Japanese traditional Kampo medicine bofutsushosan improves body mass index in participants with obesity: A systematic review and meta-analysis

• Published in: PloS one 2022-04, Vol.17 (4), p.e0266917
• Main Authors: Uneda, Kazushi, Kawai, Yuki, Yamada, Takayuki, Kaneko, Akira, Saito, Ryuji, Chen, Lin, Ishigami, Tomoaki, Namiki, Takao, Mitsuma, Tadamichi
• Format: Article
• Language: English
• Subjects: Biology and Life Sciences; Blood pressure; Body mass; Body Mass Index; Body size; Cardiovascular diseases; Care and treatment; Clinical trials; Comparative analysis; Confidence intervals; Drugs, Chinese Herbal; FDA approval; Glycolipids; Health aspects; Health risks; Heterogeneity; Humans; Japan; Medicine and Health Sciences; Medicine, Botanic; Medicine, Herbal; Medicine, Kampo; Meta-analysis; Metabolism; Obesity; Obesity - drug therapy; Parameter sensitivity; Patients; Physical Sciences; Research and Analysis Methods; Risk analysis; Risk factors; Sensitivity analysis; Traditional medicine
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0266917

The number of people with obesity is rapidly increasing worldwide. Since obesity is a critical risk factor for cardiovascular diseases and mortality, the management of obesity is an urgent issue. However, anti-obesity drugs are insufficient in current clinical settings. Bofutsushosan (BTS, Fang-Feng-Tong-Sheng-San in China) is a traditional Japanese Kampo formula for patients with obesity. Recent basic studies have indicated that BTS potentially improves the pathophysiology of obesity. However, it is still unknown whether BTS clinically reduces body mass index (BMI) in patients with obesity. We searched electronic databases, including the Medline, EMBASE, Cochrane Library, and Japanese/Chinese/Korean databases, on June 15, 2021. We conducted a meta-analysis of randomized controlled trials to evaluate the effects of BTS on BMI, waist circumference, glycolipid metabolism, and blood pressure in participants with obesity. The primary outcome was change in BMI. We included seven studies and 679 participants (351 in the BTS group and 328 in the control group). In participants with obesity, BTS significantly reduced BMI relative to controls (mean difference, MD [95% confidence interval]: -0.52 kg/m2 [-0.86, -0.18], P = 0.003). There was no significant difference in waist circumference, glycolipid parameters, or blood pressure. Sensitivity analyses showed robust outcomes for the primary endpoint, although the heterogeneity was considerable. Moreover, no serious adverse events were observed in the BTS group. BTS showed a potential benefit in safely and tolerably improving BMI in participants with obesity.