Professor Bian Zhaoxiang says Chinese medicine clinical research is gaining popularity among biomedical scientists worldwide


卞兆祥教授表示,中醫藥臨床研究越來越受到國際生物醫藥領域的關注

Date: 05 Jul 2017 (Wednesday)

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HKBU leads development of guidelines for better reporting of trials of Chinese herbal medicine formulas

浸大制定中藥複方臨床試驗報告指引 冀提升中藥研究水平

Led by Professor Bian Zhaoxiang, Associate Vice-President and Director of the Clinical Division of the School of Chinese Medicine, an international group of experts has recently published a recommendation for reporting clinical trials with Chinese medical formulas (CONSORT-CHM Formulas 2017).

The recommendation was recently published in an internationally renowned journal, Annals of Internal Medicine. Three versions of the paper, in English, traditional Chinese and simplified Chinese, were published simultaneously online. This is the first time since the journal was first launched in 1927 to publish a paper with three versions, indicating that the international medical community attaches great importance to Chinese medicine research.

Professor Bian said: “Currently, tens of thousands of clinical trials have been conducted on Chinese herbal medicine formulas, but the quality of reporting is unsatisfactory. Inadequate reporting quality not only reduces the value of Chinese herbal medicine but also affects the judgement about the efficacy and safety of Chinese medicines in general.

“Therefore, there is an urgent need to establish reporting guidelines for clinical trials of Chinese herbal medicine with a view to encouraging the publication of clinical trial reports compiled by researchers in different countries as well as enhancing the global influence of Chinese medicine,” added Professor Bian.

The group undertaking this comprehensive process comprised Chinese medicine clinical experts, methodologists, epidemiologists and a medical journal editor. They came from a variety of institutions including the University of Oxford in the UK, University of Ottawa in Canada, Beijing University of Chinese Medicine and Sichuan University in China, etc.

On the basis of the CONSORT Statement, the concept of zheng (also called “pattern” or “syndrome”), which is a core element of Chinese medicine theory, together with details of quality control of Chinese herbal medicine were added to form CONSORT-CHM Formulas 2017. The development of CONSORT-CHM Formulas 2017 was partly funded by the Hospital Authority of Hong Kong.

由協理副校長兼中醫藥學院臨床部主任卞兆祥教授率領的國際工作小組,經過10年時間的共同協作,最近完成中藥複方臨床隨機對照試驗報告規範 (CONSORT─中藥複方2017)。

有關論文最近在國際知名期刊《內科醫學年鑑》以中英文在網上同步發表,期望可向國內外的中醫藥研究人員、同行評審員和期刊編輯等目標讀者推廣使用,切實改善中藥複方臨床試驗報告的質量,以及對其研究設計和實施方法等有積極的影響。這也是《內科醫學年鑑》自1927年創刊以來,首次以英文中文繁體簡體版同時發表一個研究類文章,說明國際醫學界對中醫藥研究的重視。

卞兆祥教授說:「目前,有數萬篇中藥複方相關的臨床試驗報告發表;然而,研究報告的質量並不十分理想,這不僅降低了中醫藥的價值,亦影響對其療效和安全性的判斷。因此,急需建立臨床報告指引,以利於不同國家的研究人員發表臨床試驗報告,同時擴展中醫藥的國際影響力。」

小組成員來自英國牛津大學、加拿大渥太華大學、北京中醫藥大學及四川大學等的中醫藥臨床專家、方法學家、流行病學家和醫學期刊編輯。

CONSORT─中藥複方2017是在CONSORT聲明的基礎上,加入了中醫藥的核心元素「證」和中藥複方質量控制的具體內容而制定;部份制定工作由香港醫院管理局贊助。