As one of the oldest medical systems in the world, Chinese Medicine encapsulates unique aspects of Chinese traditional culture, philosophy, and theoretical frameworks alongside a wealth of accumulated practical experience. Despite its historical significance and widespread use, the integration of Chinese Medicine into contemporary medical research and clinical practice presents several challenges.

During 2014–2023, more than 500 research outputs in Chinese Medicine mentioned “reporting guideline” or “clinical reporting guideline” in the title, abstract, or keywords. The citation impact of these research outputs was notably high, underscoring the importance and influence of rigorous reporting standards in advancing the field. This trend highlights the growing recognition of the need for standardised and transparent reporting practices to ensure the credibility and reproducibility of research findings.

One of the obstacles is the difficulty in applying conventional reporting guidelines to Chinese Medicine trials. Reporting guidelines are essential to ensure the transparency, completeness, and reproducibility of research findings. They provide a framework for researchers to report their studies in a consistent and comprehensive manner, thereby enhancing the quality of published research. However, the unique theories and characteristics of Chinese Medicine interventions, such as individualised treatment regimens and the use of multi-component Chinese Medicine formulations, often are not included in the standardised formats of existing reporting statements. This misalignment can result in inadequate reporting and reduced transparency, ultimately affecting the credibility and reproducibility of Chinese Medicine research.

In addition, current Clinical Practice Guidelines (CPGs) are not yet applicable to guide Chinese Medicine practices. As recommendations for practitioners making informed decisions about optimal healthcare for specific clinical conditions, CPGs aim to streamline clinical practice, enhance the quality of care, and ensure consistency in treatment approaches. However, most Chinese Medicine clinical practices are still heavily reliant on individual experience, and there is often a lack of robust scientific evidence to support specific treatment schemes. This reliance on experiential knowledge, while valuable, underscores the necessity for standardised clinical practice guidelines that can bridge the gap between traditional practices and modern evidence-based medicine.

In this context, it is crucial to develop and implement appropriate reporting guidelines and clinical practice guidelines tailored to Chinese Medicine’s unique aspects. These guidelines have the potential to enhance the quality and reliability of Chinese Medicine research, improve clinical practices, and facilitate the integration of Chinese Medicine into the global healthcare system.

Aiming to enhance the quality of Chinese Medicine studies globally and reduce research waste resulting from low-quality studies with inconclusive findings, Professor Bian Zhaoxiang at Hong Kong Baptist University has collaborated with an international group of experts to develop a series of reporting guideline extensions for Chinese Medicine-related trials.  Prof. Bian has published several CONSORT (Consolidated Standards of Reporting Trials) extensions for Chinese herbal medicine formulas,^[1] moxibustion,^[2] cupping, and Tuina/massage.^[3] These guidelines cover a wide array of study types and delineate key elements of Chinese Medicine concepts, such as pattern identification, the rationale for intervention selection, and the design characteristics that should be addressed in reports.

Prof. Bian has also developed the framework for the “Reporting Guideline Network of Chinese Medicine”, particularly in clinical research. This network includes trials adopting various Chinese Medicine interventions and encompasses reporting standards from trial registration, protocol development, and results publication to evidence synthesis and clinical practice guidelines. Through this project a robust research paradigm and standard references for reporting guidelines and research transparency in traditional medicine and complementary and alternative medicine have been created.

In October 2019, Prof. Bian successfully launched the Chinese EQUATOR (Enhancing the QUAlity and Transparency Of Health Research) Centre, the first of its kind in Asia. The Chinese EQUATOR Centre has partnered with the Canadian EQUATOR Centre to develop a comprehensive training and education portfolio. This includes organising workshops, courses, seminars, and conferences for Chinese researchers, research students, editors, and peer reviewers to enhance their understanding and application of the guidelines, thereby promoting high standards in Chinese Medicine research.

Professor Lyu Aiping’s team at Hong Kong Baptist University has made significant strides in developing a series of CPGs and integrative clinical pathways for Chinese Medicine. These guidelines provide clear and precise instructions for selecting appropriate therapies within Chinese Medicine clinical settings, ensuring practitioners have a reliable framework to follow. For each disease, the primary Chinese Medicine syndrome differentiations are meticulously clarified based on expert opinions. This process involves a thorough evaluation by and consensus among leading Chinese Medicine specialists to ensure accuracy and reliability. All recommended Chinese Medicine compound prescriptions are supported by relevant research evidence and have achieved consensus among experts, underscoring the rigorous and collaborative nature of the guideline development process.

The focused areas of Prof. Lyu’s team encompass a broad range of conditions, including menopausal symptoms, irritable bowel syndrome, functional constipation, chronic gastritis, insomnia, and stroke, among others. This diverse focus ensures that the guidelines can be widely consulted and applied across various clinical scenarios, enhancing their utility and relevance.

Furthermore, each Chinese Medicine treatment recommendation is evaluated for its recommendation level and quality of evidence using the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) system, an internationally recognised methodology that ensures the processes of developing guidelines are robust, evidence-based, and aligned with global standards. This rigorous approach enhances the credibility and applicability of Chinese Medicine practices, ensuring that the guidelines are not only scientifically sound but also practical for use in clinical settings.

The integration of CPGs and Reporting Guidelines in Chinese Medicine has led to significant academic, economic, and social impacts. The dedicated efforts of Prof. Bian and Prof. Lyu ensure that Chinese Medicine practitioners can deliver care and trial results that are both effective and evidence-based, ultimately improving patient outcomes and advancing the field of Chinese Medicine internationally.

The development of reporting guidelines and CPGs enhances the credibility and acceptance of Chinese Medicine practices within the scientific community, benefiting researchers, trial participants, patients, and other key stakeholders. Adherence to reporting guidelines enhances the transparency and completeness of Chinese Medicine trials, ensuring that Chinese Medicine trials are reported in a consistent and comprehensive manner, thereby making the findings more reliable and reproducible. CPGs provide solid, evidence-based guidance for Chinese Medicine diagnosis and treatment in clinical practice. By improving the effectiveness of Chinese Medicine and reducing the utilisation of invalid treatments, these guidelines maximise patient benefits and reduce the burden of disease.

By facilitating the execution of large-scale clinical trials for Chinese herbal medicine formulas, especially in regions like Hong Kong SAR (China), these guidelines promote cross-regional collaboration and the integration of industry, academia, and research. This collaborative approach accelerates the transformation of research results into pharmaceutical products for international markets and drives economic growth within the Chinese Medicine industry.

These guidelines ensure that Chinese Medicine practices are grounded in solid evidence, thereby increasing public trust and acceptance of Chinese Medicine treatments. The transparency and completeness brought about by reporting guidelines foster greater accountability and ethical standards in Chinese Medicine research. Moreover, by providing clear and standardised instructions for Chinese Medicine diagnosis and treatment, CPGs could improve the overall quality of healthcare services, leading to better patient outcomes and enhanced public health. This protects the interests of trial participants and builds confidence among policymakers and regulators, facilitating the integration of Chinese Medicine into mainstream healthcare systems. The global recognition and recommendation of these guidelines within the international traditional medicine community would further enhance the social legitimacy and credibility of Chinese Medicine.

[1] Cheng, Chung-wah, et al. “CONSORT Extension for Chinese Herbal Medicine Formulas 2017: Recommendations, Explanation, and Elaboration.” Annals of Internal Medicine, vol. 167, no. 2, May 2017, p. 112, https://doi.org/10.7326/m16-2977.

[2] Cheng, Chung-wah, et al. “Extending the CONSORT Statement to Moxibustion.” Journal of Integrative Medicine, vol. 11, no. 1, Jan. 2013, pp. 54–63, https://doi.org/10.3736/jintegrmed2013009.

[3] Zhang, Xuan, et al. “STandards for Reporting Interventions in Clinical Trials of Tuina/Massage (STRICTOTM): Extending the CONSORT Statement.” Journal of Evidence-Based Medicine, vol. 16, no. 1, Wiley-Blackwell, Mar. 2023, pp. 68–81, https://doi.org/10.1111/jebm.12522.