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GUIDELINES
Year : 2022 | Volume
: 8
| Issue : 4 | Page : 556-564
International Clinical Practice Guideline of Chinese Medicine-Age-related Macular Degeneration
Xing-Wei Wu1, Li-Ke Xie2, Li-Na Liang2
1 First People's Hospital Affiliated to Shanghai Jiaotong University, China
2 Eye Hospital of China Academy of Chinese Medical Sciences, Beijing, China
Correspondence Address:
Dr. Li-Ke Xie
Eye Hospital of China Academy of Chinese Medical Sciences, Beijing
China
Dr. Li-Na Liang
Eye Hospital of China Academy of Chinese Medical Sciences, Beijing
China
Dr. Xing-Wei Wu
First People's Hospital Affiliated to Shanghai Jiaotong University
China
Source of Support: None, Conflict of Interest: None
DOI: 10.4103/2311-8571.353119
World Federation of Chinese Medicine Societies
International Standard of WFCMS Issued &Implemented on December 14, 2021
Foreword
Patent issues may be existed in this document, and the Word Federation of Chinese Medicine Societies declared that they are not to blame.
The main drafting Committee of this docement: First People's Hospital Affiliated to Shanghai Jiaotong University, Eye hospital,China academy of Chinese Medical Sciences, Beijing Tongren Hospital Affiliated to Capital Medical University, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, National Eye Institute/National Institute of Health.
The drafting Committee of this docement: Eye Hospital Affiliated to Shandong University of Traditional Chinese Medicine, Eye School of Chengdu University of TCM/Teaching Ineye Hospital of Chengdu University of TCM, Yixing Eye Hospital, Ningbo Eye Hospital, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Aier Eye Hospital of Wuhan, The first Affiliated Hospital of Guangxi University of Chinese Medicine Hospital, Shenzhen Hospital of Peking University, Nanjing Hospital of Traditional Chinese Medicine of Nanjing University of Chinese Medicine Hospital, Eye Hospital of Nanjing Medical University, China-Japan Friendship Hospital, Xi'an Fourth Hospital, Shanghai Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine, First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Wangjing Hospital of China academy of Chinese Medical Sciences, First Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine, Chinese Academy of Traditional Chinese Medicine, Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Yunnan University, Hunan University of Traditional Chinese Medicine, Liaocheng Eye Hospital, Shanghai Hospital of Traditional Chinese Medicine, Shuguang Hospital Attached to Shanghai University of Traditional Chinese Medicine, First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Eye Center of Zhongshan Medical University, Subei People's Hospital of Jiangsu Province, Shanghai Jiangong Hospital, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Henan Provincial Hospital of Traditional Chinese Medicine, Qianfoshan Hospital of Shandong Province, Eye Hospital of Hebei Province, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine of Hebei Province, Dongfang Hospital of Beijing University of Traditional Chinese Medicine, University of Hong Kong, Malaysian Chinese Medicine Acupuncture Medical Center, Singapore Chinese Hospital, Wellspring Clinic, Vancouver BC, Canada, American Learning and Vision Association (USA), The Ohio State University (USA), University of South Carolina (USA), St. Olav Eye Clinic (Norway), Japan-China Health Science Society.
Chief proposer of this docement: Li-Ke Xie
The main drafters of this docement: Xing-Wei Wu, Li-Ke Xie, 
, Li-Na Liang, Xiao-Feng Hao, Li-Xin Qiu,
Xin-Quan Liu, Wen-Xin Ma
The drafters and the review experts of this docement (Sort alphabetically by last name):
China: Hong-Sheng Bi, Guo-Jun Chao, Jun-Guo Duan, Jun Feng, Ya-Lan Feng, Jian-Sheng Gao, Yun Gao,Yuan-Yuan Gong, Yan Gong, Cheng-Wei Guo, Dong-Mei Han, Guan-Yu Han, Xiao-Bo Hao,Hui-Qin He, Jian-Hong Huang, Jie Huang, Qin Jiang,Chuan-Hong Jie,Ming Jin, Xiao-Qin Lei,Chuan-Ke Li, Chun-Xia Li, Qing-Sheng Li,Yamin Li,Feng-Ming Liang, Pin-Zheng Liao,Jing Liu, Kun Liu,Shao-Yan Liu, Yan-Li Liu, Bing-Wen Lu,Xu-Sheng Luo, Hai-Jiang Lv, Long Pang, Hua Peng, Qing-Hua Peng, Hong Qin, Qing-Hua Qiu, Chun-Hui Ren,Wan-Ting Shu,Yi Song, Zheng-Yu Song,Guo-Hui Su (Hong Kong), Jing Su, He Sun, Nian-Ting Tong, Hui-Juan Wang, Ming-Fang Wang, Feng Wen,Jian-Feng Wu,Zheng-Gao Xie,Qing Xu, Guang Yang, Wei Yang,Ying-Xin Yang,Yong-Sheng Yang, Li-Li Yin, Jing-Sheng Yu, Jian-Shu Yuan, Cang-Xia Zhang,Feng-Mei Zhang, Hong-Xing Zhang, Jun-Xiu Zhang, Ming-Lian Zhang, Ren-jun Zhang, Shou-Kang Zhang,Jian Zhao(Hong Kong),Jian Zhou, Shang-Kun Zhou, Zeng-Yuan Zhuang
Malaysia: Law Teik Hwong
Singapore: Qiu-Xia Lin
Canada: Wei-Dong Yu, Yue Zhou
American: Wen-Xin Ma, Jie Fan, Bill X Wu
Norway: Erik Vinje Olbjorn Ole Jørgen Frydenlund
Japan: Xiao-Fei Liu, Xuan-Fu Tong
Australian: Chi-Jing Liu
Ukraine: Vitalii Samsonov
This document is drafted according to SCM 0001-2009 Guideline Setting and Publishing Work Norms and International Organization for Standardization by the Word Federation of Chinese Medicine Societies.
This document is published by the World Federation of Chinese Medicine Societies and all rights are reserved
Introduction
This document aims to further standardize the international TCM clinical diagnosis and treatment of age-related macular degenerationbn (AMD), and to provide TCM therapeutic strategies and methods of AMD for international TCM practioners. The document is concise and practical with strong operability, guidance, universality and reference, which meets medical regulations and legal requirements. It could be regarded as a valuable reference for clinical practice, diagnosis and treatment regulations, and quality evaluation.
The published An Evidence-based Clinical Practice Guideline of Chinese Ophthalmology for Treatment of AMD, Guidelines for Diagnosis and Treatment of Common Diseases of Ophthalmology in Traditional Chinese Medicine--AMD and Clinical Practice Guideline of Traditional Chinese Medicine--AMD have played a guiding role in the treatment of AMD with Chinese medicine. However, research methods still need to improve with the increasing emergence of evidence-based medical researches and the limitation of previous guidelines. The context of this document focuses on the diagnosis and treatment of AMD with Chinese medicine based on previous guidelines, strict quality assessments are conducted according to high-quality TCM systematic reviews and randomized clinical trials in the treatment of AMD to screen therapeutic methods of high-level evidence, reliable clinical efficacy, safety, and convenient to popularize, which aims to improve the clinical efficacy of TCM treatment on AMD.
The document is a declaration file based on available research evidence and scientific methods. Clinical practitioners could regard the document as reference and make the individualized treatment according to the combination of concrete clinical situations and the document.
1. ScopeThis document provides the basic requirements of the diagnosis, differentiation, and treatment for AMD.
As a diagnosis and treatment basis for AMD, this document applies to TCM ophthalmologists, integrated Traditional and Western medicine ophthalmologists at various levels. This guideline can also be a reference for Western medicine ophthalmologists or doctors of other TCM departments.
2. Normative ReferencesThe following referenced documents are indispensable for the application of this guideline. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced guideline (including any amendments) applies.
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
2006. An Evidence-based Clinical Practice Guideline of Chinese Ophthalmology for Treatment of Age-related macular degeneration (AMD).
2012. Guidelines for Diagnosis and Treatment of Common Diseases of Ophthalmology in Traditional Chinese Medicine – AMD
2015. Clinical Practice Guideline of Traditional Chinese Medicine – Age-related macular degeneration
(SCM 2) International Standard Chinese-English Basic Nomenclature of Chinese Medicine.
3. Terms and DefinitionsFor the purposes of this document, the following terms and definitions apply.
3. 1. Age-related macular degeneration
AMD usually occurs in people over 50 years of age, sequential or simultaneous onset of both eyes, with progressive central vision loss, visual deformation and central scotoma as the main symptoms.
Note 1: AMD, also known as senile macular degeneration, is classified into two forms: dry AMD (atrophic AMD or non-neovascular AMD) and wet AMD (exudative AMD or neovascular AMD).
Note 2: AMD falls into the TCM diagnosis categories of “dim vision,” “straight vision as curved” and so on.
4. Diagnosis4. 1. History
Epidemiological investigation and many studies have found that the incidence of AMD is related to the following factors: age, smoking, long-term chronic light exposure, hypertension, nutritional metabolic disorders, cardiovascular disease, and arteriosclerosis, among which age and smoking are the main risk factors.
4. 2. Clinical manifestations
Vision decreases in one eye or both eyes? There may be no symptoms in the early stage of atrophic AMD. The central visual acuity declines with the progress of the disease. In exudative AMD, blurred vision, distortion of vision, central scotoma, and reading difficulties occur in the early stage, and visual acuity decreases markedly with rapid progress. In the late stage, the visual function will be seriously damaged due to macular hemorrhage and scar formation.
4. 3. Examination
4. 3.1. Fundus examination
4.3.1.1. Atrophic age-related macular degeneration or dry age-related macular degeneration
Pigment disorder in the macular area, fovea light reflex weakened or disappeared. At the posterior pole, yellow–white round drusens of different sizes, pigment epithelium proliferation or atrophy are observed, and geographic atrophy with a clear margin presents in the late stage.
4.3.1.2. Exudative age-related macular degeneration or wet age-related macular degeneration
Exudative and grayish-yellow choroidal neovascularization (CNV) lesions present in the fovea or adjacent to the fovea, accompanied by drusen, pigmented plaques, depigmentation, subretinal effusion, hemorrhage, edema, lipid exudation, retinal pigment epithelial detachment (PED), and disciform scar.
4. 3.2. Other examinations
4. 3.2.1. Fundus fluorescein angiography
FFA is applicable to examine patients with visual deformation, unexplained blurred vision or retinal PED, subretinal hemorrhage, hard exudation, etc., In the early stage, high fluorescence appears in the area of drusen and window-like defects in the area of depigmentation. In the late stage, low fluorescence presents due to choroidal capillary atrophy. FFA is helpful to judge whether there is leakage of subretinal neovascularization, and evaluate the area, type, size, and location of CNV.
4.3.2.2. Indocyanine green angiography
ICGA is used to observe choroidal circulation. Exudative AMD can be manifested as hot spots, abnormal large choroidal vessels, high fluorescence, etc.
Serous PED without neovascularization: weak fluorescence in the detachment area.Typical CNV: high fluorescence point or region, brightening and expanding in the late stage, but the margin of the high fluorescence area can still be determinedVascular PED: high fluorescence in the early phase, staining, and leakage in the later phaseScar: similar to FFA, showing irregular high fluorescence, accompanied by blocked fluorescence due to pigment and/or hemorrhage. In the later phase, high fluorescence spot enlarging and scar staining.4.3.2.3. Optic coherence topography
OCT can determine the degree of subretinal effusion and retinal thickening, providing some additional information of FFA and ICGA. Morphological features of CNV in OCT: localized thickening of the reflective layer corresponding to the retinal pigment epithelium/choroidal capillary, showing fusiform or irregular shape with unclear boundary. Exudation and hemorrhage are characterized by serous and/or hemorrhagic retinal and/or PED. The scar on OCT shows that the light band of retinal pigment epithelium/choroidal capillary layer is thickened with a clear boundary and higher reflection. The retinal tissue above the scar usually becomes atrophic and thin.
4. 4. Differential diagnosis
4. 4.1. Idiopathic choroidal neovascularization
Idiopathic choroidal neovascularization is an isolated lesion occurring in the macular area, presenting with exudative choroidal retinopathy with subretinal neovascularization, which will eventually lead to macular scar formation. Most CEC occurs in young- and middle-aged people, unilaterally. There is no gender difference. The clinical manifestations include decreased visual acuity, visual distortion, or micropia. The gray-white infiltrating lesions may be observed in the deep layer of the macular with the round protuberance, blurred edges, about 1/4 optic disc diameter, around by flaky, curved or circular hemorrhage, subretinal exudate. At later stage, white lipid deposition around the lesion may be observed.
4. 4.2. High myopia macular degeneration (high myopia)
Commonly seen in patients with high myopia or the length of the eye axis is longer than 26 mm. Complaints may include visual loss, visual distortion and sudden visual impairment, or accompanied by flash. Pathological changes such as leopard pattern fundus, posterior scleral staphyloma, lacquer cracks, and CNV may be observed. CNV can cause macular hemorrhage and scar formation, mostly occurring in − 11.00D to − 25.00D.
4. 4.3. Retinal angiomatous proliferation
Patients may complain of visual deformities and decreased vision. The fundus examination shows multifocal pre-retinal hemorrhage or intraretinal hemorrhage, and reddish-brown or gray irregular bands under retinal PED radiating from the optic disc, and macular degeneration caused by CNV may also be observed. Varicose retinal vessels are commonly seen due to the anastomosis of retinal vessels and neovascularization in the retina. This is rare in AMD and is the key point for differential diagnosis. In advanced cases, the obvious proliferative membrane may be observed. ICGA has important diagnostic value. Hyperfluorescent spot, also called “hot spot” is commonly seen in the middle and late stage among 70.6% of RAP patients. In some guidelines and expert consensus retinal angiomatous proliferation is defined as a subtype of wet AMD.
4. 4.4. Polypoidal choroidal vasculopathy
Patients with PCV may not have obvious symptoms. If the lesion is in the macular area or nearby, the visual acuity may drop suddenly. Some patients complain of visual distortion. About 30%–60% of the cases present multiple or single orange–red polypoid lesions, deep or preretinal hemorrhage in the fundus, and one or more hemorrhagic or serous retinal pigment epithelium detachment. OCT examination exhibits sharp PED peak, bilayer sign, PED notch, and hyporeflective cavities representing polyps lesion. ICGA is very important for diagnosis. Abnormal branch of the choroid vascular network and aneurysmal bulge can be observed. In some guidelines and expert consensus polypoid choroidal vasculopathy is defined as a subtype of wet AMD.
5. Syndrome Differentiation5. 1. Spleen deficiency with dampness retention syndrome
The vision is deformed and dark. Macular fovea reflection disappears. Pigmentary disorder, drusen, hemorrhage, exudation, and edema are present in the macular area. Head heavy as if swathed, poor appetite and eating less, loose stool, cold limbs, or there is no obvious combination of syndrome. Light tongue with white or yellow greasy coating, wiry pulse, or soggy pulse.
5. 2. Yin deficiency and effulgent fire syndrome
Vision deformation, rapid declining of visual acuity, large fresh hemorrhage at the macular; dry mouth and thirsty, hot flashes, vexing heat, night sweating and profuse dreaming, sour waist and knees, red tongue with thin coating, rapid pulse.
5. 3. Intermingled phlegm-stasis blood syndrome
Vision deformation and decline, long course of disease, scar formation, and large pigmentation in the fundus; general symptoms of fatigue, anorexia; headache, dizziness, palpitations, limb fatigue, chest distention, and discomfort. Purple tongue or tongue body has ecchymosis, light tongue, thin white fur greasy, wiry, and smooth pulse.
5. 4. Qi-blood deficiency syndrome
Vision distortion and decline, with a long course of disease.examination shows drusen, scar, and large pigmentation. Systemic symptoms include fatigue, torpid intake, tooth-marked tongue with white coating, thread, and weak pulse.
5. 5. Liver and kidney yin deficiency syndrome
Blurred and deformed vision, pigmentation in the macular area, the reflex of central fovea unclear or disappearing, drusen scattered around, and scars and large pigmentation found in the late stage. Systemic symptoms may include dry mouth, limp aching lumbus and knees, fatigue, red tongue with thin coating, thread, and weak pulse.
6. Treatment6. 1. Therapeutic principles and methods
The main principles of TCM treatment for AMD are tonifying the kidney and invigorating the spleen, cooling the blood and removing blood stasis, and softening hardness and dissipating mass. Atrophic AMD is often characterized by deficiency, deficiency and blood stasis; therefore, treatment should be focused on tonifying deficiency, as well as activating blood circulation and removing blood stasis. For wet AMD, it can be expected to get a better effect to treat with TCM according to syndrome differentiation combined with anti-vascular endothelial growth factor treatment.
6. 2. Treatment according to syndrome differentiation
6. 2.1. Spleen deficiency with dampness retention syndrome
Treatment: Invigorating the spleen and removing dampness
Prescription: Shenling Baizhu powder (Taiping Huimin Heji formula). (evidence level D, strong recommendation).
Usage: decoct in water, 1 dose a day, take it twice.
6. 2.2. Yin deficiency and effulgent fire syndrome
Treatment: Nourishing Yin and reducing fire
Main recipe: Shengpuhuang Decoction (the six meridians of ophthalmology in traditional Chinese Medicine) (evidence level D, strong recommendation).
Usage: decoct in water, 1 dose a day, take it twice.
6. 2.3. Intermingled phlegm-stasis blood syndrome
Treatment: Softening hardness and dissipating mass, removing blood stasis and phlegm
Main recipe: Huajian Erchen decoction (Yizong Jinjian) (evidence level D, strong recommendation).
Usage: decoct in water, 1 dose a day, take it twice.
6. 2.4. Qi-blood deficiency syndrome
Treatment: Supplementing Qi and nourishing blood
Main recipe: Renshen Yangrong decoction (on three causes and extreme diseases and syndromes) (evidence level D, strong recommendation).
Usage: decoct in water, 1 dose a day, take it twice.
6. 2.5. Liver and kidney yin deficiency syndrome
Treatment: Tonifying liver and kidney
Main recipe: Qiju Dihuang Decoction (medical pole). (evidence level D, strong recommendation).
Usage: decoct in water, one dose a day, take it twice.
6. 3. Traditional Chinese patent medicine
6. 3.1. Shenling Baizhu pill is applicable to spleen deficiency with dampness retention syndrome, 9 g each time, three times a day (expert consensus, strong recommendation).
6. 3.2. Hexue Mingmu tablet is applicable to yin deficiency and effulgent fire syndrome, 5 tablets at a time, three times a day (expert consensus, strong recommendation)
6. 3.3. Zhixue Quyu Mingmu tablet is applicable to yin deficiency and effulgent fire syndrome, 5 tablets each time, three times a day (evidence level B, strong recommendation)
6. 3.4. Erchen pill is applicable to intermingled phlegm-stasis blood syndrome, 9 g each time, twice a day (expert consensus, strong recommendation).
6. 3.5. Bazhen pill is applicable to qi and blood deficiency syndrome, one pill each time, twice a day (expert consensus, strong recommendation)
6. 3.6. Qiju Dihuang pill is applicable to liver and kidney yin deficiency syndrome, 8 g each time, three times a day (evidence level C, strong recommendation).
6. 3.7. Mingmu Dihuang pill is is applicable to liver and kidney yin deficiency syndrome, 8 g each time, three times a day (expert consensus, strong recommendation).
6. 4. Acupuncture
6. 4.1. Body acupuncture
6. 4.1.1. Main points
Taiyang (EX-HN5), Qiuhou (EX-HN7), Jingming (BL1), Sibai (ST2), Guangming (GB37), Tongziliao (GB1), Fengchi (GB20), Chenqi (ST1), Cuanzhu (BL2), Zusanli (ST36), Sanyinjiao (SP6), Yanglao (SI6).
6. 4.1.2. Matching points
Spleen deficiency with dampness retention syndrome: Shenshu (BL23), Pishu (BL20), Zusanli (ST36), Sanyinjiao (SP6), Zhishi (BL52), Taixi (KI3), Fuliu (KI7) and Qugu (CV2).Yin deficiency and effulgent fire syndrome: Sizhukong (TE23), Yifeng(TE17), Yiming (EX-HN 14), Shenshu (BL23), Taichong (LR3) and Shenmen (HT7).
Intermingled phlegm-stasis blood syndrome: Yangbai (GB14), Sizhukong(TE23), Hegu (LI4), Taichong (LR3), Pishu (BL20).
Qi-blood deficiency syndrome: Pishu (BL20), Ganshu (BL18), Shenshu(BL23), Taixi (KI3), Guanyuan (CV4).
6.4.1.3 The operation method
Select 2-3 periorbital acupoints and 2–3 distal acupoints each time, use them in turn, retain the needles for 15–20 minutes, once a day, 10 times as a course of treatment (evidence level D, strongly recommended).
6. 4.2. Ear acupuncture
Acupoints: eye, eye 1, eye 2, liver and kidney (expert consensus, strong recommendation).
ANNEX A
(Informative Appendix)
Evidence Evaluation and Recommendation Principle
A.1. Evaluation and GradeThe evidence classification principle of this guideline is based on the GRADE, randomized controlled trials were initially designated as high-quality evidence, the quality of which could be reduced by five factors, while observational studies were rated as low-quality evidence, but its quality could be increased by three factors. Finally, the quality of evidence is sorted into high, moderate, low, and very low.
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 one. See the table below for details:
A.2 Recommended PrincipleThe fact that most of the studies on the treatment of AMD with 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 attribute to the outcome bias. Therefore, all the evidence are required to obtain expert consensus before being included into the recommendation.
The general principle of the expert consensus is that if the total number of experts who strongly recommend one treatment exceeds 75%, then it is a strong recommendation. If the number of experts who recommend it is below or equal to 50%, then it is not recommended; other situations are sorted into weak recommendation.
ANNEX B
(Informative Appendix)
Announcement of Interest Conflicts
The opinion or interest of the funding institution would not have any impact on this guideline, and all of the members declared that there was not any interest conflicts.
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This work was supported by funds from the National Natural Science Foundation of China (81973912), Special Project of International Cooperation in TCM of the State Administration of Traditional Chinese Medicine (0610-2040NF020931), the China Center for Evidence-Based Traditional Chinese Medicine (2020YJSZX-2) and China Academy of Chinese Medical Sciences Innovation Fund (CI2021A00701-3).
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