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Abstract: Purpose: To investigate the protective effects of berberine on radiation-induced lung injury (RILI) in non-small cell lung cancer (NSCLC) patients treated with radiotherapy. Patients and methods: In this randomised, double-blind study, 90 patients with NSCLC were divided into two groups. The trial group received radiation therapy plus berberine, and the control group received radiation therapy plus a placebo for 6 weeks. Soluble intercellular adhesion molecular-1 (sICAM-1) and transforming growth factor-beta-1 (TGF-β1) were measured. RILI and pulmonary function were evaluated at 6 weeks and 6 months after treatment, respectively. Results: Of the 90 patients enroled, 43 in the control group and 42 in the trial group completed the study. The incidence of RILI was significantly lower in the trial group at 6 weeks and 6 months than that in the control group (45.2% versus 72.1% and 35.7% versus 65.1%, respectively, both P <0.05). sICAM-1 levels in the trial group were significantly lower at weeks 6 and 12 (373.64±89.33 versus 459.53±123.59 and 447.83±111.21 versus 513.91±150.46, both P <0.01), and plasma TGF-β1 levels were lower at week 3 and 6 (5.43±1.47 versus 6.22±1.78 and 5.93±2.39 versus 7.67±2.74, P <0.05 and 0.01, respectively) in comparison with the control group. Significant differences were observed in FEV1 (P =0.033) and DLCO (P =0.003) between patients receiving berberine and those receiving placebo. Independent-samples T-test showed reductions from baseline FVC at week 6 (P <0.05), and FEV1 and DLCO at month 6 (P <0.05 and 0.01, respectively) in the trial group were significantly smaller than that in the control group. Conclusion: Berberine significantly reduced the incidence of RILI, improved PF and decreased the levels of sICAM-1 and TGF-β1. The exact mechanisms remain to be further explored. [Copyright &y& Elsevier]