title: Effects of the oriental herbal medicine Bofu-tsusho-san in obesity hypertension: a multicenter, randomized, parallel-group controlled trial (ATH-D-14-01021.R2).
abstract: OBJECTIVE
  There is no clinical evidence that supports the benefit of integrative medicine, defined as combination therapy of oriental and western medicine, on obesity-related hypertension. This study evaluates the efficacy of Bofu-tsusho-san (BOF), an oriental herbal medicine, on the ambulatory blood pressure (BP) profile in hypertensive patients with obesity.
  
  
  METHODS
  The study design was a multicenter, randomized, open-label, parallel-group controlled trial in 107 hypertensive patients with obesity. Participants were randomly assigned to receive either the conventional control therapy or BOF add-on therapy. In both groups antihypertensive therapy was aimed at achieving the target clinic BP. The primary outcome was change in the ambulatory BP profile from baseline to 24 weeks after randomization.
  
  
  RESULTS
  Daytime systolic BP variability, an important parameter of ambulatory BP profile, was decreased in the BOF group, and the difference in the changes in daytime systolic BP variability was significant between the BOF and control group (Control vs BOF; the change from baseline in daytime systolic BP variability, 1.0±3.3 vs -1.0±3.3%; p=0.006).
  
  
  CONCLUSIONS
  The BOF add-on therapy effectively improved the ambulatory BP variability. This is the first report suggesting that an integrative medicine approach may exert favorable effects on obesity-related hypertension compared with conventional pharmaceutical treatment.
  
  
  BACKGROUND
  UMIN000003878.
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Kengo
authors.initials: K
authors.lastname: Azushima
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan. Electronic address: tamukou@med.yokohama-cu.ac.jp.
authors.forename: Kouichi
authors.initials: K
authors.lastname: Tamura
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Sona
authors.initials: S
authors.lastname: Haku
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Hiromichi
authors.initials: H
authors.lastname: Wakui
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Kanaoka
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Ohsawa
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Kazushi
authors.initials: K
authors.lastname: Uneda
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Ryu
authors.initials: R
authors.lastname: Kobayashi
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Kohji
authors.initials: K
authors.lastname: Ohki
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Dejima
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Akinobu
authors.initials: A
authors.lastname: Maeda
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Hashimoto
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Jin
authors.initials: J
authors.lastname: Oshikawa
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Kobayashi
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Nomura
authors.affiliation: Azushima Medical Clinic, Tokyo, Japan.
authors.forename: Chieko
authors.initials: C
authors.lastname: Azushima
authors.affiliation: Renal Division, Department of Medicine, Yamato Municipal Hospital, Yamato, Japan.
authors.forename: Yasuyo
authors.initials: Y
authors.lastname: Takeshita
authors.affiliation: Renal Division, Department of Medicine, Omori Red Cross Hospital, Tokyo, Japan.
authors.forename: Ryota
authors.initials: R
authors.lastname: Fujino
authors.affiliation: Renal Division, Department of Medicine, Omori Red Cross Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Uchida
authors.affiliation: Renal Division, Department of Medicine, Omori Red Cross Hospital, Tokyo, Japan.
authors.forename: Ken
authors.initials: K
authors.lastname: Shibuya
authors.affiliation: Renal Division, Department of Medicine, Fujisawa Municipal Hospital, Fujisawa, Japan.
authors.forename: Daisaku
authors.initials: D
authors.lastname: Ando
authors.affiliation: Renal Division, Department of Medicine, Fujisawa Municipal Hospital, Fujisawa, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Tokita
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Fujikawa
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Toya
authors.affiliation: Department of Medical Science and Cardiorenal Medicine, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Umemura
mesh_terms: D000368:Aged; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D007564:Japan; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications*; D008517:Phytotherapy; D010946:Plants, Medicinal; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D004365:Drugs, Chinese Herbal; C098310:bofu-tsusho-san
keywords: Ambulatory blood pressure monitoring; Blood pressure variability; Glucose metabolism; Hypertension; Integrative medicine; Obesity; Oriental herbal medicine