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SARS: Clinical Trials on Treatment Using a Combination of Traditional Chinese Medicine and Western Medicine
(2004; 194 pages) View the PDF document
Table of Contents
View the documentAcknowledgements
View the documentIntroduction
View the documentReport of the International Expert Meeting to review and analyse clinical reports on combination treatment for SARS
View the documentReport 1: Clinical research on treatment of SARS with integrated Traditional Chinese medicine and Western Medicine
View the documentReport 2: Clinical efficacy of the treatment of SARS with integrated Traditional Chinese medicine and Western medicine: an analysis of 524 cases
View the documentReport 3: Manifestation of symptoms in patients with SARS and analysis of the curative effect of treatment with integrated Traditional Chinese medicine and Western medicine
View the documentReport 4: Clinical study on 103 inpatients undergoing therapy with integrated Traditional Chinese medicine and Western medicine
View the documentReport 5: Clinical observations of 11 patients with SARS treated with Traditional Chinese medicine
View the documentReport 6: Effects of applying integrated therapy with Traditional Chinese medicine and Western medicine on liver and kidney functions in patients with SARS
View the documentReport 7: Clinical research on 63 patients with SARS treated with integrated Traditional Chinese medicine and Western medicine
View the documentReport 8: Influence of integrated therapy with Traditional Chinese medicine and Western medicine on lymphocytes and T-lymphocyte subpopulations of patients with SARS
View the documentReport 9: Analysis of the clinical curative effects on patients with SARS of treatment with Traditional Chinese medicine and Western medicine
View the documentReport 10: Evaluation of clinical curative effects of Traditional Chinese medicine in treatment of patients convalescing from SARS
View the documentReport A: A herbal formula for the prevention of transmission of SARS during the SARS epidemic in Hong Kong Special Administrative Region - a prospective cohort study
View the documentReport B: Effects of Chinese medicine on patients convalescing from SARS in Hong Kong special administrative region - a prospective non-randomized controlled trial
View the documentReport C: Traditional Chinese medicine in the management of patients with SARS in Hong Kong Special Administrative Region - a case-control study of 24 patients
View the documentAnnex
 

Introduction

Background

In the winter of 2002, severe acute respiratory syndrome (SARS) began to spread throughout the world. More than 5000 cases were reported in the People’s Republic of China, including over 1700 cases in China, Hong Kong Special Administrative Region (Hong Kong SAR). The total number of cases reported from Canada and Singapore was more than 200. The total number of SARS worldwide reached 8437 with incidences in 29 counties. Mortality from SARS is estimated at 10-12%.

The World Health Organization (WHO) took effective control measures including international collaboration supported at the highest political level. The global outbreak of SARS was successfully contained in early July 2003.

However, two isolated cases - in Singapore in September 2003 and Taipei in November 2003 - were caused by contamination in a laboratory. Furthermore, in December 2003, two more new SARS cases were confirmed in Guangdong, China where the first ever SARS case had been reported in 2002. Thus far, the source of infection and the mode of transmission for these two cases have not been clarified.

Research on the use of traditional medicine for treatment of SARS patients in China

China has a long history of the use of traditional medicine that has long been integrated into the national health system. When the SARS outbreak occurred in China, the State Administration of Traditional Chinese Medicine of the People’s Republic of China immediately initiated clinical research projects on the use of integrated Traditional Chinese medicine (TCM) and Western medicine for treating SARS. A total of 21 research projects were initiated to cover three aspects of SARS, namely, prevention, treatment and rehabilitation. Local governments in Beijing, Guangdong, Shanghai and Tianjin also established similar research projects.

Practitioners of TCM are estimated to have participated in the treatment of SARS in 102 of the 195 SARS-specific hospitals. Ninety-six TCM hospitals sent 2163 professionals to 93 SARS-specific hospitals. Of the 5327 patients with confirmed SARS, 3104 received treatment with TCM, which was 58.3% of the total SARS patients in China. In Hong Kong SAR, research on the use of TCM for the prevention and treatment of SARS, and during convalescence was reported. From the above-mentioned reports, it is clear that TCM and traditional medical physicians made a major contribution to combating SARS in China.

WHO International Expert Meeting

In order to better understand the potential of complementary treatment for patients with SARS and to encourage robust clinical research on SARS and its treatment with traditional medicine, the Chinese Government requested the guidance of WHO and support for 13 clinical trials of integrated treatment with TCM and Western medicine for SARS patients. The Nippon Foundation provided the financial support for WHO to organize an International Expert Meeting on Review of Treatment of SARS by Traditional Chinese Medicine, and the Integration of Traditional Chinese Medicine with Western Medicine, in Beijing, China from 8 to 10 October 2003. Sixty-eight experts from seven countries including Hong Kong SAR, Japan, the Netherlands, the People’s Republic of China, Thailand, Viet Nam and the United States of America, attended the meeting (Annex 1: list of participants).

The participants reviewed and evaluated the 13 research reports one by one (10 were from the People’s Republic of China, Reports 1-10, and three from Hong Kong SAR, Reports A-C), covering the areas of clinical treatment, convalescence and prevention. After 3 days of discussion, the participants recognized the contribution made by the TCM professionals in providing treatment to SARS patients under very trying conditions. In addition, they had carried out the prospective clinical research in such a way as to produce fruitful results and accumulated a substantial amount of data and valuable experience. Subsequently, the reports were modified to reflect the discussions and comments made during the meeting.

Results of research based on the level of evidence

The research data and findings were reviewed and debated at the meeting and the recommendations of the experts were divided into three levels as described below.

First level

There were sufficient data in the clinical reports to show that integrated treatment with TCM and Western medicine for patients with SARS is safe.

Second level

Of the reported trials, only two clinical trials included patients who were randomly selected for the studies, the others were prospective cohort studies or retrospective studies. The experts considered that the data were insufficient although it was concluded that there could be potential clinical benefits from integrated treatment with TCM and Western medicine for patients with SARS. Such potential benefits include the alleviation of fatigue, shortness of breath and other clinical symptoms; facilitation of lung inflammation absorption; reduction of the risk of oxygen desaturation and the stabilization of abnormal fluctuation of oxygen saturation in the blood; reduction in the dosage of glucocorticoid and antiviral agents (and therefore in their associated side-effects) and reduction of cost (treatment with TCM alone costs less than treatment with Western medicine alone).

Third level

The experts noted that the data in the reports were inconclusive. An example of this is the clinical observation that the mortality rate is lower for the patients treated with integrated TCM and Western medicine than for those treated with Western medicine alone. As the diagnosis of SARS is very difficult to confirm, and some cases may be misdiagnosed, this could lead to a lower recorded mortality rate. In the prevention studies, the response rate to the questionnaires was only 40% among those subjects who had taken the prevention formula; this was too low to enable an accurate assessment of its effects. In the study on convalescence, the comparison was made between only two groups, one treated with TCM and one with exercise. There was no comparison group that received neither treatment nor exercise programmes.

Utilization of the document

SARS is a newly identified human infection caused by a corona virus unlike any other known human or animal virus in its family. The analysis of epidemiological information obtained from the sites of the outbreak of SARS is still underway, but the overall case fatality ratio is known to approach 11%, although the rate among the elderly is much higher.

Currently, the major challenges for the treatment of SARS are:

• the source of the SARS virus and mode of transmission are still not well understood;
• there are problems with diagnostic tools;
• there is no effective treatment; and
• there is no vaccine for SARS.


The above-mentioned difficulties and challenges have motivated national authorities, health workers and scientists to explore the potential of complementary treatment.

The results of research on integrated treatment with TCM and Western medicine showed that it is safe and that it also has some potential clinical benefits. Therefore, the experts suggested that records of such experience could serve as reference material for treatment of SARS in the future.

This publication is intended to:

• share experience in the complementary treatment of SARS patients;

• share the experience of clinical studies in the field of traditional medicine for treatment of SARS between the physicians and researchers; and

• to further encourage and promote the quality of research in the field of traditional medicine


It must be emphasized that the purpose of this document is to report on some clinical studies on treatment and prevention selected by the Chinese government, and to record the review of these studies by an international meeting of experts. Only national health authorities have the right to determine what treatment for SARS can be recommended.

Please note that the reports contained in this document were originally written in Chinese, therefore much of the specific terminology and medical descriptions are direct translations of the original text. It is particularly the case for terms regarding Traditional Chinese medicine though this applies to Western medical terms as well. At the moment there is no standardized international English terminology for Traditional Chinese medicine. WHO is currently working on developing standard terms in English for Traditional Chinese medicine. It is not the scope of this document to propose terminologies or descriptions in the field of Traditional Chinese medicines or SARS. If clarification of anything contained within the reports is necessary, it is recommended that the original reports be referenced.

 

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