Haishengsu as an adjunct therapy to conventional chemotherapy in patients with non-small cell lung cancer: A pilot randomized and placebo-controlled clinical trial

Summary 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, 2.4 mg Haishengsu in 250 ml normal saline, iv, for 15 days) and the placebo group ( n = 41, 250 ml 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.