Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study.
OBJECTIVE
This open-label, prospective, phase I/II trial was performed to establish the safety and efficacy of Traditional Chinese Medicine (TCM) herbal products for treating non-anemia-related fatigue in patients with cancer. Although this practice is widespread in China, it has not been confirmed in a prospective clinical study.


METHODS
Thirty-three patients who had completed cancer treatment, had stable disease and no anemia, and reported moderate to severe fatigue (rated ≥4 on a 0-10 scale) were enrolled in a TCM outpatient clinic. Patients took Ren Shen Yangrong Tang (RSYRT) decoction, a soup containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct qi deficiency. Fatigue was assessed before and after RSYRT therapy, which all patients completed.


RESULTS
No discomfort or toxicity was observed. Before the study, all patients had had fatigue for at least 4 months. Fatigue severity decreased significantly from before therapy to 6 weeks after therapy: from 7.06 to 3.30 on a 0-10 scale (p<0.001). Fatigue category (mild, moderate, severe) shifted significantly (p=0.024): Of 22 patients with severe fatigue (rated ≥7) before therapy, 11 had mild fatigue and 11 had moderate fatigue after TCM treatment. The time-to-fatigue-alleviation was 2-3 weeks.


CONCLUSIONS
RSYRT therapy was safe and was associated with fatigue improvement in nonanemic cancer survivors, consistent with historical TCM clinical practice experience. Because of a possible placebo effect in this open-label study, decoction RSYRT warrants further study in randomized clinical trials to confirm its effectiveness for managing moderate to severe fatigue.
1 Department of Traditional Chinese Medicine, Peking University School of Oncology , Beijing Cancer Hospital & Institute, Haidian District, Beijing, People's Republic of China .
Yichen
Y
Xu
Yanzhi
Y
Chen
Pingping
P
Li
Xin Shelley
XS
Wang
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue / Q000188:drug therapy* / Q000209:etiology*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D011446:Prospective Studies; D017741:Survivors; D016896:Treatment Outcome
D004365:Drugs, Chinese Herbal; C072867:ren-shen-yang-rong-tang