Efficacy and safety of Shenbai Granules for recurrent colorectal adenoma: A multicenter randomized controlled trial
- PMID: 38471368
- DOI: 10.1016/j.phymed.2024.155496
Efficacy and safety of Shenbai Granules for recurrent colorectal adenoma: A multicenter randomized controlled trial
Abstract
Background: Colorectal adenoma is benign glandular tumor of colon, the precursor of colorectal cancer. But no pharmaceutical medication is currently available to treat and prevent adenomas.
Purpose: To evaluate efficacy of Shenbai Granules, an herbal medicine formula, in reducing the recurrence of adenomas.
Study design: This multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted by eight hospitals in China.
Methods: Patients who had received complete polypectomy and were diagnosed with adenomas within the recent 6 months were randomly assigned (1:1) to receive either Shenbai granules or placebo twice a day for 6 months. An annual colonoscopy was performed during the 2-year follow-up period. The primary outcome was the proportion of patients with at least one adenoma detected in the modified intention-to-treat (mITT) population during follow-up for 2 years. The secondary outcomes were the proportion of patients with sessile serrated lesions and other specified polypoid lesions. The data were analyzed using logistic regression.
Results: Among 400 randomized patients, 336 were included in the mITT population. We found significant differences between treatment and placebo groups in the proportion of patients with at least one recurrent adenoma (42.5 % vs. 58.6 %; OR, 0.47; 95 % CI, 0.29-0.74; p = 0.001) and sessile serrated lesion (1.8 % vs. 8.3 %; OR, 0.20; 95 % CI, 0.06-0.72; p = 0.01). There was no significant difference in the proportion of patients developing polypoid lesions (70.7 % vs. 77.5 %; OR, 1.43; 95 % CI, 0.88-2.34; p = 0.15) or high-risk adenomas (9.0 % vs. 13.6 %; OR, 0.63; 95 % CI, 0.32-1.25; p = 0.18).
Conclusion: Shenbai Granules significantly reduced the recurrence of adenomas, indicating that they could be an effective option for adenomas. Future studies should investigate its effects in larger patient populations and explore its mechanism of action to provide more comprehensive evidence for the use of Shenbai Granules in adenoma treatment.
Keywords: Colorectal adenoma; Prevention; Randomized controlled trial; Recurrence; Traditional chinese medicine.
Copyright © 2024 The Author(s). Published by Elsevier GmbH.. All rights reserved.
Conflict of interest statement
Declaration of competing interest All authors disclosed no relevant relationships. In this clinical trial, the study medication was provided by Jiangyin Tianjiang Pharmaceutical Co., LTD. (Jiangsu, China), which did not provide any financing for the trial. This company played a significant role in the supply of the drug and contributed towards ensuring its quality, safety, and efficacy. Although Jiangyin Tianjiang Pharmaceutical Co., LTD. (Jiangsu, China) was solely involved in the production and supply of the study drug, it had no involvement in the study design, data collection, analysis, or interpretation of the results. The trial was conducted independently and followed ethical and regulatory guidelines. To maintain transparency, we have disclosed the involvement of Jiangyin Tianjiang Pharmaceutical Co., LTD. (Jiangsu, China) in this trial. The company's role was limited to supplying the study medication and did not influence the scientific validity or integrity of the trial. Any questions or concerns about our disclosure can be directed to the corresponding author.
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