Clinical trials on treatment
using a combination of
Traditional Chinese medicine
and Western medicine
Report of the WHO International Expert Meeting to
review and analyse clinical reports on combination
treatment for SARS
8–10 October 2003
Beijing, People's Republic of China
World Health Organization
Geneva
2004
Report of the International Expert Meeting to review and analyse clinical reports on combination treatment for SARS
Background
Beginning in November 2002, severe acute respiratory syndrome (SARS) spread to 32 countries and areas, reaching a peak between April and May 2003. Up to 7 August 2003 the total number of cases was 8422, of which 5327 occurred in the People's Republic of China, 1755 in China, Hong Kong Special Administrative Region (Hong Kong SAR), 655 in china, Province of Taiwan, 251 in Canada and 238 in Singapore. The average mortality rate was 11%. In China the mortality rate was 7%, in Hong Kong SAR, 17% and in China, Province of Taiwan, 27%. The mortality rates in the other countries were 17% in Canada and 14% in Singapore.
It is estimated that TCM practitioners participated in the treatment of SARS in 102 of the 195 SARS-specific hospitals in the People’s Republic of China. NinetySARS: Treatment using a combination of Traditional Chinese medicine and Western medicine 6 six TCM hospitals sent 2163 professionals to 93 SARS-specific hospitals. Among the 5327 confirmed SARS cases, 3104 (58.3% of the total SARS patients in China) received TCM intervention. SATCM immediately initiated basic and clinical research projects on integrated TCM and Western medicine for the treatment of SARS. A total of 21 research projects were established. Local governments in Beijing, Guangdong, Shanghai
and Tianjin also established similar research projects. The prevention and treatment of SARS poses great challenges. Firstly, SARS is a completely new infectious disease, so there is a lack of scientific knowledge. The research results acquired thus far have not produced methods for making an early diagnosis of SARS in order to reduce its spread. Secondly, there is still no specific treatment for SARS. The use of high dosages of antiviral drugs and glucocorticoids is controversial because serious side-effects have been noted during the treatment process. Summarizing the experiences and potential benefits of TCM in treating SARS may be a productive way to find effective approaches for the prevention and treatment of SARS.
The WHO International Expert Meeting to Review and Analyse Clinical Reports on Integrated Treatment for SARS hosted by WHO and SATCM was held from 8 to 10 October 2003 in Beijing, People’s Republic of China. Officers from WHO Headquarters, the Western Pacific Region and the China office, as well as 51official representatives and 17 observers from Hong Kong SAR, Japan, the Netherlands, the People’s Republic of China, Thailand, Viet Nam and the United States of America attended the meeting. Officials from the Chinese Ministry of Health, National Commission of Development and Reform, Ministry of Science and Technology, Ministry of Education and SATCM attended the opening ceremony.
Objectives
The objectives of the meeting were to:
♦ Review and analyse clinical reports on the integrated treatment of SARS with TCM and Western medicine;
♦ Objectively evaluate the efficacy and safety of integrated treatment of SARS with TCM and Western medicine;
♦ Discuss the efficacy or underlying efficacy of treatment of SARS with integrated TCM and Western medicine; and
♦ Share experiences and knowledge of the treatment of SARS.Review and analysis The experts participating in the meeting reviewed and evaluated each of 13 reports (3 of which, Reports A-C, were from Hong Kong SAR), which were relevant to clinical treatment of SARS, convalescence and prevention research. After 3 days of discussion, the participants recognized the contribution made by the TCM professionals working in the clinical and research fields in providing treatment to many SARS patients in an extremely dangerous and urgent situation, while at the same time carrying out prospective clinical research that produced fruitful results and accumulating a considerable amount of data and experience.
The experts recognized the difficulties and challenges in conducting research on the treatments of SARS while the epidemic of this new disease was spreading. Due to the relative scarcity of medical resources and the heavy clinical workload, clinical research on SARS faced difficulties never previously encountered. The researchers nevertheless made every effort to improve the research design to assure quality and reduce bias. The experts recognized that integrated treatment by TCM and Western medicine for SARS is generally safe. The following potential benefits were also recognized:
♦ alleviation of clinical symptoms such as fatigue, shortness of breath and tachypnoea among others;
♦ facilitation of absorption of lung inflammation;
♦ reduction of the risk of oxygen desaturation and the stabilization of abnormal fluctuation of oxygen saturation in the blood;
♦ promotion of normalization of levels of peripheral blood lymphocyte and increase in levels of T cell subgroups;
♦ decrease in the dosage of glucocorticoid and antiviral agents and consequently in their associated side-effects;
♦ decrease in the incidence of abnormal levels of alanine aminotransferase (ALT), lactate dehydrogenase (LDH) and blood urea nitrogen (BUN), suggesting that integrated treatment with TCM and Western medicine is safe;
♦ the cost of treatment by TCM only is lower than that of treatment with Western medicine.
The following clinical observations were also noted:
♦ A group of patients at the early stage of SARS treated only with TCM all recovered without the need for glucocorticoid, antiviral agents, antibiotics or immunomodulators and were discharged from hospital.
♦ For those cases with comparable age, disease severity and underlying disease, analysis showed that the mortality rate was lower for the patients treated with integrated TCM and Western medicine than for those treated with Western medicine only.
♦ No SARS cases occurred among health care workers exposed to SARS patients and who had taken TCM for prophylaxis.
♦ During the convalescence period, treatment with TCM improved physical strength, alleviated clinical symptoms and decreased lung inflammation. These last two situations are unique in that no specific treatments with Western
medicine were evaluated for these cases so no comparison can be made.
Recommendations
The following recommendations were made by the experts who attended the meeting:
♦ According to the 13 clinical reports, treating SARS with integrated TCM and Western medicine is safe, provided that treatment is applied according to TCM principles; the potential benefits may be greater if treatment is started at an early stage.
♦ Continued follow-up of SARS patients is needed and the long-term effects of various treatments should be observed and compared.
♦ Design of clinical research projects would be further improved by paying attention to the clinical features of SARS and the individualized diagnosis and treatment principles of TCM, while strengthening the quality control of clinical research in order to minimize bias.
♦ Improve epidemiological research on SARS and its treatment schemes and increase the efficacy of treatment with integrated TCM and Western medicine. Research and develop effective TCM treatments and perfect quality control standards.
♦ Strengthen research on health economics, especially the evaluation of the effectiveness of prevention.
♦ Fully utilize TCM resources by bringing TCM into the clinical treatment system for public health emergencies, establish research networks, prepare plans for responding promptly to SARS outbreaks and for conducting research, and strengthen staff training.
♦ The experiences of treating SARS with integrated TCM and Western medicine described in the 13 clinical reports can serve as a reference for other countries in developing strategies for preventing and treating acute epidemics.
The experts who attended the meeting reached consensus that while the government and health workers of different countries are implementing clinical Report of the International Expert Meeting, they should first reinforce preventive and protective measures to reduce all nosocomial transmission. Recommendations to WHO Experts made the following recommendations to WHO:
♦ Continue to support research to improve trial design and implementation for traditional medicine in treating SARS and other diseases.
♦ Provide and support training courses, facilitate the sharing of experience and information on treatment of SARS with integrated TCM and Western medicine.
♦ Publish research relating to treatment of SARS with integrated TCM and Western medicine.
http://www.who.int/medicinedocs/collect/edmweb/pdf/s6170e/s6170e.pdf
