|Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study|
|Xu, Yichen1; Chen, Yanzhi1; Li, Pingping1; Wang, Xin Shelley2|
|刊名||JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE|
|WOS标题词||Science & Technology|
|类目[WOS]||Integrative & Complementary Medicine|
|研究领域[WOS]||Integrative & Complementary Medicine|
|关键词[WOS]||TRADITIONAL CHINESE MEDICINE ; DOUBLE-BLIND ; CLINICAL-TRIALS ; SYMPTOM BURDEN ; CHEMOTHERAPY ; PLACEBO|
Objectives: 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.
Design: 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.
Conclusion: 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.
|项目编号||NCI P01 CA124787 ; NCI P30 CA016672|
|资助机构||Key Program Foundation of Beijing Administration of TCM ; National Cancer Institute (NCI) of the National Institutes of Health ; MD Anderson Cancer Center|
|作者单位||1.Univ Texas MD Anderson Canc Ctr, Dept Symptom Res, Houston, TX 77030 USA|
2.Peking Univ, Sch Oncol, Beijing Canc Hosp & Inst, Dept Tradit Chinese Med, Beijing 100871, Peoples R China
|Xu, Yichen,Chen, Yanzhi,Li, Pingping,et al. Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study[J]. JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE,2015,21(5):281-287.|
|APA||Xu, Yichen,Chen, Yanzhi,Li, Pingping,&Wang, Xin Shelley.(2015).Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study.JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE,21(5),281-287.|
|MLA||Xu, Yichen,et al."Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study".JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE 21.5(2015):281-287.|