 83 NA. Outpatients RCT CM + WM / WM Journal of Zhejiang College of TCM NA CCMD
years
 64

Mean Sample % Duration of Impact Book for

Author (year) Type of case Design Intervention Journal
Age Size Female insomnia (Range) Factor inclusion
Uncontrolled
70 Wang L (2001) 44.6 64 50.0 NR. Inpatients Auri. Acup. Chinese Journal of Nursing 3.167 TCM-NJ
Trial
0.5 months - 23 Uncontrolled Chinese Acupuncture &
71 Li YS (2001) NR. 85 38.8 NR. Acup. 1.058 NR.
years Trial Moxibustion
International Journal of Clinical
72 Ruan JY (2001) 47 174 25.3 NR. Outpatients Controlled Trial Acup. / WM NA NR.
Acupuncture
Yunnan Journal of Traditional
3 months - 29 Uncontrolled
73 Wang YH (2000) NR. 35 60.0 Outpatients Tuna Chinese Medicine and Materia 0.144 TCM-NJ
months Trial
Medica
1 month - 27 Uncontrolled Journal of Integrated Traditional and
74 Xiao XX (2000) 56.7 112 55.4 In and Outpatients CM 0.227 CRG
years Trial Western Medicine in modern China
CM Placed in Acupoint /
75 Ruan JY (2000) 44.4 199 49.2 NR. NR. Controlled Trial Journal of Zhejiang College of TCM NA TCM-NJ
WM
1 month - 12 Uncontrolled New Jounral of Traditional Chinese
76 Chen Q (2000) NR. 126 56.3 Outpatients CM 0.374 CRG
years Trial Medicine
Journal of Traditional Chinese
2 months - 32 Uncontrolled
77 Jin X (1999) NR. 34 35.3 NR. Acup. + CM Medicine and Chinese Materia 0.344 TCM-D
years Trial
Medica of Jilin
Uncontrolled Correspondence Journal of
78 Zhao YZ (1999) NR. 48 56.3 2 months - 1 year NR. Acup. NA TCM-D
Trial Traditional Chinese Medicine
Journal of Clinical Acupuncture and
79 Wang RJ (1999) NR. 79 59.5 3 days - 5 years Outpatients RCT Acup./ Acup. 0.409 TCM-NJ
Moxibustion
1 month - 14 Uncontrolled Chinese Manipulation & Qi Gong
80 Wang ZG (1999) NR. 93 36.6 NR. Massage & Qi Gong 0.171 NR.
years Trial Therapy
1 month - 12 Uncontrolled Journal of Traditional Chinese
81 Yao S (1999) 38 46 58.7 NR. Auri. Acup. 0.059 NR.
years Trial Medicine
Xinjiang Journal of Traditional
82 Ma RF (1998) 52 54 61.1 1 month - 7 years Outpatients Case Series Acup. 0.114 NR.
Chinese Medicine
14 days - 12 Uncontrolled Acupress + Mould
83 Weng RX (1998) 48.6 50 62.0 Outpatients Journal of Zhejiang College of TCM NA TCM-D
years Trial Backbone
Uncontrolled Clinical Journal of Anhui Traditional
84 Liu P (1998) 51 46 56.5 NR. Inpatients Sleep Hygiene NA NR.
Trial Chinese Medicine
Clinical Journal of Anhui Traditional
85 Xu LQ (1998) NR. 63 63.5 1 week - 22 years NR. Case Series Auri. Acup. NA TCM-D
Chinese Medicine
Uncontrolled China Journal of basic medicine in
86 Jiang JX (1997) NR. 100 62.0 NR. NR. Skin Herbal Medication 0.501 TCM-D
Trial Traditional Chinese Medicine
 65

Mean Sample % Duration of Impact Book for

Author (year) Type of case Design Intervention Journal
Age Size Female insomnia (Range) Factor inclusion
Uncontrolled China Journal of basic medicine in
87 Huang AY (1997) NR. 80 60.0 12 days - 32 days NR. CM 0.501 NR.
Trial Traditional Chinese Medicine
Uncontrolled Journal of Clinical Acupuncture and
88 Ge BH (1997) 35 48 54.2 1 year - 3 years Outpatients Acupoint Injection 0.409 NR.
Trial Moxibustion
3 months - 24 Uncontrolled Journal of Hunan College of
89 Zhang ZY (1997) NR. 36 41.7 Outpatients CM 0.422 CCMD
months Trial Traditional Chinese Medicine
Hunan Guiding Journal of
90 Zhou XH (1997) 45.9 60 46.7 NR. In and Outpatients RCT CM / WM Traditional Chinese Medicine and NA TCM-D
Pharmacology
3 months - 20 Uncontrolled Fujian Journal of Traditional Chinese
91 Lan YM (1997) NR. 50 40.0 Outpatients CM 0.114 TCM-D
years Trial Medicine
Uncontrolled Chinese Acupuncture &
92 Zhao RX (1997) NR. 32 65.6 7 days - 8 years NR. Earlobe 1.058 NR.
Trial Moxibustion
Uncontrolled Clinical Journal of Anhui Traditional
93 Shen XM (1996) NR. 111 57.7 7 days - 32 years NR. Hidden String NA NR.
Trial Chinese Medicine
6 months - 36 CM + Sleep Hygiene /
94 Xu L (1996) 43.5 50 64.0 NR. RCT Chinese Mental Health Journal 1.173 CCMD
years CM
Uncontrolled Journal of Traditional Chinese
95 Wu XZ (1996) NR. 120 60.0 9 days - 280 days NR. Acup. 0.543 NR.
Trial Medicine
2 months - 10 Journal of Gansu College of
96 Bai JH (1996) 45.9 80 53.8 In and Outpatients RCT CM / CM 0.178 NR.
years Traditional Chinese Medicine
1 month - 30 Uncontrolled Acupress + Mould Chinese Manipulation & Qi Gong
97 Zhu F (1996) NR. 78 55.1 NR. 0.171 NR.
years Trial Backbone Therapy
0.5 months - 24 Journal of Chengdu University of
98 Li R, et al. (1995) NR. 134 48.5 In and Outpatients RCT CM / CM / WM 0.340 TCM-D
years Traditional Chinese Medicine
1 month - 10 Uncontrolled Clinical Journal of Anhui Traditional
99 Yu RM (1995) 40.7 50 38.0 NR. Nei Gong + Tuna NA NR.
years Trial Chinese Medicine
Uncontrolled Journal of Practical Traditional
100 Zhang KR (1994) NR. 149 57.7 NR. NR. CM 0.409 TCM-D
Trial Chinese Medicine
2 months - 4
101 Wei X (1994) NR. 30 36.7 In and Outpatients Case Series CM Henan Traditional Chinese Medicine 0.312 TCM-D
years
0.5 years - 10 Hunan Journal of Traditional
102 Wang BQ (1994) NR. 300 56.0 NR. Case Series CM NA TCM-D
years Chinese Medicine
2 weeks - 20 Auri. Acup./Auri. Acup./ Journal of Traditional Chinese
103 Yang CL (1988) NR. 92 NA. NR. Controlled Trial 0.059 TCM-D
years Auri. Acup. Medicine
Acup., acupuncture; CCMD, Chinese Classification of Mental Disorder; CRG, Clinical Research Guidelines of New Chinese Herbal Medicine; NA. , not available; NR. , not reported; TCM-D,
diagnosis based on TCM textbooks; TCM-NJ, Diagnosis and Therapeutic Effect of Diseases and Syndromes in Traditional Chinese Medicine; WM, Western Medication; CM, Chinese Medicines;
Auri. Acup., Auricular Acupuncture.
 66

Table 2. Diagnostic criteria for insomnia used in the 103 included studies.

Diagnostic criteria N (%)

Diagnosis and Therapeutic Effect of Diseases and Syndromes in
12 (11.7)
Traditional Chinese Medicine
Chinese Classification of Mental Disorder 11 (10.7)

Clinical Research Guidelines of New Chinese Herbal Medicine 9 (8.7)

World Health Organization 1 (1.0)

Hollister 2 (1.9)
Chinese Classification of Mental Disorder and Clinical Research
1 (1.0)
Guidelines of New Chinese Herbal Medicine
Diagnosis based on others TCM textbooks 33 (32.0)

Not reported 34 (33.0)

 67

Table 3.1 The top 10 TCM syndrome diagnostic patterns used in the 103 reviewed
papers.

TCM syndrome diagnostic pattern Chinese name N (%) *

Deficiency of both the heart and spleen 心脾兩虛 97 (94.2)
Hyperactivity of fire due to yin deficiency 陰虛火旺 65 (63.1)
Liver-qi stagnation transforming into fire 肝鬱化火 44 (42.7)
Internal disturbance of phlegm-heat 痰熱內擾 35 (34.0)
Heart-kidney noninteraction 心腎不交 31 (30.1)
Qi deficiency of the heart and gallbladder 心膽氣虛 30 (29.1)
Liver fire flaming upward 肝火上擾 15 (14.6)
Heart deficiency with timidity 心虛膽怯 15 (14.6)
Stomach disharmony 胃腑不和 13 (12.6)
Stomach Qi disharmony 胃氣不和 7 (6.8)
 68

Table 3.2 The top 12 TCM syndrome diagnostic patterns in the 26 reviewed papers
with RCT design.

TCM Syndrome Diagnostic Pattern Chinese name N (%) *

Deficiency of both the heart and spleen 心脾兩虛 24 ( 92.3 )
Hyperactivity of fire due to yin deficiency 陰虛火旺 16 ( 61.5 )
Liver-qi stagnation transforming into fire 肝鬱化火 13 ( 50.0)
Heart-kidney noninteraction 心腎不交 10 ( 38.5 )
Internal disturbance of phlegm-heat 痰熱內擾 9 ( 34.6 )
Heart deficiency with timidity 心虛膽怯 6 ( 23.1 )
Qi deficiency of the heart and gallbladder 心膽氣虛 6 ( 23.1 )
Spleen-stomach disharmony 脾胃不和 4 ( 15.4 )
Effulgent Heart-Liver fire 心肝火旺 2 ( 7.7 )
Liver fire flaming upward 肝火上擾 2 ( 7.7 )
Liver yang flaming upward 肝陽上擾 2 ( 7.7 )
Disturbance of heart by phlegm-heat 痰熱擾心 2 ( 7.7 )
 69

Table 3.3. The top 11 TCM syndrome diagnostic patterns in subjects with insomnia in
the 17 reviewed papers published in journals with impact factor above 0.5.

TCM Syndrome Diagnostic Pattern Chinese name N (%) *

Deficiency of both the heart and spleen 心脾兩虛 16 ( 94.1 )
Heart-kidney noninteraction 心腎不交 9 ( 52.9 )
Hyperactivity of fire due to yin deficiency 陰虛火旺 7 ( 41.2 )
Liver-qi stagnation transforming into fire 肝鬱化火 6 ( 35.3 )
Qi deficiency of the heart and gallbladder 心膽氣虛 5 ( 29.4 )
Internal disturbance of phlegm-heat 痰熱內擾 4 ( 23.5 )
Spleen-stomach disharmony 脾胃不和 3 ( 17.6 )
Effulgent Heart-liver fire 心肝火旺 2 ( 11.8 )
Heart deficiency with timidity 心虛膽怯 2 ( 11.8 )
Liver fire flaming upward 肝火上擾 2 ( 11.8 )
Stomach disharmony 胃腑不和 2 ( 11.8 )
 70

Table 3.4. The top 10 most common TCM syndrome diagnostic patterns in subjects
with insomnia (Total N = 9499)

TCM Syndrome Diagnostic Pattern Chinese name N (%) *

Deficiency of both the heart and spleen 心脾兩虛 2378 (25.0)
Hyperactivity of fire due to yin deficiency 陰虛火旺 1622 (17.1)
Liver-qi stagnation transforming into fire 肝鬱化火 921 (9.7)
Heart-kidney noninteraction 心腎不交 767 (8.1)
Qi deficiency of the heart and gallbladder 心膽氣虛 544 (5.7)
Internal disturbance of phlegm-heat 痰熱內擾 466 (4.9)
Liver fire flaming upward 肝火上擾 285 (3.0)
Overexertion and fatigue damage to Qi 勞倦傷氣 262 (2.8)
Heart deficiency with timidity 心虛膽怯 202 (2.1)
Spleen-stomach disharmony 脾胃不和 162 (1.7)
 71

Table 4. Summary of the TCM syndrome diagnostic patterns in different types of paper.

All reviewed papers RCT papers Papers published in journals with Papers with subjects’ clinical
Rank
( N = 103) ( N=26) impact factor above 0.5 (N=17) features (N = 37)
Deficiency of both the heart Deficiency of both the heart Deficiency of both the heart and Deficiency of both the heart and
1
and spleen and spleen spleen spleen
Hyperactivity of fire due to Hyperactivity of fire due to yin Hyperactivity of fire due to yin
2 Heart-kidney noninteraction
yin deficiency deficiency deficiency
Liver-qi stagnation Liver-qi stagnation Hyperactivity of fire due to yin Liver-qi stagnation transforming
3
transforming into fire transforming into fire deficiency into fire
Internal disturbance of Liver-qi stagnation transforming
4 Heart-kidney noninteraction Heart-kidney noninteraction
phlegm-heat into fire
Internal disturbance of Qi deficiency of the heart and Qi deficiency of the heart and
5 Heart-kidney noninteraction
phlegm-heat gallbladder gallbladder
Qi deficiency of the heart Internal disturbance of
6 Heart deficiency with timidity Internal disturbance of phlegm-heat
and gallbladder phlegm-heat
Qi deficiency of the heart and
7 Liver fire flaming upward Spleen-stomach disharmony Liver fire flaming upward
gallbladder
Heart deficiency with Overexertion and fatigue damage to
8 Spleen-stomach disharmony
timidity Qi
Effulgent Heart-liver fire/
Effulgent Heart-Liver fire/ Heart deficiency with timidity/
9 Stomach disharmony Liver fire flaming upward/ Heart deficiency with timidity
Liver fire flaming upward/
Liver yang flaming upward/ Stomach Qi disharmony
10 Stomach Qi disharmony Disturbance of Heart by Spleen-stomach disharmony
phlegm-heat
 72

Table 5. Sleep-related symptoms in the top 6 TCM syndrome diagnostic patterns for insomnia (Total N = 37).

Deficiency of Heart-kidney Qi deficiency of Liver-qi Hyperactivity of fire Internal

both the heart and noninteraction the heart and stagnation due to yin disturbance of
spleen gallbladder transforming deficiency phlegm-heat
into fire
心脾兩虛 心腎不交 心膽氣虛 肝鬱化火 陰虛火旺 痰熱內擾
Total no. of paper 35 10 7 19 24 13 108
Symptoms related to Insomnia Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total (%)
Daytime sleepiness 白天昏沉欲睡 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Difficulty falling asleep 入睡困難 1 (2.9) 0 (0.0) 0 (0.0) 1 (5.3) 1 (4.2) 0 (0.0) 3 ( 2.8 )
Difficulty falling asleep 不易入寐 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Difficulty falling asleep 不易入睡 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 4 ( 3.7 )
Difficulty falling asleep 難以入眠 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Difficulty falling asleep 難以入睡 1 (2.9) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Difficulty falling asleep 難寐 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Difficulty falling asleep 不能入眠 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Difficulty falling asleep 不能入睡 0 (0.0) 0 (0.0) 0 (0.0) 5 (26.3) 0 (0.0) 0 (0.0) 5 ( 4.6 )
Difficulty falling asleep alone 不能獨自安臥 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Dream-disturbed sleep 夢多 2 (5.7) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 3 ( 2.8 )
Dream-disturbed sleep 入寐多夢 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 2 ( 1.9 )
Dream-disturbed sleep 多夢 26 (74.3) 2 (20.0) 7 (100.0) 2 (10.5) 5 (20.8) 0 (0.0) 42 ( 38.9 )
Early awaking 早醒 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 4 ( 3.7 )
Easy awakening from sleep 易醒 26 (74.3) 1 (10.0) 1 (14.3) 1 (5.3) 4 (16.7) 0 (0.0) 33 ( 30.6 )
Easy awakening from sleep 稍寐即醒 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 4 (16.7) 0 (0.0) 4 ( 3.7 )
Easy awakening from sleep and
醒後不易再寐 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
difficulty falling asleep again
Easy awakening from sleep and
醒後再難入睡 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
difficulty falling asleep again
Frequent awakening with a start 易於驚醒 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Frequent awakening with a start 易驚醒 0 (0.0) 0 (0.0) 3 (42.9) 0 (0.0) 0 (0.0) 0 (0.0) 3 ( 2.8 )
Frequent awakening with a start 寐易驚醒 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Half asleep 朦朧不實 5 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5 ( 4.6 )
Half asleep and restless 朦朧不安 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Inability to sleep whole night 徹夜不眠 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Inability to sleep whole night 徹夜難寐 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
 73

Deficiency of Heart-kidney Qi deficiency of Liver-qi Hyperactivity of fire Internal

both the heart and noninteraction the heart and stagnation due to yin disturbance of
spleen gallbladder transforming deficiency phlegm-heat
into fire
Symptoms related to Insomnia Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Insomnia 不眠 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Insomnia 不寐 1 (2.9) 3 (30.0) 2 (28.6) 4 (21.1) 9 (37.5) 2 (15.4) 21 ( 19.4 )
Insomnia 失眠 5 (14.3) 1 (10.0) 2 (28.6) 5 (26.3) 5 (20.8) 1 (7.7) 19 ( 17.6 )
Insomnia 夜間失眠 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 1 (4.2) 1 (7.7) 3 ( 2.8 )
Late night difficulty falling asleep 夜來不易入寐 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Late night falling asleep 夜寐 0 (0.0) 0 (0.0) 2 (28.6) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Little sleep 少寐 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Nightmare 惡夢紛紜 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Restless sleep 心煩不寐 1 (2.9) 1 (10.0) 0 (0.0) 1 (5.3) 6 (25.0) 0 (0.0) 9 ( 8.3 )
Restless sleep 心煩失眠 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 1 (7.7) 2 ( 1.9 )
Restless sleep 虛煩不寐 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Restless sleep 睡眠不安 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 6 (46.2) 6 ( 5.6 )
Restless sleep 心煩難以入睡 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Restless sleep 夜寐不安 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 2 ( 1.9 )
Restless sleep 臥寐不安 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (7.7) 1 ( 0.9 )
Restless sleep 寐不得安 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Shallow sleep 夜寐短暫 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Shallow sleep 寐而不酣 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Shallow sleep 睡而不實 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Shallow sleep 睡眠不實 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (7.7) 1 ( 0.9 )
Sometimes shallow sleep 時寐時醒 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 3 ( 2.8 )
Sometimes shallow sleep 時寐醒 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Sometimes wakes up with a start 時易驚醒 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Tiredness after sleep 醒後困倦 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 4 ( 3.7 )
 74

Table 6. Non-sleep-related symptoms in the top 6 TCM syndrome diagnostic patterns for insomnia (Total N = 37).
Deficiency of Heart-kidney Qi deficiency of the Liver-qi Hyperactivity of Internal
both the heart noninteraction heart and stagnation fire due to yin disturbance of
and spleen gallbladder transforming into deficiency phlegm-heat
fire
心脾兩虛 心腎不交 心膽氣虛 肝鬱化火 陰虛火旺 痰熱內擾
Total no. of
35 10 7 19 24 13 108
paper
Symptoms related to Insomnia Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Abdomen distention after meals 食後腹脹 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 3 ( 2.8 )
Acid regurgitation 反酸 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (7.7) 1 ( 0.9 )
Acid regurgitation 吞酸 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 4 (16.7) 2 (15.4) 6 ( 5.6 )
Agitation 心情煩躁 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Agitation 煩躁 0 (0.0) 0 (0.0) 0 (0.0) 9 (47.4) 0 (0.0) 0 (0.0) 9 ( 8.3 )
Anguish in the heart 懊惱 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 6 (46.2) 6 ( 5.6 )
Anorexia 惡食 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (15.4) 2 ( 1.9 )
Anorexia 厭食 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (7.7) 1 ( 0.9 )
Belching 噯氣 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 3 (23.1) 5 ( 4.6 )
Bitter taste 口苦 0 (0.0) 0 (0.0) 0 (0.0) 16 (84.2) 3 (12.5) 12 (92.3) 31 ( 28.7 )
Blurred vision 目眩 15 (42.9) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 13 (100.0) 29 ( 26.9 )
Body weight loss 身體消瘦 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Constipation 大便秘結 0 (0.0) 0 (0.0) 0 (0.0) 4 (21.1) 0 (0.0) 0 (0.0) 4 ( 3.7 )
Constipation 大便結 0 (0.0) 0 (0.0) 0 (0.0) 2 (10.5) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Constipation 便秘 0 (0.0) 0 (0.0) 0 (0.0) 8 (42.1) 0 (0.0) 0 (0.0) 8 ( 7.4 )
Cowardly 怯弱 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Depression 抑鬱 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Discomfort in abdomen 腹中不舒 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (7.7) 1 ( 0.9 )
Distending pain of stomach 胃脘脹痛 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 2 ( 1.9 )
Distention of head 頭脹 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Dizziness 眩暈 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Dizziness 頭昏 3 (8.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 ( 2.8 )
Dizziness 頭暈 18 (51.4) 5 (50.0) 0 (0.0) 5 (26.3) 18 (75.0) 8 (61.5) 54 ( 50 )
Dizziness and headache 頭暈而痛 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Dizzy due to Meniere's disease 耳眩 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Dry mouth 口乾 1 (2.9) 2 (20.0) 0 (0.0) 1 (5.3) 17 (70.8) 0 (0.0) 21 ( 19.4 )
Dry stool 大便乾 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Dry stool 大便乾結 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (7.7) 1 ( 0.9 )
Dry throat 咽乾 0 (0.0) 1 (10.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 2 ( 1.9 )
 75
Deficiency of Heart-kidney Qi deficiency of the Liver-qi Hyperactivity of Internal
both the heart noninteraction heart and stagnation fire due to yin disturbance of
and spleen gallbladder transforming into deficiency phlegm-heat
fire
Symptoms related to Insomnia Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Dry throat 咽燥 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 4 (16.7) 0 (0.0) 5 ( 4.6 )
Easy sweating 易汗出 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Easy sweating 容易出汗 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Easy to get flu 易感冒 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Easy to Sighing 善太息 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Emission of semen 遺精 1 (2.9) 3 (30.0) 0 (0.0) 0 (0.0) 3 (12.5) 0 (0.0) 7 ( 6.5 )
Emission of semen during dreaming 夢遺 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 5 (20.8) 0 (0.0) 6 ( 5.6 )
Emission of semen during dreaming and
夢遺滑泄 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
spermatorrhea
Encumbering lower limbs 腿困 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Fatigue of muscles 肌肉酸痛 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Fatigue of the limbs 四肢困倦 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Fatigue of the limbs 四肢倦怠 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Fatigue of the limbs 肢倦 5 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5 ( 4.6 )
Favour in cold drink 喜飲冷 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 2 ( 1.9 )
Favour in drink a lot 喜飲 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Favour in sighing 喜歎息 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Feeling cold of the limbs 四肢發涼 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Fever 發熱 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 2 ( 1.9 )
Feverish sensations in the palms, soles and chest 手足心發熱 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Feverish sensations in the palms, soles and chest 手足心熱 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 6 (25.0) 0 (0.0) 6 ( 5.6 )
Feverish sensations in the palms, soles and chest 五心煩熱 1 (2.9) 4 (40.0) 0 (0.0) 0 (0.0) 11 (45.8) 0 (0.0) 16 ( 14.8 )
Flusteredness 心慌 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Fright palpitation 驚悸 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Headache 頭痛 0 (0.0) 0 (0.0) 0 (0.0) 8 (42.1) 0 (0.0) 2 (15.4) 10 ( 9.3 )
Heat in the heart 心熱 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Heavy sensation in the head 頭沉 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Heavy sensation in the head 頭重 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 4 (30.8) 4 ( 3.7 )
Hydrostomia 流涎 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Hypochondriac distension 兩脇肋脹痛 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Hypochondriac distension 兩脇脹痛 0 (0.0) 0 (0.0) 0 (0.0) 2 (10.5) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Hypochondriac pain 脇痛 0 (0.0) 0 (0.0) 0 (0.0) 6 (31.6) 2 (8.3) 0 (0.0) 8 ( 7.4 )
Idle for words 懶言 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
 76

Deficiency of Heart-kidney Qi deficiency of the Liver-qi Hyperactivity of Internal

both the heart noninteraction heart and stagnation fire due to yin disturbance of
and spleen gallbladder transforming into deficiency phlegm-heat
fire
Symptoms related to Insomnia Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Impatience 性急 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Impatience 性情急躁 0 (0.0) 1 (10.0) 0 (0.0) 4 (21.1) 0 (0.0) 0 (0.0) 5 ( 4.6 )
Impatience 急躁 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Irritability 易怒 0 (0.0) 1 (10.0) 0 (0.0) 16 (84.2) 0 (0.0) 0 (0.0) 17 ( 15.7 )
Irritability 易激怒 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Lack of strength 少力 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Lack of strength 乏力 12 (34.4) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 12 ( 11.1 )
Lack of strength 無力 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Lassitude of spirit 神疲 25 (71.4) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 26 ( 24.1 )
Lassitude of spirit 精神疲憊 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Lassitude of spirit 精神萎靡 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Less intake 食少 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Less intake 納少 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Less intake 納食減少 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Little saliva 唾液少 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Lower of sporting ability 運動能力下降 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Lumbago 腰痛 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Lusterless complexion 面色不華 3 (8.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 ( 2.8 )
Lusterless complexion 面色無華 5 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5 ( 4.6 )
Lusterless complexion 顏面無華 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Menstrual irregularities 月經不調 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 4 ( 3.7 )
Menstruation at irregular intervals 月經紊亂 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Nauseating 噁心 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (15.4) 2 ( 1.9 )
Night sweating 盜汗 0 (0.0) 3 (30.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 4 ( 3.7 )
Oppression in the chest 胸悶 0 (0.0) 0 (0.0) 0 (0.0) 4 (21.1) 0 (0.0) 8 (61.5) 12 ( 11.1 )
Oppression in the chest 胸膈滿悶 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 1 (7.7) 2 ( 1.9 )
Oppression in the chest and stuffiness in the
胸悶脘痞 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (15.4) 2 ( 1.9 )
stomach
Pain in sinews, bones, joints 筋骨關節疼痛 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Pain in the chest and hypochondrium 胸脅痛 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Pain in the chest and hypochondrium 胸脇疼痛不適 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Pale white complexion 面色蒼白 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Palpitation 心悸 29 (82.9) 3 (30.0) 7 (100.0) 0 (0.0) 9 (37.5) 0 (0.0) 48 ( 44.4 )
 77
Deficiency of Heart-kidney Qi deficiency of the Liver-qi Hyperactivity of Internal
both the heart noninteraction heart and stagnation fire due to yin disturbance of
and spleen gallbladder transforming into deficiency phlegm-heat
fire
Symptoms related to Insomnia Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Palpitation and restless 心悸不安 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 10 (41.7) 0 (0.0) 11 ( 10.2 )
Poor appetite 不思飲食 0 (0.0) 0 (0.0) 0 (0.0) 4 (21.1) 0 (0.0) 0 (0.0) 4 ( 3.7 )
Poor appetite 納差 3 (8.6) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 5 ( 4.6 )
Poor memory 健忘 26 (74.3) 1 (10.0) 0 (0.0) 0 (0.0) 19 (79.2) 0 (0.0) 46 ( 42.6 )
Profuse sputum 痰多 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 10 (76.9) 10 ( 9.3 )
Prolonged and clear urine 小便清長 0 (0.0) 0 (0.0) 3 (42.9) 0 (0.0) 0 (0.0) 0 (0.0) 3 ( 2.8 )
Red face 面赤 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Red face 面紅 0 (0.0) 1 (10.0) 0 (0.0) 5 (26.3) 0 (0.0) 0 (0.0) 6 ( 5.6 )
Red zygomatic 顴紅 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 (12.5) 0 (0.0) 3 ( 2.8 )
Reddish and yellow urine 小便黃赤 0 (0.0) 0 (0.0) 0 (0.0) 2 (10.5) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Reddish eyes 目赤 0 (0.0) 1 (10.0) 0 (0.0) 13 (68.4) 0 (0.0) 0 (0.0) 14 ( 13 )
Reddish urine 小便赤 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Reddish urine 尿赤 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Reddish urine 溲赤 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Reduction in luster complexion 面色少華 13 (37.1) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 14 ( 13 )
Restless of sit and lie down 坐臥不安 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Restlessness 心煩 0 (0.0) 2 (20.0) 0 (0.0) 7 (36.8) 12 (50.0) 13 (100.0) 34 ( 31.5 )
Restlessness 多煩 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Restlessness of deficiency type 虛煩 0 (0.0) 2 (20.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 3 ( 2.8 )
Sallow complexion 面色萎黃 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Sallow lusterless complexion 面黃無華 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Scant fluid 少津 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5 (20.8) 0 (0.0) 5 ( 4.6 )
Scant fluid 津少 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 5 (20.8) 0 (0.0) 6 ( 5.6 )
Scant fluid in mouth 口中津少 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Shortened and little urine 小便短小 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (7.7) 1 ( 0.9 )
Shortness of breath 氣短 2 (5.7) 0 (0.0) 4 (57.1) 0 (0.0) 0 (0.0) 0 (0.0) 6 ( 5.6 )
Sloppy stool 大便稀溏 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Sloppy stool 大便溏稀 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Sloppy stool 便溏 3 (8.6) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 ( 2.8 )
Sore in mouth and tongue 口舌生瘡 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 2 ( 1.9 )
Sore lower limbs 腿軟 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Sore waist 腰酸 0 (0.0) 4 (40.0) 0 (0.0) 0 (0.0) 9 (37.5) 0 (0.0) 13 ( 12 )
Sore waist 腰酸 0 (0.0) 4 (40.0) 0 (0.0) 0 (0.0) 9 (37.5) 0 (0.0) 13 ( 12 )
 78

Deficiency of Heart-kidney Qi deficiency of the Liver-qi Hyperactivity of Internal

both the heart noninteraction heart and stagnation fire due to yin disturbance of
and spleen gallbladder transforming into deficiency phlegm-heat
fire
Symptoms related to Insomnia Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Sore waist and knee 腰膝酸軟 1 (2.9) 2 (20.0) 0 (0.0) 1 (5.3) 4 (16.7) 0 (0.0) 8 ( 7.4 )
Spermatorrhea 滑精 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Spirit failing to keep to its abode 神不守舍 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Stuffiness and oppression in the chest and
胸脘痞悶 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 (15.4) 2 ( 1.9 )
stomach
Stuffiness in the stomach 脘痞 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 4 (30.8) 6 ( 5.6 )
Susceptibility to fright 易驚 0 (0.0) 1 (10.0) 1 (14.3) 0 (0.0) 1 (4.2) 0 (0.0) 3 ( 2.8 )
Susceptibility to fright 善驚 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Susceptibility to fright 遇事易驚 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Susceptibility to fright 遇事善驚 0 (0.0) 0 (0.0) 4 (57.1) 0 (0.0) 0 (0.0) 0 (0.0) 4 ( 3.7 )
Sweating 出汗 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 3 ( 2.8 )
Sweating 汗出 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 2 (8.3) 0 (0.0) 3 ( 2.8 )
Tasteless 乏味 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Tasteless 食納無味 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Tasteless 納食無味 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Tasteless 納穀無味 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Tasteless 飲食乏味 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Tasteless 飲食無味 5 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 5 ( 4.6 )
Thirsty 口渴 0 (0.0) 0 (0.0) 0 (0.0) 5 (26.3) 0 (0.0) 0 (0.0) 5 ( 4.6 )
Thirsty and drink a lot 口渴喜飲 0 (0.0) 0 (0.0) 0 (0.0) 2 (10.5) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Thoughtful 多慮 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Tidal fever 潮熱 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 3 (12.5) 0 (0.0) 4 ( 3.7 )
Timidity 膽怯 0 (0.0) 1 (10.0) 6 (85.7) 0 (0.0) 0 (0.0) 0 (0.0) 7 ( 6.5 )
Tinnitus 耳鳴 1 (2.9) 6 (60.0) 0 (0.0) 4 (21.1) 20 (83.3) 0 (0.0) 31 ( 28.7 )
Tired and loss of strength 倦怠無力 0 (0.0) 0 (0.0) 1 (14.3) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Tiredness 體倦 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 3 ( 2.8 )
Tiredness 倦怠 2 (5.7) 0 (0.0) 4 (57.1) 0 (0.0) 0 (0.0) 0 (0.0) 6 ( 5.6 )
Tiredness 疲乏 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Torpid intake 納呆 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Weak 體虛 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
White complexion 面色白 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Yellow urine 小便黃 0 (0.0) 0 (0.0) 0 (0.0) 4 (21.1) 0 (0.0) 0 (0.0) 4 ( 3.7 )
Yellow urine 尿黃 0 (0.0) 0 (0.0) 0 (0.0) 6 (31.6) 0 (0.0) 0 (0.0) 6 ( 5.6 )
 79

Table 7. Tongue features in the top 6 TCM syndrome diagnostic patterns for insomnia. (Total N = 37)
Deficiency of Heart-kidney Qi deficiency Liver-qi Hyperactivity Internal
both the heart noninteraction of the heart stagnation of fire due to disturbance of
and spleen and transforming yin deficiency phlegm-heat
gallbladder into fire
心脾兩虛 心腎不交 心膽氣虛 肝鬱化火 陰虛火旺 痰熱內擾
Total no. of paper 35 10 7 19 24 13 108
Tongue Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Pale Tongue 舌淡 28 (80.0) 1 (10.0) 7 (100.0) 0 (0.0) 1 (4.2) 0 (0.0) 37 ( 34.3 )
Pale Tongue 舌質淡 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Plump tongue 舌胖 2 (5.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Plump tongue 舌體胖 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 2 ( 1.9 )
Red tip Tongue 舌尖紅 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 2 ( 1.9 )
Red tip Tongue 舌尖紅赤 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
Red Tongue 舌紅 1 (2.9) 5 (50.0) 0 (0.0) 13 (68.4) 14 (58.3) 7 (53.8) 40 ( 37 )
Red Tongue 舌質紅 0 (0.0) 2 (20.0) 0 (0.0) 4 (21.1) 6 (25.0) 2 (15.4) 14 ( 13 )
Scanty Coating 苔少 0 (0.0) 1 (10.0) 0 (0.0) 0 (0.0) 4 (16.7) 0 (0.0) 5 ( 4.6 )
Scanty Coating 少苔 0 (0.0) 2 (20.0) 0 (0.0) 1 (5.3) 4 (16.7) 0 (0.0) 7 ( 6.5 )
Slimy Coating 苔膩 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 (12.5) 12 (92.3) 15 ( 13.9 )
Teeth-printed tongue 有齒印 1 (2.9) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 ( 0.9 )
Thin Coating 苔薄 23 (65.7) 2 (20.0) 1 (14.3) 1 (5.3) 2 (8.3) 0 (0.0) 29 ( 26.9 )
Thin tongue 舌薄 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
White Coating 苔白 8 (22.9) 0 (0.0) 0 (0.0) 0 (0.0) 3 (12.5) 0 (0.0) 11 ( 10.2 )
Yellow Coating 苔黃 0 (0.0) 1 (10.0) 0 (0.0) 16 (84.2) 3 (12.5) 12 (92.3) 32 ( 29.6 )
Dry Coating 苔燥 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 1 (4.2) 0 (0.0) 2 ( 1.9 )
No Coating 無苔 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 1 ( 0.9 )
 80

Table 8. Pulse features in the top 6 TCM syndrome diagnostic patterns for insomnia. (Total no. of paper = 37)
Deficiency of Heart-kidney Qi deficiency Liver-qi Hyperactivity Internal
both the heart noninteraction of the heart stagnation of fire due to disturbance of
and spleen and transforming yin deficiency phlegm-heat
gallbladder into fire
心脾兩虛 心腎不交 心膽氣虛 肝鬱化火 陰虛火旺 痰熱內擾
Total no. of paper 35 10 7 19 24 13 108
Pulse Chinese Name N (%) N (%) N (%) N (%) N (%) N (%) Total
Deep pulse 脈沉 1 (2.9) 0 (0.0) 0 (0.0) 1 (5.3) 0 (0.0) 0 (0.0) 2 ( 1.9 )
Thready pulse 脈細 30 (85.7) 10 (100.0) 7 (100.0) 3 (15.8) 21 (87.5) 1 (7.7) 72 ( 66.7 )
Rapid pulse 脈數 1 (2.9) 7 (70.0) 0 (0.0) 18 (94.7) 20 (83.3) 11 (84.6) 57 ( 52.8 )
Slippery pulse 脈滑 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 3 (12.5) 13 (100.0) 16 ( 14.8 )
Wiry pulse 脈弦 1 (2.9) 1 (10.0) 6 (85.7) 17 (89.5) 2 (8.3) 0 (0.0) 27 ( 25 )
Swift Pulse 脈速 0 (0.0) 0 (0.0) 0 (0.0) 1 (5.3) 1 (4.2) 1 (7.7) 3 ( 2.8 )
Weak pulse 脈弱 29 (82.9) 1 (10.0) 0 (0.0) 0 (0.0) 1 (4.2) 0 (0.0) 31 ( 28.7 )
 81
Table 9. The TCM syndrome diagnostic patterns adopted by the textbook Traditional Chinese
Internal Medicine recommended by the Ministry of Health of China for TCM classification of
insomnia.
TCM syndrome Common sleep
Common clinical symptoms and signs Tongue Pulse
diagnostic pattern problems
Excess
Irritability, thirst with desire to drink water,
Sleeplessness and Red tongue Wiry and
Liver-qi stagnation hypochondriac distension, a poor appetite, a
dream-disturbed with a yellow rapid
transforming into fire red face, a bitter taste in the month,
sleep coating. pulse.
constipation, bloody urine.
Profuse sputum, chest stuffiness, nausea, Red tongue
Slippery
Internal disturbance of belching, restlessness, a bitter tasted in the with a yellow
Sleeplessness and rapid
phlegm-heat mouth, blurred vision, a heavy sensation in and greasy
pulse.
the head. coating.
Deficiency
Pale tongue
Palpitation, poor memory, dizziness, blurred Thready
Deficiency of both Dream-disturbed with a thin
vision, weakness of the limbs, lassitude, a and weak
the heart and spleen sleep and white
poor appetite, a lusterless complexion. pulse.
coating.
Palpitation, uneasiness, dizziness, tinnitus,
poor memory, soreness and weakness in the Red tongue Thready
Hyperactivity of fire Restlessness,
lumbar region and knee joints, feverish with a scanty and rapid
due to yin deficiency sleeplessness
sensations in the palms, soles and chest, a coating. pulse.
dry mouth.
Sleeplessness,
dream-disturbed Timidity, palpitation, susceptibility to Wiry and
Qi deficiency of the
sleep, Frequent fright, shortness of breath, lassitude, clear Pale tongue thready
heart and gallbladder
awakening with a and profuse urine. pulse.
start
 82
Table 10. The top 6 TCM syndrome diagnostic patterns found in this review.
TCM syndrome Common sleep
Common clinical symptoms and signs Tongue Pulse
diagnostic pattern problems
Excess
Irritability, bitter taste, constipation, reddish
Liver-qi Difficulty falling
eyes, yellow urine, agitation, hypochondriac Red tongue
stagnation asleep, Wiry and
distension, headache, thirst, restlessness, with yellow
transforming into dream-disturbed rapid pulse
dizziness, impatience, red face, poor coating.
fire sleep
appetite, oppression in the chest, tinnitus.
Restlessness, blurred vision, oppression in
Red tongue
Internal the chest, profuse sputum, bitter taste,
with yellow Slippery and
disturbance of Restless sleep dizziness, stuffiness in the stomach, anguish
and slimy rapid pulse
phlegm-heat in the heart, heavy sensation in the head,
coating.
acid regurgitation, anorexia, belching.
Deficiency
Palpitation, lassitude, poor memory,
Easy awakening Pale tongue
Deficiency of reduction in luster complexion or lusterless
from sleep and with thin and Thready and
both the heart complexion, dizziness, blurred vision, lack
dream-disturbed white weak pulse
and spleen of strength, tasteless and fatigue of the
sleep coating.
limbs.
Restless sleep, easy Tinnitus, poor memory, palpitation,
awakening from dizziness, dry mouth, sore waist,
Hyperactivity of Red tongue
sleep, restlessness, feverish sensations in the Thready and
fire due to yin with scanty
dream-disturbed palms, soles and chest, scant fluid, emission rapid pulse
deficiency coating.
sleep, sometimes of semen during dreaming, acid
shallow sleep regurgitation, dry throat, sweating.
Dream-disturbed
Qi deficiency of Palpitation, susceptibility to fright, timidity,
sleep, Frequent Thready and
the heart and shortness of breath, tiredness, prolonged and Pale tongue
awakening with a wiry pulse
gallbladder clear urine.
start
Restless sleep, Tinnitus, dizziness, feverish sensations in
Heart-kidney Thready and
dream-disturbed the palms, soles and chest, palpitation, night Red tongue
noninteraction rapid pulse
sleep sweating, emission of semen, restlessness.
 83

Appendix A: Data Extraction Form

Research ID:
Title:
Authors:
Journal:
Year/ Volume/ Pages:
Language:
Does it fall into our exclusion criteria?
Should this study be Not related to insomnia
included in our Not related to TCM
research? Duplicate article
Discussion paper
Magazine article
Focus on elderly or childhood
Focus on one gender only
Specific medical & psychiatric condition
Particular development or life transition period
Focus on a specific TCM diagnostic pattern
Study cases less than 30
Without TCM diagnostic pattern
No specific number of cases
Type of study Randomized controlled studies
Controlled non-randomized study
Case studies
Uncontrolled trials
Epidemiological study
Cross-sectional studies
Cohort studies
Case-control studies
Other/ Specify:
Intervention
Number of cases Total
Woman
Man
% Female
Age Range: Mean:
Duration of insomnia (Range)
Impact Factor
Diagnostic criteria for insomnia used / Book for inclusion:
Inclusion Criteria of List additional inclusion criteria here:
the article i)
ii)
iii)
Exclusion Criteria of List additional exclusion criteria here:
the article i)
ii)
iii)
Study Setting Sleep Disorders Center/ Clinic
Medical Center
Nursing Home
Mental Health Center
Private Medical Clinic
University Psychology Clinic
Other/specify: Not specify
Types of Subjects Inpatients
Outpatients
Long-Term Care
Research Volunteers
Other/specify: Not specify
 84
Sample Selection Check the method(s) used in the column to the right
Randomly selected community sample (e.g. random digit dialing method)
Series of consecutive clinic patients
Prospectively selected clinic patients (not necessary all consecutive)
Physician (or other health provider) Referrals
Archival data such as a clinic data base
Solicited research volunteers
Diagnosis of insomnia Polysomnography
disorder Pittsburgh Sleep Quality Index (PSQI)
Spiegel Sleep Questionnaire
Actigraphy
Sleep Logs
MSLT Latencies
Other/specify:
Measures not specify in the article
Symptoms of TCM TCM No. of patient Sleep related Other Tongue Pulse
Diagnostic patterns diagnostic symptoms complaints
(List all Symptoms and pattern
all TCM Diagnostic
pattern mentioned in
the article)

In a few sentences,
please provide a brief
narrative summary of
the study findings here.

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