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Table of Contents
GUIDELINE
Year : 2021  |  Volume : 7  |  Issue : 2  |  Page : 265-275

International clinical practice guideline of chinese medicine alzheimer


Date of Submission01-Jan-2021
Date of Acceptance10-Feb-2021
Date of Web Publication13-May-2021

Correspondence Address:
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/wjtcm.wjtcm_28_21

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How to cite this article:
. International clinical practice guideline of chinese medicine alzheimer. World J Tradit Chin Med 2021;7:265-75

How to cite this URL:
. International clinical practice guideline of chinese medicine alzheimer. World J Tradit Chin Med [serial online] 2021 [cited 2021 Jun 16];7:265-75. Available from: https://www.wjtcm.net/text.asp?2021/7/2/265/316613




  Foreword Top


Patent issues may be existed in this guideline, and World Federation of Chinese Medicine Societies (WFCMS) declared that they are not responsible for identifying these patents.

This guideline is based on the Clinical Guideline for Diagnosis and Treatment of Internal Medicine of Traditional Chinese Medicine - Alzheimer's Disease (Standard No. T/CACM1315-2019), which was issued by China Association of Chinese Medicine in 2019. Combining evidence of clinical studies at home and abroad in recent years, evidence grading and opinion recommendation were performed. The international clinical practice guideline of Chinese medicine after expert discussion.

The main drafting committee of this guideline: Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine

The drafting committee of this guideline: Xiyuan Hospital of China Academy of Chinese Medical Sciences, Dongfang Hospital of Beijing University of Chinese Medicine, Shuguang Hospital of Shanghai University of Traditional Chinese Medicine, The Second Affiliated Hospital of Changchun University of Chinese Medicine, The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Guangdong Provincial People's Government Organs Outpatient Department, Guangdong Provincial Hospital of Chinese Medicine, Karamay Municipal People's Hospital, Urumqi Hospital of Traditional Chinese Medicine, and Korla People's Hospital.

The leader of the expert steering group: Yun-Ling Zhang

The main drafter of this guideline: Xiao-Ling Hu

The drafters of this guideline: Yue-Hua Li, Cui-Xia Zhao, Abudushalamu, Xiang-Lan Jin, Hui-Qun Pang, Li Sun,

Xian-Hong Su, Jian Wang, Rui-Ping Zhang, Cui-Song Zhang, Hong Chen, Xiao-Ling Dang, Ge-Li Sheng, Zhi Wan

This guideline is drafted according to Measures of International Standard of WFCMS and Guideline Setting and Publishing Work Norms (SCM 0001-2009) by WFCMS.

This guideline is jointly issued by World Federation of Chinese Medicine Societies and China Association of Chinese Medicine.

All rights are reserved.


  Introduction Top


This guideline is implemented under guidance and supervision of the expert steering group for formulating and revising the traditional Chinese medicine (TCM) clinical guideline and the expert steering group in geriatrics and neurology. There is no economic interest with any committee or individual in the revision process.

The purpose of this guideline is to sort out TCM diagnosis and treatment for Alzheimer's disease, to clarify the diagnosis on the name and syndromes, as well as differential diagnosis and treatment criteria of Alzheimer's disease, thus providing suggestions for TCM diagnosis and treatment, and providing reference for TCM clinical practice. The main purpose is to recommend evidence-based TCM diagnosis and treatment for Alzheimer's disease, and to standardize the process of TCM clinical diagnosis and treatment.

Criteria for screening evidence were determined by the literature evaluation group of this guideline. Through searching the CNKI database, 26 literatures that met the inclusion criteria were screened out, and literature quality evaluation and evidence grading were performed. According to the evidence levels, expert consensus was formed, and some literatures with certain value were recommended.

This guideline is based on results of TCM clinical studies on Alzheimer's disease as well as experts' experience. The target group is patients with Alzheimer's disease as the main disease, and the purpose is to provide suggestions for diagnosis, treatment and nursing, which centers on TCM.


  International Clinical Practice Guideline of Chinese Medicine - Alzheimer's Disease Top


1 Scope

This guideline provides suggestions for diagnosis, syndrome differentiation, treatment, prevention, and nursing for Alzheimer's disease (AD).

This guideline is suitable for the diagnosis and treatment for AD in people above 40 years old, and doctors in departments of geriatrics and encephalopathy as well as the TCM departments in general hospitals.


  2 Normative references Top


The following reference document is indispensable for the application of this guideline. For dated reference documents, only the dated version applies. For undated reference documents, the latest version (including any amendments) applies.

Guideline for Diagnosis and Treatment of Dementia and Cognitive Impairment in China (2015)

3 Terms and definitions

The following terms and definitions apply to this guideline.

3.1 Alzheimer's disease

A progressive degenerative disease of the central nervous system with unknown causes. It is also known as senile dementia.

Note 1: AD is regarded as dementia in TCM. Those who are in an old age are liable to deficiency of heart, liver, spleen, and kidney, as a result of which those organs fail to transport and transform essence, leading to endogenous generation of phlegm turbidity, stagnant blood and fire toxicity, marrow deficiency and brain consumption, malnutrition of spirit and apraxia of mental activity, thereby causing AD.

Note 2: It usually starts slowly without being noticed and gradually worsens over time. It mainly manifests as a syndrome of acquired cognitive dysfunction, which includes intelligence disorders (impaired memory, language and visual-spatial functions of varying degrees), personality disorders and decreased cognitive abilities (generalization, calculation, judgment, synthesis, and problem-solving), and is often accompanied by behavioral and emotional disorders, significantly decreased abilities of the patients in daily life, social communication and work, so it is also called senile dementia.

4 Diagnosis

4.1 Diagnosis on the name

The TCM “dementia” is a disorder of mental activity caused by marrow deficiency and brain consumption, which manifests as imbecile, low intelligence, forgetfulness, etc.

4.2 Clinical manifestations and stages

4.2.1 Symptoms in the early stage (duration: 1–3 years)


  4.2.1.1 Memory disorder Top


In the early stage of the disease, memory disorder of recent things is the first symptom found by family members or colleagues. Those with AD ask or answer the same questions repeatedly, forget where things are put, find it difficult to learn new things, and cannot recall what they have remembered.


  4.2.1.2 Other cognitive disorders Top


With aggravation of memory loss, other cognitive disorders are becoming more and more obvious, such as disorders of visual-spatial orientation and graphic orientation, and decreased abilities of judgment and problem-solving. The patients have decreased oral vocabulary and have difficulties in finding proper words, naming things and writing articles.


  4.2.1.3 Personality change Top


Early symptoms include apathy, passiveness, loss of interest, staying at home and sometimes irritable. The patients can take care of themselves and deal with things around them, and may present symptoms like delusion.

4.2.2 Symptoms in the middle stage (duration: 2–10 years)


  4.2.2.1 Severe loss of distant and recent memory Top


It is easy for them to forget new things and develop the disorder of distant memory, such as mistaking relationships with relatives and others. Gradual exacerbation of other cognitive disorders: They have the disorder of visual-spatial orientation and it is easier for them to get lost even in familiar places. Their abilities of judgment and problem-solving are significantly declined. They are becoming more prolix, developing fluent aphasia and becoming vague about abstract vocabulary and concepts. Their computing ability is decreased or even diminished, and their abilities of comprehension and reading are deteriorated.


  4.2.2.2 Significant personality change Top


Their acts are more likely to cause trouble for others. They are less steady and much easier to be provoked. They develop sleep disorders and sleep in the day and stay awake in the night. They have aggressive language and acts, and be suspicious. It is difficult for them to take care of themselves, and they cannot even finish simple acts such as washing dishes and dressing. They are in an agitated state, and delusion may also appear in some patients.

4.2.3 Symptoms in the late stage (duration: 8–12 years)


  4.2.3.1 Severe decline of memory Top


Only fragments of memory remain, and the patients cannot even recognize close family members.


  4.2.3.2 Other cognitive disorders Top


The patients tend to imitate and repeat others' words, and can repeat only short and simple words and phrases over and over, and only understand very simple spoken words. They develop visual sense, orientation and motor dysfunction. Aphasia, agnosia, apraxia, rigidity of limbs, paralysis or epileptic seizures may strike the patients. It is easy for them to fall. Moreover, there is no response to external stimuli. Incontinence appears and their basic life depends on nursing staff.

5 Syndrome differentiation

5.1 Syndrome of marrow deficiency

Becoming deranged as growing older, intelligence decline, or forgetfulness, decline of recent memory, dizziness, tinnitus, dry teeth and hair, soreness and weakness of waist and knees, laziness, sleepiness, walking difficulty, pale and thin tongue, white coating, deep, thready and feeble pulse.

5.2 Spleen-kidney Yang deficiency syndrome

Memory loss, agnosia, acalculia, sluggish look, uncommunicative, inarticulate, soreness and weakness of waist and knees, drowsiness, salivation, cold limbs, anorexia, lacking in strength, abdominal bloating, loose stool, pale and puffy tongue, white or slippery coating, deep, thready and feeble pulse.

5.3 Liver-kidney Yin deficiency syndrome

Decline of memory, comprehension and calculation, sluggish look, slow response, uncommunicative, limited movement, dizziness, or tinnitus, or numb limbs, soreness and weakness of waist and knees, dull-red tongue, or thin and small tongue, thin white tongue coating, or scant coating, deep, thready and feeble (or stringy) pulse.

5.4 Syndrome of Yin deficiency and effulgent fire

Amnesia, agnosia, acalculia, palpitation, insomnia and dreaminess, tidal fever, night sweating, dysphoria with feverish sensation in the chest, palms and soles, thirsty, hectic cheek, or nocturnal emission, lumbago, tinnitus, yellowish urine, red tongue with less fluid, thready, and rapid pulse.

6 Treatment

6.1 Therapeutic principles

General therapeutic principles are as follows. Combination of Chinese Materia Medica and acupuncture is chosen for the early stage, while the focus should be placed on combination of both TCM and western medicine in the middle stage, and intensive care should be adopted in the late stage.

6.2 Treatment with formulas

6.2.1 Syndrome of marrow deficiency

Pathogenesis: Deficiency of kidney essence leading to the failure of nourishing the brain.

Therapeutic methods: Nourishing kidney and spirit, as well as replenishing essence and marrow.

Formula: Bushen Yisui Decoction (Evidence level: II; recommendation level: C).

Composition of the formula: Shudihuang (Radix Rehmanniae Preparata), Shanyurou (Fructus Corni), Ziheche (Placenta Hominis), Guijiajiao (Carapax et Plastrum Testudinis), Xuduan (Radix Dipsaci), Gusuibu (Rhizoma Drynariae), Buguzhi (Fructus Psoraleae), Yuanzhi (Radix Polygalae) and Shichangpu (Rhizoma Acori Tatarinowii).

Recommended traditional Chinese patent medicines: (1) Compound Congrong Yizhi Capsules (Evidence level: II; recommendation level: C), oral administration, 4 capsules at a time, 3 times a day; (2) Roucongrong Zonggan Capsules (Evidence level: II; recommendation level: C), oral administration, 2 capsules a time, 3 times a day.

6.2.2 Spleen-kidney Yang deficiency syndrome

Pathogenesis: Spleen-kidney deficiency leading to qi and blood deficiency.

Therapeutic methods: Warming and tonifying spleen and kidney, as well as generating essence to nourish mental activity.

Formula: Bupi Yishen Decoction in Ancient and Modern Classic Recipes (Evidence level: III; recommendation level: C).

Composition of the formula: Shudihuang (Radix Rehmanniae Preparata), Shanzhuyu (Fructus Corni), Heshouwu (Radix Polygoni Multiflori), Gouqizi (Fructus Lycii), Tusizi (Semen Cuscutae), Yinyanghuo (Herba Epimedii), Renshen (Radix Ginseng), Baizhu (Rhizoma Atractylodis Macrocephalae), Fuling (Poria), Shichangpu (Rhizoma Acori Tatarinowii), Chuanxiong (Rhizoma Ligustici Chuanxiong) and Danggui (Radix Angelicae Sinensis).

6.2.3 Liver-kidney Yin deficiency syndrome

Pathogenesis: Yin deficiency of liver and kidney leading to the failure of nourishing mental activity.

Therapeutic methods: Tonifying liver and kidney, as well as nourishing yin for suppressing hyperactive yang.

Formula: Zuogui Decoction in Jing-yue's Complete Works (Evidence level: III; recommendation level: D).

Composition of the formula: Shudihuang (Radix Rehmanniae Preparata), Gouqizi (Fructus Lycii), Shanzhuyu (Fructus Corni), Shanyao (Rhizoma Dioscoreae), Niuxi (Radix Achyranthis Bidentatae), Tianma (Rhizoma Gastrodiae), Gouteng (Ramulus Uncariae Cum Uncis, decocted later), Chishao (Radix Paeoniae Rubra), Baishao (Radix Paeoniae Alba) and Yujin (Radix Curcumae).

6.2.4 Syndrome of Yin deficiency and effulgent fire

Pathogenesis: Deficiency of heart yin leading to disturbance of heart-mind.

Therapeutic methods: Nourishing yin and tonifying blood, as well as clearing liver-fire.

Formula: Huanglian Jiedu Decoction in Arcane Essentials from the Imperial Library and Tianwang Buxin Pills in Proofread Effective Prescriptions for Women's Diseases (Evidence level: II; recommendation level: C).

Composition of the formula: Suanzaoren (Semen Ziziphi Spinosae), Shengdihuang (Radix Rehmanniae Recens), Renshen (Radix Ginseng), Danshen (Radix Salviae Miltiorrhizae), Xuanshen (Radix Scrophulariae), Baifuling (Poria), Yuanzhi (Radix Polygalae), Jiegeng (Radix Platycodonis), Wuweizi (Fructus Schisandrae Chinensis), Danggui (Radix Angelicae Sinensis), Tiandong (Radix Asparagi), Maidong (Radix Ophiopogonis), Baiziren (Semen Platycladi), Huangqin (Radix Scutellariae), Huangbai (Cortex Phellodendri), Huanglian (Rhizoma Coptidis) and Zhizi (Fructus Gardeniae).

7 Symptomatic treatment

7.1 Senile dementia with decline of intelligence

If the patient is in an old age and suffers from dementia with decline of intelligence, Hailong (Syngnathus), Haima (Hippocampus), Ejiao (Colla Corii Asini, melted) and Lujiaojiao (Colla Corni Cervi, melted) are added; if combined with phlegm-heat and dry stool, Huangqin (Radix Scutellariae), Gualou (Fructus Trichosanthis), Dannanxing (Rhizoma Arisaematis Cum Bile) and Dahuang (Radix et Rhizoma Rhei, decocted later) are added. (Evidence level: III; recommendation level: D)

7.2 Combined with severe blood stasis

If combined with severe blood stasis, Jianghuang (Rhizoma Curcumae Longae), Danshen (Radix Salviae Miltiorrhizae), Honghua (Flos Carthami), Taoren (Semen Persicae), Shuizhi (Hirudo), Yujin (Radix Curcumae), Shichangpu (Rhizoma Acori Tatarinowii) and Yuanzhi (Radix Polygalae) are added (Evidence level: III; recommendation level: D); modified Xuefu Zhuyu Decoction can also be used (Evidence level: III; recommendation level: D). The recommended traditional Chinese patent medicine is Yinxingye Tablets, taken at 2 tablets a time, 3 times a day. (Evidence level: I; recommendation level: B)

7.3 Combined with symptoms of mental activity

For those who have malnutrition of heart spirit resulted from heart qi deficiency, the therapeutic methods are benefiting qi and warming yang to resolve phlegm and calm the mind, and the recommended traditional Chinese patent medicine is Shenzhiling Oral Liquid (Evidence level: I; recommendation level: B), taken at 10 mL a time and 3 times a day, which contains Dangshen (Radix Codonopsis), Guizhi (Ramulus Cinnamomi), Baishao (Radix Paeoniae Alba), Gancao (Radix Glycyrrhizae, prepared), Fuling (Poria), Ganjiang (Rhizoma Zingiberis), Yuanzhi (Radix Polygalae, prepared), Shichangpu (Rhizoma Acori Tatarinowii), Longgu (Os Draconis) and Muli (Concha Ostreae).

For those who have disturbed heart spirit resulted from hyperactivity of heart-liver fire, the therapeutic methods are purging liver-fire and calming the spirit, and the recommended formula is Huanglian Jiedu Decoction (Evidence level: I; recommendation level: B), which contains Huanglian (Rhizoma Coptidis), Huangqin (Radix Scutellariae), Huangbai (Cortex Phellodendri) and Zhizi (Fructus Gardeniae).

For those who have disturbance of the brain caused by blockade of phlegm turbidity with turbid toxicity, the therapeutic methods are opening the sweat pore, and inducing diuresis for eliminating turbidity and removing toxicity, and the recommended formula is Xingnao Powder (Evidence level: II; recommendation level: C), which contains Fuzi (Radix Aconiti Lateralis Preparata), Chuanxiong (Rhizoma Ligustici Chuanxiong), Zexie (Rhizoma Alismatis), Zhizi (Fructus Gardeniae), Baihuasheshecao (Herba Hedyotis), Manjingzi (Fructus Viticis), Xiakucao (Spica Prunellae), Juemingzi (Semen Cassiae), Shichangpu (Rhizoma Acori Tatarinowii) and Yuanzhi (Radix Polygalae).

8 Acupuncture

8.1 Acupuncture prescription (evidence level: III; recommendation level: D)

Conventional acupuncture methods: Main acupoints include Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), Neiguan (PC6), Renzhong (GV26), Taixi (KI3), Dazhong (KI4), Xuanzhong (GB39) and Zusanli (ST36). For those who have liver-kidney yin deficiency, Ganshu (BL18) and Sanyinjiao (SP6) are added; for those who have phlegm turbidity obstructing orifices, Fenglong (ST40) and Zhongwan (GV12) are added; for those who have static blood blocking collaterals, Geshu (BL17), Xuehai (SP10) and Weizhong (BL40) are added. For those who have the excess syndrome, the reducing method or even reinforcing-reducing method is adopted, while for those who have the deficiency syndrome, the reinforcing method is adopted.

8.2 Seven needles on the neck (evidence level: III; recommendation level: D)

Acupoints: Fengfu (GV16), Fengchi (GB20) on both sides, Tianzhu (BL10), Wangu (GB12), Baihui (GV20), Sishencong (EX-HN1), Neiguan (PC6), Xuehai (SP10), Zusanli (ST36) and Taixi (KI3).

Effects: Dredging meridians, regulating qi and blood, clearing the head and benefiting marrow.

Manipulation: After routine local disinfection of all the acupoints, take acupuncture needles (Φ 0.30 × 40 mm, 1.5 inches) of Huatuo Brand. Baihui: Prick the needle obliquely with the tip toward the back of the body for 0.5–1.0 inches (15–25 mm), adopt the even reinforcing-reducing method until there appears tightness and distension in the scalp of the patient. Sishenchong: Prick the needle obliquely with the tip toward the back of the body for 0.5–0.8 inches (15–20 mm), and adopt the even reinforcing-reducing method until there appears tightness and distension in the scalp of the patient. Fengfu: Prick the needle obliquely with the tip toward the mandible for 0.5–1.0 inches (15–25 mm). Fengchi: Prick the needle obliquely with the tip toward the nose tip for 0.8–1.2 inches (20–30 mm). Tianzhu: Prick the needle vertically for 0.5-0.8 inches (15–20 mm). Wangu: Prick the needle vertically for 0.5–0.8 inches (15–20 mm). Neiguan: Prick the needle vertically for 0.5–1.0 inches (15–25 mm). Xuehai: Prick the needle vertically for 1.0–1.5 inches (25–40 mm). Zusanli: Prick the needle vertically for 0.5–1.5 inches (15–40 mm). Taixi: Prick the needle vertically for 0.5–1.0 inches (15–25 mm).

All the above acupoints are treated with the even reinforcing-reducing method after arrival of qi and then the needles are left in situ for 30 mins. The course of treatment: Once every other day for a total of 12 weeks.

8.3 Sanjiao acupuncture (evidence level: II; recommendation level: C)

Acupoints: Danzhong (GV17), Zhongwan (GV12), Qihai (GV6), Xuehai (SP10) on both sides, Zusanli (ST36) on both sides and Waiguan (TE5) on both sides.

Effects: Benefiting qi and regulating blood, as well as invigorating vital qi and building up original qi.

Manipulation: Take 1.5-inch needles of Huatuo Brand. Danzhong: Prick the needle obliquely with the tip toward the head for 0.2–0.5 inches, and then adopt small-amplitude high-frequency twisting method of reinforcing for 30 s. Zhongwan: Prick the needle vertically for 1.5 inches, and then adopt small-amplitude high-frequency twisting method of reinforcing for 30 s. Qihai: Prick the needle vertically for 0.8–1.0 inches, and then adopt small-amplitude high-frequency twisting method of reinforcing for 30 s. Xuehai: Prick the needle vertically for 1.0–1.5 inches and then adopt big-amplitude low-frequency twisting method of reducing for 30 s. Zusanli: Prick the needle vertically for 0.5–1.0 inches, and then adopt small-amplitude high-frequency twisting method of reinforcing for 30 s. Waiguan: Prick the needle vertically for 0.5–1.0 inches, and then adopt the even reinforcing-reducing method of twisting for 30 s. The course of treatment: A total of 24 weeks.

8.4 Implanting catgut in acupoints (evidence level: II; recommendation level: C)

Acupoints: Shenmen (HT7), Fenglong (ST40), Taixi (KI3) and Zusanli (ST36).

Effects: Invigorating kidney and spleen, resolving phlegm and descending turbidity, opening orifices and inducing resuscitation, and treating both manifestation and root cause of disease.

Manipulation: After routine disinfection, 1% lidocaine is given to acupoints respectively for anesthesia, and about 0.3 mL is injected into each acupoint. Take proper catgut and insert it into the lumbar puncture needle. Then fix the acupoint with thumb and index fingers. Use the other hand to take the needle and prick the needle to required depth (1.5 cm in Taixi, 3 cm in Fenglong and Zusanli, and 1 cm in Shenmen toward the head). After arrival of qi through the lifting and thrusting method, withdraw the needle tube while pushing the catgut until it is buried subcutaneously in the acupoint. After pulling out the needle, sterile dry cotton balls (stick) are used to stop bleeding. Then, apply adhesive bandages for 24 h. Such treatment is needed once a month.

9 Other therapeutic methods

9.1 Prevention (Recommendation level: D)

Prevention before disease onset: Attention should be paid to preventing injury and poisoning, actively treating various chronic diseases, as well as avoiding unreasonable use of sedative sleeping pills and anesthetics.

In order to prevent aging of the body in advance, the patients should take part in proper work and exercises, live regularly, eat reasonably, keep a good mood, participate in social activities, and strengthen mental health education.

For those with family history of illness, genetic tests should be taken as early as possible for early detection, prevention and treatment, and regular screening for people over 65 years old is recommended.

9.2 Nursing (recommendation level: D)

Preventing disease from exacerbating: Attention should be paid to nursing.

9.2.1 Psychotherapy

Strengthening mental health education is a supplement to drug treatment. At the same time, doctors should also fully communicate with their families, from whom more understanding and comfort should be elicited for patients. For those AD patients in the early stage who still have consciousness, attention should be paid to emotional adjustment to keep a good mood and to avoid emotional injury. They should be encouraged to participate in various social activities and daily activities, to communicate with each other, thus improving their abilities of communication and speech, and slowing down the degeneration process. Patients should live with their families and relatives if they can, which will help them to have a sense of security, alleviate their feelings of loneliness and fear, and slow down the progress of the disease.

9.2.2 Behavior therapy

Appropriate participation in activities and exercises, such as walking, Taijiquan, finger exercises, tongue exercises, and head massage is recommended to delay the process of dementia. If the patient has visual and spatial dysfunction, and movement difficulties, certain care should be provided to prevent accidents.

9.2.3 Cognitive training

For those with cognitive disorder, especially those who are in the middle and late stages, the training of cognitive function under the guidance of professional rehabilitation personnel is recommended; therefore, they can learn some new knowledge and skills, exercise manual dexterity. The patients are also suggested to read newspapers and periodicals, to learn and use the brain, and to cultivate hobbies.

9.2.4 Life guidance

The patients should be trained to take care of themselves while receiving adequate care. But do not do all for them, and accidents such as self-injury, beating people and smashing objects should be avoided. For patients whose conditions are moderate or severe, they should wear a positioning watch or yellow cuff when they go out for activities, in case they should get lost or hurt. For those who cannot take care of themselves, attention should be placed upon preventing the occurrence of physical diseases. For those who are confined to bed, it is important to keep their urine and stool unobstructed. Moreover, incontinence should also be prevented. Nurses should change their position regularly, turn over their body and pat their back to prevent complications such as bedsores, respiratory infection and urinary infection. Bed sheets and quilts should be replaced every day for long-term bedridden patients.

The ward should be kept clean, comfortable, ventilated regularly and sufficient sunshine. The ward should be quiet so that the patients can have enough sleep. Toilets and anti-skid floors should be installed if it is possible. The patients should be accompanied when going out. Furthermore, if they go out alone, they should carry identification or contact information with them. In a word, the patients should be kept from falling, getting lost and living alone.

9.2.5 Nursing of sleep disorder

Due to impairment of orientation ability, AD patients often confuse daytime with night, thus developing sleep disorders, as a result of which they tend to be quiet and lethargic in the daytime and become restless at night. In view of this situation, the ward should be quiet and all kinds of stimulating factors should be avoided. Before going to bed, they should neither watch stimulating programs, nor drink refreshing drinks, and drugs can help when necessary.

9.2.6 Nursing of medication

Attention should be paid to patients' medication and oral medication should be delivered by hand if possible. Patients with severe psychiatric symptoms should have their oral cavity examined after taking the medicine to ensure that the medicine is swallowed. Medical staff should regularly evaluate and follow-up the patients to adjust treatment plans to slow down the progress of the disease and improve the quality of life.

9.3 Diet therapy (evidence level: III; recommendation level: D)

The patients' diet and daily life should be arranged reasonably. Nutrition intake should be reinforced, with priority be given to food which contains rich protein, low salt, low fat and rich cellulose and which is easy to digest. For patients with difficulty in swallowing or moving, the eating speed should be reduced, while the time should be prolonged to prevent choking. Strict, regular, and quantitative diet is recommended, and dietetic hygiene should also be stressed.

Although the root cause of the disease is kidney deficiency, extra nourishment should not be taken blindly. Light diet is recommended in case the function of the spleen and stomach is influenced, and the patients should not eat too much. The nature of the tonics should not be too warm or dry in case the situation be aggravated when yin is injured and fire is reinforced. Therapeutic diets in TCM are various and syndrome differentiation should also be considered when choosing proper diets. For those who have kidney deficiency and blood stasis, they can choose Shanzha Gouqi Decoction as tea and drink it frequently. For those who have liver-kidney yin deficiency, Guiyuan Gouqi Sangshen Decoction or Shanyurou Porridge is recommended. For those who have deficiency of yin and body fluids, Huangjing Porridge or Yuzhu Porridge is chosen to nourish yin and produce body fluids. For those who have blood deficiency, Longyanrou Porridge is recommended. Renshen Porridge or Huangqi Porridge is recommended for those with qi deficiency. And for those who have spleen deficiency, Changshou Powder which contains Qianshi (Semen Euryales), Yiren (Semen Coicis), Shanyao (Rhizoma Dioscoreae), Jingmi (Semen Oryzae Sativae), Renshen (Radix Ginseng), Fuling (Poria), Lianzi (Semen Nelumbinis), Hetao (Semen Juglandis) and white sugar is recommended.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.


  Appendices Top



  Appendix A Top


(Informative Appendix)


  Methodological Strategies of Guideline Quality Top


A1 Retrieval strategies of clinical symptoms

With search terms of “Alzheimer's disease”, “senile dementia” and “dementia” in the title, the following databases were searched: MEDLINE, COCHRANE Library, Clinical Trial, The National Guideline Clearinghouse (NGC), CNKI, VIP, CBM, Traditional Chinese Medicine Database, Wanfang Data, China Master's Theses Full-text Database (CMFD), etc., In the process of manual retrieval, textbooks, important outdated journals, academic conference papers of Chinese Materia Medica, published standardized documents, published monographs, clinical study results related to modern literature and guidelines, as well as implementation plans of key discipline construction were mainly searched.

The retrieval period was from January 1, 2007, to December 31, 2016.

In the last 10 years, literatures on treatment in TCM and integrated traditional Chinese and western medicine were selected as evaluation objects. Meanwhile, ancient classical medical books and medical records of well-known experts in this field, such as Wang Yongyan, Yan Dexin, Zhu Liangchun and Shen Baofan were selected with search terms of and in TCM.

For studies and reports from the same committee, at the same period, as well as duplicated studies and reports signed by the same author, only one was chosen as the target literature.

According to the above retrieval strategies, the team retrieved 324 modern literatures, 700 ancient documents and 50 books.

A2 Quality evaluation and evidence levels

A2.1 Literature Quality Evaluation

Each clinical literature retrieved was evaluated by the following methods.

  1. Evaluation on randomized clinical trials was based on the Cochrane bias risk assessment tool. Literatures with scores of modified Jadad scale greater than or equal to 1-3 were selected as evidence for this guideline (The Jadad scale is shown in Appendix B). The overall quality of the literatures was poor. There were 2 literatures with Jadad scores >3
  2. In evaluation on non-randomized clinical trials, MINORS items were used. There were 12 scoring indicators, each of which was divided into 0-2 points. The first 8 were for the study without a control group, with a maximum score of 16 points. The last 4 were for the study with a control group, with a maximum score of 24 points. A score of 0 indicated no report; a score of 1 indicated that information was reported but was insufficient; and a score of 2 indicated that the information was reported and was sufficient. Literatures with a total score greater than or equal to 13 were selected as evidence for therapeutic recommendations (The MINORS items are listed in Appendix C). The overall quality of the literatures was poor, and there was no literature whose MINORS score was greater than 13. Criteria for non-randomized clinical trials: Subjects were grouped in a non-randomized manner or given a certain intervention process. For the case of alternate grouping, i.e., grouped with odd or even numbers at the end of numbers of birthdays, hospitalization days, hospitalization and so on, it is defined as a semi-random trial
  3. No cohort studies, meta-analysis and case evaluations were retrieved.


A2.2 Evidence evaluation and grading

Clinical studies that met the above quality requirements could serve as evidence for this guideline: Results of randomized controlled large-sample trials became evidence of high-level recommendations, while those of randomized controlled small-sample trials and non-randomized controlled trials became evidence of secondary or low-level recommendations [Table A1].

A2.3 Grading Criteria of Literature Evidence

  • A2.3.1 The method of literature grading for the revision of TCM clinical diagnosis and treatment guideline was implemented according to “TCM literature evidence grading criteria” of “reference for evidence grading and recommendation intensity” in General Principles for the Compilation of TCM Clinical Diagnosis and Treatment Guidelines (ZYYXH/T).
  • A2.3.2 Recommendation levels (or recommendation intensity) were divided into A, B, C, D and E. The strength was the highest in level A and decreased in turn.
  • A2.3.3 In “grading of research topics” of the criteria, the large sample and small sample were defined as:

    Large sample: High quality single randomized controlled trial report or systematic review report with no less than 100 cases.

    Small sample: High quality single paper with less than 100 cases.
  • A2.3.4 The “expert consensus based on ancient documents” in the level III refers to contemporary expert consensus on things recorded in ancient medical records and have been used till today. The “contemporary expert consensus based on survey opinions” in the level IV. The “expert opinions” in the level V only refers to individual experts' opinions. According to the above, the number of literatures of different levels is summarized in [Table A2] and [Table A3].


A3 Recommendation levels

Recommendation levels according to the working group of evidence grading:

  1. Recommended to use: There is sufficient evidence to support its treatment, and it should be used (based on evidence of level I). Here are 4:


  2. Shenzhiling Oral Liquid, from: Li Mao, Wang Heng, Song Yu, Xu Meng. Effect of “Shenzhiling Oral Liquid” on behavioral and psychological symptoms of dementia in patients with Alzheimer's disease. Academic Journal of Shanghai University of Traditional Chinese Medicine, 2014, 28 (6): 20-25. (Evidence level: I; recommendation level: B).

    Huanglian Jiedu Decoction, from: Chen Guohua, Shan Ping, Qiu Xin. The clinical study on Huanglianjiedu Decoction on for patients with senile dementia, the type of hyperactivity of heart-fire and liver fire in TCM. Journal of Emergency in Traditional Chinese Medicine, 2007, 16 (4): 386-387,343. (Evidence level: I; recommendation level: B).

    If combined with static blood obstruction and stagnation, the traditional Chinese patent medicine of Yinxingye Tablets is recommended. From: Zhao Mingxing, Dong Zhenhua, Yu Zhonghai et al. Effects of Ginkgo biloba extract in improving episodic memory of patients with mild cognitive impairment: a randomized controlled trial. Journal of Chinese Integrative Medicine, 2012, 10 (6): 630-634. (Evidence level: I; recommendation level: B).

    Nursing, from: Cui Jinqiao. Clinical nursing analysis on 126 patients with Alzheimer's disease. Chinese and Foreign Medical Research, 2012, 10 (9): 88-89. (Evidence level: I; recommendation level: B).

  3. Selectively recommended to use: There is evidence to support it, but it is not enough, and it can be used under certain conditions (based on evidence of level II/III). Here are 11:


  4. Bushen Yisui Decoction, from: Han Sujing, Gu Yun, Huang Kai, Sun Guojun. Clinical study on the method of replenishing kidney and marrow in the treatment of senile dementia with kidney and marrow deficiency. Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease, 2016,14 (5): 547-548. (Evidence level: II; recommendation level: C).

    Compound Congrong Yizhi Capsules, from: Wang Shuihong. Clinical observation on 34 cases of Alzheimer's disease treated with Compound Congrong Yizhi Capsules. Zhejiang Journal of Traditional Chinese Medicine, 2015, 50 (5): 386-387. (Evidence level: II; recommendation level: C).

    Roucongrong Zonggan Capsules, from: Wang En, Huang Qin, Huang Miwu, et al. Observation on efficacy of Roucongrong Zonggan Capsules in treating Alzheimer's disease. Zhejiang Journal of Integrated Traditional Chinese and Western Medicine, 2011, 21 (10): 699-701. (Evidence level: II; recommendation level: C).

    Bupi Yishen Decoction, from: Li Hong. Bupi Yishen Decoction in treating 35 cases with Alzheimer's disease. Chinese Journal of Experimental Traditional Medical Formulae, 2015, 21 (5): 193-196. (Evidence level: II; recommendation level: C).

    Huanglian Jiedu Decoction combined with Tianwang Buxin Pills, from: Liu Na. Observe on the curative effect of Huanglian Jiedu decoction combined with Tianwang Buxin Dan in the treatment of heart and liver yin deficiency type senile dementia. Modern Journal of Integrated Traditional Chinese and Western Medicine, 2016, 25 (3): 1271-1273. (Evidence level: II; recommendation level: C).[27]

    Huanglian Jiedu Decoction, from: Chen Yali. Clinical efficacy analysis on Huanglian Jiedu Decoction in the treatment of senile dementia. Clinical Research, 2017, 25 (3): 27-28. (Evidence level: II; recommendation level: C).

    Xingnao Powder, from: Chang Fuye, Zhang Yunling. Clinical study on treating senile dementia with chinese herb powder with effect of restoring consciousness. Tianjin Journal of Traditional Chinese Medicine, 2008, 25 (2): 368-369. (Evidence level: II; recommendation level: C).

    Seven needles on the neck, from: Han Lepeng, Yang Dianhui. The observation of the clinical curative effect of acupuncture therapy with seven-point in nape for Alzheimer's disease. Jinan: Shandong University of Traditional Chinese Medicine, 2011. (Evidence level: III; recommendation level: D).

    Sanjiao acupuncture, from: Hu Qichao, Sun Zhaoyuan. Forty cases of senile dementia treated with the acupuncture method of tonifying qi, regulating blood circulation, invigorating vital qi and building up original qi. Shaanxi Journal of Traditional Chinese Medicine, 2010, 31 (3): 343-344. (Evidence level: III; recommendation level: C).

    Implanting catgut in acupoints, from: Zhou Youlong, Jia Jianping. Clinical observation on catgut implantation at acupoint for treatment of Alzheimer's disease. Chinese Acupuncture and Moxibustion, 2008, 28 (1): 37-40. (Evidence level: II; recommendation level: C).

    Nursing, from: Zou Jiali, Xu Huan. Clinical observation on effects of rehabilitation nursing in traditional chinese medicine on self-care ability and mental status of senile dementia patients. Journal of Guiyang College of Traditional Chinese Medicine, 2015, 37 (5): 70-71. (Evidence level: II; recommendation level: C).

  5. Recommended not to use: Most of the evidence suggests that the effects are bad or the disadvantages outweigh the advantages. (based on evidence of level II/III) No information of such literature
  6. Forbidden to use: There is sufficient evidence showing no efficacy or the disadvantages outweighing the advantages (based on evidence of level I) No information of such literature.


Evaluation on the guideline

A total of 4 reviewers, including experts in clinical and methodological fields, evaluated the guideline using AGREE. They scored an average of 5.5 points in the overall evaluation on the guideline and agreed to recommend the guideline.








  Appendix B Top


(Informative Appendix)


  Modified Jadad Scale Top


B.1 Methods of random grouping sequences

  • B.1.1 Random sequences were generated by the computer or random number table (2 points)
  • B.1.2 Random allocation was mentioned in the trial, but the method was not explained (1 point)
  • B.1.3 Semi-randomized or quasi-randomized trials refer to those which used alternate allocation of cases, such as admission order, odd or even number birthdays, etc., (0 points).


B.2 Double-blind method

  • B.2.1 A specific double-blind method was described and considered appropriate, such as the use of a completely consistent placebo (2 points)
  • B.2.2 The trial only mentioned the use of a double-blind method (1 point)
  • B.2.3 The trial mentioned the use of a double-blind method, but the method was inappropriate, such as comparing tablets and injections without mentioning the use of a double-pseudo method (0 points).


B.3 Drop-out and missing visits

  • B.3.1 Detailed description of the number and reasons of cases of drop-out and missing visits (1 point)
  • B.3.2 No mention of drop-out and missing visits (0 points).



  Appendix C Top


(Informative Appendix)

MINORS Items





 
  References Top

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Han SJ, Gu Y, Huang K, Sun GJ. Clinical study on the method of replenishing kidney and marrow in the treatment of senile dementia with kidney and marrow deficiency. Chin J Integr Med Cardio Cerebrovasc Dis 2016;14:547-8.  Back to cited text no. 6
    
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  In this article
Foreword
Introduction
International Cl...
2 Normative refe...
4.2.1.1 Memory d...
4.2.1.2 Other co...
4.2.1.3 Personal...
4.2.2.1 Severe l...
4.2.2.2 Signific...
4.2.3.1 Severe d...
4.2.3.2 Other co...
Appendices
Appendix A
Methodological S...
Appendix B
Modified Jadad Scale
Appendix C
References

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