key: cord-0893192-dxqqy8mw authors: Lee, Beom-Joon; Ah Lee, Ju; Kim, Kwan-Il; Choi, Jun-Yong; Jung, Hee-Jae title: A consensus guideline of herbal medicine for coronavirus disease 2019 date: 2020-07-05 journal: Integr Med Res DOI: 10.1016/j.imr.2020.100470 sha: fca1072fcd14e739290e27e16997a893908ebe9e doc_id: 893192 cord_uid: dxqqy8mw BACKGROUND: The Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which originated in Wuhan, Hubei Province, China in late December 2019, is the cause of ongoing pandemic. We analyzed the symptoms of SARS-CoV-2, a classification of the Chinese medicine dialectic and treatment regimen, and promptly enacted the recommendation of Korean medicine preparations in herbal medicine covered under domestic medical insurance benefits depending on the circumstances in our country. METHOD: The clinical practice guideline (CPG) for the treatment of SARS-CoV-2 was developed based on consensus from a group of experts. RESULTS: Two kinds of herbal medicines (HM) were recommended for the prevention of SARS-CoV-2; Youngyopaedoc-san plus Bojungikgitang, and Youngyopaedoc-san plus Saengmaek-san. Two herbal preparations were recommended for people with a history of exposure to SARS-CoV-2; Youngyopaedoc-san plus Bulhwangeumjeonggi-san, and Youngyopaedoc-san plus Bojungikgi-tang. Three herbal preparations were recommended for mildly symptomatic COVID-19 patients; Youngyopaedoc-san plus Galgunhaegui-tang was recommended for those without pneumonia with wind-warmth disease invading the lungs; Sosiho-tang plus Bulhwangeumjeonggi-san was recommended for those with dampness-heat disease in the lungs. For the recovery stage, Samchulkunbi-tang plus Saengmaek-san, or Samchulkunbi-tang plus Chungseuiki-tang was recommended. CONCLUSION: The CPG was developed to guide the use of Korean herbal medicine in the treatment of SARS-CoV-2, and it is expected that this will be the basis for providing proper treatment of similar infectious diseases in the future. The Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), which originated in Wuhan, Hubei Province, China in late December 2019, is the cause of ongoing pandemic. As of early March 2020, Korea had the world's second highest number of infections, exceeding 5,000 people, and the numbers were sharply increasing (1) . In a situation where more effective symptomatic treatment is required without special treatment, the Chinese government's novel coronavirus pneumonia guideline (7 th edition) (2) recommends combining traditional medicine with modern medicine. For its introduction in Korea, we analyzed the symptoms of SARS-CoV-2 infection, a classification of the Chinese medicine dialectic and treatment regimen, and promptly enacted the recommendation of Korean medicine preparations in herbal medicine covered under domestic medical insurance benefits depending on the circumstances in our country. The expert committee discussed the key syndromes of traditional medicine in SARS-CoV-2 based on the Chinese government guidelines and Korean medicine clinical practice guideline for common cold, and then modified these syndromes and herbal medicines according to the Korean environment. J o u r n a l P r e -p r o o f The CPG was developed by stakeholders (Table 1) . All comments were reviewed by the committee. In addition, we recommended the usage of Qingfeipaidu-tang (1), which is the standard herbal decoction recommended by the Chinese government, and its substitute herbal preparations for patients with mild symptoms. As there were no clinical trials on the efficacy of Korean herbal preparations for SARS-CoV-2 infection, we could not assess the quality of evidence of studies, and all recommendations were based on generative process planning (GPP) by experts in traditional medicine used on the pulmonary system. However, we identified local upper respiratory infection guidelines in Korean medicine (3), such that indirect evidence of herbal preparations on respiratory symptoms of SARS-CoV-2 was included in this guideline. This guideline is applicable to the following groups of patients: 1. those who are waiting for the polymerase chain reaction (PCR) results of their respiratory specimen; 2. those who have mild symptoms with a diagnosis of SARS-CoV-2 without pneumonia in radiologic tests; and 3. those who are in the recovery stage after showing two consecutively negative PCR results, with both tests conducted more than 24 h apart. Generally, the grade of a recommendation is rated from A to C. However, in the guidelines developed here, we used a 4-point grading system called the good practical point (GPP). The recommendations were drafted by a working group that developed the clinical practice J o u r n a l P r e -p r o o f guideline (CPG). Agreement over the final recommendations was achieved using the recommendation grades. The Delphi method was used for the consensus processes of selecting recommendations and confirming both evidence levels and recommendation grades. The survey was conducted using online survey program (https://office.naver.com/). The working group members discussed and revised these issues through several meetings and emails. First, the feedback received from the Report Approval Panel was addressed by the authors in the working group. Second, the Society of Korean Medical Pulmonary Disease circulated the draft guidelines (with modified recommendations, as noted in the internal review) to external participants for review and feedback. In addition, the monitoring committee reviewed and approved the recommendations. Recommendations on treatment strategies were developed for people in need of prevention, people with a history of exposure to the virus, patients with mild symptoms, and patients in the recovery stage (Table 2 ). Two kinds of herbal medicines (HM) were recommended for the prevention of SARS-CoV-2; Youngyopaedoc-san plus Bojungikgitang, and Youngyopaedocsan plus Saengmaek-san. Further, two herbal preparations were recommended for people with a history of exposure to SARS-CoV-2; Youngyopaedoc-san plus Bulhwangeumjeonggi-san, and Youngyopaedoc-san plus Bojungikgi-tang. Three herbal preparations were recommended for mildly symptomatic COVID-19 patients; Youngyopaedoc-san plus Galgunhaegui-tang J o u r n a l P r e -p r o o f was recommended for those without pneumonia with wind-warmth disease invading the lungs; Sosiho-tang plus Bulhwangeumjeonggi-san was recommended for those with dampness-heat disease in the lungs. For the recovery stage, Samchulkunbi-tang plus Saengmaek-san, or Samchulkunbi-tang plus Chungseuiki-tang was recommended. All levels of recommendations were GPP. The details of the formula compositions of each herbal medicine were listed in supplement 1. A total of 11 experts participated in the rapid Delphi process. All experts were affiliated with the Society of Korean Medical Pulmonary Disease working at Korean medicine hospitals (supplement 2). Delphi consensus was made by single round survey as follows (supplement 3). SARS-CoV-2 is easily transmissible, and has resulted in large numbers of infected people worldwide, with many mortalities (4). Currently, there is no cure for, or vaccine against SARS-CoV-2(5, 6). Therefore, the impact of COVID-19 is expected to be long lasting. HM has been practiced since ancient times for the treatment of respiratory diseases and infectious diseases, and its effectiveness has been proven by various studies (7) . The researchers have This article does not contain any studies with human or animal subjects performed by the any of the authors. -Clinical consideration: Only if there are symptoms of external contraction due to cold and dampness, respiratory symptoms, including fever, weakness, body aches, cough, sputum, chest tightness, and choke, digestive symptoms, including anorexia, nausea, vomiting and sticky stool with discomfort. Mild symptomatic patients with COVID-19 and dampness-heat disease in the lungs. Sosiho-tang + Bulhwangeumjeonggi-san (Xiao Chaihu Tang + Buhuanjin Zhengqi San) -Clinical consideration: Only if there are symptoms of external contraction due to heat and dampness, respiratory symptoms, including mild or no fever, mild chills, weakness, heaviness of head and body, muscle ache, dry cough with thick sputum, sore throat, dry mouth with anorexia, excess thirst, anhidrosis or hypohidrosis, digestive symptoms, including oppression in the chest and gastric stuffiness or nausea with anorexia and loose stool or sticky stool with discomfort. World Health Organization. Coronavirus disease 2019 (COVID-19) Situation report -44 National Health Commission of People's Republic of China. Diagnosis and treatment of pneumonia caused by novel coronavirus Guideline Center for Korean Medicine and The Society of Internal Korean Medicine. Korean Medicine Clinical Practice Guideline for Common cold (pre-certified version) World Health Organization. Coronavirus disease (COVID-19) Pandemic Systematic review of the efficacy and safety of antiretroviral drugs against SARS, MERS or COVID-19: initial assessment A Review of SARS-CoV-2 and the Ongoing Clinical Trials Traditional Chinese Medicine in the Treatment of Patients Infected with 2019-New Coronavirus (SARS-CoV-2): A Review and Perspective Clinical Observation of Qingfeipaidu Decoction in the Treatment of COVID-19 Tang) -Clinical consideration: Recovery means two consecutive sets of negative test results Qingfeipaidu-Tang) and its replacement medicines: Consider the use of for symptom improvement in adults with COVID-19 Clinical consideration: Consider the severity of symptoms of external contraction and respiratory dysfunctions induced by heat as well as digestive symptoms due to dampness: Symptom comparison between Korean patients and Chinese patients is required • If there are no digestive symptoms due to dampness, caution for adverse reactions due to dryness is required • If heat sense becomes severe, focus on the herbal composition of Mahaenggamseok-tang (Ma Xing Gan Shi Tang) and Sosiho-tang (Xiao Chaihu Tang); To resolve cough, focus on the herbal composition of Saganmahwang-tang (Shegan ma huangtang); If digestive symptoms are present, including stool problems, focus on the herbal composition of Oryeong-san Adults with COVID-19 (replacement medicine of Chungpaebaedoc-tang