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To evaluate the effectiveness of (芍薬甘草湯) as premedication for ERCP in suppressing duodenal peristalsis.

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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

100019e

21. Others References

Fujinami H. Assessment of diminished persistalsis using Shakuyakukanzoto (TJ-68) as premedication for endoscopic retrograde cholangiopancreatography (ERCP): randomized placebo-controlled trial. Nikkei

Medical (Supplement) 2010; 8: 34 (in Japanese).

Fujinami H, Kudo T, Nakayama Y, et al. Assessment of diminished peristalsis using Shakuyakukanzoto (TJ-68) as premedication for endoscopic retrograde cholangiopancreatography (ERCP): a randomized, placebo-controlled trial. Gastrointestinal Endoscopy 2010; 71: AB227.

1. Objectives

To evaluate the effectiveness of shakuyakukanzoto (芍 薬 甘 草 湯) as premedication for ERCP in suppressing duodenal peristalsis.

2. Design

Randomized controlled trial (RCT). 3. Setting

No. 3 Department of Internal Medicine, Toyama University Hospital, Japan. 4. Participants

Thirty patients undergoing ERCP (20 males, 10 females; mean age 66.5 years). 5. Intervention

Arm 1: shakuyakukanzoto group: TSUMURA Shakuyakukanzoto (芍薬甘草湯) Extract Granules 5.0 g dissolved in 50 mL warm water (n=10).

Arm 2: anticholinergic group: scopolamine butylbromide solution 20 mg/mL intravenous injection (n=10). Arm 3: placebo group: warm (37°C) water 50 mL (n=10).

The liquids in arm 1 and arm 3 were sprayed directly into the duodenum through an endoscope. 6. Main outcome measures

Assessment by DVD image analysis of the time required to stop peristalsis (RT: seconds) and period of cessation of peristalsis (DT: minutes).

7. Main results

Peristalsis stopped in 8/10 patients in arm 1, 10/10 in arm 2, and 0/10 in arm 3. RT was 76.0±23.9 in arm 1 and 42.4±6.1 in arm 2. DT was 11.3±4.2 in arm 1 and 14.9±5.3 in arm 2. There was no significant difference in RT and DT between these groups.

8. Conclusions

Shakuyakukanzoto is effective as premedication for ERCP in suppressing duodenal peristalsis. Its effects are similar to scopolamine butylbromide solution 20 mg/mL intravenous injection.

9. From Kampo medicine perspective None.

10. Safety assessment in the article Not mentioned.

11. Abstractor’s comments

In clinical terms, this is a highly significant clinical trial because it assessed peristalsis in three groups during actual ERCP. Anticholinergics are generally used to reduce peristaltic action for upper gastrointestinal endoscopy and ERCP, but they are contraindicated for patients with ischemic heart disease, prostatic hypertrophy, glaucoma, etc. Such patients cannot take anticholinergics. Shakuyakukanzoto appears to be a very safe premedication that will reliably suppress peristalsis in such patients.

12. Abstractor and date

参照

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