title: A preliminary randomised controlled study of short-term Antrodia cinnamomea treatment combined with chemotherapy for patients with advanced cancer.
abstract: BACKGROUND
  Antrodia cinnamomea (AC) is a popular medicinal mushroom in Taiwan that has been widely used for treatment of various cancers. Few clinical studies have reported its application and efficiency in therapeutic chemotherapy strategies. We performed a double-blind, randomized clinical study to investigate whether AC given for 30 days had acceptable safety and efficacy in advanced cancer patients receiving chemotherapy.
  
  
  METHODS
  Patients with advanced and/or metastatic adenocarcinoma, performance status (PS) 0-2, and adequate organ function who had previously been treated with standard chemotherapy were randomly assigned to receive routine chemotherapy regimens with AC (20 ml twice daily) orally for 30 days or placebo. The primary endpoint was 6-month overall survival (OS); the secondary endpoints were disease control rate (DCR), quality of life (QoL), adverse event (AE), and biochemical features within 30 days of treatment.
  
  
  RESULTS
  From August 2010 to July 2012, 37 subjects with gastric, lung, liver, breast, and colorectal cancer (17 in the AC group, 20 in the placebo group) were enrolled in the study. Disease progression was the primary cause of death in 4 (33.3 %) AC and 8 (66.7 %) placebo recipients. Mean OSs were 5.4 months for the AC group and 5.0 months for the placebo group (p = 0.340), and the DCRs were 41.2 and 55 %, respectively (p = 0.33). Most hematologic, liver, or kidney functions did not differ significantly between the two groups, but platelet counts were lower in the AC group than in the placebo group (p = 0.02). QoL assessments were similar in the two groups, except that the AC group showed significant improvements in quality of sleep (p = 0.04).
  
  
  CONCLUSIONS
  Although we found a lower mortality rate and longer mean OS in the AC group than in the control group, A. cinnamomea combined with chemotherapy was not shown to improve the outcome of advanced cancer patients, possibly due to the small sample size. In fact, the combination may present a potential risk of lowered platelet counts. Adequately powered clinical trials will be necessary to address this question.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01287286 .
authors: Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan. missuriae0116@gmail.com.|Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan. missuriae0116@gmail.com.|Department of Internal Medicine, Division of Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan. missuriae0116@gmail.com.
authors: Ming-Yen
authors: MY
authors: Tsai
authors: Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.|School of Chinese Medicine for Post Baccalaureate, I-Shou University, Kaohsiung, 83301, Taiwan.
authors: Yu-Chiang
authors: YC
authors: Hung
authors: Department of Internal Medicine, Division of Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
authors: Yen-Hao
authors: YH
authors: Chen
authors: Graduate Institute of Integrated Medicine, College of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan.
authors: Yung-Hsiang
authors: YH
authors: Chen
authors: Department of Medical Research, China Medical University Hospital and School of Chinese Medicine, China Medical University, Taichung, 40402, Taiwan.
authors: Yu-Chuen
authors: YC
authors: Huang
authors: Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
authors: Chao-Wei
authors: CW
authors: Kao
authors: Department of Internal Medicine, Division of Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
authors: Yu-Li
authors: YL
authors: Su
authors: School of Chinese Medicine for Post Baccalaureate, I-Shou University, Kaohsiung, 83301, Taiwan.
authors: Hsien-Hsueh Elley
authors: HH
authors: Chiu
authors: Department of Internal Medicine, Division of Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan. kmrau58@cgmh.org.tw.
authors: Kun-Ming
authors: KM
authors: Rau
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000737:chemistry / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D055491:Antrodia / Q000737:chemistry*; D001688:Biological Products / Q000009:adverse effects* / Q000737:chemistry / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000401:mortality; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001688:Biological Products
keywords: Advanced and metastatic cancer; Antrodia cinnamomea; Chemotherapy; Outcome