Haishengsu as an adjunct therapy to conventional chemotherapy in patients with non-small cell lung cancer: a pilot randomized and placebo-controlled clinical trial.
OBJECTIVE
To investigate the effect of Haishengsu, an extract from Tegillarca granosa, on non-small cell lung cancer as an adjunct to conventional chemotherapy. DESIGNS/SETTINGS: Randomized, double-blind, placebo-controlled trial was conducted in 83 patients. The Haishengsu (n=42, 2.4mg Haishengsu in 250ml normal saline, iv, for 15 days) and the placebo group (n=41, 250ml normal saline, iv) were also treated with two cycles (28 days for each cycle) of conventional chemotherapy consisting mitomycin, vindesine and cisplatin.


RESULTS
The curative effect of conventional chemotherapy was observed in 62% of Haishengsu group patients and in 39% in of the placebo group patients (P=0.04, RR 1.59, 95% CI: 1.01-2.49). Improvement in Karnofsky performance status scores was seen in 66.7% of Haishengsu group patients and in 17.1% of the placebo group patients (P<0.01, RR 3.63, 95%CI: 1.77-7.41). The ratio of patients with no or only mild gastrointestinal reaction in the Haishengsu and the placebo group was 83.3% and 39.0%, respectively (P<0.01, RR 2.13, 95% CI: 1.42-3.20).


CONCLUSIONS
This study suggests that Haishengsu may be an effective adjunct therapy to the conventional chemotherapy for non-small cell lung cancer. The short-term therapeutic effect of chemotherapy may be improved and the chemotherapy-induced nausea or vomiting may be reduced by concurrent Haishengsu administration.
Li
Guang-Yao
GY
Liaocheng People's Hospital (Liaocheng Clinical School of Taishan Medical University), Liaocheng, Shandong Province 252000, P R China.
Yu
Xiao-Min
XM
Zhang
Hong-Wei
HW
Zhang
Bin
B
Wang
Chun-Bo
CB
Xin
Yan-Chun
YC
Yang
Chun-Zheng
CZ
Zhou
Ren-Xiang
RX
Wang
Le-Xin
LX
D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001835:Body Weight; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D018450:Disease Progression; D004435:Eating; D041981:Gastrointestinal Tract / Q000503:physiopathology; D006801:Humans; D017567:Karnofsky Performance Status; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008974:Mollusca; D009325:Nausea / Q000188:drug therapy; D010865:Pilot Projects; D014839:Vomiting / Q000188:drug therapy
D000970:Antineoplastic Agents