The toxicity and side effects caused by adjuvant chemotherapy (ACT) after radical surgery for lung adenocarcinoma (LAC) lead to early termination frequently. This study was conducted to provide an objective basis for the effect of Chinese herbal medicine formulas (CHMFs) combined with chemotherapy in reducing toxicity and enhancing efficacy of ACT. From February 17th, 2012 to March 20th, 2015, 233 patients from 7 hospitals diagnosed with LAC in IB~IIIA stage were randomly assigned into ACT + CHMF group (116 patients) and ACT + placebo group (117 patients). CHMF was taken orally until the end of chemotherapy. Chemotherapy-related toxic, side effects were investigated as the primary outcome. Disease-free survival (DFS) and overall survival (OS) were used as the secondary outcome. At one week following chemotherapy, the incidence of dry mouth, diarrhea and thrombocytopenia significantly decreased in CHMF group (P = 0.017, P = 0.033, P = 0.019, respectively). At two weeks following chemotherapy, fatigue and diarrhea were more obvious in the placebo group (P = 0.028, P = 0.025, respectively). In addition, patients in the CHMF group showed an increase in median DFS from 37.1 to 51.5 months compared with placebo group although there was no statistical significance (P = 0.16). In the stage IB subgroup, the CHMF group had a significantly better DFS (HR (95% CI) = 0.53 (0.28–0.99), P = 0.046). There was no significant difference in OS between the groups (P = 0.72). For patients with LAC, ACT combined with CHMF after radical surgery can prolong the DFS time especially in the early stage, and reduces the chemotherapy-related toxic and side effects. NCT 01441752. Registered 14 July, 2011.

中文翻译：

---

肺腺癌根治术后中草药方与安慰剂的辅助化疗：一项多中心、随机、双盲、安慰剂对照试验

肺腺癌 (LAC) 根治性手术后辅助化疗 (ACT) 引起的毒副作用导致经常提前终止化疗。本研究旨在为中药方剂（CHMFs）联合化疗对ACT减毒增效的作用提供客观依据。2012年2月17日至2015年3月20日，将来自7家医院的233例IB~IIIA期LAC患者随机分为ACT+CHMF组（116例）和ACT+安慰剂组（117例）。口服 CHMF 直至化疗结束。化疗相关的毒副作用作为主要结果进行了研究。无病生存期（DFS）和总生存期（OS）被用作次要结果。化疗后一周，口干的发生率，CHMF组的腹泻和血小板减少症显着降低（分别为P = 0.017，P = 0.033，P = 0.019）。化疗后两周，安慰剂组的疲劳和腹泻更为明显（分别为 P = 0.028，P = 0.025）。此外，与安慰剂组相比，CHMF 组患者的中位 DFS 从 37.1 个月增加到 51.5 个月，但无统计学意义（P = 0.16）。在 IB 期亚组中，CHMF 组的 DFS 明显更好（HR (95% CI) = 0.53 (0.28–0.99)，P = 0.046）。组间 OS 无显着差异（P = 0.72）。对于 LAC 患者，根治术后 ACT 联合 CHMF 可延长 DFS 时间，尤其是在早期，减少化疗相关毒副作用。NCT 01441752。2011 年 7 月 14 日注册。