International Clinical Practice Guideline of Chinese Medicine Anxiety

Foreword Patent issues may be existed in this guideline, and the World Federation of Chinese Medicine Societies (WFCMS) declared that they are not responsible for identifying these patents. International Clinical Practice Guideline of Chinese Medicine-Anxiety is based on the Guidelines for Diagnosis and Treatment of Common Internal Diseases in Chinese Medicine-Anxiety (Standard No. ZYYXH/T 132-2008) published by the China Association of Chinese Medicine in 2008. Combined with clinical study evidence at home and abroad in recent years, as well as evidence grading and opinion recommendation, after expert discussion, this guideline was formed. The main drafting committee of this guideline: The Third Affiliated Hospital of Beijing University of Chinese Medicine. The drafting committee of this guideline: Xuanwu Hospital of Capital Medical University, American Institute of Health in Traditional Chinese Medicine, College and Association of Acupuncturists of Alberta Canada, Kumamoto Kampo Institute of Japan, Queen Mary University of London, et al. The main drafters of this guideline: Qi-Sheng Tang, Miao Qu, Wen-Jun Sun. The drafters and review experts of this guideline: Chang-Qing Yang, Wang-Lin Boxin, Ji-En Zhao, Ping Wang, et al. Based on the previous version, this guideline structurally adds a foreword, introduction, scope, normative references, terms and definitions, and the corresponding content of the English version; in terms of content, it updates the diagnostic criteria of Western medicine and the diagnostic criteria of Chinese medicine and adds evidence grading and level recommendation for the intervention programs. This guideline is drafted according to the Measures of International Standard of WFCMS and Guideline Setting and Publishing Work Norms (SCM 0001-2009) by WFCMS. This guideline is published by the WFCMS. All rights are reserved. INTRODUCTION At present, there is still a lack of international standards and guidelines for prevention and treatment of anxiety in Chinese medicine, which makes the study on the treatment of anxiety in Chinese medicine lack of international influence and lack of unity and recognition. Therefore, based on the previous version, this guideline intends to integrate and absorb the study results and successful experience of the prevention and treatment of anxiety in Chinese medicine at home and abroad and draw on the evidence-based medicine method to grade and recommend modern clinical study literature and ancient documents on anxiety, so as to draft a clinical practice guideline of Chinese medicine in the prevention and treatment of anxiety. This guideline plays an important role in normalizing the use of Chinese medicine methods and improving clinical efficacy in treating anxiety. Literature retrieval, a Delphi method questionnaire survey, expert interviews, and conference discussion were used for formulation of this guideline. At first, a guideline drafting group was set up to form a list of initial issues, draft key issues, and outcomes in the participants, interventions, comparisons, and outcomes format, and develop a work plan. Retrieval strategies were based on the key issues and outcomes, and the literature retrieval covered Chinese literature (including modern literature and ancient documents), English literature, and existing relevant international guidelines. According to the grading suggestion of traditional medical evidence and the grading suggestion of the ancient document evidence on Chinese medicine, quality evaluation and evidence grading of the literature were carried out. The Delphi method was used to obtain clinical experts’ consensus on the guideline, and the final guideline was formed after the expert discussion. This guideline mainly provides the prevention, healthcare, diagnosis, and treatment recommendations of Chinese medicine for anxiety. It recommends the diagnosis and treatment of anxiety in Chinese medicine with evidence-based medical evidence; guides standard use of Chinese medicine and clinical practice for clinicians, nurses, and patients; and improves awareness of patients and their families about prevention and treatment knowledge of anxiety in Chinese medicine. INTERNATIONAL CLINICAL PRACTICE GUIDELINE OF CHINESE MEDICINE ANXIETY 1. Scope This guideline specifies terms and definitions, clinical manifestations, syndrome differentiation, medication, and other therapies for anxiety. This guideline is applicable to the prevention and treatment of Chinese medicine for anxiety such as generalized anxiety and panic disorder. It applies to neurologists, psychiatrists, Chinese medicine practitioners, nurses, and patients as a reference. 2. Normative references Contents of the following reference documents constitute indispensable clauses of this guideline through normative citing. For dated reference documents, only the dated version applies. For undated reference documents, the latest version (including any amendments) applies. ZYYXH/T 132-2008, Guidelines for Diagnosis and Treatment of Common Internal Diseases in Chinese Medicine – Anxiety World Health Organization. ICD-10 Classification of Mental and Behavioural Disorders Diagnostic Criteria for Research. Geneva: World Health Organization: 1993 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington: American Psychiatric Association; 2013. 3. Terms and definitions The following terms and definitions apply for this guideline. 3.1. Anxiety Anxiety is characterized by extensive and persistent anxiety or recurrent episodes of panic disorder, often accompanied by autonomic disorders and motor disorders. Note 1: Clinically, it is divided into two main forms – generalized anxiety and panic disorder. Note 2: According to clinical manifestations and characteristics, the disease can be attributed to the category of mental diseases. Anxiety is equivalent to “depression,” “fright palpitation,” “severe palpitation,” “insomnia,” “amnesia,” “lily disease,” “kidney amassment,” and “lantern disease” in Chinese medicine. 4. Clinical manifestations 4.1 Generalized anxiety 4.1.1 Psychogenic anxiety Psychogenic anxiety is the core symptom of anxiety. It is characterized by fear and nervousness without clear objects and specific content or excessive worry or annoyance about certain problems in real life. The patient knows that this is a subjective concern, but it cannot be controlled. 4.1.2 Somatic anxiety Somatic anxiety is mainly the manifestation of autonomic nerve hyperactivity. Its symptoms involve multiple systems, which is often the initial chief complaint of the patient, such as dry mouth, upper abdominal discomfort, nausea, swallowing obstruction, borborygmus, abdominal pain, abdominal distension, diarrhea, dyspnea or tachypnea, dizziness, palpitation, chest discomfort, tachycardia, frequent urination, urgent urination, impotence, premature ejaculation, sexual hypoactivity, irregular menstruation, excessive sweating, and facial flushing or paleness. 4.1.3 Psychological alertness It can be characterized by irritability, decreased concentration, and sensitivity to noise. Because of the inability to concentrate, the patient is often accompanied by memory loss. 4.1.4 Motor restlessness Motor restlessness is related to muscle tension. It can manifest as restlessness, trembling, inability to relax, as well as pain in the head (usually bilateral, with forehead or occiput), shoulders, and back. 4.1.5 Sleep disorder It manifests as difficult to fall asleep and easy to wake up after falling asleep. The patient often complains of nightmares and night terrors, which appear to wake up suddenly and often feel extreme fear. 4.2 Panic disorder 4.2.1 Typical manifestations of attack Often, the patient suddenly has a strong fear in his/her daily activities, as if he/she is about to die (a sense of death) or is about to lose his/her sense of reason (out of control), making the patient intolerable. At the same time, the patient feels palpitation, chest tightness, chest pain, shortness of breath, and a choking sensation in the throat, so he/she screams, calls for help, or runs out of the room. Some are accompanied by significant autonomic symptoms such as hyperventilation, dizziness, excessive sweating, facial flushing or paleness, tremors, numbness of hands and feet, and gastrointestinal discomfort, as well as painful experiences, such as depersonalization and derealization. 4.2.2 Panic attack characteristics The attack is not limited to any particular situation or a certain type of environment. It is a sudden attack that peaks within 10 min, generally no more than 1 h. Consciousness is clear at the time of the attack, and the course of attack can be recalled afterward. Although this attack lasts for a short time, soon it can be repeated again. Anticipatory anxiety: Most patients are nervous during the intermittent period due to fear of recurrence, and some symptoms of autonomic nerve hyperactivity may occur Help-seeking and avoidance behavior: The strong fear during a panic attack makes the patient intolerable and often urges help. During the intermittent period, most patients are worried about not getting help during an attack. Therefore, they voluntarily avoid some activities, such as not wanting to go out alone, not wanting to go to a crowded place, or not traveling by bus. They need to be accompanied when they go out. 4.3 Physical–chemical examination So far, no specific physical and chemical indicators have been found for anxiety. Clinically, anxiety assessment scales are used to evaluate the severity of anxiety, including the self-rating scale and examiner-rating scale, such as Zung Self-Rating Anxiety Scale, Hamilton Anxiety Scale, and Generalized Anxiety Disorder Scale. 5. Syndrome differentiation 5.1 Syndrome of liver depression transforming into fire Restlessness, depression and dysphoria, chest and hypochondriac distending pain, oppression in stomach with belching, no appetite, irregular stool, impatience and irritability, bitter taste in mouth, dry mouth, headache, red eyes, tinnitus, gastric upset and acid regurgitation, constipation, red tongue, yellow coating, stringy pulse or stringy and rapid pulse. 5.2 Syndrome of internal blockade of static blood Palpitation or severe palpitation, restless sleep at night, insomnia, excessive suspicion and dysphoria, chest tightness, headache and stabbing pain in the chest from time to time, dark red tongue with ecchymosis on the edge or petechiae on the surface, dark purple lips or dark eyes, hesitant pulse or stringy and tight pulse. 5.3 Syndrome of phlegm-fire disturbing heart Panic and restless, upset and distraction, irritability and excessive talk, fright during sleeping, dizzy and headache, bitter taste in mouth, dry mouth, red tongue with yellow and greasy coating, slippery and rapid pulse. 5.4 Syndrome of deficiency of both heart and spleen Palpitation and dizziness, fear and fright, insomnia and dreaminess, lusterless complexion, fatigue, lack of appetite, pale tongue, thin coating, thready and weak pulse. 5.5 Syndrome of qi deficiency of heart and gallbladder Palpitation and timidity, fear and fright, trance, restlessness, fidget, insomnia and dreaminess, excessive suspicion and consideration, pale tongue, thin and white fur or normal coating, deep pulse or feeble and stringy pulse. 5.6 Syndrome of disharmony between heart and kidney Depressed mood, sentimentality, dysphoria and insomnia, palpitation and restlessness, amnesia, dizziness and tinnitus, soreness and weakness of the waist and knees, feverishness in palms and soles, dry mouth with less fluid, or night sweating, red tongue, thin coating, thready pulse or thready and rapid pulse. 5.7 Syndrome of kidney deficiency and liver depression Depressed mood, lassitude and fatigue, lags in response, dysphoria and irritability, soreness and weakness of waist and knees, shortness of breath and chest oppression, frequent signing, amnesia, insomnia and dreaminess, pale or dark tongue, white coating, deep and thready pulse, or deep and stringy pulse. 6. Medication 6.1 Basic therapeutic principles This disease belongs to radical deficiency and symptomatic excess, which is a syndrome of intermingled deficiency and excess. The radical deficiency is mainly deficiency of kidney essence, deficiency of both heart and spleen, and qi deficiency of heart and gallbladder. The symptomatic excess is mainly liver depression and qi stagnation, turbid phlegm, and blood stasis. It is necessary to pay attention to distinguishing yin, yang, deficiency, and excess and to keep an eye on the law of taking both deficiency and excess into account. Excess syndromes need to be treated by regulating qi and resolving stagnation or accompanied by activating blood circulation, clearing heat, dissipating phlegm, and eliminating dampness; deficiency syndromes need to be treated by nourishing heart, invigorating spleen, nourishing liver, and supplementing kidney. 6.2 Syndrome of liver depression transforming into fire Therapeutic methods Clearing liver fire, as well as regulating qi and facilitating the middle. Prescription Modified Danzhi Xiaoyao Power (Evidence level: I; highly recommend). Danpi (Cortex Moutan Radicis) 15 g, Zhizi (Fructus Gardeniae) 15 g, Shengdi (Radix Rehmanniae Recens) 15 g, Huangqin (Radix Scutellariae) 10 g, Chaihu (Radix Bupleuri) 12 g, Xiangfu (Rhizoma Cyperi) 12 g, Zhiqiao (Fructus Aurantii) 10 g, Chenpi (Pericarpium Citri Reticulatae) 10 g, Chuanxiong (Rhizoma Ligustici Chuanxiong) 15 g, Baishao (Radix Paeoniae Alba) 12 g, Fuling (Poria) 20 g, Baizhu (Rhizoma Atractylodis Macrocephalae) 15 g, Danggui (Radix Angelicae Sinensis) 12 g, and Zhigancao (Radix Glycyrrhizae Preparata) 6 g are included. Modified If combined with severe thermal potential, bitter taste in mouth, and constipation, Longdancao (Radix Gentianae) 9 g and Dahuang (Radix et Rhizoma Rhei, decocted later) 6 g are added for purging heat and catharsis. If combined with liver fire invading stomach, hypochondriac pain, bitter taste in mouth, gastric upset and acid regurgitation, as well as belching and vomiting, Huanglian (Rhizoma Coptidis) 6 g and Wuzhuyu (Fructus Evodiae) 9 g are added. If combined with liver fire flaring up, headache, red eyes, and tinnitus, Juhua (Flos Chrysanthemi) 10 g, Gouteng (Ramulus Uncariae Cum Uncis, decocted later) 10 g, and Cijili (Fructus Tribuli) 12 g are added. 6.3 Syndrome of internal blockade of static blood Therapeutic methods Activating blood circulation and resolving stasis, as well as regulating qi and dredging collaterals. Prescription Modified Xuefu Zhuyu Decoction (Evidence level: I; highly recommend). Taoren (Semen Persicae) 12 g, Honghua (Flos Carthami) 9 g, Danggui (Radix Angelicae Sinensis) 10 g, Shengdi (Radix Rehmanniae Recens) 15 g, Chuanxiong (Rhizoma Ligustici Chuanxiong) 5 g, Chishao (Radix Paeoniae Rubra) 15 g, Niuxi (Radix Achyranthis Bidentatae) 10 g, Jiegeng (Radix Platycodonis) 5 g, Chaihu (Radix Bupleuri) 3 g, Zhiqiao (Fructus Aurantii) 6 g, Gancao (Radix Glycyrrhizae) 3 g, Dangshen (Radix Salviae Miltiorrhizae) 30 g, Shenglongchi (Dens Draconis) 30 g, and Hupofen (Succinum) 6 g are included. Modified If combined with a cool sensation outside the body, hidrosis, and aversion to wind, Fangfeng (Radix Saposhnikoviae) 10 g, Maidong (Radix Ophiopogonis) 10 g, Wuweizi (Fructus Schisandrae Chinensis) 10 g, and Yuanshen (Radix Scrophulariae) 20 g are added. If combined with obvious distending pain, Xiangfu (Rhizoma Cyperi) 12 g, Qingpi (Pericarpium Citri Reticulatae Viride) 9 g, and Yujin (Radix Curcumae) 12 g are added. If combined with poor and stomach distension, and 12 g of and Chenpi (Pericarpium Citri Reticulatae) 10 g are added. If combined with manifestations, (Radix 9 g and (Radix 12 g are added. If combined with heat manifestations, Danpi (Cortex Moutan Radicis) 10 g and Zhizi (Fructus Gardeniae) 12 g are added. Syndrome of phlegm-fire disturbing heart Therapeutic methods Clearing heat and clearing phlegm, as well as heart for Prescription Modified Huanglian Decoction (Evidence level: I; highly recommend). Huanglian (Rhizoma Coptidis) 10 g, (Rhizoma 15 g, Chenpi (Pericarpium Citri Reticulatae) 6 g, Fuling (Poria) 15 g, Zhigancao (Radix Glycyrrhizae Preparata) 6 g, (Rhizoma Cum 10 g, (Fructus 10 g, in 10 g, (Fructus 10 (Semen 15 g, (Radix 10 g, (Fructus 10 g, Longdancao (Radix Gentianae) 10 g, Shenglongchi (Dens decocted 15 g and decocted 30 g are included. Modified If combined with excess fire and dysphoria, Huanglian (Rhizoma Coptidis) 15 g can be added to clearing fire and If combined with 20 g and (Rhizoma 30 g are added. If heat to both qi and yin, Wuweizi (Fructus Schisandrae Chinensis) 10 g and (Rhizoma 10 g are added. Syndrome of deficiency of both heart and spleen Therapeutic methods blood and invigorating spleen, as well as heart and anxiety. Prescription Modified Decoction (Evidence level: I; highly recommend). Dangshen (Radix Salviae Miltiorrhizae) 15 g, 10 g, Baizhu (Rhizoma Atractylodis Macrocephalae) 10 g, Gancao (Radix Glycyrrhizae) 6 g, (Radix 10 g, Danggui (Radix Angelicae Sinensis) 12 g, 15 g, (Semen 15 g, (Radix 10 g, (Radix 9 g, (Fructus 5 and (Rhizoma Recens) 3 are included. Modified If combined with obvious symptoms of heart deficiency such as palpitation, insomnia, and red tongue with less coating, 15 g, (Semen 12 g, and (Radix 12 g are added for nourishing heart for If combined with and abdominal after of and to so Dangshen (Radix Salviae Miltiorrhizae) is used at 20 g, and (Fructus decocted later) 6 g, and Chenpi (Pericarpium Citri Reticulatae) 15 Syndrome of deficiency of heart and gallbladder Therapeutic methods fright and the as well as heart for Prescription Modified (Evidence level: I; highly recommend). (Radix 9 g, Fuling (Poria) 12 g, 12 g, (Radix 10 g, (Rhizoma 9 g, (Dens Draconis) 30 g, Danggui (Radix Angelicae Sinensis) 12 g, Baishao (Radix Paeoniae Alba) 12 g, and Baizhu (Rhizoma Atractylodis Macrocephalae) 12 g are included. Modified If combined with dysphoria and insomnia, (Semen 20 g and decocted 30 g are added. If combined with fright and timidity, decocted 30 g, decocted 30 g, and decocted 30 g are added. Syndrome of disharmony between heart and kidney Therapeutic methods and clearing heart, as well as nourishing for Prescription Modified (Evidence level: I; highly recommend). Huanglian (Rhizoma Coptidis) 10 g, (Cortex 5 g, 10 g, (Rhizoma 10 g, (Cortex 10 g, and Shengdi (Radix Rehmanniae Recens) 20 g are included. Modified If combined with severe and feverishness in palms and soles, (Radix 10 g and Maidong (Radix Ophiopogonis) 10 g are added for clearing If combined with insomnia, 15 g and (Semen 15 g are added. Syndrome of kidney deficiency and liver depression Therapeutic methods kidney and regulating as well as resolving depression for Prescription Modified (Evidence level: I; highly recommend). Zhizi (Fructus Gardeniae) 10 g, 10 g, Yujin (Radix Curcumae) 30 g, (Radix et 30 g, 10 g, (Fructus 15 g, 20 g (Fructus 15 g, and 20 g are included. Modified If it to be liver (Fructus Citri 15 g and (Flos 10 g are added. If it to be deficiency, fire be and (Radix 15 g and (Fructus 12 g are added for supplementing kidney and (Cortex 9 g and (Semen 12 g are added for supplementing kidney If it to be deficiency, and kidney be (Radix Rehmanniae Preparata) 12 g and (Rhizoma 10 g are added. 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