Zhi Zhu Kuanzhong Capsule Makes Historic Inclusion in International Medical Guideline, Marking a Milestone in TCM Globalization

Actively promoting the internationalization of Traditional Chinese Medicine (TCM) and enhancing its global influence is an inevitable choice for the revitalization and development of TCM. From November 21 to November 24, 2024, the latest version of the "Asian Consensus on Functional Dyspepsia" was released at the Asian Pacific Digestive Week (APDW) conference held in Indonesia, incorporating the proprietary Chinese medicine Langzhi Zhizhu Kuanzhong Capsules, which have undergone multiple evidence-based medical validations, into clinical guidelines.

It is reported that this marks the first time a Chinese proprietary medicine for digestive disorders has been included in an internationally authoritative general guideline, backed by scientific validation meeting the “gold standard” of international medical practice. This achievement represents another significant milestone in the global integration of traditional Chinese medicine.

In recent years, guided by the revitalization of Traditional Chinese Medicine (TCM), numerous TCM enterprises have been actively exploring new pathways for integrating TCM with modern science and technology. By leveraging evidence-based medical research—recognized as the “gold standard” in international medical evaluation—these companies aim to clearly articulate and substantiate the efficacy of TCM, thereby enhancing global understanding and acceptance of this traditional practice.

The development of Langzhi Zhizhu Kuanzhong Capsules exemplifies the ongoing pursuit of breakthroughs in evidence-based medical research and validation for classic traditional Chinese medicine (TCM) formulas. The formulation of Zhizhu Kuanzhong Capsules is derived from classic TCM literature, tracing its origins to “Zhizhu Tang” (Zhi Zhu Decoction) in Zhang Zhongjing’s *Jin Gui Yao Lue* (*Essential Prescriptions from the Golden Cabinet*) from the late Eastern Han Dynasty, as well as “Zhizhu Wan” (Zhi Zhu Pills) in *Nei Wai Shang Bian Huo Lun* (*Treatise on Differentiating Internal and External Injuries*) by Zhang Yuansu and Li Dongyuan during the Jin and Yuan dynasties.

How can classic traditional Chinese medicine (TCM) formulas, refined through millennia of empirical practice, achieve modern breakthroughs? Zhizhu Kuanzhong Capsules completed two independent, large-sample, multicenter, randomized, double-blind, placebo-controlled clinical trials evaluating efficacy in the treatment of functional dyspepsia—one conducted across China from 2013 to 2016, and the other internationally from 2018 to 2023. The results consistently demonstrated that Zhizhu Kuanzhong Capsules significantly alleviate symptoms of functional dyspepsia, with a favorable safety profile and consistent performance, making it the only TCM product to successfully conduct clinical trials for functional dyspepsia in strict accordance with international standards.

Furthermore, Zhizhu Kuanzhong Capsules have also participated in state-led modernization research on traditional Chinese medicine (TCM), such as the “Demonstration Study on International Cooperation in TCM for Belt and Road Initiative Countries” supported by the Ministry of Science and Technology of China. Modern pharmacodynamic studies have also shown that Zhizhu Kuanzhong Capsules exert a triple effect of enhancing gastrointestinal motility, alleviating anxiety and depression, and reducing gastrointestinal visceral hypersensitivity, thereby effectively treating functional dyspepsia.

Research findings on Zhizhu Kuanzhong Capsules have been selected for presentations at international conferences on multiple occasions and have resulted in the publication of seven SCI-indexed research articles. Notably, in March 2019, the study “A Multicenter Clinical Trial of Zhizhu Kuanzhong Capsules in the Treatment of Functional Dyspepsia” was published in the prestigious international medical journal Journal of Gastroenterology and Hepatology (JGH), marking it as the first and only research study on a Chinese proprietary medicine to be indexed by JGH to date.

Backed by robust clinical research data and empirical evidence, Zhizhu Kuanzhong Capsules have been successfully registered and launched in Singapore, Hong Kong (China), Canada, and other countries and regions. They are recommended for the treatment of functional dyspepsia (FD) in the first international guideline, the APAGE “Asia-Pacific Guidelines on the Management of Overlap between FD and Other Gastrointestinal Symptoms,” as well as in international expert consensus documents such as “Herbal medicines in functional dyspepsia-Untapped opportunities not without risks.” The inclusion of Zhizhu Kuanzhong Capsules in the “Asian Consensus on Functional Dyspepsia” further demonstrates the international medical community’s recognition and affirmation of the modernized, evidence-based research on traditional Chinese medicine.

In fact, as a common yet complex disorder of the digestive system, functional dyspepsia has long been a global challenge affecting a large number of patients. Global epidemiological surveys indicate that the worldwide prevalence of functional dyspepsia ranges from 10% to 30%; in China, it accounts for more than 50% of outpatient visits to gastroenterology departments. Despite its persistently high incidence worldwide, the international medical community still lacks effective treatment options.

In Traditional Chinese Medicine (TCM) theory, functional dyspepsia is closely associated with disorders of the spleen and stomach functions and impaired flow of qi. Therefore, TCM holds unique advantages and potential in treating such conditions. The classic formula underlying Zhizhu Kuanzhong Capsules has undergone thousands of years of clinical practice and validation in TCM, demonstrating its remarkable efficacy in treating spleen and stomach disorders. However, due to the complex composition of Chinese herbal medicines, their diverse mechanisms of action, as well as challenges posed by global cultural differences and modern scientific verification systems, the recognition of TCM within the international medical community continues to face numerous difficulties.

Langzhi Zhizhu Kuanzhong Capsules, through scientific and rigorous modern pharmacological studies and clear evidence-based medical data, clearly elucidate the multiple mechanisms of action of Zhizhu Kuanzhong Capsules, including enhancing gastrointestinal motility, alleviating anxiety and depression, and reducing visceral hypersensitivity. These mechanisms correspond precisely to the three internationally recognized key approaches for effectively inhibiting the pathogenesis of functional dyspepsia.

Data indicates that the Asia Pacific Digestive Disease Week complements major international events such as Digestive Disease Week (DDW) in the United States and United European Gastroenterology Week (UEGW), serving as a bridge connecting gastroenterology experts and scholars in the Asia-Pacific region with their global counterparts. It also provides an authoritative platform for the internationalization of Traditional Chinese Medicine. The conference showcases cutting-edge scientific research, multidisciplinary integration, and extensive academic outputs, facilitating global academic exchange and collaboration. By promoting medical advancements into healthcare systems across the Asia-Pacific region, it serves as a reference for standardizing medical diagnosis and treatment practices. As an authoritative international scientific consensus guideline, the Asian Consensus on Functional Dyspepsia holds significant importance in advancing international research and clinical practice in digestive diseases.

The inclusion of Langzhi Zhizhu Kuanzhong Capsules in the Asian Consensus on Functional Dyspepsia, with a recommendation for their use in treating functional dyspepsia, signifies formal recognition by the international medical community of the efficacy, scientific validity, and safety of traditional Chinese medicine (TCM) in the prevention and treatment of specific diseases. This acknowledgment affirms the clinical value of TCM and establishes it as an internationally accepted standard therapeutic regimen.

Zhizhu Kuanzhong Capsules not only provide new therapeutic insights for patients with functional dyspepsia worldwide and enhance the image of traditional Chinese medicine (TCM) in the international medical community, but also pave a new path for the internationalization of China’s TCM industry.