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Redalyc.Usefulness of a Japanese Herbal Medicine, Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas ISSN: 0717-7917 [email protected] Universidad de Santiago de Chile Chile Hioki, Chizuko; Yoshida, Toshihide Usefulness of a Japanese herbal medicine, "Bofu-tsusho-san" with tailor-made diet therapy in subjects with metabolic syndrome Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas, vol. 4, núm. 5, septiembre, 2005, pp. 92-97 Universidad de Santiago de Chile Santiago, Chile Available in: http://www.redalyc.org/articulo.oa?id=85640504 How to cite Complete issue Scientific Information System More information about this article Network of Scientific Journals from Latin America, the Caribbean, Spain and Portugal Journal's homepage in redalyc.org Non-profit academic project, developed under the open access initiative Boletín Latinoamericano y del Caribe de Plantas Medicinales y Aromáticas Septiembre de 2005; Volumen 4, Nº 5, Pág. 92-97. ISSN 0717 7917 Original Paper Japón Usefulness of a Japanese herbal medicine, "Bofu-tsusho-san" with tailor- made diet therapy in subjects with metabolic syndrome Efectividad de una Medicina Herbal Japonesa, “Bofu-tsusho-san”, junto a una dieta personalizada en sujetos con síndrome metábolico. Received June 7, 2005; Accepted: July 12, 2005. Chizuko HIOKI1*and Toshihide YOSHIDA2 1 Clinical Research Institute for Endocrine and Metabolic Diseases, National Hospital Organization, Kyoto Medical Center, Kyoto 612-8555, Japan 2 Department of Diabetes and Metabolism, Kyoto City Hospital, Kyoto, 604-8845, Japan E-mail: [email protected] / [email protected] Abstract Resumen We conducted a randomized, double-blind placebo Hemos realizado un estudio del medicamento herbal bofu- controlled study of bofu-tsusho-san (BF), in obese women tsusho-san (BF) en mujeres obesas con intolerancia a la with impaired glucose tolerance (IGT). The Kampo glucosa (IGT). El estudio se realizó con distribución aleatoria, formula, Bofu-tsusho-san consists of the total 18 cruds doble ciego y controlado con placebo. Esta formula Kampo drugs (Table 1), including Ephedrae Herba which consiste en un total de 18 ingredientes, que incluyen Ephedrae enhances noradrenaline release from sympathetic nerve Herba que aumenta la secreción de noradrenalina por las ending, Glycyrrhizae Radix, Forsythiae Fructus, terminaciones del sistema simpático, Glycyrrhizae Radix, Schizonepetae Spica and 12 other crude drugs. BF Forsythiae Fructus, Schizonepetae Spica y otras 12 drogas showed thermogenic and lipolytic anti-obesity effects via vegetales. BF demostró efectos termogénicos y lipolíticos ephedrine and inhibitory action of cyclic AMP debido a la efedrina, vía inhibición de la acción de la AMPc phosphodiesterase 2.5 times stronger than that of caffeine. fosfodiesterasa, que resulta ser 2.5 veces mas fuerte que la de BF was effective not only for the reducing body weight, la cafeína. BF fue efectivo no solo reduciendo el peso corporal visceral fat and waist circumference, but also for the y la circunferencia de la cintura, sino que también mejoró la improvement of insulin resistance without adverse effects resistencia a la insulina sin efectos adversos en el on glucose or lipid metabolism. BF may be effective for metabolismo de la glucosa o de los lípidos. BF puede ser treating metabolic syndrome and symptoms associated efectivo para el tratamiento del síndrome metabólico y otros with obesity. síntomas relacionados con la obesidad Key words:. obesity, traditional herbal medicine, bofu- Palabras clave: Obesidad, Medicina Tradicional, bofu-tsusho- tsusho-san, metabolic syndrome san, síndrome metabólico BLACPMA.- Septiembre de 2005; Volumen 4, n 5, p. 92 Hioki: Efectividad de Bofu-tsusho-san INTRODUCTION METHODS Adiposities play a role not merely in passive energy storage but also as an endocrine organ, Clinical study of bofu-tsusho-san producing bioactive substances termed The subjects were 81 obese women with IGT adipocytokines. On the other hand, it is thought (mean age: 53.8 ± 12.9 years: mean body mass that the association of adiposity with the metabolic index: 36.5 ± 4.8 kg/㎡) who visited the Outpatient disorder is not absolute and the metabolic Obesity Clinic of Kyoto Prefectural University of syndrome does not describe underlying causality, Medicine. Subjects were classified by categories nor does metabolic syndrome necessarily reflect of glucose tolerance according to the 1999´s any reasonably related pathophysiologic WHO diagnostic criteria. IGT was diagnosed process；nevertheless the term metabolic when the FPG levels was < 7.0 mmol/l (126 mg/dl) with a 2-h OGTT value ≥ 7.8 mmol/l (140 syndrome refers to consequences of excessive body fat, such as obesity, hypertension, insulin mg/dl) and <11.1 mmol/l (200 mg/dl) (6, 7). resistance, dyslipidemia and hyperglycemia Subjects with kidney, heart and/or liver disease, including impaired glucose tolerance (IGT). IGT is any metabolic or endocrine disease, psychiatric a predictor not only of type 2 diabetes (1), but also disorders or cancer were excluded. of cardiovascular disease and other complications The study was a randomized, double-blind, of diabetes (2). In addition, greater visceral placebo-controlled trial. Randomization, 41 to the adiposity also increases the risk of IGT (3, 4). herbal group and 40 to the placebo group, was We previously conducted a randomized clinical performed. Each group consisted of Japanese safety and efficacy trial of bofu-tsusho-san (Table women with IGT. In the BF group the mean age 1) used in oriental medicine in Japan, and reported (52.6 ± 14.0 years), height (157.4 ± 12.5 cm), the effectiveness in reducing bodyweight, waist body weight (90.8 ± 17.9 kg), BMI (36.7 ± 6.8 kg/㎡), subcutaneous fat (426.4±135.4 cm2) and circumference, visceral adiposity and insulin 2 resistance in obese women with IGT (5). In this visceral fat (197.6 ± 69.7 cm ) before treatment paper, we introduce the usefulness of BF in obese were measured. In the placebo group the mean treatment and a successful attempt to study about age (54.8 ± 12.5 years), height (158.8 ± 7.2 cm), how the traditional treatment methods can fit into a body weight (90.3 ± 12.2 kg), BMI (36.1 ± 3.3 2 modern biomedical context. kg/㎡), subcutaneous fat (422.3 ± 106.8 cm ) and 2 visceral fat (177.2 ± 73.3 cm ) were also Table 1: Composition of Bofu-tsusho-san measured. The morphometric and biochemical parameters Herbal drugs Weight (g) were measured once monthly for evaluation 1. Scutellariae Radix 44.4 during the trial. Waist circumference was 2. Glycyrrizae Radix 44.4 measured at the narrowest part of the torso. Hip 3. Platcodi Radix 44.4 circumference was measured at the point of 4. Gypsum fibrosum 44.4 maximum extension of the buttocks. Serum total 5. Atractylodis Rhizoma 44.4 cholesterol, triglyceride levels and blood glucose 6. Rhei Rhizoma 33.3 were measured. Blood glucose and serum insulin 7. Schizonepetae Spica 26.7 levels were measured after overnight fast and 8. Gardeniae Fructus 26.7 during a 75-g oral glucose tolerance test. Blood 9. Paeoniae Radix 26.7 samples were collected at 0, 30, 60, 90 and 120 10. Cnidium Rhizoma 26.7 min to determine glucose and insulin levels. 11. Angelicae Radix 26.7 Homeostasis model assessment of insulin 12. Menthae Herba 26.7 resistance (HOMA-IR) was calculated by the 13. Ledebouriellae Radix 26.7 following formula: fasting serum insulin (µU/ml) × 14. Ephedrae Herba 26.7 fasting blood glucose (mg/dl)/405 (8, 9). 15. Forsythiae Fructus 26.7 Resting metabolic rate (RMR) was measured in 16. Zingiberis Rhizoma 6.7 the morning by a closed-circuit indirect Total* 502.3 calorimeter (Sanborn Wedge type Spiro meter: Other components metabograph, Model SS-80; Fukada Medical Talcum 66.7 Laboratory Co, Tokyo, Japan) with a mouthpiece, Natrium Sulphuricum 15.6 in a temperature-controlled room (22－24 ℃) after an overnight fast (10). The expected RMR (*) The amount of each crude drug required to prepare was calculated as body weight times the standard 100g of BF dry extract. values of RMR, which were reported by the Japan national nutritional research (11), The adjusted BLACPMA.- Septiembre de 2005; Volumen 4, n 5, p. 93 Hioki: Efectividad de Bofu-tsusho-san RMR was then obtained as: adjusted RMR = measured RMR-expected RMR for each subject RESULTS (12). fter 12 weeks of the BF treatment, the mean At the same time, each subject was instructed A decrease in body weight from values at the start concerning a diet of 1,200 kcal/day （1 kcal = of diet and exercise were 6.4 % (or 5.9 kg; p<0.05 ） 4.18kJ maintaining total protein in the meals at vs. 0 weeks,) in the BF group, and 5.0 % (or 4.6 70 g/day, and exercise (5,000 steps/day), kg) in the placebo group. The mean decrease in especially for 30 minutes after every meal. As for body fat was not significant in either group. At the the behavioral therapy, subjects were also advised end of the subsequent 24 week period, however, not to eat such a large helping at one meal but the BF treatment group lost significantly greater divide it into 3 portions in a day, and not to eat amounts of body weight and body fat compared after 8:00 PM except water and raw vegetables. with the placebo. The mean decreases in body After two months of diet and exercise therapy, weight and fat were 11.8 % (or 10.8 kg; p<0.01 active or placebo drug had been taken at 30min vs.0 weeks) and 9.4 kg (p<0.01 vs.0 weeks) of before each meal, three times a day (active: BF the BF group versus 7.6 % (or 6.9 kg; p<0.05 vs. extracts 7.5 g/day, containing 24 mg/day 0 weeks) and 6.3 kg (p < 0.05 vs.
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