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).

CONCLUSION:

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.

CLINICAL TRIAL REGISTRATION:

UMIN000003878.

• Authors: Kengo Azushima, Kouichi Tamura, Sona Haku, Hiromichi Wakui, Tomohiko Kanaoka, Masato Ohsawa, Kazushi Uneda, Ryu Kobayashi, Kohji Ohki, Toru Dejima, Akinobu Maeda, Tatsuo Hashimoto, Jin Oshikawa, Yusuke Kobayashi, Koichiro Nomura, Chieko Azushima, Yasuyo Takeshita, Ryota Fujino, Ken Uchida, Ken Shibuya, Daisaku Ando, Yasuo Tokita, Tetsuya Fujikawa, Yoshiyuki Toya, Satoshi Umemura
• Journal: Atherosclerosis (Atherosclerosis) Vol. 240 Issue 1 Pg. 297-304 (May 2015) ISSN: 1879-1484 [Electronic] Ireland
• PMID: 25818388 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Chemical References

• Antihypertensive Agents
• Drugs, Chinese Herbal
• bofu-tsusho-san

Topics

• Aged
• Antihypertensive Agents (adverse effects, therapeutic use)
• Blood Pressure (drug effects)
• Blood Pressure Monitoring, Ambulatory
• Drug Therapy, Combination
• Drugs, Chinese Herbal (adverse effects, therapeutic use)
• Female
• Humans
• Hypertension (diagnosis, drug therapy, etiology, physiopathology)
• Japan
• Male
• Middle Aged
• Obesity (complications)
• Phytotherapy
• Plants, Medicinal
• Prospective Studies
• Time Factors
• Treatment Outcome