비만 환자에서 한방 비만 변증에 따른 방풍통성산과 방기황기탕의 치료효과 및 부작용 비교: 무작위 배정, 이중 맹검, 위약-대조군 임상시험

초록

Objectives :This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods :166 subjects(body mass index ≥ 25 kg/m2) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results :The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) ＞ stagnation of the liver qi(肝鬱) ＞ yang deficiency(陽虛) ＞ spleen deficiency(脾虛) ＞ phlegm(痰飮) ＞ blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions :Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.

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