Clinical Comparative of Tropisetron Hydrochloride with or without Traditional Chinese Medicine Compound in Prevention of Chemotherapy-induced Nausea and Emesis

Objective To evaluate the efficacy and side effects of tropisetron hydrochloride plus three Traditional Chinese Medicine Compounds for the prophylaxis of chemotherapy-induced nausea and emesis. Methods A randomized trial was carried out. Eighty-four patients were randomly devided into group A and group B. According to the general appearances, Group B was further divided into B1(Stomach-Cold Group), B2(Stomach-Heat Group) and B3(Neutral Group). All patients received tropisetron hydrochloride before CTX-based or DDP-based chemotherapy. Participants in group B1, B2 and B3 were additionally treated with Ding-xiang-shi-di Decoction, Ju-pi-zhu-ru Decoction and Xiao-ban-xia Plus Fu-ling Decoction respectively. Gastrointestinal reactions induced by chemotherapy and side effects of the anti-emetics were recorded within 7d after chemotherapy. Results Acute nausea was prevented completely for 42.9% of the patients in group A and for 66.7% in group B (P<0.05). Complete control rate of acute emesis was achieved for 61.9% of patients in group A and 85.7% in group B (P<0.05). With regard to delayed nausea, complete control rate and effective control rate in Group A was 19.0% and 38.1%, while 42.9% (P<0.05) and 63.5% (P<0.05) in group B. Group B also had a better complete and effective control rate than Group A in delayed emesis with 56.7% vs. 33.3% (P<0.05) and 84.1% vs. 54.1%(P<0.01). Both anti-emetic regiments were well tolerated and no difference in adverse events between the two groups was observed (P>0.05). Conclusion Tropisetron hydrochloride plus different Traditional Chinese Medicine Compound is more effective than Tropisetron hydrochloride alone in the prevention of chemotherapy-induced nausea and emesis. The therapeutic schedule is safe, effective and feasible.