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To confirm the efficacy of shosaikoto for chronic hepatitis C.

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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

990003e

1. Infections (including Viral Hepatitis) Reference

Nakajima O, Sone M, Onishi H, et al. Preventive effect of shosaikoto on the progression of chronic hepatitis C to cirrhosis*. Rinsho to Kenkyu (Japanese Journal of Clinical and Experimental Medicine) 1999; 76: 1008-16 (in Japanese). Ichushi Web ID: 1999207089 MOL, MOL-Lib

1. Objectives

To confirm the efficacy of shosaikoto (小柴胡湯) for chronic hepatitis C.

2. Design

Randomized controlled trial (RCT).

3. Setting

Multiple general hospitals, Japan.

4. Participants

Ninety-nine patients with chronic active hepatitis C who completed interferon therapy.

5. Intervention

Arm 1: oral administration of Kanebo Shosaikoto (小柴胡湯) Extract Fine Granules 6 g/day, t.i.d.(n=49)

Arm 2: oral administration of one of the commonly used liver protectors.(n=50) Patients were followed for 50 months in both arms.

6. Main outcome measures

Level of aspartate aminotransferase (AST), alanine aminotransferase (ALT), choline esterase (Ch-E), procollagen III peptide (PIIIP), type IV collagen, and hepatitis C virus (HCV)-RNA.

7. Main results

AST and ALT were significantly decreased at 50 months in arm 1, but not in arm 2. Ch-E did not change in arm 1, but decreased significantly in arm 2. Type IV collagen and HCV-RNA decreased significantly in arm 1, and increased significantly in arm 2. Changes in PIIIP were similar to those of type IV collagen.

8. Conclusions

Shosaikoto is effective for the treatment of chronic hepatitis C, and its prevention of the progression to cirrhosis is implied.

9. From Kampo medicine perspective

Patients with “in-sho (陰証, yin pattern)” and “kyo-sho (虚証, deficiency pattern)” were excluded before

the allocation.

10. Safety assessment in the article

None.

11. Abstractor’s comments

This study confirmed the efficacy of shosaikoto for the treatment of chronic hepatitis C.

12. Abstractor and date

参照

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