A randomized, controlled, multicenter phase III clinical trial of Huo Xiang Zheng Qi oral liquid for the prevention and control of nausea and vomiting caused by multiday cisplatin-based regimen
Abstract
Background: Standardized chemotherapy-induced nausea and vomiting (CINV) prevention in HEC is critical, yet NK1RAs remain inaccessible for some patients due to cost and availability. Our prior study demonstrated HXZQ + 5HT3RAs + dexamethasone's superior efficacy; this phase III trial aimed to validate this regimen.
Method: This multicenter, double-blind, randomized phase III trial (10 hospitals, Southwest China; March 2023-August 2024) assigned patients to group HX (HXZQ + 5HT3RA + dexamethasone) or group C (control). Primary endpoints: mean No CINV Days (NCDs) during the full cycle and complete control (CC) rate beyond the risk period. Secondary endpoints: safety, CC rate during the risk period, mean no nausea days and life function.
Results: A total of 166 patients were enrolled and 139 patients completed the study, 73 in group HX and 66 in group C. The mean NCDs was significantly better in group HX (17.92 ± 4.06) than that in group C (15.26 ± 5.91, P = .002). Group HX showed better NCDs in acute, delayed and the period beyond the risk phases than group C, with a higher CC rate of CINV beyond the risk phase (80.8% vs 60.6%, P = .009). The mean no nausea days in group HX was significantly better than that in group C (18.26 vs 15.45, P = .001). Group HX also showed a trend to better functional living index-emesis score, but only achieved the significance during the period beyond the risk phase.
Conclusion: HXZQ in combination with a 5-HT3 receptor antagonist and…
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: 166 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.