Skip to content
DraconiticResearch
Search Sources API
203,203 studies31 sourcesUpdated 59 min ago
Peer-reviewedCC BYActa pharmaceutica Sinica. B

Association between the use of traditional Chinese medicine patterns as an inclusion criterion and statistical significance in primary outcomes of randomized placebo-controlled trials of Chinese herbal formulas.

  • Zhijun Bu1,2
  • Meirong Song1,2
  • Chen Chen1
  • Xinyi Shi1,2
  • Xuefeng Wang3
  • Yao Li1,2
  • Jinchen Chong1,2
  • Yijia Zhu1,2
  • Feng Jiang1,4
  • Yugen Chen4,5,6
6 affiliations
  1. 1The Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Chinese Medicine, Nanjing 210029, China.
  2. 2Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing 210023, China.
  3. 3Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.
  4. 4Department of Colorectal Surgery, Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing 210029, China.
  5. 5The Jiangsu Province Key Laboratory of Tumor Systems Biology and Chinese Medicine, Nanjing 210029, China.
  6. 6The Jiangsu Collaborative Innovation Center of Chinese Medicine in Prevention and Treatment of Tumor, The Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China.
Read full textPDFDOICite

Abstract

Randomized, placebo-controlled trials of Chinese herbal formulas (CHFs) are commonly used to evaluate efficacy, but a proportion of such trials fail to demonstrate statistically significant effects on primary outcomes. Some researchers have pointed out that excluding traditional Chinese medicine (TCM) pattern differentiation from inclusion criteria may reduce the alignment between treatment and enrolled patient characteristics, which could, in turn, affect observed efficacy. This study analyzed 378 randomized, placebo-controlled trials of CHFs with clearly defined primary outcomes that were published between January 1, 2020, and October 21, 2025, and identified through searches of eight databases. A total of 92,691 participants were included in the primary outcome analyses. Of these, 324 trials (85.7%) reported statistically significant results on primary outcomes, and 197 (52.1%) used TCM patterns as an inclusion criterion. Multivariable Poisson regression revealed that trials using TCM patterns were more likely to report statistically significant results (adjusted risk ratio [aRR] = 1.14; 95% CI: 1.06-1.23; P = 0.001). The association was generally consistent across prespecified subgroups and sensitivity analyses; however, only 52 studies (13.8%) were evaluated as low risk of bias according to the Cochrane Risk of Bias 2.0 tool. Because this study included only published trials and few published pattern-based trials reported statistically nonsignificant primary outcomes, the observed association should be interpreted cautiously and may be influenced by publication bias, selective outcome reporting, and contextual differences in research and reporting practices. Further high-quality, prospectively registered, methodologically rigorous, and better-standardized trials are needed to evaluate this association.

Related

  1. Comparison between practical and traditional blood flow restriction methods in upper limb resistance training: a study protocol for a randomized controlled clinical trial
    Gabriel Martins da Silva, Julia Waszczuk Vendrame, Guilherme Henrique da Silva Brandão +5
    TrialsPeer-reviewedCC BY-NC-ND 4.0Clinical trials & evidence synthesisCrossref
  2. Outcomes reported in randomized controlled trials of traditional Chinese medicine for chronic pharyngitis: a scoping review
    Danni Li, Chenyao Zhang, Tongyang Jia +4
    Frontiers in pharmacologyPeer-reviewedCC BYFull textPharmacology & toxicologyEurope PMCCrossref
  3. Statistical analysis plan for transfusion of modified whole blood versus blood components therapy in patients with severe trauma: randomized controlled trial - WEBSTER trial.
    Alberto Federico García, Andrés Gempeler, Edgar-Yaset Caicedo +3
    Critical care sciencePeer-reviewedCC BYFull textGeneral medicineEurope PMC
  4. Beyond Statistical Significance—What Did EMERGE Really Tell Us About Early Metformin?
    Karla Hemming, Stephan D. Fihn
    JAMA Network OpenPeer-reviewedCC BY 4.0General medicineCrossref
  5. Association between an ITHBC theory-based nursing pathway and discharge readiness among mothers of preterm infants: a non-randomized controlled study with a historical control group
    Fang Tang, Yihong Wu, Liping Dai +5
    Frontiers in medicinePeer-reviewedCC BYFull textObstetrics, gynaecology & paediatricsEurope PMCPMC

Cite

BibTeXRIS
BibTeX
@article{bu2026association,
  title = {{Association between the use of traditional Chinese medicine patterns as an inclusion criterion and statistical significance in primary outcomes of randomized placebo-controlled trials of Chinese herbal formulas.}},
  author = {Zhijun Bu and Meirong Song and Chen Chen and Xinyi Shi and Xuefeng Wang and Yao Li and Jinchen Chong and Yijia Zhu and Feng Jiang and Yugen Chen},
  journal = {Acta pharmaceutica Sinica. B},
  year = {2026},
  month = jul,
  doi = {10.1016/j.apsb.2026.07.033},
  url = {https://europepmc.org/article/MED/42948704},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Association between the use of traditional Chinese medicine patterns as an inclusion criterion and statistical significance in primary outcomes of randomized placebo-controlled trials of Chinese herbal formulas.
AU  - Zhijun Bu
AU  - Meirong Song
AU  - Chen Chen
AU  - Xinyi Shi
AU  - Xuefeng Wang
AU  - Yao Li
AU  - Jinchen Chong
AU  - Yijia Zhu
AU  - Feng Jiang
AU  - Yugen Chen
PY  - 2026
DA  - 2026/07/25
JO  - Acta pharmaceutica Sinica. B
DO  - 10.1016/j.apsb.2026.07.033
UR  - https://europepmc.org/article/MED/42948704
AB  - Randomized, placebo-controlled trials of Chinese herbal formulas (CHFs) are commonly used to evaluate efficacy, but a proportion of such trials fail to demonstrate statistically significant effects on primary outcomes. Some researchers have pointed out that excluding traditional Chinese medicine (TCM) pattern differentiation from inclusion criteria may reduce the alignment between treatment and enrolled patient characteristics, which could, in turn, affect observed efficacy. This study analyzed 378 randomized, placebo-controlled trials of CHFs with clearly defined primary outcomes that were published between January 1, 2020, and October 21, 2025, and identified through searches of eight databases. A total of 92,691 participants were included in the primary outcome analyses. Of these, 324 trials (85.7%) reported statistically significant results on primary outcomes, and 197 (52.1%) used TCM patterns as an inclusion criterion. Multivariable Poisson regression revealed that trials using TCM patterns were more likely to report statistically significant results (adjusted risk ratio [aRR] = 1.14; 95% CI: 1.06-1.23; P = 0.001). The association was generally consistent across prespecified subgroups and sensitivity analyses; however, only 52 studies (13.8%) were evaluated as low risk of bias according to the Cochrane Risk of Bias 2.0 tool. Because this study included only published trials and few published pattern-based trials reported statistically nonsignificant primary outcomes, the observed association should be interpreted cautiously and may be influenced by publication bias, selective outcome reporting, and contextual differences in research and reporting practices. Further high-quality, prospectively registered, methodologically rigorous, and better-standardized trials are needed to evaluate this association.
SN  - 2211-3835
SN  - 2211-3843
ER  -