Effect of compound Zhuye Shigao Granule ( ) on acute radiation-induced esophagitis in cancer patients: A randomized controlled trial.

ABSTRACT

OBJECTIVE: To observe the efficacy and safety of the Chinese medicine (CM) Compound Zhuye Shigao Granule (, CZSG) on acute radiation-induced esophagitis (ARIE) in cancer patients. METHODS: In a blinded, randomized, Kangfuxin Solution (, KFX)-controlled, single-centre clinical trial, 120 patients with lung, esophagus or mediastinal cancer were prospectively enrolled and assigned to the treatment group (60 cases) and control group (60 cases) by the random number table method. All patients received concurrent or sequential radiotherapy (2 Gy per day, 5 times per week, for 4 weeks) and were treated for 4 weeks since the radiation therapy. Patients in the treatment group were given 12 mg CZSG orally, thrice daily, while patients in the control group were given 10 mL KFX orally, thrice daily. The major indicators were observed, including the incidence and grade of esophagitis, time of occurrence and duration. Minor indicators were changes of CM symptoms, weight and Karnofsky Performance Status (KPS) Scale during 4 weeks from the beginning, recorded once a week. Blood routine examination and hepatorenal function were detected at the 2nd and 4th weeks. RESULTS: The incidence and grade of ARIE were significantly decreased in the treatment group compared with the control group (P<0.05). CZSG appeared to significantly delay the time of ARIE occurrence and reduce the duration compared with KFX (P<0.05). The scores of CM symptoms, KPS and weight were improved significantly in the treatment group compared with the control group (P<0.05). There were no blood routine and hepatorenal function abnormal or obvious side-effects in both groups. Hemoglobin was improved and neutrophil and interleukin 6 were decreased in both groups after 4-week treatment compared with before treatment (P<0.05), and there was no significant difference between the two groups (P>0.05). CONCLUSIONS: CZSG can decrease the incidence and grade of ARIE, delay the time of occurrence, reduce duration and alleviate the damage of ARIE. It is safe and effective in the prevention and cure of ARIE.