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Table of Contents
GUIDELINES
Year : 2023  |  Volume : 9  |  Issue : 1  |  Page : 101-110

Guidelines


1 Hunan University of Chinese Medicine, Changsha, China
2 Eye Hospital of China Academy of Chinese Medical Sciences, Beijing, China

Date of Submission10-Feb-2022
Date of Acceptance08-May-2022
Date of Web Publication07-Jul-2022

Correspondence Address:
Dr. Li-Ke Xie
Eye Hospital of China Academy of Chinese Medical Sciences, Beijing

Dr. Qing-Hua Peng
Hunan University of Chinese Medicine, Changsha

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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/wjtcm.wjtcm_24_22

Rights and Permissions

How to cite this article:
Peng QH, Xie LK, Wang YL, Yao XL, Liang LN, Hao XF. Guidelines. World J Tradit Chin Med 2023;9:101-10

How to cite this URL:
Peng QH, Xie LK, Wang YL, Yao XL, Liang LN, Hao XF. Guidelines. World J Tradit Chin Med [serial online] 2023 [cited 2023 Feb 3];9:101-10. Available from: https://www.wjtcm.net/text.asp?2023/9/1/101/350335



International Clinical Practice Guideline of Chinese Medicine Dry Eye

World Federation of Chinese Medicine Societies

International Standard of WFCMS

Issued & implemented on December 14 2021

Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. Main Drafting Committee: Hunan University of Chinese Medicine, Eye Hospital of China Academy of Chinese Medical Sciences, Jiangsu Provincial Hospital of Traditional Chinese Medicine, The First Hospital of Hunan University of Chinese Medicine. Participants Drafting Committee: Shandong University of Traditional Chinese Medicine Affiliated Eye Hospital, Eye School of Chengdu University of TCM/Teaching Ineye Hospital of Chengdu University of TCM, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Tongren Hospital, Shanghai Jiaotong University School of Medicine, China-Japan Friendship Hospital, Xi'an Traditional Chinese Medicine Hospital, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Beijing Tongren Hospital, Capital Medical University, Beijing Tongren Hospital, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, The First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, The First People's Hospital Affiliated to Shanghai Jiaotong University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Dongzhimen Hospital Affiliated Beijing University of Chinese Medicine, Hebei Eye Hospital, Dongfang Hospital Affiliated Beijing University of Chinese Medicine, Shandong University of Chinese Medicine, Tainan Cikang Biotechnology Co. Ltd, China Medical University Hospital Hsinchu Taiwan, Hong Kong university, Hong Kong Suruibing Chinese Medicine Clinic, Wellspring Clinic, Vancouver BC, Canada (Canada), Singapore Chinese Hospital, American NEI/NIH, American Learning and Vision Association (USA), St. Olav Eye Clinic (Norway), Japan-China Health Science Association.

Proposer: Li-Ke Xie

The Main Drafters: Qing-Hua Peng, Li-Ke Xie, Yu-Liang Wang, Xiao-Lei Yao, Li-Na Liang, Xiao-Feng Hao

Participating drafters and review experts (in alphabetical order of surnames):

China: Hong-Sheng Bi, Lai-Hua Chen, Ying-Shan Chen(Taiwan), Juan Cheng, Jun-Guo Duan, Ping He, Yan-Yun Jiang, Chuan-Hong Jie, Ming Jin, Jian-Chao Li, Feng-Ming Liang, Qian-Hong Liu, Shao-Yan Liu, Xin-Quan Liu, Guang-Xiong Luo(Taiwan), Dong-Li Ma, Wan-Hong Liao, Long Pang, Zhi-Pei Peng(Hongkong), Yu-Hui Qin, Rui-Bing Su(Hongkong), He Sun, Qing-Jin Wang, Xing-Wei Wu, Jia-Jun Xu, Jing-Sheng Yu, Ming-Lian Zhang, Jian Zhou, Wei-Jie Zhu(Hongkong), Xiao-Lin Zhu, Zeng-Yuan Zhuang.

Canada: Wei-Dong Yu

Singapore: Qiu-Xia Lin

America: Andy Rosenfarb, Christina Jia Qi Bi, Quan -Dong Ruan, Yue Zhou

Norway: Erik VinjeOlbjorn, Ole Jørgen Frydenlund

Japan: Xuanfu Tong

The drafting process of this document complies with the “World Federation of Chinese Medicine Association Standards Management Measures” issued by the WFCMS and the SCM 0001-2009 “Standard Formulation and Release Work Specification.”

This document is issued by the World Federation of Chinese Medicine Societies, and the copyright belongs to the WFCMS.


  Introduction Top


This document aims to further standardize the international TCM clinical diagnosis and treatment of dry eye, and to provide international the TCM therapeutic strategies and methods of dry eye for international TCM practitioners. The guideline is concise and practical with strong operability, guidance, universality, and reference. It could be regarded as a valuable reference for clinical practice, diagnosis, and treatment regulations and quality evaluation.

The published Guideline for diagnosis and treatment of common ophthalmic diseases in traditional Chinese medicine dry eye (ZYYXH/T291f2012) has played a guiding role in the treatment of dry eye with Chinese medicine. However, research methods still need to improve with the increasing emergence of evidence-based medical researches and limitation of previous guidelines.

With the rapid development of evidence-based medicine in the field of traditional Chinese medicine, research results on dry eye with a high level of evidence continue to emerge. Based on the previous guidelines, this document screened out a safe, reliable, and easy-to-promote treatment method from high-quality research on the treatment of dry eye with traditional Chinese medicine with a high level of evidence, so as to improve the clinical efficacy of traditional Chinese medicine in the treatment of dry eye.

The guideline is a declaration file based on available research evidences and specific methods. Clinical practitioners could regard the guideline as reference and make the individualized treatment according to the combination of concrete clinical situations and the guideline.

1. Scope

This document provides the terms, definitions, diagnosis, differentiation, and treatment of dry eye.

As a diagnosis and treatment basis for dry eye, this document applies to TCM ophthalmologist, combined Chinese and Western medicine ophthalmologist. This guideline can also be a reference for Western medicine ophthalmologist or doctors of other TCM departments.

[TAG:2]2 Normative References[/TAG:2]

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all revisions) is applicable to this document.

GB/T 16751.1 Clinic terminology of traditional Chinese medical diagnosis and treatment – Diseases

GB/T 16751.2 Clinic terminology of traditional Chinese medical diagnosis and treatment – Syndromes

GB/T 16751.3 Clinic terminology of traditional Chinese medical diagnosis and treatment – Therapeutic methods

ZYYXH/T291 Guidelines for Diagnosis and Treatment of Common Diseases of Ophthalmology in Traditional Chinese Medicine – Dry eye

2013. Experts' Consensus about clinical diagnosis and treatment of dry eye by the Corneal Disease Group of Ophthalmological Society, Chinese Medical

2020. Asian Dry Eye Association China Branch; Cross-Strait Medical and Health Exchange Association Ophthalmology Professional Committee Ocular Surface and Lacrimal Disease Group; Chinese Medical Doctor Association Ophthalmologist Branch Ocular Surface and Dry Eye Group Chinese Expert Consensus on Dry Eye

SCM 2 International Standard Chinese-English Basic Nomenclature of Chinese Medicine by the Guiding Committee of WFCMS International Standard Chinese-English Basic Nomenclature of Chinese Medicine WHO International Standard Terminologies on Traditional Medicine in the Western Pacific Region by the World Health Organization.

3. Terms and Definitions

The following terms and definitions apply for this document.

3. 1 Dry eye

Dry eye is a chronic ocular surface disease caused by multiple factors. It is a disease of instability of the tear film or imbalance of the ocular surface microenvironment caused by abnormal tear quality, quantity, and dynamics. It can be accompanied by ocular surface inflammatory reactions and tissues. Injury and nerve abnormalities, causing a variety of eye discomfort and (or) visual dysfunction.

Annotation 1: Various names appearing clinically in China (such as dry eye, dry eye disease, and dry eye syndrome) are collectively referred to as dry eye.

Annotation 2: It belongs to the categories of “White xerotic syndrome,” “Dry coma,” and “The syndrome of tear about to dry up” of traditional Chinese medicine.

3. 2 White xerotic syndrome

Latent pathogen at qi aspect is a disease caused by dampness-heat of spleen and lung, which is characterized by not swelling or redness, discomforts, and astringency, and faintness.

Annotation: According to the description of “White xerotic syndrome,” “Dry coma,” and “The syndrome of tear about to dry up” in “Precious Book of Ophthalmology,” the White xerotic syndrome is the least severe of the three, and similar to mild dry eye in modern medicine.

3. 3 Dry coma

Essence and blood cannot provide nutrition, or the divine water is burnt dry, which cannot nourish the eyes, resulting in less tears, dryness and discomfort, blurred vision, and thin white eyes and red veins.

Annotation: According to the description of “White xerotic syndrome,” “Dry coma,” and “The syndrome of tear about to dry up” in “Precious Book of Ophthalmology,” the Dry coma belongs to the second severe of the three, and similar to moderate dry eye in western medicine.

3. 4 The syndrome of tear about to dry up

Fire stagnation steaming vitreous humor, or heat accumulation in bladder, or has always been deficiency syndrome caused blurred vision, cervical malignancy with cachexia of eyeball, tear dried up, dryness of exterior eye.

Annotation: According to the description of “White xerotic syndrome,” “Dry coma,” and “The syndrome of tear about to dry up” in “Precious Book of Ophthalmology,” The syndrome of tear about to dry up is the most severe of the three, and similar to severe dry eye in western medicine.

4. Diagnosis

4. 1 History of illness

Patients with this disease often overuse their eyes, such as reading books frequently or working on a computer screen for a long time.

4. 2 Diagnostic indicators

Dry eye can be diagnosed if there are clinical symptoms of dry eye (4.3) and one of 4.4 and 4.5 is met.

4. 3 Clinical Symptoms

Dryness, foreign body sensation, burning sensation, itching, pain, red eyes, fatigue, blurred vision, and fluctuations in vision.

4. 4 Frequently used inspections

4. 4.1 Slit-lamp microscope

Conjunctiva congestion, papillary hyperplasia, or eyelid thickening or dulling, the glandular mouth is blocked by yellow and white viscous secretions and is blurred; in severe cases, new blood vessels may be observed at the limbus through the eye slit lamp.

4. 4.2 Schirmer test

Schirmer test (ST) and Schirmer test I (STI) ≤5 mm/5 min were abnormal when less than 10 mm/5 min.

4. 4.3 Tear breakup time

Tear breakup time (BUT) was abnormal when Fluorescein breakup time(FBUT) ≤5 s or Noninvasive breakup time(NIBUT) <10 s.

4. 4.4 Determination of tear osmotic pressure

Using the freezing point-osmotic pressure measuring instrument for detection, generally greater than 312 mOms/L can be diagnosed as dry eye.

4. 4.5 Dyeing test

HE staining positive, lissamine green staining test positive, fluorescent staining positive.

4. 4.6 Tear interference imaging

The normal spontaneous blink rate is 10–15 times/min. Tear interference imaging equipment such as LipiView can observe that the blinking frequency and completeness of the patient's eyes decrease, and the thickness of the tear film lipid layer becomes thinner.

4. 4.7  Meibomian gland More Details imaging

Infrared imaging technology can be used to see the meibomian glands, and patients generally have varying degrees of meibomian gland loss and morphological abnormalities.

4. 5 Other inspections

4. 5.1 Impression cytology

Manifestations of decreased density of conjunctival goblet cells, increased nuclear-to-cytoplasmic ratio, squamous epithelial metaplasia, and corneal epithelial conjunctivation.

4. 5.2. Immunoassay

Most patients with Sjogren's syndrome can be positive Anti-Sjögren's-syndrome-related antigen A autoantibodies and Anti-Sjögren's-syndrome-related antigen B autoantibodies ,and often combined with abnormal results of rheumatoid factor, immunoglobulin and erythrocyte sedimentation rate.

4. 6 Differential diagnosis

4. 6.1 Chronic conjunctivitis

Chronic conjunctivitis refers to chronic inflammation caused by etiological factors such as conjunctival infection, symptoms and signs of foreign body sensation in the eyes, burning sensation, itching, photophobia, tearing, conjunctival congestion, and mucus-like secretions. However, the Schirmer test and tear BUT of patients with this disease are generally normal; conjunctival scrape cytology can be identified.

4. 6.2 Herpes simplex keratitis

Herpes simplex keratitis refers to the pathological changes of the cornea in the form of punctate, dendritic, map-shaped, disc-shaped cornea after the cornea is infected by herpes simplex virus. The disease only has corneal punctate pathological changes that are similar to dry eyes, but corneal irritation symptoms are more severe, and can lead to latent infection and disease persistence.

5. Pattern Identification

5. 1 Excess pattern

5. 1.1 Pattern of stagnation-heat in liver meridian

Eyeball dryness causes heat and pain, or hyperemia in white of the eye, or punctate corneal opacity in black of the eye, or nonpermanent vision; bitter taste in mouth and unmoistened throat, dysphoria and anger, or insomnia and dreamfulness, dry stool or dark urine; red tongue, thin yellow coating or thick yellow coating, wiry slippery rapid pulse.

5. 1.2 Pattern of pathogenic heat retention

In the late stage of suffering from wind-heat red eye or epidemic red eye, slight photophobia and dacryorrhea, a little ophthalmic gum, dry and discomfort, white of the eye with a few red thread veins linger, and slightly red in palpebral conjunctiva. Red tongue, thin yellow coating, rapid pulse.

Annotation 1: Wind-heat red eye refers to the sudden onset of external wind-heat. The main features are hyperemia of ocular conjunctiva, irritation, itching, and simultaneous pain.

Annotation 2: Epidemic red eye refers to the qi of pestilence. Hyperemia of ocular conjunctiva and spot-like subconjunctival hemorrhage, which often affects the eyes, and quickly spread, causing widespread eye diseases.

5. 1.3 Pattern of dampness-heat of spleen and stomach

Eyes are dry and dull pain, often with white foamy ophthalmic gum in canthus, slightly red veins in the white of the eye, which are difficult to heal repeatedly; it may be accompanied by sticky sensation in mouth or fetid mouth odor, discomfort with constipation and dark urine; yellow greasy coating, soggy rapid pulse.

5. 2 Deficiency pattern

5. 2.1 Pattern of lung yin deficiency

Eyes are dry and discomfort, nonpermanent vision, normal white of the eye or slightly red vessels, black of the eyes may have punctate opacity, which are difficult to heal repeatedly;it may be accompanied by dry mouth and dry nose, dry throat,constipation; thin dry coating, thread weak pulse.

5. 2.2 Pattern of liver-kidney yin deficiency

Eyes are dry and photophobia, frequent nictation, blurred vision, slightly hyperemia in white of the eye, and long-term use of eyes will aggravate the above symptoms; it can be combined with dry mouth and dry coating, aching and weakness of loins and knee, dizziness and tinnitus, dreamfulness; red tongue, thin coating, thread rapid pulse.

5. 2.3 Pattern of deficiency of both qi and yin

Eyes are dry and discomfort, cervical malignancy with cachexia of eyeball, the eyes blink frequently, the shame is afraid of the light, the white eyes are faintly red, and nonpermanent vision. After a long time, the symptoms are aggravated. Hesitant, even filiform, difficult to heal with delays; dry mouth and little jin, fatigue, dizziness, tinnitus, and aching and weakness of loins and knee; pale red tongue, thin fur, thin or thin deep pulses.

6. Treatment

The traditional Chinese medicine treatment mode of dry eye refers to [Figure 1].
Figure 1: Traditional Chinese Medicine Treatment Mode for Dry Eye

Click here to view


6. 1 Therapeutic principles and methods

First identify the deficiency and excess, based on the principle of nourishing yin and moistening dryness, nourishing liver and kidney.

6. 2 Principle-method-recipe-medicinal

6. 2.1 Pattern of stagnation-heat in liver meridian

Therapeutic methods: Clearing liver and resolving depression, nourishing blood, and improving vision.

Formula and herbs: Modified Danzhi Xiaoyao Powder (Internal Medicine Summary). Danpi (Tree Peony Root Bark), Zhizi (Gardenia), Danggui (Chinese Angelica), Baishao (Debark Peony Root), Chaihu (Chinese Thorowax Root), Baizhu (White Atractylodes Rhizome), Fuling (Poria), Gancao (Liquorice Root), and Bohe (Peppermint) are included (Ib, high priority).

Addition and subtraction: If combined with spontaneous dry mouth and thirst, Baihe (Lily bulb) and Shengdihuang (Unprocessed Rehmannia Root) are added to enhance the power of nourishing yin and promoting fluid production; if combined with punctate corneal opacity in black of the eye, Mimenghua (Pale Butterfly Flower), Juhua (Chrysanthemum Flower), and Zhenzhumu (Nacre) are added to improve vision to removing nebula, or Guizhencao (Stitchweed) is added to clearing heat and detoxification and to strengthen the power of liver-clearing.

Medication method: Take one dose a day, decoct in water, and take it after heating up in the morning and evening.

6. 2.2 Pattern of pathogenic heat retention

Therapeutic methods: Clear heat and soothe the lung

Formula and herbs: Modified Mulberry Root Bark Decoction (Precious Book of Ophthalmology). Sangbaipi (White Mulberry Root-Bark), Digupi (Chinese Wolfberry Root-bark), Zexie (Oriental Waterplantain Rhizome), Maidong (Dwarf Lilyturf Tuber), Xuanshen (Figwort Root), Huangqin (Baical Skullcap Root), Gancao (Liquorice Root), Fuling (Poria), Jiegeng (Platycodon), Juhua (Chrysanthemum Flower), Xuanfuhua (Inula Flower), Shihu (Dendrobium), Yuzhu (Fragrant Solomonseal Rhizome), and Fangfeng (Divaricate Saposhnikovia Root) are included (Ib, high priority).

Addition and subtraction: If combined with spontaneous heat syndrome, Jinyinhua (Honeysuckle Flower) and Chishao (Red Peony Root) are added to enhance the power of heat-clearing and detoxification, blood-cooling, and stasis-resolving; if combined with yin deficiency but no dampness, Fuling (Poria) and Zexie (Oriental Waterplantain Rhizome) can be subtracted.

Medication method: Take one dose a day, decoct in water, and take it after heating up in the morning and evening.

6. 2.3 Pattern of dampness-heat of spleen and stomach

Therapeutic methods: Clearing heat and draining dampness and regulating qi movement

Formula and herbs: Modified Three Kernels Decoction (Detailed Analysis of Warm Diseases). Kuxingren (Bitter Apricot Seed), Huashi (Talc), Danzhuye (Lophatherum Herb), Doukou (Cardamon Fruit), Houpo (Officinal Magnolia Bark), Yiyiren (Semen Coicis), Banxia (Pinellia Tuber), Fuling (Poria), Sangbaipi (White Mulberry Root-Bark), Digupi (Chinese Wolfberry Root-bark), and Mudanpi (Tree Peony Root Bark) are included (Ib, high priority).

Addition and subtraction If combined with epigastric upset in abdominal, nausea, and belching, Huanglian (Rhizoma Coptidis) and Wuzhuyu (Medicinal Evodia Fruit) are added to clearing heat and resolving dampness, harmonizing stomach, and dispersing mass; if combined with discomfort with constipation and dark urine, Huangbai (Cortex Phellodendri) and Chixiaodou (Rice Bean) are added to clearing heat and drying dampness

Medication method: Take one dose a day, decoct in water, and take it after heating up in the morning and evening.

6. 2.4 Pattern of lung yin deficiency

Therapeutic methods: Nourishing yin and moistening lung

Formula and herbs: Modified Yin-Nourishing and Lung-Clearing Decoction (Jade Key to the Secluded Chamber). Shengdihaung (Radix Rehmanniae Recens), M Formula and herbs: Modified Yin-Nourishing and Lung-Clearing Decoction (Jade Key to the Secluded Chamber). Shengdihaung (Radix Rehmanniae Recens), Maidong (Dwarf Lilyturf Tuber), Gancao (Liquorice Root), Chuanbeimu (Tendrilleaf Fritillary Bulb), Mudanpi (Tree Peony Root Bark), Bohe (Herba Menthae), Lianqiao (Weeping Forsythia Capsule), Baishao (Debark Peony Root), and Tiandong (Cochinchinese Asparagus Root) are included (Ib, high priority).

Addition and subtraction If combined with shortness of breath and reluctance to speak, Taizishen (Heterophylly Falsestarwort Root) and Wuweizi (Fructus Schisandrae Chinensis) could be used to replenishing qi and nourishing yin; if combined with punctate corneal opacity in black of the eye, Chantui (Cicada Slough), Mimenghua (Pale butterfly flower), and Juhua (Chrysanthemum flower) could be used to improve vision to removing nebula.

Medication method: Take one dose a day, decoct in water, and take it after heating up in the morning and evening.

6. 2.5 Pattern of liver-kidney yin deficiency

Therapeutic methods: Nourishing liver and kidney and nourishing yin and blood

Formula and herbs: Modified Qiju Dihuang Pill (Precious Mirror for Advancement of Medicine). Gouqizi (Barbary Wolfberry Fruit), Juhua (Chrysanthemum Flower), Shudi (Prepared Rehmannia Root), Shanyurou (Asiatic Cornelian Cherry Fruit), Shanyao (Common Yam Rhizome), Fuling (Poria), Mudanpi (Tree Peony Root Bark), Zexie (Oriental Waterplantain Rhizome), Danggui (Chinese Angelica), and Chantui (Cicada Slo) are included (Ib, high priority).

Addition and subtraction If combined with bitter taste in mouth and unmoistened throat, Baihe (Lily Bulb) and Huangjing (Dcrystalline Lens) are added to enhance the power of nourishing yin and promoting fluid production; if combined with punctate corneal opacity in black of the eye, Mimenghua (Pale Butterfly Flower) and Juemingzi (Cassia Seed) could be used to improve vision to removing nebula.

Medication method: Take one dose a day, decoct in water, and take it after heating up in the morning and evening.

6. 2.6 Pattern of deficiency of both qi and yin

Therapeutic methods: Replenishing qi and nourishing yin and nourishing liver and kidney

Formula and herbs: Modified Sheng Mai Powder (Revelation of Medicine) and Modified Qiju Dihuang Pill (Precious Mirror for Advancement of Medicine), Maidong (Dwarf Lilyturf Tuber), Renshen (Ginseng), Shengdihuang (Unprocessed Rehmannia Root), Wuweizi (Fructus Schisandrae Chinensis), Gouqizi (Barbary Wolfberry Fruit), Juhua (Chrysanthemum Flower), Shudihuang (Prepared Rehmannia Root), Shanzhuyu (Asiatic Cornelian Cherry Fruit), Shanyao (Common Yam Rhizome), Fuling (Indian Bread), Mudanpi (Tree Peony Root Bark), and Zexie (Oriental Waterplantain Rhizome are included (Ib, high priority).

Addition and subtraction If combined with blood deficiency syndrome, Baishao (Radix Paeoniae Alba) and Danggui (Chinese Angelica) could be used to nourishing blood and regulating nutrient treating, causing the eyes to receive luxuriant from blood; if combined with corneal opacity in black of the eye, Mimenghua (Pale Butterfly Flower) and Chantui (Cicada Slo) could be used to improve vision to removing nebula. If combined with faintly red in white eyes, Digupi (Chinese Wolfberry Root-Bark) and Baiwei (Blackend Swallowwort Root) could be used to clearing heat and removing hyperemia.

Medication method: Take one dose a day, decoct in water, and take it after heating up in the morning and evening.

6. 3 Traditional Chinese patent medicine

Traditional Chinese patent medicine (TCPM) should be selected for the suitable prediabetes syndrome and should not be blindly used. Sugar-free granules, capsules, concentrated pills, or tablets are recommended.

Sheng Mai Injection: Used for syndrome of deficiency of lung yin and liver-kidney yin deficiency of dry eye, 40 to 100 ml at a time, adding 5%–10% glucose injection 100 ml, intravenous drip, once a day (IIb, low priority).

Liuwei Dihuang Pill: Used for syndrome of liver-kidney yin deficiency of dry eye, 8 capsules at a time, 3 times a day, take with warm water (IIb, low priority).

Qiju Dihuang Pill: Used for syndrome of stagnation-heat in liver meridian and syndrome of liver-kidney yin deficiency of dry eye, 8 capsules at a time, 3 times a day, take with warm water (IIb, low priority).

6. 4 External drug treatment

6. 4.1 Fumigation

According to the syndrome differentiation and treatment described in 5 and 6 of this document, place the decoction and fumigate the eye (Ib, high priority).

6. 4.2 Ultrasonic atomization

According to the signs, decoctions of Juhua (Chrysanthemum Flower), Huanglian (Rhizoma Coptidis), Chaihu (Chinese Thorowax Root), and other drugs are selected and placed in an ultrasonic nebulizer to spray the affected eyes (Ib, high priority).

6. 5 Acupuncture and moxibustion therapy

Acupuncture at acupoints such as Jingming, Fengchi, Zhizhu, Sizhukong, Taiyang, Qiuhou, Tongziliao, Sibai, Chengqi, Hegu, and Waiguan. According to the difference between the cold-heat-deficiency-excess in nature of disease, and the possessions of channel and collateral in zang-fu organs, the acupoints can be added or subtracted (Ib, high priority).

APPENDIX A

(Information)

Chinese Expert Consensus on Dry Eye

2020. Asian Dry Eye Association China Branch, Cross-Strait Medical and Health Exchange Association Ophthalmology Professional Committee Ocular Surface and Lacrimal Disease Group, Chinese Medical Doctor Association Ophthalmologist Branch Ocular Surface and Dry Eye Group “Chinese Expert Consensus on Dry Eye”

A.1 Diagnosis

A.1.1 The diagnosis of dry eye should include the following:

a) Whether it can be diagnosed with dry eye

b) The etiology and classification of dry eye

c) Severity of dry eye

A.1.2 The ocular surface and dry eye group proposed the current diagnostic criteria for dry eye in China:

a) The patient complained of one of the subjective symptoms such as dryness, foreign body sensation, burning sensation, itching, pain, red eyes, fatigue, blurred vision, and fluctuations in vision.

b) Patients have dry eye-related symptoms, Chinese Dry Eye Questionnaire ≥7 points or OSDI d13 points; at the same time, patients with FBUT >5 s and ≤10 s or NIBUT is 10–12 s, Schirmer I test (no anesthesia) >5 mm/5 min and ≤10 mm/5 min, the cornea and conjunctiva must be inspected by fluorescein sodium staining method. If the staining is positive (≥5 points), dry eye can be diagnosed.)

A.2 Classification and diagnosis

A.2.1 Classification by pathogen and risk factors

A.2.1.1 Systemic factors

Many systemic diseases, especially immune system diseases, and imbalances of the endocrine system can cause dry eye, such as Sjögren syndrome, Steven Johnson syndrome, graft-versus-host disease, various connective tissue and collagen vascular diseases, severe liver dysfunction, Thyroid dysfunction, diabetes and gout are more common in women after menopause, other diseases such as vitamin A deficiency and androgen deficiency are also prone to dry eye.

A.2.1.2 Local factors of the eye

Local infection and immune-related diseases, such as infectious conjunctivitis, allergic conjunctivitis, abnormal density of nerve fiber plexus under the corneal epithelial basement membrane; abnormal nerve function in various parts, such as lacrimal gland, meibomian gland, ocular surface epithelial cells (goblet cells) and cornea;Abnormal tear dynamics caused by various reasons, such as eyelid skin and conjunctival relaxation, lacrimal caruncle hyperplasia, blepharospasm, ocular acne, etc. There are also mite blepharitis, abnormal eyelid structure.

A.2.1.3 Environmental factors

Including air pollution, light pollution, radiation, high altitude, low humidity, and strong wind.

A.2.1.4 Lifestyle-related factors

Such as long-term operation of the video terminal, little outdoor activities, long-term close-up flat vision, lack of sleep, use of air-conditioning, smoking, long-term wear of contact lenses, eye makeup, and long-term driving.

A.2.1.5 Surgery-related factors

Including various operations that cause damage to the lacrimal gland, accessory lacrimal gland, meibomian gland, ocular surface epithelial cells, and corneal epithelial subbasement membrane nerve fiber plexus;

Laser corneal refractive surgery, cataract extraction surgery, etc., lead to a higher incidence of dry eye. Most patients recover within 3 to 6 months after surgery, but a few patients can continue for a longer period of time.

A.2.1.6 Drug-related factors

Including systemic and topical medications:

a) Systemic medication, such as menopausal hormone supplementation, antidepressant, antihistamine, anticholinergic, antipsychotic drugs, isotretinoin, diuretics, contraceptives, systemic chemotherapy drugs, etc.;

b) Local medications, such as eye disinfectants, antiviral drugs, antiglaucoma drugs (receptor blockers, etc.), eye drops containing preservatives, and eye ointments.

A.2.1.7 Other factors

In addition to the above factors, there are other factors such as anxiety, depression and other emotions that can also cause dry eyes.

A.2.2 According to the main components of tears or functional abnormalities

A.2.2.1 aqueous tear deficiency dry eye

Caused by insufficient production of aqueous tears and/or qualitative abnormalities, such as Sjögren syndrome and dry eyes caused by many systemic diseases.

A.2.2.2 Lipid deficiency dry eye

It is caused by abnormalities in the quality or quantity of the lipid layer, such as meibomian gland dysfunction, blepharitis, and dry eyes caused by various factors such as increased tear evaporation.

A.2.2.3 Mucin deficiency dry eye

Ocular surface epithelial cells (especially goblet cells) are damaged due to various factors. At present, related studies use conjunctival imprinting cell inspection and fern-like tests to understand mucin deficiency, but there is no clinical method to directly detect mucin deficiency. Lissamine green and tiger red staining can indirectly indicate areas lacking mucin coverage. Dry eyes caused by clinical ocular surface drug toxic damage, chemical ocular trauma, thermal burns, limbal dysfunction, and long-term wearing of contact lenses generally belong to this type.

A.2.2.4 Abnormal tear dynamics dry eye

Dry eyes caused by abnormal tear fluid dynamics, including abnormal blinking (such as decreased blinking frequency and incomplete blinking), abnormal tear discharge, loose conjunctiva, and abnormal eyelids. Part of the video terminal syndrome and dry eyes caused by nerve paralysis or exposed eyelid insufficiency caused by various reasons generally belong to this type.

A.2.2.5 mixed dry eye

The most common type of dry eye in clinic is dry eye caused by the above two or more reasons

A.2.3 Classified by severity of dry eye

A.2.3.1 Mild

There are no obvious signs of ocular surface damage under a slit-lamp microscope (corneal fluorescein staining points <5) and tear film breakup time (BUT)≧2 s.

A.2.3.2 Moderate

The scope of corneal damage under a slit-lamp microscope is not more than 2 quadrants and (or) corneal fluorescein staining points ≥5 and <30, BUT ≧2 s.

A.2.3.3 Severe

Slit-lamp microscopy examination of the corneal damage range of 2 quadrants and above and (or) corneal fluorescent staining points ≥30, BUT <2s. Corneal fluorescein stained spots merged into thick dots, flakes or accompanied by filaments.

Annotation: The amount of tear secretion is an important indicator for judging the severity of dry eye due to lack of water. Due to the poor stability and reproducibility of the Schirmer test, the result is not used as an indicator of the severity of dry eye. However, in some cases, it can also be used as a reference indicator. For example, if the result of Schirmer test is 0, it can be considered severe dry eye.

APPENDIX B

(specification)

TCM Treatment map of Dry eye

Figure B.1 specifies the traditional Chinese medicine treatment model for dry eye, as shown in the following figure:

APPENDIX C

(Information):

Evidence Evaluation and Recommendation Principle

1. Evaluation

The evidence classification principle of this document is based on the Composition of Evidence Body of Traditional Medicine and Recommendations for Its Evidence Grading by Prof. Jianping Liu. In addition, if a randomized controlled trial is defined as high risk, its grade recommendation is reduced by one level.



The process of screening and evaluation of the literature is carried out independently by two evaluators. If the views of the two parties are inconsistent, they would resolve through negotiation or adjudication by a third party. See the table below for details:

2. Recommended principles

Because the fact that most of the studies on the treatment of dry eye in TCM are not comprehensive, the design of studies is often less standardized, the selection of formula is diverse, and the efficacy standard is not uniform, which attributed to the outcome bias. Therefore, all the evidences of this document are required to obtain expert consensus before being included in the recommendation.

The recommended grading criteria on the current guidelines are generally recommended for evidence based on the recommended strength-level criteria developed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) team, which is divided into strong and weak levels. When the evidence clearly shows the advantages or disadvantages of the intervention, it can be classified as a high priority by groups of this document. When the pros and cons are uncertain in a study or when the quality of the evidence shows the pros and cons are equivalent, it can be considered a low priority.

In view of the above, this guideline stipulates that if the evidence is level I and obtain expert consensus, then it is considered to be a high priority. If the evidence is level II and obtains expert consensus, it is considered to be a low priority.[18]

APPENDIX D

(Information):

Declaration of Conflict of Interest

The review of the International Clinical Practice Guideline of Chinese Medicine Dry Eye by the Ethics Committee has not identified any commercial, professional, or other interests expressly related to the subject matter of this document, and all situations of conflict of interest that may be influenced by the results of this document.



 
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Qinghua P, Xiaolei Y, Jun P, Quanlong W, Hanyu T. The study on the effects to partial inflammation of extract of Buddleja officinalis on dry eye in castrated rabbits. Chin Arch Tradit Chin Med 2010;28:1351-6.  Back to cited text no. 17
    
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Wei S, Changwei Z, Yuliang W. Experimental study on the effects of Bides bipinnata tear secretion and expression of related genes of apoptosis of lacrimal gland. J Clin Ophthalmol 2013;21:80-3.  Back to cited text no. 18
    


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