Abstract
OBJECTIVE:
To formulate the first clinical practice guideline for the treatment of cough using Chinese medicine based on the grading of recommendations assessment, development, and evaluation (GRADE) systematic approach, including clinical evidence, evaluation of ancient literature, and expert consensus.
METHODS:
In the process of development, the regulation of "evidence-based, consensus-assisted, and empirical" was followed, and a comprehensive systematic approach of recommendation assessment, GRADE, evidence-based evaluation, expert consensus, and the Delphi method was used. In the process of guideline development, evidence-based evaluation of ancient literature was included for the first time, and clinical evidence was fully integrated with clinical expert consensus.
RESULTS:
The clinical practice guidelines for the treatment of cough with Chinese herbal medicine were developed after a comprehensive consideration of evidence-based evaluation and expert opinions. The guideline recommendations focused on recommending herbal compound decoctions and Chinese patent medicines for cough in different conditions. Based on the GRADE systematic approach, we conducted an evidence-based evaluation of the recommended Chinese patent medicines one by one; meanwhile, the expert consensus method was used to unify the recommendations of both.
CONCLUSION:
Based on clinical evidence, ancient literature evaluation, and expert consensus, a clinical practice guideline for Traditional Chinese Medicine (TCM) in the treatment of cough was developed, providing the first current clinical practice guideline for domestic and foreign TCM and Western medicine practitioners, especially respiratory professionals at home and abroad.
Keywords: Medicine, Chinese Traditional; clinical practice; cough practice guide; international standard
1. INTRODUCTION
In recent years, the incidence of cough has increased significantly with changes in the natural and social environment.1 Cough is one of the most common symptoms in patients in respiratory specialties and community outpatient clinics. In China, the prevalence of chronic cough in adults is about 2.0%-28.3%.2,⇓,⇓-5 Due to the complex etiology, it is difficult to make a definitive diagnosis. Western Medicine always treats it by targeting the cause and symptomatic treatment, such as cough suppression and expectoration. Commonly used drugs such as codeine, compound methoxamine capsules, and acetylcysteine are used. However, it has been clinically found that cough is one of the most common and intolerable symptoms for patients due to its susceptibility,6,7 long-term persistence,7,⇓-9 relapse and intractability,4,10 which can even affect the quality of life and mood of patients,8,11,⇓,⇓- 14 and also impose a serious health and economic burden on society.7,15,16 Western Medicine has limitations in terms of etiology-based and symptomatic treatment, especially for some patients with normal lung images but frequent coughing episodes, and it is difficult to achieve the desired therapeutic effect. During its long-term development, Traditional Chinese Medicine (TCM) has unique therapeutic ideas and methods with obvious results.17,⇓,⇓-20 However, there are no independent clinical practice guidelines for cough in TCM. The published Guidelines for the Diagnosis and Treatment of Cough (2015) and Guidelines for the Diagnosis and Treatment of Cough (2021) both recommend TCM interventions.4,10
Therefore, with the support of the "International Technical Standards for Chinese Medicine" project of the National Key Research and Development Program, Professor ZHANG Hongchun of China-Japan Friendship Hospital and Professor SUN Zengtao of Tianjin University of Traditional Chinese Medicine led a project research group to develop the "Development of International Technical Standards for Chinese Medicine. Clinical Practice Guidelines for Cough in Chinese Medicine" (hereinafter referred to as "Guidelines"), which was developed based on the "Expert Consensus on TCM Diagnosis and Treatment of Cough (2021)".21 In the preparation process, the principle of "evidence-based, consensus-assisted, and empirical" was followed, and each piece of evidence was scored and synthesized using a combination of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) systematic approach, ancient evidence-based evaluation, expert consensus, and Delphi method; its evidence-based evidence was fully integrated with the opinions of clinical practice. Considering the opinions of TCM practice, we evaluated the ancient literary evidence for each TCM compound and the evidence for each proprietary TCM; and used the expert consensus approach to unify the recommendations for both.
This guideline provides general principles for clinicians, including TCM and Western Medicine practitioners, especially domestic and foreign respiratory professionals, in selecting TCM for cough. It aims to improve the quality of physicians' prescriptions, reduce the risk of irrational drug use, and guide physicians in the rational use of herbal medicine for cough according to medical resources and drug availability.
2. METHODS
The guidelines were developed under the guidance of CHEN Yolong's team at Lanzhou University and strictly followed the GRADE system approach. We established 6 groups of guideline working groups (see supplementary annex for details). A steering committee consisting of six experts from the fields of clinical research, evidence-based medicine and ancient Chinese literature research guided and supervised the development process. The Evidence Assessment Group consisted of Chinese medicine practitioners (FANG Hanyu, HONG Zheng, YU Bang), clinical experts LI Demin, evidence-based medicine experts CHEN Wei, and ancient literature researcher ZHANG Chuchu.
2.1. Determination of TCM syndrome types
Under the guidance of Prof. CHEN Wei, the evidence was retrieved and evaluated using the GRADE system approach; under the guidance of researcher ZHANG Chuchu, the evidence-based evaluation of ancient texts was conducted based on the Grading Scale for Evidence Evaluation in Traditional Chinese Medicine.22,23 The synthesis and recommendation of the final evidence followed the GRADE systematic approach (Tables 1 and 2). The types and criteria for judging the TCM syndromes of cough are based on the "Expert Consensus on TCM Diagnosis and Treatment of Cough (2021)".21 There are 9 major TCM syndromes, along with 3 subtypes:
Table 1.
Descriptions of GRADE evidence quality
| Grade | Code | Definition |
|---|---|---|
| High | A | The authors have a lot of confidence that the true effect is similar to the estimated effect. |
| Moderate | B | The authors believe that the true effect is probably close to the estimated effect. |
| Low | C | The true effect might be markedly different from the estimated effect. |
| Very low | D | The true effect is probably markedly different from the estimated effect. |
Note: GRADE: grading of recommendations assessment, development, and evaluation.
Table 2.
Grading and expression of GRADE recommended intensity
| Recommended grade | Recommended terms in this guide | Code |
|---|---|---|
| Strong recommendations to support the use of certain therapies | Strong recommendation | 1 |
| Weak recommendation to support the use of certain therapies | Weak recommendation | 2 |
| Uncertain | Not recommended | 3 |
| Strong recommendation against using certain therapies | opposition | 4 |
| Weak recommendation against the use of certain therapies | Not recommended | 5 |
Note: GRADE: grading of recommendations assessment, development, and evaluation.
(a) Wind and cold attacking lungs: heavy cough, shortness of breath, itching, thin and white sputum, nasal congestion, clear runny nose, headache, aching limbs, aversion to cold and fever, no sweat. Thin and white tongue coating, floating or tight pulse.
External cold and internal drink: wheezing and coughing, clear and excessive sputum, fear of cold, fever, head and body pain, no sweating, chest discomfort, dry vomiting, inability to lie down with wheezing and coughing, body pain, swelling of head, face and limbs. White and smooth tongue coating, and floating pulse.
(b) Wind and heat attacking lungs: cough frequently, coarse breath or hoarseness, sore throat, hard to cough up sputum, yellow sticky sputum, runny nose, thirst, headache, fear of wind, body heat, red tongue with thin yellow coating, floating or slippery pulse.
(c) Dryness invading lungs: dry cough with little or no sputum, dry throat and dry nose, chest pain when coughing, or sticky sputum that is not easy to cough up.
Warm dryness damaging lungs: dry cough with little or no sputum, chest pain when coughing, sticky sputum that cannot be easily removed, dry pharynx and dry nose, with initial chills, body heat and headache. Red tongue with thin yellow coating, thin and rapid pulse.
Cold dryness damaging lungs: dry cough with little or no sputum, sputum is sticky and not easy to be expelled, dry throat and nose, sputum is clear and thin, and there is no sweating. Thin white and dry tongue coating, floating stringy pulse.
(d) Wind excessiveness and spasm: cough, dry cough without sputum or little sputum, dry throat, itchy cough, or choking cough, shortness of breath, sudden onset or aggravation when exposed to external heat or cold, odor and other factors, mostly seen at night and in the morning, with recurrent attacks of coughing, fear of cold, fever, limb aches. Thin and white tongue coating, stringy pulse.
(e) Phlegm-dampness accumulating in lungs: coughing sputum, coughing heavily, white sticky or thick or thin sputum, deteriorate in early morning, coughing because of sputum, relief after coughing up sputum, chest tightness, abdominal fullness, poor appetite, constipation. White and greasy tongue coating, moist and smooth pulse.
(f) Phlegm-heat confined in lungs: cough with shortness of breath, sputum sound in the throat, excessive sputum, sticky or thick yellow sputum, hard to cough up sputum or vomit, fishy sputum, blood in sputum, distension and fullness in the chest, coughing with pain, red face, fever, thirsty, dry mouth, dry stool. Red tongue with thin yellow greasy coating, slippery pulse.
(g) Abnormal rising of stomach Qi: paroxysmal choking and shortness of breath, vomiting acidic and bitter water when coughing, aggravated by lying down or after satiety, upper abdominal discomfort with belching and acid swallowing, noisy or burning stomach. Red tongue with white and greasy coating, weak pulse.
(h) Liver fire invading lungs: paroxysmal cough with red face and red eyes, coughing leading to chest pain, which may increase or decrease with mood swings, often with little and sticky sputum stagnation in the throat, or sputum like strips, irritable heat and dry throat, dry mouth with bitterness, and pain in the chest. Red tongue, thin yellow tongue coating with little fluid, stringy pulse.
(i) Lung Yin deficiency: dry cough, short cough, little sputum and sticky white sputum, or blood in sputum, gradually hoarse voice, fever in the afternoon, red cheekbones, heat in palms and sole of feet, sweating when asleep, dry mouth and throat, slow onset, gradual loss of weight, fatigue. Red tongue with little coating, thin and rapid pulse.
2.2. Literature search strategy
2.2.1. Keywords
Randomized, controlled, trial, randomized controlled trials (RCT), blinded, single-blind, double-blind, acute bronchitis, chronic bronchitis, cough variant asthma, post-cold/infection cough, upper airway cough syndrome, eosinophilic cough, allergic cough, laryngeal cough, gastroesophageal reflux cough.
2.2.2. Databases
The China National Knowledge Infrastructure Database, Chinese Science and Technology Journal Database, Wanfang Database, Chinese Biomedical Literature Database, PubMed and web of science were included in the search, concerning the 9 common diseases causing cough mentioned in keywords. Etiologic synonyms were then searched and adjusted for specific interventions. The search period started from the establishment of each database and ended on December 30, 2021.
2.3. Inclusion criteria
Inclusion criteria were developed based on PICOS principles (PICOS is a new information formatted retrieval method proposed by CHEN Yolong's team based on the theory of evidence-based medicine. It is the abbreviation of participants, interventions, comparisons, outcomes, symptoms. This will divide each question into five parts: participants, interventions, comparisons, outcomes, symptoms.).
2.3.1. Population
Patients 18 years of age or older who met the TCM diagnosis of cough21 or the western medical diagnosis of the 9 diseases4,10 mentioned above.
2.3.2. Intervention
Interventions included TCM monotherapy to be evaluated and conventional western medical treatment. Appropriate additions, subtractions, or reductions based on the same herbal compound were considered as the same therapy.
2.3.3. Comparison
Conventional treatment that used western medicine alone.
2.3.4. Outcome
At least one of the following was required: efficiency, clinical symptoms (e.g., cough, sputum).
2.3.5. Study design
Type of included studies were RCTs and Meta-analysis.
2.4. Exclusion Criteria
(a) The following types of literature were excluded: animal experiments, case reports, empirical reports, theoretical discussions. (b) Not meeting diagnostic criteria for cough (e.g., abnormal chest X-ray). (c) Cough not caused by any of the nine diseases mentioned above: pregnancy cough, psychological cough, acquired immure deficiency syndrome cough, drug-induced cough, etc. (d) The age of participants was not specified. (e) Combined use of multiple TCM therapies. (f) Multiple studies with same original data. (g) Studies with no access to full text.
3. RESULTS
Different from the previous ones, we reported the results of evidence-based evaluation of relevant interventions in ancient texts for the first time in the Clinical Practice Guidelines for Chinese Medicine (Table 3). We believe that this can provide an important reference and basis not only for the consensus expert group to form recommendations, but also for clinicians when using them.
Table 3.
Evidence based Evaluation of Cough in Ancient Chinese Literature
| Level of evidence | TCM prescriptions | Source |
|---|---|---|
| High | Xiaoqinglong decoction (小青龙汤) | Treatise on Febrile Diseases |
| High | Erchen decoction (二陈汤) | Tai Ping Hui Min He Ji Ju Fang |
| High | Xingsu powder (杏苏散) | Treatment of Epidemic Febrile Disease |
| High | San-ao decoction (三拗汤) | Tai Ping Hui Min He Ji Ju Fang |
| High | Maxing Shigan decoction (麻杏石甘汤) | Treatise on Febrile Diseases |
| Moderate | Sangju decoction (桑菊饮) | Treatment of Epidemic Febrile Disease |
| Moderate | Zhisou powder (止嗽散) | Yi Xue Xin Wu |
| Moderate | Sangxing Powder (桑杏汤) | Treatment of Epidemic Febrile Disease |
| Moderate | Shashen Maidong decoction (沙参麦冬汤) | Treatment of Epidemic Febrile Disease |
| Moderate | Sanzi Yangqin decoction (三子养亲汤) | Han Shi Yi Tong |
| Moderate | Xuanfu Daizhe decoction (旋覆代赭汤) | Treatise on Febrile Diseases |
| Moderate | Daige powder (黛蛤散) | Wei Sheng Hong Bao |
| Moderate | Qingjin Huatan decoction (清金化痰汤) | Yi Xue Tong Zhi |
| Low | Huangqin Xiebai powder (黄芩泻白散) | Zheng Yin Mai Zhi |
Notes: TCM: Traditional Chinese Medicine.
This guide is applicable to cough patients over 18 years old. The diagnostic criteria are as follows: the main clinical symptoms of this disease are cough, no sputum or spitting; Auscultation showed rough breathing sounds in both lungs; X-ray examination of the lung showed no obvious abnormality or thickening of lung markings. According to the course of disease, it can be divided into three types: acute cough, subacute cough and chronic cough. We suggest that clinicians should pay attention to diagnosis and differentiation when using it, and judge whether the cough is caused by other reasons.
Finally, 253 studies were included, and we developed the Clinical Practice Guidelines for the Treatment of Cough with Chinese herbal medicine, which provides clinical recommendations and specifications for the treatment of cough in the industry. The recommendations of the protocol (Table 4) were endorsed by 45 of the 55 domestic and international consensus panel experts, with an agreement rate of 82%. (At the end of the article, we attach a list of all the members of the guide working group.)
Table 4.
Recommendations for the treatment of cough with TCM
| TCM syndrome | Recommended medication | Level of evidence | Recommended level |
|---|---|---|---|
| Wind and cold attacking lungs | San-ao decoction (三拗汤) | C | 1 |
| Zhisou powder (止嗽散) | B | 1 | |
| External cold and internal drink | Xiaoqinglong decoction (小青龙汤)/ Xiaoqinglong granules (小青龙胶囊) | B | 1 |
| Wind and heat attacking lungs | Sangju decoction (桑菊饮) | C | 1 |
| Warm dryness damaging lungs | Sangxing powder (桑杏汤) | C | 1 |
| Cold dryness damaging lungs | Xingsu powder(杏苏散) | D | 1 |
| Wind excessiveness and spasm | Suhuang Zhike soup (苏黄止咳汤) /Suhuang Zhike granules (苏黄止咳胶囊) | B | 1 |
| Phlegm-dampness accumulating in lungs | Erchen decoction (二陈汤) | B | 1 |
| Sanzi Yangqin decoction (三子养亲汤) | D | 1 | |
| Phlegm-heat confined in lungs | Qingjin Huatan decoction (清金化痰汤) a | B | 1 |
| Feilike granules (肺力咳胶囊)b | C | 2 | |
| Abnormal rising of stomach Qi | Xuanfu Daizhe decoction (旋覆代赭汤) | D | 1 |
| Liver fire invading lungs | Huangqin Xiebai powder (黄芩泻白散) | (Based on experts consensus) | 2 |
| Daige powder (黛蛤散) | (Based on experts consensus) | 2 | |
| Lung Yin deficiency | Shashen Maidong decoction (沙参麦冬汤) | B | 1 |
Notes: TCM: Traditional Chinese Medicine. a,b: we suggest that only one of these two interventions should be selected.
Among the included studies, 49 had a high level of evidence and the majority of which were RCTs.
More specifically, of these high-level evidence studies, 7 were related to Xiaoqinglong decoction (小青龙汤);24,⇓,⇓,⇓,⇓,⇓- 30 and 6 were related to Erchen decoction (二陈汤);31,⇓,⇓,⇓,⇓- 36 and 2 were related to Xingsu powder (杏苏散);37- 38 and 6 were related to San-ao decoction (三拗汤);39,⇓,⇓,⇓,⇓-44 and 4 were related to Maxing Shigan decoction (麻杏石甘汤); 45-48and 3 were related to Sangju decoction (桑菊饮); 49-51and 8 were related to Zhisou powder (止嗽散);52,⇓,⇓,⇓,⇓,⇓,⇓-59 and 1 were related to Sangxing Powder (桑杏汤); 60 and 7 were related to Shashen Maidong decoction (沙参麦冬汤);61,⇓,⇓,⇓,⇓,⇓-67 and 1 were related to Sanzi Yangqin decoction (三子养亲汤); 68and 1 were related to Xuanfu Daizhe decoction (旋覆代赭汤); 69and 3 were related to Qingjin Huatan decoction (清金化痰汤).70,⇓-72 However, Daige powder (黛蛤散) and Huangqin Xiebai powder (黄芩泻白散) lacked high-level evidence studies.
4. DISCUSSION
This is the latest English clinical guideline for the treatment of cough with Chinese herbal medicine following the GRADE system, and the first guideline to use evidence-based evaluation methods from ancient literature in research and development.
The development of clinical practice guidelines requires the preparers to always adhere to a strict development process and provide the latest and best clinical evidence. At the same time, the publication of the guidelines is conducive to promoting standardized treatment protocols, reducing variation in clinical efficacy, and promoting the integration of TCM and evidence-based medicine. Chinese medicine has a long history, many academic schools, and significant regional and professional differences. Such differences in clinical experience, regional medication habits, and professional understanding are not conducive to the standardization of TCM treatment protocols or the preparation and publication of TCM guidelines. In the current study, we found that the clinical evidence for TCM in the treatment of cough is incomplete in the modern evidence-based medical evaluation system. As a medicine based on practical experience, TCM has a long history in Asia with rich experience and case reports. In the past, due to limited conditions, treatment protocols derived from ancient literature were rarely considered for inclusion in the development of clinical practice guidelines, resulting in the absence of some clinically meaningful and valuable treatment protocols. This situation has further led to selection bias in the design of clinical trials or realistic studies by industry stakeholders. They prefer to study the existing consensus or guideline-recommended drug regimens, which further leads to the lack of high-quality clinical study reports for some TCM interventions. To improve and shape clinical practice guidelines for TCM for cough, we used an evidence-based evaluation of ancient Chinese literature, combined with empirical and clinical practice opinions, and reported the results to all members of the clinical consensus panel. Clinical experts were fully informed that the results of the evidence-based evaluation of ancient literature should be considered on the same footing as the results of modern evidence-based evaluation when recommending protocols. For the recommendation of the final treatment plan, both should be combined with their own clinical experience. Therefore, we believe that the ancient literature, in essence, provides evidence from a real-world perspective. In the process of guideline writing and production, the evidence-based evaluation methods of ancient texts should be emphasized and studied.
In the process of developing the guide, we encountered several limitations. First, although we did not restrict the language and type of publications and searched four English-language databases, we ended up including clinical studies that were not published in English-language journals, and the conclusions drawn were vulnerable to cultural and linguistic influences; the RCTs included were low-quality, single-center, small-sample clinical trials. The methodological quality is insufficient to make a clear judgment on the risk of bias. Second, considering the available clinical trial evidence, this guideline chose "effective rate" as the primary outcome indicator. Because of the different criteria for effectiveness across RCTs and the corresponding high heterogeneity, the results cannot be strongly recommended. In future clinical trials, more objective indicators should be selected. Last, given that the included clinical studies were rarely followed up, thus preventing the calculation of health output parameters and the construction of pharmacoeconomic models, future clinical trials need to be followed up accordingly to improve the authenticity and reliability of the results and provide health economics evaluation. We will update this guideline on time according to the progress of research in modern and ancient literature.
In addition, we recognize that TCM interventions have their characteristics and that the training of clinicians should be strengthened in their practical application. For example, when developing and recommending treatment plans for individual patients in the future, the plan should be recommended considering the actual situation, especially for patients who cannot easily decoct or carry compounded drugs, in addition to recommending proprietary Chinese medicine, other dosage forms can also be prepared by medical institutions for clinical use.
During the preparation of this guideline, all experts participating in the expert seminar of this guideline and members of the guideline working group have signed a written statement of interest. There is no conflict of interest related to the guideline with pharmaceutical enterprises, aiming to develop the current clinical practice guideline that is most suitable for clinical practice and conforms to TCM.
5. ACKNOWLEDGEMENTS
We would like to express our gratitude to each expert and staff. Their grouping and responsibilities have been shown in the supplementary annex.
6. SUPPORTING INFORMATION
Supporting data to this article can be found online at http://journaltcm.cn.
Contributor Information
Hongchun ZHANG, Email: 13701226664@139.com.
Zengtao SUN, Email: zengtaosun2021@126.com.
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