Effect of haishengsu as an adjunct therapy for patients with advanced renal cell cancer: a randomized and placebo-controlled clinical trial.

Abstract

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.

• Authors: Ji-Zhu Liu, Shou-Guo Chen, Bin Zhang, Chun-Bo Wang, Xiao-Wen Zhao, Guang-Yao Li, Le-Xin Wang
• Journal: Journal of alternative and complementary medicine (New York, N.Y.) (J Altern Complement Med) Vol. 15 Issue 10 Pg. 1127-30 (Oct 2009) ISSN: 1557-7708 [Electronic] United States
• PMID: 19821717 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Albumins
• Antineoplastic Agents
• Drugs, Chinese Herbal
• Interferon-alpha
• Interleukin-2
• Plant Extracts
• haishengsu
• Fluorouracil

Topics

• Albumins (pharmacology, therapeutic use)
• Animals
• Antineoplastic Agents (administration & dosage, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Arcidae
• Carcinoma, Renal Cell (drug therapy)
• Chemotherapy, Adjuvant
• Drugs, Chinese Herbal (pharmacology, therapeutic use)
• Energy Intake (drug effects)
• Female
• Fluorouracil (administration & dosage)
• Gastrointestinal Tract (drug effects)
• Humans
• Interferon-alpha (administration & dosage)
• Interleukin-2 (administration & dosage)
• Karnofsky Performance Status
• Kidney Neoplasms (drug therapy)
• Male
• Middle Aged
• Plant Extracts (chemistry, pharmacology, therapeutic use)
• Remission Induction
• Weight Gain (drug effects)