A novel infusible botanically-derived drug, PG2, for cancer-related fatigue: a phase II double-blind, randomized placebo-controlled study.
OBJECTIVE
This study investigated the efficacy of the botanical-derived drug, PG2, a partially purified extract of Astragalus membranaceus, as a complementary and palliative medicine for managing cancer-related fatigue (CRF).


METHODS
Patients with advanced cancer and moderate to severe CRF were randomized to receive either PG2 or a placebo (normal saline, NS) in the first treatment cycle (four weeks) in a double-blind manner; thereafter, on the next cycle (four weeks), all patients received open-label treatment with PG2.


RESULTS
PG2 significantly improved CRF in the NS-primed group. In the first four week cycle, PG2 administration resulted in a greater fatigue-improvement response rate than seen with NS alone. In addition, approximately 82% of patients who reported an improvement of fatigue symptoms following the first cycle of PG2 experienced sustained benefits after administration of the second treatment cycle. Among patients treated with PG2 who did not report an improvement in symptoms throughout the first treatment cycle, approximately 71% showed significant improvement after the second treatment cycle. No major or irreversible toxicities were observed with PG2 treatment.


CONCLUSIONS
PG2 might be an effective and safe treatment for relieving CRF among advanced cancer patients.
Department of Radiation Oncology and Hospice Center, Mackay Memorial Hospital, Taipei, Taiwan.
Hong-Wen
HW
Chen
I-Hsin
IH
Lin
Yu-Jen
YJ
Chen
Kao-Hwa
KH
Chang
Meng-Hao
MH
Wu
Wen-Hao
WH
Su
Gwo-Che
GC
Huang
Yuen-Liang
YL
Lai
D000368:Aged; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D010919:Placebos; D010944:Plants / Q000737:chemistry*
D010919:Placebos