title: Effectiveness of a novel herbal agent MB-6 as a potential adjunct to 5-fluoracil-based chemotherapy in colorectal cancer.
abstract: Natural products, such as fermented soybeans, have been used to treat various physical conditions, including cancer. MB-6 is a botanical preparation composed of fermented soybean extract, green tea extract, Antrodia camphorata mycelia, spirulina, grape seed extract, and curcumin extract. Based on this, we hypothesized that MB-6 would increase the effectiveness of chemotherapy in patients with colon cancer. In a rodent study, MB-6, in combination with leucovorin/5-fluorouracil chemotherapy, increased the survival rate and life span of colon cancer tumor-bearing BALB/c mice as compared with treatment with chemotherapy alone. In a proof-of-concept clinical study, 72 patients with metastatic colorectal cancer were randomized to receive leucovorin, 5-fluorouracil, and oxaliplatin in combination with either MB-6 or placebo for 16 weeks. The primary outcome was the best overall response, and secondary outcomes included progression-free survival, overall survival, and adverse effects. Up to 77 weeks after treatment, there was follow-up with the patients. No significant difference in the best overall response rate and overall survival was observed between the 2 groups. Patients in the MB-6 group had a significantly lower disease progression rate than patients in the placebo group, during the study period (0.0% vs 15.8%, P = .026). The placebo group had a significantly higher incidence of adverse events at least grade 4 compared with the MB-6 group (28.9% vs 2.9%, respectively, P = .004) and a significantly higher occurrence of increased serum creatinine compared with the MB-6 group (29% vs 5.9%, P = .014). MB-6 is a promising botanical supplement that may increase the effectiveness of chemotherapy in patients with metastatic colorectal cancer.
authors.affiliation: Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung, Taiwan. Electronic address: wtchen@mail.cmuh.org.tw.
authors.forename: William Tzu-Liang
authors.initials: WT
authors.lastname: Chen
authors.affiliation: Division of Medical Oncology in the Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan and Chang Gung University College of Medicine, Taoyuan, Taiwan.
authors.forename: Tsia-Sheng
authors.initials: TS
authors.lastname: Yang
authors.affiliation: Division of Colorectal Surgery, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan.
authors.forename: Hung-Chang
authors.initials: HC
authors.lastname: Chen
authors.affiliation: Division of Colon and Rectal Surgery, Department of Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.
authors.forename: Hong-Hwa
authors.initials: HH
authors.lastname: Chen
authors.affiliation: Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Hua-Che
authors.initials: HC
authors.lastname: Chiang
authors.affiliation: Division of Colorectal Surgery, Department of Surgery, Changhua Christian Hospital, Changhua, Taiwan.
authors.forename: Tsang-Chi
authors.initials: TC
authors.lastname: Lin
authors.affiliation: Division of Colon and Rectal Surgery, Jia-Yi St Martin de Porres Hospital, Chiayi, Taiwan.
authors.forename: Chung-Hung
authors.initials: CH
authors.lastname: Yeh
authors.affiliation: Division of Colorectal Surgery, Department of Surgery, China Medical University Hospital, Taichung, Taiwan.
authors.forename: Tao-Wei
authors.initials: TW
authors.lastname: Ke
authors.affiliation: Division of Medical Oncology in the Hematology-Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan and Chang Gung University College of Medicine, Taoyuan, Taiwan.
authors.forename: Jen-Shi
authors.initials: JS
authors.lastname: Chen
authors.affiliation: Department of Colorectal Surgery, Taipei Buddhist Tzu Chi General Hospital, Taipei, Taiwan.
authors.forename: Koung-Hung
authors.initials: KH
authors.lastname: Hsiao
authors.affiliation: Institute of Biochemical Sciences, National Taiwan University College of Life Science and Institute of Toxicology of Medicine National Taiwan University, Taipei, Taiwan; Institute of Biological Chemistry, Academia Sinica, Taipei, Taiwan.
authors.forename: Min-Liang
authors.initials: ML
authors.lastname: Kuo
mesh_terms: D000368:Aged; D000818:Animals; D000972:Antineoplastic Agents, Phytogenic / Q000494:pharmacology / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D055491:Antrodia; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D003404:Creatinine / Q000097:blood; D018450:Disease Progression; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000627:therapeutic use; D019684:Magnoliopsida; D008297:Male; D008807:Mice, Inbred BALB C; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D000077150:Oxaliplatin; D008517:Phytotherapy; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D011919:Rats, Inbred Strains; D053545:Spirulina
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; D010936:Plant Extracts; D000077150:Oxaliplatin; D003404:Creatinine; D002955:Leucovorin; D005472:Fluorouracil
keywords: BALB/c mice; Herbal medicine; MB-6; Metastatic colorectal cancer; Overall survival; Progression-free survival; Tolerability