Efficacy and safety of TiaoPi AnChang decoction to reduce CAPOX-Induced adverse reactions in Chinese patients with colorectal cancer: a randomized, double-blind, placebo-controlled trial
Abstract
Purpose: This study evaluated the efficacy of TiaoPi AnChang Decoction (TPACD) against CAPOX-induced adverse reactions (CIARs) and improving survival outcomes in colorectal cancer (CRC) patients receiving CAPOX as adjuvant chemotherapy. This paper presents an interim analysis of the clinical trial, with a primary focus on CIARs.
Patients and methods: This was a randomized, double-blind, placebo-controlled trial enrolling high-risk stage II or III CRC patients undergoing CAPOX who were diagnosed with spleen-kidney deficiency syndrome. The study planned to randomly assign 98 patients in a 1:1 ratio to either the TPACD group (30 mL orally, twice daily) or the placebo group (matched placebo). The trial duration spanned 4 chemotherapy cycles (approximately 84 days), during which we assessed the incidence of CIARs (graded via CTCAE), Traditional Chinese Medicine (TCM) syndrome scores, quality of life (QoL, evaluated via EORTC QLQ-C30), peripheral blood immune cell subsets, tumor markers, safety, and survival outcomes. A linear mixed-effects model was applied to adjust for baseline differences.
Results: Among 496 screened CRC patients, 108 were randomized into the TPACD group (n = 54) or the placebo group (n = 54). The incidence of overall CIARs was significantly lower in the TPACD group (P = 0.009), particularly for grade ≥2 CIARs (37.77% vs. 67.70%, P = 0.008). Subgroup analyses revealed that the treatment effect was homogeneous, with no significant interaction observed between…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 496 participants or records.
Read the paper
Related studies
- Quercetin Influences Quorum Sensing in Food Borne Bacteria: In-Vitro and In-Silico Evidence
- Phenolic-protein interactions: insight from in-silico analyses – a review
- In Silico Discovery of Candidate Drugs against Covid-19
- Neuropharmacological Effects of Quercetin: A Literature-Based Review
- In vitro and in silico anti-dengue activity of compounds obtained from Psidium guajava through bioprospecting
- Effect of Quercetin Rich Onion Extracts on Bacterial Quorum Sensing
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.