In 2017, the CONSORT-CHM Formulas 2017 extension was introduced to enhance the reporting transparency of randomized controlled trials (RCTs) involving Chinese herbal medicine (CHM) formulas. This development aimed to detail the rationale, design, analysis, and interpretation of CHM formula interventions, thereby improving clinical trial execution and advancing Traditional Chinese Medicine (TCM). However, a review assessing the reporting quality of RCTs with CHM formulas has been lacking. This study aimed to evaluate the reporting characteristics and adherence to the CONSORT-CHM Formulas 2017 checklist over the past five years.

The study adhered to the PRISMA 2020 guidelines and was pre-registered on the Open Science Framework. The research team conducted a systematic search and utilized a customized quality assessment form to evaluate the reporting quality of studies based on the CONSORT-CHM Formulas 2017 checklist, which includes 22 extended items. The analysis focused on RCTs published from 2017 to 2022. The study included 3265 RCTs conducted in China, with the majority published in Chinese. The trials primarily aimed to evaluate the clinical efficacy and safety of CHM formulas, with a focus on diseases of the digestive, genitourinary, and musculoskeletal systems. The most common intervention type was fixed CHM formulas, followed by individualized prescriptions and Chinese patent medicines.

The reporting quality of the RCTs was suboptimal, with an average compliance rate of 52.1%. Notably, only 4.4% of the trials adopted blinding, and a significant number of trials had sample sizes of fewer than 100 participants. The reporting of safety outcomes was also limited, with only 39.3% of the RCTs reporting adverse effects. The study found that the reporting rates for the quality control and safety assessment of CHM formulas were extremely low, at nearly 0.0%. The study also identified several areas of improvement over the past five years, including the reporting of background and objectives, interventions for patent proprietary CHM formulas, and outcomes.

The study highlighted that while there has been some improvement in reporting quality, significant deficiencies remain, particularly in the areas of safety administration and quality control of CHM formulas. The authors suggest that adherence to the CONSORT-CHM Formulas 2017 guidelines is necessary and recommend continued efforts by journals, editors, reviewers, and investigators to promote and endorse these reporting guidelines effectively.

The findings underscore the need for improved transparency and consistency in the reporting of RCTs involving CHM formulas. By addressing the identified deficiencies, the research community can enhance the credibility and reliability of clinical trials in this domain, ultimately contributing to the advancement of TCM. The study's insights serve as a call to action for stakeholders to ensure that future trials are conducted and reported in a manner that aligns with international standards, thereby facilitating the integration and acceptance of CHM formulas in global healthcare practices.
DOI: 10.1007/s11684-024-1092-4