| Methods | Parallel placebo-controlled randomised trial |
| Participants | SETTING: Outpatients at the Obesity Clinic of Kyoto Prefectual University, Japan |
| WHO PARTCIPATED: n= 81 (44 in treatment group mean age 52.6 yrs, mean weight 90.8 kg, mean BMI 36.7; in the 41 in control group mean age 54.8, mean weight 90.3, mean BMI 36.1) | |
| INCLUSION CRITERIA: IGT (WHO 1999) and obese | |
| EXCLUSION CRITERIA: People with kidney, heart and/or liver disease, any metabolic or endocrine disease, psychiatric disorders and cancer. | |
| CO-MORBIDITIES: obesity | |
| CO-MEDICATIONS: none reported | |
| Interventions | INTERVENTION: Bofu-tsusho-san (Scutellariae Radix, Glycyrrhizae Radix, Platycodi Radix, Gypsum Fibrosum, Atractylodis Rhizoma, Rhei Rhizoma, Schizonepetae Spica, Gardeniae Fructus, Paeoniae Radix, Cnidium Rhizoma, Angelicae Radix, Menthae Herba, Ledebouriellae Radix, Ephedrae Herba, Forsythiae Fructus, Zingiberis Rhizoma, Talcum, Natrium Sulphuricum), dry extract, three times a day (t.i.d) 30 mins before meals, for 24 wks plus lifestyle modification (diet & exercise). |
| CONTROL: placebo three times a day (t.i.d) 30 mins before meals, for 24wks plus lifestyle modification (diet & exercise) | |
| Lifestyle modification for all participants involved a diet of 1200 kcal/day, analysed based on food ingestion records, and exercise (5000 steps/day) determined by pedometer recordings. | |
| Outcomes | FBG (mg/dL), 2hr-GTT (mg/dL), HbA1c (%), triglycerides (mg/dL), HDL (mg/dL), LDL (mg/dL), total cholesterol (mg/dL), fasting insulin (μU/mL), 2hr insulin (μU/mL), insulin AUC, HOMA-IR. |
| Outcomes for all measures were assessed at baseline, 12 weeks, and 24 weeks. | |
| Note: For FBG mg/dL & 2hr-GTT conversion to mmol/L: mg/dl of glucose to mmol/l, divided by 18. | |
| For total cholesterol, HDL, LDL mg/dL conversion to mmol/L: convert mg/dl of HDL or LDL cholesterol to mmol/l, divided by 38.67. | |
| For triglycerides mg/dL conversion to mmol/L: mg/dl of triglycerides to mmol/l, divide by 89. | |
| Study details | DURATION OF INTERVENTION: 24 weeks |
| DURATION OF FOLLOW-UP: 24 weeks | |
| RUN-IN PERIOD: after 2 months of lifestyle modification (diet and exercise therapy as described above), the active drug or placebo was introduced. | |
| Publication details | LANGUAGE OF PUBLICATION: English and Japanese |
| COMMERCIAL FUNDING: no | |
| NON-COMMERCIAL FUNDING: This study was supported, in part, by a Grant-in-Aid (No.14571106; to TY) for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan. | |
| PUBLICATION STATUS (PEER REVIEW JOURNAL): yes | |
| PUBLICATION STATUS (JOURNAL SUPPLEMENT): no | |
| PUBLICATION STATUS (ABSTRACT): yes | |
| Stated aim of study | The aim of the study was to determine whether BF was effective in decreasing visceral adiposity and insulin resistance. |
| Notes | |
Risk of bias table