Effect of haishengsu as an adjunct therapy for patients with advanced renal cell cancer: a randomized and placebo-controlled clinical trial.
OBJECTIVE
The purpose of this study was to investigate the effect of Haishengsu, an extract from Tegillarca L. granosa, on the effects and side-effects of immunotherapy in patients with advanced renal cell cancer.


METHODS
Fifty-five (55) patients with renal cell cancer were randomly divided into a Haishengsu group (n = 27, 2.4 mg, intravenously for 15 days) and a control group (n = 28). All patients were also treated with interleukin-2, interferon-alpha, and fluorouracil.


RESULTS
In the Haishengsu group, the prevalence of gastrointestinal reactions to the immunotherapy was lower than in the control group (18.5% versus 64.3%, p < 0.01). In comparison with the control group, more patients from the Haishengsu group had increased food intake (74.1% versus 14.3%, p < 0.01), weight gain (77.8% versus 10.7%, p < 0.01) or an increase in Karnofsky Performance Status score (55.6% versus 17.9%, p < 0.01). The remission rate of cancer in the Haishengsu group was higher than in the control group (51.9% and 21.4%, p < 0.01).


CONCLUSIONS
Addition of Haishengsu to the conventional immunotherapy is associated with an increased remission rate in patients with advanced renal cell cancer. Haishengsu was also associated with a reduced rate of gastrointestinal side-effects from the immunotherapeutic agents, and an improvement in the physical functionality of the patients.
Liu
Ji-Zhu
JZ
Liaocheng People's Hospital and Liaocheng Clinical School of Taishan Medical University , Liaocheng Shandong, China.
Chen
Shou-Guo
SG
Zhang
Bin
B
Wang
Chun-Bo
CB
Zhao
Xiao-Wen
XW
Li
Guang-Yao
GY
Wang
Le-Xin
LX
D000418:Albumins / Q000494:pharmacology / Q000627:therapeutic use*; D000818:Animals; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D049893:Arcidae; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D004365:Drugs, Chinese Herbal / Q000494:pharmacology / Q000627:therapeutic use*; D002149:Energy Intake / Q000187:drug effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D041981:Gastrointestinal Tract / Q000187:drug effects*; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage; D017567:Karnofsky Performance Status; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000737:chemistry / Q000494:pharmacology / Q000627:therapeutic use*; D012074:Remission Induction; D015430:Weight Gain / Q000187:drug effects
D000418:Albumins; D000970:Antineoplastic Agents; D004365:Drugs, Chinese Herbal; D016898:Interferon-alpha; D007376:Interleukin-2; D010936:Plant Extracts; C532636:haishengsu; D005472:Fluorouracil