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To evaluate the antiobesity effect of bofutsushosan extract granules in obese patients and the course of highsensitivity Creactive protein (HSCRP) as an promoting factor.

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Evidence Reports of Kampo Treatment

Task Force for Evidence Reports / Clinical Practice Guideline Committee for EBM, the Japan Society for Oriental Medicine

070003e

4. Metabolism and Endocrine Diseases Reference

Namiki T. Basic and clinical investigation of the effect of Kampo medicines on arteriosclerosis*. Uehara Kinen Seimei Kagaku Zaidan Kenkyu Hokokushu (Research Reports of Uehara Memorial Foundation) 2007; 21: 60-3 (in Japanese). Ichushi Web ID: 2008156867

1. Objectives

To evaluate the anti-obesity effect of bofutsushosan (防風通聖散) extract granules in obese patients and the course of high-sensitivity C-reactive protein (HS-CRP) as an arteriosclerosis-promoting factor. 2. Design

Randomized controlled trial using sealed envelopes for allocation (RCT-envelope). 3. Setting

The outpatient department of internal medicine at a general hospital, Japan. 4. Participants

Patients who were obese (body mass index [BMI] of 25 or greater), hypertensive (diastolic blood pressure of 90 mmHg or higher and/or a systolic blood pressure of 140 mmHg or higher), treatment-naïve or taking oral antihypertensives, and aged ≥20 to <80 years were included after giving written informed consent. Exclusion criteria were: 1) serious complications (cardiac disease, renal disease, malignancy, etc.); 2) use of medications that might affect the outcome of this trial; 3) pregnant, lactating, or likely to become pregnant; and 4) considered ineligible by the investigator.

5. Intervention

Arm 1: bofu group: conventional therapy plus oral administration of bofutsushosan (防風通聖散) extract granules (manufacturer, not specified) 7.5 mg/day before or between meals for 12 weeks in 25 patients (16 males and 9 females; mean age, 63.3±12.3 years).

Arm 2: control group: continuation of conventional therapy in 30 patients (19 males and 11 females; mean age, 64.2±10.3 years).

6. Main outcome measures

1) Body weight, BMI, blood pressure, pulse; 2) levels of fasting blood glucose, hemoglobin a1c (Hba1c), and insulin; 3) levels of total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), and triglyceride; 4) visceral fat (measured by computed tomography [CT]); and 5) blood biochemistry including HS-CRP level, hepatic and renal functions, and electrolyte levels. 1) to 3) were measured at weeks 0, 4, 12, and 24; 4) at weeks 0 and 24; and 5) at weeks 0, 4, 8, 12, and 24.

7. Main results

Body weight was reduced by 1.16 kg (–1.5%) (from 77.82±17.53 kg at week 0 to 76.63±17.66 kg at week 24) in the bofu group, in contrast to the reduction of 1.49 kg (–2.8%) (from 71.79±10.16 kg at week 0 to 70.30±10.36 kg at week 24) in the control group. But the between-group difference was not significant. BMI was decreased by 1.6% (from 30.62±5.81 at week 0 to 30.14±5.78 at week 24) in the bofu group and 2.1% (from 27.80±2.56 at week 0 to 27.22±2.79 at week 24) in the control group.

HS-CRP was 1199.00±1040.46 µg/dL at week 0, then gradually increased by 914.54 µg/dL to 2113.54±4524.08 µg/dL at week 24 in the control group, while it was 2918.17±4239.03 µg/dL at week 0, transiently increased to 5229.26±11066.85 µg/dL at week 4, then decreased to 2694.92±3606.66 µg/dL at week 24 (decrease of 223.25 µg/dL from the week 0 level) in the bofu group.

8. Conclusions

Although body weight and BMI were higher in the bofu group than in the control group, HS-CRP at week 24 was decreased in the bofu group and increased in the control group.

9. From Kampo medicine perspective

As a basic evaluation, the anti-arteriosclerosis effect of keishibukuryogan is also described in this paper. 10. Safety assessment in the article

None.

11. Abstractor’s comments

This study is an RCT that used HS-CRP as an outcome measure to evaluate arteriosclerosis. The study is very interesting in that it used a novel approach to assess a Kampo medicine. Although results on body weight and BMI were negative, further studies are expected to reveal some positive effects.

12. Abstractor and date

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