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EVIDENCE-BASED INTEGRATIVE MEDICINE Appraisal of Clinical Practice Guidelines for Ischemic Stroke Management in Chinese Medicine with Appraisal of Guidelines for Research and Evaluation Instrument: A Systematic Review YUWEN Ya (宇文亚)1, SHI Nan-nan (史楠楠)1, HAN Xue-jie (韩学杰)1, GAO Ying (高 颖)2, XU Jian-long (徐建龙)3, LIU Da-sheng (刘大胜)1, Bacon Ng4, Dora Tsui4, ZHONG Li-dan (钟丽丹)5, Eric Ziea4, BIAN Zhao-xiang (卞兆祥)5, and LU Ai-ping (吕爱平)1,5 Objective:: To systematically review the clinical practice guidelines (CPGs) for ischemic stroke in ABSTRACT Objective Chinese medicine (CM) with the Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) instrument. Methods:: CM CPGs for ischemic stroke were searched in 5 online databases and hand-searches in CPGMethods related handbooks published from January 1990 to December 2012. The CPGs were categorized into evidence based (EB) guideline, consensus based with no explicit consideration of evidence based (CB-EB) guideline and consensus based (CB) guideline according to the development method. Three reviewers independently appraised the CPGs based on AGREE Ⅱ instrument, and compared the CPGs' recommendations on CM Results:: Five CM CPGs for ischemic stroke were identified and included. pattern classification and treatment. Results Among them, one CPG was EB guideline, two were CB guidelines and two were CB-EB guidelines. The quality score of the EB guideline was higher than those of the CB-EB and CB guidelines. Five CM patterns in the CPGs were recommended in the EB CPG. The comprehensive protocol of integrative Chinese and Western medicine recommended in the EB CPG was mostly recommended for ischemic stroke in the CPGs. The recommendations Conclusion:: The quality of EB CPG was higher than those of CB and CB-EB varied based on the CM patterns. Conclusion CPGs in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions. KEYWORDS clinical practice guideline, ischemic stroke, Appraisal of Guidelines for Research and Evaluation, systematic review
Clinical practice guideline (CPG), as a systematically developed statement, is a document with the aim of guiding the decisions and criteria regarding the diagnosis, treatment in specific areas of healthcare.(1) Stroke is the leading cause of serious, long-term disability disease that affects about 15 million people worldwide each year, of these, 5 million die and another 5 million are permanently disabled. (2) It is mainly categorized as apoplexy in Chinese medicine (CM), and about 85 percent of strokes are ischemic strokes. Thrombolysis, as the most successfully therapy for acute ischemic stroke, is rarely totally effective in treating ischemic stroke for the strict therapeutic time window and some pharmacological therapies have the potential to cause side events.(3,4) CM interventions have proven to be beneficial for patients with ischemic stroke.(5) In recent years, increasing numbers of stroke patients have sought CM to improve physical functions.(6-9) As more patients start using CM, conventional health care practitioners increasingly feel the need to acquaint themselves with CM.(10-12) In such a case, CPG could
become an important guideline for them in the clinical practice, and issued CM CPGs for ischemic stroke management could not only assist in designing CM clinical trials regarding ischemic stroke diagnosis and treatment,(13) but also guide some CM practitioners in the real practice.
©The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag Berlin Heidelberg 2014 Supported by the projects from the State Administration of Traditional Chinese Medicine (No. ZYYS-2011[0032]-2), the China Academy of Chinese Medical Sciences (No. Z0135, Z0260, and Z0221), and the Hong Kong Hospital Authority 1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing (100700), China; 2. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing (100700), China; 3. Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing (100091), China; 4. Chinese Medicine Department, Hong Kong Hospital Authority, Hong Kong SAR, China; 5. School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, SAR, China Correspondence to: Prof. LU Ai-ping, Tel: 86-852-34112457, Fax: 86-852-34112461, E-mail: [email protected]; Prof. HAN Xue-jie, Tel: 86-10-64014411 Ext. 3312, Fax: 86-1084032881, E-mail: [email protected] DOI: 10.1007/s11655-014-1834-2
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Over the past 2 decades, increasing numbers of CM CPGs for ischemic stroke have been issued, providing the normative diagnostic and therapeutic methods for the clinical practitioners in China. (13) With the exponential increase in CPG production, concerning about their quality has risen,(14,15) some clinical practitioners are frustrated by facing many CM CPGs for ischemic stroke at the same time, as they were not clear about their quality. Therefore, this study is aimed to assess the quality of CM CPGs for ischemic stroke using the Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) instrument to identify their quality with the hope of contributing to a better quality of CPG development and revision.
METHODS Data Sources and Searches The data from 5 databases were collected from January 1990 to December 2012 to identify CM CPGs for ischemic stroke management. Two international specific public databases for CPG: National Guideline Clearinghouse and Guidelines International Network were searched for the CM CPGs for ischemic stroke. Since there is no specific public database in China for CM CPGs, we searched for CM CPGs on 3 public databases: Community Support Services of Niagara (http://www.cssn.net.cn), which is the largest comprehensive standard service wed site in China, SinoMed (http://www.sinomed.ac.cn) and China National Knowledge Infrastructure (http://www.cnki.net), which are the main sources of professional technical literature on biomedicine in China. The following search terms were used: "clinical practice guideline," "traditional Chinese medicine", "Chinese medicine", "ischemic stroke" and "apoplexy". The search was supplemented with a manual search of handbooks in China.
Records identified by computer searches (n =371)
Records identified by manual searches (n =8)
Deleting duplicate records (n =368)
Full text paper (n =12)
Records excluded due to not meet inclusion criteria through title and abstract (n =356)
Included (n =5)
Inclusion criteria not meet through full text evaluated (n =7)
Systematic review (n =5)
Figure 1. Identification of Clinical Practice Guidelines in CM for Ischemic Stroke
classification and treatment.
Categorization of CPGs CPGs were categorized into evidence based (EB) guideline, consensus based with no explicit consideration of evidence based (CB-EB) guideline and consensus based (CB) guideline according to the development method. (16) CB is developed by the agreement with a group of experts. EB is developed after the systematic retrieval and appraisal of information from the literature. It usually includes strategies for describing the strength of the evidence, and try to clearly separate opinions from evidence they make statements not just about which of two treatment options is "better", but quantity the absolute difference in outcome, including both benefits and harm.(17) CB-EB is developed by combining a consensus of experts and a less formal literature analysis to create evidence.
Quality Appraisal Data Selection Figure 1 shows the process for selecting the articles. In step 1, the titles and abstracts for the articles retrieved by our literature searches were screened by two independent reviewers for potential relevant to this study. In step 2, we excluded the abstracts published in conference book. The inclusion criteria for the articles were as followings: the title was named as ischemic stroke/apoplexy and guideline and traditional Chinese medicine/Chinese medicine; and the guideline was produced at national authorities or national academic associations or professional administration organizations, and the guideline recommendations were on pattern
The quality of each selected CPG was evaluated independently by 3 reviewers (Yuwen Y, Shi NN, Xu JL) using the AGREE Ⅱ instrument. The reviewers have rich experience in CM CPGs development and are familiar with the AGREE Ⅱ usage. Before applying the AGREE Ⅱ, the reviewers first carefully read the CM CPGs for ischemic stroke and all information about the CPGs development process. AGREE Ⅱ consists of 6 domains divided into 23 items and each domain shows the distinct dimension of guideline quality (Table 1). Each item is rated from 1 (strongly disagree) to 7 (strongly agree). The
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Table 1.
AGREE Ⅱ Instrument
Domain
No. of Item
Scope and purpose
3 items
Stakeholder involvement
3 items
Rigor of development
8 items
Systematic methods were used to search for evidence. The criteria for selecting the evidence are clearly described. The strengths and limitations of the body of evidence are clearly described. The methods for formulating the recommendations are clearly described. The health benefits, side effects, and risks have been considered in formulating the recommendations. There is an explicit link between the recommendations and the supporting evidence. The guideline has been externally reviewed by experts prior to its publication. A procedure for updating the guideline is provided.
Clarity of presentation
3 items
The recommendations are specific and unambiguous. The different options for management of the condition or health issue are clearly presented. Key recommendations are easily identifiable.
Applicability
4 items
The guideline describes facilitators and barriers to its application. The guideline provides advice and/ortools on how the recommendations can be put into practice. The potential resource implications of applying the recommendations have been described. The guideline presents monitoring and/or auditing criteria.
Editorial independence
2 items
The views of the funding body have not influenced the content of the guideline. Competing interests of the guideline development group members have been recorded and addressed. Rated the overall quality of the guideline. I would recommend this guideline for use.
Overall guideline assessment
Detailed criteria The overall objective(s) of the guideline is (are) specifically described. The health question(s) covered by the guidelines is (are) specially described. The population (patients, public, etc) to whom the guideline is meant to apply are specifically described. The guidelines development group includes individuals from all relevant professional groups. The views and preferences of the target population (patients, public, etc) have been sought. The target users of the guideline are clearly defined.
appraisers were asked to give each item assessment according to the detailed criteria within the AGREE Ⅱ tool. Upon completing the 23 items, they also were asked to give an overall assessment of guideline from 1 (lowest) to 7 (highest) and to state if they would recommend the guideline, recommend with modifications or not recommend it.(18) Average appraisal scores were calculated for each appraiser by taking the average rating for all items of a single guideline.(1-7) From this, the overall average appraisal scores and deviations were calculated for 3 appraisers for a single guideline. Domain scores of the guideline were calculated by summing up all the scores of the individual items in a domain and by scaling the total as a percentage of the maximum possible score for that domain for interdomain comparison. Besides that, the average scores of each domain for the guidelines were calculated.
Guideline Comparison In addition to the quality, we compared the guideline recommendations in 3 areas addressed by the CM CPGs for ischemic stroke management: (1) CM pattern classification: The most common CM patterns that are associated with ischemic stroke were explored
based on their frequency. (2) Interventions for ischemic stroke management: CM interventions in the CPGs were extracted and the interventions recommended by most CPGs were obtained. (3) Indications for prescription and withdrawal of the interventions: The indications of the most common therapeutics recommended in the CPGs were explored based on their usage. All data was extracted and analyzed by 2 independent reviewers, and the difference was resolved by consensus.
RESULTS General Information about the CM CPGs We identified 379 titles, of which 12 full articles were assessed for eligibility and 5 CM CPGs for ischemic stroke satisfied the inclusion criteria.(19-23) After 2000, the number of CM CPGs for ischemic stroke has increased rapidly. Among these CPGs, the proportion of the EB guideline was small (1, 20%), indicating that EB has not been a major part of CM CPGs for ischemic stroke treatment, as shown in Table 2. The only EB CPG was supported by World Health Organization/ Western Pacific Region (WHO/WPR), but others by national organizations and academic associations.
Quality Assessment of the CM CPGs Average appraisal scores and average overall
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Table 2. No.
Title
CPGs in CM for Ischemic Stroke from 1990–2012
Publish date
Issued by
Funding
Category
Level
1
Evidence-based guideline of ischemic stroke in traditional Chinese medicine
2011
China Press of Traditional Chinese Medicine
WHO/WPR
EB
Academic association level
2
Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine
2008
China Press of Traditional Chinese Medicine
SATCM
CB-EB
Academic association level
3
Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine
2008
China Press of Traditional Chinese Medicine
SATCM
CB-EB
Academic association level
4
Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs
2002
Chinese Medical Science and Technology Press
SFDA
CB
Professional administration level
5
Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine
1996
Encephalopathy emergency group, SATCM
SSTC
CB
Academic association level
Notes: The guidelines were all published in Chinese. WHO/WPR: World Health Organization/Western Pacific Region; SATCM: State Administration of Traditional Chinese Medicine of the People's Republic of China; SFDA: State Food and Drug Administration; SSTC: State Science and Technology Commission; CPG: clinical practice guideline; EB: evidence based guideline; CB: consensus based guideline
Table 3.
Appraiser Recommendations for Use of the CPGs in CM for Ischemic Stroke
Title
Average Score
Apr 1
Apr 2
Apr 3
Average
SD
Evidence-based guideline of ischemic stroke in traditional Chinese medicine
Average
5
6
4
5.0
0.9
Overall assessment
5
6
5
5.3
0.5
Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine
Average
2
3
2
2.3
0.5
Overall assessment
2
4
2
2.7
0.9
Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine
Average
2
3
2
2.3
0.5
Overall assessment
2
4
2
2.7
0.9
Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs
Average
3
3
2
2.7
0.5
Overall assessment
2
4
2
2.7
0.9
Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine
Average
2
3
2
2.3
0.5
Overall assessment
3
5
2
3.3
1.2
Notes: Apr: appraiser; SD: standard deviation
assessments for the CM CPGs for ischemic stroke are shown in Table 3. The overall average assessment scores of the quality of EB CPG (5.3±0.5) were higher than those of CB-EB CPGs (2.7±0.9, 2.7±0.9) and CB CPGs (2.7±0.9, 3.3±1.2). The overall assessment averages were higher than the average scores calculated from the individual items. Two appraisers recommended the EB with modifications, while one recommended the EB without modifications. Two appraisers did not recommend the CB-EB and CB CPGs for use, while one appraiser recommended them with modifications according to the AGREE Ⅱ assessment (Table 4). Figure 2 showed that the EB CPG had higher domain scores than those of the CB-EB and CB CPGs, but we did not find the obvious difference between CB-
EB and CB CPGs. The details are as followings: (1) Scope and purpose: The health questions covered by the guideline were not well described in the CPGs. Among the guidelines, the EB CPG scored 70%, two CB-EB CPGs scored 20% and 17%, and two CB CPGs scored 13% and 31%. (2) Stakeholder involvement: The majority of guideline development groups did not involve nurses' and patients' perspective. Among the CPGs, the EB CPG scored 67%, two CB-EB CPGs scored 13% and 13%, and two CB CPGs scored 15% and 26%. (3) Rigor of development: Only the EB guideline had described the search methods of the evidence in details, and the levels of evidence and grading of recommendations were reported clearly, through which the link between recommendations and supporting evidence is explicit. Nearly all CPGs had undergone internal and external expert review before published. The
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Table 4. Recommendations on Pattern Classification in the CPGs in CM for Ischemic Stroke Title
Patterns A
B
C
D
E
F
G
Evidence-based guideline of ischemic stroke in traditional Chinese medicine
•
•
•
•
•
•
•
H
I
J
K
Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine
•
•
•
•
•
•
•
Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine
•
•
•
•
•
•
•
•
Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs
•
•
•
•
•
•
•
Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine
•
•
•
•
•
•
•
Notes: A: Internal obstruction of phlegm-heat pattern (Sudden onset, loss of consciousness, nasal snore and wheezy phlegm, hemiplegia, stiffness and spasm in the affected limb, feverish sensations in the nape and neck, restlessness, or cold extremities and convulsion, a red tongue with a yellow and greasy and dry coating and a wiry, slippery and rapid pulse). B: Phlegm misting the heart-mind pattern (Loss of consciousness, hemiplegia, deviation of tongue and mouth, profuse sputum or salivation, a pale complexion and dark lips, incontinence of urine and stool, a dark-purple and atrophic tongue with a white and greasy coating, sunken, slippery and moderate pulse). C: Declining and failure of vital-primordial qi pattern (Loss of consciousness, closed eyes with mouth open, paralysis and weakness of the affected limb, cold extremities, sweats, incontinence of urine and stool, a dark-purple and atrophic tongue with a white and greasy coating, extremely faint pulse). D: Wind phlegm obstructing the meridians pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, numbness in the affected limb, dizziness, stick mouth with profuse sputum, dark-red tongue with a white and greasy coating, wiry and slippery pulse). E: Phlegm-heat in the fu-organs pattern (Hemiplegia, stiffness and spasm of the effected limbs, slurred speech, deviation of the tongue and mouth, abdominal distension and constipation, dizziness, blurred vision, stick mouth with profuse sputum, a red tongue with yellow and greasy coating, a wiry and slippery pulse). F: Syndrome of blood stasis due to qi deficiency (Hemiplegia, paralysis and weakness of the affected limbs, deviation of the tongue and mouth, a bright pale complexion, shortness of breath, lassitude, numbness in the affected side, palpitation, spontaneous sweating, a dark tongue with a thin and white or white and greasy coating, a sunken and fine pulse). G: Wind-stirring due to yin deficiency pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, numbness in the affected limb, feverish sensations in palms, soles and chest, dizziness, blurred vision, a red tongue with no or a scanty coating, thread, fine and rapid pulse). H: Upward-disturbance of wind-fire pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, numbness in the affected side, headache with a distending sensation, a red face and eyes, irritability, constipation, bloody urine, a red tongue with a yellow coating, wiry and rapid pulse). I: Hyperactivity of wind-phlegm and fire pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, sensory deprivation, sudden onset, dizziness, irritability, stiffness and spasm of the affected limb, stick mouth with profuse sputum, a red tongue with a yellow and greasy coating, wiry and slippery pulse). J: Wind-phlegm and stasis obstructing the meridians pattern (Hemiplegia, deviation of the mouth and tongue, slurred speech, sensory deprivation, dizziness, stick mouth with profuse sputum, a dark-red tongue with white thin or white and greasy coating, a wiry and slippery pulse). K: Phlegm-dampness misting the heart-mind pattern (Hemiplegia, deviation of the mouth and tongue, slurred speech, sensory deprivation, loss of consciousness, wheezy phlegm, incontinence of urine and stool, a dark-purple with white and greasy coating, a deep and moderate and slippery pulse).
procedure of updates was considered in few guidelines. The EB CPG scored 74%, two CB-EB CPGs scored 17% and 13%, and two CB CPGs scored 13% and 19%. (4) Clarity of presentation: Key recommendations of most CPGs were easy to identify. All CPGs had no tools for application. The EB CPG scored 69%, two CB-EB CPGs scored 37% and 48%, and two CB CPGs scored 26% and 30%. (5) Applicability: All CPGs did not define clearly the potential cost implications or any details of the barrier from other organizations during the application of CPGs, and did not present performance monitoring indicators. The EB CPG scored 35%, two CB-EB CPGs scored 6% and 10%, and two CB CPGs scored 8% and 11%. (6) Editorial independence: Few CPGs had the definition of the editorial independence or the conflict of
interest of the guideline authors. The EB CPG scored 50%, two CB-EB CPGs scored 19% and 22%, and two CB CPGs scored 33% and 28%. Furthermore, the lowest average scores of the domains were found for applicability (14%), as shown in Figure 3.
Comparison of Recommendations in the CM CPGs Recommended CM Patterns in the CPGs Eleven single CM patterns were recommended in the CM CPGs for ischemic stroke. The industry got consensus on 7 CM patterns of ischemic stroke in the "Evidence-based guideline of ischemic stroke in traditional Chinese medicine" over time (Table 4). In the pattern distribution, the top 7 CM patterns in the CM
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CPG1 CPG2 CPG3 CPG4 CPG5
80 70 60 50 40 30 20 10 0
S pu cop rp e os an e d St in ak vo eh lv ol em de en r t R de igo ve r o lo f pm en C t pr lari es ty en of ta tio n Ap pl ic ab ilit y Ed in ito de ri a pe l nd en ce
Score (%)
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Figure 2. Scaled Domain Scores of the CPGs in CM for Ischemic Stroke according to the AGREE Ⅱ Instrument Notes: CPG 1: Evidence-based guideline of ischemic stroke in traditional Chinese medicine. CPG 2: Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine. CPG 3: Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine. CPG 4: Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs. CPG 5: Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine Scope and purpose Stakeholder involvement Rigor of development Clarity of presentation Applicability Editorial independence 0
0.1
0.2
0.3
0.4
0.5
Average score
Figure 3. Average Domain Score of the CPGs in CM for Ischemic Stroke According to the AGREE Ⅱ Instrument
CPGs for ischemic stroke included phlegm-heat excess syndrome (5; 100%), pattern of blood stasis due to qi deficiency (5; 100%), stirring wind due to yin deficiency pattern (5; 100%), pattern of phlegm-heat blocking internally (3; 60%), pattern of orifices confused by phlegm (3; 60%), pattern of source qi collapse (3; 60%), pattern of wind phlegm blocking collaterals (3; 60%).
Recommended Interventions in the CPGs As shown in Table 5, Chinese herbal decoction, Chinese patent medicine (CPM), acupuncture, massage, medicated bath and rehabilitation training comprised the CM approaches in the CPGs for ischemic stroke management. In general, the comprehensive protocol of integrative Chinese and Western medicine was recommended for the ischemic stroke patients with top 7 CM patterns. Specifically, ischemic stroke patients with the top 7 CM patterns were recommended treating with diversified therapies based on their CM patterns. For example, ischemic stroke patient with phlegm-heat excess syndrome was recommended treating with Xinglou
Chengqi Decoction (星蒌承气汤), Dachengqi Decoction (大承气汤), Dachaihu Decoction (大柴胡汤), Qingkailing Injection (清开灵注射液), Didang Decoction (抵当汤), and Niuhuang Qingxin Pill (牛黄清心丸). Acupuncture and medicated bath are popularly recommended by all CPGs. The commonly used acupuncture points recommended in the CPGs were Nei Guan (P36), Shui Gou (DU26), San Yin Jiao (SP6), Ji Quan (HT1), Chi Ze (LU5) and Wei Zhong (BL40). Some commonly used herbs for medicated bath for ischemic stroke were Aconiti Radix Cocta, Aconiti Kusnezoffii Radix Cocta , Carthami Flos , Chuanxiong Rhizoma , Mori Ramulus , Angelicae Radix and Caulis Trachelospermi. The therapeutics should be adjusted on the basis of the change of CM patterns.
Indications and Recommended Protocols The EB CPG showed that acupuncture should be used as early as possible when the ischemic stroke patient's condition was stable, massage was effective for the ischemic stroke patients with limb spasm, medicated bath was recommended for post-stroke shoulder-hand syndrome patients, and the Western rehabilitation training should be used for ischemic stroke patients with some complications in restoration stage and sequel stage. In general, the ischemic stroke patients with the important 7 CM patterns could be treated with the comprehensive therapy protocol of integrateive Chinese and Western medicine.
DISCUSSION Compared to the previous systematic review,(24) we reported not only the quality of CM CPGs for ischemic stroke management in China but also the consistency of their commendations. In regard to the quality of CM CPGs for ischemic stroke, the AGREE Ⅱ assessment showed that the quality of the EB CPG for ischemic stroke was higher than those of CB-EB and CB CPGs, which agreement with the published. (16,25-28) CM CPGs for ischemic stroke could be categorized as CB, CB-EB and EB guideline, according to the development method. EB CPG is the mainstream and trend of guideline development, because CB and CB-EB CPGs could not reflect the current medical knowledge and were liable to bias(29,30) and it has better quality than CB and CB-EB CPGs.(16) Since CM depends much upon experts' experience, the majority of CM CPGs for ischemic stroke were developed by expert consensus method, CB and CB-EB CPGs were the mainstream
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Recommendations on Management in the Clinical Practice Guidelines in CM for Ischemic Stroke CPG1
Pattern
CHM and CPM
CPG2 Rehabilitation approaches
Rehabilitation approaches
CHM and CPM Lingyangjiao Decoction Huanglian Jiedu Decoction Angong Niuhuang Pill Jufang Zhibao Dan
Rehabilitation training Acupuncture Massage Medicated bath
CHM and CPM
A
Lingyangjiao Decoction (羚羊角汤) Angong Niuhuang Pill Jufang Zhibao Dan (局方至宝丹) Niuhuang Qingxin Pill
B
Ditan Decoction (涤痰汤) Suhexiang Pill (苏合香丸)
Ditan Decoction Suhexiang Pill
Ditan Decoction Suhexiang Pill Xingnaojing Injection (醒脑静注射液)
C
Shenfu Decoction (参附汤) Sini Decoction (四逆汤) Shengmai Drink (生脉饮)
Shenfu Decoction
Shenfu Decoction Shengmai Powder Shenfu Injection (参附注射液) Shenmai Injection (生脉注射液)
D
Huatan Tongluo Decoction (化痰通络汤) Tongmai Capsule (通脉胶囊) Xinmaitong Capsule (通脉胶囊)
Huatan Tongluo Decoction
Huatan Tongluo Decoction Quantianma Capsule (全天麻胶囊) Zhongfeng Huichun Pill (中风回春片)
E
Xinglou Chengqi Decoction Dachengqi Decoction Dachaihu Decoction
Xinglou Chengqi Decoction Didang Decoction
Xinglou Chengqi Decoction Dachaihu Decoction Xinqingning Tablet (新清宁片) Niuhuang Qingxin Pill Qingkailing Injection
F
Buyang Huanwu Decoction (补阳还五汤) Naoxintong Pill (脑心通片) Tongxinluo Pill (通心络片)
Buyang Huanwu Decoction
Buyang HuanWu Decoction Naoxintong Pill Nao' an Pill (脑安片) Xiaoshuan Tongluo Pill (消栓通络片) Shengmai Injection
G
Zhengan Xifeng Decoction (镇肝熄风汤) Yuyin Xifeng Decoction (育阴熄风汤)
Yuyin Tongluo Decoction (育阴通络汤)
Yuyin Tongluo Decoction Dabuyin Pill (大补阴丸) Tianma Gouteng Granule (天麻钩藤颗粒)
H
Rehabilitation training Acupuncture Massage Medicated bath
CPG3
Qingxin Xuanqiao Decoction (清心宣窍汤) Angong Niuhuang Pill Niuhuang Qingxin Pill Zixue Powder (紫雪散) Qingkailing Injection
Rehabilitation approaches Acupuncture Massage Medicated bath
Tianma Gouteng Drink (天麻钩藤饮)
Notes: CHM: Chinese herbal medicine; the ingredients of the CHM and CPM listed above are available at http://bbs.etjournals. com/showtopic-324.aspx
of CM CPGs for ischemic stroke in a long time. In 2009, sponsored and directed by WHO/WPR, CM researcher in China begun to study and develop the first batch of EB CPGs on CM. Thirty-three EB CPGs on CM including ischemic stroke were published by CPCM in 2011.(19) Nowadays, an increasing number of Chinese researchers begin to focus their attention on EB CPG in CM for ischemic stroke development. The average score for applicability was the lowest of 6 domains of AGREE Ⅱ instrument. The reason was that applicability contains items about organizational barriers, resource implications for recommendations, and key review criteria for monitoring and/or audit purposes. Few CPGs had the consideration for the organizational barriers to guideline implementation and for the supplied monitoring criteria to assess the guideline impact.
These may be partly because ischemic stroke treating with pattern classification and treatment was accepted popularly by the industry,(13) as well as traditional herbal medicine is easily available and low-cost. It is difficult to determine the potential cost implications or details of the administrative impact of applying the guideline.(15) CM pattern classification, which is identified from a comprehensive analysis of the patient's overall signs and symptoms, was a basic unit in CM theory. (31) The longterm clinical practice of CM confirms its importance and essential role in the prevention and treatment of ischemic stroke.(32-34) Currently, the integration of CM pattern classifications and biomedical diagnoses is becoming a common clinical diagnostic model in China and has produced better clinical outcomes.(35) In this study, we found that 7 CM patterns are the most common patterns
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for ischemic stroke patients. Among these CM patterns, phlegm-heat excess syndrome, pattern of orifices confused by phlegm, pattern of phlegm-heat blocking internally, pattern of wind phlegm blocking collaterals were observed in the acute stage of ischemic stroke. Furthermore, pattern of source qi collapse could be observed in the acute stage of ischemic stroke in critical condition. Pattern of blood stasis due to qi deficiency and stirring wind due to yin deficiency pattern were observed in ischemic stroke patients in the recovery phase and the sequel phase. In the actual clinical practice, the above-mentioned CM patterns could be used as a single pattern or combination (two or three) patterns.(19)
than that of CB CPG and CB-EB CPG in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions. In order to improve the quality of CM CPGs for ischemic stroke, the guidelines should be developed on the evidence based medicine.
REFERENCES 1. Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer handbook. Available at: http://www.sign. ac.uk/guidelines/fulltext/50 (last accessed 15 February 2013). 2. Stroke statistics. Available at: http://www.strokecenter.org/ patients/about-stroke/ stroke-statistics (last accessed 20 February 2013). 3. Barreto AD. Intravenous thrombolytics for ischemic stroke.
For treatment of ischemic stroke in the CPGs, the CM comprehensive project also recommended in the EB occupies the foremost place for the treatment of ischemic stroke, which were consistent with the published.(32,33) The Chinese herbal formula generated from well-known Chinese classic herbal formulas such as Angong Niuhuang Pills, Buyang Huanwu Decoction, or from currently effective practice formulae such as Xinglou Chengqi Decoction. It has been shown that acupuncture could not only decrease the relapse in ischemic stroke patients, but also improve self-care ability and quality of life. (34) Acupuncture and massage combined with functional training has good effects on evaluating neurological function, and Activity of Daily Living Scale with National Institutes of Health Stroke Scale, Functional Independence Measure and Barthel Index. (35) The clinical study demonstrated that the CM comprehensive project could significantly improve the nerve defect, motor function, capability of daily living activities, and reduce the sever disability. Furthermore, the project has good cost-effectiveness ratio.(36-39) The major limitation of this study was that the sample size was relatively small for there were only 5 CM CPGs for ischemic stroke management were included and analyzed. Also there is no much data about the use of the CM CPGs for ischemic stroke management, and it is hard to demonstrate how important of CPG in clinical practice at present. Fortunately, there is a project starting in 2013 to collect the data from 42 CM hospitals about the use of CM CPGs included ischemic stroke in China, and we hope we can report the data later.
Neurotherapeutics 2011;8:388-399. 4. Sharma VK, Venketasubramanian N, Teoh H L, Chan BP. Hyperdense middle cerebral artery sign and stroke outcomes after intravenous thrombolysis. Cerebrovasc Dis 2011;31:207-208. 5. Zhang Y, Jin H, Ma D, Fu Y, Xie Y, Li Z, et al. Efficacy of integrated rehabilitation technique of traditional Chinese medicine for ischemic stroke: a randomized controlled trial. Am J Chin Med 2013;41:971-981. 6. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States—prevalence, costs, and patterns of use. N Engl J Med 1993;328:246-252. 7. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Rompay MV, et al. Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey. JAMA 1998;280:569-1575. 8. Kessler RC, Davis RB, Foster DF, van Rompay MI, Walters EE, Wilkey SA, et al. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann Intern Med 2001;135:262-268. 9. Cohen MH, Kemper KJ. Complementary therapies in pediatrics: a legal perspective. Pediatrics 2005;115:774-780. 10. Liao CC, Lin JG, Tsai CC, Lane HL, Su TC, Wang HH, et al. An investigation of the use of traditional Chinese medicine in stroke patients in Taiwan. Evid Based Complement Alternat Med 2012;2012:387164. 11. Chang H, Kwon YD, Yoon SS. Use of acupuncture therapy as a supplement to conventional medical treatments for acute ischemic stroke patients in an academic medical center in Korea. Complem Ther Med 2011;19:256-263. 12. Ng TP, Tan CH, Kua EH. The use of Chinese herbal medicines and their correlates in Chinese older adults: the Singapore Chinese longitudinal aging study. Age Ageing 2004;33:135-142. 13. Yuwen Y, Shi NN, Wang LY, Xie YM, Han XJ, Lu AP.
Conclusions In conclusion, the quality of EB CPG was higher
Development of clinical practice guidelines in 11 common diseases with Chinese medicine interventions in China.
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•9•
Health 2009;47:689-693.
Chin J Integr Med 2012;18:112-119. 14. Song J, Chen KJ. Set clinical therapeutic guideline in
27. Alonso-Coello P, Irfan A, Solà I, Delgado-Noguera M, Rigau D,
traditional medicine urgently. Chin J Integr Tradit West Med
Tort S, et al. The quality of clinical practice guidelines over the
(Chin) 2006;26:581-584.
last two decades: a systematic review of guideline appraisal studies. Qual Saf Health Care 2010;19: e58.
15. Yuwen Y, Xu JL, Shi NN, Wang LY, Han XJ, Wang YY, et al. Assessing the quality of the first batch of evidence-
28. Gorman SK, Chung MH, Slavik RS, Zed PJ, Wilbu K,
based clinical practice guidelines in traditional Chinese
Dhingra VK. A critical appraisal of the quality of critical care
medicine. J Tradit Chin Med 2011;31:376-381.
pharmacotherapy clinical practice guidelines and their strength of recommendations. Inten Care Med 2010;36:1636-1643.
16. Cruse H, Winiarek M, Marshburn J, Clark O, Djulbegovic B. Quality and methods of developing practice guidelines.
29. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized
BMC Health Serv Res 2002;2:1-73.
controlled trials and recommendations of clinical experts:
17. New Zealand Guideline Group. Handbook for the preparation
treatments for myocardial infarction. JAMA 1992;268:240-248.
of explicit evidence-based clinical practice guidelines. New Zealand 2001;5.
30. Mulrow CD. Systematic reviews: rationale for systematic reviews. Br Med J 1994;309:597-599.
18. Appraisal of Guidelines for Research & Evaluation (AGREEⅡ) instrument. Available at: http://www.agreetrust.org/resource-
31. LU AP, Jiang M, Zhang C, Chan K. An integrative approach of linking traditional Chinese medicine pattern classification and
center/agree-ii/ (last accessed 15 February 2013).
biomedicine diagnosis. J Ethnopharmacol 2012;141:549-576.
19. Cao HX, Wang YY. Clinical practice guideline in traditional Chinese medicine for ischemic stroke. In: Evidence-based
32. Yuwen Y, Xie YM, Zou YH, Li Z H, Wang YY. Rehabilitation
guideline of clinical practice in Chinese medicine internal
scheme of traditional Chinese medicine for early
China. 1st ed. Beijing: China Press of Traditional Chinese
ischemic stroke. J Shanghai Univ Tradit Chin Med (Chin) 2009;23:28-30.
Medicine;2011:283-310. 20. China Association of Chinese Medicine. Ischemic Stroke. In:
33. Guo JW, Huang Y. Preliminary analysis of comprehensive
Guidelines for diagnosis and treatment of common internal
therapeutic regimen for acute ischemic stroke patients with yin
diseases in Chinese medicine disease of modern medicine.
series-syndromes. J New Chin Med (Chin) 2010;42:12-14.
1st ed. Beijing: China Press of Traditional Chinese Medicine;
34. Shen PF, Kong L, Ni LW, Guo HL, Yang S, Zhang LL, et al. Acupuncture intervention in ischemic stroke: a randomized
2008:260-264.
controlled prospective study. Am J Chin Med 2012;40:685-693.
21. China Association of Chinese Medicine. China Association of Chinese Medicine, Apoplexy. In: Guidelines for diagnosis
35.
Gong B, Li CQ, Ling LL. Effect of acupuncture and
and treatment of common internal diseases in Chinese
massage combined with functional training on neurological
medicine symptoms of modern medicine. 1st ed. Beijing:
function and activities of daily living of patients with cerebral
China Press of Traditional Chinese Medicine; 2008:56-62.
infarction. Chin J Clin Rehabil (Chin) 2006;10:1-4.
22. State Food and Drug Administration. Guidelines for clinical
36. Yuwen Y, Xie YM, Zhao XQ, Zou YH, Wang XZ, Ma ZY,
researches of new traditional Chinese drugs on ischemic
et al. Effect of traditional Chinese medicine synthetic
stroke. In: Zheng XY, ed. Guideline for clinical researches of
rehabilitation project on early rehabilitation for patients
new traditional Chinese drugs. 1st ed. Beijing: China Medical
with ischemic stroke. World Sci Tech/Mod Tradit Chin Med
Science Press; 2002:99-104.
Mater Med (Chin) 2010;12:526-530.
23. Encephalopathy Emergency Group, State Administration
37. Geng C, Mei XM, Yan ZM, Li YJ, Bi DR, Chen XY, et
of Traditional Chinese Medicine of the People's Republic of
al. Research of comprehensive treatment of traditional
China. Standard for diagnosis and effectiveness assessment
Chinese medicine in treating acute ischemic stroke. Chin J
of stroke. J Beijing Univ Tradit Chin Med (Chin) 1996;19:55-59.
Integr Tradit West Med Intens Crit (Chin) 2009;16:356-358.
24. Navarro Puerto MA, Ibarluzea IG, Ruiz OG, Alvarez FM,
38. Fu YB, Zou YH, Li ZH, Jin H, Xie, ZJ, Ma DY, et al. Clinical
Herreros RG, Pintiado RE, et al. Analysis of the quality of
study of comprehensive Chinese Medicine intervention
clinical practice guidelines on established ischemic stroke.
project in treating ischemic stroke at early stage. China J
Int J Technol Assess Health Care 2008;24:333-341.
Tradit Chin Med Pharm (Chin) 2011;26:987-989.
25. Gallardo CR, Rigau D, Irfan A, Ferrer A, Caylà, JA, Bonfill
39. You JS, Wang LX, Liang WX, Huang Y, Cai YF, Guo JW.
X, et al. Quality of tuberculosis guidelines: urgent need for
Effect of integrative medical therapy on the prognosis of
improvement. Int J Tuberc Lung Dis 2010;14:1045-1051.
patients suffering from yin syndrome type acute ischemic
26. Kinnunen-Amoroso M, Pasternack I, Mattila S, Parantainen
stroke, Chin J Integr Tradit West Med (Chin) 2011;31:195-199.
A. Evaluation of the practice guidelines of Finnish institute
(Received August 9, 2013) Edited by YUAN Lin
of occupational health with AGREE instrument. Industri
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EVIDENCE-BASED INTEGRATIVE MEDICINE Appraisal of Clinical Practice Guidelines for Ischemic Stroke Management in Chinese Medicine with Appraisal of Guidelines for Research and Evaluation Instrument: A Systematic Review YUWEN Ya (宇文亚)1, SHI Nan-nan (史楠楠)1, HAN Xue-jie (韩学杰)1, GAO Ying (高 颖)2, XU Jian-long (徐建龙)3, LIU Da-sheng (刘大胜)1, Bacon Ng4, Dora Tsui4, ZHONG Li-dan (钟丽丹)5, Eric Ziea4, BIAN Zhao-xiang (卞兆祥)5, and LU Ai-ping (吕爱平)1,5 Objective:: To systematically review the clinical practice guidelines (CPGs) for ischemic stroke in ABSTRACT Objective Chinese medicine (CM) with the Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) instrument. Methods:: CM CPGs for ischemic stroke were searched in 5 online databases and hand-searches in CPGMethods related handbooks published from January 1990 to December 2012. The CPGs were categorized into evidence based (EB) guideline, consensus based with no explicit consideration of evidence based (CB-EB) guideline and consensus based (CB) guideline according to the development method. Three reviewers independently appraised the CPGs based on AGREE Ⅱ instrument, and compared the CPGs' recommendations on CM Results:: Five CM CPGs for ischemic stroke were identified and included. pattern classification and treatment. Results Among them, one CPG was EB guideline, two were CB guidelines and two were CB-EB guidelines. The quality score of the EB guideline was higher than those of the CB-EB and CB guidelines. Five CM patterns in the CPGs were recommended in the EB CPG. The comprehensive protocol of integrative Chinese and Western medicine recommended in the EB CPG was mostly recommended for ischemic stroke in the CPGs. The recommendations Conclusion:: The quality of EB CPG was higher than those of CB and CB-EB varied based on the CM patterns. Conclusion CPGs in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions. KEYWORDS clinical practice guideline, ischemic stroke, Appraisal of Guidelines for Research and Evaluation, systematic review
Clinical practice guideline (CPG), as a systematically developed statement, is a document with the aim of guiding the decisions and criteria regarding the diagnosis, treatment in specific areas of healthcare.(1) Stroke is the leading cause of serious, long-term disability disease that affects about 15 million people worldwide each year, of these, 5 million die and another 5 million are permanently disabled. (2) It is mainly categorized as apoplexy in Chinese medicine (CM), and about 85 percent of strokes are ischemic strokes. Thrombolysis, as the most successfully therapy for acute ischemic stroke, is rarely totally effective in treating ischemic stroke for the strict therapeutic time window and some pharmacological therapies have the potential to cause side events.(3,4) CM interventions have proven to be beneficial for patients with ischemic stroke.(5) In recent years, increasing numbers of stroke patients have sought CM to improve physical functions.(6-9) As more patients start using CM, conventional health care practitioners increasingly feel the need to acquaint themselves with CM.(10-12) In such a case, CPG could
become an important guideline for them in the clinical practice, and issued CM CPGs for ischemic stroke management could not only assist in designing CM clinical trials regarding ischemic stroke diagnosis and treatment,(13) but also guide some CM practitioners in the real practice.
©The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag Berlin Heidelberg 2014 Supported by the projects from the State Administration of Traditional Chinese Medicine (No. ZYYS-2011[0032]-2), the China Academy of Chinese Medical Sciences (No. Z0135, Z0260, and Z0221), and the Hong Kong Hospital Authority 1. Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing (100700), China; 2. Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing (100700), China; 3. Xiyuan Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing (100091), China; 4. Chinese Medicine Department, Hong Kong Hospital Authority, Hong Kong SAR, China; 5. School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Kowloon, Hong Kong, SAR, China Correspondence to: Prof. LU Ai-ping, Tel: 86-852-34112457, Fax: 86-852-34112461, E-mail: [email protected]; Prof. HAN Xue-jie, Tel: 86-10-64014411 Ext. 3312, Fax: 86-1084032881, E-mail: [email protected] DOI: 10.1007/s11655-014-1834-2
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Over the past 2 decades, increasing numbers of CM CPGs for ischemic stroke have been issued, providing the normative diagnostic and therapeutic methods for the clinical practitioners in China. (13) With the exponential increase in CPG production, concerning about their quality has risen,(14,15) some clinical practitioners are frustrated by facing many CM CPGs for ischemic stroke at the same time, as they were not clear about their quality. Therefore, this study is aimed to assess the quality of CM CPGs for ischemic stroke using the Appraisal of Guidelines for Research and Evaluation (AGREE Ⅱ) instrument to identify their quality with the hope of contributing to a better quality of CPG development and revision.
METHODS Data Sources and Searches The data from 5 databases were collected from January 1990 to December 2012 to identify CM CPGs for ischemic stroke management. Two international specific public databases for CPG: National Guideline Clearinghouse and Guidelines International Network were searched for the CM CPGs for ischemic stroke. Since there is no specific public database in China for CM CPGs, we searched for CM CPGs on 3 public databases: Community Support Services of Niagara (http://www.cssn.net.cn), which is the largest comprehensive standard service wed site in China, SinoMed (http://www.sinomed.ac.cn) and China National Knowledge Infrastructure (http://www.cnki.net), which are the main sources of professional technical literature on biomedicine in China. The following search terms were used: "clinical practice guideline," "traditional Chinese medicine", "Chinese medicine", "ischemic stroke" and "apoplexy". The search was supplemented with a manual search of handbooks in China.
Records identified by computer searches (n =371)
Records identified by manual searches (n =8)
Deleting duplicate records (n =368)
Full text paper (n =12)
Records excluded due to not meet inclusion criteria through title and abstract (n =356)
Included (n =5)
Inclusion criteria not meet through full text evaluated (n =7)
Systematic review (n =5)
Figure 1. Identification of Clinical Practice Guidelines in CM for Ischemic Stroke
classification and treatment.
Categorization of CPGs CPGs were categorized into evidence based (EB) guideline, consensus based with no explicit consideration of evidence based (CB-EB) guideline and consensus based (CB) guideline according to the development method. (16) CB is developed by the agreement with a group of experts. EB is developed after the systematic retrieval and appraisal of information from the literature. It usually includes strategies for describing the strength of the evidence, and try to clearly separate opinions from evidence they make statements not just about which of two treatment options is "better", but quantity the absolute difference in outcome, including both benefits and harm.(17) CB-EB is developed by combining a consensus of experts and a less formal literature analysis to create evidence.
Quality Appraisal Data Selection Figure 1 shows the process for selecting the articles. In step 1, the titles and abstracts for the articles retrieved by our literature searches were screened by two independent reviewers for potential relevant to this study. In step 2, we excluded the abstracts published in conference book. The inclusion criteria for the articles were as followings: the title was named as ischemic stroke/apoplexy and guideline and traditional Chinese medicine/Chinese medicine; and the guideline was produced at national authorities or national academic associations or professional administration organizations, and the guideline recommendations were on pattern
The quality of each selected CPG was evaluated independently by 3 reviewers (Yuwen Y, Shi NN, Xu JL) using the AGREE Ⅱ instrument. The reviewers have rich experience in CM CPGs development and are familiar with the AGREE Ⅱ usage. Before applying the AGREE Ⅱ, the reviewers first carefully read the CM CPGs for ischemic stroke and all information about the CPGs development process. AGREE Ⅱ consists of 6 domains divided into 23 items and each domain shows the distinct dimension of guideline quality (Table 1). Each item is rated from 1 (strongly disagree) to 7 (strongly agree). The
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Table 1.
AGREE Ⅱ Instrument
Domain
No. of Item
Scope and purpose
3 items
Stakeholder involvement
3 items
Rigor of development
8 items
Systematic methods were used to search for evidence. The criteria for selecting the evidence are clearly described. The strengths and limitations of the body of evidence are clearly described. The methods for formulating the recommendations are clearly described. The health benefits, side effects, and risks have been considered in formulating the recommendations. There is an explicit link between the recommendations and the supporting evidence. The guideline has been externally reviewed by experts prior to its publication. A procedure for updating the guideline is provided.
Clarity of presentation
3 items
The recommendations are specific and unambiguous. The different options for management of the condition or health issue are clearly presented. Key recommendations are easily identifiable.
Applicability
4 items
The guideline describes facilitators and barriers to its application. The guideline provides advice and/ortools on how the recommendations can be put into practice. The potential resource implications of applying the recommendations have been described. The guideline presents monitoring and/or auditing criteria.
Editorial independence
2 items
The views of the funding body have not influenced the content of the guideline. Competing interests of the guideline development group members have been recorded and addressed. Rated the overall quality of the guideline. I would recommend this guideline for use.
Overall guideline assessment
Detailed criteria The overall objective(s) of the guideline is (are) specifically described. The health question(s) covered by the guidelines is (are) specially described. The population (patients, public, etc) to whom the guideline is meant to apply are specifically described. The guidelines development group includes individuals from all relevant professional groups. The views and preferences of the target population (patients, public, etc) have been sought. The target users of the guideline are clearly defined.
appraisers were asked to give each item assessment according to the detailed criteria within the AGREE Ⅱ tool. Upon completing the 23 items, they also were asked to give an overall assessment of guideline from 1 (lowest) to 7 (highest) and to state if they would recommend the guideline, recommend with modifications or not recommend it.(18) Average appraisal scores were calculated for each appraiser by taking the average rating for all items of a single guideline.(1-7) From this, the overall average appraisal scores and deviations were calculated for 3 appraisers for a single guideline. Domain scores of the guideline were calculated by summing up all the scores of the individual items in a domain and by scaling the total as a percentage of the maximum possible score for that domain for interdomain comparison. Besides that, the average scores of each domain for the guidelines were calculated.
Guideline Comparison In addition to the quality, we compared the guideline recommendations in 3 areas addressed by the CM CPGs for ischemic stroke management: (1) CM pattern classification: The most common CM patterns that are associated with ischemic stroke were explored
based on their frequency. (2) Interventions for ischemic stroke management: CM interventions in the CPGs were extracted and the interventions recommended by most CPGs were obtained. (3) Indications for prescription and withdrawal of the interventions: The indications of the most common therapeutics recommended in the CPGs were explored based on their usage. All data was extracted and analyzed by 2 independent reviewers, and the difference was resolved by consensus.
RESULTS General Information about the CM CPGs We identified 379 titles, of which 12 full articles were assessed for eligibility and 5 CM CPGs for ischemic stroke satisfied the inclusion criteria.(19-23) After 2000, the number of CM CPGs for ischemic stroke has increased rapidly. Among these CPGs, the proportion of the EB guideline was small (1, 20%), indicating that EB has not been a major part of CM CPGs for ischemic stroke treatment, as shown in Table 2. The only EB CPG was supported by World Health Organization/ Western Pacific Region (WHO/WPR), but others by national organizations and academic associations.
Quality Assessment of the CM CPGs Average appraisal scores and average overall
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Table 2. No.
Title
CPGs in CM for Ischemic Stroke from 1990–2012
Publish date
Issued by
Funding
Category
Level
1
Evidence-based guideline of ischemic stroke in traditional Chinese medicine
2011
China Press of Traditional Chinese Medicine
WHO/WPR
EB
Academic association level
2
Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine
2008
China Press of Traditional Chinese Medicine
SATCM
CB-EB
Academic association level
3
Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine
2008
China Press of Traditional Chinese Medicine
SATCM
CB-EB
Academic association level
4
Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs
2002
Chinese Medical Science and Technology Press
SFDA
CB
Professional administration level
5
Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine
1996
Encephalopathy emergency group, SATCM
SSTC
CB
Academic association level
Notes: The guidelines were all published in Chinese. WHO/WPR: World Health Organization/Western Pacific Region; SATCM: State Administration of Traditional Chinese Medicine of the People's Republic of China; SFDA: State Food and Drug Administration; SSTC: State Science and Technology Commission; CPG: clinical practice guideline; EB: evidence based guideline; CB: consensus based guideline
Table 3.
Appraiser Recommendations for Use of the CPGs in CM for Ischemic Stroke
Title
Average Score
Apr 1
Apr 2
Apr 3
Average
SD
Evidence-based guideline of ischemic stroke in traditional Chinese medicine
Average
5
6
4
5.0
0.9
Overall assessment
5
6
5
5.3
0.5
Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine
Average
2
3
2
2.3
0.5
Overall assessment
2
4
2
2.7
0.9
Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine
Average
2
3
2
2.3
0.5
Overall assessment
2
4
2
2.7
0.9
Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs
Average
3
3
2
2.7
0.5
Overall assessment
2
4
2
2.7
0.9
Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine
Average
2
3
2
2.3
0.5
Overall assessment
3
5
2
3.3
1.2
Notes: Apr: appraiser; SD: standard deviation
assessments for the CM CPGs for ischemic stroke are shown in Table 3. The overall average assessment scores of the quality of EB CPG (5.3±0.5) were higher than those of CB-EB CPGs (2.7±0.9, 2.7±0.9) and CB CPGs (2.7±0.9, 3.3±1.2). The overall assessment averages were higher than the average scores calculated from the individual items. Two appraisers recommended the EB with modifications, while one recommended the EB without modifications. Two appraisers did not recommend the CB-EB and CB CPGs for use, while one appraiser recommended them with modifications according to the AGREE Ⅱ assessment (Table 4). Figure 2 showed that the EB CPG had higher domain scores than those of the CB-EB and CB CPGs, but we did not find the obvious difference between CB-
EB and CB CPGs. The details are as followings: (1) Scope and purpose: The health questions covered by the guideline were not well described in the CPGs. Among the guidelines, the EB CPG scored 70%, two CB-EB CPGs scored 20% and 17%, and two CB CPGs scored 13% and 31%. (2) Stakeholder involvement: The majority of guideline development groups did not involve nurses' and patients' perspective. Among the CPGs, the EB CPG scored 67%, two CB-EB CPGs scored 13% and 13%, and two CB CPGs scored 15% and 26%. (3) Rigor of development: Only the EB guideline had described the search methods of the evidence in details, and the levels of evidence and grading of recommendations were reported clearly, through which the link between recommendations and supporting evidence is explicit. Nearly all CPGs had undergone internal and external expert review before published. The
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Table 4. Recommendations on Pattern Classification in the CPGs in CM for Ischemic Stroke Title
Patterns A
B
C
D
E
F
G
Evidence-based guideline of ischemic stroke in traditional Chinese medicine
•
•
•
•
•
•
•
H
I
J
K
Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine
•
•
•
•
•
•
•
Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine
•
•
•
•
•
•
•
•
Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs
•
•
•
•
•
•
•
Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine
•
•
•
•
•
•
•
Notes: A: Internal obstruction of phlegm-heat pattern (Sudden onset, loss of consciousness, nasal snore and wheezy phlegm, hemiplegia, stiffness and spasm in the affected limb, feverish sensations in the nape and neck, restlessness, or cold extremities and convulsion, a red tongue with a yellow and greasy and dry coating and a wiry, slippery and rapid pulse). B: Phlegm misting the heart-mind pattern (Loss of consciousness, hemiplegia, deviation of tongue and mouth, profuse sputum or salivation, a pale complexion and dark lips, incontinence of urine and stool, a dark-purple and atrophic tongue with a white and greasy coating, sunken, slippery and moderate pulse). C: Declining and failure of vital-primordial qi pattern (Loss of consciousness, closed eyes with mouth open, paralysis and weakness of the affected limb, cold extremities, sweats, incontinence of urine and stool, a dark-purple and atrophic tongue with a white and greasy coating, extremely faint pulse). D: Wind phlegm obstructing the meridians pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, numbness in the affected limb, dizziness, stick mouth with profuse sputum, dark-red tongue with a white and greasy coating, wiry and slippery pulse). E: Phlegm-heat in the fu-organs pattern (Hemiplegia, stiffness and spasm of the effected limbs, slurred speech, deviation of the tongue and mouth, abdominal distension and constipation, dizziness, blurred vision, stick mouth with profuse sputum, a red tongue with yellow and greasy coating, a wiry and slippery pulse). F: Syndrome of blood stasis due to qi deficiency (Hemiplegia, paralysis and weakness of the affected limbs, deviation of the tongue and mouth, a bright pale complexion, shortness of breath, lassitude, numbness in the affected side, palpitation, spontaneous sweating, a dark tongue with a thin and white or white and greasy coating, a sunken and fine pulse). G: Wind-stirring due to yin deficiency pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, numbness in the affected limb, feverish sensations in palms, soles and chest, dizziness, blurred vision, a red tongue with no or a scanty coating, thread, fine and rapid pulse). H: Upward-disturbance of wind-fire pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, numbness in the affected side, headache with a distending sensation, a red face and eyes, irritability, constipation, bloody urine, a red tongue with a yellow coating, wiry and rapid pulse). I: Hyperactivity of wind-phlegm and fire pattern (Hemiplegia, deviation of the tongue and mouth, slurred speech, sensory deprivation, sudden onset, dizziness, irritability, stiffness and spasm of the affected limb, stick mouth with profuse sputum, a red tongue with a yellow and greasy coating, wiry and slippery pulse). J: Wind-phlegm and stasis obstructing the meridians pattern (Hemiplegia, deviation of the mouth and tongue, slurred speech, sensory deprivation, dizziness, stick mouth with profuse sputum, a dark-red tongue with white thin or white and greasy coating, a wiry and slippery pulse). K: Phlegm-dampness misting the heart-mind pattern (Hemiplegia, deviation of the mouth and tongue, slurred speech, sensory deprivation, loss of consciousness, wheezy phlegm, incontinence of urine and stool, a dark-purple with white and greasy coating, a deep and moderate and slippery pulse).
procedure of updates was considered in few guidelines. The EB CPG scored 74%, two CB-EB CPGs scored 17% and 13%, and two CB CPGs scored 13% and 19%. (4) Clarity of presentation: Key recommendations of most CPGs were easy to identify. All CPGs had no tools for application. The EB CPG scored 69%, two CB-EB CPGs scored 37% and 48%, and two CB CPGs scored 26% and 30%. (5) Applicability: All CPGs did not define clearly the potential cost implications or any details of the barrier from other organizations during the application of CPGs, and did not present performance monitoring indicators. The EB CPG scored 35%, two CB-EB CPGs scored 6% and 10%, and two CB CPGs scored 8% and 11%. (6) Editorial independence: Few CPGs had the definition of the editorial independence or the conflict of
interest of the guideline authors. The EB CPG scored 50%, two CB-EB CPGs scored 19% and 22%, and two CB CPGs scored 33% and 28%. Furthermore, the lowest average scores of the domains were found for applicability (14%), as shown in Figure 3.
Comparison of Recommendations in the CM CPGs Recommended CM Patterns in the CPGs Eleven single CM patterns were recommended in the CM CPGs for ischemic stroke. The industry got consensus on 7 CM patterns of ischemic stroke in the "Evidence-based guideline of ischemic stroke in traditional Chinese medicine" over time (Table 4). In the pattern distribution, the top 7 CM patterns in the CM
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CPG1 CPG2 CPG3 CPG4 CPG5
80 70 60 50 40 30 20 10 0
S pu cop rp e os an e d St in ak vo eh lv ol em de en r t R de igo ve r o lo f pm en C t pr lari es ty en of ta tio n Ap pl ic ab ilit y Ed in ito de ri a pe l nd en ce
Score (%)
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Figure 2. Scaled Domain Scores of the CPGs in CM for Ischemic Stroke according to the AGREE Ⅱ Instrument Notes: CPG 1: Evidence-based guideline of ischemic stroke in traditional Chinese medicine. CPG 2: Guideline for diagnosis and treatment of ischemic stroke in traditional Chinese medicine. CPG 3: Guideline for diagnosis and treatment of apoplexy in traditional Chinese medicine. CPG 4: Guideline on ischemic stroke for clinical researches of new traditional Chinese drugs. CPG 5: Standard for diagnosis and effectiveness assessment of apoplexy in traditional Chinese medicine Scope and purpose Stakeholder involvement Rigor of development Clarity of presentation Applicability Editorial independence 0
0.1
0.2
0.3
0.4
0.5
Average score
Figure 3. Average Domain Score of the CPGs in CM for Ischemic Stroke According to the AGREE Ⅱ Instrument
CPGs for ischemic stroke included phlegm-heat excess syndrome (5; 100%), pattern of blood stasis due to qi deficiency (5; 100%), stirring wind due to yin deficiency pattern (5; 100%), pattern of phlegm-heat blocking internally (3; 60%), pattern of orifices confused by phlegm (3; 60%), pattern of source qi collapse (3; 60%), pattern of wind phlegm blocking collaterals (3; 60%).
Recommended Interventions in the CPGs As shown in Table 5, Chinese herbal decoction, Chinese patent medicine (CPM), acupuncture, massage, medicated bath and rehabilitation training comprised the CM approaches in the CPGs for ischemic stroke management. In general, the comprehensive protocol of integrative Chinese and Western medicine was recommended for the ischemic stroke patients with top 7 CM patterns. Specifically, ischemic stroke patients with the top 7 CM patterns were recommended treating with diversified therapies based on their CM patterns. For example, ischemic stroke patient with phlegm-heat excess syndrome was recommended treating with Xinglou
Chengqi Decoction (星蒌承气汤), Dachengqi Decoction (大承气汤), Dachaihu Decoction (大柴胡汤), Qingkailing Injection (清开灵注射液), Didang Decoction (抵当汤), and Niuhuang Qingxin Pill (牛黄清心丸). Acupuncture and medicated bath are popularly recommended by all CPGs. The commonly used acupuncture points recommended in the CPGs were Nei Guan (P36), Shui Gou (DU26), San Yin Jiao (SP6), Ji Quan (HT1), Chi Ze (LU5) and Wei Zhong (BL40). Some commonly used herbs for medicated bath for ischemic stroke were Aconiti Radix Cocta, Aconiti Kusnezoffii Radix Cocta , Carthami Flos , Chuanxiong Rhizoma , Mori Ramulus , Angelicae Radix and Caulis Trachelospermi. The therapeutics should be adjusted on the basis of the change of CM patterns.
Indications and Recommended Protocols The EB CPG showed that acupuncture should be used as early as possible when the ischemic stroke patient's condition was stable, massage was effective for the ischemic stroke patients with limb spasm, medicated bath was recommended for post-stroke shoulder-hand syndrome patients, and the Western rehabilitation training should be used for ischemic stroke patients with some complications in restoration stage and sequel stage. In general, the ischemic stroke patients with the important 7 CM patterns could be treated with the comprehensive therapy protocol of integrateive Chinese and Western medicine.
DISCUSSION Compared to the previous systematic review,(24) we reported not only the quality of CM CPGs for ischemic stroke management in China but also the consistency of their commendations. In regard to the quality of CM CPGs for ischemic stroke, the AGREE Ⅱ assessment showed that the quality of the EB CPG for ischemic stroke was higher than those of CB-EB and CB CPGs, which agreement with the published. (16,25-28) CM CPGs for ischemic stroke could be categorized as CB, CB-EB and EB guideline, according to the development method. EB CPG is the mainstream and trend of guideline development, because CB and CB-EB CPGs could not reflect the current medical knowledge and were liable to bias(29,30) and it has better quality than CB and CB-EB CPGs.(16) Since CM depends much upon experts' experience, the majority of CM CPGs for ischemic stroke were developed by expert consensus method, CB and CB-EB CPGs were the mainstream
Chin J Integr Med Table 5.
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Recommendations on Management in the Clinical Practice Guidelines in CM for Ischemic Stroke CPG1
Pattern
CHM and CPM
CPG2 Rehabilitation approaches
Rehabilitation approaches
CHM and CPM Lingyangjiao Decoction Huanglian Jiedu Decoction Angong Niuhuang Pill Jufang Zhibao Dan
Rehabilitation training Acupuncture Massage Medicated bath
CHM and CPM
A
Lingyangjiao Decoction (羚羊角汤) Angong Niuhuang Pill Jufang Zhibao Dan (局方至宝丹) Niuhuang Qingxin Pill
B
Ditan Decoction (涤痰汤) Suhexiang Pill (苏合香丸)
Ditan Decoction Suhexiang Pill
Ditan Decoction Suhexiang Pill Xingnaojing Injection (醒脑静注射液)
C
Shenfu Decoction (参附汤) Sini Decoction (四逆汤) Shengmai Drink (生脉饮)
Shenfu Decoction
Shenfu Decoction Shengmai Powder Shenfu Injection (参附注射液) Shenmai Injection (生脉注射液)
D
Huatan Tongluo Decoction (化痰通络汤) Tongmai Capsule (通脉胶囊) Xinmaitong Capsule (通脉胶囊)
Huatan Tongluo Decoction
Huatan Tongluo Decoction Quantianma Capsule (全天麻胶囊) Zhongfeng Huichun Pill (中风回春片)
E
Xinglou Chengqi Decoction Dachengqi Decoction Dachaihu Decoction
Xinglou Chengqi Decoction Didang Decoction
Xinglou Chengqi Decoction Dachaihu Decoction Xinqingning Tablet (新清宁片) Niuhuang Qingxin Pill Qingkailing Injection
F
Buyang Huanwu Decoction (补阳还五汤) Naoxintong Pill (脑心通片) Tongxinluo Pill (通心络片)
Buyang Huanwu Decoction
Buyang HuanWu Decoction Naoxintong Pill Nao' an Pill (脑安片) Xiaoshuan Tongluo Pill (消栓通络片) Shengmai Injection
G
Zhengan Xifeng Decoction (镇肝熄风汤) Yuyin Xifeng Decoction (育阴熄风汤)
Yuyin Tongluo Decoction (育阴通络汤)
Yuyin Tongluo Decoction Dabuyin Pill (大补阴丸) Tianma Gouteng Granule (天麻钩藤颗粒)
H
Rehabilitation training Acupuncture Massage Medicated bath
CPG3
Qingxin Xuanqiao Decoction (清心宣窍汤) Angong Niuhuang Pill Niuhuang Qingxin Pill Zixue Powder (紫雪散) Qingkailing Injection
Rehabilitation approaches Acupuncture Massage Medicated bath
Tianma Gouteng Drink (天麻钩藤饮)
Notes: CHM: Chinese herbal medicine; the ingredients of the CHM and CPM listed above are available at http://bbs.etjournals. com/showtopic-324.aspx
of CM CPGs for ischemic stroke in a long time. In 2009, sponsored and directed by WHO/WPR, CM researcher in China begun to study and develop the first batch of EB CPGs on CM. Thirty-three EB CPGs on CM including ischemic stroke were published by CPCM in 2011.(19) Nowadays, an increasing number of Chinese researchers begin to focus their attention on EB CPG in CM for ischemic stroke development. The average score for applicability was the lowest of 6 domains of AGREE Ⅱ instrument. The reason was that applicability contains items about organizational barriers, resource implications for recommendations, and key review criteria for monitoring and/or audit purposes. Few CPGs had the consideration for the organizational barriers to guideline implementation and for the supplied monitoring criteria to assess the guideline impact.
These may be partly because ischemic stroke treating with pattern classification and treatment was accepted popularly by the industry,(13) as well as traditional herbal medicine is easily available and low-cost. It is difficult to determine the potential cost implications or details of the administrative impact of applying the guideline.(15) CM pattern classification, which is identified from a comprehensive analysis of the patient's overall signs and symptoms, was a basic unit in CM theory. (31) The longterm clinical practice of CM confirms its importance and essential role in the prevention and treatment of ischemic stroke.(32-34) Currently, the integration of CM pattern classifications and biomedical diagnoses is becoming a common clinical diagnostic model in China and has produced better clinical outcomes.(35) In this study, we found that 7 CM patterns are the most common patterns
Chin J Integr Med
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for ischemic stroke patients. Among these CM patterns, phlegm-heat excess syndrome, pattern of orifices confused by phlegm, pattern of phlegm-heat blocking internally, pattern of wind phlegm blocking collaterals were observed in the acute stage of ischemic stroke. Furthermore, pattern of source qi collapse could be observed in the acute stage of ischemic stroke in critical condition. Pattern of blood stasis due to qi deficiency and stirring wind due to yin deficiency pattern were observed in ischemic stroke patients in the recovery phase and the sequel phase. In the actual clinical practice, the above-mentioned CM patterns could be used as a single pattern or combination (two or three) patterns.(19)
than that of CB CPG and CB-EB CPG in CM for ischemic stroke and integrative approaches were included in CPGs as major interventions. In order to improve the quality of CM CPGs for ischemic stroke, the guidelines should be developed on the evidence based medicine.
REFERENCES 1. Scottish Intercollegiate Guidelines Network. SIGN 50: a guideline developer handbook. Available at: http://www.sign. ac.uk/guidelines/fulltext/50 (last accessed 15 February 2013). 2. Stroke statistics. Available at: http://www.strokecenter.org/ patients/about-stroke/ stroke-statistics (last accessed 20 February 2013). 3. Barreto AD. Intravenous thrombolytics for ischemic stroke.
For treatment of ischemic stroke in the CPGs, the CM comprehensive project also recommended in the EB occupies the foremost place for the treatment of ischemic stroke, which were consistent with the published.(32,33) The Chinese herbal formula generated from well-known Chinese classic herbal formulas such as Angong Niuhuang Pills, Buyang Huanwu Decoction, or from currently effective practice formulae such as Xinglou Chengqi Decoction. It has been shown that acupuncture could not only decrease the relapse in ischemic stroke patients, but also improve self-care ability and quality of life. (34) Acupuncture and massage combined with functional training has good effects on evaluating neurological function, and Activity of Daily Living Scale with National Institutes of Health Stroke Scale, Functional Independence Measure and Barthel Index. (35) The clinical study demonstrated that the CM comprehensive project could significantly improve the nerve defect, motor function, capability of daily living activities, and reduce the sever disability. Furthermore, the project has good cost-effectiveness ratio.(36-39) The major limitation of this study was that the sample size was relatively small for there were only 5 CM CPGs for ischemic stroke management were included and analyzed. Also there is no much data about the use of the CM CPGs for ischemic stroke management, and it is hard to demonstrate how important of CPG in clinical practice at present. Fortunately, there is a project starting in 2013 to collect the data from 42 CM hospitals about the use of CM CPGs included ischemic stroke in China, and we hope we can report the data later.
Neurotherapeutics 2011;8:388-399. 4. Sharma VK, Venketasubramanian N, Teoh H L, Chan BP. Hyperdense middle cerebral artery sign and stroke outcomes after intravenous thrombolysis. Cerebrovasc Dis 2011;31:207-208. 5. Zhang Y, Jin H, Ma D, Fu Y, Xie Y, Li Z, et al. Efficacy of integrated rehabilitation technique of traditional Chinese medicine for ischemic stroke: a randomized controlled trial. Am J Chin Med 2013;41:971-981. 6. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. Unconventional medicine in the United States—prevalence, costs, and patterns of use. N Engl J Med 1993;328:246-252. 7. Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Rompay MV, et al. Trends in alternative medicine use in the United States, 1990–1997: results of a follow-up national survey. JAMA 1998;280:569-1575. 8. Kessler RC, Davis RB, Foster DF, van Rompay MI, Walters EE, Wilkey SA, et al. Long-term trends in the use of complementary and alternative medical therapies in the United States. Ann Intern Med 2001;135:262-268. 9. Cohen MH, Kemper KJ. Complementary therapies in pediatrics: a legal perspective. Pediatrics 2005;115:774-780. 10. Liao CC, Lin JG, Tsai CC, Lane HL, Su TC, Wang HH, et al. An investigation of the use of traditional Chinese medicine in stroke patients in Taiwan. Evid Based Complement Alternat Med 2012;2012:387164. 11. Chang H, Kwon YD, Yoon SS. Use of acupuncture therapy as a supplement to conventional medical treatments for acute ischemic stroke patients in an academic medical center in Korea. Complem Ther Med 2011;19:256-263. 12. Ng TP, Tan CH, Kua EH. The use of Chinese herbal medicines and their correlates in Chinese older adults: the Singapore Chinese longitudinal aging study. Age Ageing 2004;33:135-142. 13. Yuwen Y, Shi NN, Wang LY, Xie YM, Han XJ, Lu AP.
Conclusions In conclusion, the quality of EB CPG was higher
Development of clinical practice guidelines in 11 common diseases with Chinese medicine interventions in China.
Chin J Integr Med
•9•
Health 2009;47:689-693.
Chin J Integr Med 2012;18:112-119. 14. Song J, Chen KJ. Set clinical therapeutic guideline in
27. Alonso-Coello P, Irfan A, Solà I, Delgado-Noguera M, Rigau D,
traditional medicine urgently. Chin J Integr Tradit West Med
Tort S, et al. The quality of clinical practice guidelines over the
(Chin) 2006;26:581-584.
last two decades: a systematic review of guideline appraisal studies. Qual Saf Health Care 2010;19: e58.
15. Yuwen Y, Xu JL, Shi NN, Wang LY, Han XJ, Wang YY, et al. Assessing the quality of the first batch of evidence-
28. Gorman SK, Chung MH, Slavik RS, Zed PJ, Wilbu K,
based clinical practice guidelines in traditional Chinese
Dhingra VK. A critical appraisal of the quality of critical care
medicine. J Tradit Chin Med 2011;31:376-381.
pharmacotherapy clinical practice guidelines and their strength of recommendations. Inten Care Med 2010;36:1636-1643.
16. Cruse H, Winiarek M, Marshburn J, Clark O, Djulbegovic B. Quality and methods of developing practice guidelines.
29. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized
BMC Health Serv Res 2002;2:1-73.
controlled trials and recommendations of clinical experts:
17. New Zealand Guideline Group. Handbook for the preparation
treatments for myocardial infarction. JAMA 1992;268:240-248.
of explicit evidence-based clinical practice guidelines. New Zealand 2001;5.
30. Mulrow CD. Systematic reviews: rationale for systematic reviews. Br Med J 1994;309:597-599.
18. Appraisal of Guidelines for Research & Evaluation (AGREEⅡ) instrument. Available at: http://www.agreetrust.org/resource-
31. LU AP, Jiang M, Zhang C, Chan K. An integrative approach of linking traditional Chinese medicine pattern classification and
center/agree-ii/ (last accessed 15 February 2013).
biomedicine diagnosis. J Ethnopharmacol 2012;141:549-576.
19. Cao HX, Wang YY. Clinical practice guideline in traditional Chinese medicine for ischemic stroke. In: Evidence-based
32. Yuwen Y, Xie YM, Zou YH, Li Z H, Wang YY. Rehabilitation
guideline of clinical practice in Chinese medicine internal
scheme of traditional Chinese medicine for early
China. 1st ed. Beijing: China Press of Traditional Chinese
ischemic stroke. J Shanghai Univ Tradit Chin Med (Chin) 2009;23:28-30.
Medicine;2011:283-310. 20. China Association of Chinese Medicine. Ischemic Stroke. In:
33. Guo JW, Huang Y. Preliminary analysis of comprehensive
Guidelines for diagnosis and treatment of common internal
therapeutic regimen for acute ischemic stroke patients with yin
diseases in Chinese medicine disease of modern medicine.
series-syndromes. J New Chin Med (Chin) 2010;42:12-14.
1st ed. Beijing: China Press of Traditional Chinese Medicine;
34. Shen PF, Kong L, Ni LW, Guo HL, Yang S, Zhang LL, et al. Acupuncture intervention in ischemic stroke: a randomized
2008:260-264.
controlled prospective study. Am J Chin Med 2012;40:685-693.
21. China Association of Chinese Medicine. China Association of Chinese Medicine, Apoplexy. In: Guidelines for diagnosis
35.
Gong B, Li CQ, Ling LL. Effect of acupuncture and
and treatment of common internal diseases in Chinese
massage combined with functional training on neurological
medicine symptoms of modern medicine. 1st ed. Beijing:
function and activities of daily living of patients with cerebral
China Press of Traditional Chinese Medicine; 2008:56-62.
infarction. Chin J Clin Rehabil (Chin) 2006;10:1-4.
22. State Food and Drug Administration. Guidelines for clinical
36. Yuwen Y, Xie YM, Zhao XQ, Zou YH, Wang XZ, Ma ZY,
researches of new traditional Chinese drugs on ischemic
et al. Effect of traditional Chinese medicine synthetic
stroke. In: Zheng XY, ed. Guideline for clinical researches of
rehabilitation project on early rehabilitation for patients
new traditional Chinese drugs. 1st ed. Beijing: China Medical
with ischemic stroke. World Sci Tech/Mod Tradit Chin Med
Science Press; 2002:99-104.
Mater Med (Chin) 2010;12:526-530.
23. Encephalopathy Emergency Group, State Administration
37. Geng C, Mei XM, Yan ZM, Li YJ, Bi DR, Chen XY, et
of Traditional Chinese Medicine of the People's Republic of
al. Research of comprehensive treatment of traditional
China. Standard for diagnosis and effectiveness assessment
Chinese medicine in treating acute ischemic stroke. Chin J
of stroke. J Beijing Univ Tradit Chin Med (Chin) 1996;19:55-59.
Integr Tradit West Med Intens Crit (Chin) 2009;16:356-358.
24. Navarro Puerto MA, Ibarluzea IG, Ruiz OG, Alvarez FM,
38. Fu YB, Zou YH, Li ZH, Jin H, Xie, ZJ, Ma DY, et al. Clinical
Herreros RG, Pintiado RE, et al. Analysis of the quality of
study of comprehensive Chinese Medicine intervention
clinical practice guidelines on established ischemic stroke.
project in treating ischemic stroke at early stage. China J
Int J Technol Assess Health Care 2008;24:333-341.
Tradit Chin Med Pharm (Chin) 2011;26:987-989.
25. Gallardo CR, Rigau D, Irfan A, Ferrer A, Caylà, JA, Bonfill
39. You JS, Wang LX, Liang WX, Huang Y, Cai YF, Guo JW.
X, et al. Quality of tuberculosis guidelines: urgent need for
Effect of integrative medical therapy on the prognosis of
improvement. Int J Tuberc Lung Dis 2010;14:1045-1051.
patients suffering from yin syndrome type acute ischemic
26. Kinnunen-Amoroso M, Pasternack I, Mattila S, Parantainen
stroke, Chin J Integr Tradit West Med (Chin) 2011;31:195-199.
A. Evaluation of the practice guidelines of Finnish institute
(Received August 9, 2013) Edited by YUAN Lin
of occupational health with AGREE instrument. Industri
