Article Impact Level: HIGH Data Quality: STRONG Summary of Frontiers of Medicine, 18(4), 757–761. https://doi.org/10.1007/s11684-024-1092-4 Dr. Juan Wang et al.
Points
- A recent study assessed adherence to the CONSORT-CHM Formulas 2017 guidelines in 3,265 RCTs involving Chinese herbal medicine (CHM) formulas from 2017 to 2022.
- Findings revealed low overall compliance, with an average adherence rate of 52.1%, and only 4.4% of trials utilizing blinding as a methodological feature.
- Many trials had small sample sizes (under 100 participants), and only 39.3% reported safety outcomes. Quality control and safety assessments for CHM formulas were reported in nearly 0.0% of trials.
- Some improvements were noted in reporting background, objectives, interventions, and outcome measures over recent years.
- The study calls for stricter adherence to guidelines to improve transparency, enhance trial credibility, and support the integration of CHM into global healthcare.
Summary
A recent study evaluated the adherence to the CONSORT-CHM Formulas 2017 guidelines in randomized controlled trials (RCTs) involving Chinese herbal medicine (CHM) formulas. The CONSORT-CHM Formulas 2017 extension, introduced to improve the transparency and reporting of clinical trials using CHM formulas, includes 22 extended items that focus on trial design, rationale, analysis, and interpretation. The study systematically assessed RCTs published between 2017 and 2022 to determine the quality of reporting and adherence to these guidelines, utilizing a customized quality assessment form based on the checklist. In total, 3,265 RCTs, primarily published in Chinese, were reviewed.
The study found that the overall compliance with the CONSORT-CHM Formulas 2017 checklist was suboptimal, with an average compliance rate of only 52.1%. Of particular concern was the lack of blinding, with only 4.4% of trials implementing this important methodological feature. Additionally, most trials had sample sizes under 100 participants, and safety outcomes were poorly reported, with just 39.3% of trials documenting adverse effects. The study also noted that the quality control and safety assessment reporting for CHM formulas was alarmingly low, nearing 0.0%. However, some improvements were observed in areas such as reporting background and objectives, interventions for proprietary CHM formulas, and outcome measures over the past five years.
The study concluded that while there has been some progress in reporting quality, significant deficiencies remain, particularly in safety administration and quality control of CHM formulas. The authors emphasize the need for full adherence to the CONSORT-CHM Formulas 2017 guidelines and call for continued efforts from journals, editors, reviewers, and investigators to ensure the transparency and consistency of future trials. Improved reporting will enhance the credibility of clinical trials involving CHM formulas and facilitate the integration of traditional Chinese medicine into global healthcare practices.
Link to the article: https://link.springer.com/article/10.1007/s11684-024-1092-4
References Wang, J., Shi, D., Wang, Y., Zhang, X., Li, H., Wang, X., Luo, S., Hu, L., Deng, J., Zhang, L., Lau, C. T., Cheng, C. W., Han, F., Li, J., Wang, P., Lyu, A., Bian, Z., & Zhang, X. (2024). Transparency and reporting characteristics of randomized controlled trials with Chinese herbal medicine formulas interventions. Frontiers of Medicine, 18(4), 757–761. https://doi.org/10.1007/s11684-024-1092-4
