Background: 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.
Fang Feng Tong Sheng San is a traditional Japanese Kampo formula for patients with obesity. Recent basic studies have indicated that Fang Feng Tong Sheng San potentially improves the pathophysiology of obesity. However, it is still unknown whether Fang Feng Tong Sheng San clinically reduces body mass index (BMI) in patients with obesity.
Methods: 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 Fang Feng Tong Sheng San on BMI, waist circumference, glycolipid metabolism, and blood pressure in participants with obesity. The primary outcome was change in BMI.
Results: We included seven studies and 679 participants (351 in the Fang Feng Tong Sheng San group and 328 in the control group). In participants with obesity, Fang Feng Tong Sheng San 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.
Conclusion: Fang Feng Tong Sheng San showed a potential benefit in safely and tolerably improving BMI in participants with obesity.