ABSTRACT Aim Targeted therapy is recommended for lung adenocarcinoma patients with epidermal growth factor receptor (EGFR) mutations. We aimed to investigate clinical efficacy and safety, as well as the potential underlying mechanisms, of Qilian mixture as an adjunct treatment during gefitinib therapy in these patients. Methods We conducted a randomized controlled clinical trial in lung adenocarcinoma patients with EGFR mutations between July 2020 and June 2021. Patients received either gefitinib (control group) or Qilian mixture with gefitinib (study group) for 12 weeks. Quality of life, clinical symptoms, Response Evaluation Criteria in Solid Tumors (RECIST), serum tumor markers, and adverse effects were evaluated. We also tested the intestinal flora and performed network pharmacology analysis. Results A total of 46 patients were analyzed (23 patients in each group). Intergroup baseline characteristics were comparable. The study group had significantly improved quality of life and clinical symptoms compared with control group. Serum tumor marker levels and incidence of diarrhea were lower in the study group than in the control group. There were no significant intergroup differences in RECIST and other adverse effects. Compared with the control group, the study group exhibited better intestinal flora diversity. Network pharmacology analysis indicated that the Qilian mixture influences carcinogenesis, lipid metabolism and atherosclerosis, calcium homeostasis, and reproductive hormone regulation pathways. Conclusion As an adjunct treatment during gefitinib therapy for lung adenocarcinoma patients with EGFR mutations, Qilian mixture safely improved short‐term clinical symptoms and quality of life, with future research requiring a large sample size and pharmacological mechanism studies in intestinal flora changes and related signaling pathways. Trial Registration ClinicalTrials.gov identifier: ChiCTR2100047349
Li et al. (Thu,) studied this question.