Traditional Chinese medicine is effective for

image: Based on the results of a randomized, double-blind clinical trial, Yupingfeng granules are not inferior to allopathic pidotimod in the treatment of recurrent pediatric respiratory tract infections.
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Credit: Pediatric Survey

The practice of traditional Chinese medicine (TCM) began as early as the 14e century BC. J.-C., and it has now become a mecca for research. Despite this, TCM is often viewed with great skepticism in the Western world and equated with pseudoscience. This is often because the effects of TCMs are poorly understood and few studies have documented their efficacy and safety via randomized controlled clinical trials (RCTs). One of these MCTs is Yupingfeng (YPF, 玉屏风) – a proprietary formula available as a compound granule that includes Astragalus base (Huangqi), Rhizome of Atractylodis macrocephalae (Baizhu), and Saposhnikaviae base (Fangfeng) – which is often used in China to treat recurrent respiratory tract infections (RRTI) in children. Although YPF is known to improve immune function, evidence for its effectiveness against pediatric RRTIs has remained weak.

To fill this gap, a large group of Chinese researchers conducted a multicenter RCT to assess the safety and efficacy of YPF in children with IRRT. The results of this double-blind RCT were first published on June 2, 2022 in the journal Pediatric survey. Professor Kunling Shen, who led this study, explains: We wanted to carry out a rigorous investigation to understand the therapeutic benefits of YPF. That’s why we conducted a large-scale RCT, the gold standard of clinical studies, and recruited patients not from a single center but from multiple hospitals.

This study recruited 351 children with IRTI (2-6 years old) who were randomly assigned to three groups. While the first group received YPF, the second group received pidotimod, a conventional allopathic drug that has been used for RRTI treatment since the 1990s. The third group received only placebo treatment. To eliminate as much bias as possible, neither the patients nor their physicians were informed of the treatment given. After 8 weeks of treatment, investigators looked at the proportion of patients whose frequency of infections was reduced to average levels (ie, RRTIs returning to the normal norm). They also looked at the reduction in RRTI events and safety in each group.

During the 52 weeks of follow-up after treatment, the proportion of IRTI returning to the normal norm was only 39% in the placebo group. However, it was much better at 73% and 67% in the YPF and pidotimod groups, respectively. These two groups also showed a substantially greater reduction in RRTI events during follow-up. Moreover, the safety profile was similar in the three groups. Together, the results indicated that YPF was not inferior to pidotimod in treating RRTI, nor did it have any safety concerns. YPF also costs less than pidotimod and was therefore a more economically feasible option.

The strength of our study lies in its rigorous design. It’s the the biggest multicenter study to prove that YPF, a TCM, can be as effective as an allopathic drug in the treatment of RRTI. This is a major step forward in sharing the benefits of TCM with the world,” comments Professor Rong Ma, who led this study with Professor Shen.

Indeed, this study cemented the value of YPF in the treatment of RRTI, which is common among children in China and other parts of the world. It shows that TCMs can be as effective and safe as allopathic medicines, even though we don’t fully understand the biological mechanisms underlying their effects. Dr. Julian L. Allen, Associate Editor at Pediatric Survey, wrote an editorial and said Just because we don’t understand how a medicine works doesn’t mean it doesn’t work. This well-designed RCT could be an important step in addressing Western skepticism surrounding TCM and reaping the benefits of its holistic effects.

Indeed, the adoption of YPF in RRTI treatment could benefit thousands of children worldwide, and particularly those from low socio-economic backgrounds. YPF could be part of a line of TCMs that are gaining worldwide recognition for their therapeutic benefits, scratching the “nickname” while focusing on the “science.”

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Reference

DOI: https://doi.org/10.1002/ped4.12326

Author: Baoping Xu1Xinmin Li2Siyuan Hu2Yixiao Bao3Fengmei Chen4Zhimin Chen5Yonggang Du6Enmei LiusevenYufeng Liu8Qinghui Understanding Agreement9BaolingsutenBo Wang4Jianwen Xu11Guiping Xu12Qiaozhi Yang13Liwei Gao1Xiaohui Liu14Lei Li15Rong Ma2Kunling Shen1

Memberships:

1 China National Center for Clinical Research in Respiratory Diseases, Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, China

2 The first teaching hospital of Tianjin University of Traditional Chinese Medicine, China

3 Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China

4 Guangdong Women and Children Hospital and Health Institute, Guangzhou, China

5 Zhejiang University Medical School Children’s Hospital, China

6 Changzhi People’s Hospital, China

seven Chongqing Medical University Children’s Hospital, China

8 The Fourth Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, China

9 Shandong University Qilu Children’s Hospital, China

ten Heji Hospital Affiliated with Changzhi Medical College, China

11 The Third Affiliated Hospital of Xinxiang Medical College, China

12 Huizhou Traditional Chinese Medicine Hospital, China

13 Liaocheng People’s Hospital, China

14 Beijing Children’s Hospital, Capital Medical University, National Center for Children’s Health, China

About Professor Kunling Shen

Professor Kunling Shen is a professor at Beijing Children’s Hospital and head of China’s National Center for Clinical Research in Respiratory Diseases. Her research interests are in respiratory medicine, virology, and sleep science, and she has published over 100 books and articles on these topics. She served as president of the Asian Society for Pediatric Research and the Society of Pediatrics of the Chinese Medical Association. Professor Shen is a member of the Standing Committee of the International Pediatric Association and a Foreign Academician of the Russian Academy of Sciences.

About Professor Rong Ma

Professor Rong Ma is a professor in the Department of Pediatrics at the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, China. His research interests focus on the treatment of neurological and pulmonary diseases in children with traditional Chinese medicine. He served as President of the Pediatrics Branch of the Chinese Association of Chinese Medicine and Vice-Chairman of the Expert Committee on the Rational Use of Pediatric Medicines of the National Health Commission of China.